cialis black 200 mg dosage

خواص دارویی و گیاهی

Generic Name: tadalafil
Dosage Form: tablet, film coated

Medically reviewed by Drugs.com. Last updated on Feb 1, 2018.

Cialis® is indicated for the treatment of erectile dysfunction (ED).

Cialis is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Cialis is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).

If Cialis is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of Cialis decreases from 4 weeks until 26 weeks, and the incremental benefit of Cialis beyond 26 weeks is unknown [see Clinical Studies (14.3)].

Do not split Cialis tablets; entire dose should be taken.

The recommended dose of Cialis for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

Cialis may be taken without regard to food.

Renal Impairment

Cialis for Use as Needed

Cialis for Once Daily Use

Erectile Dysfunction

Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia

Hepatic Impairment

Cialis for Use as Needed

Cialis for Once Daily Use

Nitrates

Concomitant use of nitrates in any form is contraindicated [see Contraindications (4.1)].

Alpha-Blockers

ED — When Cialis is coadministered with an alpha-blocker in patients being treated for ED, patients should be stable on alpha-blocker therapy prior to initiating treatment, and Cialis should be initiated at the lowest recommended dose [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].

BPH — Cialis is not recommended for use in combination with alpha-blockers for the treatment of BPH [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].

CYP3A4 Inhibitors

Cialis for Use as Needed — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of Cialis is 10 mg, not to exceed once every 72 hours [see Warnings and Precautions (5.10) and Drug Interactions (7.2)].

Cialis for Once Daily Use — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose is 2.5 mg [see Warnings and Precautions (5.10) and Drug Interactions (7.2)].

Four strengths of almond-shaped tablets are available in different sizes and different shades of yellow:

Administration of Cialis to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, Cialis was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology (12.2)].

Cialis is contraindicated in patients with a known serious hypersensitivity to tadalafil (Cialis or ADCIRCA®). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)].

Do not use Cialis in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including Cialis, may potentiate the hypotensive effects of GC stimulators.

Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options.

Before prescribing Cialis, it is important to note the following:

Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including Cialis, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.

Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of Cialis. In such a patient, who has taken Cialis, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of Cialis before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking Cialis should seek immediate medical attention. [see Contraindications (4.1) and Patient Counseling Information (17.1)].

Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors.

The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for Cialis, and therefore until further information is available, Cialis is not recommended for the following groups of patients:

As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure. In a clinical pharmacology study, tadalafil 20 mg resulted in a mean maximal decrease in supine blood pressure, relative to placebo, of 1.6/0.8 mm Hg in healthy subjects [see Clinical Pharmacology (12.2)]. While this effect should not be of consequence in most patients, prior to prescribing Cialis, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Patients with severely impaired autonomic control of blood pressure may be particularly sensitive to the actions of vasodilators, including PDE5 inhibitors.

Physicians should be aware that Cialis for once daily use provides continuous plasma tadalafil levels and should consider this when evaluating the potential for interactions with medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors of CYP3A4) and with substantial consumption of alcohol [see Drug Interactions (7.1, 7.2, 7.3)].

There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention.

Cialis should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease).

Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including Cialis, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision, including permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 in males aged ≥50.

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An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period. The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.20). Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.

Neither the rare postmarketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [see Adverse Reactions (6.2)].

Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore, PDE5 inhibitors, including Cialis, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population; however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including Cialis, for this uncommon condition.

Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.

Physicians should advise patients to stop taking PDE5 inhibitors, including Cialis, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including Cialis. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.1, 6.2)].

Physicians should discuss with patients the potential for Cialis to augment the blood-pressure-lowering effect of alpha-blockers and antihypertensive medications [see Drug Interactions (7.1) and Clinical Pharmacology (12.2)].

Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5 inhibitors, including Cialis, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these two drug classes can lower blood pressure significantly [see Drug Interactions (7.1) and Clinical Pharmacology (12.2)], which may lead to symptomatic hypotension (e.g., fainting). Consideration should be given to the following:

ED

[see Dosage and Administration (2.7) and Drug Interactions (7.1)].

BPH

Cialis for Use as Needed

Cialis should be limited to 5 mg not more than once in every 72 hours in patients with creatinine clearance less than 30 mL/min or end-stage renal disease on hemodialysis. The starting dose of Cialis in patients with creatinine clearance 30 – 50 mL/min should be 5 mg not more than once per day, and the maximum dose should be limited to 10 mg not more than once in every 48 hours. [see Use in Specific Populations (8.7)].

Cialis for Once Daily Use

ED

BPH and ED/BPH

Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, Cialis for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min. In patients with creatinine clearance 30 – 50 mL/min, start dosing at 2.5 mg once daily, and increase the dose to 5 mg once daily based upon individual response [see Dosage and Administration (2.6), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].

Cialis for Use as Needed

In patients with mild or moderate hepatic impairment, the dose of Cialis should not exceed 10 mg. Because of insufficient information in patients with severe hepatic impairment, use of Cialis in this group is not recommended [see Use in Specific Populations (8.6)].

Cialis for Once Daily Use

Cialis for once daily use has not been extensively evaluated in patients with mild or moderate hepatic impairment. Therefore, caution is advised if Cialis for once daily use is prescribed to these patients. Because of insufficient information in patients with severe hepatic impairment, use of Cialis in this group is not recommended [see Use in Specific Populations (8.6)].

Patients should be made aware that both alcohol and Cialis, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with Cialis can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Clinical Pharmacology (12.2)].

Cialis is metabolized predominantly by CYP3A4 in the liver. The dose of Cialis for use as needed should be limited to 10 mg no more than once every 72 hours in patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole [see Drug Interactions (7.2)]. In patients taking potent inhibitors of CYP3A4 and Cialis for once daily use, the maximum recommended dose is 2.5 mg [see Dosage and Administration (2.7)].

The safety and efficacy of combinations of Cialis and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to take Cialis with other PDE5 inhibitors, including ADCIRCA.

Studies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5. PDE5 is found in platelets. When administered in combination with aspirin, tadalafil 20 mg did not prolong bleeding time, relative to aspirin alone. Cialis has not been administered to patients with bleeding disorders or significant active peptic ulceration. Although Cialis has not been shown to increase bleeding times in healthy subjects, use in patients with bleeding disorders or significant active peptic ulceration should be based upon a careful risk-benefit assessment and caution.

The use of Cialis offers no protection against sexually transmitted diseases. Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.

Prior to initiating treatment with Cialis for BPH, consideration should be given to other urological conditions that may cause similar symptoms. In addition, prostate cancer and BPH may coexist.

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.

Tadalafil was administered to over 9000 men during clinical trials worldwide. In trials of Cialis for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For Cialis for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.

Cialis for Use as Needed for ED

In eight primary placebo-controlled clinical studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the discontinuation rate due to adverse events in patients treated with tadalafil 10 or 20 mg was 3.1%, compared to 1.4% in placebo treated patients.

When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1) for Cialis for use as needed:

a The term flushing includes: facial flushing and flushing

Cialis for Once Daily Use for ED

In three placebo-controlled clinical trials of 12 or 24 weeks duration, mean age was 58 years (range 21 to 82) and the discontinuation rate due to adverse events in patients treated with tadalafil was 4.1%, compared to 2.8% in placebo-treated patients.

The following adverse reactions were reported (see Table 2) in clinical trials of 12 weeks duration:

The following adverse reactions were reported (see Table 3) over 24 weeks treatment duration in one placebo-controlled clinical study:

Cialis for Once Daily Use for BPH and for ED and BPH

In three placebo-controlled clinical trials of 12 weeks duration, two in patients with BPH and one in patients with ED and BPH, the mean age was 63 years (range 44 to 93) and the discontinuation rate due to adverse events in patients treated with tadalafil was 3.6% compared to 1.6% in placebo-treated patients. Adverse reactions leading to discontinuation reported by at least 2 patients treated with tadalafil included headache, upper abdominal pain, and myalgia. The following adverse reactions were reported (see Table 4).

Additional, less frequent adverse reactions (<1%) reported in the controlled clinical trials of Cialis for BPH or ED and BPH included: gastroesophageal reflux disease, upper abdominal pain, nausea, vomiting, arthralgia, and muscle spasm.

Back pain or myalgia was reported at incidence rates described in Tables 1 through 4. In tadalafil clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. The back pain/myalgia associated with tadalafil treatment was characterized by diffuse bilateral lower lumbar, gluteal, thigh, or thoracolumbar muscular discomfort and was exacerbated by recumbency. In general, pain was reported as mild or moderate in severity and resolved without medical treatment, but severe back pain was reported with a low frequency (<5% of all reports). When medical treatment was necessary, acetaminophen or non-steroidal anti-inflammatory drugs were generally effective; however, in a small percentage of subjects who required treatment, a mild narcotic (e.g., codeine) was used. Overall, approximately 0.5% of all subjects treated with Cialis for on demand use discontinued treatment as a consequence of back pain/myalgia. In the 1-year open label extension study, back pain and myalgia were reported in 5.5% and 1.3% of patients, respectively. Diagnostic testing, including measures for inflammation, muscle injury, or renal damage revealed no evidence of medically significant underlying pathology. Incidence rates for Cialis for once daily use for ED, BPH and BPH/ED are described in Tables 2, 3 and 4. In studies of Cialis for once daily use, adverse reactions of back pain and myalgia were generally mild or moderate with a discontinuation rate of <1% across all indications.

Across placebo-controlled studies with Cialis for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with Cialis (2.5% of patients) [see Use in Specific Populations (8.5)].

Across all studies with any Cialis dose, reports of changes in color vision were rare (<0.1% of patients).

The following section identifies additional, less frequent events (<2%) reported in controlled clinical trials of Cialis for once daily use or use as needed. A causal relationship of these events to Cialis is uncertain. Excluded from this list are those events that were minor, those with no plausible relation to drug use, and reports too imprecise to be meaningful:

Body as a Whole — asthenia, face edema, fatigue, pain, peripheral edema

Cardiovascular — angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia

Digestive — abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage

Musculoskeletal — arthralgia, neck pain

Nervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo

Renal and Urinary — renal impairment

Respiratory — dyspnea, epistaxis, pharyngitis

Skin and Appendages — pruritus, rash, sweating

Ophthalmologic — blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids

Otologic — sudden decrease or loss of hearing, tinnitus

Urogenital — erection increased, spontaneous penile erection

The following adverse reactions have been identified during post approval use of Cialis. 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. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors.

Cardiovascular and Cerebrovascular — Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of Cialis without sexual activity. Others were reported to have occurred hours to days after the use of Cialis and sexual activity. It is not possible to determine whether these events are related directly to Cialis, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1)].

Body as a Whole — hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, and exfoliative dermatitis

Nervous — migraine, seizure and seizure recurrence, transient global amnesia

Ophthalmologic — visual field defect, retinal vein occlusion, retinal artery occlusion

Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including Cialis. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking [see Warnings and Precautions (5.4)].

Otologic — Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including Cialis. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of Cialis, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions (5.5)].

Urogenital — priapism [see Warnings and Precautions (5.3)].

Nitrates — Administration of Cialis to patients who are using any form of organic nitrate, is contraindicated. In clinical pharmacology studies, Cialis was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken Cialis, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of Cialis before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Dosage and Administration (2.7), Contraindications (4.1), and Clinical Pharmacology (12.2)].

Alpha-Blockers — Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5 inhibitors, including Cialis, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, tamsulosin or alfuzosin. [see Dosage and Administration (2.7), Warnings and Precautions (5.6), and Clinical Pharmacology (12.2)].

Antihypertensives — PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood-pressure-lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendrofluazide, enalapril, and metoprolol). Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo. [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.2)].

Alcohol — Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Substantial consumption of alcohol (e.g., 5 units or greater) in combination with Cialis can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache. Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations. [see Warnings and Precautions (5.9) and Clinical Pharmacology (12.2)].

[See Dosage and Administration (2.7) and Warnings and Precautions (5.10)].

Antacids — Simultaneous administration of an antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil reduced the apparent rate of absorption of tadalafil without altering exposure (AUC) to tadalafil.

H2 Antagonists (e.g. Nizatidine) — An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics.

Cytochrome P450 Inhibitors — Cialis is a substrate of and predominantly metabolized by CYP3A4. Studies have shown that drugs that inhibit CYP3A4 can increase tadalafil exposure.

CYP3A4 (e.g., Ketoconazole) — Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased tadalafil 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20 mg alone. Ketoconazole (200 mg daily) increased tadalafil 10-mg single-dose exposure (AUC) by 107% and Cmax by 15%, relative to the values for tadalafil 10 mg alone [see Dosage and Administration (2.7)].

Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure.

HIV Protease inhibitor — Ritonavir (500 mg or 600 mg twice daily at steady state), an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil 20-mg single-dose exposure (AUC) by 32% with a 30% reduction in Cmax, relative to the values for tadalafil 20 mg alone. Ritonavir (200 mg twice daily), increased tadalafil 20-mg single-dose exposure (AUC) by 124% with no change in Cmax, relative to the values for tadalafil 20 mg alone. Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure [see Dosage and Administration (2.7)].

Cytochrome P450 Inducers — Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure.

CYP3A4 (e.g., Rifampin) — Rifampin (600 mg daily), a CYP3A4 inducer, reduced tadalafil 10-mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone. Although specific interactions have not been studied, other CYP3A4 inducers, such as carbamazepine, phenytoin, and phenobarbital, would likely decrease tadalafil exposure. No dose adjustment is warranted. The reduced exposure of tadalafil with the coadministration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of Cialis for once daily use; the magnitude of decreased efficacy is unknown.

