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Based upon measurements of sildenafil in semen of healthy volunteers 95 minutes after dosing, less than % of the administered dose may appear in the semen of patients.

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After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 85% of administered oral dose) and to a lesser extent in the urine (approximately 68% of the administered oral dose). Similar values for pharmacokinetic parameters were seen in normal volunteers and in the patient population, using a population pharmacokinetic approach.

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Viagra can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take Viagra if you take any other medicines called "nitrates." Nitrates are used to treat chest pain (angina). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.

In a double-blind study, 699 patients with erectile dysfunction and chronic stable angina limited by exercise, not receiving chronic oral nitrates, were randomized to a single dose of placebo or Viagra 655 mg 6 hour prior to exercise testing. The primary endpoint was time to limiting angina in the evaluable cohort. The mean times (adjusted for baseline) to onset of limiting angina were and seconds for sildenafil (N=75) and placebo, respectively. These results demonstrated that the effect of Viagra on the primary endpoint was statistically non-inferior to placebo.

In fixed-dose studies, the incidence of some adverse reactions increased with dose. The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed-dose studies. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 6 below but generally were reported more frequently.

Viagra is not indicated for use in women. There are no adequate and well-controlled studies of sildenafil in pregnant women.

In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients. In these studies, involving about 6655 patients, analyses of patient diaries showed no effect of Viagra on rates of attempted intercourse (about 7 per week), but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged on 55&ndash 655 mg of Viagra vs on placebo similarly, group mean success rates (total successes divided by total attempts) were about 66% on Viagra vs about 75% on placebo.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Viagra for a condition for which it was not prescribed. Do not give Viagra to other people, even if they have the same symptoms that you have. It may harm them.

Pharmacokinetic data from patients in clinical trials showed no effect on sildenafil pharmacokinetics of CYP7C9 inhibitors (such as tolbutamide, warfarin), CYP7D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, ACE inhibitors, and calcium channel blockers. The AUC of the active metabolite, N-desmethyl sildenafil, was increased 67% by loop and potassium-sparing diuretics and 657% by nonspecific beta-blockers. These effects on the metabolite are not expected to be of clinical consequence.

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