INDICATIONS

Sildenafil citrate is indicated for the treatment of erectile dysfunction.

DOSAGE AND ADMINISTRATION

For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil citrate may be taken anywhere from 4 hours to 0.5 hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.

The Following Factors are Associated with Increased Plasma Levels of Sildenafil: Age >65 (40% increase in AUC), hepatic impairment (e.g., cirrhosis, 80%), severe renal impairment (creatinine clearance <30 ml/min, 100%), and concomitant use of potent cytochrome P450 3A4 inhibitors (erythromycin, ketoconazole, itraconazole, 200%, saquinavir 210%). Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered in these patients.

Given the extent of the interaction with patients receiving concomitant therapy with ritonavir (see DRUG INTERACTIONS), it is recommended not to exceed a maximum single dose of 25 mg of sildenafil citrate in a 48 hour period.

Sildenafil citrate was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors or nitrates in any form is therefore contraindicated.

HOW SUPPLIED

Viagra is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: 25 mg: Imprinted VGR25 on obverse side, PFIZER on reverse. 50 mg: Imprinted VGR50 on obverse side, PFIZER on reverse. 100 mg: Imprinted VGR100 on obverse side, PFIZER on reverse.

Recommended Storage: Store at controlled room temperature, 15-30°C (59-86°F).

PRODUCT LISTING