Aspirin — Tadalafil did not potentiate the increase in bleeding time caused by aspirin.

Cytochrome P450 Substrates — Cialis is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms. Studies have shown that tadalafil does not inhibit or induce P450 isoforms CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.

CYP1A2 (e.g. Theophylline) — Tadalafil had no significant effect on the pharmacokinetics of theophylline. When tadalafil was administered to subjects taking theophylline, a small augmentation (3 beats per minute) of the increase in heart rate associated with theophylline was observed.

CYP2C9 (e.g. Warfarin) — Tadalafil had no significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did tadalafil affect changes in prothrombin time induced by warfarin.

CYP3A4 (e.g. Midazolam or Lovastatin) — Tadalafil had no significant effect on exposure (AUC) to midazolam or lovastatin.

P-glycoprotein (e.g. Digoxin) — Coadministration of tadalafil (40 mg once per day) for 10 days did not have a significant effect on the steady-state pharmacokinetics of digoxin (0.25 mg/day) in healthy subjects.

Risk Summary

Cialis (tadalafil) is not indicated for use in females.

There are no data with the use of Cialis in pregnant women to inform any drug-associated risks for adverse developmental outcomes. In animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures up to 11 times the maximum recommended human dose (MRHD) of 20 mg/day (see Data).

Data

Animal Data

Animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given orally to pregnant rats or mice at exposures up to 11 times the maximum recommended human dose (MRHD) of 20 mg/day during organogenesis. In a prenatal/postnatal developmental study in rats, postnatal pup survival decreased following maternal exposure to tadalafil doses greater than 10 times the MRHD based on AUC. Signs of maternal toxicity occurred at doses greater than 16 times the MRHD based on AUC. Surviving offspring had normal development and reproductive performance.

In another rat prenatal and postnatal development study at doses of 60, 200, and 1000 mg/kg, a reduction in postnatal survival of pups was observed. The no observed effect level (NOEL) for maternal toxicity was 200 mg/kg/day and for developmental toxicity was 30 mg/kg/day. This gives approximately 16 and 10 fold exposure multiples, respectively, of the human AUC for the MRHD of 20 mg.

Tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats.

Risk Summary

Cialis is not indicated for use in females.

There is no information on the presence of tadalafil and/or metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Tadalafil and/or its metabolites are present in the milk of lactating rats at concentrations approximately 2.4-fold greater than found in the plasma.

Infertility

Based on the data from 3 studies in adult males, tadalafil decreased sperm concentrations in the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months. This effect was not seen in the study of 20 mg tadalafil taken for 6 months. There was no adverse effect of tadalafil 10 mg or 20 mg on mean concentrations of testosterone, luteinizing hormone or follicle stimulating hormone. The clinical significance of the decreased sperm concentrations in the two studies is unknown. There have been no studies evaluating the effect of tadalafil on fertility in men [see Clinical Pharmacology (12.2)].

Based on studies in animals, a decrease in spermatogenesis was observed in dogs, but not in rats [see Nonclinical Toxicology (13.1)].

Cialis is not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years have not been established.

A randomized, double-blind, placebo-controlled trial in pediatric patients (7 to 14 years of age) with Duchenne muscular dystrophy, who received Cialis 0.3 mg/kg, Cialis 0.6 mg/kg, or placebo daily for 48 weeks failed to demonstrate any benefit of treatment with Cialis on a range of assessments of muscle strength and performance.

Juvenile Animal Study

No adverse effects were observed in a study in which tadalafil was administered orally at doses of 60, 200, and 1000 mg/kg/day to juvenile rats on postnatal days 14 to 90. The highest plasma tadalafil exposures (AUC) achieved were approximately 10-fold that observed at the MRHD.

Of the total number of subjects in ED clinical studies of tadalafil, approximately 19 percent were 65 and over, while approximately 2 percent were 75 and over. Of the total number of subjects in BPH clinical studies of tadalafil (including the ED/BPH study), approximately 40 percent were over 65, while approximately 10 percent were 75 and over. In these clinical trials, no overall differences in efficacy or safety were observed between older (>65 and ≥75 years of age) and younger subjects (≤65 years of age). However, in placebo-controlled studies with Cialis for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with Cialis (2.5% of patients) [see Adverse Reactions (6.1)]. No dose adjustment is warranted based on age alone. However, a greater sensitivity to medications in some older individuals should be considered. [see Clinical Pharmacology (12.3)].

In clinical pharmacology studies, tadalafil exposure (AUC) in subjects with mild or moderate hepatic impairment (Child-Pugh Class A or B) was comparable to exposure in healthy subjects when a dose of 10 mg was administered. There are no available data for doses higher than 10 mg of tadalafil in patients with hepatic impairment. Insufficient data are available for subjects with severe hepatic impairment (Child-Pugh Class C). [see Dosage and Administration (2.6) and Warnings and Precautions (5.8)].

In clinical pharmacology studies using single-dose tadalafil (5 to 10 mg), tadalafil exposure (AUC) doubled in subjects with creatinine clearance 30 to 80 mL/min. In subjects with end-stage renal disease on hemodialysis, there was a two-fold increase in Cmax and 2.7- to 4.8-fold increase in AUC following single-dose administration of 10 or 20 mg tadalafil. Exposure to total methylcatechol (unconjugated plus glucuronide) was 2- to 4-fold higher in subjects with renal impairment, compared to those with normal renal function. Hemodialysis (performed between 24 and 30 hours post-dose) contributed negligibly to tadalafil or metabolite elimination. In a clinical pharmacology study (N=28) at a dose of 10 mg, back pain was reported as a limiting adverse event in male patients with creatinine clearance 30 to 50 mL/min. At a dose of 5 mg, the incidence and severity of back pain was not significantly different than in the general population. In patients on hemodialysis taking 10- or 20-mg tadalafil, there were no reported cases of back pain. [see Dosage and Administration (2.6) and Warnings and Precautions (5.7)].

Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.

Cialis (tadalafil) is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:

The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol.

Cialis is available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.

Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. The inhibition of phosphodiesterase type 5 (PDE5) enhances erectile function by increasing the amount of cGMP. Tadalafil inhibits PDE5. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect in the absence of sexual stimulation.

The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum and pulmonary arteries is also observed in the smooth muscle of the prostate, the bladder and their vascular supply. The mechanism for reducing BPH symptoms has not been established.

Studies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5. PDE5 is found in the smooth muscle of the corpus cavernosum, prostate, and bladder as well as in vascular and visceral smooth muscle, skeletal muscle, urethra, platelets, kidney, lung, cerebellum, heart, liver, testis, seminal vesicle, and pancreas.

In vitro studies have shown that the effect of tadalafil is more potent on PDE5 than on other phosphodiesterases. These studies have shown that tadalafil is >10,000-fold more potent for PDE5 than for PDE1, PDE2, PDE4, and PDE7 enzymes, which are found in the heart, brain, blood vessels, liver, leukocytes, skeletal muscle, and other organs. Tadalafil is >10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels. Additionally, tadalafil is 700-fold more potent for PDE5 than for PDE6, which is found in the retina and is responsible for phototransduction. Tadalafil is >9,000-fold more potent for PDE5 than for PDE8, PDE9, and PDE10. Tadalafil is 14-fold more potent for PDE5 than for PDE11A1 and 40-fold more potent for PDE5 than for PDE11A4, two of the four known forms of PDE11. PDE11 is an enzyme found in human prostate, testes, skeletal muscle and in other tissues (e.g., adrenal cortex). In vitro, tadalafil inhibits human recombinant PDE11A1 and, to a lesser degree, PDE11A4 activities at concentrations within the therapeutic range. The physiological role and clinical consequence of PDE11 inhibition in humans have not been defined.

Effects on Blood Pressure

Tadalafil 20 mg administered to healthy male subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (difference in the mean maximal decrease of 1.6/0.8 mm Hg, respectively) and in standing systolic and diastolic blood pressure (difference in the mean maximal decrease of 0.2/4.6 mm Hg, respectively). In addition, there was no significant effect on heart rate.

Effects on Blood Pressure When Administered with Nitrates

In clinical pharmacology studies, tadalafil (5 to 20 mg) was shown to potentiate the hypotensive effect of nitrates. Therefore, the use of Cialis in patients taking any form of nitrates is contraindicated [see Contraindications (4.1)].

A study was conducted to assess the degree of interaction between nitroglycerin and tadalafil, should nitroglycerin be required in an emergency situation after tadalafil was taken. This was a double-blind, placebo-controlled, crossover study in 150 male subjects at least 40 years of age (including subjects with diabetes mellitus and/or controlled hypertension) and receiving daily doses of tadalafil 20 mg or matching placebo for 7 days. Subjects were administered a single dose of 0.4 mg sublingual nitroglycerin (NTG) at pre-specified timepoints, following their last dose of tadalafil (2, 4, 8, 24, 48, 72, and 96 hours after tadalafil). The objective of the study was to determine when, after tadalafil dosing, no apparent blood pressure interaction was observed. In this study, a significant interaction between tadalafil and NTG was observed at each timepoint up to and including 24 hours. At 48 hours, by most hemodynamic measures, the interaction between tadalafil and NTG was not observed, although a few more tadalafil subjects compared to placebo experienced greater blood-pressure lowering at this timepoint. After 48 hours, the interaction was not detectable (see Figure 1).

Figure 1: Mean Maximal Change in Blood Pressure (Tadalafil Minus Placebo, Point Estimate with 90% CI) in Response to Sublingual Nitroglycerin at 2 (Supine Only), 4, 8, 24, 48, 72, and 96 Hours after the Last Dose of Tadalafil 20 mg or Placebo

Therefore, Cialis administration with nitrates is contraindicated. In a patient who has taken Cialis, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of Cialis before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Contraindications (4.1)].

Effect on Blood Pressure When Administered With Alpha-Blockers

Six randomized, double-blinded, crossover clinical pharmacology studies were conducted to investigate the potential interaction of tadalafil with alpha-blocker agents in healthy male subjects [see Dosage and Administration (2.7) and Warnings and Precautions (5.6)]. In four studies, a single oral dose of tadalafil was administered to healthy male subjects taking daily (at least 7 days duration) an oral alpha-blocker. In two studies, a daily oral alpha-blocker (at least 7 days duration) was administered to healthy male subjects taking repeated daily doses of tadalafil.

Doxazosin — Three clinical pharmacology studies were conducted with tadalafil and doxazosin, an alpha[1]-adrenergic blocker.

In the first doxazosin study, a single oral dose of tadalafil 20 mg or placebo was administered in a 2-period, crossover design to healthy subjects taking oral doxazosin 8 mg daily (N=18 subjects). Doxazosin was administered at the same time as tadalafil or placebo after a minimum of seven days of doxazosin dosing (see Table 5 and Figure 2).

Figure 2: Doxazosin Study 1: Mean Change from Baseline in Systolic Blood Pressure

Blood pressure was measured manually at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours after tadalafil or placebo administration. Outliers were defined as subjects with a standing systolic blood pressure of 30 mm Hg at one or more time points. There were nine and three outliers following administration of tadalafil 20 mg and placebo, respectively. Five and two subjects were outliers due to a decrease from baseline in standing systolic BP of >30 mm Hg, while five and one subject were outliers due to standing systolic BP <85 mm Hg following tadalafil and placebo, respectively. Severe adverse events potentially related to blood-pressure effects were assessed. No such events were reported following placebo. Two such events were reported following administration of tadalafil. Vertigo was reported in one subject that began 7 hours after dosing and lasted about 5 days. This subject previously experienced a mild episode of vertigo on doxazosin and placebo. Dizziness was reported in another subject that began 25 minutes after dosing and lasted 1 day. No syncope was reported.

In the second doxazosin study, a single oral dose of tadalafil 20 mg was administered to healthy subjects taking oral doxazosin, either 4 or 8 mg daily. The study (N=72 subjects) was conducted in three parts, each a 3-period crossover.

In part A (N=24), subjects were titrated to doxazosin 4 mg administered daily at 8 a.m. Tadalafil was administered at either 8 a.m., 4 p.m., or 8 p.m. There was no placebo control.

In part B (N=24), subjects were titrated to doxazosin 4 mg administered daily at 8 p.m. Tadalafil was administered at either 8 a.m., 4 p.m., or 8 p.m. There was no placebo control.

In part C (N=24), subjects were titrated to doxazosin 8 mg administered daily at 8 a.m. In this part, tadalafil or placebo were administered at either 8 a.m. or 8 p.m.

The placebo-subtracted mean maximal decreases in systolic blood pressure over a 12-hour period after dosing in the placebo-controlled portion of the study (part C) are shown in Table 6 and Figure 3.

Figure 3: Doxazosin Study 2 (Part C): Mean Change from Time-Matched Baseline in Systolic Blood Pressure

Blood pressure was measured by ABPM every 15 to 30 minutes for up to 36 hours after tadalafil or placebo. Subjects were categorized as outliers if one or more systolic blood pressure readings of 30 mm Hg from a time-matched baseline occurred during the analysis interval.

Of the 24 subjects in part C, 16 subjects were categorized as outliers following administration of tadalafil and 6 subjects were categorized as outliers following placebo during the 24-hour period after 8 a.m. dosing of tadalafil or placebo. Of these, 5 and 2 were outliers due to systolic BP 30 mm Hg following tadalafil and placebo, respectively.

