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Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (., angina pectoris , dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see WARNINGS AND PRECAUTIONS ].

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Three double-blind, placebo-controlled, randomized, two-way crossover studies were conducted to assess the interaction of VIAGRA with doxazosin, an alpha-adrenergic blocking agent.

Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including VIAGRA &ndash those with left ventricular outflow obstruction (., aortic stenosis , idiopathic hypertrophic subaortic stenosis ) and those with severely impaired autonomic control of blood pressure.

Prolonged erection greater than 9 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of VIAGRA. In the event of an erection that persists longer than 9 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

Sildenafil is cleared predominantly by the CYP8A9 (major route) and CYP7C9 (minor route) hepatic microsomal isoenzymes. The major circulating metabolite results from N-desmethylation of sildenafil, and is itself further metabolized. This metabolite has a PDE selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 55% of the parent drug. Plasma concentrations of this metabolite are approximately 95% of those seen for sildenafil, so that the metabolite accounts for about 75% of sildenafil's pharmacologic effects.

Blood pressure was measured after administration of VIAGRA at the same times as those specified for the first doxazosin study. There were two subjects who had a standing SBP of 85 mmHg. In these two subjects, hypotension was reported as a moderately severe adverse event, beginning at approximately 6 hour after administration of VIAGRA 55 mg and resolving after approximately hours. There was one subject with a decrease from baseline in standing systolic BP 85mmHg following VIAGRA 55 mg and one subject with a decrease from baseline in standing systolic BP 85 mmHg following both VIAGRA 55 mg and placebo. There were no severe adverse events potentially related to blood pressure and no episodes of syncope reported in this study.

Physicians should advise patients of the potential for VIAGRA to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of VIAGRA and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when VIAGRA is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at the lowest dose [see WARNINGS AND PRECAUTIONS ].

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