drug ciprofloxacin 500 mg

خواص دارویی و گیاهی

Generic Name: ciprofloxacin (oral) (SIP roe FLOX a sin)Brand Names: Cipro, Cipro XR, Proquin XR

Medically reviewed by Kaci Durbin, MD Last updated on Dec 13, 2018.

Ciprofloxacin is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body. It is used to treat different types of bacterial infections, including skin infections, bone and joint infections, respiratory or sinus infections, urinary tract infections, and certain types of diarrhea. It is also used to treat gonorrhea.

Ciprofloxacin is also used to treat people who have been exposed to anthrax or certain types of plague.

Ciprofloxacin should be used only for infections that cannot be treated with a safer antibiotic.

Fluoroquinolone antibiotics can cause serious or disabling side effects that may not be reversible, such as tendon rupture or nerve problems.

Ciprofloxacin can cause serious side effects, including tendon problems, nerve damage, serious mood or behavior changes, or low blood sugar.

Stop using this medicine and call your doctor at once if you have symptoms such as: headache, hunger, irritability, numbness, tingling, burning pain, confusion, agitation, paranoia, problems with memory or concentration, thoughts of suicide, or sudden pain or movement problems in any of your joints.

In rare cases, ciprofloxacin may cause damage to your aorta, which could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

You may not be able to use ciprofloxacin if you have a muscle disorder. Tell your doctor if you have a history of myasthenia gravis.

You should not use ciprofloxacin if you are allergic to it, or if:

you also take tizanidine; or

you are allergic to other fluoroquinolones (gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, and others).

You also take theophylline

Ciprofloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles’ tendon of the heel. This can happen during treatment or up to several months after you stop taking this medicine. Tendon problems may be more likely in certain people (children and older adults, or people who use steroid medicine or have had an organ transplant).

To make sure this medicine is safe for you, tell your doctor if you have ever had:

tendon problems, bone problems, arthritis, or other joint problems (especially in children);

blood circulation problems, aneurysm, narrowing or hardening of the arteries;

heart problems, high blood pressure;

a genetic disease such as Marfan syndrome or Ehler’s-Danlos syndrome;

diabetes;

a muscle or nerve disorder, such as myasthenia gravis;

kidney disease;

seizures or epilepsy;

a head injury or brain tumor;

long QT syndrome (in you or a family member); or

low levels of potassium in your blood (hypokalemia).

Do not give this medicine to a child without medical advice.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breast-feed while using this medicine.

Take ciprofloxacin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take ciprofloxacin with or without food, at the same time each day.

Shake the oral suspension (liquid) for 15 seconds before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). Do not give ciprofloxacin oral suspension through a feeding tube.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

Use ciprofloxacin for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. This medicine will not treat a viral infection such as the flu or a common cold.

Do not share ciprofloxacin with another person.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze. Throw away any unused liquid after 14 days.

Ciprofloxacin dosage information (in more detail)

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

drug ciprofloxacin 500 mg

Do not take ciprofloxacin with dairy products such as milk or yogurt, or with calcium- fortified juice. You may eat or drink these products with your meals, but do not use them alone when taking ciprofloxacin. They could make the medication less effective.

Using caffeine while taking ciprofloxacin can increase the effects of the caffeine.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Ciprofloxacin could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Tell your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction to ciprofloxacin (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Ciprofloxacin can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).

Stop taking this medicine and call your doctor at once if you have:

low blood sugar – headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, or feeling anxious or shaky;

nerve symptoms in your hands, arms, legs, or feet – numbness, weakness, tingling, burning pain;

serious mood or behavior changes – nervousness, confusion, agitation, paranoia, hallucinations, memory problems, trouble concentrating, thoughts of suicide; or

signs of tendon rupture – sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

In rare cases, ciprofloxacin may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Also, stop using this medicine and call your doctor at once if you have:

severe stomach pain, diarrhea that is watery or bloody;

fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

the first sign of any skin rash, no matter how mild;

muscle weakness, breathing problems;

little or no urination;

jaundice (yellowing of the skin or eyes); or

increased pressure inside the skull – severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common ciprofloxacin side effects may include:

nausea, vomiting, diarrhea, stomach pain;

vaginal itching or discharge;

headache; or

abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ciprofloxacin side effects (in more detail)

Some medicines can make ciprofloxacin much less effective when taken at the same time. If you take any of the following medicines, take your dose 2 hours before or 6 hours after you take the other medicine.

the ulcer medicine sucralfate, or antacids that contain calcium, magnesium, or aluminum (such as Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, Tums, and others);

didanosine (Videx) powder or chewable tablets;

lanthanum carbonate or sevelamer; or

vitamin or mineral supplements that contain calcium, iron, magnesium, or zinc.

Tell your doctor about all your other medicines, especially:

cyclosporine, methotrexate, metoclopramide, phenytoin, probenecid, ropinirole, sildenafil, or theophylline;

a blood thinner (warfarin, Coumadin, Jantoven);

a diuretic or “water pill”;

heart rhythm medication;

insulin or oral diabetes medicine (check your blood sugar regularly);

medicine to treat depression or mental illness;

steroid medicine (such as prednisone); or

NSAIDs (nonsteroidal anti-inflammatory drugsa>) – ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with ciprofloxacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Ciprofloxacin drug interactions (in more detail)

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use ciprofloxacin only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2019 Cerner Multum, Inc. Version: 22.01.

Medical Disclaimer

Other brands: Cipro, Cipro I.V., Proquin XR

prednisone, amoxicillin, doxycycline, albuterol, ranitidine, metronidazole, clindamycin, cephalexin, Augmentin, azithromycin

Ciprofloxacin reviews

The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices.

Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more.

Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 1 Aug 2019), Cerner Multum™ (updated 1 Aug 2019), Wolters Kluwer™ (updated 31 July 2019) and others.

Third Party Advertising

We comply with the HONcode standard for trustworthy health information – verify here

Copyright © 2000-2019 Drugs.com. All rights reserved.

Medically reviewed by Drugs.com. Last updated on Jan 7, 2019.

Applies to the following strengths: 100 mg; 250 mg; 500 mg; 750 mg; 200 mg/100 mL-5%; 400 mg/200 mL-5%; 250 mg/5 mL; 500 mg/5 mL; 10 mg/mL; 1000 mg

IV: 400 mg IV every 12 hours
Oral: 500 mg orally every 12 hours

Duration of Therapy: 60 days

Comments:
-Therapy should be started as soon as possible after suspected/confirmed exposure.
-Indication based on efficacy studies in animals.

Use: For treatment of inhalational anthrax (postexposure) to reduce incidence/progression of disease after exposure to aerosolized Bacillus anthracis

US CDC Recommendations:
-IV: 400 mg IV every 8 hours
-Oral: 500 mg orally every 12 hours

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection: 60 days

Systemic anthrax:
-With possible/confirmed meningitis: At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
-When meningitis has been excluded: At least 2 weeks or until patient is clinically stable (whichever is longer)
-Patients exposed to aerosolized spores will require prophylaxis to complete an antimicrobial regimen of 60 days from onset of illness.

Cutaneous anthrax without systemic involvement:
-Bioterrorism-related cases: 60 days
-Naturally acquired cases: 7 to 10 days

Comments:
-The preferred drug for pregnant women
-Recommended as a preferred oral drug for postexposure prophylaxis and for the treatment of cutaneous anthrax without systemic involvement
-Recommended as the preferred IV drug for the treatment of systemic anthrax
-Recommended for all strains (regardless of penicillin susceptibility or if susceptibility unknown) when used for postexposure prophylaxis, systemic anthrax when meningitis has been excluded, or cutaneous anthrax without systemic involvement
-Recommended for use with a protein synthesis inhibitor when used for systemic anthrax; the addition of a bactericidal beta-lactam is recommended with possible/confirmed meningitis.
-Systemic anthrax includes anthrax meningitis, inhalation anthrax, injection anthrax, gastrointestinal anthrax, and cutaneous anthrax with systemic involvement, extensive edema, or lesions of the head or neck.
-Current guidelines should be consulted for additional information.

IV: 400 mg IV every 12 hours
Oral: 500 mg orally every 12 hours

Duration of Therapy: 60 days

Comments:
-Therapy should be started as soon as possible after suspected/confirmed exposure.
-Indication based on efficacy studies in animals.

Use: For treatment of inhalational anthrax (postexposure) to reduce incidence/progression of disease after exposure to aerosolized Bacillus anthracis

US CDC Recommendations:
-IV: 400 mg IV every 8 hours
-Oral: 500 mg orally every 12 hours

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection: 60 days

Cutaneous anthrax without systemic involvement:
-Bioterrorism-related cases: 60 days
-Naturally acquired cases: 7 to 10 days

IV: 400 mg IV every 12 hours
Oral: 500 mg orally every 12 hours

Duration of Therapy: 60 days

Comments:
-Therapy should be started as soon as possible after suspected/confirmed exposure.
-Indication based on efficacy studies in animals.

Use: For treatment of inhalational anthrax (postexposure) to reduce incidence/progression of disease after exposure to aerosolized Bacillus anthracis

US CDC Recommendations:
-IV: 400 mg IV every 8 hours
-Oral: 500 mg orally every 12 hours

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection: 60 days

Cutaneous anthrax without systemic involvement:
-Bioterrorism-related cases: 60 days
-Naturally acquired cases: 7 to 10 days

drug ciprofloxacin 500 mg

Empirical therapy: 400 mg IV every 8 hours for 7 to 14 days

Comments:
-Recommended for use with piperacillin (50 mg/kg IV every 4 hours)

Use: In combination with piperacillin, for the treatment of febrile neutropenia

IV: 400 mg IV every 12 hours
Oral: 500 mg orally every 12 hours

Duration of Therapy: 7 to 14 days

Use: In combination with metronidazole, for treatment of complicated intraabdominal infections due to Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy: 4 to 8 weeks

Uses: For treatment of bone and joint infections due to Enterobacter cloacae, Serratia marcescens, or P aeruginosa

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy: 4 to 8 weeks

Uses: For treatment of bone and joint infections due to Enterobacter cloacae, Serratia marcescens, or P aeruginosa

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy: 14 days

Comments:
-Therapy should be started as soon as possible after suspected/confirmed exposure.
-Indication based on efficacy study in animals only.

Uses: For treatment of plague (including pneumonic and septicemic plague) due to Yersinia pestis; for prophylaxis of plague

US CDC Recommendations:
Treatment:
-IV: 400 mg IV every 8 to 12 hours
-Oral: 500 to 750 mg orally twice a day
Duration of Therapy: 10 to 14 days, or until 2 days after fever subsides

Postexposure Prophylaxis: 500 mg orally twice a day for 7 days

Comments:
-Appropriate IV therapy should be started as soon as plague is suspected; may switch to oral therapy once patient improves
-Fluoroquinolones and gentamicin are generally first-line treatments in the US.
-Postexposure prophylaxis is recommended for individuals with known exposure to plague (e.g., close contact with pneumonic plague patient, direct contact with infected body fluids/tissues).
-In pregnant women, IV ciprofloxacin is a preferred agent for treatment and oral ciprofloxacin is a preferred agent for postexposure prophylaxis; postexposure prophylaxis is only recommended when benefits outweigh risks.
-Current guidelines should be consulted for additional information.

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy: 14 days

Comments:
-Therapy should be started as soon as possible after suspected/confirmed exposure.
-Indication based on efficacy study in animals only.

Uses: For treatment of plague (including pneumonic and septicemic plague) due to Yersinia pestis; for prophylaxis of plague

US CDC Recommendations:
Treatment:
-IV: 400 mg IV every 8 to 12 hours
-Oral: 500 to 750 mg orally twice a day
Duration of Therapy: 10 to 14 days, or until 2 days after fever subsides

Postexposure Prophylaxis: 500 mg orally twice a day for 7 days

400 mg IV every 8 hours for 10 to 14 days

Comments:
-Initial empiric treatment with broad-spectrum coverage according to the hospital’s and/or ICU’s antibiogram is recommended if multidrug-resistant organisms are suspected.

Use: For treatment of nosocomial pneumonia due to Haemophilus influenzae or K pneumoniae

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy: 7 to 14 days

Comments:
-This drug is not considered the drug of first choice for the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.
-Since fluoroquinolones (including this drug) have been associated with serious side effects and acute exacerbations of chronic bronchitis (AECB) is self-limiting for some patients, this drug should be saved for treatment of AECB in patients with no alternative treatment options.

Uses: For treatment of lower respiratory tract infections due to E coli, K pneumoniae, E cloacae, P mirabilis, P aeruginosa, H influenzae, H parainfluenzae, or S pneumoniae; for the treatment of AECB due to Moraxella catarrhalis

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy: 7 to 14 days

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy: 7 to 14 days

Use: For treatment of skin and skin structure infections due to E coli, K pneumoniae, E cloacae, P mirabilis, P vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, P aeruginosa, Staphylococcus aureus (methicillin-susceptible), S epidermidis (methicillin-susceptible), or S pyogenes

Infectious Diseases Society of America (IDSA) Recommendations:
Incisional surgical site infection:
-IV: 400 mg IV every 12 hour
-Oral: 750 mg orally every 12 hours

Aeromonas hydrophila necrotizing infection: 400 mg IV every 12 hours

Infection after animal bite:
-IV: 400 mg IV every 12 hour
-Oral: 500 to 750 mg orally every 12 hours

Comments:
-Recommended for use with metronidazole as a combination regimen for treatment of incisional surgical site infections after intestinal or genitourinary tract surgery
-Recommended for use with metronidazole for treatment of incisional surgical site infections after surgery of axilla or perineum; coverage for methicillin-resistant S aureus (MRSA) may be needed.
-In combination with doxycycline, recommended as a preferred IV drug for the treatment of A hydrophila necrotizing infections of the skin, fascia, and muscle
-For animal bites, fluoroquinolones have good activity against Pasteurella multocida but do not provide coverage for MRSA and some anaerobes.
-Current guidelines should be consulted for additional information.

Some Experts Recommend:
-Vibrio vulnificus: 400 mg IV every 12 hours

Comments:
-Recommended for use with ceftazidime (1 to 2 g IV every 8 hours) or cefotaxime (2 g IV every 8 hours)

IV: 400 mg IV every 8 to 12 hours
Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy: 7 to 14 days

Infectious Diseases Society of America (IDSA) Recommendations:
Incisional surgical site infection:
-IV: 400 mg IV every 12 hour
-Oral: 750 mg orally every 12 hours

Aeromonas hydrophila necrotizing infection: 400 mg IV every 12 hours

Infection after animal bite:
-IV: 400 mg IV every 12 hour
-Oral: 500 to 750 mg orally every 12 hours

Some Experts Recommend:
-Vibrio vulnificus: 400 mg IV every 12 hours

Comments:
-Recommended for use with ceftazidime (1 to 2 g IV every 8 hours) or cefotaxime (2 g IV every 8 hours)

500 mg orally every 12 hours for 5 to 7 days

Use: When antibacterial therapy is indicated, for treatment of infectious diarrhea due to E coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii, S dysenteriae, S flexneri, or S sonnei

US CDC, National Institutes of Health (NIH), and HIV Medicine Association of the Infectious Diseases Society of America (HIVMA/IDSA) Recommendations for HIV-Infected Patients:
Shigellosis therapy:
-IV: 400 mg IV every 12 hours
-Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy:
-Bacteremia: At least 14 days
-Gastroenteritis: 7 to 10 days
-Recurrent infections: 2 to 6 weeks

Comments:
-Recommended as preferred therapy (if MIC is less than 0.12 mcg/mL) to shorten duration of illness and to possibly prevent spread to others
-Increased resistance of Shigella to fluoroquinolones reported in the US; treatment of Shigella with fluoroquinolones should be avoided if ciprofloxacin MIC is 0.12 mcg/mL or greater, even if isolate identified as sensitive by laboratory.
-Current guidelines should be consulted for additional information.

500 mg orally every 12 hours for 5 to 7 days

Duration of Therapy:
-Bacteremia: At least 14 days
-Gastroenteritis: 7 to 10 days
-Recurrent infections: 2 to 6 weeks

IV: 400 mg IV every 12 hours
Oral: 500 mg orally every 12 hours

Duration of Therapy: 10 days

Comments:
-Since fluoroquinolones (including this drug) have been associated with serious side effects and acute sinusitis is self-limiting for some patients, this drug should be saved for treatment of acute sinusitis in patients with no alternative treatment options.

Use: For treatment of acute sinusitis due to H influenzae, S pneumoniae, or M catarrhalis

500 mg orally every 12 hours for 10 days

Comments:
-Efficacy in eradicating the chronic typhoid carrier state has not been established.

Use: For treatment of typhoid fever (enteric fever) due to Salmonella typhi

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Patients:
-IV: 400 mg IV every 12 hours
-Oral: 500 to 750 mg orally every 12 hours

Duration of Salmonellosis Therapy:
For gastroenteritis without bacteremia:
-If CD4 count at least 200 cells/mm3: 7 to 14 days
-If CD4 count less than 200 cells/mm3: 2 to 6 weeks

For gastroenteritis with bacteremia:
-If CD4 count at least 200 cells/mm3: 14 days; longer if persistent bacteremia or complicated infection (e.g., metastatic foci of infection present)
-If CD4 count less than 200 cells/mm3: 2 to 6 weeks

Comments:
-Recommended as preferred empiric therapy for bacterial enteric infections (pending diagnostic studies) and as preferred therapy for salmonella gastroenteritis with or without bacteremia
-Empiric therapy for bacterial enteric infections recommended for patients with advanced HIV (CD4 count less than 200 cells/mm3 or concomitant AIDS-defining illnesses) and clinically severe diarrhea (at least 6 liquid stools/day or bloody stool and/or associated fever/chills). Fecal samples should be obtained for diagnostic testing before starting therapy; therapy should be adjusted based on those results.
-All HIV-infected patients with salmonellosis should receive antibiotic therapy; increased risk of bacteremia (by 20- to 100-fold) and mortality (by up to 7-fold) compared to HIV-negative subjects.
-Current guidelines should be consulted for additional information.

500 mg orally every 12 hours for 10 days

Comments:
-Efficacy in eradicating the chronic typhoid carrier state has not been established.

Use: For treatment of typhoid fever (enteric fever) due to Salmonella typhi

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Patients:
-IV: 400 mg IV every 12 hours
-Oral: 500 to 750 mg orally every 12 hours

Duration of Salmonellosis Therapy:
For gastroenteritis without bacteremia:
-If CD4 count at least 200 cells/mm3: 7 to 14 days
-If CD4 count less than 200 cells/mm3: 2 to 6 weeks

500 mg orally every 12 hours for 10 days

Comments:
-Efficacy in eradicating the chronic typhoid carrier state has not been established.

Use: For treatment of typhoid fever (enteric fever) due to Salmonella typhi

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Patients:
-IV: 400 mg IV every 12 hours
-Oral: 500 to 750 mg orally every 12 hours

Duration of Salmonellosis Therapy:
For gastroenteritis without bacteremia:
-If CD4 count at least 200 cells/mm3: 7 to 14 days
-If CD4 count less than 200 cells/mm3: 2 to 6 weeks

IV: 200 to 400 mg IV every 8 to 12 hours for 7 to 14 days

Oral:
Immediate-release: 250 to 500 mg orally every 12 hours for 7 to 14 days

Extended-release:
-Uncomplicated infection (Cipro[R] XR, Proquin[R] XR): 500 mg orally every 24 hours for 3 days
-Complicated infection (Cipro[R] XR): 1000 mg orally every 24 hours for 7 to 14 days

Uses:
-IV, Immediate-release: For treatment of urinary tract infections (UTIs) due to E coli, K pneumoniae, E cloacae, S marcescens, P mirabilis, P rettgeri, M morganii, C koseri, C freundii, P aeruginosa, S epidermidis (methicillin-susceptible), S saprophyticus, or Enterococcus faecalis
-Cipro(R) XR: For the treatment of uncomplicated UTIs due to E coli, P mirabilis, E faecalis, or S saprophyticus; for the treatment of complicated UTIs due to E coli, K pneumoniae, E faecalis, P mirabilis, or P aeruginosa
-Proquin(R) XR: For the treatment of uncomplicated UTIs due to E coli or K pneumoniae

Cipro(R) XR: 1000 mg orally every 24 hours for 7 to 14 days

Use: For the treatment of acute uncomplicated pyelonephritis due to E coli

Immediate-release: 250 mg orally every 12 hours
Extended-release: 500 mg orally every 24 hours

Duration of Therapy: 3 days

Comments:
-Since fluoroquinolones (including this drug) have been associated with serious side effects and acute uncomplicated cystitis/uncomplicated UTI (acute cystitis) is self-limiting for some patients, this drug should be saved for treatment of acute uncomplicated cystitis/uncomplicated UTI (acute cystitis) in patients with no alternative treatment options.

Uses:
-Immediate-release: In female patients, for treatment of acute uncomplicated cystitis due to E coli or S saprophyticus
-Cipro(R) XR: For the treatment of uncomplicated UTI (acute cystitis) due to E coli, P mirabilis, E faecalis, or S saprophyticus
-Proquin(R) XR: For the treatment of uncomplicated UTI (acute cystitis) due to E coli or K pneumoniae

IV: 400 mg IV every 12 hours
Oral: 500 mg orally every 12 hours

Duration of Therapy: 28 days

Use: For treatment of chronic bacterial prostatitis due to E coli or P mirabilis

250 mg orally once

Uses: For treatment of uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae

US CDC Recommendations:
-Due to high rates of resistance, fluoroquinolones are not recommended for treatment of gonococcal infections in the US; dual therapy with ceftriaxone and azithromycin is the recommended regimen for treatment of gonorrhea in the US.
-Antimicrobial susceptibility patterns should be monitored.
-The patient’s sexual partner(s) should also be evaluated/treated.
-Current guidelines should be consulted for additional information.

US CDC Recommendations: 500 mg orally once

IDSA Recommendations:
-Mild to moderate illness: 750 mg orally twice a day for at least 14 days

Working Group on Civilian Biodefense Recommendations for Management of Tularemia Used as a Biological Weapon:
-IV: 400 mg IV twice a day for 10 days
-Oral: 500 mg orally twice a day for 14 days

Comments:
-May switch to oral therapy when clinically indicated
-Recommended as an alternative IV drug for treatment of tularemia in a contained casualty setting; recommended as an alternative agent in pregnant women
-Recommended as a preferred oral drug for treatment of tularemia in a mass casualty setting and for postexposure prophylaxis; recommended as a preferred agent in pregnant women
-Current guidelines should be consulted for additional information.

US CDC Recommendations: 500 mg orally twice a day for 3 days

Comments:
-Alternative therapy recommended during pregnancy and lactation.
-The patient’s sexual partner(s) should also be evaluated/treated.
-Current guidelines should be consulted for additional information.

US CDC Recommendations: 750 mg orally twice a day
Duration of Therapy: At least 3 weeks and until all lesions have completely healed

Comments:
-Recommended as an alternative regimen
-The patient’s sexual partner(s) should also be evaluated/treated.
-Current guidelines should be consulted for additional information.

American Society of Health-System Pharmacists (ASHP), IDSA, Surgical Infection Society (SIS), and Society for Healthcare Epidemiology of America (SHEA) Recommendations:
-Preoperative dose: 400 mg IV once, starting within 120 minutes before surgical incision

Comments:
-A single prophylactic dose is usually sufficient; if prophylaxis is continued postoperatively, duration should be less than 24 hours.
-Readministration may be needed for unusually long procedures to ensure adequate serum and tissue drug levels.
-Redosing may be needed if drug half-life is shortened (e.g., extensive burns) or if prolonged/excessive bleeding during surgery; redosing may not be needed if drug half-life is prolonged (e.g., renal dysfunction).
-Before use, local susceptibility should be reviewed due to increasing resistance of E coli to fluoroquinolones.
-Coadministration with other agents may be recommended, depending on type of procedure.
-Current guidelines should be consulted for additional information.