During the 24-hour period after 8 p.m. dosing, 17 subjects were categorized as outliers following administration of tadalafil and 7 subjects following placebo. Of these, 10 and 2 subjects were outliers due to systolic BP 30 mm Hg, following tadalafil and placebo, respectively.

Some additional subjects in both the tadalafil and placebo groups were categorized as outliers in the period beyond 24 hours.

Severe adverse events potentially related to blood-pressure effects were assessed. In the study (N=72 subjects), 2 such events were reported following administration of tadalafil (symptomatic hypotension in one subject that began 10 hours after dosing and lasted approximately 1 hour, and dizziness in another subject that began 11 hours after dosing and lasted 2 minutes). No such events were reported following placebo. In the period prior to tadalafil dosing, one severe event (dizziness) was reported in a subject during the doxazosin run-in phase.

In the third doxazosin study, healthy subjects (N=45 treated; 37 completed) received 28 days of once per day dosing of tadalafil 5 mg or placebo in a two-period crossover design. After 7 days, doxazosin was initiated at 1 mg and titrated up to 4 mg daily over the last 21 days of each period (7 days on 1 mg; 7 days of 2 mg; 7 days of 4 mg doxazosin). The results are shown in Table 7.

Blood pressure was measured manually pre-dose at two time points (-30 and -15 minutes) and then at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours post dose on the first day of each doxazosin dose, (1 mg, 2 mg, 4 mg), as well as on the seventh day of 4 mg doxazosin administration.

Following the first dose of doxazosin 1 mg, there were no outliers on tadalafil 5 mg and one outlier on placebo due to a decrease from baseline in standing systolic BP of >30 mm Hg.

There were 2 outliers on tadalafil 5 mg and none on placebo following the first dose of doxazosin 2 mg due to a decrease from baseline in standing systolic BP of >30 mm Hg.

There were no outliers on tadalafil 5 mg and two on placebo following the first dose of doxazosin 4 mg due to a decrease from baseline in standing systolic BP of >30 mm Hg. There was one outlier on tadalafil 5 mg and three on placebo following the first dose of doxazosin 4 mg due to standing systolic BP 30 mm Hg in standing systolic blood pressure, and one subject on placebo had standing systolic blood pressure <85 mm Hg. All adverse events potentially related to blood pressure effects were rated as mild or moderate. There were two episodes of syncope in this study, one subject following a dose of tadalafil 5 mg alone, and another subject following coadministration of tadalafil 5 mg and doxazosin 4 mg.

Tamsulosin — In the first tamsulosin study, a single oral dose of tadalafil 10, 20 mg, or placebo was administered in a 3 period, crossover design to healthy subjects taking 0.4 mg once per day tamsulosin, a selective alpha[1A]-adrenergic blocker (N=18 subjects). Tadalafil or placebo was administered 2 hours after tamsulosin following a minimum of seven days of tamsulosin dosing.

Blood pressure was measured manually at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours after tadalafil or placebo dosing. There were 2, 2, and 1 outliers (subjects with a decrease from baseline in standing systolic blood pressure of >30 mm Hg at one or more time points) following administration of tadalafil 10 mg, 20 mg, and placebo, respectively. There were no subjects with a standing systolic blood pressure <85 mm Hg. No severe adverse events potentially related to blood-pressure effects were reported. No syncope was reported.

In the second tamsulosin study, healthy subjects (N=39 treated; and 35 completed) received 14 days of once per day dosing of tadalafil 5 mg or placebo in a two-period crossover design. Daily dosing of tamsulosin 0.4 mg was added for the last seven days of each period.

Blood pressure was measured manually pre-dose at two time points (-30 and -15 minutes) and then at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post dose on the first, sixth and seventh days of tamsulosin administration. There were no outliers (subjects with a decrease from baseline in standing systolic blood pressure of >30 mm Hg at one or more time points). One subject on placebo plus tamsulosin (Day 7) and one subject on tadalafil plus tamsulosin (Day 6) had standing systolic blood pressure <85 mm Hg. No severe adverse events potentially related to blood pressure were reported. No syncope was reported.

Alfuzosin — A single oral dose of tadalafil 20 mg or placebo was administered in a 2-period, crossover design to healthy subjects taking once-daily alfuzosin HCl 10 mg extended-release tablets, an alpha[1]-adrenergic blocker (N=17 completed subjects). Tadalafil or placebo was administered 4 hours after alfuzosin following a minimum of seven days of alfuzosin dosing.

Blood pressure was measured manually at 1, 2, 3, 4, 6, 8, 10, 20, and 24 hours after tadalafil or placebo dosing. There was 1 outlier (subject with a standing systolic blood pressure 30 mm Hg at one or more time points. No severe adverse events potentially related to blood pressure effects were reported. No syncope was reported.

Effects on Blood Pressure When Administered with Antihypertensives

Amlodipine — A study was conducted to assess the interaction of amlodipine (5 mg daily) and tadalafil 10 mg. There was no effect of tadalafil on amlodipine blood levels and no effect of amlodipine on tadalafil blood levels. The mean reduction in supine systolic/diastolic blood pressure due to tadalafil 10 mg in subjects taking amlodipine was 3/2 mm Hg, compared to placebo. In a similar study using tadalafil 20 mg, there were no clinically significant differences between tadalafil and placebo in subjects taking amlodipine.

Angiotensin II receptor blockers (with and without other antihypertensives) — A study was conducted to assess the interaction of angiotensin II receptor blockers and tadalafil 20 mg. Subjects in the study were taking any marketed angiotensin II receptor blocker, either alone, as a component of a combination product, or as part of a multiple antihypertensive regimen. Following dosing, ambulatory measurements of blood pressure revealed differences between tadalafil and placebo of 8/4 mm Hg in systolic/diastolic blood pressure.

Bendrofluazide — A study was conducted to assess the interaction of bendrofluazide (2.5 mg daily) and tadalafil 10 mg. Following dosing, the mean reduction in supine systolic/diastolic blood pressure due to tadalafil 10 mg in subjects taking bendrofluazide was 6/4 mm Hg, compared to placebo.

Enalapril — A study was conducted to assess the interaction of enalapril (10 to 20 mg daily) and tadalafil 10 mg. Following dosing, the mean reduction in supine systolic/diastolic blood pressure due to tadalafil 10 mg in subjects taking enalapril was 4/1 mm Hg, compared to placebo.

Metoprolol — A study was conducted to assess the interaction of sustained-release metoprolol (25 to 200 mg daily) and tadalafil 10 mg. Following dosing, the mean reduction in supine systolic/diastolic blood pressure due to tadalafil 10 mg in subjects taking metoprolol was 5/3 mm Hg, compared to placebo.

Effects on Blood Pressure When Administered with Alcohol

Alcohol and PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. The interaction of tadalafil with alcohol was evaluated in 3 clinical pharmacology studies. In 2 of these, alcohol was administered at a dose of 0.7 g/kg, which is equivalent to approximately 6 ounces of 80-proof vodka in an 80-kg male, and tadalafil was administered at a dose of 10 mg in one study and 20 mg in another. In both these studies, all patients imbibed the entire alcohol dose within 10 minutes of starting. In one of these two studies, blood alcohol levels of 0.08% were confirmed. In these two studies, more patients had clinically significant decreases in blood pressure on the combination of tadalafil and alcohol as compared to alcohol alone. Some subjects reported postural dizziness, and orthostatic hypotension was observed in some subjects. When tadalafil 20 mg was administered with a lower dose of alcohol (0.6 g/kg, which is equivalent to approximately 4 ounces of 80-proof vodka, administered in less than 10 minutes), orthostatic hypotension was not observed, dizziness occurred with similar frequency to alcohol alone, and the hypotensive effects of alcohol were not potentiated.

Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations.

Effects on Exercise Stress Testing

The effects of tadalafil on cardiac function, hemodynamics, and exercise tolerance were investigated in a single clinical pharmacology study. In this blinded crossover trial, 23 subjects with stable coronary artery disease and evidence of exercise-induced cardiac ischemia were enrolled. The primary endpoint was time to cardiac ischemia. The mean difference in total exercise time was 3 seconds (tadalafil 10 mg minus placebo), which represented no clinically meaningful difference. Further statistical analysis demonstrated that tadalafil was non-inferior to placebo with respect to time to ischemia. Of note, in this study, in some subjects who received tadalafil followed by sublingual nitroglycerin in the post-exercise period, clinically significant reductions in blood pressure were observed, consistent with the augmentation by tadalafil of the blood-pressure-lowering effects of nitrates.

Effects on Vision

Single oral doses of phosphodiesterase inhibitors have demonstrated transient dose-related impairment of color discrimination (blue/green), using the Farnsworth-Munsell 100-hue test, with peak effects near the time of peak plasma levels. This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina. In a study to assess the effects of a single dose of tadalafil 40 mg on vision (N=59), no effects were observed on visual acuity, intraocular pressure, or pupilometry. Across all clinical studies with Cialis, reports of changes in color vision were rare (<0.1% of patients).

Effects on Sperm Characteristics

Three studies were conducted in men to assess the potential effect on sperm characteristics of tadalafil 10 mg (one 6 month study) and 20 mg (one 6 month and one 9 month study) administered daily. There were no adverse effects on sperm morphology or sperm motility in any of the three studies. In the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months, results showed a decrease in mean sperm concentrations relative to placebo, although these differences were not clinically meaningful. This effect was not seen in the study of 20 mg tadalafil taken for 6 months. In addition there was no adverse effect on mean concentrations of reproductive hormones, testosterone, luteinizing hormone or follicle stimulating hormone with either 10 or 20 mg of tadalafil compared to placebo.

Effects on Cardiac Electrophysiology

The effect of a single 100-mg dose of tadalafil on the QT interval was evaluated at the time of peak tadalafil concentration in a randomized, double-blinded, placebo, and active (intravenous ibutilide) -controlled crossover study in 90 healthy males aged 18 to 53 years. The mean change in QTc (Fridericia QT correction) for tadalafil, relative to placebo, was 3.5 milliseconds (two-sided 90% CI=1.9, 5.1). The mean change in QTc (Individual QT correction) for tadalafil, relative to placebo, was 2.8 milliseconds (two-sided 90% CI=1.2, 4.4). A 100-mg dose of tadalafil (5 times the highest recommended dose) was chosen because this dose yields exposures covering those observed upon coadministration of tadalafil with potent CYP3A4 inhibitors or those observed in renal impairment. In this study, the mean increase in heart rate associated with a 100-mg dose of tadalafil compared to placebo was 3.1 beats per minute.

Over a dose range of 2.5 to 20 mg, tadalafil exposure (AUC) increases proportionally with dose in healthy subjects. Steady-state plasma concentrations are attained within 5 days of once per day dosing and exposure is approximately 1.6-fold greater than after a single dose. Mean tadalafil concentrations measured after the administration of a single oral dose of 20 mg and single and once daily multiple doses of 5 mg, from a separate study, (see Figure 4) to healthy male subjects are depicted in Figure 4.

Figure 4: Plasma tadalafil concentrations (mean ± SD) following a single 20-mg tadalafil dose and single and once daily multiple doses of 5 mg

Absorption — After single oral-dose administration, the maximum observed plasma concentration (Cmax) of tadalafil is achieved between 30 minutes and 6 hours (median time of 2 hours). Absolute bioavailability of tadalafil following oral dosing has not been determined.

The rate and extent of absorption of tadalafil are not influenced by food; thus Cialis may be taken with or without food.

Distribution — The mean apparent volume of distribution following oral administration is approximately 63 L, indicating that tadalafil is distributed into tissues. At therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins.

Less than 0.0005% of the administered dose appeared in the semen of healthy subjects.

Metabolism — Tadalafil is predominantly metabolized by CYP3A4 to a catechol metabolite. The catechol metabolite undergoes extensive methylation and glucuronidation to form the methylcatechol and methylcatechol glucuronide conjugate, respectively. The major circulating metabolite is the methylcatechol glucuronide. Methylcatechol concentrations are less than 10% of glucuronide concentrations. In vitro data suggests that metabolites are not expected to be pharmacologically active at observed metabolite concentrations.

Excretion — The mean oral clearance for tadalafil is 2.5 L/hr and the mean terminal half-life is 17.5 hours in healthy subjects. Tadalafil is excreted predominantly as metabolites, mainly in the feces (approximately 61% of the dose) and to a lesser extent in the urine (approximately 36% of the dose).

Geriatric — Healthy male elderly subjects (65 years or over) had a lower oral clearance of tadalafil, resulting in 25% higher exposure (AUC) with no effect on Cmax relative to that observed in healthy subjects 19 to 45 years of age. No dose adjustment is warranted based on age alone. However, greater sensitivity to medications in some older individuals should be considered [see Use in Specific Populations (8.5)].

Patients with Diabetes Mellitus — In male patients with diabetes mellitus after a 10 mg tadalafil dose, exposure (AUC) was reduced approximately 19% and Cmax was 5% lower than that observed in healthy subjects. No dose adjustment is warranted.

Patients with BPH — In patients with BPH following single and multiple-doses of 20 mg tadalafil, no statistically significant differences in exposure (AUC and Cmax) were observed between elderly (70 to 85 years) and younger (≤60 years of age) subjects. No dose adjustment is warranted.

Carcinogenesis — Tadalafil was not carcinogenic to rats or mice when administered daily for 2 years at doses up to 400 mg/kg/day. Systemic drug exposures, as measured by AUC of unbound tadalafil, were approximately 10-fold for mice, and 14- and 26-fold for male and female rats, respectively, the exposures in human males given Maximum Recommended Human Dose (MRHD) of 20 mg.

