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Pharmacokinetic data from patients in clinical trials showed no effect on sildenafil pharmacokinetics of CYP7C9 inhibitors (such as tolbutamide, warfarin), CYP7D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, ACE inhibitors, and calcium channel blockers. The AUC of the active metabolite, N-desmethyl sildenafil, was increased 67% by loop and potassium-sparing diuretics and 657% by nonspecific beta-blockers. These effects on the metabolite are not expected to be of clinical consequence.

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In fixed-dose studies, the incidence of some adverse reactions increased with dose. The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed-dose studies. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 6 below but generally were reported more frequently.

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Sildenafil citrate is a white to off-white crystalline powder with a solubility of mg/mL in water and a molecular weight of .

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Cardiovascular: angina pectoris, AV block, migraine, syncope, tachycardia, palpitation, hypotension, postural hypotension, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormal electrocardiogram, cardiomyopathy.

Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 655 mg or decreased to 75 mg.

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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.

There are no controlled clinical data on the safety or efficacy of Viagra in the following groups if prescribed, this should be done with caution.

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