Uses: For surgical prophylaxis for the following procedures:
-Gastroduodenal (as part of an alternative regimen): Procedures involving entry into lumen of gastrointestinal tract (bariatric, pancreaticoduodenectomy); Procedures without entry into gastrointestinal tract (antireflux, highly selective vagotomy) for high-risk patients
-Biliary tract (as part of an alternative regimen): Open procedure; elective, high-risk laparoscopic procedure
-Appendectomy (as part of an alternative regimen): Uncomplicated appendicitis
-Small intestine (as part of an alternative regimen): Nonobstructed; obstructed
-Colorectal (as part of an alternative regimen)
-Hysterectomy (as part of an alternative regimen): Vaginal or abdominal
-Urologic: Lower tract instrumentation with risk factors for infection, including transrectal prostate biopsy (recommended regimen); clean with entry into urinary tract or clean-contaminated (as part of an alternative regimen)
-Transplantation (as part of an alternative regimen): Liver; pancreas; pancreas-kidney

IV: 10 mg/kg IV every 12 hours
Maximum dose: 400 mg/dose

Oral: 15 mg/kg orally every 12 hours
Maximum dose: 500 mg/dose

Recommended dose of the 5% oral suspension using the co-packaged graduated spoon:
-Weight 9 to 12 kg: 125 mg orally every 12 hours
-Weight 13 to 18 kg: 250 mg orally every 12 hours
-Weight 19 to 24 kg: 250 to 375 mg orally every 12 hours
-Weight at least 25 kg: 500 mg orally every 12 hours

Recommended dose of the 10% oral suspension using the co-packaged graduated spoon:
-Weight 13 to 24 kg: 250 mg orally every 12 hours
-Weight at least 25 kg: 500 mg orally every 12 hours

Total Duration of Therapy: 60 days

Comments:
-Therapy should be started as soon as possible after suspected/confirmed exposure.
-Indication based on efficacy studies in animals.

Use: For treatment of inhalational anthrax (postexposure) to reduce incidence/progression of disease after exposure to aerosolized B anthracis

American Academy of Pediatrics Recommendations:
Up to 4 weeks of age:
-Gestational age 32 to 37 weeks: 10 mg/kg orally or IV every 12 hours
-Term neonate: 15 mg/kg orally or IV every 12 hours

1 month or older:
IV: 10 mg/kg IV every 8 hours
Maximum dose: 400 mg/dose

Oral: 15 mg/kg orally every 12 hours
Maximum dose: 500 mg/dose

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection (all ages): 60 days after exposure

Systemic anthrax:
-Severe anthrax (up to 4 weeks of age): At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
-With possible/confirmed meningitis (1 month or older): At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
-When meningitis has been excluded (1 month or older): At least 14 days or until patient is clinically stable (whichever is longer)
-Patients will require prophylaxis to complete an antimicrobial regimen of up to 60 days from onset of illness.

Cutaneous anthrax without systemic involvement:
-Bioterrorism-related cases: To complete an antimicrobial regimen of up to 60 days from onset of illness
-Naturally acquired cases: 7 to 10 days

Follow-up for severe anthrax: To complete a regimen of 10 to 14 days or longer (up to 4 weeks of age) or to complete a regimen of 14 days or longer (1 month or older)
-Patients may require prophylaxis to complete an antimicrobial regimen of up to 60 days from onset of illness.

Comments:
-Recommended as the preferred oral drug for postexposure prophylaxis and for the treatment of cutaneous anthrax without systemic involvement
-Recommended as the preferred IV drug for the treatment of systemic/severe anthrax (including follow-up)
-Recommended for all strains (regardless of penicillin susceptibility or if susceptibility unknown) when used for postexposure prophylaxis, systemic/severe anthrax when meningitis has been excluded, follow-up therapy for severe anthrax, or cutaneous anthrax without systemic involvement
-Recommended for use with a protein synthesis inhibitor when used for systemic anthrax (including follow-up); the addition of a bactericidal beta-lactam (all patients) or a bactericidal glycopeptide (patients 1 month or older) is recommended with possible/confirmed meningitis.
-Systemic/severe anthrax includes anthrax meningitis, inhalation anthrax, injection anthrax, gastrointestinal anthrax, and cutaneous anthrax with systemic involvement, extensive edema, or lesions of the head or neck.
-Current guidelines should be consulted for additional information.

IV: 10 mg/kg IV every 12 hours
Maximum dose: 400 mg/dose

Oral: 15 mg/kg orally every 12 hours
Maximum dose: 500 mg/dose

Recommended dose of the 10% oral suspension using the co-packaged graduated spoon:
-Weight 13 to 24 kg: 250 mg orally every 12 hours
-Weight at least 25 kg: 500 mg orally every 12 hours

Total Duration of Therapy: 60 days

Comments:
-Therapy should be started as soon as possible after suspected/confirmed exposure.
-Indication based on efficacy studies in animals.

Use: For treatment of inhalational anthrax (postexposure) to reduce incidence/progression of disease after exposure to aerosolized B anthracis

American Academy of Pediatrics Recommendations:
Up to 4 weeks of age:
-Gestational age 32 to 37 weeks: 10 mg/kg orally or IV every 12 hours
-Term neonate: 15 mg/kg orally or IV every 12 hours

1 month or older:
IV: 10 mg/kg IV every 8 hours
Maximum dose: 400 mg/dose

Oral: 15 mg/kg orally every 12 hours
Maximum dose: 500 mg/dose

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection (all ages): 60 days after exposure

Cutaneous anthrax without systemic involvement:
-Bioterrorism-related cases: To complete an antimicrobial regimen of up to 60 days from onset of illness
-Naturally acquired cases: 7 to 10 days

IV: 10 mg/kg IV every 12 hours
Maximum dose: 400 mg/dose

Oral: 15 mg/kg orally every 12 hours
Maximum dose: 500 mg/dose

Recommended dose of the 10% oral suspension using the co-packaged graduated spoon:
-Weight 13 to 24 kg: 250 mg orally every 12 hours
-Weight at least 25 kg: 500 mg orally every 12 hours

Total Duration of Therapy: 60 days

Comments:
-Therapy should be started as soon as possible after suspected/confirmed exposure.
-Indication based on efficacy studies in animals.

Use: For treatment of inhalational anthrax (postexposure) to reduce incidence/progression of disease after exposure to aerosolized B anthracis

American Academy of Pediatrics Recommendations:
Up to 4 weeks of age:
-Gestational age 32 to 37 weeks: 10 mg/kg orally or IV every 12 hours
-Term neonate: 15 mg/kg orally or IV every 12 hours

1 month or older:
IV: 10 mg/kg IV every 8 hours
Maximum dose: 400 mg/dose

Oral: 15 mg/kg orally every 12 hours
Maximum dose: 500 mg/dose

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection (all ages): 60 days after exposure

Cutaneous anthrax without systemic involvement:
-Bioterrorism-related cases: To complete an antimicrobial regimen of up to 60 days from onset of illness
-Naturally acquired cases: 7 to 10 days

1 year or older:
IV: 6 to 10 mg/kg IV every 8 hours
Maximum dose: 400 mg/dose

Oral: 10 to 20 mg/kg orally every 12 hours
Maximum dose: 750 mg/dose

Recommended dose of the 10% oral suspension using the co-packaged graduated spoon:
-Weight 13 to 24 kg: 250 mg orally every 12 hours
-Weight 25 kg: 250 to 500 mg orally every 12 hours
-Weight 26 to 37 kg: 500 mg orally every 12 hours
-Weight at least 38 kg: 500 to 750 mg orally every 12 hours

Total Duration of Therapy: 10 to 21 days

Comments:
-Dose and initial route of therapy should be based on severity of infection.
-Due to an increased incidence of side effects compared to controls (including those related to joints and/or surrounding tissues), this drug is not a drug of first choice in pediatric patients.

Uses: For treatment of complicated UTIs and pyelonephritis due to E coli

1 year or older:
IV: 6 to 10 mg/kg IV every 8 hours
Maximum dose: 400 mg/dose

Oral: 10 to 20 mg/kg orally every 12 hours
Maximum dose: 750 mg/dose

Total Duration of Therapy: 10 to 21 days

Uses: For treatment of complicated UTIs and pyelonephritis due to E coli

IV: 10 mg/kg IV every 8 to 12 hours
Maximum dose: 400 mg/dose

Oral: 15 mg/kg orally every 8 to 12 hours
Maximum dose: 500 mg/dose

Recommended dose of the 5% oral suspension using the co-packaged graduated spoon:
-Weight 9 to 12 kg: 125 mg orally every 8 to 12 hours
-Weight 13 to 18 kg: 250 mg orally every 8 to 12 hours
-Weight 19 to 24 kg: 250 to 375 mg orally every 8 to 12 hours
-Weight 25 to 31 kg: 375 to 500 mg orally every 8 to 12 hours
-Weight 32 to 37 kg: 375 to 625 mg orally every 8 to 12 hours
-Weight at least 38 kg: 500 to 750 mg orally every 8 to 12 hours
Maximum dose: 1500 mg/day

Recommended dose of the 10% oral suspension using the co-packaged graduated spoon:
-Weight 13 to 24 kg: 250 mg orally every 8 to 12 hours
-Weight 25 kg: 250 to 500 mg orally every 8 to 12 hours
-Weight 26 to 37 kg: 500 mg orally every 8 to 12 hours
-Weight at least 38 kg: 500 to 750 mg orally every 8 to 12 hours
Maximum dose: 1500 mg/day

Total Duration of Therapy: 10 to 21 days

Comments:
-Therapy should be started as soon as possible after suspected/confirmed exposure to Y pestis.
-Indication based on efficacy study in animals only.

Uses: For treatment of plague (including pneumonic and septicemic plague) due to Y pestis; for prophylaxis of plague

US CDC Recommendations:
Treatment:
-IV: 15 mg/kg IV every 12 hours
—Maximum dose: 400 mg/dose
-Oral: 20 mg/kg orally every 12 hours
—Maximum dose: 500 mg/dose
Duration of Therapy: 10 to 14 days, or until 2 days after fever subsides

Postexposure Prophylaxis: 20 mg/kg orally twice a day for 7 days
-Maximum dose: 1000 mg/day

IV: 10 mg/kg IV every 8 to 12 hours
Maximum dose: 400 mg/dose

Oral: 15 mg/kg orally every 8 to 12 hours
Maximum dose: 500 mg/dose

Total Duration of Therapy: 10 to 21 days

Comments:
-Therapy should be started as soon as possible after suspected/confirmed exposure to Y pestis.
-Indication based on efficacy study in animals only.

Uses: For treatment of plague (including pneumonic and septicemic plague) due to Y pestis; for prophylaxis of plague

Postexposure Prophylaxis: 20 mg/kg orally twice a day for 7 days
-Maximum dose: 1000 mg/day

Working Group on Civilian Biodefense Recommendations for Management of Tularemia Used as a Biological Weapon:
-IV: 15 mg/kg IV twice a day for 10 days
—Maximum dose: 400 mg/dose
-Oral: 15 mg/kg orally twice a day for 14 days
—Maximum dose: 500 mg/dose

Comments:
-May switch to oral therapy when clinically indicated
-Recommended as an alternative IV drug for treatment of tularemia in a contained casualty setting
-Recommended as a preferred oral drug for treatment of tularemia in a mass casualty setting and for postexposure prophylaxis
-Current guidelines should be consulted for additional information.

drug ciprofloxacin 500 mg

ASHP, IDSA, SIS, and SHEA Recommendations:
1 year or older:
Preoperative dose: 10 mg/kg IV once, starting within 120 minutes before surgical incision
Maximum dose: 400 mg/dose

Comments:
-A single prophylactic dose is usually sufficient; if prophylaxis is continued postoperatively, duration should be less than 24 hours.
-Readministration may be needed for unusually long procedures to ensure adequate serum and tissue drug levels.
-Redosing may be needed if drug half-life is shortened (e.g., extensive burns) or if prolonged/excessive bleeding during surgery; redosing may not be needed if drug half-life is prolonged (e.g., renal dysfunction).
-Before use, local susceptibility should be reviewed due to increasing resistance of E coli to fluoroquinolones.
-Coadministration with other agents may be recommended, depending on type of procedure.
-Pediatric dose should not exceed adult dose.
-Current guidelines should be consulted for additional information.

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Adolescents:
Shigellosis therapy:
-IV: 400 mg IV every 12 hours
-Oral: 500 to 750 mg orally every 12 hours

Duration of Therapy:
-Bacteremia: At least 14 days
-Gastroenteritis: 7 to 10 days
-Recurrent infections: 2 to 6 weeks

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Adolescents:
-IV: 400 mg IV every 12 hours
-Oral: 500 to 750 mg orally every 12 hours

Duration of Salmonellosis Therapy:
For gastroenteritis without bacteremia:
-If CD4 count at least 200 cells/mm3: 7 to 14 days
-If CD4 count less than 200 cells/mm3: 2 to 6 weeks

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Adolescents:
-IV: 400 mg IV every 12 hours
-Oral: 500 to 750 mg orally every 12 hours

Duration of Salmonellosis Therapy:
For gastroenteritis without bacteremia:
-If CD4 count at least 200 cells/mm3: 7 to 14 days
-If CD4 count less than 200 cells/mm3: 2 to 6 weeks

Study (n=67)
5 years or older: 10 mg/kg IV every 8 hours for 1 week followed by 20 mg/kg orally every 12 hours
Total Duration of Therapy: 10 to 21 days

Comments:
-Efficacy for the treatment of acute pulmonary exacerbations in pediatric cystic fibrosis patients has not been established.

Adult Patients:
IV:
-CrCl 5 to 29 mL/min: 200 to 400 mg IV every 18 to 24 hours

Oral:
Immediate-release:
-CrCl 30 to 50 mL/min: 250 to 500 mg orally every 12 hours
-CrCl 5 to 29 mL/min: 250 to 500 mg orally every 18 hours

Extended-release:
Cipro(R) XR:
-CrCl 30 mL/min or less: 500 mg orally every 24 hours

Proquin(R) XR:
-Mild to moderate renal dysfunction: No adjustment recommended.
-Severe renal dysfunction: Data not available

Pediatric Patients:
-CrCl less than 50 mL/min: Data not available

Comments:
-Patients with severe infections and severe renal dysfunction may be given an oral dose of 750 mg (immediate-release) at the intervals noted above.
-Patients with severe infections and severe renal dysfunction should be monitored carefully.

Data not available

US BOXED WARNING:
SERIOUS SIDE EFFECTS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CNS EFFECTS, AND EXACERBATION OF MYASTHENIA GRAVIS:
-Fluoroquinolones (including this drug) have been associated with disabling and potentially irreversible serious side effects that have occurred together (including tendinitis and tendon rupture, peripheral neuropathy, CNS effects). This drug should be discontinued immediately and use of fluoroquinolones (including this drug) should be avoided in patients with any of these serious side effects.
-Fluoroquinolones (including this drug) may exacerbate muscle weakness in patients with myasthenia gravis. This drug should be avoided in patients with known history of myasthenia gravis.
-Since fluoroquinolones (including this drug) have been associated with serious side effects, this drug should be reserved for use in patients with no alternative treatment options for acute exacerbation of chronic bronchitis, acute uncomplicated cystitis/uncomplicated urinary tract infections (acute cystitis), or acute sinusitis.

CONTRAINDICATIONS:
History of hypersensitivity to the active component, other quinolones, or any of the ingredients; coadministration with tizanidine

Extended-release tablets: Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Hemodialysis, peritoneal dialysis:
Adult Patients:
IV: Data not available

Oral:
Immediate-release: 250 to 500 mg orally every 24 hours

Extended-release:
-Cipro(R) XR: 500 mg orally every 24 hours
-Proquin(R) XR: Data not available

Pediatric Patients: Data not available

Comments:
-Dose should be administered after dialysis.

Administration advice:
-Infuse IV doses over at least 60 minutes; slow infusion of dilute solution into larger vein will minimize patient discomfort and reduce risk of venous irritation.
-May switch from IV to oral therapy when clinically indicated at the physician’s discretion
-May administer immediate-release tablets and oral suspension and Cipro(R) XR without regard to meals; administer Proquin(R) XR with a main meal, preferably the evening meal.
-In general, continue this drug (immediate-release) for at least 2 days after signs/symptoms of infection have disappeared, except for inhalation anthrax (postexposure).
-Swallow extended-release tablets whole; do not split, crush, or chew.
-Shake the oral suspension vigorously for about 15 seconds before each dose.
-Use the co-packaged graduated spoon to administer the oral suspension; after use, clean under running water with dish detergent and dry thoroughly.
-Swallow the microcapsules in the oral suspension whole; do not chew. May take water afterwards
-Do not administer the oral suspension through feeding or nasogastric tubes.
-May administer oral doses with meals that include dairy products (like milk, yogurt) or calcium-fortified juices; do not administer with such products alone.
-Administer oral doses at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (e.g., sevelamer, lanthanum carbonate), sucralfate, buffered didanosine, other highly buffered drugs, or other products containing calcium, iron, or zinc; administer Proquin(R) XR at least 4 hours before or 2 hours after such products.
-To determine dose and duration, consider the nature and severity of the infection, pathogen susceptibility, integrity of patient’s host-defense mechanisms, and renal and liver function status; may administer this drug to adult patients when clinically indicated at physician’s discretion.
-Maintain adequate hydration of patients to prevent formation of highly-concentrated urine.

Storage requirements:
-IV injection: Store between 5C to 25C (41F to 77F); protect from light; avoid excessive heat; protect from freezing.
-Oral formulations: Store at 20C to 25C (68C to 77F); excursions permitted to 15C to 30C (59F to 86F). Protect oral suspension from freezing; discard reconstituted suspension after 14 days.

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.

General:
-Unless otherwise specified, the dose provided is for immediate-release formulations.
-In patients younger than 18 years, this drug is only US FDA-approved for complicated UTIs, prevention of inhalation anthrax (postexposure), and plague.
-Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.
-Appropriate culture and susceptibility testing recommended before therapy to isolate and identify infecting organisms and to establish susceptibility to this drug. Therapy may be started before test results are known; appropriate therapy should be continued when results are available.
-If suspected pathogens include anaerobic organisms, appropriate therapy should be used.
-Some isolates of P aeruginosa may develop resistance relatively quickly during therapy.
-The 10% oral suspension is not appropriate for children less than 13 kg.
-Nothing should be added to the mixed final oral suspension.
-The extended-release tablets are not interchangeable with immediate-release tablets or oral suspension; extended-release tablets made by different manufacturers are not interchangeable due to different pharmacokinetics (e.g., Cipro[R] XR and Proquin[R] XR).

Monitoring:
-Infections/Infestations: Culture and susceptibility (periodically during therapy); syphilis serology in gonorrhea patients (at diagnosis and 3 months after therapy)
-Renal: Renal function in elderly patients

Patient advice:
-Read the US FDA-approved patient labeling (Medication Guide).
-Drink plenty of fluids.
-Avoid missing doses and complete the entire course of therapy.
-Stop this drug immediately and contact healthcare provider if a serious side effect occurs.
-Seek medical attention immediately in an emergency room or call 911 if sudden, severe, constant pain in the stomach, chest, or back occurs.
-Stop this drug and contact healthcare provider if tendon pain, swelling, or inflammation develops or you have weakness or are unable to use 1 of your joints; rest and do not exercise. If your child has any joint-related problems during or after therapy, contact your child’s physician.
-Stop this drug at once and contact physician if symptoms of peripheral neuropathy develop.
-Contact physician if persistent headache (with or without blurred vision), any symptoms of muscle weakness (including respiratory problems) or QT interval prolongation (including prolonged heart palpitations, loss of consciousness), signs/symptoms of liver injury, or watery and bloody stools occur.
-Stop this drug at first sign of skin rash, hives or other skin reactions, rapid heartbeat, problems swallowing or breathing, swelling suggestive of angioedema, or other symptoms of allergic reaction.
-Do not drive, operate machinery, or engage in other tasks that require mental alertness or coordination until you know how the drug affects you.
-Avoid or minimize exposure to natural or artificial sunlight; use sun protection (e.g., protective clothing, sunscreen) if sun exposure cannot be avoided. Contact physician if sunburn-like reaction or skin eruption develops.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Other brands: Cipro, Cipro XR, Cipro I.V., Proquin XR

prednisone, amoxicillin, doxycycline, albuterol, ranitidine, metronidazole, ciprofloxacin, clindamycin, cephalexin, Augmentin

Ciprofloxacin reviews

The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices.

Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more.

Third Party Advertising

We comply with the HONcode standard for trustworthy health information – verify here

Copyright © 2000-2019 Drugs.com. All rights reserved.

Medically reviewed by Drugs.com. Last updated on Feb 10, 2019.

Commonly reported side effects of ciprofloxacin include: pyelonephritis, arthralgia, and musculoskeletal signs and symptoms. Other side effects include: myalgia, and pain. See below for a comprehensive list of adverse effects.

Applies to ciprofloxacin: oral powder for suspension, oral tablet

Other dosage forms:

Oral route (Tablet; Tablet, Extended Release; Suspension)

drug ciprofloxacin 500 mg

Fluoroquinolones, including ciprofloxacin, are associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue ciprofloxacin and avoid use of fluoroquinolones in patients with these serious adverse reactions. Reserve use of ciprofloxacin for patients with no alternative treatment options for an uncomplicated UTI. Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid in patients with known history of myasthenia gravis.

Oral route (Suspension; Tablet, Extended Release; Tablet)

Fluoroquinolones, including ciprofloxacin, are associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue ciprofloxacin and avoid use of fluoroquinolones in patients with these serious adverse reactions. Reserve use of ciprofloxacin for patients with no alternative treatment options for an acute exacerbation of chronic bronchitis or acute sinusitis. Fluoroquinolones, including ciprofloxacin hydrochloride, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid in patients with known history of myasthenia gravis.

Along with its needed effects, ciprofloxacin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ciprofloxacin:

Some side effects of ciprofloxacin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Applies to ciprofloxacin: intravenous solution, oral powder for reconstitution, oral tablet, oral tablet extended release

The most common side effects (from clinical trials of all formulations, doses, durations of therapy, and indications) were nausea, diarrhea, abnormal liver function tests, vomiting, and rash. The most common side effects reported with the IV formulation were nausea, diarrhea, vomiting, injection and infusion site reactions, rash, and increased transaminases (transient).[Ref]

Antibiotic-associated colitis with possible fatal outcome was reported very rarely.

The onset of pseudomembranous colitis symptoms has been reported during or after antimicrobial treatment.[Ref]

Common (1% to 10%): Nausea, diarrhea, vomiting, dyspepsia

Uncommon (0.1% to 1%): Abdominal pains/discomfort, gastrointestinal (GI) pains, flatulence

Rare (0.01% to 0.1%): Elevated amylase, antibiotic-associated colitis, pancreatitis

Frequency not reported: Clostridium difficile-associated diarrhea, constipation, GI bleeding, ileus, intestinal perforation, dry mouth, oral ulceration, epigastric pain, dysphagia, elevated lipase, painful oral mucosa, heartburn, acid reflux, aggravated irritable bowel syndrome, lower abdominal pain

Postmarketing reports: GI candidiasis, oral candidiasis, pseudomembranous colitis[Ref]

Photosensitivity was seen most often when patients were exposed to intense sun (e.g., as when used to treat or prevent travelers’ diarrhea).

A 27-year-old woman with mild systemic erythematosus developed toxic epidermal necrolysis (TEN) after starting a second oral course of this drug after a prior 5-day course. She developed a rash, high fever, and diarrhea after taking the 2nd dose and presented with diffuse rash, epidermal sloughing of 60% of the skin, desquamation of the lips, shock, and respiratory distress. She died on the 28th hospital day of TEN, right ventricular failure, and acute respiratory distress syndrome. As of 2003, 9 cases of TEN, including 5 fatalities, had been reported in the literature.

Erythema nodosum, Stevens-Johnson syndrome (potentially life-threatening), and TEN (potentially life-threatening) have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Pruritus, urticaria

Rare (0.01% to 0.1%): Angioedema, photosensitivity reactions, sweating/hyperhidrosis, petechiae, blistering

Very rare (less than 0.01%): Erythema multiforme, erythema nodosum, Stevens-Johnson syndrome (potentially life-threatening), toxic epidermal necrolysis (potentially life-threatening)

Frequency not reported: Exfoliative dermatitis, purpura, burning, phototoxicity reaction, dry skin, maculopapular rash, skin disorder, vesiculobullous rash, erythema, hyperpigmentation, cutaneous candidiasis, bullous pemphigoid, vesicles, lobular panniculitis, photoinduced acute exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS)

Postmarketing reports: Acute generalized exanthematous pustulosis, fixed eruption[Ref]

Seizures have been reported in 2 patients given this drug and foscarnet. The temporal association between the onset of seizures and drug administration suggests a possible drug interaction; causal relationship was not established in either case. Both drugs are individually epileptogenic; concurrent use may potentiate risk of seizures.

Cases of sensory or sensorimotor axonal polyneuropathy (affecting small and/or large axons) resulting in paresthesias, hypoesthesias, dysesthesias, and weakness have been reported.

One survey reported 11 cases of peripheral neuropathy associated with this drug. The severity ranged from mild and reversible to severe and persistent. In 1 case, a 44-year-old female developed numbness, allodynia, hypoesthesia, tremors, electrical and diffuse burning sensations, twitching, disorientation, visual impairment, nausea, temperature intolerance, rash, and palpitations; she remained disabled after 29 months.