Mutagenesis — Tadalafil was not mutagenic in the in vitro bacterial Ames assays or the forward mutation test in mouse lymphoma cells. Tadalafil was not clastogenic in the in vitro chromosomal aberration test in human lymphocytes or the in vivo rat micronucleus assays.

Impairment of Fertility — There were no effects on fertility, reproductive performance or reproductive organ morphology in male or female rats given oral doses of tadalafil up to 400 mg/kg/day, a dose producing AUCs for unbound tadalafil of 14-fold for males or 26-fold for females the exposures observed in human males given the MRHD of 20 mg. In beagle dogs given tadalafil daily for 3 to 12 months, there was treatment-related non-reversible degeneration and atrophy of the seminiferous tubular epithelium in the testes in 20-100% of the dogs that resulted in a decrease in spermatogenesis in 40-75% of the dogs at doses of ≥10 mg/kg/day. Systemic exposure (based on AUC) at no-observed-adverse-effect-level (NOAEL) (10 mg/kg/day) for unbound tadalafil was similar to that expected in humans at the MRHD of 20 mg.

There were no treatment-related testicular findings in rats or mice treated with doses up to 400 mg/kg/day for 2 years.

Animal studies showed vascular inflammation in tadalafil-treated mice, rats, and dogs. In mice and rats, lymphoid necrosis and hemorrhage were seen in the spleen, thymus, and mesenteric lymph nodes at unbound tadalafil exposure of 2- to 33-fold above the human exposure (AUCs) at the MRHD of 20 mg. In dogs, an increased incidence of disseminated arteritis was observed in 1- and 6-month studies at unbound tadalafil exposure of 1- to 54-fold above the human exposure (AUC) at the MRHD of 20 mg. In a 12-month dog study, no disseminated arteritis was observed, but 2 dogs exhibited marked decreases in white blood cells (neutrophils) and moderate decreases in platelets with inflammatory signs at unbound tadalafil exposures of approximately 14- to 18-fold the human exposure at the MRHD of 20 mg. The abnormal blood-cell findings were reversible within 2 weeks after stopping treatment.

The efficacy and safety of tadalafil in the treatment of erectile dysfunction has been evaluated in 22 clinical trials of up to 24-weeks duration, involving over 4000 patients. Cialis, when taken as needed up to once per day, was shown to be effective in improving erectile function in men with erectile dysfunction (ED).

Cialis was studied in the general ED population in 7 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12-weeks duration. Two of these studies were conducted in the United States and 5 were conducted in centers outside the US. Additional efficacy and safety studies were performed in ED patients with diabetes mellitus and in patients who developed ED status post bilateral nerve-sparing radical prostatectomy.

In these 7 trials, Cialis was taken as needed, at doses ranging from 2.5 to 20 mg, up to once per day. Patients were free to choose the time interval between dose administration and the time of sexual attempts. Food and alcohol intake were not restricted.

Several assessment tools were used to evaluate the effect of Cialis on erectile function. The 3 primary outcome measures were the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) and Questions 2 and 3 from Sexual Encounter Profile (SEP). The IIEF is a 4-week recall questionnaire that was administered at the end of a treatment-free baseline period and subsequently at follow-up visits after randomization. The IIEF EF domain has a 30-point total score, where higher scores reflect better erectile function. SEP is a diary in which patients recorded each sexual attempt made throughout the study. SEP Question 2 asks, “Were you able to insert your penis into the partner’s vagina?” SEP Question 3 asks, “Did your erection last long enough for you to have successful intercourse?” The overall percentage of successful attempts to insert the penis into the vagina (SEP2) and to maintain the erection for successful intercourse (SEP3) is derived for each patient.

Results in ED Population in US Trials — The 2 primary US efficacy and safety trials included a total of 402 men with erectile dysfunction, with a mean age of 59 years (range 27 to 87 years). The population was 78% White, 14% Black, 7% Hispanic, and 1% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Most (>90%) patients reported ED of at least 1-year duration. Study A was conducted primarily in academic centers. Study B was conducted primarily in community-based urology practices. In each of these 2 trials, Cialis 20 mg showed clinically meaningful and statistically significant improvements in all 3 primary efficacy variables (see Table 11). The treatment effect of Cialis did not diminish over time.

Results in General ED Population in Trials Outside the US — The 5 primary efficacy and safety studies conducted in the general ED population outside the US included 1112 patients, with a mean age of 59 years (range 21 to 82 years). The population was 76% White, 1% Black, 3% Hispanic, and 20% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Most (90%) patients reported ED of at least 1-year duration. In these 5 trials, Cialis 5, 10, and 20 mg showed clinically meaningful and statistically significant improvements in all 3 primary efficacy variables (see Tables 12, 13 and 14). The treatment effect of Cialis did not diminish over time.

a Treatment duration in Study F was 6 months

In addition, there were improvements in EF domain scores, success rates based upon SEP Questions 2 and 3, and patient-reported improvement in erections across patients with ED of all degrees of disease severity while taking Cialis, compared to patients on placebo.

Therefore, in all 7 primary efficacy and safety studies, Cialis showed statistically significant improvement in patients’ ability to achieve an erection sufficient for vaginal penetration and to maintain the erection long enough for successful intercourse, as measured by the IIEF questionnaire and by SEP diaries.

Efficacy Results in ED Patients with Diabetes Mellitus — Cialis was shown to be effective in treating ED in patients with diabetes mellitus. Patients with diabetes were included in all 7 primary efficacy studies in the general ED population (N=235) and in one study that specifically assessed Cialis in ED patients with type 1 or type 2 diabetes (N=216). In this randomized, placebo-controlled, double-blinded, parallel-arm design prospective trial, Cialis demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 15).

Efficacy Results in ED Patients following Radical Prostatectomy — Cialis was shown to be effective in treating patients who developed ED following bilateral nerve-sparing radical prostatectomy. In 1 randomized, placebo-controlled, double-blinded, parallel-arm design prospective trial in this population (N=303), Cialis demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 16).

Results in Studies to Determine the Optimal Use of Cialis — Several studies were conducted with the objective of determining the optimal use of Cialis in the treatment of ED. In one of these studies, the percentage of patients reporting successful erections within 30 minutes of dosing was determined. In this randomized, placebo-controlled, double-blinded trial, 223 patients were randomized to placebo, Cialis 10, or 20 mg. Using a stopwatch, patients recorded the time following dosing at which a successful erection was obtained. A successful erection was defined as at least 1 erection in 4 attempts that led to successful intercourse. At or prior to 30 minutes, 35% (26/74), 38% (28/74), and 52% (39/75) of patients in the placebo, 10-, and 20-mg groups, respectively, reported successful erections as defined above.

Two studies were conducted to assess the efficacy of Cialis at a given timepoint after dosing, specifically at 24 hours and at 36 hours after dosing.

In the first of these studies, 348 patients with ED were randomized to placebo or Cialis 20 mg. Patients were encouraged to make 4 total attempts at intercourse; 2 attempts were to occur at 24 hours after dosing and 2 completely separate attempts were to occur at 36 hours after dosing. The results demonstrated a difference between the placebo group and the Cialis group at each of the pre-specified timepoints. At the 24-hour timepoint, (more specifically, 22 to 26 hours), 53/144 (37%) patients reported at least 1 successful intercourse in the placebo group versus 84/138 (61%) in the Cialis 20-mg group. At the 36-hour timepoint (more specifically, 33 to 39 hours), 49/133 (37%) of patients reported at least 1 successful intercourse in the placebo group versus 88/137 (64%) in the Cialis 20-mg group.

In the second of these studies, a total of 483 patients were evenly randomized to 1 of 6 groups: 3 different dosing groups (placebo, Cialis 10, or 20 mg) that were instructed to attempt intercourse at 2 different times (24 and 36 hours post-dosing). Patients were encouraged to make 4 separate attempts at their assigned dose and assigned timepoint. In this study, the results demonstrated a statistically significant difference between the placebo group and the Cialis groups at each of the pre-specified timepoints. At the 24-hour timepoint, the mean, per patient percentage of attempts resulting in successful intercourse were 42, 56, and 67% for the placebo, Cialis 10-, and 20-mg groups, respectively. At the 36-hour timepoint, the mean, per-patient percentage of attempts resulting in successful intercourse were 33, 56, and 62% for placebo, Cialis 10-, and 20-mg groups, respectively.

The efficacy and safety of Cialis for once daily use in the treatment of erectile dysfunction has been evaluated in 2 clinical trials of 12-weeks duration and 1 clinical trial of 24-weeks duration, involving a total of 853 patients. Cialis, when taken once daily, was shown to be effective in improving erectile function in men with erectile dysfunction (ED).

Cialis was studied in the general ED population in 2 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12- and 24-weeks duration, respectively. One of these studies was conducted in the United States and one was conducted in centers outside the US. An additional efficacy and safety study was performed in ED patients with diabetes mellitus. Cialis was taken once daily at doses ranging from 2.5 to 10 mg. Food and alcohol intake were not restricted. Timing of sexual activity was not restricted relative to when patients took Cialis.

Results in General ED Population — The primary US efficacy and safety trial included a total of 287 patients, with a mean age of 59 years (range 25 to 82 years). The population was 86% White, 6% Black, 6% Hispanic, and 2% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Most (>96%) patients reported ED of at least 1-year duration.

The primary efficacy and safety study conducted outside the US included 268 patients, with a mean age of 56 years (range 21 to 78 years). The population was 86% White, 3% Black, 0.4% Hispanic, and 10% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Ninety-three percent of patients reported ED of at least 1-year duration.

In each of these trials, conducted without regard to the timing of dose and sexual intercourse, Cialis demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 17). When taken as directed, Cialis was effective at improving erectile function.

In the 6 month double-blind study, the treatment effect of Cialis did not diminish over time.

a Twenty-four-week study conducted in the US.

b Twelve-week study conducted outside the US.

c Statistically significantly different from placebo.

Efficacy Results in ED Patients with Diabetes Mellitus — Cialis for once daily use was shown to be effective in treating ED in patients with diabetes mellitus. Patients with diabetes were included in both studies in the general ED population (N=79). A third randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design trial included only ED patients with type 1 or type 2 diabetes (N=298). In this third trial, Cialis demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 18).

a Statistically significantly different from placebo.

The efficacy and safety of Cialis for once daily use for the treatment of the signs and symptoms of BPH was evaluated in 3 randomized, multinational, double-blinded, placebo-controlled, parallel-design, efficacy and safety studies of 12 weeks duration. Two of these studies were in men with BPH and one study was specific to men with both ED and BPH [see Clinical Studies (14.4)]. The first study (Study J) randomized 1058 patients to receive either Cialis 2.5 mg, 5 mg, 10 mg or 20 mg for once daily use or placebo. The second study (Study K) randomized 325 patients to receive either Cialis 5 mg for once daily use or placebo. The full study population was 87% White, 2% Black, 11% other races; 15% was of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.

The primary efficacy endpoint in the two studies that evaluated the effect of Cialis for the signs and symptoms of BPH was the International Prostate Symptom Score (IPSS), a four week recall questionnaire that was administered at the beginning and end of a placebo run-in period and subsequently at follow-up visits after randomization. The IPSS assesses the severity of irritative (frequency, urgency, nocturia) and obstructive symptoms (incomplete emptying, stopping and starting, weak stream, and pushing or straining), with scores ranging from 0 to 35; higher numeric scores representing greater severity. Maximum urinary flow rate (Qmax), an objective measure of urine flow, was assessed as a secondary efficacy endpoint in Study J and as a safety endpoint in Study K.

The results for BPH patients with moderate to severe symptoms and a mean age of 63.2 years (range 44 to 87) who received either Cialis 5 mg for once daily use or placebo (N=748) in Studies J and K are shown in Table 19 and Figures 5 and 6, respectively.

In each of these 2 trials, Cialis 5 mg for once daily use resulted in statistically significant improvement in the total IPSS compared to placebo. Mean total IPSS showed a decrease starting at the first scheduled observation (4 weeks) in Study K and remained decreased through 12 weeks.

Figure 5: Mean IPSS Changes in BPH Patients by Visit in Study J

Figure 6: Mean IPSS Changes in BPH Patients by Visit in Study K

In Study J, the effect of Cialis 5 mg once daily on maximum urinary flow rate (Qmax) was evaluated as a secondary efficacy endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (Cialis 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.

In Study K, the effect of Cialis 5 mg once daily on Qmax was evaluated as a safety endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (Cialis 5 mg: 1.6 mL/sec, placebo: 1.1 mL/sec); however, these changes were not significantly different between groups.

Efficacy Results in Patients with BPH initiating Cialis and Finasteride – Cialis for once daily use initiated together with finasteride was shown to be effective in treating the signs and symptoms of BPH in men with an enlarged prostate (>30 cc) for up to 26 weeks. This additional double-blinded, parallel-design study of 26 weeks duration randomized 696 men to initiate either Cialis 5 mg with finasteride 5 mg or placebo with finasteride 5 mg. The study population had a mean age of 64 years (range 46-86). Patients with multiple co-morbid conditions such as erectile dysfunction, diabetes mellitus, hypertension, and other cardiovascular disease were included.

