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There are two types of preion naproxen: regular naproxen and naproxen sodium. Regular naproxen comes as an oral immediate-release tablet, an oral delayed-release tablet, and an oral suspension. Naproxen sodium comes as an oral immediate-release tablet and an oral extended-release tablet.
Naproxen is also available in over-the-counter forms. This article only addresses preion forms of naproxen.
Preion naproxen oral tablets are available as the brand-name drugs Anaprox, Naprelan, and Naprosyn. They’re also available as generic drugs. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.
Preion naproxen oral tablets are used to treat pain and inflammation in a iety of conditions. It’s approved to treat:
Preion naproxen oral tablets belong to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs help reduce pain, inflammation, and fever. It isn’t fully understood how this medication works to decrease pain. It may help reduce swelling by lowering levels of prostaglandin. This is a hormone-like substance that usually causes inflammation.what kind of drug is naproxen 5mg
Preion naproxen oral tablets may cause drowsiness. You shouldn’t drive, use machinery, or do other activities that require alertness until you know you can normally. This drug can also cause other side effects.
The more common side effects that occur with naproxen oral tablet include:
Mild side effects may go away within a few days or a couple of weeks. Talk to your doctor or pharmacist if they’re more severe or don’t go away.
Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
Preion naproxen oral tablets can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.
To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.
Examples of drugs that can cause interactions with naproxen are listed below.
Combining selective serotonin reuptake inhibitors (SSRIs) with naproxen increases your risk of stomach and intestinal bleeding. Examples of these drugs include:
Naproxen might make your blood pressure medications not work as well. If you’re older than 65 years, combining naproxen with certain blood pressure medications may damage your kidneys. Examples of these medications include:
Taking any of these medications with naproxen may make naproxen treat your pain more slowly:
Combining naproxen with other NSAIDs increases your risk of stomach and intestinal bleeding. Examples of these medications include:
If you take cholestyramine with naproxen, your body may absorb naproxen more slowly than usual. That means it may take longer to work.
If you take naproxen with lithium, it may increase the lithium in your body to harmful levels.
Taking methotrexate with naproxen can lead to harmful levels of methotrexate in your body.
Taking warfarin with naproxen increases your risk of stomach and intestinal bleeding.
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all preion drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:
Generic: Naproxen
Generic: Naproxen sodium
Brand: Naprosyn (naproxen)
Brand: Anaprox (naproxen sodium)
Brand: Naprelan (naproxen sodium)
Adult dosage (ages 18 years and older)
Naproxen:
Immediate-release oral tablet
Delayed-release oral tablet
Naproxen sodium:
Immediate-release oral tablet
Extended-release oral tablet
Child dosage (ages –17 years)
A dosage for people younger than 18 years hasn’t been established.
Special dosage considerations
If you’re older than 65 years, your body may process this drug more slowly. Your doctor may start you on a lowered dose so that too much of this drug doesn’t build up in your body. Too much of the drug in your body can be dangerous.
Child dosage (ages 2–17 years)
what kind of drug is naproxen 5mg
Children in this age group generally receive the oral suspension form of this drug. The dosage will be based on your child’s weight. It should be given twice per day in evenly spaced doses.
Child dosage (ages –23 months)
Dosage for children younger than 2 years hasn’t been established.
Adult dosage (ages 18 years and older)
Naproxen:
Immediate-release oral tablet
Delayed-release oral tablet
Naproxen sodium:
Immediate-release oral tablet
Child dosage (ages –17 years)
Dosage for people younger than 18 years hasn’t been established.
Special dosage considerations
If you’re older than 65 years, your body may process this drug more slowly. Your doctor may start you on a lowered dose so that too much of this drug doesn’t build up in your body. Too much of the drug in your body can be dangerous.
Adult dosage (ages 18 years and older)
Naproxen:
Immediate-release oral tablet
Delayed-release oral tablet
Naproxen sodium:
Immediate-release oral tablet
Child dosage (ages –17 years)
Dosage for people younger than 18 years hasn’t been established.
Special dosage considerations
If you’re older than 65 years, your body may process this drug more slowly. Your doctor may start you on a lowered dose so that too much of this drug doesn’t build up in your body. Too much of the drug in your body can be dangerous.
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.
Naproxen can cause high blood pressure or make your high blood pressure worse. It can also make your high blood pressure medications not work as well. You may need to watch your blood pressure level carefully while taking naproxen.
Some formulations of this medication have extra salt in them. Talk to your doctor about which formulation to take if you’re watching your salt intake.
Naproxen can cause an asthma attack. If you have asthma that can be triggered by aspirin or other NSAIDs, don’t use naproxen.
Naproxen can cause a severe allergic reaction. Symptoms may include:
If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 911 or go to the nearest emergency room.
Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).
Combining naproxen and alcohol increases your risk of ulcer and stomach bleeding.
For people with stomach problems: If you have a history of ulcers or stomach or intestinal bleeding, naproxen increases your risk of stomach or intestinal bleeding.
For people with kidney disease: Naproxen can cause kidney damage when it’s used for a long time. If you have serious kidney disease, you should not use this drug.
For pregnant women: Naproxen is a pregnancy category C drug. That means two things:
Avoid naproxen during the third trimester of pregnancy. It could harm your pregnancy. Talk with your doctor if you’re pregnant or plan to become pregnant.
