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Therefore, age 65, hepatic impairment and severe renal impairment are associated with increased plasma levels of sildenafil. A starting oral dose of 75 mg should be considered in those patients [see DOSAGE AND ADMINISTRATION ].

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VIAGRA is rapidly absorbed. Maximum observed plasma concentrations are reached within 85 to 675 minutes (median 65 minutes) of oral dosing in the fasted state. When VIAGRA is taken with a high fat meal, the rate of absorption is reduced, with a mean delay in Tmax of 65 minutes and a mean reduction in Cmax of 79%. The mean steady state volume of distribution (Vss) for sildenafil is 655 L, indicating distribution into the tissues. Sildenafil and its major circulating N-desmethyl metabolite are both approximately 96% bound to plasma proteins. Protein binding is independent of total drug concentrations.

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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.

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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.

Studies have produced relevant data on the effects of VIAGRA on cardiac output. In one small, open-label, uncontrolled, pilot study, eight patients with stable ischemic heart disease underwent Swan-Ganz catheterization. A total dose of 95 mg sildenafil was administered by four intravenous infusions.

Physicians should advise patients to stop taking PDE5 inhibitors, including VIAGRA, 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 VIAGRA. 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 ].

Placebo-subtracted mean maximum decrease in systolic blood pressure (mm Hg) VIAGRA 75 mg Supine (-, ) Standing (-, )

Physicians should discuss with patients the contraindication of VIAGRA with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see CONTRAINDICATIONS ].

Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including VIAGRA, 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 occur. In some patients, concomitant use of these two drug classes can lower blood pressure significantly [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY ] leading to symptomatic hypotension (., dizziness, lightheadedness , fainting ).

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 55-655 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.

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