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In addition, N-desmethyl metabolite AUC and C max values significantly increased by 755% and 79%, respectively in subjects with severe renal impairment compared to subjects with normal renal function.

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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 7 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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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.

Viagra has systemic vasodilatory properties and may further lower blood pressure in patients taking anti-hypertensive medications.

One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 655 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=678) was conducted. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of Viagra. On a global improvement question, 88% of patients reported improved erections on Viagra versus 67% on placebo. Diary data indicated that on Viagra, 59% of attempts at sexual intercourse were successful compared to 68% on placebo.

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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 55 mg Viagra or matching placebo are shown in Figure 8.

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