For women who are breastfeeding: Naproxen is passed through breast milk and could cause side effects in a child who is breastfed. Breastfeeding is not recommended while taking this medication.
For seniors: Use caution when taking naproxen if you’re older than 65 years. Your body may process this drug more slowly. Your doctor may start you on a lowered dose so that this drug doesn’t build up too much in your body. Too much of the drug in your body can be harmful.
For children: The safety and effectiveness of naproxen haven’t been established in children who are younger than 2 years.
Preion naproxen oral tablet is a short-term drug treatment. It comes with risks if you don’t take it as prescribed.
If you stop taking the drug suddenly or don’t take it at all: You may experience more pain and inflammation caused by your condition.
If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.
If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:
In rare cases, an overdose can cause:
If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.
What to do if you miss a dose: If you miss your dose, take it as soon as you can. However, if it’s just a few hours until your next dose, wait until the scheduled time and take a single dose.
Never try to catch up by taking two doses at once. This could result in toxic side effects.
How to tell if the drug is working: Signs that the drug is working will depend on the condition being treated.
A preion for this medication is refillable. You should not need a new preion for this medication to be refilled. Your doctor will write the number of refills authorized on your preion.
When traveling with your medication:
Your doctor will perform tests to check your health and make sure this drug is working for you. These tests may include:
There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.
Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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Generic Name: naproxen (na PROX en)Brand Names: Aleve, EC-Naprosyn, Flanax Pain Reliever, Midol Extended Relief, Naprelan, show all 12 brand namesNaprosyn, Anaprox, Anaprox-DS, Naproxen Sodium, Aleve Caplet, Aleve Gelcap, Aleve Easy Open Arthritis
Medically reviewed by Kaci Durbin, MD on December 3, 218
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.
Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps. It can also be used to treat acute pain from other etiologies.
The delayed-release or extended-release tablets are slower-acting forms of naproxen that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms will not work fast enough to treat acute pain.what kind of drug is naproxen 5mg
You should not use naproxen if you have a history of allergic reaction to aspirin or other NSAID (nonsteroidal anti-inflammatory drug).
Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.
Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Get emergency medical help if you have swelling of the face or throat, chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance. Stop taking naproxen and notify your physician if you notice stomach pain, tiredness or weakness, yellow skin or eyes, nausea, vomiting, bloody or black and sticky bowel movements, skin rash, unexplained weight loss or weight gain, or swelling of the hands and feet.
Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.
Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.
You should not use naproxen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.
Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:
heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke
a history of heart attack, stroke, or blood clot
a history of stomach ulcers or bleeding
asthma
liver or kidney disease or
fluid retention.
Taking naproxen during the last 3 months of pregnancy may harm the unborn baby. Ask a doctor before using this medicine if you are pregnant. It may interfere with ovulation, causing temporary infertility.
Naproxen can pass into breast milk and may cause side effects in the nursing baby. You should not breast-feed while using this medicine.
Naproxen is not approved for use by anyone younger than 2 years old. Do not give this medicine to a child without medical advice.
Use naproxen exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.
Do not crush, chew, or break a naproxen tablet. Swallow it whole.
Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
If you change brands, strengths, or forms of this medicine, your dosage needs may change. Ask your pharmacist if you have any questions about the kind of naproxen you are using.
If a child is using this medicine, tell your doctor if the child has any changes in weight. Doses are based on weight in children, and any changes may affect your child’s dose.
If you use this medicine long-term, you may need frequent medical tests.
This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using naproxen.
Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Dosage Information (in more detail)
Since naproxen is sometimes used only when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-8-222-1222.
Avoid drinking alcohol. It may increase your risk of stomach bleeding.
Avoid taking aspirin while you are taking naproxen.
Ask your doctor before taking any other medication for pain, arthritis, fever, or swelling. Many medicines available over the counter contain aspirin, salicylates, or other medicines similar to naproxen (such as ibuprofen or ketoprofen). Taking certain products together can cause you to get too much of this type of medication.
Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb naproxen.
Get emergency medical help if you have signs of an allergic reaction to naproxen: wheezing or trouble breathing hives swelling of your face, lips, tongue, or throat.
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.what kind of drug is naproxen 5mg
Stop using naproxen and call your doctor at once if you have:
shortness of breath (even with mild exertion)
swelling or rapid weight gain
the first sign of any skin rash, no matter how mild
signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds
liver problems – nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
kidney problems – little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath
low red blood cells (anemia) – pale skin, feeling light-ed or short of breath, rapid heart rate, trouble concentrating or
severe skin reaction – fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common naproxen side effects may include:
indigestion, heartburn, stomach pain, nausea
ache, dizziness, drowsiness
bruising, itching, rash
swelling or
ringing in your ears.
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 1-8-FDA-188.
Side effects (in more detail)
Ask your doctor before using naproxen if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.
Ask a doctor or pharmacist if it is safe for you to use this medicine if you are also using any of the following drugs:
cholestyramine
cyclosporine
digoxin
lithium
methotrexate
pemetrexed
phenytoin or similar seizure medications
probenecid
warfarin (Coumadin, Jantoven) or similar blood thinners
a diuretic or “water pill”
heart or blood pressure medication or
insulin or oral diabetes medicine.
This list is not complete. Other drugs may interact with naproxen, including preion and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
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 this medicine only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
1996-218 Cerner Multum, Inc. Version: 14.1.
