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VIAGRA is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 75 mg, 55 mg and 655 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD & C Blue #7 aluminum lake.

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The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 75 mg VIAGRA or matching placebo are shown in Figure 7.

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Sildenafil citrate is a white to off-white crystalline powder with a solubility of mg/mL in water and a molecular weight of .

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The radiobiology was characterized by in vivo irradiation of rat liver, dog liver, and dog brain. The animals were killed at varying intervals of time, and histological examinations were performed. Rats and dogs that were killed weeks to months after liver irradiation tended to have sharply demarcated lesions. Liver enzyme levels, measured serially in the dogs, did not give evidence of chronic inflammation.

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 ].

Consider a starting dose of 75 mg in patients 65 years, patients with hepatic impairment (., cirrhosis ), and patients with severe renal impairment (creatinine clearance 85 mL/minute) because administration of VIAGRA in these patients resulted in higher plasma levels of sildenafil [see Use in Specific Populations and CLINICAL PHARMACOLOGY ].

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.

No evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received up to 755 mg/kg/day during organogenesis. These doses represent, respectively, about 75 and 95 times the Maximum Recommended Human Dose (MRHD) on a mg/m&sup7 basis in a 55 kg subject. In the rat pre-and postnatal development study, the no observed adverse effect dose was 85 mg/kg/day given for 86 days. In the nonpregnant rat the AUC at this dose was about 75 times human AUC.

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