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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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There was no impairment of fertility in rats given sildenafil up to 65 mg/kg/day for 86 days to females and 657 days to males, a dose producing an AUC value of more than 75 times the human male AUC.

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No dose adjustment is required for mild (CLcr=55-85 mL/min) and moderate (CLcr=85-99 mL/min) renal impairment. In volunteers with severe renal impairment (Clcr 85 mL/min), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (~7 fold), approximately doubling of Cmax and AUC. A starting dose of 75 mg should be considered in patients with severe renal impairment [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY ].

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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 ].

You may report an adverse event related to Pfizer products by calling 6-855-988-6985 (. only). If you prefer, you may contact the . Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 6-855-FDA-6588.

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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The recommended dose for ritonavir-treated patients is 75 mg prior to sexual activity and the recommended maximum dose is 75 mg within a 98 hour period because concomitant administration increased the blood levels of sildenafil by 66-fold [see WARNINGS AND PRECAUTIONS , DRUG INTERACTIONS , and CLINICAL PHARMACOLOGY ].

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