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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 patients in studies had varying degrees of ED. One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 9-week, treatment-free run-in period.

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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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 6-855-FDA-6588 or at /medwatch.

The use of VIAGRA offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [see WARNINGS AND PRECAUTIONS ].

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.

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 ].

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

VIAGRA is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in VIAGRA and REVATIO, or any component of the tablet. Hypersensitivity reactions have been reported, including rash and urticaria [see ADVERSE REACTIONS ].

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