Viagra - Indications & Dosage

INDICATION AND USAGE

VIAGRA 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, VIAGRA 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 [ketoconazole, itraconazole, erythromycin (182%), 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.

Ritonavir greatly increased the systemic level of sildenafil in a study of healthy, non-HIV infected volunteers (11-fold increase in AUC, see Drug Interactions.) Based on these pharmacokinetic data, it is recommended not to exceed a maximum single dose of 25 mg of VIAGRA in a 48 hour period.

VIAGRA 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.

Simultaneous administration of VIAGRA doses above 25 mg and an alpha-blocker may lead to symptomatic hypotension in some patients. Doses of 50 mg or 100 mg of VIAGRA should not be taken within 4 hours of alpha-blocker administration. A 25 mg dose of VIAGRA may be taken at any time.

HOW SUPPLIED

VIAGRA® (sildenafil citrate) is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:

25 mg50 mg100 mgObverseVGR25VGR50VGR100ReversePFIZERPFIZERPFIZERBottle of 30NDC-0069-4200-30NDC-0069-4210-30NDC-0069-4220-30Bottle of 100N/ANDC-0069-4210-66NDC-0069-4220-66Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Rx only

© 2002 Pfizer Inc.