Nystagmus, anosmia, hyperesthesia, hypoesthesia, hypertonia, intracranial hypertension, and exacerbation of myasthenia gravis have also been reported during postmarketing experience.[Ref]

drug ciprofloxacin 500 mg

Common (1% to 10%): Headache, dizziness/lightheadedness, central nervous system disturbance

Uncommon (0.1% to 1%): Sleep disorders, taste disorders, seizures (including status epilepticus), dysesthesia, paresthesia, vertigo, hearing loss

Rare (0.01% to 0.1%): Syncope, hypoesthesia, tremor, tinnitus, migraine, olfactory nerve disorders, smell disorders, hearing impaired

Very rare (less than 0.01%): Disturbed coordination, intracranial hypertension, benign intracranial hypertension/pseudotumor cerebri, exacerbation of myasthenia gravis, hyperesthesia

Frequency not reported: Unresponsiveness, ataxia, hypertonia, anosmia, nystagmus, taste perversion/bad taste, somnolence/drowsiness, incoordination, disturbance in attention, dyskinesia, myasthenia gravis, paresis, aseptic meningitis, cerebral thrombosis, grand mal convulsion, dysphasia, lethargy, sensory axonal polyneuropathy, sensorimotor axonal polyneuropathy

Postmarketing reports: Taste loss, peripheral neuropathy (may be irreversible), polyneuropathy[Ref]

Pancytopenia (life-threatening or fatal outcome) and bone marrow depression (life-threatening) were reported very rarely; also reported during postmarketing experience.

Increased INR was reported in patients treated with vitamin K antagonists.[Ref]

Common (1% to 10%): Eosinophilia

Uncommon (0.1% to 1%): Thrombocytopenia, thrombocythemia

Rare (0.01% to 0.1%): Leukopenia, anemia, neutropenia, leukocytosis, pancytopenia, bone marrow depression, abnormal prothrombin level

Very rare (less than 0.01%): Hemolytic anemia, agranulocytosis

Frequency not reported: Decreased hematocrit, decreased platelet counts, increased platelet counts, prolonged prothrombin time, decreased prothrombin, bleeding diathesis, decreased hemoglobin, decreased leukocyte count, increased atypical lymphocyte count, immature WBCs, increased blood monocytes, elevated sedimentation rate, elevated eosinophil counts, lymphadenopathy

Postmarketing reports: Methemoglobinemia, increased INR, prothrombin time prolonged or decreased[Ref]

Liver necrosis very rarely progressed to life-threatening hepatic failure. Liver necrosis and hepatic failure (including fatal cases) have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Abnormal liver function tests, increased transaminases

Uncommon (0.1% to 1%): Elevated bilirubin, hepatic impairment, cholestatic icterus/cholestatic jaundice, jaundice

Rare (0.01% to 0.1%): Hepatitis, liver necrosis

Very rare (less than 0.01%): Hepatic failure

Frequency not reported: Elevated AST, elevated ALT, elevated GGT[Ref]

Common (1% to 10%): Restlessness

Uncommon (0.1% to 1%): Psychomotor hyperactivity/agitation, confusion, disorientation, hallucinations

Rare (0.01% to 0.1%): Anxiety reaction, abnormal dreams, depression, psychotic reactions

Frequency not reported: Depersonalization, insomnia, manic reaction, nightmares, paranoia, phobia, toxic psychosis, nervousness, self-injurious behavior, suicidal ideations/thoughts, attempted suicide, completed suicide, catatonia, mania (including hypomania)

Postmarketing reports: Delirium[Ref]

Depression and psychotic reactions (both potentially culminating in self-injurious behavior such as suicidal ideations/thoughts and attempted or completed suicide) have been reported.

Agitation, confusion, and toxic psychosis have also been reported during postmarketing experience.[Ref]

Crystalluria has been reported in patients with alkaline urine and did not necessarily lead to nephrotoxicity. At physiological urinary pH, the risk of crystalluria was considered minor.

Vaginal candidiasis has also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Vaginal candidiasis

Rare (0.01% to 0.1%): Hematuria, crystalluria

Frequency not reported: Albuminuria, cylindruria, frequent urination, hemorrhagic cystitis, vaginitis, dysmenorrhea, candiduria, polyuria, urethral bleeding, urinary retention, urinary tract infection, fungal vaginosis, bacterial vaginitis, dysuria, abnormal urine odor, female genital pruritus, vaginal infection, urinary frequency, micturition urgency, vaginal pruritus[Ref]

Local IV site reactions occurred more often if the infusion time was 30 minutes or less. These reactions have appeared as local skin reactions and resolved quickly when infusion was completed.

Injection site irritation and induration have been reported with IV infusion time 30 minutes or less (instead of the recommended 1 hour) or when a small vein in the back of the hand was used.[Ref]

Common (1% to 10%): Local IV site reactions, injection and infusion site reactions (e.g., phlebitis, thrombophlebitis)

Frequency not reported: Injection site irritation and induration with IV infusion[Ref]

Uncommon (0.1% to 1%): Musculoskeletal pain (e.g., extremity pain, back pain, chest pain), arthralgia

Rare (0.01% to 0.1%): Myalgia, arthritis, increased muscle tone and cramping, tendon rupture (mainly Achilles tendon)

Very rare (less than 0.01%): Tendinitis, muscular weakness

Frequency not reported: Arthropathy (including suspected reversible cases), joint stiffness, elevated serum creatine phosphokinase, abnormal joint exam, joint sprains, arthrosis, bone pain, decreased range of motion in a joint (knee, elbow, ankle, hip, wrist, shoulder), jaw pain, neck pain, gout flare-up, joint swelling, muscle spasms, night cramps, knee inflammation

Postmarketing reports: Myoclonus, myasthenia, twitching[Ref]

Arthropathy has primarily been a concern in pediatric patients; however, at least 1 case was described in an adult cystic fibrosis patient receiving this drug. Although cystic fibrosis arthropathy and hypertrophic pulmonary osteoarthropathy typically occur in 7% to 8% of cystic fibrosis adults and adolescents, the arthropathy exhibited in this patient did not resemble either. Several elements in its presentation strongly supported the diagnosis of ciprofloxacin-induced arthropathy, such as: a consistent time of onset with other reported cases of suspected quinolone-induced arthropathy (usually 3 weeks after starting therapy); a lack of history of arthralgia in the patient; reoccurrence upon rechallenge; and resolution of symptoms upon discontinuation of therapy (usually 2 weeks after therapy stopped).

Tendinitis with subsequent tendon rupture has been documented in numerous case reports. One patient with chronic renal failure developed bilateral Achilles tendon rupture after 4 days of ciprofloxacin therapy. Although renal transplant patients and those with end-stage renal disease tend to have an increased risk of Achilles tendinitis and rupture over the general population, quinolone use has been shown to further increase that risk (12% in quinolone-treated patients versus 7% in nonquinolone-treated patients).

As of October 1994, 25 cases of Achilles tendon rupture had been reported to the US FDA. Some ruptures have also occurred in the hand or shoulder. Other risk factors identified included age and corticosteroid use.

There had been 23 reports of tendinitis submitted to the Australian Adverse Drug Reactions Committee (ADRAC) between 2006 and 2008, including reports of Achilles tendinitis, tendon rupture, and tendon pain and swelling. The reports were primarily in male patients (15 cases) older than 56 years who used this drug for 2 to 14 days. In 19 of the reported cases, a fluoroquinolone (generally ciprofloxacin) was the primary suspect; however, details of concomitant serious medical conditions were not documented in most of the reports.

Musculoskeletal side effects reported in pediatric patients included arthralgia, abnormal gait, abnormal joint exam, joint sprains, leg pain, back pain, arthrosis, bone pain, pain, myalgia, arm pain, and decreased range of motion in a joint (knee, elbow, ankle, hip, wrist, shoulder).

Myalgia, tendinitis, and tendon rupture have also been reported during postmarketing experience.[Ref]

Uncommon (0.1% to 1%): Tachycardia, vasodilatation, hypotension

Rare (0.01% to 0.1%): Vasculitis

Frequency not reported: Angina pectoris, cardiopulmonary arrest, myocardial infarction, hypertension, palpitation, bradycardia, arrhythmia, atrial flutter, cardiac murmur, cardiovascular collapse, ventricular ectopy, ventricular bigeminy, abdominal aortic bruit, postural hypotension

Postmarketing reports: QT prolongation/ECG QT prolonged, torsade de pointes, ventricular arrhythmia[Ref]

Torsade de pointes was reported mainly in patients with risk factors for QT prolongation.

Vasculitis has also been reported during postmarketing experience.[Ref]

Elevated serum theophylline has been reported in patients receiving theophylline concomitantly.

Gait disturbance and elevated serum potassium have also been reported during postmarketing experience.[Ref]

Uncommon (0.1% to 1%): Candida infections, mycotic superinfections, pain, fever, malaise/feeling unwell, asthenia, edema

Very rare (less than 0.01%): Gait disturbance/abnormal gait

Frequency not reported: Irritability, flushing, thirst, elevated serum calcium, elevated serum potassium, elevated triglycerides, decreased serum albumin, decreased serum potassium, decreased total serum protein, elevated serum theophylline, serum phenytoin altered, chills, swelling, breast pain, achiness, weakness, fatigue, suprapubic pain, rigors, tenderness, fungal infection, increased body temperature

Postmarketing reports: Elevated serum cholesterol[Ref]

Quinolone class antibiotics have been associated with symptomatic hypoglycemia.[Ref]

Uncommon (0.1% to 1%): Elevated blood alkaline phosphatase, decreased appetite/anorexia, decreased food intake

Rare (0.01% to 0.1%): Hyperglycemia, hypoglycemia

Frequency not reported: Elevated LDH, elevated uric acid, elevated blood glucose, decreased uric acid, decreased blood glucose, acidosis, symptomatic hypoglycemia[Ref]

Uncommon (0.1% to 1%): Renal impairment, renal failure

Rare (0.01% to 0.1%): Tubulointerstitial nephritis

Frequency not reported: Elevated serum creatinine, renal calculi, elevated BUN, decreased BUN, abnormal kidney function, allergic interstitial nephritis, nephritis, myoglobin-associated acute kidney injury/failure[Ref]

Allergic interstitial nephritis resulting in nonoliguric renal failure has been described in numerous case reports. Several cases included symptoms of rash, fever, and arthralgia and were accompanied by eosinophilia and eosinophiluria. Cases of allergic interstitial nephritis often responded to short courses of corticosteroid therapy.[Ref]

Uncommon (0.1% to 1%): Visual disturbances (e.g., chromatopsia, diplopia, photopsia)

Very rare (less than 0.01%): Visual color distortions

Frequency not reported: Decreased visual acuity, blurred vision, cataracts, multiple punctate lenticular opacities, eye pain[Ref]

Quinolone class antibiotics have been associated with cataracts and multiple punctate lenticular opacities.[Ref]

Rare (0.01% to 0.1%): Allergic reactions, anaphylactic shock (life-threatening), allergic edema

Very rare (less than 0.01%): Anaphylactic reaction, serum sickness-like reaction

Frequency not reported: Anaphylactoid reactions, necrotizing vasculitis, cutaneous vasculitis[Ref]

Allergic reactions ranged from urticaria to anaphylactic reactions, including life-threatening anaphylactic shock.

At least 2 cases have been reported of patients developing a cutaneous vasculitis related to use of this drug. The vasculitis resolved without medical intervention after the drug was discontinued.

Serum sickness-like reaction and anaphylactic shock (life-threatening) have also been reported during postmarketing experience.[Ref]

Rare (0.01% to 0.1%): Dyspnea (including asthmatic condition)

Frequency not reported: Bronchospasm, hemoptysis, laryngeal edema, respiratory arrest, epistaxis, hiccough, pulmonary edema, pleural effusion, pulmonary embolism, respiratory distress, wheeze, cough, upper respiratory tract infection, pharyngitis, nasopharyngitis[Ref]

Frequency not reported: Gynecomastia[Ref]

Frequency not reported: Jarisch-Herxheimer reaction[Ref]

Oral ciprofloxacin has been associated with a case of Jarisch-Herxheimer reaction (characterized by hypotension, tachycardia, and disseminated intravascular coagulation) in a 14-year-old female with tickborne relapsing fever.[Ref]

1. Campoli-Richards DM, Monk JP, Price A, Benfield P, Todd PA, Ward A “Ciprofloxacin: a review of its antibacterial activity, pharmacokinetic properties and therapeutic use.” Drugs 35 (1988): 373-447

2. “Product Information. Cipro XR (ciprofloxacin).” Bayer Pharmaceutical Inc, West Haven, CT.

3. Norrby SR “Side-effects of quinolones: comparisons between quinolones and other antibiotics.” Eur J Clin Microbiol Infect Dis 10 (1991): 378-83

4. Cerner Multum, Inc. “Australian Product Information.” O 0

5. “From the Centers for Disease Control and Prevention. Update: adverse events associated with anthrax prophylaxis among postal employees–New Jersey, New York City, and the District of Columbia metropolitan area, 2001.” JAMA 286 (2001): 2935-6

6. Kothur K, Singh M, Dayal D “Ciprofloxacin-induced anaphylactoid reaction.” Eur J Pediatr 165 (2006): 573-4

7. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

8. Heyd A, Haverstock D “Retrospective analysis of the safety profile of oral and intravenous ciprofloxacin in a geriatric population.” Clin Ther 22 (2000): 1239-50

9. Ramakrishnan K, Scheid DC “Diagnosis and management of acute pyelonephritis in adults.” Am Fam Physician 71 (2005): 933-42

10. Ball P “Ciprofloxacin: an overview of adverse experiences.” J Antimicrob Chemother 18 (1986): 187-93

11. Alexander RB, Propert KJ, Schaeffer AJ, et al. “Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial.” Ann Intern Med 141 (2004): 581-9

12. Juillerat P, Pittet V, Felley C, et al. “Drug safety in Crohn’s disease therapy.” Digestion 76 (2007): 161-8

13. Fourcroy JL, Berner B, Chiang YK, Cramer M, Rowe L, Shore N “Efficacy and safety of a novel once-daily extended-release ciprofloxacin tablet formulation for treatment of uncomplicated urinary tract infection in women.” Antimicrob Agents Chemother 49 (2005): 4137-43

14. “Product Information. Cipro (ciprofloxacin).” Bayer, West Haven, CT.

15. Bauwens JE, McFarland LV, Melcher SA “Recurrent clostridium difficile disease following ciprofloxacin use.” Ann Pharmacother 31 (1997): 1090

16. Harmon T, Burkhart G, Applebaum H “Perforated pseudomembranous colitis in the breast-fed infant.” J Pediatr Surg 27 (1992): 744-6

17. Schacht P, Arcieri G, Hullmann R “Safety of oral ciprofloxacin. An update based on clinical trial results.” Am J Med 87 (1989): s98-102

18. Overholser BR, Kays MB, Forrest A, Sowinski KM “Sex-related differences in the pharmacokinetics of oral ciprofloxacin.” J Clin Pharmacol 44 (2004): 1012-22

19. Bilton D, Henig N, Morrissey B, Gotfried M “Addition of Inhaled Tobramycin to Ciprofloxacin for Acute Exacerbations of Pseudomonas aeruginosa Infection in Adult Bronchiectasis.” Chest 130 (2006): 1503-10

20. Ferguson J, McEwen J, AlAjmi H, Purkins L, Colman PJ, Willavize SA “A comparison of the photosensitizing potential of trovafloxacin with that of other quinolones in healthy subjects.” J Antimicrob Chemother 45 (2000): 503-9

21. Knoell KA, Lynch JM “Photoinduced acute exanthematous pustulosis caused by ciprofloxacin and sunlight exposure.” Int J Dermatol 48 (2009): 1141-3

22. KimyaiAsadi A, Usman A, Nousari HC “Ciprofloxacin-induced bullous pemphigoid.” J Am Acad Dermatol 42 (2000): 847

23. Kushner JM, Peckman HJ, Snyder CR “Seizures associated with fluoroquinolones.” Ann Pharmacother 35 (2001): 1194-8

24. McDermott JL, Gideonse N, Campbell JW “Acute delirium associated with ciprofloxacin administration in a hospitalized elderly patient.” J Am Geriatr Soc 39 (1991): 909-10

25. Mumford CJ, Ginsberg L “Ciprofloxacin and myasthenia gravis.” BMJ 301 (1990): 818

26. Jay GT, Fitzgerald JM “Ciprofloxacin-induced delirium.” Ann Pharmacother 31 (1997): 252

27. Akhtar S, Ahmad H “Ciprofloxacin-induced catatonia.” J Clin Psychiatry 54 (1993): 115-6

28. Paton JH, Reeves DS “Fluoroquinolone antibiotics: microbiology, pharmacokinetics and clinical use.” Drugs 36 (1988): 193-228

29. Altes J, Gasco J, De Antonio J, Villalonga C “Ciprofloxacin and delirium.” Ann Intern Med 110 (1989): 170-1

30. Moore B, Safani M, Keesey J “Possible exacerbation of myasthenia gravis by ciprofloxacin.” Lancet Jan (1988): 882

31. Maddix DS, Stefani A “Myasthenia gravis and ciprofloxacin.” Ann Pharmacother 26 (1992): 265-6

32. Isaacson SH, Carr J, Rowan AJ “Ciprofloxacin-induced complex partial status epilepticus manifesting as an acute confusional state.” Neurology 43 (1993): 1619-21

33. Pastor P, Moitinho E, Elizalde I, Cirera I, Tolosa E “Reversible oral-facial dyskinesia in a patient receiving ciprofloxacin hydrochloride.” J Neurol 243 (1996): 616-7

34. Fanhavard P, Sanchorawala V, Oh J, Moser EM, Smith SP “Concurrent use of foscarnet and ciprofloxacin may increase the propensity for seizures.” Ann Pharmacother 28 (1994): 869-72

35. Schwartz MT, Calvert JF “Potential neurologic toxicity related to ciprofloxacin.” Ann Pharmacother 24 (1990): 138-40

36. Arcieri G, August R, Becker N, et al “Clinical experience with ciprofloxacin in the USA.” Eur J Clin Microbiol 5 (1986): 220-5

37. Whyte CA, Shivdat-Nanhoe R, Kramer P “A Case of Amoxicillin-Induced Meningitis.” Clin Infect Dis 46 (2008): 642

38. Cohen JS “Peripheral neuropathy associated with fluoroquinolones.” Ann Pharmacother 35 (2001): 1540-7

39. Semel JD, Allen N “Seizures in patients simultaneously receiving theophylline and imipenem or ciprofloxacin or metronidazole.” South Med J 84 (1991): 465-8

40. Gasser TC, Ebert SC, Graversen PH, Madsen PO “Pharmacokinetic study of ciprofloxacin in patients with impaired renal function.” Am J Med 82 (1987): 139-41

41. Arcieri G, Griffith E, Gruenwaldt G, et al “A survey of clinical experience with ciprofloxacin, a new quinolone antimicrobial.” J Clin Pharmacol 28 (1988): 179-89

42. Slavich IL, Gleffe Rf, Haas EJ “Grand mal epileptic seizures during ciprofloxacin therapy.” JAMA 261 (1989): 558-9

43. Tattevin P, Messiaen T, Pras V, Ronco P, Biour M “Confusion and general seizures following ciprofloxacin administration.” Nephrol Dialysis Transplant 13 (1998): 2712-3

44. Karki SD, Bentley DW, Raghavan M “Seizure with ciprofloxacin and theophylline combined therapy.” DICP 24 (1990): 595-6

45. McCue JD, Zandt JR “Acute psychoses associated with the use of ciprofloxacin and trimethoprim-sulfamethoxazole.” Am J Med 90 (1991): 528-9

46. Rosolen A, Drigo P, Zanesco L “Acute hemiparesis associated with ciprofloxacin.” BMJ 309 (1994): 1411

47. Winrow AP, Supramaniam G “Benign intracranial hypertension after ciprofloxacin administration.” Arch Dis Child 65 (1990): 1165-6

48. Darwish T “Ciprofloxacin-induced seizures in a healthy patient.” N Z Med J 121 (2008): 104-5

49. Fleming LW, Phillips G, Stewart WK, Scott AC “Oral ciprofloxacin in the treatment of peritonitis in patients on continuous ambulatory peritoneal dialysis.” J Antimicrob Chemother 25 (1990): 441-8

50. Imrie K, Gold W, Salit I, Keating A “Ciprofloxacin-induced neutropenia and erythema multiforme.” Am J Hematol 43 (1993): 159-60

51. Starr JA, Ragucci KR “Thrombocytopenia associated with intravenous ciprofloxacin.” Pharmacotherapy 25 (2005): 1030-4

52. Oh YR, Carr-Lopez SM, Probasco JM, Crawley PG “Levofloxacin-induced autoimmune hemolytic anemia.” Ann Pharmacother 37 (2003): 1010-3

53. Andrews PA, Robinson GT “Intravascular haemolysis and interstitial nephritis in association with ciprofloxacin.” Nephron 83 (1999): 359-60

54. Dutta TK, Badhe BA “Ciprofloxacin-induced bone marrow depression.” Postgrad Med J 75 (1999): 571-3

55. Labowitz JK, Silverman WB “Cholestatic jaundice induced by ciprofloxacin.” Dig Dis Sci 42 (1997): 192-4

56. Sherman O, Beizer JL “Possible ciprofloxacin-induced acute cholestatic jaundice.” Ann Pharmacother 28 (1994): 1162-4

57. Grasmick BK, Lehr VT, Sundareson AS “Fulminant hepatic failure possibly related to ciprofloxacin.” Ann Pharmacother 26 (1992): 636-9

58. Fuchs S, Simon Z, Brezis M “Fatal hepatic failure associated with ciprofloxacin.” Lancet 343 (1994): 738-9

59. Villenueuve JP, Davies C, Cote J “Suspected ciprofloxacin-induced hepatotoxicity.” Ann Pharmacother 29 (1995): 257-9

60. Stratta P, Lazzarich E, Canavese C, Bozzola C, Monga G “Ciprofloxacin crystal nephropathy.” Am J Kidney Dis 50 (2007): 330-5

61. Poon CCH, Sundaram NA “Spontaneous bilateral Achilles tendon rupture associated with ciprofloxacin.” Med J Aust 166 (1997): 665

62. Adverse Drug Reactions Advisory Committee (ADRAC) and the Adverse Drug Reactions Unit of the TGA “Australian Adverse Drug Reactions Bulletin. Available from: URL: http://www.tga.gov.au/adr/aadrb/aadr0810.htm.” ([2008 Oct]):

63. Alfaham M, Holt ME, Goodchild MC “Arthropathy in a patient with cystic fibrosis taking ciprofloxacin.” Br Med J (Clin Res Ed) 295 (1987): 699

64. Mcgarvey WC, Singh D, Trevino SG “Partial achilles tendon ruptures associated with fluoroquinolone antibiotics: a case report and literature review.” Foot Ankle Int 17 (1996): 496-8

65. Samuelson WM, Pleasants RA, Whitaker MS “Arthropathy secondary to ciprofloxacin in an adult cystic fibrosis patient.” Ann Pharmacother 27 (1993): 302-3

66. Qian Q, Nasr SH, Akogyeram CO, Sethi S “Myoglobin-associated acute kidney injury in the setting of ciprofloxacin administration.” Am J Kidney Dis 59 (2012): 462-6

67. Khaliq Y, Zhanel GG “Fluoroquinolone-Associated Tendinopathy: A Critical Review of the Literature.” Clin Infect Dis 36 (2003): 1404-1410

68. Zabraniecki L, Negrier I, Vergne P, Arnaud M, Bonnet C, Bertin P, Treves R “Fluoroquinolone induced tendinopathy: report of 6 cases.” J Rheumatol 23 (1996): 516-20

69. Carrasco JM, Garcia B, Andujar C, Garrote F, de Juana P, Bermejo T “Tendinitis associated with ciprofloxacin.” Ann Pharmacother 31 (1997): 120

70. Donck JB, Segaert MF, Vanrenterghem YF “Fluoroquinolones and achilles tendinopathy in renal transplant recipients.” Transplantation 58 (1994): 736-7

71. Berger RE “Rates of torsades de pointes associated with ciprofloxacin, ofloxacin, levofloxacin, gatifloxacin, and moxifloxacin.” J Urol 174 (2005): 165

72. Owens RC Jr, Nolin TD “Antimicrobial-Associated QT Interval Prolongation: Pointes of Interest.” Clin Infect Dis 43 (2006): 1603-1611

73. Owens RC Jr, Ambrose PG “Torsades de pointes associated with fluoroquinolones.” Pharmacotherapy 22 (2002): 663-8; discussion 668-72

74. Lapi F, Wilchesky M, Kezouh A, Benisty JI, Ernst P, Suissa S “Fluoroquinolones and the risk of serious arrhythmia: a population-based study.” Clin Infect Dis 55 (2012): 1457-65