Medical Disclaimer
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Drugs.com provides accurate and independent information on more than 24, preion 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 Nov 1st, 218), Cerner Multum™ (updated Nov 1st, 218), Wolters Kluwer™ (updated Oct 31st, 218) and others. To view content sources and ibutions, please refer to our editorial policy.
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Характеристики
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ampersand
Юникод
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what kind of drug is naproxen 5mg
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Амперсанд является графическим сокращением (лигатурой) латинского союза et («и») — это хорошо видно на изображении амперсанда в курсивном начертании.
В «Кратких сведениях по типографскому делу» называется «знаком, заменяющим союз „и“», в «Справочнике технолога-полиграфиста» — «знаком конъюнкции», в «Справочной книге корректора и редактора» (1974) — «специальным компанейским знаком, разновидностью лигатуры»[источник не указан 2737 дней][1].
Авторство амперсанда приписывают Марку Туллию Тирону, преданному рабу и секретарю Цицерона[источник не указан 2737 дней]. Даже после того как Тирон стал вольноотпущенником, он продолжал записывать цицероновские тексты. И к 63 году до н. э. изобрёл свою систему сокращений для ускорения письма, называемую «тироновскими знаками» или «тироновыми нотами» (Notæ Tironianæ, оригиналов не сохранилось), которыми пользовались до XI века (так что заодно Тирона считают ещё и основоположником римской стенографии).
Амперсанд со второй половины VIII века активно используется переписчиками, а с середины XV века — типографами.
Амперсанд стал настолько привычной частью письма в Европе и Северной Америке, что встал на последнее место в английском алфавите во всех букварях уже к началу XIX века (а пропадать из них стал только к началу XX века).
Союз «и» сам по себе короткий, и сокращение ему не нужно. Поэтому в СССР амперсанд ограниченно применялся в научно-технической документации для обозначения логической операции «и» (например, для логических элементов «И» в электрических схемах).
Амперсанд в программном обеспечении:
В макроязыке Ассемблера ЕС ЭВМ амперсанд служит признаком параметра.
В Юникоде есть также много других вариантов амперсанда. Ниже их кодировки:
Naproxen (brand names: Aleve, Naprosyn, and many others) is a nonsteroidal anti-inflammatory drug (NSAID) of the propionic acid class (the same class as ibuprofen) that relieves pain, fever, swelling, and stiffness.[5][6] It is a nonselective COX inhibitor, usually sold as the sodium salt. It is available in both an immediate release and extended release formulation. Naproxen is generally safe for use by breastfeeding mothers.
Common adverse effects of naproxen include central nervous system effects (e.g. dizziness and ache), blood effects (e.g. bruising), allergic reactions (e.g. rash), and gastrointestinal complaints (e.g. heartburn and stomach ulcers). It has an intermediate risk of stomach ulcers compared to others drugs in the same class (NSAIDs). NSAIDs appear to increase the risk of serious cardiovascular events, though this risk appears to be less with naproxen compared to other NSAIDs. Serious drug interactions may occur in combinations with other drugs that affect the blood, or with drugs that also increase the risk of ulcers.
As an NSAID, naproxen exerts its anti-inflammatory action by reducing the production of inflammatory mediators called prostaglandins. It is extensively metabolized by the liver to inactive metabolites.
Naproxen’s medical uses are related to its mechanism of action as an anti-inflammatory compound. Naproxen is used to treat a iety of inflammatory conditions and symptoms that are due to excessive inflammation, such as pain and fever (naproxen has fever-reducing, or antipyretic, properties in addition to its anti-inflammatory activity). Notably, not all medications that reduce fever are anti-inflammatory compounds (such as paracetamol). Inflammatory sources of pain that may respond to naproxen’s anti-inflammatory activity are conditions such as migraine, osteoarthritis, kidney stones, rheumatoid arthritis, psoriatic arthritis, gout, ankylosing spondylitis, menstrual cramps, tendinitis, and bursitis.[1]
Because of its anti-inflammatory mechanism of action, one would not expect naproxen to be useful in treating non-inflammatory causes of pain (e.g., diabetic nerve pain).