Cialis with finasteride demonstrated statistically significant improvement in the signs and symptoms of BPH compared to placebo with finasteride, as measured by the total IPSS at 12 weeks, the primary study endpoint (see Table 20). Key secondary endpoints demonstrated improvement in total IPSS starting at the first scheduled observation at week 4 (Cialis -4.0, placebo -2.3: p<.001) and the score remained decreased through 26 weeks (Cialis -5.5, placebo -4.5; p=.022). However, the magnitude of the treatment difference between placebo/finasteride and Cialis/finasteride decreased from 1.7 points at Week 4 to 1.0 point at Week 26, as shown in Table 20 and in Figure 7. The incremental benefit of Cialis beyond 26 weeks is unknown.

a Overall ITT population.

b Mixed model for repeated measurements.

c Unadjusted mean.

Figure 7: Mean Total IPSS Changes By Visit in BPH Patients Taking Cialis for Once Daily Use Together With Finasteride

In the 404 patients who had both ED and BPH at baseline, changes in erectile function were assessed as key secondary endpoints using the EF domain of the IIEF questionnaire. Cialis with finasteride (N=203) was compared to placebo with finasteride (N=201). A statistically significant improvement from baseline (Cialis/finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (Cialis/finasteride 3.7, placebo/finasteride -1.1; p<.001), week 12 (Cialis/finasteride 4.7, placebo/finasteride 0.6; p<.001), and week 26 (Cialis/finasteride 4.7, placebo/finasteride 0.0; p<.001).

The efficacy and safety of Cialis for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either Cialis 2.5 mg, 5 mg, for once daily use or placebo. ED severity ranged from mild to severe and BPH severity ranged from moderate to severe. The full study population had a mean age of 63 years (range 45 to 83) and was 93% White, 4% Black, 3% other races; 16% were of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.

In this study, the co-primary endpoints were total IPSS and the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). One of the key secondary endpoints in this study was Question 3 of the Sexual Encounter Profile diary (SEP3). Timing of sexual activity was not restricted relative to when patients took Cialis.

The efficacy results for patients with both ED and BPH, who received either Cialis 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8.

Cialis 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. Cialis 5 mg for once daily use also resulted in statistically significant improvement in SEP3. Cialis 2.5 mg did not result in statistically significant improvement in the total IPSS.

Cialis for once daily use resulted in improvement in the IPSS total score at the first scheduled observation (week 2) and throughout the 12 weeks of treatment (see Figure 8).

Figure 8: Mean IPSS Changes in ED/BPH Patients by Visit in Study L

In this study, the effect of Cialis 5 mg once daily on Qmax was evaluated as a safety endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (Cialis 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.

Cialis (tadalafil) is supplied as follows:

Four strengths of almond-shaped tablets are available in different sizes and different shades of yellow, and supplied in the following package sizes:

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Keep out of reach of children.

“See FDA-approved patient labeling (Patient Information)”

Physicians should discuss with patients the contraindication of Cialis with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of Cialis with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.

Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of Cialis. In such a patient, who has taken Cialis, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of Cialis before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking Cialis should seek immediate medical attention [see Contraindications (4.1) and Warnings and Precautions (5.1)].

Physicians should discuss with patients the contraindication of Cialis with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension. Patients should be counseled that the concomitant use of Cialis with GC stimulators may cause blood pressure to drop to an unsafe level.

Physicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Physicians should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention [see Warnings and Precautions (5.1)].

Physicians should discuss with patients the potential for Cialis to augment the blood-pressure-lowering effect of alpha-blockers, and antihypertensive medications [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].

Physicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing Cialis for once daily use, especially the potential for interactions with medications (e.g., nitrates, alpha-blockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol. [see Dosage and Administration (2.7), Warnings and Precautions (5.6), Drug Interactions (7.1, 7.2), Clinical Pharmacology (12.2), and Clinical Studies (14.2)].

There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention.

Physicians should advise patients to stop use of all PDE5 inhibitors, including Cialis, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including possible permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including Cialis, for this uncommon condition [see Warnings and Precautions (5.4) and Adverse Reactions (6.2)].

The use of Cialis offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.

Physicians should instruct patients on the appropriate administration of Cialis to allow optimal use.

For Cialis for use as needed in men with ED, patients should be instructed to take one tablet at least 30 minutes before anticipated sexual activity. In most patients, the ability to have sexual intercourse is improved for up to 36 hours.

For Cialis for once daily use in men with ED or ED/BPH, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity. Cialis is effective at improving erectile function over the course of therapy.

For Cialis for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day.

Revision Date: 02/2018

Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA

www.Cialis.com

Copyright © 2003, 2018, Eli Lilly and Company. All rights reserved.

CLS-0004-USPI-20180215

Patient Information

Cialis® (See-AL-iss)

(tadalafil) tablets

Read this important information before you start taking Cialis and each time you get a refill. There may be new information. You may also find it helpful to share this information with your partner. This information does not take the place of talking with your healthcare provider. You and your healthcare provider should talk about Cialis when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your healthcare provider or pharmacist.

What Is The Most Important Information I Should Know About Cialis?

Cialis can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke. Never take Cialis with any nitrate or guanylate cyclase stimulator medicines.

Do not take Cialis if you take any medicines called “nitrates.” Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.

Do not take Cialis if you take medicines called guanylate cyclase stimulators which include:

Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates or guanylate cyclase stimulators, such as riociguat.

(See “Who Should Not Take Cialis?”)

Tell all of your healthcare providers that you take Cialis. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took Cialis.

After taking a single tablet, some of the active ingredient of Cialis remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications (see “Can Other Medicines Affect Cialis?”).

Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.

What Is Cialis?

Cialis is a prescription medicine taken by mouth for the treatment of:

Cialis for the Treatment of ED

ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his healthcare provider for help if the condition bothers him. Cialis helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.

Some form of sexual stimulation is needed for an erection to happen with Cialis.

Cialis does not:

Cialis is only for men over the age of 18, including men with diabetes or who have undergone prostatectomy.

Cialis for the Treatment of Symptoms of BPH

BPH is a condition that happens in men, where the prostate gland enlarges which can cause urinary symptoms.

Cialis for the Treatment of ED and Symptoms of BPH

ED and symptoms of BPH may happen in the same person and at the same time. Men who have both ED and symptoms of BPH may take Cialis for the treatment of both conditions.

Cialis is not for women or children.

Cialis must be used only under a healthcare provider’s care.

Who Should Not Take Cialis?

Do not take Cialis if you:

Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above.

What Should I Tell My Healthcare Provider Before Taking Cialis?

Cialis is not right for everyone. Only your healthcare provider and you can decide if Cialis is right for you. Before taking Cialis, tell your healthcare provider about all your medical problems, including if you:

Can Other Medicines Affect Cialis?

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Cialis and other medicines may affect each other. Always check with your healthcare provider before starting or stopping any medicines. Especially tell your healthcare provider if you take any of the following*:

How Should I Take Cialis?

How Should I Take Cialis for Symptoms of BPH?

For symptoms of BPH, Cialis is taken once daily.

How Should I Take Cialis for ED?

For ED, there are two ways to take Cialis – either for use as needed OR for use once daily.

Cialis for use as needed:

OR

Cialis for once daily use is a lower dose you take every day.

How Should I Take Cialis for Both ED and the Symptoms of BPH?

For both ED and the symptoms of BPH, Cialis is taken once daily.

What Should I Avoid While Taking Cialis?

What Are The Possible Side Effects Of Cialis?

See “What Is The Most Important Information I Should Know About Cialis?”

The most common side effects with Cialis are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking Cialis. Back pain and muscle aches usually go away within 2 days.

Call your healthcare provider if you get any side effect that bothers you or one that does not go away.

Uncommon side effects include:

An erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis, including the inability to have erections.

Color vision changes, such as seeing a blue tinge (shade) to objects or having difficulty telling the difference between the colors blue and green.

In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including Cialis) reported a sudden decrease or loss of vision in one or both eyes. It is uncertain whether PDE5 inhibitors directly cause the vision loss. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including Cialis, and call a healthcare provider right away.

Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including Cialis. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking Cialis and contact a healthcare provider right away.

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

How Should I Store Cialis?

Store Cialis at room temperature between 59° and 86°F (15° and 30°C).

Keep Cialis and all medicines out of the reach of children.

General Information About Cialis:

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use Cialis for a condition for which it was not prescribed. Do not give Cialis to other people, even if they have the same symptoms that you have. It may harm them.

This is a summary of the most important information about Cialis. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Cialis that is written for health providers. For more information you can also visit www.Cialis.com, or call 1-877-Cialis1 (1-877-242-5471).

What Are The Ingredients In Cialis?

Active Ingredient: tadalafil

Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.

This Patient Information has been approved by the U.S. Food and Drug Administration

Rx only

Cialis® (tadalafil) is a registered trademark of Eli Lilly and Company.

*The brands listed are trademarks of their respective owners and are not trademarks of Eli Lilly and Company. The makers of these brands are not affiliated with and do not endorse Eli Lilly and Company or its products.

Revision Date: 05/2017

Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA

www.Cialis.com

Copyright © 2003, 2017, Eli Lilly and Company. All rights reserved.

CLS-0002-PPI-20170505

PACKAGE LABEL – Cialis 2.5 mg tablets, 30 count, blister pack

NDC 0002-4465-34

TA 4465

30 tablets (2 cards of 15 tablets)

Each tablet contains 2.5 mg of tadalafil.

Cialis®

(tadalafil) tablets

2.5 mg

for once daily use

Rx only

www.Cialis.com

Lilly

PACKAGE LABEL – Cialis 5mg tablets, 30 count, bottle

NDC 0002-4462-30

30 Tablets

Cialis®

(tadalafil) tablets

5mg

Tablets should not be split.

Entire dose should be taken.

Rx only

Lilly

PACKAGE LABEL – Cialis 10mg tablets, 30 count, bottle

NDC 0002-4463-30

30 Tablets

Cialis®

(tadalafil) tablets

10mg

Tablets should not be split.

Entire dose should be taken.

Rx only

Lilly

PACKAGE LABEL – Cialis 20 mg tablets, 30 count, bottle

NDC 0002-4464-30

30 Tablets

Cialis®

(tadalafil) tablets

20mg

Tablets should not be split.

Entire dose should be taken.

Rx only

Lilly

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07/01/2010 10:12

Western Galilee students

Are you aware that Viagra may be the wrong merchandise for you personally, although now we’ve all observed the commercials for Viagra as of this time and point? Yes.

These days getting cialis online isn’t just easier but also convenient Cialis Black 200mg as you get just as much information on the medicine information or Erectile dysfunction can easily compare prices and in addition should you be lucky.

Dec. 7, 2009
Gil Hoffman , THE JERUSALEM POST

Erectile dysfunction or ED is not only an accidental condition in the life of a guy. If we look further into the issue, we will realize that there are various factors leading to impotence problems, as well as the most important one.

Our testosterone level is half of what it had been at 20 40 years, as guys approach. We start to lose our muscle mass, we start to lose our sex drive and we start to reduce our vitality that is overall. Need to possess sexual activity our erections are really not what they used to be, when we do. We gradually become less.

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Here are some key points about Cialis. More detail is in the main article.

Cialis increases blood flow to the penis, and this enables a man to achieve an erection. It does not lead to sexual arousal. It should be used with caution, and only under medical supervision.

Tadalafil was approved by the United States (U.S.) Food and Drug Administration (FDA) in 2003 for the treatment of erectile dysfunction (ED). It is also used to treat pulmonary arterial hypertension and benign prostatic hyperplasia, a condition in which the prostate gland becomes enlarged, causing problems with urination.

Penile erection occurs when the penis fills with blood. This happens because the blood vessels that bring blood flow to the penis dilate, increasing the blood supply. At the same time, the blood vessels that remove blood from the penis contract. The blood accumulates in the penis, causing an erection.

When a man is sexually stimulated, nitric oxide is released into the penis. Nitric oxide enables the production of cGMP, which controls the dilation and contraction of the blood vessels that carry blood to and from the penis.

Another substance, PDE5, destroys cGMP. When this occurs, the blood vessels return to their normal size, and the erection ends. Tadalafil stops PDE5 from destroying cGMP. This causes the erection to last for longer.

The muscles of the arteries in the walls of the lungs also contain PDE5, which is why the same drug can also help with pulmonary hypertension treatment.

Cialis comes in yellow, film-coated and almond-shaped tablets in 5, 10 and 20 milligram (mg) doses.

Patients with erectile dysfunction can take Cialis as needed, but it should not be taken more frequently than once every 24 hours.

For the medication to work, a man needs to be sexually aroused. The drug does not provide an erection without sexual stimulation.

A first dose is 10 milligrams (mg) at least 30 minutes before sexual activity. Dosage can then be adjusted depending on how the individual responds. The maximum is 20 mg as a single dose.

The patient should take no more than one dose in 24 hours, but a daily dose of 10 mg to 20 mg is not recommended. This is because a portion of the drug remains in the system for at least 24 hours.

Patients who expect to be sexually active at least twice a week can take a daily dose of 5 mg, and this may be reduced to 2.5 mg once daily, depending on the individual reaction.

Tadalafil for erectile dysfunction is only for use by adults aged 18 years and above.

Taking tadalafil, or Cialis, with a nitrate medication can cause a serious and sudden drop in blood pressure, or hypotension.

A man who is taking a nitrate drug prescription for heart problems or chest pain should not use tadalafil.

The producers of the drug, Eli Lilly, warn that if the following symptoms occur during sexual activity, they could be a sign of a serious complication. Immediate medical assistance should be sought:

If an erection lasts for more than 4 hours, this is known as priapism. It can damage the penis, so medical assistance is necessary.