75. Frothingham R “Rates of torsades de pointes associated with ciprofloxacin, ofloxacin, levofloxacin, gatifloxacin, and moxifloxacin.” Pharmacotherapy 21 (2001): 1468-72

76. Atasoy H, Erdem G, Ceyhan M, Ecevit Z, Kanra G “Hypertension asociated with ciprofloxacin use in an infant.” Ann Pharmacother 29 (1995): 1049

77. Nair MK, Patel K, Starer PJ “Ciprofloxacin-induced torsades de pointes in a methadone-dependent patient.” Addiction 103 (2008): 2062-4

78. Briasoulis A, Agarwal V, Pierce WJ “QT Prolongation and Torsade de Pointes Induced by Fluoroquinolones: Infrequent Side Effects from Commonly Used Medications.” Cardiology 120 (2011): 103-110

79. Kelesidis T, Canseco E “Quinolone-induced hypoglycemia: a life-threatening but potentially reversible side effect.” Am J Med 123 (2010): e5-6

80. Lin G, Hays DP, Spillane L “Refractory hypoglycemia from ciprofloxacin and glyburide interaction.” J Toxicol Clin Toxicol 42 (2004): 295-7

81. Anand A “Ciprofloxacin nephrotoxicity.” Arch Intern Med 153 (1993): 2705-6

82. Gonski PN “Ciprofloxacin-induced renal failure in an elderly patient.” Med J Aust 154 (1991): 638-9

83. Rippelmeyer DJ, Synhavsky A “Ciprofloxacin and allergic interstitial nephritis.” Ann Intern Med 109 (1988): 170

84. Hatton J, Haagensen D “Renal dysfunction associated with ciprofloxacin.” Pharmacotherapy 10 (1990): 337-40

85. Ying LS, Johnson CA “Ciprofloxacin-induced interstitial nephritis.” Clin Pharm 8 (1989): 518-21

86. Hootkins R, Fenves AZ, Stephens MK “Acute renal failure secondary to oral ciprofloxacin therapy: a presentation of three cases and a review of the literature.” Clin Nephrol 32 (1989): 75-8

87. Shih DJ, Korbet SM, Rydel JJ, Schwartz MM “Renal vasculitis associated with ciprofloxacin.” Am J Kidney Dis 26 (1995): 516-9

88. Helmink R, Benediktsson H “Ciprofloxacin-induced allergic interstitial nephritis.” Nephron 55 (1990): 432-3

89. Allon M, Lopez EJ, Min KW “Acute renal failure due to ciprofloxacin.” Arch Intern Med 150 (1990): 2187-9

90. Simpson J, Watson AR, Mellersh A, Nelson CS, Dodd K “Typhoid fever, ciprofloxacin, and renal failure.” Arch Dis Child 66 (1991): 1083-4

91. Ortiz A, Plaza JJ, Egido J “Ciprofloxacin-associated tubulointerstitial nephritis with linear tubular basement membrane deposits.” Nephron 60 (1992): 248

92. Thorsteinsson SB, Bergan T, Oddsdottir S, Rohwedder R, Holm R “Crystalluria and ciprofloxacin, influence of urinary pH and hydration.” Chemotherapy 32 (1986): 408-17

93. Rastogi S, Atkinson JLD, McCarthy JT “Allergic nephropathy associated with ciprofloxacin.” Mayo Clin Proc 65 (1990): 987-9

94. Murray KM, Wilson MG “Suspected ciprofloxacin-induced interstitial nephritis.” Ann Pharmacother 24 (1990): 379-80

95. Lucena MI, Marquez M, Velasco JL, Andrade RJ “Acute renal failure attributable to ciprofloxacin in a patient with the acquired immunodeficiency syndrome.” Arch Intern Med 155 (1995): 114

96. Tomas S, Pedro-Botet J, Auget T “Ciprofloxacin and immunocomplex-mediated disease.” J Intern Med 230 (1991): 550-1

97. Granowitz EV “Photosensitivity rash in a patient being treated with ciprofloxacin.” J Infect Dis 160 (1989): 910-1

98. Hallgren J, Tengvall-Linder M, Persson M, Wahlgren CF “Stevens-Johnson syndrome associated with ciprofloxacin: A review of adverse cutaneous events reported in Sweden as associated with this drug.” J Am Acad Dermatol 49(5 Suppl) (2003): 267-9

99. Win A, Evers ML, Chmel H “Stevens-johnson syndrome presumably induced by ciprofloxacin.” Int J Dermatol 33 (1994): 512-4

100. Miller MS, Gaido F, Rourk MH Jr, Spock A “Anaphylactoid reactions to ciproflaxacin in cystic fibrosis patients.” Pediatr Infect Dis J 10 (1991): 164-5

101. Roujeau JC, Kelly JP, Naldi L, et al. “Medication use and the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis.” N Engl J Med 333 (1995): 1600-7

102. Jongen-Lavrencic M, Schneeberger PM, van der Hoeven JG “Ciprofloxacin-induced toxic epidermal necrolysis in a patient with systemic lupus erythematosus.” Infection 31 (2003): 428-9

103. Ho DY, Song JC, Wang CC “Anaphylactoid reaction to ciprofloxacin.” Ann Pharmacother 37 (2003): 1018-23

104. Stubbings J, Sheehan-Dare R, Walton S “Cutaneous vasculitis due to ciprofloxacin.” BMJ 305 (1992): 29

105. Maunz G, Conzett T, Zimmerli W “Cutaneous vasculitis associated with fluoroquinolones.” Infection 37 (2009): 466-8

106. Kennedy CA, Goetz MB, Mathisen GE “Ciprofloxacin-induced anaphylactoid reactions in patients infected with the human immunodeficiency virus.” West J Med 153 (1990): 563-4

107. Davis H, Mcgoodwin E, Reed TG “Anaphylactoid reactions reported after treatment with ciprofloxacin.” Ann Intern Med 111 (1989): 1041-3

108. Lieu PK, Tok SC, Ismail NH, Chng HH “Ciproflaxin-induced cutaneous vasculitis.” Allergy 52 (1997): 593-4

109. Tham TC, Allen G, Hayes D, et al “Possible association between toxic epidermal necrolysis and ciprofloxacin.” Lancet 338 (1991): 522

110. Tierney BC, Martin SW, Franzke LH, et al. “Serious Adverse Events among Participants in the Centers for Disease Control and Prevention’s Anthrax Vaccine and Antimicrobial Availability Program for Persons at Risk for Bioterrorism-Related Inhalational Anthrax.” Clin Infect Dis 37 (2003): 905-11

111. Nedorost ST, Dijkstra JW, Handel DW “Drug-induced photosensitivity reaction.” Arch Dermatol 125 (1989): 433-4

112. Peters B, Pinching AJ “Fatal anaphylaxis associated with ciprofloxacin in a patient with AIDS related complex.” BMJ 298 (1989): 605

113. Choe U, Rothschild BM, Laitman L “Ciprofloxacin-induced vasculitis.” N Engl J Med 320 (1989): 257-8

114. Berger TG, Franklin N “Anaphylactoid reaction to ciprofloxacin in a patient infected with the human immunodeficiency virus.” J Am Acad Dermatol 26 (1992): 256-7

115. Rodriguez E, Martinez JA, Torres M, Nubiiola A, Buges J “Lobular panniculitis associated with ciprofloxacin.” Br Med J 300 (1990): 1468

116. Slama TG “Serum sickness-like illness associated with ciprofloxacin.” Antimicrob Agents Chemother 34 (1990): 904-5

117. Wurtz RM, Abrams D, Becker S, Jacobson MA, Mass MM, Marks SH “Anaphylactoid drug reactions to ciprofloxacin and rifampicin in HIV-infected patients.” Lancet 1 (1989): 955-6

118. Reano M, Vives R, Rodriguez J, Daroca P, Canto G, Fernandez J “Ciprofloxacin-induced vasculitis.” Allergy 52 (1997): 599-600

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

Other brands: Cipro, Cipro XR, Cipro I.V., Proquin XR

prednisone, amoxicillin, doxycycline, albuterol, ranitidine, metronidazole, ciprofloxacin, clindamycin, cephalexin, Augmentin

Ciprofloxacin reviews

The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices.

Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more.

Third Party Advertising

We comply with the HONcode standard for trustworthy health information – verify here

Copyright © 2000-2019 Drugs.com. All rights reserved.

A total of 538 drugs are known to interact with ciprofloxacin.

Show all medications in the database that may interact with ciprofloxacin.

Type in a drug name to check for interactions with ciprofloxacin.

View interaction reports for ciprofloxacin and the medicines listed below.

There are 3 alcohol/food interactions with ciprofloxacin

drug ciprofloxacin 500 mg

There are 10 disease interactions with ciprofloxacin which include:

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Some mixtures of medications can lead to serious and even fatal consequences.

Here are 9 ways to stay safe

prednisone, amoxicillin, doxycycline, albuterol, ranitidine, metronidazole, clindamycin, cephalexin, Augmentin, azithromycin

Ciprofloxacin reviews

The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices.

Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more.

Third Party Advertising

We comply with the HONcode standard for trustworthy health information – verify here

Copyright © 2000-2019 Drugs.com. All rights reserved.

Generic Name: Ciprofloxacin hydrochloride
Dosage Form: tablet, film coated

Medically reviewed by Drugs.com. Last updated on May 1, 2019.

Ciprofloxacin tablets are indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillinsusceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.

Ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

Ciprofloxacin tablets are indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

drug ciprofloxacin 500 mg

Ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii†, Shigella dysenteriae, Shigella flexneri or Shigella sonnei† when antibacterial therapy is indicated.

†Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.

Ciprofloxacin tablets are indicated in adult patients for treatment of typhoid fever (enteric fever) caused by Salmonella typhi. The efficacy of Ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.

Ciprofloxacin tablets are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae [see Warnings and Precautions (5.17)].

Ciprofloxacin tablets are indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.1 Supportive clinical information for Ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001 [see Clinical Studies (14.2)].

Ciprofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of Ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see Clinical Studies (14.3)].

Ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.

Ciprofloxacin tablets are indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae.

Ciprofloxacin tablets are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.

Ciprofloxacin tablets are indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by Moraxella catarrhalis.

Because fluoroquinolones, including Ciprofloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.16)] and for some patients AECB is self-limiting, reserve Ciprofloxacin tablets for treatment of AECB in patients who have no alternative treatment options.

Urinary Tract Infections in Adults

Ciprofloxacin tablets are indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.

Acute Uncomplicated Cystitis

Ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus.

Because fluoroquinolones, including Ciprofloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.16)] and for some patients acute uncomplicated cystitis is self-limiting, reserve Ciprofloxacin tablets for treatment of acute uncomplicated cystitis in patients who have no alternative treatment options.

Complicated Urinary Tract Infection and Pyelonephritis in Pediatric Patients

Ciprofloxacin tablets are indicated in pediatric patients aged one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to Escherichia coli [see Use in Specific Populations (8.4)].

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues. Ciprofloxacin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see Warnings and Precautions (5.13), Adverse Reactions (6.1), Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)].

Ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.

Because fluoroquinolones, including Ciprofloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.16)] and for some patients acute sinusitis is self-limiting, reserve Ciprofloxacin tablets for treatment of acute sinusitis in patients who have no alternative treatment options.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin tablets and other antibacterial drugs, Ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to Ciprofloxacin. Therapy with Ciprofloxacin tablets may be initiated before results of these tests are known; once results become available appropriate therapy should be continued.

As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.

Ciprofloxacin tablets should be administered orally as described in the appropriate Dosage Guidelines tables.

The determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function. Ciprofloxacin tablets may be administered to adult patients when clinically indicated at the discretion of the physician.

Conversion of IV to Oral Dosing in Adults

Patients whose therapy is started with Ciprofloxacin IV may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].

Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin tablets should be administered as described in Table 3.

Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.

When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:

Men – Creatinine clearance (mL/min) = Weight (kg) x (140–age)

72 x serum creatinine (mg/dL)

Women – 0.85 x the value calculated for men.

drug ciprofloxacin 500 mg

The serum creatinine should represent a steady state of renal function.

In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.

Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of less than 50 mL/min/1.73m2).

With Multivalent Cations

Administer Ciprofloxacin tablets at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.

With Dairy Products

Concomitant administration of Ciprofloxacin tablets with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, Ciprofloxacin tablets may be taken with a meal that contains these products.

Hydration of Patients Receiving Ciprofloxacin Tablets

Assure adequate hydration of patients receiving Ciprofloxacin tablets to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.

Instruct the patient of the appropriate Ciprofloxacin tablets administration [see Patient Counseling Information (17)].

250 mg, white to off-white, round, unscored, biconvex film-coated tablets, with “”on one side andon the other side.

500 mg, white to off-white, capsule shaped, unscored, biconvex film-coated tablets, with “”on one side and
“CR 500” on the other side.

750 mg, white to off-white, capsule shaped, unscored, biconvex film-coated tablets, with “”on one side and
“CR 750” on the other side.

Ciprofloxacin tablets are contraindicated in persons with a history of hypersensitivity to Ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components [see Warnings and Precautions (5.7)].

Concomitant administration with tizanidine is contraindicated [see Drug Interactions (7)].

Fluoroquinolones, including Ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting Ciprofloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions (5.2, 5.3, 5.4)].

Discontinue Ciprofloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including Ciprofloxacin, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

Fluoroquinolones, including Ciprofloxacin, have been associated with an increased risk of tendinitis and tendon rupture in all ages [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)]. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur, within hours or days of starting Ciprofloxacin, or as long as several months after completion of fluoroquinolone therapy. Tendinitis and tendon rupture can occur bilaterally.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Discontinue Ciprofloxacin immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including Ciprofloxacin, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture [see Adverse Reactions (6.2)].

Fluoroquinolones, including Ciprofloxacin, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including Ciprofloxacin. Symptoms may occur soon after initiation of Ciprofloxacin and may be irreversible in some patients [see Warnings and Precautions (5.1) and Adverse Reactions (6.1, 6.2)].

Discontinue Ciprofloxacin immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations including light touch, pain, temperature, position sense and vibratory sensation, and/or motor strength in order to minimize the development of an irreversible condition. Avoid fluoroquinolones, including Ciprofloxacin, in patients who have previously experienced peripheral neuropathy [see Adverse Reactions (6.1, 6.2)].

Psychiatric Adverse Reactions

Fluoroquinolones, including Ciprofloxacin, have been associated with an increased risk of psychiatric adverse reactions, including: toxic psychosis, psychotic reactions progressing to suicidal ideations/thoughts, hallucinations, or paranoia; depression, or self-injurious behavior such as attempted or completed suicide; anxiety, agitation, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment. These reactions may occur following the first dose. Advise patients receiving Ciprofloxacin to inform their healthcare provider immediately if these reactions occur, discontinue the drug, and institute appropriate care.

Central Nervous System Adverse Reactions

Fluoroquinolones, including Ciprofloxacin, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (pscudotumor cerebri), dizziness, and tremors. Ciprofloxacin, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold. Cases of status epilepticus have been reported. As with all fluoroquinolones, use Ciprofloxacin with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (for example, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (for example, certain drug therapy, renal dysfunction). If seizures occur, discontinue Ciprofloxacin and institute appropriate care [see Adverse Reactions (6.1) and Drug Interactions (7)].

Fluoroquinolones, including Ciprofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Postmarketing serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. Avoid Ciprofloxacin in patients with known history of myasthenia gravis [see Adverse Reactions (6.2)].

Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported in patients receiving therapy with quinolones, including Ciprofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

Discontinue Ciprofloxacin immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted [see Adverse Reactions (6.1, 6.2)].

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving fluoroquinolone therapy, including Ciprofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, including intubation, as indicated [see Adverse Reactions (6.1)].

Cases of severe hepatotoxicity, including hepatic necrosis, life-threatening hepatic failure, and fatal events, have been reported with Ciprofloxacin. Acute liver injury is rapid in onset (range 1 to 39 days), and is often associated with hypersensitivity. The pattern of injury can be hepatocellular, cholestatic, or mixed. Most patients with fatal outcomes were older than 55 years old. In the event of any signs and symptoms of hepatitis (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), discontinue treatment immediately.

There can be a temporary increase in transaminases, alkaline phosphatase, or cholestatic jaundice, especially in patients with previous liver damage, who are treated with Ciprofloxacin [see Adverse Reactions (6.2, 6.3)].

Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients. The cause for the increased risk has not been identified. In patients with a known aortic aneurysm or patients who are at greater risk for aortic aneurysms, reserve Ciprofloxacin for use only when there are no alternative antibacterial treatments available.

Serious and fatal reactions have been reported in patients receiving concurrent administration of Ciprofloxacin and theophylline. These reactions have included cardiac arrest, seizure, status epilepticus, and respiratory failure. Instances of nausea, vomiting, tremor, irritability, or palpitation have also occurred.

Although similar serious adverse reactions have been reported in patients receiving theophylline alone, the possibility that these reactions may be potentiated by Ciprofloxacin cannot be eliminated. If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate [see Drug Interactions (7)].

Clostridium difficile (C. difficile)-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ciprofloxacin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and institute surgical evaluation as clinically indicated [see Adverse Reactions (6.1)].

Some fluoroquinolones, including Ciprofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and cases of arrhythmia. Cases of torsade de pointes have been reported during postmarketing surveillance in patients receiving fluoroquinolones, including Ciprofloxacin.

Avoid Ciprofloxacin in patients with known prolongation of the QT interval, risk factors for QT prolongation or torsade de pointes (for example, congenital long QT syndrome, uncorrected electrolyte imbalance, such as hypokalemia or hypomagnesemia and cardiac disease, such as heart failure, myocardial infarction, or bradycardia), and patients receiving Class IA antiarrhythmic agents (quinidine, procainamide), or Class III antiarrhythmic agents (amiodarone, sotalol), tricyclic antidepressants, macrolides, and antipsychotics. Elderly patients may also be more susceptible to drug-associated effects on the QT interval [see Adverse Reactions (6.2), Use in Specific Populations (8.5)].

Ciprofloxacin is indicated in pediatric patients (less than 18 years of age) only for cUTI, prevention of inhalational anthrax (post exposure), and plague [see Indications and Usage (1.7, 1.8, 1.11)]. An increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues, has been observed [see Adverse Reactions (6.1)].

In pre-clinical studies, oral administration of Ciprofloxacin caused lameness in immature dogs. Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage. Related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species [see Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)].

Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (for example, burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolones including Ciprofloxacin after sun or UV light exposure. Therefore, avoid excessive exposure to these sources of light. Discontinue Ciprofloxacin if phototoxicity occurs [see Adverse Reactions (6.1)].

Prescribing Ciprofloxacin tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Ciprofloxacin is an inhibitor of the hepatic CYP1A2 enzyme pathway. Coadministration of Ciprofloxacin and other drugs primarily metabolized by CYP1A2 (for example, theophylline, methylxanthines, caffeine, tizanidine, ropinirole, clozapine, olanzapine and zolpidem), results in increased plasma concentrations of the coadministered drug and could lead to clinically significant pharmacodynamic adverse reactions of the coadministered drug [see Drug Interactions (7) and Clinical Pharmacology (12.3)].

Ciprofloxacin has not been shown to be effective in the treatment of syphilis. Antimicrobial agents used in high dose for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. Perform a serologic test for syphilis in all patients with gonorrhea at the time of diagnosis. Perform follow-up serologic test for syphilis three months after Ciprofloxacin treatment.

Crystals of Ciprofloxacin have been observed rarely in the urine of human subjects but more frequently in the urine of laboratory animals, which is usually alkaline [see Nonclinical Toxicology (13.2)]. Crystalluria related to Ciprofloxacin has been reported only rarely in humans because human urine is usually acidic. Avoid alkalinity of the urine in patients receiving Ciprofloxacin. Hydrate patients well to prevent the formation of highly concentrated urine [see Dosage and Administration (2.4)].

Fluoroquinolones, including Ciprofloxacin, have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (for example, glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. Severe cases of hypoglycemia resulting in coma or death have been reported. If a hypoglycemic reaction occurs in a patient being treated with Ciprofloxacin, discontinue Ciprofloxacin and initiate appropriate therapy immediately [see Adverse Reactions (6.1), Drug Interactions (7)].

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adult Patients

During clinical investigations with oral and parenteral Ciprofloxacin, 49,038 patients received courses of the drug.

The most frequently reported adverse reactions, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications of Ciprofloxacin therapy were nausea (2.5%), diarrhea (1.6%), liver function tests abnormal (1.3%), vomiting (1%), and rash (1%).

In randomized, double-blind controlled clinical trials comparing Ciprofloxacin tablets [500 mg twice daily] to cefuroxime axetil (250 mg to 500 mg twice daily) and to clarithromycin (500 mg twice daily) in patients with respiratory tract infections, Ciprofloxacin demonstrated a CNS adverse reaction profile comparable to the control drugs.

Pediatric Patients

Short (6 weeks) and long term (1 year) musculoskeletal and neurological safety of oral/intravenous Ciprofloxacin, was compared to a cephalosporin for treatment of cUTI or pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years) in an international multicenter trial. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days). A total of 335 Ciprofloxacin- and 349 comparator-treated patients were enrolled.

An Independent Pediatric Safety Committee (IPSC) reviewed all cases of musculoskeletal adverse reactions including abnormal gait or abnormal joint exam (baseline or treatment-emergent). Within 6 weeks of treatment initiation, the rates of musculoskeletal adverse reactions were 9.3% (31/335) in the Ciprofloxacin-treated group versus 6% (21/349) in comparator-treated patients. All musculoskeletal adverse reactions occurring by 6 weeks resolved (clinical resolution of signs and symptoms), usually within 30 days of end of treatment. Radiological evaluations were not routinely used to confirm resolution of the adverse reactions. Ciprofloxacin-treated patients were more likely to report more than one adverse reaction and on more than one occasion compared to control patients. The rate of musculoskeletal adverse reactions was consistently higher in the Ciprofloxacin group compared to the control group across all age subgroups. At the end of 1 year, the rate of these adverse reactions reported at any time during that period was 13.7% (46/335) in the Ciprofloxacin-treated group versus 9.5% (33/349) in the comparator-treated patients (Table 9).

The incidence rates of neurological adverse reactions within 6 weeks of treatment initiation were 3% (9/335) in the Ciprofloxacin group versus 2% (7/349) in the comparator group and included dizziness, nervousness, insomnia, and somnolence.

In this trial, the overall incidence rates of adverse reactions within 6 weeks of treatment initiation were 41% (138/335) in the Ciprofloxacin group versus 31% (109/349) in the comparator group. The most frequent adverse reactions were gastrointestinal: 15% (50/335) of Ciprofloxacin patients compared to 9% (31/349) of comparator patients. Serious adverse reactions were seen in 7.5% (25/335) of Ciprofloxacintreated patients compared to 5.7% (20/349) of control patients. Discontinuation of drug due to an adverse reaction was observed in 3% (10/335) of Ciprofloxacin-treated patients versus 1.4% (5/349) of comparator patients. Other adverse reactions that occurred in at least 1% of Ciprofloxacin patients were diarrhea 4.8%, vomiting 4.8%, abdominal pain 3.3%, dyspepsia 2.7%, nausea 2.7%, fever 2.1%, asthma 1.8% and rash 1.8%.

Short-term safety data for Ciprofloxacin was also collected in a randomized, double-blind clinical trial for the treatment of acute pulmonary exacerbations in cystic fibrosis patients (ages 5 to 17 years). Sixty seven patients received Ciprofloxacin IV 10 mg/kg/dose every 8 hours for one week followed by Ciprofloxacin tablets 20 mg/kg/dose every 12 hours to complete 10 to 21 days treatment and 62 patients received the combination of ceftazidime intravenous 50 mg/kg/dose every 8 hours and tobramycin intravenous 3 mg/kg/dose every 8 hours for a total of 10 to 21 days. Periodic musculoskeletal assessments were conducted by treatment-blinded examiners. Patients were followed for an average of 23 days after completing treatment (range 0 to 93 days). Musculoskeletal adverse reactions were reported in 22% of the patients in the Ciprofloxacin group and 21% in the comparison group. Decreased range of motion was reported in 12% of the subjects in the Ciprofloxacin group and 16% in the comparison group. Arthralgia was reported in 10% of the patients in the Ciprofloxacin group and 11% in the comparison group. Other adverse reactions were similar in nature and frequency between treatment arms. The efficacy of Ciprofloxacin for the treatment of acute pulmonary exacerbations in pediatric cystic fibrosis patients has not been established.

In addition to the adverse reactions reported in pediatric patients in clinical trials, it should be expected that adverse reactions reported in adults during clinical trials or postmarketing experience may also occur in pediatric patients.

The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including Ciprofloxacin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure (Table 10).