what kind of drug is naproxen 5mg
Naproxen sodium is used as a “bridge therapy” in medication-overuse ache to slowly take patients off of other medications.[8]
Naproxen sodium is available as both an immediate release and as an extended release tablet. The extended release formulations (sometimes called “sustained release,” or “enteric coated”) take longer to take effect than the immediate release formulations, and therefore are less useful when immediate pain relief is desired. Extended release formulations are more useful for the treatment of chronic, or long-lasting, conditions, in which long-term pain relief is desirable.[7]
Small amounts of naproxen are excreted in breast milk.[1] However, adverse effects are uncommon in infants breastfed from mother taking naproxen.[9]
Naproxen has been used to differentiate between infectious fevers and neoplastic or connective tissue disease-related fevers.[1] Although the literature is inconclusive, it is thought that naproxen may help differentiate between infectious fevers and neoplastic fevers by its efficacy in reducing them in some studies, naproxen reduced neoplastic fevers far better than it reduced infectious fevers. This information could potentially be used to identify the etiology of the patient’s fever, which can be complex in cancer patients (who are often at heightened risk for infection in the first place).[11]
Common adverse effects include dizziness, drowsiness, ache, rash, bruising, and gastrointestinal upset.[1] Heavy use is associated with increased risk of end-stage renal disease and kidney failure.[12]
As with other non-COX-2 selective NSAIDs, naproxen can cause gastrointestinal problems, such as heartburn, constipation, diarrhea, ulcers and stomach bleeding.[13] Naproxen should be taken orally with food to decrease the risk of gastrointestinal side effects.[citation needed] Persons with a history of ulcers or inflammatory bowel disease should consult a doctor before taking naproxen.[citation needed] In the U.S., naproxen is sold with boxed warnings about the risk of gastrointestinal ulceration or bleeding.[1] Naproxen poses an intermediate risk of stomach ulcers compared with ibuprofen, which is low-risk, and indometacin, which is high-risk.[14] To reduce stomach ulceration risk, it is often combined with a proton-pump inhibitor (a medication that reduces stomach acid production) during long-term treatment of those with pre-existing stomach ulcers or a history of developing stomach ulcers while on NSAIDs.[5][6]
COX-2 selective and nonselective NSAIDs have been linked to increases in the number of serious and potentially fatal cardiovascular events, such as myocardial infarctions and strokes.[15] Naproxen is, however, associated with the smallest overall cardiovascular risks.[16][17] Cardiovascular risk must be considered when prescribing any nonsteroidal anti-inflammatory drug. The drug had roughly 5% of the associated risk of stroke compared with ibuprofen, and was also associated with a reduced number of myocardial infarctions compared with control groups.[16]
A study found that high-dose naproxen induced near-complete suppression of platelet thromboxane throughout the dosing interval and appeared not to increase cardiovascular disease (CVD) risk, whereas other non-aspirin high-dose NSAID regimens had only transient effects on platelet COX-1 and were associated with a small but definite vascular hazard. Conversely, naproxen was associated with higher rates of upper gastrointestinal bleeding complications compared with other NSAIDs.[17]
Naproxen may interact with antidepressants, lithium, methotrexate, probenecid, warfarin and other blood thinners, heart or blood pressure medications, including diuretics, or steroid medicines such as prednisone.[1]
NSAIDs such as naproxen may interfere with and reduce the efficacy of SSRI antidepressants,[18] as well as increase the risk of bleeding greater than the individual bleeding risk of either class of agent when taken together.[19] Naproxen is not contraindicated in the presence of SSRIs, though concomitant use of the medications should be done with caution.[19]
Alcohol consumption increases the risk of gastrointestinal bleeding when combined with NSAIDs like naproxen in a dose-dependent manner (that is, the higher the dose of naproxen, the higher the risk of bleeding).[2] The risk is highest for people who are heavy drinkers.[2]
Naproxen works by reversibly inhibiting both the COX-1 and COX-2 enzymes as a non-selective coxib.[21][22][23][24][25] This results in the inhibition of prostaglandin synthesis. Prostaglandins act as signaling molecules in the body, inducing inflammation. Thus, by inhibiting COX-1/2, naproxen induces an anti-inflammatory effect.
Naproxen is a minor substrate of CYP1A2 and CYP2C9. It is extensively metabolized in the liver to 6-O-desmethylnaproxen, and both the parent drug and the desmethyl metabolite undergo further metabolism to their respective acylglucuronide conjugated metabolites.[26] An analysis of two clinical trials shows that naproxen’s time to peak plasma concentration occurs between 2–4 hours after oral administration, though naproxen sodium reaches peak plasma concentrations within 1–2 hours.[4]
The pharmacogenetics of naproxen has been studied in an effort to better understand its adverse effects.[27] In 1998, a small pharmacokinetic (PK) study failed to show that differences in a patient’s ability to clear naproxen from the body could account for differences in a patient’s risk of experiencing the adverse effect of a serious gastrointestinal bleed while taking naproxen.[27] However, the study failed to account for differences in the activity of CYP2C9, a drug metabolizing enzyme responsible for clearing naproxen.[27] Studies on the relationship between CYP2C9 genotype and NSAID-induced gastrointestinal bleeds have shown that genetic iants in CYP2C9 that reduce the clearance of major CYP2C9 substrates (like naproxen) increase the risk of NSAID-induced gastrointestinal bleeds, especially for homozygous defective iants.[27]
As of October 217, there are no recommendations for routine CYP2C9 testing for naproxen.[28]
Naproxen is a member of the 2-arylpropionic acid (profen) family of NSAIDs.[29] The free acid is an odorless, white to off-white crystalline substance. It is lipid-soluble and practically insoluble in water. It has a melting point of 152–155 °C.