In rare cases, Cialis can undermine the blood flow to the optic nerve of the eye, causing sudden loss of vision. This is more likely in patients with hypertension, diabetes, high cholesterol, pre-existing eye problems, or heart disease.

People with the following conditions should not take Cialis unless a physician agrees:

The FDA has warned about sudden hearing loss experienced by people using tadalafil and similar products.

In 2016, the FDA announced that they were “evaluating the need for regulatory action” following indications that using Cialis and similar drugs might increase the risk of melanoma skin cancer.

However, some researchers have questioned how serious the risk is.

Cialis is available by prescription and should be used under the supervision of a medical professional.

It can be purchased online, but this is not advisable.

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The FDA issued a warning in 2015 about counterfeit tadalafil tablets that had become available in the U.S. It is important always to obtain medications from a reputable source, because using fake drugs can be dangerous.

Article last updated by Yvette Brazier on Wed 2 August 2017.Visit our Erectile Dysfunction / Premature Ejaculation category page for the latest news on this subject, or sign up to our newsletter to receive the latest updates on Erectile Dysfunction / Premature Ejaculation.All references are available in the References tab.

Drugs – January-March 2016. (2016, February 8). Retrieved from https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm509478.htm

FDA. (2015, January 25). Counterfeit versions of Cialis tablets identified entering the United States [news release]. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm431071.htm

Information for healthcare professionals: Sildenafil (marketed as Viagra and Revatio), Vardenafil (marketed as Levitra), Tadalafil (marketed as Cialis). (2007, November). Retrieved from http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124841.htm

Lamb, T. (2016, July 6). Summer 2016 update on ED drugs Viagra / Cialis / Levitra: Medical and legal developments. Retrieved from http://www.drug-injury.com/druginjurycom/2016/07/fda-pde-5-inhibitors-cialis-levitra-viagra-melanoma-skin-cancer-side-effects-drug-injury-lawsuits.html

Prostate enlargement (Benign prostatic hyperplasia). (2014, September). Retrieved from https://www.niddk.nih.gov/health-information/urologic-diseases/prostate-problems/prostate-enlargement-benign-prostatic-hyperplasia

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They all have approval from the United States Food and Drug Administration (FDA), and they have the same function, but there are some differences between them.

It is important to understand these differences in order to make the best choice about which to choose.

Viagra is the brand name for the drug sildenafil, Cialis is the brand name for tadalafil, Levitra is the brand name for vardenafil, and Stendra is the brand name for avanafil.

The drugs all work in a similar way.

They are all PDE5 inhibitors. This means they help to relax the muscles and increase blood flow to the body.

This makes it easier for blood to get into the penis, and it allows people with erectile dysfunction (ED) to experience a lasting erection during sexual activity.

The drugs act relatively quickly. Manufacturers of PDE5 inhibitors recommend taking the pill at least 30 minutes to 1 hour before sexual stimulation, but the timing depends on the drug.

How long the effect of each drug lasts is one of the key differences between them:

Viagra, Cialis, Levitra, and Stendra all come from the same class of chemicals, and they have many similar side effects and interactions.

For instance, manufacturers recommend not taking PDE5 inhibitors with grapefruit or grapefruit juice, because the fruit may affect how the drugs work. Nitrates will also interact with these drugs, so people should not use them together.

There are some drug-specific side effects to be aware of, however.

The side effects include:

Interactions and warnings

Interactions with Viagra do occur, and it is important for people to be aware of them before choosing a medication for ED. Any drugs for pulmonary hypertension may also interact with Viagra, causing blood pressure to drop to unsafe levels.

A recent study in JAMA Internal Medicine has suggested that Viagra could increase the risk of skin cancer. The study found that 3.7 percent of skin cancer cases in men who used the drug sildenafil might have been prevented by not taking it.

The side effects include:

Interactions and warnings

Cialis may have some more serious side effects. People should not use it with guanylate cyclase stimulators or blood pressure medications, as this combination can trigger an unsafe dip in blood pressure.

A person who is taking Cialis and has prostate problems should avoid prescription alpha-blockers, as Cialis serves the same function. It will be like an additional dose.

People should also avoid certain antifungal medications and antibiotics when taking Cialis.

Anybody who is considering taking medications such as Cialis for ED should always involve their doctor in the decision.

The doctor may ask if the person has a history of any of the following:

All of these conditions may affect the doctor’s decision to prescribe Cialis.

The side effects of Levitra include:

Interactions and warnings

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If a doctor has told a person to avoid sexual activity due to health problems, they should avoid Levitra.

Sexual activity can put extra strain on the heart, especially if it is already weak from heart disease.

As with Cialis, a person should not use Levitra with:

A doctor may ask a person if they have a history of any of the following:

All of these conditions may affect a doctor’s decision to prescribe Levitra. People who are taking drugs to treat an abnormal heartbeat should also avoid taking Levitra.

The manufacturers of Stendra claim that it has a low rate of side effects.

However, like the other treatments for ED, there is a risk of adverse effects, including:

A person should seek medical treatment if they experience:

Interactions and warnings

People should not use Stendra if they have or have had:

Anyone with any kind of health condition should speak to a doctor before taking Stendra or any of these medications.

A person should not take Stendra with the following drugs:

People can take Stendra with or without food and with up to three servings of alcohol. It is important not to drink more than three alcoholic drinks, for example, three glasses of wine or three measures of whiskey, as this can lead to adverse effects.

All four medications may sometimes cause priapism, an erection that will not go away. If a person experiences an erection lasts for more than 4 hours, they should seek medical attention to avoid lasting damage.

In rare cases, these drugs can cause serious side effects, including sudden loss of vision in one or both eyes or sudden hearing loss. If a person experiences these symptoms, they should stop taking the drug immediately and call their doctor.

The other thing a person might consider is the cost and availability of each of these drugs. Some drugs have been around longer and may be more widely available than others.

Generic versions of Viagra, Cialis, and Levitra have approval from the FDA. These may be cheaper than brand-name drugs.

Viagra has been available since 1998 and is possibly the best-known drug for ED in the world. Its use in the U.S. is widespread, and most pharmacies sell it.

Cialis has been on the market since 2003. It is widely available and may be a cheaper option than Viagra.

Levitra received approval in 2003, and is available in most pharmacies in the U.S.
There is a generic version, but it is not widely available.

Stendra received FDA approval in 2012 and is widely available in the U.S.

Every person is different, and a drug that suits one person may not suit another.

Cialis is the only drug of the four that has approval for use by people with benign prostatic hyperplasia (BPH) or enlarged prostate. People with both ED and BPH should consider Cialis as their treatment option. Cialis also helps to improve urine flow.

A person can take Cialis every day to keep the body ready for sexual stimulation at any time. This allows for some sexual freedom that may be missing with the other options.

Viagra or Levitra may be better for people who do not engage regularly in sexual activity and would rather take one pill each time they plan on having sex.

Stendra does not have any significant advantages.

Personal reasons may also guide a choice. Each body reacts to medications differently. Side effects vary between people, and the potential side effects may help an individual to decide which drug suits them best. For instance, if one drug causes nausea, they might consider another drug.

Viagra, Levitra, Cialis, and Stendra will not cure ED, but they may provide relief from its symptoms.

There are many side effects and interactions to consider, but, with the right choice and correct use, studies show that these drugs can help a person to overcome ED and engage in sexual activity.

It is worth remembering, meanwhile, that none of these drugs will provide sexual stimulation. The person will need stimulation in order to have an erection.

The only way to know which drug is best for you may be through trial and error. People should work directly with a doctor to track side effects and decide which drug is their best treatment option.

Article last updated by Yvette Brazier on Fri 15 February 2019.Visit our Erectile Dysfunction / Premature Ejaculation category page for the latest news on this subject, or sign up to our newsletter to receive the latest updates on Erectile Dysfunction / Premature Ejaculation.All references are available in the References tab.

Erectile Dysfunction: AUA Guideline (2018). https://www.auanet.org/guidelines/male-sexual-dysfunction-erectile-dysfunction-(2018)

Goldstein, I. (2012). Avanafil for the treatment of erectile dysfunction: A multicenter, randomized, double-blind study in men with diabetes mellitus. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3498142/

Highlights of prescribing information. (2012). https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202276s000lbl.pdf

Li, W.-Q., et al. (2014). Sildenafil use and increased risk of incident melanoma in US men: A prospective cohort study. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4178948/

Stendra avanafil tablets. (2019). https://www.stendra.com/

Treat ED or ED+BPH with CIALIS. (n.d.). https://www.cialis.com/cialis-for-ed-and-bph.html

What is erectile dysfunction? (2017). https://www.viagra.com/learning/what-is-ed

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Erectile dysfunction, or ED, is when a man has difficulty achieving or maintaining an erection. An estimated 30 million men experience ED at some point. A wide range of factors can influence ED.

In this article, we look at the relationship between hydration and both ED and sex drive, how you can tell if you are dehydrated, and other causes of erectile dysfunction.

It is possible for a person’s hydration levels to influence temporary ED. A lack of sufficient body water can affect a person physiologically and mentally.

Several elements are needed for a man to achieve and maintain an erection. A breakdown in one or more of these steps means he may not be able to achieve an erection that is firm enough for sex. The process includes:

When a man is dehydrated, he does not have as much blood volume in his body as when he is properly hydrated. Therefore, his blood vessels become constricted, as there is not enough blood to keep them tense. This impairs blood flow to all parts of the body, including the penis.

Little research has looked at whether dehydration directly causes erectile dysfunction, so further studies are needed.

When a person is dehydrated, their body releases greater amounts of the enzyme angiotensin I, which leads to the blood vessels constricting.

The presence of angiotensin II, which the body makes from angiotensin I, has been associated with sexual dysfunction in animal studies, although more research is needed into how this affects humans.

In addition to the physical effects of dehydration that impact penile erection, mood is also associated with dehydration.

A small scale 2011 study found that mild dehydration was associated with impaired memory, tension, and anxiety in men.

A person’s mental state can have a profound effect on their sex drive and ED. According to the American Academy of Family Physicians, stress, anxiety, depression, and nervousness can all contribute to ED. Therefore, it is possible that the mood changes associated with dehydration could lead to ED.

A person’s fluid needs may vary based on their body size, physical activity level, and exposure to warm temperatures.

When a person is mildly dehydrated, they may experience symptoms that include:

Drinking enough water can help a person feel better on several levels, including sexual performance. A person should drink enough water, so their urine is clear in color, and they do not feel thirsty.

If a person does not drink water or other fluids when they start having signs of dehydration, they may progress to severe dehydration. This can turn into a medical emergency.

Symptoms of severe dehydration include:

A man can experience ED for a number of reasons. Men of all ages can experience the condition. While people associate getting older with ED, this does not have to be the case.

Certain conditions that affect blood flow can cause ED, including:

Taking certain medications is also associated with ED. These include antidepressants, blood pressure-lowering medicines, and medications for pain.

In addition, mental health disorders, anxiety, or a dysfunctional relationship with a partner can all contribute to ED in men.

ED is a common and often treatable condition affecting men. Although doctors have not conducted specific research studies related to how dehydration specifically affects ED, there are other studies and literature that can establish a link.

However, dehydration is usually a temporary condition and not typically the sole contributor to long-term ED. If a man is consistently having trouble getting or maintaining an erection, he should talk to his doctor for a diagnosis.

Article last reviewed by Mon 14 May 2018.Visit our Erectile Dysfunction / Premature Ejaculation category page for the latest news on this subject, or sign up to our newsletter to receive the latest updates on Erectile Dysfunction / Premature Ejaculation.All references are available in the References tab.

cialis black 200 mg dosage

Alcohol and sex. (n.d.). Retrieved from https://wellness.appstate.edu/alcohol-and-sex

Dehydration. (2017, October 10). Retrieved from https://labtestsonline.org/conditions/dehydration

Erectile dysfunction (ED). (2017, June 7). Retrieved from https://familydoctor.org/condition/erectile-dysfunction/

Preventing erectile dysfunction. (2017, July). Retrieved from https://www.niddk.nih.gov/health-information/urologic-diseases/erectile-dysfunction/prevention

Thornton, S. N. (2009, September). Hydration increases tissue perfusion and thus erectile function [Abstract]. The Journal of Sexual Medicine, 6(9), 2621–2622. Retrieved from https://www.jsm.jsexmed.org/article/S1743-6095(15)32665-5/abstract?code=jsxm-site

What is erectile dysfunction? (n.d.). Retrieved from https://www.urologyhealth.org/urologic-conditions/erectile-dysfunction/printable-version

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APANall, R. (2018, May 14). “Does drinking water improve erectile dysfunction?.” Medical News Today. Retrieved fromhttps://www.medicalnewstoday.com/articles/321795.php.

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It works by relaxing the muscles in the walls of blood vessels in certain areas of the body. In most cases, Viagra works well and has changed people’s lives for the better.

The word Viagra is the brand name for sildenafil citrate and is used to treat erectile dysfunction and pulmonary arterial hypertension.Originally developed by scientists in the United Kingdom, it was brought onto the market by Pfizer Inc., a pharmaceutical company in the United States.Viagra is also sold under brand name Revatio. Sildenafil citrate’s chemical formula is C22H30N6O4S.

In this article, we look briefly at the effects of Viagra, why it is used, the side effects, and history.

Viagra is generally safe to use in moderation. However, taking it may cause a range of adverse effects.

According to clinical trial results, the most common side effects include:

Less commonly, some users have experienced cyanopsia, where everything appears to have a tinted blue tinge.