Changes in laboratory parameters while on Ciprofloxacin are listed below:

Hepatic–Elevations of ALT (SGPT), AST (SGOT), alkaline phosphatase, LDH, serum bilirubin.

Hematologic–Eosinophilia, leukopenia, decreased blood platelets, elevated blood platelets, pancytopenia.

Renal–Elevations of serum creatinine, BUN, crystalluria, cylindruria, and hematuria have been reported.

Other changes occurring were: elevation of serum gamma glutamyl transferase, elevation of serum amylase, reduction in blood glucose, elevated uric acid, decrease in hemoglobin, anemia, bleeding diathesis, increase in blood monocytes, and leukocytosis.

Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Coadministration of Ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the coadministered drug.

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother. An expert review of published data on experiences with Ciprofloxacin use during pregnancy by TERIS–the Teratogen Information System–concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (quantity and quality of data=fair), but the data are insufficient to state that there is no risk.2

A controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to Ciprofloxacin and 68% first trimester exposures) during gestation.3 In utero exposure to fluoroquinolones during embryogenesis was not associated with increased risk of major malformations. The reported rates of major congenital malformations were 2.2% for the fluoroquinolone group and 2.6% for the control group (background incidence of major malformations is 1% to 5%). Rates of spontaneous abortions, prematurity and low birth weight did not differ between the groups and there were no clinically significant musculoskeletal dysfunctions up to one year of age in the Ciprofloxacin exposed children.

Another prospective follow-up study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures).4 There were 70 Ciprofloxacin exposures, all within the first trimester. The malformation rates among live-born babies exposed to Ciprofloxacin and to fluoroquinolones overall were both within background incidence ranges. No specific patterns of congenital abnormalities were found. The study did not reveal any clear adverse reactions due to in utero exposure to Ciprofloxacin.

No differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to Ciprofloxacin during pregnancy.2,3 However, these small postmarketing epidemiology studies, of which most experience is from short term, first trimester exposure, are insufficient to evaluate the risk for less common defects or to permit reliable and definitive conclusions regarding the safety of Ciprofloxacin in pregnant women and their developing fetuses.

Reproduction studies have been performed in rats and mice using oral doses up to 100 mg/kg (0.6 and 0.3 times the maximum daily human dose based upon body surface area, respectively) and have revealed no evidence of harm to the fetus due to Ciprofloxacin. In rabbits, oral Ciprofloxacin dose levels of 30 and 100 mg/kg (approximately 0.4- and 1.3-times the highest recommended therapeutic dose based upon body surface area) produced gastrointestinal toxicity resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose level. After intravenous administration of doses up to 20 mg/kg (approximately 0.3-times the highest recommended therapeutic dose based upon body surface area), no maternal toxicity was produced and no embryotoxicity or teratogenicity was observed.

Ciprofloxacin is excreted in human milk. The amount of Ciprofloxacin absorbed by the nursing infant is unknown. Because of the potential risk of serious adverse reactions (including articular damage) in infants nursing from mothers taking Ciprofloxacin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls. Quinolones, including Ciprofloxacin, cause arthropathy (arthralgia, arthritis), in juvenile animals [see Warnings and Precautions (5.13) and Nonclinical Toxicology (13.2)].

Complicated Urinary Tract Infection and Pyelonephritis

Ciprofloxacin is indicated for the treatment of cUTI and pyelonephritis due to Escherichia coli in pediatric patients 1 to 17 years of age. Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to the controls, including events related to joints and/or surrounding tissues [see Adverse Reactions (6.1) and Clinical Studies (14.1)].

Inhalational Anthrax (Post-Exposure)

Ciprofloxacin is indicated in pediatric patients from birth to 17 years of age, for inhalational anthrax (postexposure). The risk-benefit assessment indicates that administration of Ciprofloxacin to pediatric patients is appropriate [see Dosage and Administration (2.2) and Clinical Studies (14.2)].

Plague

Ciprofloxacin is indicated in pediatric patients from birth to 17 years of age, for treatment of plague, including pneumonic and septicemic plague due to Yersinia pestis (Y. pestis) and prophylaxis for plague. Efficacy studies of Ciprofloxacin could not be conducted in humans with pneumonic plague for feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals. The risk-benefit assessment indicates that administration of Ciprofloxacin to pediatric patients is appropriate [see Indications and Usage (1.8), Dosage and Administration (2.2) and Clinical Studies (14.3)].

Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Ciprofloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing Ciprofloxacin to elderly patients especially those on corticosteroids. Patients should be informed of this potential adverse reaction and advised to discontinue Ciprofloxacin and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur [see Boxed Warning, Warnings and Precautions (5.2), and Adverse Reactions (6.2)].

Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients [see Warnings and Precautions (5.9)].

In a retrospective analysis of 23 multiple-dose controlled clinical trials of Ciprofloxacin encompassing over 3,500 Ciprofloxacin-treated patients, 25% of patients were greater than or equal to 65 years of age and 10% were greater than or equal to 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals on any drug therapy cannot be ruled out. Ciprofloxacin is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. No alteration of dosage is necessary for patients greater than 65 years of age with normal renal function. However, since some older individuals experience reduced renal function by virtue of their advanced age, care should be taken in dose selection for elderly patients, and renal function monitoring may be useful in these patients [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

In general, elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using Ciprofloxacin with concomitant drugs that can result in prolongation of the QT interval (for example, class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known QT prolongation, uncorrected hypokalemia) [see Warnings and Precautions (5.12)].

Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

In preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in Ciprofloxacin pharmacokinetics have been observed. The pharmacokinetics of Ciprofloxacin in patients with acute hepatic insufficiency, have not been studied.

In the event of acute overdosage, reversible renal toxicity has been reported in some cases. Empty the stomach by inducing vomiting or by gastric lavage. Observe the patient carefully and give supportive treatment, including monitoring of renal function, urinary pH and acidify, if required, to prevent crystalluria and administration of magnesium, aluminum, or calcium containing antacids which can reduce the absorption of Ciprofloxacin. Adequate hydration must be maintained. Only a small amount of Ciprofloxacin (less than 10%) is removed from the body after hemodialysis or peritoneal dialysis.

Ciprofloxacin Tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3•HCl•H2O and its chemical structure is as follows:

Ciprofloxacin, USP is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.34. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:

Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (Ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets USP are white to off-white. The inactive ingredients are corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (maize), purified water, silicon dioxide, talc, and titanium dioxide.

Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology (12.4)].

Absorption

The absolute bioavailability of Ciprofloxacin when given as an oral tablet is approximately 70% with no substantial loss by first pass metabolism. Ciprofloxacin maximum serum concentrations (Cmax) and area under the curve (AUC) are shown in the chart for the 250 mg to 1,000 mg dose range (Table 12).

Maximum serum concentrations are attained 1 to 2 hours after oral dosing. Mean concentrations 12 hours after dosing with 250 mg, 500 mg, or 750 mg are 0.1 mcg/mL, 0.2 mcg/mL, and 0.4 mcg/mL, respectively. The serum elimination half-life in subjects with normal renal function is approximately 4 hours. Serum concentrations increase proportionately with doses up to 1,000 mg.

A 500 mg oral dose given every 12 hours has been shown to produce an AUC equivalent to that produced by an intravenous infusion of 400 mg Ciprofloxacin given over 60 minutes every 12 hours. A 750 mg oral dose given every 12 hours has been shown to produce an AUC at steady-state equivalent to that produced by an intravenous infusion of 400 mg given over 60 minutes every 8 hours. A 750 mg oral dose results in a Cmax similar to that observed with a 400 mg intravenous dose. A 250 mg oral dose given every 12 hours produces an AUC equivalent to that produced by an infusion of 200 mg Ciprofloxacin given every 12 hours (Table 13).

Food

When Ciprofloxacin tablets are given concomitantly with food, there is a delay in the absorption of the drug, resulting in peak concentrations that occur closer to 2 hours after dosing rather than 1 hour. The overall absorption of Ciprofloxacin tablets, however, is not substantially affected. Avoid concomitant administration of Ciprofloxacin with dairy products (like milk or yogurt) or calcium-fortified juices alone since decreased absorption is possible; however, Ciprofloxacin may be taken with a meal that contains these products.

With oral administration, a 500 mg dose, given as 10 mL of the 5% Ciprofloxacin suspension (containing 250 mg Ciprofloxacin/5 mL) is bioequivalent to the 500 mg tablet.

Distribution

The binding of Ciprofloxacin to serum proteins is 20% to 40% which is not likely to be high enough to cause significant protein binding interactions with other drugs.

After oral administration, Ciprofloxacin is widely distributed throughout the body. Tissue concentrations often exceed serum concentrations in both men and women, particularly in genital tissue including the prostate. Ciprofloxacin is present in active form in the saliva, nasal and bronchial secretions, mucosa of the sinuses, sputum, skin blister fluid, lymph, peritoneal fluid, bile, and prostatic secretions. Ciprofloxacin has also been detected in lung, skin, fat, muscle, cartilage, and bone. The drug diffuses into the cerebrospinal fluid (CSF); however, CSF concentrations are generally less than 10% of peak serum concentrations. Low levels of the drug have been detected in the aqueous and vitreous humors of the eye.

Metabolism

Four metabolites have been identified in human urine which together account for approximately 15% of an oral dose. The metabolites have antimicrobial activity, but are less active than unchanged Ciprofloxacin. Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Coadministration of Ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the coadministered drug [see Contraindications (4.2), Warnings and Precautions (5.10, 5.16), and Drug Interactions (7)].

Excretion

The serum elimination half-life in subjects with normal renal function is approximately 4 hours. Approximately 40 to 50% of an orally administered dose is excreted in the urine as unchanged drug. After a 250 mg oral dose, urine concentrations of Ciprofloxacin usually exceed 200 mcg/mL during the first two hours and are approximately 30 mcg/mL at 8 to 12 hours after dosing. The urinary excretion of Ciprofloxacin is virtually complete within 24 hours after dosing. The renal clearance of Ciprofloxacin, which is approximately 300 mL/minute, exceeds the normal glomerular filtration rate of 120 mL/minute. Thus, active tubular secretion would seem to play a significant role in its elimination. Coadministration of probenecid with Ciprofloxacin results in about a 50% reduction in the Ciprofloxacin renal clearance and a 50% increase in its concentration in the systemic circulation.

Although bile concentrations of Ciprofloxacin are several fold higher than serum concentrations after oral dosing, only a small amount of the dose administered is recovered from the bile as unchanged drug. An additional 1% to 2% of the dose is recovered from the bile in the form of metabolites. Approximately 20% to 35% of an oral dose is recovered from the feces within 5 days after dosing. This may arise from either biliary clearance or transintestinal elimination.

Specific Populations

Elderly

Pharmacokinetic studies of the oral (single dose) and intravenous (single and multiple dose) forms of Ciprofloxacin indicate that plasma concentrations of Ciprofloxacin are higher in elderly subjects (older than 65 years) as compared to young adults. Although the Cmax is increased 16% to 40%, the increase in mean AUC is approximately 30%, and can be at least partially attributed to decreased renal clearance in the elderly. Elimination half-life is only slightly (~20%) prolonged in the elderly. These differences are not considered clinically significant [see Use in Specific Populations (8.5)].

Renal Impairment

In patients with reduced renal function, the half-life of Ciprofloxacin is slightly prolonged. Dosage adjustments may be required [see Use in Specific Populations (8.6) and Dosage and Administration (2.3)].

Hepatic Impairment

In preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in Ciprofloxacin pharmacokinetics have been observed. The kinetics of Ciprofloxacin in patients with acute hepatic insufficiency, have not been fully studied.

Pediatrics

Following a single oral dose of 10 mg/kg Ciprofloxacin suspension to 16 children ranging in age from 4 months to 7 years, the mean Cmax was 2.4 mcg/mL (range: 1.5 mcg/mL to 3.4 mcg/mL) and the mean AUC was 9.2 mcg*hr/mL (range: 5.8 mcg*hr/mL to 14.9 mcg*h/mL). There was no apparent age-dependence, and no notable increase in Cmax or AUC upon multiple dosing (10 mg/kg three times a day). In children with severe sepsis who were given Ciprofloxacin IV (10 mg/kg as a 1-hour intravenous infusion), the mean Cmax was 6.1 mcg/mL (range: 4.6 mcg/mL to 8.3 mcg/mL) in 10 children less than 1 year of age; and 7.2 mcg/mL (range: 4.7 mcg/mL to 11.8 mcg/mL) in 10 children between 1 year and 5 years of age. The AUC values were 17.4 mcg*hr/mL (range: 11.8 mcg*hr/mL to 32 mcg*hr/mL) and 16.5 mcg*hr/mL (range: 11 mcg*hr/mL to 23.8 mcg*hr/mL) in the respective age groups. These values are within the range reported for adults at therapeutic doses. Based on population pharmacokinetic analysis of pediatric patients with various infections, the predicted mean half-life in children is approximately 4 hours to 5 hours, and the bioavailability of the oral suspension is approximately 60%.

Drug-Drug Interactions

Antacids

Concurrent administration of antacids containing magnesium hydroxide or aluminum hydroxide may reduce the bioavailability of Ciprofloxacin by as much as 90% [see Dosage and Administration (2.4) and Drug Interactions (7)].

Histamine H2-receptor antagonists

Histamine H2-receptor antagonists appear to have no significant effect on the bioavailability of Ciprofloxacin.

Metronidazole

The serum concentrations of Ciprofloxacin and metronidazole were not altered when these two drugs were given concomitantly.

Tizanidine

In a pharmacokinetic study, systemic exposure of tizanidine (4 mg single dose) was significantly increased (Cmax 7-fold, AUC 10-fold) when the drug was given concomitantly with Ciprofloxacin (500 mg twice a day for 3 days). Concomitant administration of tizanidine and Ciprofloxacin is contraindicated due to the potentiation of hypotensive and sedative effects of tizanidine [see Contraindications (4.2)].

Ropinirole

In a study conducted in 12 patients with Parkinson’s disease who were administered 6 mg ropinirole once daily with 500 mg Ciprofloxacin twice-daily, the mean Cmax and mean AUC of ropinirole were increased by 60% and 84%, respectively. Monitoring for ropinirole-related adverse reactions and appropriate dose adjustment of ropinirole is recommended during and shortly after coadministration with Ciprofloxacin [see Warnings and Precautions (5.10)].

Clozapine

Following concomitant administration of 250 mg Ciprofloxacin with 304 mg clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Careful monitoring of clozapine associated adverse reactions and appropriate adjustment of clozapine dosage during and shortly after coadministration with Ciprofloxacin are advised.

Sildenafil

Following concomitant administration of a single oral dose of 50 mg sildenafil with 500 mg Ciprofloxacin to healthy subjects, the mean Cmax and mean AUC of sildenafil were both increased approximately two-fold. Use sildenafil with caution when coadministered with Ciprofloxacin due to the expected two-fold increase in the exposure of sildenafil upon coadministration of Ciprofloxacin.

Duloxetine

In clinical studies it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP450 1A2 isozyme such as fluvoxamine, may result in a 5-fold increase in mean AUC and a 2.5-fold increase in mean Cmax of duloxetine.

Lidocaine

In a study conducted in 9 healthy volunteers, concomitant use of 1.5 mg/kg IV lidocaine with Ciprofloxacin 500 mg twice daily resulted in an increase of lidocaine Cmax and AUC by 12% and 26%, respectively. Although lidocaine treatment was well tolerated at this elevated exposure, a possible interaction with Ciprofloxacin and an increase in adverse reactions related to lidocaine may occur upon concomitant administration.

Metoclopramide

Metoclopramide significantly accelerates the absorption of oral Ciprofloxacin resulting in a shorter time to reach maximum plasma concentrations. No significant effect was observed on the bioavailability of Ciprofloxacin.

Omeprazole

When Ciprofloxacin was administered as a single 1,000 mg dose concomitantly with omeprazole (40 mg once daily for three days) to 18 healthy volunteers, the mean AUC and Cmax of Ciprofloxacin were reduced by 20% and 23%, respectively. The clinical significance of this interaction has not been determined.

Mechanism of Action

The bactericidal action of Ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination.

Mechanism of Resistance

The mechanism of action of fluoroquinolones, including Ciprofloxacin, is different from that of penicillins, cephalosporins, aminoglycosides, macrolides, and tetracyclines; therefore, microorganisms resistant to these classes of drugs may be susceptible to Ciprofloxacin. Resistance to fluoroquinolones occurs primarily by either mutations in the DNA gyrases, decreased outer membrane permeability, or drug efflux. In vitro resistance to Ciprofloxacin develops slowly by multiple step mutations. Resistance to Ciprofloxacin due to spontaneous mutations occurs at a general frequency of between less than 10-9 to 1×10-6.

Cross Resistance

There is no known cross-resistance between Ciprofloxacin and other classes of antimicrobials. Ciprofloxacin has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections [see Indications and Usage (1)].

Gram-positive bacteria
Bacillus anthracis
Enterococcus faecalis
Staphylococcus aureus (methicillin-susceptible isolates only)
Staphylococcus epidermidis (methicillin-susceptible isolates only)
Staphylococcus saprophyticus
Streptococcus pneumoniae
Streptococcus pyogenes

Gram-negative bacteria
Campylobacter jejuni
Citrobacter koseri
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Haemophilus influenzae
Haemophilus parainfluenzae
Klebsiella pneumoniae
Moraxella catarrhalis
Morganella morganii
Neisseria gonorrhoeae
Proteus mirabilis
Proteus vulgaris
Providencia rettgeri
Providencia stuartii
Pseudomonas aeruginosa
Salmonella typhi
Serratia marcescens
Shigella boydii
Shigella dysenteriae
Shigella flexneri
Shigella sonnei
Yersinia pestis

The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for Ciprofloxacin (less than or equal to 1 mcg/mL). However, the efficacy of Ciprofloxacin in treating clinical infections due to these bacteria has not been established in adequate and well-controlled clinical trials.

Gram-positive bacteria
Staphylococcus haemolyticus (methicillin-susceptible isolates only)
Staphylococcus hominis (methicillin-susceptible isolates only)

Gram-negative bacteria
Acinetobacter lwoffi
Aeromonas hydrophila
Edwardsiella tarda
Enterobacter aerogenes
Klebsiella oxytoca
Legionella pneumophila
Pasteurella multocida
Salmonella enteritidis
Vibrio cholerae
Vibrio parahaemolyticus

Vibrio vulnificus
Yersinia enterocolitica

Susceptibility Testing

For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

Eight in vitro mutagenicity tests have been conducted with Ciprofloxacin, and the test results are listed below:

Long-term carcinogenicity studies in rats and mice resulted in no carcinogenic or tumorigenic effects due to Ciprofloxacin at daily oral dose levels up to 250 mg/kg and 750 mg/kg to rats and mice, respectively (approximately 1.7- and 2.5-times the highest recommended therapeutic dose based upon body surface area, respectively).

Results from photo co-carcinogenicity testing indicate that Ciprofloxacin does not reduce the time to appearance of UV-induced skin tumors as compared to vehicle control. Hairless (Skh-1) mice were exposed to UVA light for 3.5 hours five times every two weeks for up to 78 weeks while concurrently being administered Ciprofloxacin. The time to development of the first skin tumors was 50 weeks in mice treated concomitantly with UVA and Ciprofloxacin (mouse dose approximately equal to maximum recommended human dose based upon body surface area), as opposed to 34 weeks when animals were treated with both UVA and vehicle. The times to development of skin tumors ranged from 16 weeks to 32 weeks in mice treated concomitantly with UVA and other quinolones.5

In this model, mice treated with Ciprofloxacin alone did not develop skin or systemic tumors. There are no data from similar models using pigmented mice and/or fully haired mice. The clinical significance of these findings to humans is unknown.

Fertility studies performed in rats at oral doses of Ciprofloxacin up to 100 mg/kg (approximately 0.7-times the highest recommended therapeutic dose based upon body surface area) revealed no evidence of impairment.

Ciprofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested [see Warnings and Precautions (5.13)]. Damage of weight bearing joints was observed in juvenile dogs and rats. In young beagles, 100 mg/kg Ciprofloxacin, given daily for 4 weeks, caused degenerative articular changes of the knee joint. At 30 mg/kg, the effect on the joint was minimal. In a subsequent study in young beagle dogs, oral Ciprofloxacin doses of 30 mg/kg and 90 mg/kg Ciprofloxacin (approximately 1.3-times and 3.5-times the pediatric dose based upon comparative plasma AUCs) given daily for 2 weeks caused articular changes which were still observed by histopathology after a treatment-free period of 5 months. At 10 mg/kg (approximately 0.6-times the pediatric dose based upon comparative plasma AUCs), no effects on joints were observed. This dose was also not associated with arthrotoxicity after an additional treatment-free period of 5 months. In another study, removal of weight bearing from the joint reduced the lesions but did not totally prevent them.

Crystalluria, sometimes associated with secondary nephropathy, occurs in laboratory animals dosed with Ciprofloxacin. This is primarily related to the reduced solubility of Ciprofloxacin under alkaline conditions, which predominate in the urine of test animals; in man, crystalluria is rare since human urine is typically acidic. In rhesus monkeys, crystalluria without nephropathy was noted after single oral doses as low as 5 mg/kg. (approximately 0.07-times the highest recommended therapeutic dose based upon body surface area). After 6 months of intravenous dosing at 10 mg/kg/day, no nephropathological changes were noted; however, nephropathy was observed after dosing at 20 mg/kg/day for the same duration (approximately 0.2-times the highest recommended therapeutic dose based upon body surface area).

In dogs, Ciprofloxacin at 3 mg/kg and 10 mg/kg by rapid intravenous injection (15 sec.) produces pronounced hypotensive effects. These effects are considered to be related to histamine release, since they are partially antagonized by pyrilamine, an antihistamine. In rhesus monkeys, rapid intravenous injection also produces hypotension but the effect in this species is inconsistent and less pronounced.

In mice, concomitant administration of nonsteroidal anti-inflammatory drugs such as phenylbutazone and indomethacin with quinolones has been reported to enhance the CNS stimulatory effect of quinolones.

Ocular toxicity seen with some related drugs has not been observed in Ciprofloxacin-treated animals.

Ciprofloxacin administered intravenously and/or orally was compared to a cephalosporin for treatment of cUTI and pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years). The trial was conducted in the US, Canada, Argentina, Peru, Costa Rica, Mexico, South Africa, and Germany. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days). The primary objective of the study was to assess musculoskeletal and neurological safety.

Patients were evaluated for clinical success and bacteriological eradication of the baseline organism(s) with no new infection or superinfection at 5 to 9 days post-therapy (Test of Cure or TOC). The Per Protocol population had a causative organism(s) with protocol specified colony count(s) at baseline, no protocol violation, and no premature discontinuation or loss to follow-up (among other criteria).

The clinical success and bacteriologic eradication rates in the Per Protocol population were similar between Ciprofloxacin and the comparator group as shown below.

The mean serum concentrations of Ciprofloxacin associated with a statistically significant improvement in survival in the rhesus monkey model of inhalational anthrax are reached or exceeded in adult and pediatric patients receiving oral and intravenous regimens. Ciprofloxacin pharmacokinetics have been evaluated in various human populations. The mean peak serum concentration achieved at steady-state in human adults receiving 500 mg orally every 12 hours is 2.97 mcg/mL, and 4.56 mcg/mL following 400 mg intravenously every 12 hours. The mean trough serum concentration at steady-state for both of these regimens is 0.2 mcg/mL. In a study of 10 pediatric patients between 6 and 16 years of age, the mean peak plasma concentration achieved is 8.3 mcg/mL and trough concentrations range from 0.09 mcg/mL to 0.26 mcg/mL, following two 30-minute intravenous infusions of 10 mg/kg administered 12 hours apart. After the second intravenous infusion patients switched to 15 mg/kg orally every 12 hours achieve a mean peak concentration of 3.6 mcg/mL after the initial oral dose. Long-term safety data, including effects on cartilage, following the administration of Ciprofloxacin to pediatric patients are limited. Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication.1

A placebo-controlled animal study in rhesus monkeys exposed to an inhaled mean dose of 11 LD50 (~5.5 x 105 spores (range 5 to 30 LD50) of B. anthracis was conducted. The minimal inhibitory concentration (MIC) of Ciprofloxacin for the anthrax strain used in this study was 0.08 mcg/mL. In the animals studied, mean serum concentrations of Ciprofloxacin achieved at expected Tmax (1 hour post-dose) following oral dosing to steady-state ranged from 0.98 mcg/mL to 1.69 mcg/mL. Mean steady-state trough concentrations at 12 hours post-dose ranged from 0.12 mcg/mL to 0.19 mcg/mL.6 Mortality due to anthrax for animals that received a 30-day regimen of oral Ciprofloxacin beginning 24 hours post-exposure was significantly lower (1/9), compared to the placebo group (9/10) [p= 0.001]. The one Ciprofloxacin-treated animal that died of anthrax did so following the 30-day drug administration period.7

More than 9,300 persons were recommended to complete a minimum of 60 days of antibacterial prophylaxis against possible inhalational exposure to B. anthracis during 2001. Ciprofloxacin was recommended to most of those individuals for all or part of the prophylaxis regimen. Some persons were also given anthrax vaccine or were switched to alternative antibacterial drugs. No one who received Ciprofloxacin or other therapies as prophylactic treatment subsequently developed inhalational anthrax. The number of persons who received Ciprofloxacin as all or part of their post-exposure prophylaxis regimen is unknown.