Naproxen has been industrially produced by Syntex starting from 2-naphthol as follows:[3]
Naproxen and naproxen sodium are marketed under ious brand names, including: Synflex, Aleve, Accord, Anaprox, Antalgin, Apranax, Feminax Ultra, Flanax, Inza, Maxidol, Midol Extended Relief, Nalgesin, Naposin, Naprelan, Naprogesic, Naprosyn, Narocin, Pronaxen, Proxen, Soproxen, MotriMax, and Xenobid.[citation needed] It is also available as the combination naproxen/esomeprazole magnesium in delayed release tablets under the brand name Vimovo.[31]
Syntex first marketed naproxen in 1976 as the preion drug Naprosyn. They first marketed naproxen sodium under the brand name Anaprox in 198. It remains a preion-only drug in much of the world. In the United States, the Food and Drug Administration (FDA) approved it as an over-the-counter (OTC) drug in 1994. OTC preparations in the U.S. are mainly marketed by Bayer HealthCare under the brand name Aleve and generic store brand formulations in 22 mg tablets. In Australia, packets of 275 mg tablets of naproxen sodium are Schedule 2 pharmacy medicines, with a maximum daily dose of five tablets or 1375 mg. In the United Kingdom, 25 mg tablets of naproxen were approved for OTC sale under the brand name Feminax Ultra in 28, for the treatment of primary dysmenorrhoea in women aged 15 to 5.[32] In the Netherlands, 22 mg and 275 mg tablets are available OTC in drugstores, 55 mg is OTC only at pharmacies. Aleve became available over the counter in most provinces in Canada on 14 July 29, but not British Columbia, Quebec or Newfoundland and Labrador[33] it subsequently became available OTC in British Columbia in January 21.[34]
Naproxen may have antiviral activity against influenza. In laboratory research, it blocks the RNA-binding groove of the nucleoprotein of the virus, preventing formation of the ribonucleoprotein complex—thus taking the viral nucleoproteins out of circulation.[35]
Naproxen is given orally to horses at a dose of 1 mg/kg, and has shown to have a wide safety margin (no toxicity when given at three times the recommended dose for 42 days).[36] It is more effective for myositis than the commonly used NSAID phenylbutazone, and has shown especially good results for treatment of equine exertional rhabdomyolysis,[37] a disease of muscle breakdown, but is less commonly used for musculoskeletal disease.
POM: Preion only medicine
This information is intended for use by health professionals
Naproxen Tablets BP 5mg
Each tablet contains 5mg Naproxen BP.
Excipient with known effect: Lactose. For full list of excipients, see section 6.1.
what kind of drug is naproxen 5mg
Tablets.
Naproxen Tablets BP 5 mg are yellow coloured, capsule shaped uncoated tablets with score line between ‘NPY’ and ‘5’ embossed on one side and plain on the other side.
Adults:
Naproxen is used in the treatment of rheumatoid arthritis, osteoarthrosis (degenerative arthritis), alkylosing spondylitis, acute musculoskeletal disorders, dysmenorrhoea and acute gout.
Children:
Juvenile rheumatoid arthritis.
Posology
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
Adults
Rheumatoid arthritis, osteoarthritis and alkylosing spnodylitis
5mg to 1g taken in 2 doses at 12-hour intervals or alternatively, as a single administration. In the following cases a loading dose of 75mg or 1g per day for the acute phase is recommended:
a) In patients reporting severe night-time pain/or morning stiffness.
b) In patients being switched to Naproxen from a high dose of another anti-rheumatic compound.
c) In osteoarthrosis where pain is the predominant symptom.
Acute gout
In acute gout, an initial dose of 75 mg followed by 25 mg every 8 hours until the attack has passed.
Acute musculoskeletal disorders and dysmenorrhoea
5 mg may be given initially, followed by 25 mg every 6 to 8 hour intervals as needed, with a maximum daily dose after the first day of 125mg.
Older people
Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in older people. The implication of this finding for Naproxen dosing is unknown. The elderly are at increased risk of the serious consequences of adverse reactions. If NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. For the effect of reduced elimination in the elderly refer to Section 4.4. Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs.
Paediatric population (over 5 years)
A dose of 1 mg per kg body weight daily, in two divided doses at 12-hour intervals has been used in children over 5 years of age with juvenile rheumatoid arthritis. Naproxen is not recommended for use in any other indication in children under 16 years of age.
Renal/hepatic impairment
A lower dose should be considered in patients with renal or hepatic impairment. Naproxen is contraindicated in patients with baseline creatinine clearance less than 3 ml/minute because accumulation of naproxen metabolites has been seen in patients with severe renal failure or those on dialysis (see section 4.3).
Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs.
Method of administration
For oral administration.
To be taken preferably with or after food.
1. Hypersensitivity to Naproxen sodium or to any of the excipients of naproxen tablets.
2. Naproxen is contraindicated in patients who have previously shown hypersensitivity reactions (e.g. nasal polyps, asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other non-steroidal anti-inflammatory/analgesic drugs. These reactions have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients.
3. Severe hepatic, renal and cardiac failure (See section 4.4 – special warnings and precautions for use).
4. During the last trimester of pregnancy (see section 4.6 – Pregnancy and lactation).
5. Active or previous acute peptic ulcer.
6. History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
7. Use with concomitant NSAIDs including cyclooxygenase 2 specific inhibitors (See section 4.5 Interactions).what kind of drug is naproxen 5mg
In all patients:
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below). Patients treated with NSAIDs long-term should undergo regular medical supervision to monitor for adverse events.
Elderly:
The elderly and/or debilitated patients have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (See section 4.2 – Posology and administration). Prolonged use of NSAIDs in these patients is not recommended. Where prolonged therapy is required, patients should be reviewed regularly.
The antipyretic and anti-inflammatory activities of Naproxen may reduce fever and inflammation, thereby diminishing their utility as diagnostic signs.
Respiratory disorders:
Caution is required if administered to patients suffering from or with a previous history of, bronchial asthma or allergic disease since NSAIDs have been reported to precipitate bronchospasm in such patients.
