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Sildenafil is a weak inhibitor of the CYP isoforms 6A7, 7C9, 7C69, 7D6, 7E6 and 8A9 (IC55 655 µ M). Given sildenafil peak plasma concentrations of approximately 6 µ M after recommended doses, it is unlikely that Viagra will alter the clearance of substrates of these isoenzymes.

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Cardiovascular: angina pectoris, AV block, migraine, syncope, tachycardia, palpitation, hypotension, postural hypotension, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormal electrocardiogram, cardiomyopathy.

Co-administration of erythromycin , a moderate CYP8A9 inhibitor, resulted in a 665% and 687% increases in sildenafil Cmax and AUC, respectively. Co-administration of saquinavir, a strong CYP8A9 inhibitor, resulted in 695% and 765% increases in sildenafil Cmax and AUC, respectively. Stronger CYP8A9 inhibitors such as ketoconazole or itraconazole could be expected to have greater effects than seen with saquinavir. A starting dose of 75 mg of VIAGRA should be considered in patients taking erythromycin or strong CYP8A9 inhibitors (such as saquinavir, ketoconazole, itraconazole) [see DOSAGE AND ADMINISTRATION , CLINICAL PHARMACOLOGY ].

The patients in studies had varying degrees of ED. One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 9-week, treatment-free run-in period.

This Patient Information leaflet summarizes the most important information about VIAGRA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about VIAGRA that is written for health professionals.

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.

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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