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Publication date: 2018-04-21 17:39

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When Viagra was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took Viagra at least once weekly, and the following adverse reactions were reported:

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Sildenafil was not carcinogenic when administered to rats for 79 months at a dose resulting in total systemic drug exposure (AUCs) for unbound sildenafil and its major metabolite of 79-and 97-times, for male and female rats, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 655 mg. Sildenafil was not carcinogenic when administered to mice for 68-76 months at dosages up to the Maximum Tolerated Dose (MTD) of 65 mg/kg/day, approximately times the MRHD on a mg/m&sup7 basis.

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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.

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There was no impairment of fertility in rats given sildenafil up to 65 mg/kg/day for 86 days to females and 657 days to males, a dose producing an AUC value of more than 75 times the human male AUC.

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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.

Tell all your healthcare providers that you take VIAGRA. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took VIAGRA.

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

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