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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 reaction of anaphylaxia with desensibilization on guinea pigs and the method of double diffusion in agar gel were used to study the antigenic composition of the rat skeletal muscles 8, 7 and 85 days after their cross sections were connected with polyurethane glue and silk.

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Twenty subjects received VIAGRA 55 mg, but only 69 subjects received matching placebo. One patient discontinued the study prematurely due to an adverse event of hypotension following dosing with VIAGRA 55 mg. This patient had been taking minoxidil, a potent vasodilator, during the study.

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In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.

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However, since higher plasma levels may increase the incidence of adverse reactions, a starting dose of 75 mg should be considered in older subjects due to the higher systemic exposure [see DOSAGE AND ADMINISTRATION ].

The safety and efficacy of combinations of VIAGRA with other PDE5 Inhibitors, including REVATIO or other pulmonary arterial hypertension ( PAH ) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied. Such combinations may further lower blood pressure. Therefore, the use of such combinations is not recommended.

After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 85% of administered oral dose) and to a lesser extent in the urine (approximately 68% of the administered oral dose). Similar values for pharmacokinetic parameters were seen in normal volunteers and in the patient population, using a population pharmacokinetic approach.

Consistent with its known effects on the nitric oxide/cGMP pathway [see CLINICAL PHARMACOLOGY ], VIAGRA was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated.

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