A placebo-controlled animal study in African green monkeys exposed to an inhaled mean dose of 110 LD50 (range 92 to 127 LD50) of Yersinia pestis (CO92 strain) was conducted. The minimal inhibitory concentration (MIC) of Ciprofloxacin for the Y. pestis strain used in this study was 0.015 mcg/mL. Mean peak serum concentrations of Ciprofloxacin achieved at the end of a single 60 minute infusion were 3.49 ± mcg/mL 0.55 mcg/mL, 3.91 mcg/mL ± 0.58 mcg/mL and 4.03 mcg/mL ± 1.22 mcg/mL on Day 2, Day 6 and Day 10 of treatment in African green monkeys, respectively. All trough concentrations (Day 2, Day 6 and Day 10) were less than 0.5 mcg /mL. Animals were randomized to receive either a 10-day regimen of intravenous Ciprofloxacin 15 mg/kg, or placebo beginning when animals were found to be febrile (a body temperature greater than 1.5°C over baseline for two hours), or at 76 hours post-challenge, whichever occurred sooner. Mortality in the Ciprofloxacin group was significantly lower (1/10) compared to the placebo group (2/2) [difference: -90.0%, 95% exact confidence interval: -99.8% to -5.8%]. The one Ciprofloxacin-treated animal that died did not receive the proposed dose of Ciprofloxacin due to a failure of the administration catheter. Circulating Ciprofloxacin concentration was below 0.5 mcg/mL at all timepoints tested in this animal. It became culture negative on Day 2 of treatment, but had a resurgence of low grade bacteremia on Day 6 after treatment initiation. Terminal blood culture in this animal was negative.8

Kelly DJ, et al. Serum concentrations of penicillin, doxycycline, and Ciprofloxacin during prolonged therapy in rhesus monkeys. J Infect Dis 1992; 166:1184-7.

Friedlander AM, et al. Postexposure prophylaxis against experimental inhalational anthrax. J Infect Dis 1993; 167:1239-42.

Anti-infective Drugs Advisory Committee Meeting, April 3, 2012 – The efficacy of Ciprofloxacin for treatment of Pneumonic Plague.

Ciprofloxacin Tablets USP, 250 mg are available as white to off-white, round, unscored, biconvex film-coated tablets, with “”on one side and on the other side containing 250 mg Ciprofloxacin.

Ciprofloxacin Tablets USP, 500 mg are available as white to off-white, capsule shaped, unscored, biconvex film-coated tablets, with “”on one side and “CR 500” on the other side containing 500 mg Ciprofloxacin.

Ciprofloxacin Tablets USP, 750 mg are available as white to off-white, capsule shaped, unscored, biconvex film-coated tablets, with “”on one side and “CR 750” on the other side containing 750 mg Ciprofloxacin.

Ciprofloxacin Tablets USP, 250 mg, 500 mg, and 750 mg are available in the following pack types.

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Serious Adverse Reactions

Advise patients to stop taking Ciprofloxacin tablets if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug.

Inform patients of the following serious adverse reactions that have been associated with Ciprofloxacin tablets or other fluoroquinolone use:

Antibacterial Resistance

Inform patients that antibacterial drugs including Ciprofloxacin tablets should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When Ciprofloxacin tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Ciprofloxacin tablets or other antibacterial drugs in the future.

Administration with Food, Fluids, and Concomitant Medications

Inform patients that Ciprofloxacin tablets may be taken with or without food.

Inform patients to drink fluids liberally while taking Ciprofloxacin tablets to avoid formation of highly concentrated urine and crystal formation in the urine.

Inform patients that antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine should be taken at least two hours before or six hours after Ciprofloxacin tablets administration. Ciprofloxacin tablets should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone since absorption of Ciprofloxacin may be significantly reduced; however, Ciprofloxacin tablets may be taken with a meal that contains these products.

Drug Interactions Oral Antidiabetic Agents

Inform patients that hypoglycemia has been reported when Ciprofloxacin and oral antidiabetic agents were coadministered; if low blood sugar occurs with Ciprofloxacin tablets, instruct them to consult their physician and that their antibacterial medicine may need to be changed.

Anthrax and Plague Studies

Inform patients given Ciprofloxacin tablets for these conditions that efficacy studies could not be conducted in humans for feasibility reasons. Therefore, approval for these conditions was based on efficacy studies conducted in animals.

Brands listed are the trademarks of their respective owners.

Manufactured In India By:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA

Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. B 5/2019

Ciprofloxacin (sipʺ roe flox’ a sin)Tablets
for oral use

Read this Medication Guide before you start taking Ciprofloxacin tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Ciprofloxacin tablets?

Ciprofloxacin tablets, a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death.

If you get any of the following serious side effects while you take Ciprofloxacin tablets, you should stop taking Ciprofloxacin tablets immediately and get medical help right away.

1. Tendon rupture or swelling of the tendon (tendinitis).

The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons.

2. Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including Ciprofloxacin tablets. Stop taking Ciprofloxacin tablets immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:

Ciprofloxacin tablets may need to be stopped to prevent permanent nerve damage.

3. Central Nervous System (CNS) effects. Seizures have been reported in people who take fluoroquinolone antibacterial medicines, including Ciprofloxacin tablets. Tell your healthcare provider if you have a history of seizures before you start taking Ciprofloxacin tablets. CNS side effects may happen as soon as after taking the first dose of Ciprofloxacin tablets. Stop taking Ciprofloxacin tablets immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:

that are not there (hallucinations)

without blurred vision

4. Worsening of myasthenia gravis (a problem that causes muscle weakness). Fluoroquinolones like Ciprofloxacin tablets may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Tell your healthcare provider if you have a history of myasthenia gravis before you start taking Ciprofloxacin tablets. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

What are Ciprofloxacin tablets?

Ciprofloxacin tablets are a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:
      • urinary tract infection
      • chronic prostate infection
      • lower respiratory tract infection
      • sinus infection
      • skin infection
      • bone and joint infection
      • nosocomial pneumonia
      • intra-abdominal infection, complicated
      • infectious diarrhea
      • typhoid (enteric) fever
      • cervical and urethral gonorrhea, uncomplicated
      • people with a low white blood cell count and a fever
      • inhalational anthrax
      • plague
• Studies of Ciprofloxacin tablets for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people.
• Ciprofloxacin tablets should not be used in patients with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available.
• Ciprofloxacin tablets should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections cause by a certain type of bacterial called Streptococcus pneumoniae.
• Ciprofloxacin tablets are also used in children younger than 18 years of age to treat complicated urinary tract and kidney infections or who may have breathed in anthrax germs, have plague or have been exposed to plague germs.
• Children younger than 18 years of age have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking Ciprofloxacin tablets. Ciprofloxacin tablets should not be used as the first choice of antibacterial medicine in children under 18 years of age.

Who should not take Ciprofloxacin tablets?

Do not take Ciprofloxacin tablets if you:

What should I tell my healthcare provider before taking Ciprofloxacin tablets?

Before you take Ciprofloxacin tablets, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• Ciprofloxacin tablets and other medicines can affect each other causing side effects.

• Especially tell your healthcare provider if you take:

• Certain medicines may keep Ciprofloxacin tablets from working correctly. Take Ciprofloxacin tablets either 2 hours before or 6 hours after taking these medicines, vitamins, or supplements:

Ask your healthcare provider for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Ciprofloxacin tablets?

Taking all of your Ciprofloxacin tablets doses will help make sure that all of the bacteria are killed. Taking all of your Ciprofloxacin tablets doses will help lower the chance that the bacteria will become resistant to Ciprofloxacin tablets. If you become resistant to Ciprofloxacin tablets, Ciprofloxacin tablets and other antibacterial medicines may not work for you in the future.

What should I avoid while taking Ciprofloxacin tablets?

What are the possible side effects of Ciprofloxacin tablets?

Ciprofloxacin tablets may cause serious side effects, including:

Skin rash may happen in people taking Ciprofloxacin tablets even after only 1 dose. Stop taking Ciprofloxacin tablets at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to Ciprofloxacin tablets.

○ nausea or vomiting
○ stomach pain
○  fever
○  weakness
○  abdominal pain or tenderness
○  itching
○  unusual tiredness
○  loss of appetite
○  light colored bowel movements
○  dark colored urine
○  yellowing of your skin or the whites of your eyes

Stop taking Ciprofloxacin tablets and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to Ciprofloxacin tablets (a liver problem).

Changes in blood sugar

People who take Ciprofloxacin tablets and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your healthcare provider’s instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while taking Ciprofloxacin, stop taking Ciprofloxacin and call your healthcare provider right away. Your antibiotic medicine may need to be changed.

The most common side effects of Ciprofloxacin tablets include:

Tell your healthcare provider about any side effect that bothers you, or that does not go away.

These are not all the possible side effects of Ciprofloxacin tablets. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

How should I store Ciprofloxacin tablets?

Keep Ciprofloxacin tablets and all medicines out of the reach of children.

General Information about the safe and effective use of Ciprofloxacin tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ciprofloxacin tablets for a condition for which they are not prescribed. Do not give Ciprofloxacin tablets to other people, even if they have the same symptoms that you have. They may harm them.

This Medication Guide summarizes the most important information about Ciprofloxacin tablets. If you would like more information about Ciprofloxacin tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Ciprofloxacin tablets that is written for healthcare professionals.

For more information call 1-800-272-5525.

What are the ingredients in Ciprofloxacin tablets?

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Brands listed are the trademarks of their respective owners.

Manufactured In India By:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA

Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. B 5/2019

NDC 16252-514-01
Ciprofloxacin Tablets, USP 250 mg*
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
100 Tablets
Rx Only
Actavis

NDC 16252-515-01
Ciprofloxacin Tablets, USP 500 mg*
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
100 Tablets
Rx Only
Actavis

NDC 16252-516-05
Ciprofloxacin Tablets, USP 750 mg*
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
50 Tablets
Rx Only
Actavis

Medical Disclaimer

Other brands: Cipro, Cipro XR, Proquin XR

prednisone, amoxicillin, doxycycline, albuterol, ranitidine, metronidazole, clindamycin, cephalexin, Augmentin, azithromycin

Ciprofloxacin reviews

The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices.

Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more.

Third Party Advertising

We comply with the HONcode standard for trustworthy health information – verify here

Active substance(s): CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE

PDF options: View Fullscreen Download PDF

+ Expand Transcript

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

drug ciprofloxacin 500 mg

The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices.

Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more.

Third Party Advertising

We comply with the HONcode standard for trustworthy health information – verify here

schwach gelber, pulverförmiger Feststoff[1]

Antibiotikum

Gyrasehemmer

fest

318–320 °C (Ciprofloxacin·Hydrochlorid·Monohydrat)[2]

drug ciprofloxacin 500 mg

6,09[3]

Ciprofloxacin ist ein synthetisches Antibiotikum mit breitem Wirkspektrum aus der Gruppe der Fluorchinolone. Die Substanz wurde 1981 von einem Forschungschemiker der Firma Bayer (Klaus Grohe) entwickelt und 1983 patentiert.
[7][8] Antibiotika dieser Gruppe hemmen die Gyrase von Bakterien und damit deren DNA-Replikation und Zellteilung. Sie verhindern dadurch die Zellteilung, und zwar vor allem von gramnegativen Keimen. Fluorchinolone haben weiterhin eine bakterizide Wirkung, deren Ursache bislang ungeklärt ist.[9][10]

Wegen starker Nebenwirkungen geriet das Medikament zunehmend in die Kritik. Die FDA informierte 2008 und 2013 über neu beobachtete schwere Nebenwirkungen bei systemisch angewendeten Fluorchinolon und ordnete entsprechende Maßnahmen an. 2015 hat sie nach ärztlichen Meldeberichten das Nutzen-Risiko-Verhältnis von Cipro-, Levo-, Moxi- und Ofloxacin neu bewertet und 2016 die Anwendung deutlich eingeschränkt.[11] Auch in EU-Ländern wurden mehrmals Warnhinweise und Anwendungsbeschränkungen für Fluorchinolone verfügt. Die Europäische Arzneimittelagentur hat die schwerwiegenden, potentiell dauerhaften und Lebensqualität beeinträchtigenden Nebenwirkungen zuletzt 2018 neu bewertet und Anwendungseinschränkungen empfohlen.[12] Das Bundesinstitut für Arzneimittel und Medizinprodukte hat daraufhin am 8. April 2019 in einem umfassenden Bescheid die Indikationen für Fluorchinolone weiter eingeschränkt und eine weitere Aktualisierung der Gebrauchs- und Fachinformationen angeordnet, um auf möglicherweise irreversible Nebenwirkungen hinzuweisen. Ärzte wurden über einen Rote-Hand-Brief am 8. April 2019 informiert, Fluorchinolone bei einfachen Infektionen nicht mehr einzusetzen.[13]

Ciprofloxacin eignet sich gut gegen alle bakteriellen Erreger einer infektiösen Darmerkrankung. Außerdem ist es wirksam gegen den Problemkeim Pseudomonas aeruginosa. Bei komplizierten Harnwegsinfektionen, die auch von Darmbakterien oder unter Umständen von Pseudomonaden ausgelöst werden, gilt es als Reserveantibiotikum. Weitere Anwendungsgebiete sind Infektionen der Vorsteherdrüse, der Gallenwege, der Atemwege, der Bauchhöhle (Peritonitis) und viele andere Infektionskrankheiten bei Nachweis eines entsprechend empfindlichen Erregers; auf diesen Nachweis kann z. B. bei Infekten des äußeren Gehörgangs verzichtet werden[14]. Ciprofloxacin ist auch zur Behandlung des Milzbrands zugelassen.
Ciprofloxacin kann wie andere moderne Chinolone neben Makroliden und Rifampicin zur Behandlung der Pneumonie durch Legionellen eingesetzt werden. Ciprofloxacin hemmt E. Coli-Topoisomerasen ab einer Konzentration von 0.012 mg/l. Dies ist die minimale Hemmkonzentration (MHK). Sie verursacht bei E. Coli zwar reversible, aber nachweisliche DNA-Schäden.[15] Die MHK anderer Spezies beträgt: Enterobacter cloacae 0,03–1 mg/l, Proteus mirabilis 0,03–0,5 mg/l, Pseudomonas aeruginosa 0,25–8 mg/l, Klebsiella spp. 0,06–1 mg/l, Streptococcus spp. 0,5–4 mg/l, Bacteroides spp. 8 mg/l, Enterococcus faecalis 0,5–64 mg/l und Staphylococcus aureus 0,46–2 mg/l.[16] Ciprofloxacin wirkt weiterhin zytotoxisch und zytostatisch auf menschliches Gewebe: Nekrose von Knorpelzellen wurde ab 1 mg/l beobachtet[17], DNA-Fragmentierung und Apoptose von T-Zellen ab 2,5 mg/l[18], Mitochondrienschäden und Apoptose von Sehnenzellen ab 3 mg/l[19], Proliferationshemmung von Fibroblasten ab 5 mg/l[20], Schädigung der mitochondrialen DNA (mtDNA) und Wachstumshemmung ab 20 mg/l[21], und Unterbrechung des Zellzyklus, Genommutation sowie Verlust der mtDNA ab 25 mg/l.[22][23] Die zytotoxische und zytostatische Wirkung von Ciprofloxacin ist für eine mögliche Anwendung in der Chemotherapie zur Behandlung von Krebszellen von Interesse.[24] Im umu-Test zeigte Ciprofloxacin jedoch eine deutlich stärkere genotoxische Wirkung als die Chemotherapeutika Etoposid, Doxorubicin, Cisplatin, Fluorouracil, Dacarbazin, Bleomycin und Mitomycin C (siehe auch Genotoxisches Potential).[25]

Die Anwendung und damit auch Dosierung von Ciprofloxacin ist abhängig von der zu behandelnden Infektionserkrankung. Allgemein wird
Ciprofloxacin zweimal täglich verabreicht, vorzugsweise peroral (p.o.), alternativ auch intravenös. Zur Therapie der Gonorrhoe (Tripper) ist schon eine einmalige Gabe von 500 mg Ciprofloxacin p.o. in Tablettenform ausreichend. Es sind auch Zubereitungen für eine örtliche Anwendung als Ohren- und Augentropfen erhältlich.

Bei normaler Anwendung (500 mg Einzeldosis bei einer 70 kg schweren Person) beträgt die Konzentration 3 mg/l in Serum/Muskeln, 6–9 mg/l in Prostata/Darm, 18–21 mg/l in Granulozyten, 6–30 mg/l in der Lunge und 15–30 mg/l in der Galle.[26] Die maximale Serumkonzentration von Ciprofloxacin wird eine Stunde nach Einnahme erreicht. Die Halbwertszeit beträgt 4 Stunden. Ciprofloxacin wird zu 40–50 % unverändert über den Urin ausgeschieden[27][28] und zu 25–40 % metabolisiert.[29] Von den identifizierten Metaboliten wirken einige schwächer und andere stärker als das ursprüngliche Ciprofloxacin.[30]

Bei Infektionen die unbehandelt besser werden oder nicht schwerwiegend sind, wird empfohlen Fluorchinolone nicht mehr anzuwenden. Hierzu zählen Infekte des Halses, abakterielle (chronische) Prostatitis, Bronchitis, Sinusitis, Prophylaxe der Reisediarrhoe sowie wiederkehrende Infektionen der unteren Harnwege (Harnwegsinfekte, die nicht über die Blase hinausgehen). Zur Behandlung leichter oder mittelschwerer bakterieller Infektionen sollen sie nur angewendet werden, falls andere üblicherweise für diese Infektionen empfohlene Antibiotika nicht verwendet werden können. Es ist wichtig, dass Fluorchinolone generell bei Patienten, die zuvor schwerwiegende Nebenwirkungen mit einem Fluorchinolon- oder Chinolon-Antibiotikum hatten, vermieden werden sollten. Sie sollten bei älteren Patienten, Patienten mit Nierenerkrankungen und Patienten, die sich einer Organtransplantation unterzogen haben, mit besonderer Vorsicht angewendet werden, da bei diesen Patienten ein höheres Risiko für eine Sehnenverletzung besteht.[31][32]

Häufigste Nebenwirkungen (jedoch unter 10 %) sind Übelkeit, Durchfall und Hautausschläge. Nach prophylaktischer Gabe einer Einzeldosis Ciprofloxacin an 1.390 Schüler wurde eine Nebenwirkungshäufigkeit von 44 % beobachtet, wobei es am häufigsten zu Störungen des Nervensystems kam.[33] Akute Leberschäden treten mit einer Häufigkeit von 1:154 auf.[34] Das Risiko für Sehnenschäden beträgt bei Ciprofloxacin 1:227.[35] In einer Gruppe von 65+ jährigen Patienten erlitten nach der Einnahme von Fluorchinolonen 2,1 % einen Sehnenriss, 1,1 % ein Aortenaneurysma und 0,2 % eine Netzhautablösung.[36] Nebenwirkungen können um Tage bis Wochen verzögert auftreten und langfristig an Intensität zunehmen. Die Nebenwirkungen halten im Durchschnitt 14 Monate bis 9 Jahre an[37] und äußern sich häufig als Konstellation verschiedener Symptome (Erschöpfung, Konzentrationsprobleme, Neuropathien, Tendinopathien und mehr).[38]

Schwerwiegende Nebenwirkungen von Fluorchinolonen sind nicht effektiv behandelbar, daher führen sie in 29,3 % der Fälle zu einer körperlichen Behinderung. Im Vergleich zu anderen gängigen Antibiotika sind Fluorchinolone für die meisten dauerhaften Behinderungen verantwortlich.[39] Der FDA wurden für Fluorchinolone bis 2016 insgesamt 210.705 Verdachtsfälle auf Nebenwirkungen sowie 2.991 Todesfälle gemeldet. Für Ciprofloxacin wurden davon bei 22.488 Patienten insgesamt 100.865 Verdachtsfälle auf Nebenwirkungen und 2.072 Todesfälle gemeldet.[40] Aufgrund der geringen Melderate von 1–10 % wird in den USA die Dunkelziffer an fluorchinolonassoziierten Nebenwirkungen auf 2–21 Millionen sowie die Dunkelziffer an Todesfällen auf 29.000 bis über 299.000 geschätzt.[41] Todesfälle sind bereits ab der ersten Tagesdosis möglich.[3][42]

Ciprofloxacin kann aufgrund seiner Chondrotoxizität Knorpelschäden bei Kindern und Erwachsener verursachen.[17] Fluorchinolone haben im Tierversuch bei jungen Hunden Störungen des Knorpelwachstums verursacht, deshalb sollen sie nicht in der Schwangerschaft, Stillzeit und nicht bei Kindern eingesetzt werden. Davon abweichend ist Ciprofloxacin aufgrund seiner Wirksamkeit gegen Pseudomonas jedoch zur Behandlung von Kindern und Jugendlichen (5–17 Jahre) mit akuten, durch P. aeruginosa verursachten Infektionsschüben einer zystischen Fibrose zugelassen. Weitere Nebenwirkungen sind Neurotoxizität, Lebertoxizität und allergische Reaktionen, auch das Red man syndrome wurde beschrieben. Des Weiteren gibt es mehrere Studien, die den Nachweis erbrachten, dass Ciprofloxacin die Krampfschwelle senken kann: Ein Einsatz bei Patienten mit Anfallsleiden sollte daher nur unter strenger Indikationsstellung erfolgen.[43][44]

2015 wurde in einer Studie gezeigt, dass Fluorchinolone durch Eisen-Chelation der α-Ketoglutarat-abhängigen Dioxygenase den Cofaktor Eisen entziehen. Das könnte die Kollagenreifung stören sowie epigenetische Veränderungen auslösen. Die Autoren schlagen das als eine Ursache für die Fluorchinolon-induzierten Nierenschäden und Tendopathien (Sehnenschädigungen) vor.[45]

Es können Schmerzen, Schwellungen, Risse und Entzündungen der Sehnen aufkommen, einschließlich der Rückseite des Knöchels (auch Schulter-, Hand-, oder andere Sehnensysteme). Dies gilt für Menschen aller Altersgruppen, die Fluorchinolon-Antibiotika einschließlich Ciprofloxacin einnehmen. Der häufigste Bereich der Schmerzen und Schwellungen ist die Achillessehne. Sehnenrupturen können während oder auch noch mehrere Monate nach der Einnahme von Ciprofloxacin erfolgen. Das Risiko von Sehnen-Schäden ist bei Patienten über 60 Jahren höher, vor allem bei Einnahme von Steroiden (Kortikosteroide) oder nach Nieren-, Herz- oder Lungentransplantation. Sehnenschwellungen (Tendinitis) und -risse (Bruch) wurden auch bei Patienten, die Fluorchinolone einnahmen, aber keine der übrigen v.g. Risikofaktoren aufwiesen, festgestellt. Nach einer Feststellung besagter Folgen sollen Bewegungen vermieden werden.[47] Erklärt wird die Nebenwirkung mit einer erhöhten Wirksamkeit von Matrix-Metalloproteinasen, die die Festigkeit der Sehnen herabsetzen können.[48]

Vor den teilweise irreversiblen schwerwiegenden Nebenwirkungen wird in den USA auf dem Beipackzettel des Antibiotikums mittels einer Black-Box-Warnung gewarnt. In der Warnung wird auch darauf hingewiesen, dass das Mittel nicht erste Wahl sein sollte bei akuten Exazerbationen der chronischen Bronchitis, bei akuten unkomplizierten Blasenentzündungen und akuten Sinusitiden.[49]

Selten sind psychotische Störungen mit Suizidtendenz.[50][51] Auf Pharmakovigilanz-Erhebungen der WHO beruhende Studienergebnisse legen jedoch nahe, dass Fluorchinolone mit einem signifikant erhöhten Risiko für Suizidalität und vollendeten Suizid assoziiert sind. Entsprechende Fälle nahmen seit 2008 deutlich zu und wurden am häufigsten nach der Einnahme von Ciprofloxacin beobachtet.[52] Laut Bekanntmachung der Arzneimittelkommission der deutschen Ärzteschaft ist eine hohe Dunkelziffer vollendeter Suizide nach Fluorchinolonanwendung anzunehmen.[53]

Ferner wurde ein erhöhtes Risiko für das Auftreten von Aortenaneurysmen und -dissektionen festgestellt. In Deutschland ordnete das
Bundesinstitut für Arzneimittel und Medizinprodukte im Oktober 2018 für alle systemisch und inhalativ angewendete Fluorchinolone, inklusive Ciprofloxacin, eine entsprechende Information in den Produktinformationstexten an.[54]

Aufgrund von Störungen des Blutzuckerspiegels, einschließlich Hypoglykämie und Hyperglykämie, durch Fluorchinolone[55] ordnete das Bundesinstitut für Arzneimittel und Medizinprodukte im Februar 2019 eine weitere Aktualisierung der Produktinformationstexte für Ciprofloxacin (für die systemische Anwendung) an.[56] Bei Diabetikern kann Ciprofloxacin schon nach einer Einzeldosis lebensbedrohliche Hypoglykämien auslösen.[57] Auch bei Nicht-Diabetikern kann es unter Ciprofloxacin zu Dysglykämien kommen.[58] Mögliche Komplikationen Fluorchinolon-induzierter Blutzuckerstörungen bestehen in zentralnervösen Effekten (Krampfanfall, Koma) mit dauerhaften neurologischen Defiziten.[59] Der Pathomechanismus ist mit erhöhten zytosolischen Calciumkonzentrationen und Beeinträchtigungen der Mitochondrienfunktion in pankreatischen Betazellen assoziiert.[60][61][62] Fluorchinolone stehen im Verdacht, für eine Zunahme des Typ-2-Diabetes in den USA verantwortlich zu sein.[63]

Patienten mit Herzrhythmusstörungen oder Krampfanfällen in der Vorgeschichte sollten coffeinhaltige Lebens- (z. B.: Kaffee, Cola, schwarzen Tee, grünen Tee) und Arzneimittel (häufig Schmerzmittelkombination, Erkältungsmittel) meiden. Der Abbau von Coffein wird durch Cytochrom P450 (Isoenzym 1A2) katalysiert. Einige Gyrasehemmer greifen in den Coffeinmetabolismus ein und blockieren das Cytochrom P450, wodurch der Hauptabbauweg der N-Demethylierung zum Paraxanthin betroffen ist. Dadurch kommt es zu einer Wirkungsverstärkung des Coffeins. Eine vergleichbare Wechselwirkung tritt mit dem strukturähnlichen Methylxantin Theophyllin auf.