In very rare cases, Viagra use can lead to nonarteritic anterior ischemic optic neuropathy, or damage to the optic nerve.

Other potential side effects include:

Since 2007, Viagra’s labeling in the U.S. has included a warning of the potential risk of sudden hearing loss.

Viagra can decrease blood supply to the optic nerve, causing sudden vision loss. This very rare adverse event occurs mainly in people with heart disease, hypertension, diabetes, high cholesterol, or pre-existing eye problems. The link between vision loss and Viagra is as yet unknown.

People with HIV who take protease inhibitors should discuss using Viagra with their doctors. Protease inhibitors increase the risk and severity of side effects. These individuals should have no more than 25 milligrams (mg) of Viagra at a time, and not more often than every 48 hours.

Individuals taking alpha-blockers should make sure they take Viagra at least 4 hours before or after taking alpha-blockers. This can help prevent dangerously low blood pressure.

The following individuals should not take Viagra, or should check with their doctor first:

Some athletes take Revatio to increase their exercise capacity, but there is little evidence to support this use.

Effects

Viagra can help men who cannot achieve or sustain an erection due to erectile dysfunction. It improves the erectile response when a man is already sexually stimulated, but it does not provide sexual stimulation. If there is no sexual stimulation, viagra will not work.

When sexual stimulation occurs, nitric oxide is released by the nervous system in the erectile tissue of the penis. Nitric oxide stimulates an enzyme that produces messenger cyclic guanosine monophosphate (cGMP).

cGMP causes the arteries in the penis to dilate, so that the arteries and the erectile tissue fill with blood. An erection results.

Viagra prevents cGMP from becoming degraded, so the blood flow and the erection can continue.

The dosage will be different if the drug is taken for erectile dysfunction or for pulmonary arterial hypertension.

Viagra

For erectile dysfunction, Viagra comes in blue, diamond-shaped pills, in doses of 25, 50, or 100 mg.

The individual takes a maximum of one pill in a 24-hour period, 30 minutes to 1 hour before sexual intercourse.

Revatio

cialis black 200 mg dosage

For pulmonary arterial hypertension, Viagra comes in white, round, film-coated tablets. People take one 20-mg Revatio tablet three times a day.

A Viagra overdose can be serious. If you believe you have had more than the standard dosage, call a doctor or local Poison Control Center.

symptoms of an overdose might include:

Deaths from viagra overdose are rare but possible.

Initially, Viagra was designed by Pfizer scientists working in the U.K. They were, in fact, working on a drug for hypertension, or high blood pressure, and angina pectoris, a symptom of ischemic heart disease.

During the phase 1 trials, it was noted that the drug did very little to prevent angina but did induce marked penile erections. Hitting the market in 1998, Viagra was the first oral treatment approved to treat erectile dysfunction in the U.S.

Viagra’s meteoric rise to fame has seen it enter usage as an illicit drug. But, Viagra use in individuals without erectile dysfunction does not seem to have any effect. Although, researchers have noted that there is a significant placebo effect. On a similar note, there is no proven benefit for women taking the drug.

In 2008, Viagra generated some $1.93 billion of revenue for Pfizer.

Article last updated by Yvette Brazier on Mon 19 November 2018.Visit our Erectile Dysfunction / Premature Ejaculation category page for the latest news on this subject, or sign up to our newsletter to receive the latest updates on Erectile Dysfunction / Premature Ejaculation.All references are available in the References tab.

Viagra (sildenafil) facts. (n.d.). Retrieved from https://www.bpas.org/more-services-information/erectile-dysfunction/viagra/

Worldwide revenue of Pfizer’s Viagra from 2003 to 2016 (in million U.S. dollars). (n.d.). Retrieved from https://www.statista.com/statistics/264827/pfizers-worldwide-viagra-revenue-since-2003/

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MLANordqvist, Christian. “Uses and risks of viagra.” Medical News Today. MediLexicon, Intl., 19 Nov. 2018. Web.15 Aug. 2019.

APANordqvist, C. (2018, November 19). “Uses and risks of viagra.” Medical News Today. Retrieved fromhttps://www.medicalnewstoday.com/articles/232912.php.

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cialis black 200 mg dosage

Just as the name of the drug suggests, Cialis Black is black indeed as opposed to the conventional Cialis that is orange in color. Due to higher content of Tadalafil (80mg), Cialis Black is stronger than the conventional Cialis (available in 5, 10 and 20 mg dosage tablets).

Other (non-active) Cialis Black ingredients include iron oxide (colorant), magnesium stearate and hypromellose (bulking agents), hydroxypropyl cellulose (binding agent), lactose monohydrate (shaping agent, quantity too small to cause troubles for patients with lactose intolerance except for severe cases), microcrystalline cellulose (an extender, an emulsifier and a bulking agent), sodium lauryl sulfate, talc, titanium dioxide and a food additive E1518.

The benefits of Cialis Black can be better explained by comparing its effects with those of conventional Cialis. While both medication types are fast acting and need to be taken between 20 to 60 minutes prior to sex, the positive effects of Cialis, represented by strong ability to achieve and keep an erection, can be felt for up to 36 hours, while those of Cialis Black can last for as long as 40 hours essentially making the latter a true “week-end pill.” A tablet of Cialis Black every couple of days will do the work in the vast majority of cases.

Cialis Black is especially beneficial for some categories of ED patients. First, Cialis Black is recommended for men with psychogenic ED whose erectile troubles are caused by factors of psychological nature (anxiety, insecurity, fear, etc.) as well as for men with weak sexual constitution.

In addition, due to its high Tadalafil content, Cialis Black is used to help eliminate strong symptoms of impotence – when a patient essentially loses the ability to achieve an erection.

In some cases, critical decrease in libido triggered by lack of sleep, hormonal disorders, psycho-emotional stress, and high physical exertion can undermine a patient’s ability to achieve an adequate erection. In such cases, conventional Cialis tablets cannot deliver the desired effect. Cialis Black, being a stronger sexual stimulant, can help a man manage the problem.

Cialis Black can be used as an on-demand drug, if your ED is inconsistent and you can sometimes achieve an erection without medications. Take a pill of Cialis Black 20-40 minutes in advance to intended sexual activity with a glass of water. Avoid daily in-take of Black Cialis tadalafil 800mg. An optimal dose of 1 Black Cialis pill in any 36-hour period is recommended.

Two types of Cialis Black tablets are currently available on the market: 200 mg (Black Cialis c200) and 800 mg (Black Cialis c800) or total ingredients’ weight (including the non-active components). The latter dosage, containing 80 mg of active ingredient Tadalafil is the most popular dosage. Pay attention, Cialis Black 800 mg does not contain 800 mg of pure Tadalafil (that would be a lethal dose), but just 80mg.

Shift to a conventional Cialis with a lower content of the active ingredient (5, 10 or 20 mg) when you are in a risk group for side effects or if your physician recommended you to be conservative with the dosage.

It is strongly advisable to follow your physician’s prescription before starting treatment with Cialis Black in order to minimize any possible complications and side effects. Exceeding the recommended dose might result in side effects such as indigestion, nausea, back pain, dizziness, and headache. These side effects do not necessarily must be reported to the physician. Although very rare, serious side effects are possible. The more serious side effects include chest pain, change in vision, hearing problems, breathing problems, itching or irregular heartbeat.

If you feel any changes in vision, stop using Cialis 800 Black immediately and contact your physician. If you experience chest pain while engaging in sexual intercourse after taking Cialis Black, discontinue further sexual activities until you have consulted with your physician. As with virtually any drug, if you are experiencing signs of an allergic reaction, immediately contact the nearest emergency room.

The Cialis Black 800mg side effects enlisted above are caused by the effects of Tadalafil, the active ingredient and are typical of any drug in PDE5 inhibitor class (such as Sildenafil Citrate or Vardenafil).

Cialis Black has high contents of the working ingredient Tadalafil. While original Cialis is distributed in pills of 20mg Tadalafil maximum, Cialis Black includes 80mg of Tadalafil in each tablet. This makes the effect consistent and strong, but also elevates the risk of side effects when taken together with other drugs or when used under unfavorable conditions. Most importantly, you must avoid mixing Cialis Black 80mg with other popular PDE5 inhibitors such as Vardenafil or Sildenafil Citrate.

The list of further conflicting medications includes:

Pay attention that taking Cialis Black with any nitrate medicine may cause a serious drop in blood pressure, which may result in fainting, heart attack or stroke.

The list above may not describe all feasible interactions. Give your physician a list of all the non-prescription drugs, prescription medicines, dietary supplements and herbs you use in advance of taking Cialis Black.

While the most popular PDE5 inhibitor, Viagra (Sildenafil Citrate) must not be taken with fatty foods, Black Cialis 800mg and other Tadalafil-containing generics can generally be taken with any food you please. On the positive note, it means that by choosing the “week-end pill”, you do not have to change your lifestyle and eating habits much. Meanwhile, eliminating alcohol is always a good idea, because alcohol itself can be a trigger for ED.

Grapefruits as well as grapefruit juice can interact with Tadalafil. Discuss the consumption of grapefruit products with your healthcare provider. Do not decrease or increase the amount of grapefruit products in your diet without talking to your physician first. For your information, it takes some 72 hours to eliminate all grapefruit nutrients from your body.

The list of Cialis Black analogs includes but is not limited to the following medicines: Cialis, Brand Cialis, Tadapox, Sidalis, Extra Super Cialis, Cialis Professional, Cialis Super Active, Cialis Super Force (Tadalafil + Dapoxetine), Cialis Soft, Cialis Strips, Cialis Extra Dosage, Tadacip, Tadalis SX, Erectafil, Cialis Jelly, Cialis Sublingual, Apcalis SX, Forzest, Regalis, Apcalis, Tadalafilum, Tadalofilo, Tadala Black, Tadora, Tadarise, Tadafil, Tadagris

1. Does Black Cialis 800mg contain 800mg of tadalafil?

No, Black Cialis c800 contains just 80mg of active ingredient tadalafil and many other non-active ingredients

2. What is the difference between Cialis Black 800mg and conventional Cialis?

Cialis Black can help men achieve erection over 40 hours as opposed to regular Cialis that lasts up to 36 hours

3. Can I take fatty meals and alcohol with Cialis Black?

You can eat any meals of your choice while taking Cialis Black, but you should better limit your alcohol consumption to 1 shot or, better yet, eliminate it all together

4. Can I take other male performance enhancement drugs parallel to Black Cialis 800mg?

No, you must avoid mixing Cialis Black with other ED drugs, because Cialis Black contains a high dose of tadalafil, a PDE5 inhibitor, you must eliminate taking other drugs from PDE5 inhibitor class, such as Sildenafil Citrate, Vardenafil as well as Tadalafil itself.

5. Do I need sexual stimulation to achieve erection after taking Cialis Black?

Yes, just like other PDE5 inhibitors, Cialis Black works only upon sexual stimulation.

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Disclaimer: The website’s administration draws the user’s attention that all data mentioned in the particular piece of article is posted purely for the purpose of education. No type of the contents in this article by no means encourages any form of self-treatment. Only a qualified healthcare specialist is capable of making a diagnosis and give expert guidelines for an efficient course of therapy regarding the personal preferences in each particular case.

cialis black 200 mg dosage

In addition, due to its high Tadalafil content, Cialis Black is used to help eliminate strong symptoms of impotence – when a patient essentially loses the ability to achieve an erection.

The list of further conflicting medications includes:

Pay attention that taking Cialis Black with any nitrate medicine may cause a serious drop in blood pressure, which may result in fainting, heart attack or stroke.

1. Does Black Cialis 800mg contain 800mg of tadalafil?

No, Black Cialis c800 contains just 80mg of active ingredient tadalafil and many other non-active ingredients

2. What is the difference between Cialis Black 800mg and conventional Cialis?

Cialis Black can help men achieve erection over 40 hours as opposed to regular Cialis that lasts up to 36 hours

3. Can I take fatty meals and alcohol with Cialis Black?

You can eat any meals of your choice while taking Cialis Black, but you should better limit your alcohol consumption to 1 shot or, better yet, eliminate it all together

4. Can I take other male performance enhancement drugs parallel to Black Cialis 800mg?

5. Do I need sexual stimulation to achieve erection after taking Cialis Black?

Yes, just like other PDE5 inhibitors, Cialis Black works only upon sexual stimulation.

cialis black 200 mg dosage

In addition, due to its high Tadalafil content, Cialis Black is used to help eliminate strong symptoms of impotence – when a patient essentially loses the ability to achieve an erection.

The list of further conflicting medications includes:

Pay attention that taking Cialis Black with any nitrate medicine may cause a serious drop in blood pressure, which may result in fainting, heart attack or stroke.

1. Does Black Cialis 800mg contain 800mg of tadalafil?

No, Black Cialis c800 contains just 80mg of active ingredient tadalafil and many other non-active ingredients

2. What is the difference between Cialis Black 800mg and conventional Cialis?

Cialis Black can help men achieve erection over 40 hours as opposed to regular Cialis that lasts up to 36 hours

3. Can I take fatty meals and alcohol with Cialis Black?

You can eat any meals of your choice while taking Cialis Black, but you should better limit your alcohol consumption to 1 shot or, better yet, eliminate it all together

4. Can I take other male performance enhancement drugs parallel to Black Cialis 800mg?

5. Do I need sexual stimulation to achieve erection after taking Cialis Black?

Yes, just like other PDE5 inhibitors, Cialis Black works only upon sexual stimulation.

cialis black 200 mg dosage

In addition, due to its high Tadalafil content, Cialis Black is used to help eliminate strong symptoms of impotence – when a patient essentially loses the ability to achieve an erection.