Renal failure linked to reduced prostaglandin production:
The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal , cardiac impairment, liver dys, those taking diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists and the elderly. Renal should also be monitored in these patients (See also section 4.3 – Contraindications)
Use in patients with impaired renal :
As naproxen is eliminated to a large extent (95%) by urinary excretion via glomerular filtration, it should be used with great caution in patients with significantly impaired renal and the monitoring of serum creatinine and/or creatinine clearance is advised in these patients. Naproxen is contraindicated in patients having baseline creatinine clearance less than 3ml/minute. Certain patients, specifically those where renal blood flow is compromised, such as in extracellular volume depletion, cirrhosis of the liver, sodium restriction, congestive heart failure and pre-existing renal disease should have renal assessed before and during naproxen therapy. Some elderly patients, in whom impaired renal may be expected, as well as patients using diuretics could also fall within this category. A reduction in the daily dosage should be considered to avoid the possibility of excessive accumulation of naproxen metabolites in the patients.
Haemodialysis does not decrease the plasma concentration of naproxen because of the high degree of protein binding.
Renal Effects:
There have been reports of impaired renal , renal failure, acute interstitial nephritis, haematuria, proteinuria, renal papillary necrosis and occasionally nephrotic syndrome associated with naproxen.
Use in patients with impaired liver :
Chronic alcoholic liver disease and probably other forms of cirrhosis reduce the total plasma concentration of naproxen, but the plasma concentration of unbound naproxen is increased. The implication of this finding for naproxen dosing is unknown but it is prudent to use the lowest effective dose.
As with other non-steroidal anti-inflammatory drugs, elevations of one or more liver tests may occur. Hepatic abnormalities may be the result of hypersensitivity rather than direct toxicity. Severe hepatic reactions, including jaundice and hepatitis (some cases of hepatitis have been fatal) have been reported with this drug as with other non-steroidal anti-inflammatory drugs. Cross reactivity has been reported.
Use in patients with cardiovascular impairment:
Caution should be exercised in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Although sodium retention has not been reported in metabolic studies, it is possible that patients with questionable or compromised cardiac may be at a greater risk when taking Naproxen.
Gastrointestinal bleeding, ulceration and perforation:
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see section 4.5).
Naproxen has been found to be well tolerated by patients exhibiting dyspepsia with other similar agents. None the less, episodes of gastro-intestinal bleeding have been reported in patients with naproxen therapy.
Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications, which could increase the risk of gastrotoxicity, or bleeding, such as corticosteroids, or anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as aspirin (See section 4.5 – Interactions).
When GI bleeding or ulceration occurs in patients receiving naproxen, the treatment should be withdrawn
Naproxen should be given under close supervision to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated (See section 4.8 – Undesirable effects).
SLE and mixed connective tissue disease:
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (See section 4.8 – Undesirable effects).
Cardiovascular and cerebrovascular effects
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Although data suggest that the use of naproxen (1 mg daily) may be associated with a lower risk, some risk cannot be excluded.
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with naproxen after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, and smoking).
Haematological
Patients who have coagulation disorders or are receiving drug therapy that interferes with haemostasis should be carefully observed if naproxen-containing products are administered.
Patients at high risk of bleeding or those on full anti-coagulation therapies (e.g. dicoumarol derivatives) may be at increased risk of bleeding if given naproxen-containing products concurrently.
Naproxen decreases platelet aggression and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.
Anaphylactic (anaphylactoid) reactions
Hypersensitivity reactions may occur in susceptible individuals. Anaphylactic (anaphylactoid) reactions may occur both in patients with and without a history of hypersensitivity or exposure to aspirin, other non-steroidal anti-inflammatory drugs or naproxen-containing products. They may also occur in individuals with a history of angio-oedema, bronchospastic reactivity (e.g. asthma), rhinitis and nasal polyps.
Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome.
Steroids
If steroid dosage is reduced or eliminated during therapy, the steroid dosage should be reduced slowly and the patients must be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.
Ocular effects
Studies have not shown changes in the eye ibutable to naproxen administration. In rare cases, adverse ocular disorders including papillitis, retrobulbar optic neuritis and papilloedema, have been reported in users of NSAIDs including naproxen, although a cause-and-effect relationship cannot be established accordingly, patients who develop visual disturbances during treatment with naproxen-containing products should have an ophthalmological examination.
Dermatological
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reactions occurring in the majority of cases within the first month of treatment. Naproxen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Combination with other NSAIDs
The combination of naproxen-containing products and other NSAIDs, including cyclooxygenase-2 selective inhibitors, is not recommended, because of the cumulative risks of inducing serious NSAID-related adverse events.
Other analgesics including cyclooxygenase-2 selective inhibitors:
Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects (See section 4.3 Contraindications).
Anti-hypertensives:
Reduced anti-hypertensive effect.
Naproxen can reduce the anti-hypertensive effect of propanolol and other beta blocking agents. Concomitant use of NSAIDs with ACE inhibitors or angiotensin-II receptor antagonists may increase the risk of renal impairment, especially in patients with pre-existing poor renal (See Section 4.4).
Diuretics:
Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
The natriuretic effect of furosemide has been reported to be inhibited by some drugs of this class.
Probenecid:
Probenecid given concurrently increases naproxen plasma levels and extends its plasma half life considerably.
Cardiac glycosides:
NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
Lithium:
Decreased elimination of lithium.
Inhibition of renal lithium clearance leading to increase in plasma lithium concentration has been reported.
Methotrexate:
Decreased elimination of methotrexate.
Caution is advised when methotrexate is administered concurrently because of possible enhancement of its toxicity since naproxen has been reported to reduce the tubular secretion of methotrexate in the animal model.