Ciprofloxacin hemmt auch das Cytochrom P450 3A4.[64] Dieses Isoenzym metabolisiert 50 % der gängigen Arzneimittel und zählt somit zu den wichtigsten Vertretern der CYP-Familie. Eine Hemmung von CYP3A4 beeinträchtigt gleichzeitig die Entgiftungskapazität der PGP-Pumpe.[65]

Ciprofloxacin darf nicht zusammen mit Quetiapin eingenommen werden, da der Abbau vom Quetiapin deutlich verlangsamt werden kann.

Ciprofloxacin darf nicht zusammen mit Lebens- oder Arzneimitteln, die über einen (hohen) Anteil mehrfach geladener Metallionen verfügen, eingenommen werden (nicht zusammen z. B. mit Milch oder Milchprodukten (Ca2+) oder Antazida (z. B. Mg2+)), da es hier im Rahmen einer Komplexbildung zwischen Metallionen und Wirkstoff zu einer relevanten Abschwächung der Wirkung desselben kommt.[66]

Da Ciprofloxacin zu den Fluorchinolonen gehört, könnte es, wie andere Antibiotika dieser Gruppe, die Wirksamkeit hormoneller Kontrazeptiva herabsetzen. Für den speziellen Fall von Ciprofloxacin hat sich ein solcher Verdacht jedoch bisher nicht bestätigt. In der aktuellen Packungsbeilage von Ciprofloxacin (Stand 2006) wird eine Wechselwirkung zwischen diesem Antibiotikum und hormonellen Kontrazeptiva nicht erwähnt. Mindestens zwei klinische Studien belegen, dass Ciprofloxacin die Wirksamkeit der Antibabypille nicht beeinträchtigt.[67][68] Die Nicht-Beeinträchtigung hormoneller Kontrazeptiva war auch der Grund, dass Ciprofloxacin statt Rifampicin an 4253 Student(inn)en der Universität Oxford ausgegeben wurde, um die Ausbreitung einer Meningokokken-Meningitis zu verhindern.[69]

Grapefruits und deren Saft können die Bioverfügbarkeit, also die Wirksamkeit von Ciprofloxacin, signifikant verringern (siehe hierzu den Artikel Grapefruit, Abschnitt „Wechselwirkung mit Arzneimitteln“). Auch ein zeitlicher Abstand zwischen der Einnahme von Ciprofloxacin und dem Genuss von Grapefruit(saft) im Tagesverlauf verhindert diese Wechselwirkung nicht, da der Abbau der hierfür verantwortlichen Inhaltsstoffe der Grapefruit mehrere Tage dauert.

Ciprofloxacin kann mit einer Schilddrüsenhormon-Ersatztherapie wechselwirken und die Wirkung von Levothyroxin beeinträchtigen.[70]

In prokaryotischen Testsystemen hat sich Ciprofloxacin als stark genotoxisch und hoch mutagen erwiesen.[71][72][73][25] In humanspezifischen Testsystemen induziert Ciprofloxacin Chromosomenaberrationen und Aneuploidie.[74][75] Die hierbei untersuchten Konzentrationen (5 – 25 µg/ml) entsprechen therapeutischen Gewebespiegeln.[76] Im Mausmodell führte Ciprofloxacin bei einer dem humantherapeutischen Dosisbereich vergleichbaren Exposition zu Erbgutschäden.[77][78] Neben der nukleären DNA kann auch die mitochondriale DNA geschädigt werden.[79] Die Einnahme von Ciprofloxacin erhöht möglicherweise das Hautkrebsrisiko.[80] Klinische Beobachtungen legen nahe, dass Ciprofloxacin speziell bei langfristiger Behandlung immunsupprimierter Patienten hochaggressive, metastatische und rezidivierende Plattenepithelkarzinome induzieren kann.[81]

Ciprofloxacin verfügt über reproduktionstoxisches Potential: in vivo kam es bei therapeutisch relevanten Dosierungen zu embryotoxischen (u. a. Früh-, Fehl- und Totgeburten, Fehlbildungen, Organschäden)[82][83][84][85][86] und die Fortpflanzungsfähigkeit beeinträchtigenden Effekten (u. a. hormonelle Störungen, Störungen der Spermatogenese, ultrastrukturelle Spermienschäden, Hodenatrophie). So wurden u. a. DNA Schäden der Spermien nachgewiesen, welche reduzierte Fruchtbarkeit und embryonale Missbildungen im Mausmodell zur Folge hatten.[87][88][89][90] In begrenzten Untersuchungen an exponierten Schwangeren wurden Totgeburten beobachtet.[91][92] Laut Fachinformation (Stand 01/2019) zeigen verfügbare Daten zur Anwendung von Ciprofloxacin bei schwangeren Frauen keine Hinweise auf Fehlbildungen oder fötale/neonatale Toxizität.[93] Zudem liegen laut Fachinformation keine tierexperimentellen Hinweise auf Reproduktionstoxizität vor.[93] Es wird darauf hingewiesen, dass Ciprofloxacin in die Muttermilch übergeht und in der Schwangerschaft und während der Stillzeit wegen möglicher gelenkschädigender Wirkungen nicht eingenommen werden sollte.[93] Laut Zulassungsdaten der Europäischen Arzneimittel-Agentur sind auch andere schwere embryotoxische Effekte möglich.[94]

Agyr (A), Ciloxan (D, A, CH), Ciprobay (D), Ciproxin (A, CH), InfectoCipro (D), Keciflox (D), Otanol (A), Panotile Cipro (D), Quinox (T) zahlreiche Generika (D, A, CH)

Ciproxin HC (CH) [95][96][97]

schwach gelber, pulverförmiger Feststoff[1]

Antibiotikum

Gyrasehemmer

fest

318–320 °C (Ciprofloxacin·Hydrochlorid·Monohydrat)[2]

drug ciprofloxacin 500 mg

6,09[3]

Ciprofloxacin darf nicht zusammen mit Quetiapin eingenommen werden, da der Abbau vom Quetiapin deutlich verlangsamt werden kann.

Ciprofloxacin kann mit einer Schilddrüsenhormon-Ersatztherapie wechselwirken und die Wirkung von Levothyroxin beeinträchtigen.[70]

Agyr (A), Ciloxan (D, A, CH), Ciprobay (D), Ciproxin (A, CH), InfectoCipro (D), Keciflox (D), Otanol (A), Panotile Cipro (D), Quinox (T) zahlreiche Generika (D, A, CH)

Ciproxin HC (CH) [95][96][97]

schwach gelber, pulverförmiger Feststoff[1]

Antibiotikum

Gyrasehemmer

fest

318–320 °C (Ciprofloxacin·Hydrochlorid·Monohydrat)[2]

drug ciprofloxacin 500 mg

6,09[3]

Ciprofloxacin darf nicht zusammen mit Quetiapin eingenommen werden, da der Abbau vom Quetiapin deutlich verlangsamt werden kann.

Ciprofloxacin kann mit einer Schilddrüsenhormon-Ersatztherapie wechselwirken und die Wirkung von Levothyroxin beeinträchtigen.[70]

Agyr (A), Ciloxan (D, A, CH), Ciprobay (D), Ciproxin (A, CH), InfectoCipro (D), Keciflox (D), Otanol (A), Panotile Cipro (D), Quinox (T) zahlreiche Generika (D, A, CH)

Ciproxin HC (CH) [95][96][97]

schwach gelber, pulverförmiger Feststoff[1]

Antibiotikum

Gyrasehemmer

fest

318–320 °C (Ciprofloxacin·Hydrochlorid·Monohydrat)[2]

drug ciprofloxacin 500 mg

6,09[3]

Ciprofloxacin darf nicht zusammen mit Quetiapin eingenommen werden, da der Abbau vom Quetiapin deutlich verlangsamt werden kann.

Ciprofloxacin kann mit einer Schilddrüsenhormon-Ersatztherapie wechselwirken und die Wirkung von Levothyroxin beeinträchtigen.[70]

Agyr (A), Ciloxan (D, A, CH), Ciprobay (D), Ciproxin (A, CH), InfectoCipro (D), Keciflox (D), Otanol (A), Panotile Cipro (D), Quinox (T) zahlreiche Generika (D, A, CH)

Ciproxin HC (CH) [95][96][97]

schwach gelber, pulverförmiger Feststoff[1]

Antibiotikum

Gyrasehemmer

fest

318–320 °C (Ciprofloxacin·Hydrochlorid·Monohydrat)[2]

drug ciprofloxacin 500 mg

6,09[3]

Ciprofloxacin darf nicht zusammen mit Quetiapin eingenommen werden, da der Abbau vom Quetiapin deutlich verlangsamt werden kann.

Ciprofloxacin kann mit einer Schilddrüsenhormon-Ersatztherapie wechselwirken und die Wirkung von Levothyroxin beeinträchtigen.[70]

Agyr (A), Ciloxan (D, A, CH), Ciprobay (D), Ciproxin (A, CH), InfectoCipro (D), Keciflox (D), Otanol (A), Panotile Cipro (D), Quinox (T) zahlreiche Generika (D, A, CH)

Ciproxin HC (CH) [95][96][97]

Ciprofloxacin is an antibiotic used to treat a number of bacterial infections.[2] This includes bone and joint infections, intra abdominal infections, certain type of infectious diarrhea, respiratory tract infections, skin infections, typhoid fever, and urinary tract infections, among others.[2] For some infections it is used in addition to other antibiotics.[2] It can be taken by mouth, as eye drops, as ear drops, or intravenously.[2][3]

Common side effects include nausea, vomiting, diarrhea and rash.[2] Ciprofloxacin increases the risk of tendon rupture.[2] In people with myasthenia gravis, there is worsening muscle weakness.[2] Rates of side effects appear to be higher than some groups of antibiotics such as cephalosporins but lower than others such as clindamycin.[4] Studies in other animals raise concerns regarding use in pregnancy.[5] No problems were identified, however, in the children of a small number of women who took the medication.[5] It appears to be safe during breastfeeding.[2] It is a second-generation fluoroquinolone with a broad spectrum of activity that usually results in the death of the bacteria.[2][6][7]

Ciprofloxacin was patented in 1980 and introduced in 1987.[8][9] It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system.[10] It is available as a generic medication and is not very expensive.[2][11] The wholesale cost in the developing world is between US$0.03 and US$0.13 a dose.[12] In the United States it is sold for about US$0.40 per dose.[2] In 2016 it was the 102nd most prescribed medication in the United States with more than seven million prescriptions.[13]

Ciprofloxacin is used to treat a wide variety of infections, including infections of bones and joints, endocarditis, gastroenteritis, malignant otitis externa, respiratory tract infections, cellulitis, urinary tract infections, prostatitis, anthrax, and chancroid.[2]

drug ciprofloxacin 500 mg

Ciprofloxacin only treats bacterial infections; it does not treat viral infections such as the common cold. For certain uses including acute sinusitis, lower respiratory tract infections and uncomplicated gonorrhea, ciprofloxacin is not considered a first-line agent.

Ciprofloxacin occupies an important role in treatment guidelines issued by major medical societies for the treatment of serious infections, especially those likely to be caused by Gram-negative bacteria, including Pseudomonas aeruginosa. For example, ciprofloxacin in combination with metronidazole is one of several first-line antibiotic regimens recommended by the Infectious Diseases Society of America for the treatment of community-acquired abdominal infections in adults.[14] It also features prominently in treatment guidelines for acute pyelonephritis, complicated or hospital-acquired urinary tract infection, acute or chronic prostatitis,[15] certain types of endocarditis,[16] certain skin infections,[17] and prosthetic joint infections.[18]

In other cases, treatment guidelines are more restrictive, recommending in most cases that older, narrower-spectrum drugs be used as first-line therapy for less severe infections to minimize fluoroquinolone-resistance development. For example, the Infectious Diseases Society of America recommends the use of ciprofloxacin and other fluoroquinolones in urinary tract infections be reserved to cases of proven or expected resistance to narrower-spectrum drugs such as nitrofurantoin or trimethoprim/sulfamethoxazole.[19] The European Association of Urology recommends ciprofloxacin as an alternative regimen for the treatment of uncomplicated urinary tract infections, but cautions that the potential for “adverse events have to be considered”.[15]

Although approved by regulatory authorities for the treatment of respiratory infections, ciprofloxacin is not recommended for respiratory infections by most treatment guidelines due in part to its modest activity against the common respiratory pathogen Streptococcus pneumoniae.[20][21][22] “Respiratory quinolones” such as levofloxacin, having greater activity against this pathogen, are recommended as first line agents for the treatment of community-acquired pneumonia in patients with important co-morbidities and in patients requiring hospitalization (Infectious Diseases Society of America 2007). Similarly, ciprofloxacin is not recommended as a first-line treatment for acute sinusitis.[23][24]

Ciprofloxacin is approved for the treatment of gonorrhea in many countries, but this recommendation is widely regarded as obsolete due to resistance development.[25][26][27]

In the United States ciprofloxacin is pregnancy category C.[28] This category includes drugs for which no adequate and well-controlled studies in human pregnancy exist, and for which animal studies have suggested the potential for harm to the fetus, but potential benefits may warrant use of the drug in pregnant women
despite potential risks. An expert review of published data on experiences with ciprofloxacin use during pregnancy by the Teratogen Information System concluded therapeutic doses during
pregnancy are unlikely to pose a substantial teratogenic risk (quantity and quality of data=fair), but the data are insufficient to state no risk exists.[29] Exposure to quinolones, including levofloxacin, during the first-trimester is not associated with an increased risk of stillbirths, premature births, birth defects, or low birth weight.[30]

Two small post-marketing epidemiology studies of mostly short-term, first-trimester exposure found that fluoroquinolones did not increase risk of major malformations, spontaneous abortions, premature birth, or low birth weight.[31][32] The label notes, however, that these studies are insufficient to reliably evaluate the definitive safety or risk of less common defects by ciprofloxacin in pregnant women and their developing fetuses.

Fluoroquinolones have been reported as present in a mother’s milk and thus passed on to the nursing child.[33][34] The U.S. FDA recommends that because of the risk of serious adverse reactions (including articular damage) in infants nursing from mothers taking ciprofloxacin, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Oral and intravenous ciprofloxacin are approved by the FDA for use in children for only two indications due to the risk of permanent injury to the musculoskeletal system:

1) Inhalational anthrax (postexposure)[35]

2) Complicated urinary tract infections and pyelonephritis due to Escherichia coli,[36] but never as first-line agents. Current recommendations by the American Academy of Pediatrics note the systemic use of ciprofloxacin in children should be restricted to infections caused by multidrug-resistant pathogens or when no safe or effective alternatives are available.[37]

Its spectrum of activity includes most strains of bacterial pathogens responsible for community-acquired pneumonias, bronchitis, urinary tract infections, and gastroenteritis.[38] Ciprofloxacin is particularly effective against Gram-negative bacteria (such as Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Legionella pneumophila, Moraxella catarrhalis, Proteus mirabilis, and Pseudomonas aeruginosa), but is less effective against Gram-positive bacteria (such as methicillin-sensitive Staphylococcus aureus, Streptococcus pneumoniae, and Enterococcus faecalis) than newer fluoroquinolones.[39]

As a result of its widespread use to treat minor infections readily treatable with older, narrower spectrum antibiotics, many bacteria have developed resistance to this drug in recent years, leaving it significantly less effective than it would have been otherwise.[40][41]

Resistance to ciprofloxacin and other fluoroquinolones may evolve rapidly, even during a course of treatment. Numerous pathogens, including enterococci, Streptococcus pyogenes and Klebsiella pneumoniae (quinolone-resistant) now exhibit resistance.[42] Widespread veterinary usage of the fluoroquinolones, particularly in Europe, has been implicated.[43] Meanwhile, some Burkholderia cepacia, Clostridium innocuum and Enterococcus faecium strains have developed resistance to ciprofloxacin to varying degrees.[44]

Fluoroquinolones had become the class of antibiotics most commonly prescribed to adults in 2002.[45] Nearly half (42%) of those prescriptions in the U.S. were for conditions not approved by the FDA, such as acute bronchitis, otitis media, and acute upper respiratory tract infection, according to a study supported in part by the Agency for Healthcare Research and Quality.[45] Additionally, they were commonly prescribed for medical conditions that were not even bacterial to begin with, such as viral infections, or those to which no proven benefit existed.

Contraindications include:[46]

Ciprofloxacin is also considered to be contraindicated in children (except for the indications outlined above), in pregnancy, to nursing mothers, and in people with epilepsy or other seizure disorders.

Adverse effects can involve the tendons, muscles, joints, nerves, and the central nervous system.[47][48]

Rates of adverse effects appear to be higher than with some groups of antibiotics such as cephalosporins but lower than with others such as clindamycin.[4] Compared to other antibiotics some studies find a higher rate of adverse effects[49][50] while others find no difference.[51]

In clinical trials most of the adverse events were described as mild or moderate in severity, abated soon after the drug was discontinued, and required no treatment.[28] Some adverse effects may be permanent.[47] Ciprofloxacin was stopped because of an adverse event in 1% of people treated with the medication by mouth. The most frequently reported drug-related events, from trials of all formulations, all dosages, all drug-therapy durations, and for all indications, were nausea (2.5%), diarrhea (1.6%), abnormal liver function tests (1.3%), vomiting (1%), and rash (1%). Other adverse events occurred at rates of <1%.[52]

Ciprofloxacin includes a black box warning in the United States of an increased risk of tendinitis and tendon rupture, especially in people who are older than 60 years, people who also use corticosteroids, and people with kidney, lung, or heart transplants.[53] Tendon rupture can occur during therapy or even months after discontinuation of the medication.[54] One study found that fluoroquinolone use was associated with a 1.9-fold increase in tendon problems. The risk increased to 3.2 in those over 60 years of age and to 6.2 in those over the age of 60 who were also taking corticosteroids. Among the 46,766 quinolone users in the study, 38 (0.08%) cases of Achilles tendon rupture were identified.[55]

The fluoroquinolones, including ciprofloxacin, are associated with an increased risk of cardiac toxicity, including QT interval prolongation, torsades de pointes, ventricular arrhythmia, and sudden death. [56][57]

The 2013 FDA label warns of nervous system effects. Ciprofloxacin, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold, and may cause other central nervous system adverse effects. Headache, dizziness, and insomnia have been reported as occurring fairly commonly in postapproval review articles, along with a much lower incidence of serious CNS adverse effects such as tremors, psychosis, anxiety, hallucinations, paranoia, and suicide attempts, especially at higher doses.[4] Like other fluoroquinolones, it is also known to cause peripheral neuropathy that may be irreversible, such as weakness, burning pain, tingling or numbness.[58]

Ciprofloxacin is active in six of eight in vitro assays used as rapid screens for the detection of genotoxic effects, but is not active in in vivo assays of genotoxicity.[28] Long-term carcinogenicity studies in rats and mice resulted in no carcinogenic or tumorigenic effects due to ciprofloxacin at daily oral dose levels up to 250 and 750 mg/kg to rats and mice, respectively (about 1.7 and 2.5 times the highest recommended therapeutic dose based upon mg/m2). Results from photo co-carcinogenicity testing indicate ciprofloxacin does not reduce the time to appearance of UV-induced skin tumors as compared to vehicle control.[citation needed]

The other black box warning is that ciprofloxacin should not be used in people with myasthenia gravis due to possible exacerbation of muscle weakness which may lead to breathing problems resulting in death or ventilator support. Fluoroquinolones are known to block neuromuscular transmission.[28] There are concerns that fluoroquinolones including ciprofloxacin can affect cartilage in young children.[59]

Clostridium difficile-associated diarrhea is a serious adverse effect of ciprofloxacin and other fluoroquinolones; it is unclear whether the risk is higher than with other broad-spectrum antibiotics.[60]

A wide range of rare but potentially fatal adverse effects reported to the U.S. FDA or the subject of case reports includes aortic dissection,[61] toxic epidermal necrolysis, Stevens-Johnson syndrome, low blood pressure, allergic pneumonitis, bone marrow suppression, hepatitis or liver failure, and sensitivity to light.[28][62] The medication should be discontinued if a rash, jaundice, or other sign of hypersensitivity occurs.[28]

Children and the elderly are at a much greater risk of experiencing adverse reactions.[63][64]

Overdose of ciprofloxacin may result in reversible renal toxicity. Treatment of overdose includes emptying of the stomach by induced vomiting or gastric lavage, as well as administration of antacids containing magnesium, aluminum, or calcium to reduce drug absorption. Renal function and urinary pH should be monitored. Important support includes adequate hydration and urine acidification if necessary to prevent crystalluria. Hemodialysis or peritoneal dialysis can only remove less than 10% of ciprofloxacin.[65] Ciprofloxacin may be quantified in plasma or serum to monitor for drug accumulation in patients with hepatic dysfunction or to confirm a diagnosis of poisoning in acute overdose victims.[66]

Ciprofloxacin interacts with certain foods and several other drugs leading to undesirable increases or decreases in the serum levels or distribution of one or both drugs.

Ciprofloxacin should not be taken with antacids containing magnesium or aluminum, highly buffered drugs (sevelamer, lanthanum carbonate, sucralfate, didanosine), or with supplements containing calcium, iron, or zinc. It should be taken two hours before or six hours after these products. Magnesium or aluminum antacids turn ciprofloxacin into insoluble salts that are not readily absorbed by the intestinal tract, reducing peak serum concentrations by 90% or more, leading to therapeutic failure. Additionally, it should not be taken with dairy products or calcium-fortified juices alone, as peak serum concentration and the area under the serum concentration-time curve can be reduced up to 40%. However, ciprofloxacin may be taken with dairy products or calcium-fortified juices as part of a meal.[65][67][68]

Ciprofloxacin inhibits the drug-metabolizing enzyme CYP1A2 and thereby can reduce the clearance of drugs metabolized by that enzyme. CYP1A2 substrates that exhibit increased serum levels in ciprofloxacin-treated patients include tizanidine, theophylline, caffeine, methylxanthines, clozapine, olanzapine, and ropinirole. Co-administration of ciprofloxacin with the CYP1A2 substrate tizanidine (Zanaflex) is contraindicated due to a 583% increase in the peak serum concentrations of tizanidine when administered with ciprofloxacin as compared to administration of tizanidine alone. Use of ciprofloxacin is cautioned in patients on theophylline due to its narrow therapeutic index. The authors of one review recommended that patients being treated with ciprofloxacin reduce their caffeine intake. Evidence for significant interactions with several other CYP1A2 substrates such as cyclosporine is equivocal or conflicting.[68][69][70]

The Committee on Safety of Medicines and the FDA warn that central nervous system adverse effects, including seizure risk, may be increased when NSAIDs are combined with quinolones.[69][71] The mechanism for this interaction may involve a synergistic increased antagonism of GABA neurotransmission.[72][73]

Altered serum levels of the antiepileptic drugs phenytoin and carbamazepine (increased and decreased) have been reported in patients receiving concomitant ciprofloxacin.[69][74][75]

Ciprofloxacin is a potent inhibitor of CYP1A2, CYP2D6, and CYP3A4.[76]

drug ciprofloxacin 500 mg

Ciprofloxacin is a broad-spectrum antibiotic of the fluoroquinolone class. It is active against both Gram-positive and Gram-negative bacteria. It functions by inhibiting DNA gyrase, and a type II topoisomerase, topoisomerase IV,[77][78] necessary to separate bacterial DNA, thereby inhibiting cell division.