The list of further conflicting medications includes:

Pay attention that taking Cialis Black with any nitrate medicine may cause a serious drop in blood pressure, which may result in fainting, heart attack or stroke.

1. Does Black Cialis 800mg contain 800mg of tadalafil?

No, Black Cialis c800 contains just 80mg of active ingredient tadalafil and many other non-active ingredients

2. What is the difference between Cialis Black 800mg and conventional Cialis?

Cialis Black can help men achieve erection over 40 hours as opposed to regular Cialis that lasts up to 36 hours

3. Can I take fatty meals and alcohol with Cialis Black?

You can eat any meals of your choice while taking Cialis Black, but you should better limit your alcohol consumption to 1 shot or, better yet, eliminate it all together

4. Can I take other male performance enhancement drugs parallel to Black Cialis 800mg?

5. Do I need sexual stimulation to achieve erection after taking Cialis Black?

Yes, just like other PDE5 inhibitors, Cialis Black works only upon sexual stimulation.

McMahon CG(1).

Author information:
(1)Australian Centre for Sexual Health, St Luke’s Hospital Complex, Sydney, Australia. cmcmahon@mail.usyd.edu.au

Comment in
J Urol. 2003 Aug;170(2 Pt 1):684.

The objectives of this study were to evaluate the efficacy and tolerability of
high dose sildenafil as a salvage therapy for patients refractory to the maximum
recommended dose of sildenafil. Fifty four fully evaluated patients with chronic
erectile failure (ED) who had previously failed to respond to a home trial of
sildenafil (100 mg) with erections suitable for sexual intercourse were studied.
Each man was treated at home with sildenafil at escalating doses of up to 200 mg
until either maximal response or intolerable adverse effects occurred. Erectile
function was quantified using the erectile function domain of the International
Index of Erectile Function (IIEF) before treatment, with sildenafil 100 mg and
with maximal dose of sildenafil and a global efficacy question after 4 weeks of
treatment. The mean age of the study group was 59.6+/-11.2 y. 13/54 (24%) had
arteriogenic ED, 16/54 (30%) had mixed vasculogenic ED, 9/54 (17%) had cavernosal
veno-occlusive dysfunction, 11/54 (20%) had post radical retropubic prostatectomy
ED and 5/54 (9%) had psychogenic ED. 13/54 (24.1%) responded to sildenafil at a
median maximal dose of 200 mg, 4/13 required 150 mg and 9/13 required 200 mg.
41/54 (76%) failed to respond to sildenafil. Mean IIEF question 3 and 4 scores
were 1.5 and 1.4 at baseline, 2.2 and 1.9 with sildenafil 100 mg, 2.8 and 2.5
with sildenafil 150 mg and 3.0 and 2.9 with sildenafil 200 mg, respectively.
After 4 weeks, treatment was regarded as having improved their erections by 37%,
46.3% and 68% of patients with sildenafil 100 mg, 150 mg and 200 mg,
respectively. 34/54 (63%) reported adverse effects with maximal dose sildenafil
comprising headache (19), facial flushing (32), dyspepsia (14), nasal congestion
(11), dizziness (5) and visual disturbances (5). 4/13 (31%) responders refused to
continue treatment due to adverse effects.In conclusion, sildenafil at doses of
up to 200 mg is an effective salvage therapy for 24.1% of previous sildenafil
non-responders but is limited by a significantly higher incidence of adverse
effects and a 31% treatment discontinuation rate.

cialis black 200 mg dosage

PDE5 inhibitors became the medication of choice in the treatment of erectile dysfunction. In Canadian medicine they are clinically indicated for the therapy of sexual disorders caused by physiological factors. Blocking the degradative effect of a cGMP-specific enzyme, these drugs increase a blood flow to the penile tissue. That is why even ocasional taking of these medications helps to achieve and maintain a stronger erection for a long sexual intercourse.

Cialis (learn more) is one of three most famous options for erectile dysfunction treatment. As well as Viagra (more about this medication here: www.canadianhealthmall.com/viagra-generic) and Kamagra it is proved by the U.S. Food and Drug Administration (FDA). Despite of few contraindications and some side-effects, related to dose and general health state, it is considered to be quite safe and reliable drug. What are the differences between ordinary and Black Cialis? And are there some interesting facts you might not know about Tadalafil?

If this information is not enough for you, learn more about erectile dysfunction treatment here: https://www.canadianhealthmall.com/erectile-dysfunction

Cialis is always dosed in almond-shaped tablets with different strength (from 2,5 to 200 mg). Usually it is recommended to start from a small concentration. An optimal dose for everyday treatment is 10 mg. The effect from Cialis appears only after sexual stimulation and lasts 36 hours (in comparison with 4 hours after taking Viagra).

cialis black 200 mg dosage

For Use as Needed even 10 mg of world famous yellow tablets is an enough normal dose. As for 800 mg Black Cialis, be sure, that the real strength and quantity of chemicals is significantly less. Producers enrich the generic formula with some herbals and other ingredients assisting tadalafil. That is why Cialis Black is called 800 mg tablets.

Black Cialis is quite popular among travellers and busy people, preferring an active life-style to the indoors time spending. The effect, that Black Cialis has on potention, is a much more durable. Some consumers even call this medication “a week-tablet”. Probably, taking Tadalafil once a week is not enough for constant treatment.

Though, effect from taking black pills actually lasts for 36 – 78 hours. And anyway hardly a patient will have a permanent erection without a sexual arousal. As a first-aid remedy, Black Cialis will be certainly effective in situations when you are not sure, whether the sexual intercourse is going to happen or not.

Natural herbal ingredients are not that safe as many people believe. Because of some poorly studied unregulated effects, they should not be taken together with nitrates. Such chemicals as amyl nitrate, mononitrate, isosorbide and nitroglycerin, included in many antihypertension medications, are under special risk. In combination with PDE5 inhibitors they slow a blood flow extremelly and may even cause a heart attack or stroke. These risks especially concern elderly men, who are prescribed with medications for heart desorder treatment and simultaneously suffer from erectile dysfunction.

Black Cialis is produced by Chineese and Indian pharmasists. Its generic formula has nothing to do with the branded one. Although main active ingredient (Tadalafil) is the same, as well as the way Black Cialis works. (Let us remind, that it affects the blood flow to the penile tissue). The tablets are taken like the original Cialis. Though they are considered to have a stronger effect and never should be taken twice a day!

It is known that some patients experience optic neuropathy (NAION) or even temporary loss of vision after taking Tadalafil and other PDE5 inhibitors. However, as it was found by the U.S. FDA researchers, side-effects related to vision impairment might be associated with other factors. Some general problems with health, e.g. diabetes or hypertension, as well as aging and smoking lead to NAION regardless of the Tadalafil taking. And they certainly appear as a risk factor in ED treatment.

It is known that the positive effect of PDE5 inhibitors on male potention was discovered during a heart disorders clinical study. In 1994, when researchers discovered that Sildenafil causes penile erection, they could not guess that it would take a long time before FDA supports its use in erectile dysfunction treatment. Moreover, the list of precautions to taking Cialis contains heart deseases. However, in 2014 it was announced, that U.S. FDA has approved Tadalafil medications (a 40 mg dose) for the treatment of PAH (pulmonary arterial hypertension).

A lot of us believe that erectile problems are age-related. It is partly true, but only because of general health problems that come with aging (including serious heart disorders or diabetes). Clinical studies showed that Cialis works perfectly even if a patient is older than 70 years old. Though, in such cases all possible contradictions should be taken into consideration. A dose may be reduced to 5-10 mg as well.

Many consumers ask, what may happen if they overdose. The full list of contradictions and side-effects from taking Black Cialis is still under research. Overdose with Tadalafil may lead to many unpleasant states, such as a chest pain, spontaneous long erection, headache, dyzziness or fainting. Due to the results of official clinical trials, the most likely negative reaction is headache. It was felt by 15% of examinees taking an original medication for Use as Needed in 20 mg dose.

Other possible side effects from taking Cialis include Back Pain (6%), Flushing (3%), Dyspepsia (10%) and so on. Very rarely patients face with enormously durable erection. If you experience this state for a long time after sexual intercourse or even without sexual arousal, it is certainly the reason to call an ambulance. Taking Cialis in this case may lead to a heart attack or stroke.

Any unpleasant effects might be avoided if you will consult to you doctor first. Tell your physician about a recent problems with your heart, chest, liver, blood cell and kidneys. A doctor will choose a proper dose of Cialis or other PDE5 medication for you in this case.

List of contradictions to Cialis includes some food and alcohol incompetible with Tadalafil. The most dangerous is… grapefruit. Because of interfering with a special enzyme destructing the effect of medication. Remember, that it takes approximately 72 hours to get rid of all grapefruit nutrients inside your body. Alcohol, due to the obvious reasons, is also in a group of risk.

Female Cialis is different from black. The active ingredient of this medicaton is the same (Tadalafil). A mechanism of work is also similar. Tadalafil helps to relax muscles and improves a blood flow to the vaginal tissue. Women have a stronger libido and more chances to experience orgasm. Although, last one is not guaranteed. Female Cialis can strengthen response to stimulation, but women’s sensibility still depends on psychological factors a lot.

To sum up, let’s recognize that a full prediction of possible side effects may be done only by a specialist in PDE5 pharmacy. It is worth noticing that often appearance of side effects indicates the good absorption and response to the medication. All Cialis products are proved to be quite safe and effective. Although, some contradictions mentioned should be taken into consideration.

In comparison with other PDE5 inhibitors Black Cialis is considered to be the most durable and strong remedy. However, the tolerance and sensibility to any medication is an individual factor. It is recommended to try different options before you will find and choose the ED treatment suitable for you.

All types of content published on this web page was posted with an informational purpose only. By no means, such contents are used with an intension to substitute a professional medical advice. Under no circumstances users should apply the information from this website for self-diagnosing or self-treatment before consulting a legal healthcare provider. Promptly contact a healthcare supervisor in a case there are the suspicions about the development of a medical problem.

cialis black 200 mg dosage

خواص دارویی و گیاهی

Generic Name: tadalafil Dosage Form: tablet, film coated

Medically reviewed by Drugs.com. Last updated on Feb 1, 2018.

Cialis® is indicated for the treatment of erectile dysfunction (ED).

cialis black 200 mg dosage

Do not split Cialis tablets; entire dose should be taken.

Cialis may be taken without regard to food.

Renal Impairment

Cialis for Use as Needed

Cialis for Once Daily Use

Erectile Dysfunction

Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia

Hepatic Impairment

Cialis for Use as Needed

Cialis for Once Daily Use

Nitrates

Alpha-Blockers

CYP3A4 Inhibitors

Before prescribing Cialis, it is important to note the following:

cialis black 200 mg dosage

ED

[see Dosage and Administration (2.7) and Drug Interactions (7.1)].

BPH

Cialis for Use as Needed

Cialis for Once Daily Use

ED

BPH and ED/BPH

Cialis for Use as Needed

Cialis for Once Daily Use

Cialis for Use as Needed for ED

a The term flushing includes: facial flushing and flushing

Cialis for Once Daily Use for ED

Cialis for Once Daily Use for BPH and for ED and BPH

Body as a Whole — asthenia, face edema, fatigue, pain, peripheral edema

Musculoskeletal — arthralgia, neck pain

Nervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo

Renal and Urinary — renal impairment

Respiratory — dyspnea, epistaxis, pharyngitis

Skin and Appendages — pruritus, rash, sweating

Otologic — sudden decrease or loss of hearing, tinnitus

Urogenital — erection increased, spontaneous penile erection

Nervous — migraine, seizure and seizure recurrence, transient global amnesia

Urogenital — priapism [see Warnings and Precautions (5.3)].

[See Dosage and Administration (2.7) and Warnings and Precautions (5.10)].

Risk Summary

Cialis (tadalafil) is not indicated for use in females.

Data

Animal Data

Risk Summary

Cialis is not indicated for use in females.

Infertility

Juvenile Animal Study

Effects on Blood Pressure

Effects on Blood Pressure When Administered with Nitrates

Effect on Blood Pressure When Administered With Alpha-Blockers

Figure 2: Doxazosin Study 1: Mean Change from Baseline in Systolic Blood Pressure

Effects on Blood Pressure When Administered with Antihypertensives

Effects on Blood Pressure When Administered with Alcohol

Effects on Exercise Stress Testing

Effects on Vision

Effects on Sperm Characteristics

Effects on Cardiac Electrophysiology

a Treatment duration in Study F was 6 months

a Treatment duration in Study F was 6 months

a Treatment duration in Study F was 6 months

a Twenty-four-week study conducted in the US.

b Twelve-week study conducted outside the US.

c Statistically significantly different from placebo.

a Statistically significantly different from placebo.

Figure 5: Mean IPSS Changes in BPH Patients by Visit in Study J

Figure 6: Mean IPSS Changes in BPH Patients by Visit in Study K

a Overall ITT population.

b Mixed model for repeated measurements.

c Unadjusted mean.

Figure 8: Mean IPSS Changes in ED/BPH Patients by Visit in Study L

Cialis (tadalafil) is supplied as follows:

Keep out of reach of children.

“See FDA-approved patient labeling (Patient Information)”

Revision Date: 02/2018

Generic Name: tadalafil
Dosage Form: tablet, film coated

Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA

Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA