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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.

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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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Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including VIAGRA, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may occur. In some patients, concomitant use of these two drug classes can lower blood pressure significantly [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY ] leading to symptomatic hypotension (., dizziness, lightheadedness , fainting ).

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When a man is aroused, muscles in the penis relax to allow this greater blood flow. Viagra helps to elevate the levels of a substance (cyclic guanosine monophosphate, or cGMP) that causes the tissues to relax, leads to an inflow of blood, and causes an erection with sexual stimulation.

It is estimated roughly 85 million men in the . and over 655 million men worldwide suffer from ED. A large . survey determined about 55 percent of men 95 to 75 years of age experience some degree of ED.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

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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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