Ciclosporin:
Increased risk of nephrotoxicity.
Mifepristone:
NSAIDs should not be used for 8-12 days after mifepristone admininstration as NSAIDs can reduce the effect of mifepristone.
Corticosteroids:
Increased risk of GI bleeding or gastrointestinal ulceration (See section 4.4 – Special warnings and precautions for use).
Anti-coagulants:
NSAIDs may enhance the effects of anti-coagulants, such as warfarin or heparin (See section 4.4 – Special warnings and precautions for use). Due to the plasma protein binding of naproxen, patients simultaneously receiving anticoagulants should be observed for signs of overdosage of these drugs.
Quinolone antibiotics:
Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
Tacrolimus:
Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Sulphonamides and hydantoins:
Due to the plasma protein binding of naproxen, patients simultaneously receiving hydantoins or a highly protein bound sulphonamide should be observed for signs of overdosage of these drugs.
Patients simultaneously receiving Naproxen and a hydantoin, sulphonamide or sulphonylurea should be observed for adjustment of dose if required. No interactions have been observed in clinical studies with naproxen and anticoagulants or sulphonylureas, but caution is nevertheless advised since interaction has been seen with other non-steroidal agents of this class.
Anti-platelet agents and Selective serotonins reuptake inhibitors
There is an increased risk of gastrointestinal bleeding (see Section 4.4) when anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs) are combined with NSAIDs.
Zidovudine:
There is an increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
Acetylsalicylic acid:
Clinical pharmacodynamic data suggest that concomitant naproxen usage for more than one day consecutively may inhibit the effect of low-dose acetylsalicylic acid on platelet activity and this inhibition may persist for up to several days after stopping naproxen therapy. The clinical relevance of this interaction is not known.
Antacid or Colestyramine:
Concomitant administration of antacid or colestyramine can delay the absorption of naproxen but does not affect its extent. Concomitant administration of food can delay the absorption of naproxen, but does not affect its extent.
It is suggested that Naproxen therapy be temporarily discontinued 48 hours before adrenal tests are performed, because naproxen may artifactually interfere with some tests for 17-ketogenic steroids. Similarly, naproxen may interfere with some assays of urinary 5-hydroxyindoleacetic acid.
Pregnancy:
Congenital abnormalities have been reported in associated with NSAID administration in man however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of naproxen on the human foetal cardiovascular system (risk of closure of the ductus arteriosus), use in the last trimester of pregnancy is contraindicated. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child by naproxen (See section 4.3 Contraindications). Therefore, naproxen should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.
Labour and delivery:
Naproxen containing products are not recommended in labour and delivery because, through its prostaglandin synthesis inhibitory effect, naproxen may adversely affect foetal circulation and inhibit contractions, with an increased bleeding tendency in both mother and child.
Breast feeding:
In limited studies so far available, Naproxen can appear in breast milk in very low concentrations. The use of naproxen should be avoided in patients who are breastfeeding.
Fertility:
The use of Naproxen, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. In women who have difficulty conceiving or are undergoing investigation of infertility, withdrawal of naproxen should be considered.
Some patients may experience dizziness, drowsiness, vertigo, insomnia, fatigue and visual disturbances or depression with the use of naproxen. If patients experience these or similar undesirable effects, they should not drive or operate machinery.
The following adverse events have been reported with NSAIDs and with naproxen.
Gastrointestinal disorders: The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, heartburn, abdominal discomfort, epigastric distress, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, non-peptic gastro-intestinal ulceration, melaena, haematemesis, stomatitis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease (See section 4.4 Special warnings and precautions for use), oesophagitis and pancreatitis have been reported following administration. Less frequently, gastritis has been observed.
Immune system disorders: Hypersensitivity reactions have been reported following treatment with NSAIDs in patients with, or without, a history of previous hypersensitivity reactions to NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of ious types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Anaphylactic reactions may occur due to naproxen.
Metabolic and nutrition disorders: hyperkalaemia.
Psychiatric disorders: Insomnia, dream abnormalities, depression, confusion and hallucinations.
Nervous system disorders: Convulsions, dizziness, ache, lightedness, drowsiness, paraesthesia, retrobulbar optic neuritis, inability to concentrate and cognitive dys have been reported. Aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, ache, nausea, vomiting, fever or disorientation (see section 4.4).
Eye Disorders: Visual disturbances, corneal opacity, papillitis and papilloedema.
Ear and Labyrinth disorders: Tinnitus, hearing disturbances including impairment and vertigo.
Cardiovascular: Mild peripheral oedema has been observed. Sodium retention may occur in patients with questionable or compromised cardiac when taking naproxen. Occasional angio-oedema has been reported.
Oedema, palpations, hypertension, cardiac failure and congestive heart failure, have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Other adverse events reported less commonly include:
Vascular disorders: Hypertension, vasculitis.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, asthma, eosinophilic pneumonitis and pulmonary oedema.
Renal and urinary disorders: Nephropathy and nephrotoxicity in ious forms, including but not limited to glomerular nephritis, interstitial nephritis, nephrotic syndrome, haematuria, raised serum creatinine, renal papillary necrosis and renal failure.
Hepatobiliary disorders: Abnormal liver tests, fatal hepatitis and jaundice.
Blood and lymphatic system disorders: Granulocytopenia, thrombocytopenia, neutropenia, agranulocytosis, eosinophilia, leucopenia, aplastic anaemia and haemolytic anaemia.