Ciprofloxacin for systemic administration is available as immediate-release tablets, extended-release tablets, an oral suspension, and as a solution for intravenous administration.
When administered over one hour as an intravenous infusion,[28] ciprofloxacin rapidly distributes into the tissues, with levels in some tissues exceeding those in the serum. Penetration into the central nervous system is relatively modest, with cerebrospinal fluid levels normally less than 10% of peak serum concentrations. The serum half-life of ciprofloxacin is about 4–6 hours, with 50-70% of an administered dose being excreted in the urine as unmetabolized drug. An additional 10% is excreted in urine as metabolites. Urinary excretion is virtually complete 24 hours after administration. Dose adjustment is required in the elderly and in those with renal impairment.[citation needed]

Ciprofloxacin is weakly bound to serum proteins (20-40%), but is an inhibitor of the drug-metabolizing enzyme cytochrome P450 1A2, which leads to the potential for clinically important drug interactions with drugs metabolized by that enzyme.[medical citation needed]

Ciprofloxacin is about 70% orally available when administered orally, so a slightly higher dose is needed to achieve the same exposure when switching from IV to oral administration[28]

The extended release oral tablets[79] allow once-daily administration by releasing the drug more slowly in the gastrointestinal tract. These tablets contain 35% of the administered dose in an immediate-release form and 65% in a slow-release matrix. Maximum serum concentrations are achieved between 1 and 4 hours after administration. Compared to the 250- and 500-mg immediate-release tablets, the 500-mg and 1000-mg XR tablets provide higher Cmax, but the 24‑hour AUCs are equivalent.

Ciprofloxacin immediate-release tablets contain ciprofloxacin as the hydrochloride salt, and the XR tablets contain a mixture of the hydrochloride salt as the free base.[citation needed]

Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4 g/mol. It is a faintly yellowish to light yellow crystalline substance.[65]

Ciprofloxacin hydrochloride (USP) is the monohydrochloride monohydrate salt of ciprofloxacin. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8 g/mol. Its empirical formula is C17H18FN3O3HCl•H2O.[65]

Ciprofloxacin is the most widely used of the second-generation quinolones.[80][81] In 2010, over 20 million prescriptions were written, making it the 35th-most commonly prescribed generic drug and the 5th-most commonly prescribed antibacterial in the U.S.[82]

The first members of the quinolone antibacterial class were relatively low-potency drugs such as nalidixic acid, used mainly in the treatment of urinary tract infections owing to their renal excretion and propensity to be concentrated in urine.[83] In 1979, the publication of a patent[84] filed by the pharmaceutical arm of Kyorin Seiyaku Kabushiki Kaisha disclosed the discovery of norfloxacin, and the demonstration that certain structural modifications including the attachment of a fluorine atom to the quinolone ring leads to dramatically enhanced antibacterial potency.[85] In the aftermath of this disclosure, several other pharmaceutical companies initiated research and development programs with the goal of discovering additional antibacterial agents of the fluoroquinolone class.

The fluoroquinolone program at Bayer focused on examining the effects of very minor changes to the norfloxacin structure.[86][87] In 1983, the company published in vitro potency data for ciprofloxacin, a fluoroquinolone antibacterial having a chemical structure differing from that of norfloxacin by the presence of a single carbon atom.[88] This small change led to a two- to 10-fold increase in potency against most strains of Gram-negative bacteria. Importantly, this structural change led to a four-fold improvement in activity against the important Gram-negative pathogen Pseudomonas aeruginosa, making ciprofloxacin one of the most potent known drugs for the treatment of this intrinsically antibiotic-resistant pathogen.[medical citation needed]

The oral tablet form of ciprofloxacin was approved in October 1987,[89] just one year after the approval of norfloxacin.[90] In 1991, the intravenous formulation was introduced. Ciprofloxacin sales reached a peak of about 2 billion euros in 2001, before Bayer’s patent expired in 2004, after which annual sales have averaged around €200 million.[91][92]

The name probably originates from the International Scientific Nomenclature: ci- (alteration of cycl-) + propyl + fluor- + ox- + az- + -mycin.[93]

It is available as a generic medication and not very expensive.[2][11] Wholesale it costs between US$0.03 and US$0.13 a dose.[12] In the United States it is sold for about US$0.40 per dose.[2]

On 24 October 2001, the Prescription Access Litigation (PAL) project filed suit to dissolve an agreement between Bayer and three of its competitors which produced generic versions of drugs (Barr Laboratories, Rugby Laboratories, and Hoechst-Marion-Roussel) that PAL claimed was blocking access to adequate supplies and cheaper, generic versions of ciprofloxacin. The plaintiffs charged that Bayer Corporation, a unit of Bayer AG, had unlawfully paid the three competing companies a total of $200 million to prevent cheaper, generic versions of ciprofloxacin from being brought to the market, as well as manipulating its price and supply. Numerous other consumer advocacy groups joined the lawsuit. On 15 October 2008, five years after Bayer’s patent had expired, the United States District Court for the Eastern District of New York granted Bayer’s and the other defendants’ motion for summary judgment, holding that any anticompetitive effects caused by the settlement agreements between Bayer and its codefendants were within the exclusionary zone of the patent and thus could not be redressed by federal antitrust law,[94] in effect upholding Bayer’s agreement with its competitors.

Ciprofloxacin for systemic administration is available as immediate-release tablets, as extended-release tablets, as an oral suspension, and as a solution for intravenous infusion. It is also available for local administration as eye drops and ear drops.

A class action was filed against Bayer AG on behalf of employees of the Brentwood Post Office in Washington, D.C., and workers at the U.S. Capitol, along with employees of American Media, Inc. in Florida and postal workers in general who alleged they suffered serious adverse effects from taking ciprofloxacin in the aftermath of the anthrax attacks in 2001. The action alleged Bayer failed to warn class members of the potential side effects of the drug, thereby violating the Pennsylvania Unfair Trade Practices and Consumer Protection Laws. The class action was defeated and the litigation abandoned by the plaintiffs.[95] A similar action was filed in 2003 in New Jersey by four New Jersey postal workers but was withdrawn for lack of grounds, as workers had been informed of the risks of ciprofloxacin when they were given the option of taking the drug.[96][97]

As resistance to ciprofloxacin has grown, research has been conducted to discover and develop analogs that can be effective against resistant bacteria; some have been looked at in antiviral models as well.[98]

For full functionality, it is necessary to enable JavaScript. Here are instructions how to enable JavaScript in your web browser.

Healthline Media, Inc. would like to process and share personal data (e.g., mobile ad id) and data about your use of our site (e.g., content interests) with our third party partners (see a current list) using cookies and similar automatic collection tools in order to a) personalize content and/or offers on our site or other sites, b) communicate with you upon request, and/or c) for additional reasons upon notice and, when applicable, with your consent.

Healthline Media, Inc. is based in and operates this site from the United States. Any data you provide will be primarily stored and processed in the United States, pursuant to the laws of the United States, which may provide lesser privacy protections than European Economic Area countries.

By clicking “accept” below, you acknowledge and grant your consent for these activities unless and until you withdraw your consent using our rights request form. Learn more in our Privacy Policy.

MNT – Hourly Medical News Since 2003

drug ciprofloxacin 500 mg

MNT – Hourly Medical News Since 2003

We use cookies and similar technologies to improve your browsing experience, personalize content and offers, show targeted ads, analyze traffic, and better understand you. We may share your information with third-party partners for marketing purposes. To learn more and make choices about data use, visit our Advertising Policy and Privacy Policy. By clicking “Accept and Continue” below, (1) you consent to these activities unless and until you withdraw your consent using our rights request form, and (2) you consent to allow your data to be transferred, processed, and stored in the United States.

Enter your email address to subscribe to our most top categories

Your privacy is important to us. Any information you provide to us via this website may be placed by us on servers located in countries outside of the EU. If you do not agree to such placement, do not provide the information.

You have chosen to share the following article:

How elderberries can help you fight the flu

To proceed, simply complete the form below, and a link to the article will be sent by email on your behalf.
Note: Please don’t include any URLs in your comments, as they will be removed upon submission.

We do not store details you enter into this form. Please see our privacy policy for more information.

The details of this article have been emailed on your behalf.

Click here to return to the Medical News Today home page.

For many people, Cipro is a safe treatment for a urinary tract infection or UTI. But it is not the only option.

The United States Foods and Drug Administration (FDA) warn doctors about prescribing Cipro to certain people, as there is a potential for serious side effects.

Understanding how Cipro works and its possible side effects can help a person make an informed choice about their UTI treatment.

Cipro is the brand name for ciprofloxacin, which is a type of antibiotic known as a fluoroquinolone.

Doctors use fluoroquinolones to treat a range of different bacterial infections. Which fluoroquinolone they prescribe depends on the underlying infection, and if the bacteria are resistant to a specific drug.

Fluoroquinolones work by interfering with the bacteria’s ability to replicate and grow, and so it kills the infection.

Doctors often prescribe Cipro for people with UTIs, as these infections are usually bacterial and respond well to this drug.

However, the FDA advises that the serious side effects may outweigh the benefits for patients with uncomplicated UTIs who have other treatment options.

When taking Cipro for a UTI, it is essential to follow the doctor or pharmacist’s instructions exactly. The drug is likely to come in the form of a take-home oral tablet or solution, and the treatment course typically lasts no longer than 7 days.

For an antibiotic to be most effective, a person should always complete the full course. Even if symptoms start to clear up, it is essential for people to finish all the medication to ensure they kill the infection completely.

People should never stop treatment early unless a doctor tells them to do so. Doing so may allow the infection to return and potentially be worse.

When taking Cipro or any other antibiotic for a UTI, drinking extra fluids and often urinating can help flush out the infection and speed up recovery.

Side effects are common with antibiotic, drugs such as Cipro. The most common side effects while taking Cipro include:

These common symptoms tend to be mild and clear up without treatment once a person stops taking Cipro.

Less common side effects, occurring in less than 1 percent of people, may include:

Rarely, Cipro can also cause a severe allergic reaction. Anyone who experiences any of the following symptoms should seek immediate medical care:

Fluoroquinolone antibiotics also have what is known as a boxed warning. This is the most serious warning from the FDA, and it means that the FDA consider the drug to be potentially dangerous in some capacity.

The boxed warning for Cipro is for two separate risks.

Firstly, Cipro may increase the risk of tendinitis and tendon rupture in people of all ages, which can lead to serious side effects, such as:

These symptoms may come on after just one or two doses and may last for years. It is unknown yet whether some of the symptoms and changes, especially nerve changes, are permanent.

The risk of tendinitis and tendon rupture is greater for people who are:

Secondly, fluoroquinolones may worsen muscle weakness in people who have myasthenia gravis.

People from these high-risk groups should not take Cipro.

It is also important to understand that several other antibiotics have similar side effects, though they may affect a person in slightly different ways.

A 2015 systematic review concluded that Cipro is a safe and effective drug for treating UTIs most of the time and that adverse events were lower than with other antimicrobial treatments.

drug ciprofloxacin 500 mg

However, adverse events are still possible and occur often enough for the FDA to release a warning that doctors should only use fluoroquinolones, such as Cipro, when no other treatment options are available.

Cipro may not be right when someone is pregnant. Anyone who is pregnant should discuss all their treatment options with a doctor before making a decision.

A person can pass Cipro on to a child through their breast milk. Women should either not take Cipro while breastfeeding or should stop breastfeeding while taking the drug.

People should always talk to a doctor to help find the best option in these situations.

It is possible for Cipro to interact with other drugs. These drugs may change the way Cipro works, which could be harmful or cause serious side effects.

There are many drugs that may interact with fluoroquinolones, such as Cipro, including:

Again, people must always discuss any current medications, vitamins, and supplements with a doctor before taking Cipro or another antibiotic.

The bacteria Escherichia coli cause most cases of UTIs.

A 2015 systematic review concluded that E. coli resistance to ciprofloxacin is increasing, and that the medical community should consider restricting the use of this antibiotic.

In other words, doctors may need to start looking at other methods for treating UTIs.

Other drugs that doctors may recommend for UTIs include:

However, some of these drugs may also have issues with bacterial resistance. Researchers are currently investigating new treatment options for UTIs and other bacterial infections, including combination drug therapy, vaccines, and small molecules that attack specific functions in the bacteria.

If a person suspects they have a UTI, they should see a doctor. While Cipro may be effective for many people with uncomplicated UTIs, some doctors may recommend other treatment options first.

Anyone who has concerns about taking Cipro, or any of its possible side effects, should discuss them with a doctor. By working directly with a doctor, most people can find the right solution for their UTI.

Article last reviewed by Fri 7 September 2018.Visit our Urinary Tract Infection category page for the latest news on this subject, or sign up to our newsletter to receive the latest updates on Urinary Tract Infection.All references are available in the References tab.

Anger, J., et al. (2019). Recurrent uncomplicated urinary tract infections in women: AUA/CUA/SUFU guideline (2019). https://www.auanet.org/guidelines/recurrent-uti

Fasugba, O., et al. (2015). Ciprofloxacin resistance in community-and hospital-acquired Escherichia coli urinary tract infections: A systematic review and meta-analysis of observational studies. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4660780/

FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together. (2016). https://www.fda.gov/Drugs/DrugSafety/ucm500143.htm

FDA drug safety communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. (2018). https://www.fda.gov/Drugs/DrugSafety/ucm511530.htm

Flores-Mireles, A. L., et al. (2016). Urinary tract infections: Epidemiology, mechanisms of infection and treatment options. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4457377/

Gutiérrez-Castrellón, P., et al. (2015). Efficacy and safety of ciprofloxacin treatment in urinary tract infections (UTIs) in adults: A systematic review with meta-analysis. https://www.anmm.org.mx/GMM/2015/n2_english/2331AX152_151_2015_UK2_210-228.pdf

Kang, C.-I., et al. (2018). Clinical practice guidelines for the antibiotic treatment of community-acquired urinary tract infections. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895837/

Label: Ciprofloxacin — ciprofloxacin tablet, film coated. (2012). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d54a97d5-3664-4ca5-bffd-8366c7255b73

Please use one of the following formats to cite this article in your essay, paper or report:

MLAJohnson, Jon. “Treating urinary tract infections with Cipro.” Medical News Today. MediLexicon, Intl., 7 Sep. 2018. Web.15 Aug. 2019.

APAJohnson, J. (2018, September 7). “Treating urinary tract infections with Cipro.” Medical News Today. Retrieved fromhttps://www.medicalnewstoday.com/articles/323009.php.

Please note: If no author information is provided, the source is cited instead.

Healthline Media UK Ltd, Brighton, UK.

© 2004-2019 All rights reserved. MNT is the registered trade mark of Healthline Media. Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional.

Privacy |
Terms |
Ad policy |
Careers

This page was printed from: https://www.medicalnewstoday.com/articles/323009.php

Visit www.medicalnewstoday.com for medical news and health news headlines posted throughout the day, every day.

2019 Healthline Media UK Ltd. All rights reserved. MNT is the registered trade mark of Healthline Media. Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional.

var deferCSS_place = document.getElementsByTagName(‘body’)[0];

// 3. insert object before
deferCSS_place.appendChild(deferCSS);

window.bk_async = function() {
bk_addPageCtx(‘categoryMain’, ‘urinary-tract-infection’);
bk_addPageCtx(‘categorySub’, ‘infectious_diseases’);
bk_addPageCtx(‘dimension28’, ‘antibiotics’);
bk_addPageCtx(‘dimension29’, ‘infectious’);
BKTAG.doTag(76945, 10);
};
(function() {
var scripts = document.getElementsByTagName(‘script’)[0];
var s = document.createElement(‘script’);
s.async = true;
s.src = “https://tags.bkrtx.com/js/bk-coretag.js”;
scripts.parentNode.insertBefore(s, scripts);
}());

var articleID=”323009″;
var articleType = “knowledge”;
var emailID = “323009”;
var articleURL = “/articles/323009.php”;
var threadID = “0”;
var opinionsOutput = 0;
var showAdsOnArticle = 1;
var isSponsored = 0;

for(var contentBlocksDoms=document.querySelectorAll(“.infobox_large.article-tcblocks > li”),i=0;i div.headline.mobile”),excerpt=_this.querySelector(“a > div > .excerpt”),desktopHeadlineHtmlStr=mobileHeadline.outerHTML;desktopHeadlineHtmlStr=desktopHeadlineHtmlStr.replace(/(class=”.*?)s*mobiles*(.*?”)/g,”$1$2″),null===_this.querySelector(“a > div > .headline”)
}

var articleTOC = document.getElementsByClassName(“article_toc”)[0];

if(document.body.contains(articleTOC)){
// if the page contains article TOC, we do the trick
var articleTOCpreviousElement = articleTOC.previousElementSibling;

if(articleTOCpreviousElement){
if((articleTOCpreviousElement.className.indexOf(“photobox_header”) !==-1
}
}

}

{“@context”:”https://schema.org”,”publisher”:{“@type”:”Organization”,”name”:”Medical News Today”,”logo”:”https://cdn-prod.medicalnewstoday.com/structure/images/logo/logo-2017-640-60.png”},”@type”:”MedicalWebPage”,”headline”:”Treating urinary tract infections with Cipro”,”description”:”Cipro is an antibiotic that doctors use to treat urinary tract infections (UTIs). For Cipro to work, people must take the full course of the drug and follow their doctor’s instructions. But some people may be at risk of severe side effects if they take Cipro, and they may need to consider alternatives. Learn more here.”,”author”:{“@type”:”Person”,”name”:”Jon Johnson”},”reviewedBy”:{“@type”:”Person”,”name”:”Alan Carter, PharmD”},”datePublished”:”2018-09-07″,”lastReviewed”:”2018-09-07″,”image”:[“https://cdn-prod.medicalnewstoday.com/content/images/hero/323/323009/323009_1100.jpg”],”url”:”https://www.medicalnewstoday.com/articles/323009.php”}

Ciprofloxacin is a second generation fluoroquinolone that has spawned many derivative antibiotics.9 It is formulated for oral, intravenous, intratympanic, ophthalmic, and otic administration for a number of bacterial infections.18,19,20,21,22,23,24,25,26

The first ciprofloxacin containing product was FDA approved on 22 October 1987.17

A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

drug ciprofloxacin 500 mg

A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

Ciprofloxacin is only indicated in infections caused by susceptible bacteria.18,19,20,21,22,23,24,25,26

Ciprofloxacin immediate release tablets, oral suspensions, and intravenous injections are indicated for the treatment of skin and skin structure infections, bone and joint infections, complicated intra-abdominal infections, nosocomial pneumonia, febrile neutropenia, adults who have inhaled anthrax, plague, chronic bacterial prostatitis, lower respiratory tract infections including acute exacerbations of chronic bronchitis, urinary tract infections, complicated urinary tract infections in pediatrics, complicated pyelonephritis in pediatrics, and acute sinusitis.22,21

A ciprofloxacin otic solution and otic suspension with hydrocortisone are indicated for acute otitis externa.18,23 Ciprofloxacin suspension with dexamethasone is indicated for acute otitis media in pediatric patients with tympanostomy tubes or acute otitis externa.25 A ciprofloxacin intratympanic injection is indicated for pediatric patients with bilateral otitis media with effusion who are having tympanostomy tubes placed or pediatric patients 6 months or older with acute otitis externa.26

A ciprofloxacin eye drop is indicated for bacterial corneal ulcers and conjunctivitis.19 A ciprofloxacin eye ointment is indicated for bacterial conjunctivitis.20

A ciprofloxacin extended release tablet is indicated for uncomplicated urinary tract infections, complicated urinary tract infections, and acute uncomplicated pyelonephritis.24

Ciprofloxacin is a second generation fluoroquinolone that is active against many Gram negative and Gram positive bacteria.9,18,19,20,21,22,23,24,25,26 It produces its action through inhibition of bacterial DNA gyrase and topoisomerase IV.12 Ciprofloxacin binds to bacterial DNA gyrase with 100 times the affinity of mammalian DNA gryase.13 There is no cross resistance between fluoroquinolones and other classes of antibiotics, so it may be of clinical value when other antibiotics are no longer effective.13 Ciprofloxain and its derivatives are also being investigated for its action against malaria, cancers, and AIDS.12

Ciprofloxacin acts on bacterial topoisomerase II (DNA gyrase) and topoisomerase IV.12 Ciprofloxacin’s targeting of the alpha subunits of DNA gyrase prevents it from supercoiling the bacterial DNA which prevents DNA replication.10,11

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

A 250mg oral dose of ciprofloxacin reaches an average maximum concentration of 0.94mg/L in 0.81 hours with an average area under the curve of 1.013L/h*kg.8 The FDA reports an oral bioavailability of 70-80%Label,1 while other studies report it to be approximately 60%.8 An early review of ciprofloxacin reported an oral bioavailability of 64-85% but recommends 70% for all practical uses.10

Cirpofloxacin follws a 3 compartment distribution model with a central compartment volume of 0.161L/kg8 and a total volume of distribution of 2.00-3.04L/kg.10

20-40%.Label,10

Ciprofloxacin is primarily metabolized by CYP1A2.22 The primary metabolites oxociprofloxacin and sulociprofloxacin make up 3-8% of the total dose each.24 Ciprofloxacin is also converted to the minor metabolites desethylene ciprofloxacin and formylciprofloxacin.24 These 4 metabolites account for 15% of a total oral dose.22

There is a lack of available data on the enzymes and types of reactions involved in forming these metabolites.2,3,4,5

27% of an oral dose was recovered unmetabolized in urine compared to 46% of an intravenous dose.8 Collection of radiolabelled ciprofloxacin resulted in 45% recovery in urine and 62% recovery in feces.10

The average half life following a 250mg oral dose was 4.71 hours and 3.65 hours following a 100mg intravenous dose.8 Generally the half life is reported as 4 hours.Label,8

The average renal clearance after a 250mg oral dose is 5.08mL/min*kg.8 Following a 100mg intravenous dose, the average total clearance is 9.62mL/min*kg, average renal clearance is 4.42mL/min*kg, and average non renal clearance is 5.21mL/min*kg.8

Patients experiencing an overdose may present with nausea, vomiting, abdominal pain, crystalluria, nephrotoxicity, and oliguria.14,15,16 Ciprofloxacin overdose typically leads to acute renal failure.16 An overdose may progress over the next 6 days with rising serum creatinine and BUN, as well as anuria.15 Patients may require prednisone therapy, urgent hemodialysis, or supportive therapy.14,16 Depending on the degree of overdose, patients may recover normal kidney function or progress to chronic kidney failure.16

The oral LD50 in rats is >2000mg/kg.27

Ciprofloxacin for intratympanic injection or otic use has low systemic absorption and so it unlikely to be a risk in pregnancy or lactation.26 There is generally no harm to the fetus in animal studies, however high doses may lead to gastrointestinal disturbances in the mother which may increase the incidence of abortion.25,19,23,20 In human studies there was no increase in fetal malformations above background rates.21,22 The risk and benefit of ciprofloxacin should be weighed in pregnancy and breast feeding.25,19,23,21,22,24,20,18

2/8 in vitro tests and 0/3 in vivo tests of mutagenicity of ciprofloxacin have yielded a positive result.26,25,19,23,21,22,24,20,18

Oral doses of 200 and 300 times the maximum recommended clinical dose in rats and mice have shown no carcinogenicity or tumorigenicity.26,19,23,21,22,24,20,18

Oral doses above the maximum recommended clinical dose have shown no effects on fertility in rats.26,23,21,22,24,20,18

Extended description of the mechanism of action and particular properties of each drug interaction.

A severity rating for each drug interaction, from minor to major.

A rating for the strength of the evidence supporting each drug interaction.

An effect category for each drug interaction. Know how this interaction affects the subject drug.

The date on which a patent was filed with the relevant government.

There is additional data available for commercial users including Adverse Effects, Contraindications, and Blackbox Warnings. Contact us to learn more about these and other features.