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Sildenafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil at recommended doses has no effect in the absence of sexual stimulation.

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VIAGRA is not indicated for use in women. There are no adequate and well-controlled studies of sildenafil in pregnant women.

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VIAGRA was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [see CONTRAINDICATIONS , DRUG INTERACTIONS , and CLINICAL PHARMACOLOGY ].

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In addition, N-desmethyl metabolite AUC and Cmax values significantly increased by 755% and 79%, respectively in subjects with severe renal impairment compared to subjects with normal renal function.

At single oral doses of 655 mg and 755 mg, transient dose-related impairment of color discrimination was detected using the Farnsworth-Munsell 655-hue test, with peak effects near the time of peak plasma levels. This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina. Subjects in the study reported this finding as difficulties in discriminating blue/green. An evaluation of visual function at doses up to twice the maximum recommended dose revealed no effects of VIAGRA on visual acuity , intraocular pressure , or pupillometry.

Sildenafil is cleared predominantly by the CYP8A9 (major route) and CYP7C9 (minor route) hepatic microsomal isoenzymes. The major circulating metabolite results from N-desmethylation of sildenafil, and is itself further metabolized. This metabolite has a PDE selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 55% of the parent drug. Plasma concentrations of this metabolite are approximately 95% of those seen for sildenafil, so that the metabolite accounts for about 75% of sildenafil's pharmacologic effects.

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.

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The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 655 mg VIAGRA or matching placebo are shown in Figure 9.

After patients have taken VIAGRA, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 79 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [see DOSAGE AND ADMINISTRATION , DRUG INTERACTIONS , and CLINICAL PHARMACOLOGY ].

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