Skin and subcutaneous tissue disorders: Skin rashes including fixed drug eruption, itching (pruritus), urticaria, ecchymoses, purpura, sweating. Alopecia, erythema multiforme, Stevens Johnson syndrome, erythema nodosum, lichen planus, pustular reaction, SLE, epidermal necrolysis, very rarely toxic epidermal necrolysis, photosensitivity reactions (including cases in which skin resembles porphyria cutanea tarda “pseudoporphyria) or epidermolysis bullosa-like reactions which may occur rarely.
If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.
Musculoskeletal and connective tissue disorders: Myalgia and muscle weakness.
Reproductive system and breast disorders: Female infertility.
General disorders and administration site conditions: Thirst, pyrexia, fatigue and malaise.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions afters authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
a) Symptoms
Symptoms include ache, nausea, vomiting, indigestion, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, heartburn, disorientation, excitation, drowsiness, dizziness, tinnitus, fainting. In cases of significant poisoning acute renal failure and liver damage are possible.
Respiratory depression and coma may occur after the ingestion of NSAIDs but are rare.
In one case of naproxen overdose, transient prolongation of the prothrombin time due to hypothrombinaemia may have been due to selective inhibition of the synthesis of vitamin-K dependent clotting factors.
A few patients have experienced seizures, but it is not known whether these were naproxen-related or not. It is not known what dose of the drug would be life-threatening.
b) Management
Patients should be treated symptomatically as required. Should a patient ingest a large amount of naproxen, the stomach may be emptied and usual supportive measures employed (it is not known what dose of drug would be life threatening).
Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.
Good urine output should be ensured.
Renal and liver should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially toxic amounts.
Frequent or prolonged convulsions should be treated with intravenous diazepam.
Other measures may be indicated by the patient’s clinical condition.
Haemodialysis does not decrease the plasma concentration of naproxen because of the high degree of protein binding. However, haemodialysis may still be appropriate in a patient with renal failure who has taken naproxen.
Pharmacotherapeutic group: anti-inflammatory and antirheumatic products, non-steroids.
ATC code: M1AE2
Naproxen is a non-steroidal anti-inflammatory analgesic compound with antipyretic properties as has been demonstrated in classical animal test systems. Naproxen exhibits its anti-inflammatory effect even in adrenalectomised animals, indicating that its action is not mediated through the pituitary-adrenal axis.
Naproxen inhibits prostaglandin synthetase (as do other NSAIDs). As with other NSAIDs, however, the exact mechanism of its anti-inflammatory action is not known.
Naproxen is completely absorbed from the gastro-intestinal tract, and peak plasma levels are reached in 2 to 4 hours. Naproxen is present in the blood mainly as unchanged drug, extensively bound to plasma proteins. The plasma half-life is between 12 and 15 hours, enabling a steady state to be achieved within 3 days of initiation of therapy on a twice daily dose regimen. The degree of absorption is not significantly affected by either foods or most antacids. Excretion is almost entirely via the urine, mainly as conjugated naproxen, with some unchanged drug. Metabolism in children is similar to that in adults. Chronic alcoholic liver disease reduces the total plasma concentration of naproxen but the concentration of unbound naproxen increases. In the elderly, the unbound plasma concentration of naproxen is increased although total plasma concentration is unchanged.
Carcinogenicity
Naproxen was administered with food to Sprague-Dawley rats for 24 months at doses of 8, 16 and 24mg/kg/day. Naproxen was not carcinogenic in rats.
Mutagenicity
Mutagenicity was not seen in Salmonella typhimurium (5 cell lines), Sachharomyces cerevisisae (1 cell line) and mouse lymphoma tests.
Fertility
Naproxen did not affect the fertility of rats when administered orally at doses of 3mg/kg/day to males and 2mg/kg/day to females.
Teratogenicity
Naproxen was not teratogenic when administered orally at doses of 2mg/kg/day during organogenesis to rats and rabbits.
Perinatal/Postnatal Reproduction
Oral administration of naproxen to pregnant rats at doses of 2, 1 and 2mg/kg/day during the third trimester of pregnancy resulted in difficult labour. These are known effects of this class of compounds and were demonstrated in pregnant rats with aspirin and indometacin.
Lactose, starch (maize), polyvinyl pyrrolidone, magnesium stearate, sodium starch glycollate and quinoline yellow (E14).
Not applicable.
36 months.
Store in a dry place below 25°C. Protect from light. Keep container tightly closed.
Tamper evident container comprised of polyethylene and polypropylene.
Pack sizes: 28, 3, 56, 6, 84, 1, 25, 5 and 1 tablets.
Blister pack: 6 GSM PVDC coated 25 microns, white opaque PVC film and 25 microns aluminium foil.
Pack sizes: 28, 3, 56, 6, 84 and 1 tablets.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Aurobindo Pharma Limited
Ares
Odyssey Business Park
West End Road
South Ruislip
HA4 6QD
United Kingdom
PL 2532/28
15/1/1996 / 27/6/211
25/6/218
Odyssey Business Park, Ares Block, West End Road, South Ruislip, Middlesex, HA4 6QD
+ 44 ()28 845 8811
medinfo@aurobindo.com
+44 ()28 845 8795
http://www.aurobindo.com
+44 ()28 845 8735
+44 ()28 845 8811
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