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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 ].

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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.

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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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Do not use VIAGRA in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including VIAGRA, may potentiate the hypotensive effects of GC stimulators.

Heart disease can clog or narrow the arteries. This can stop blood from flowing to the penis, and may cause ED. Talk to your doctor to make sure your heart is healthy enough for sex.

Co-administration of erythromycin , a moderate CYP8A9 inhibitor, resulted in a 665% and 687% increases in sildenafil Cmax and AUC, respectively. Co-administration of saquinavir, a strong CYP8A9 inhibitor, resulted in 695% and 765% increases in sildenafil Cmax and AUC, respectively. Stronger CYP8A9 inhibitors such as ketoconazole or itraconazole could be expected to have greater effects than seen with saquinavir. A starting dose of 75 mg of VIAGRA should be considered in patients taking erythromycin or strong CYP8A9 inhibitors (such as saquinavir, ketoconazole, itraconazole) [see DOSAGE AND ADMINISTRATION , CLINICAL PHARMACOLOGY ].

Try using The Erection Hardness Score, a self-assessment tool used in VIAGRA clinical studies, to rate your own erection. If you’re concerned about your hardness score, ask your doctor if VIAGRA can help.

Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.

Administration of VIAGRA with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, VIAGRA was shown to potentiate the hypotensive effects of nitrates [see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , CLINICAL PHARMACOLOGY ].

Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity.

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