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Viagra was administered to over 8755 patients (aged 69&ndash 87 years) during pre-marketing clinical trials worldwide. Over 555 patients were treated for longer than one year.

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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.

VIAGRA may affect the way other medicines work, and other medicines may affect the way VIAGRA works, causing side effects.
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This Patient Information leaflet summarizes the most important information about Viagra. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Viagra that is written for health professionals.

The product information provided in this site is intended for residents of the United States. The products discussed herein may have different product labeling in different countries.

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.

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.

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