Revatio (Sildenafil Citrate) - Indications and Dosage

INDICATIONS AND USAGE

REVATIO® is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when REVATIO was added to background epoprostenol therapy [see Clinical Studies].

Limitation of Use

The efficacy of REVATIO has not been adequately evaluated in patients taking bosentan concurrently.

DOSAGE AND ADMINISTRATION

Pulmonary Arterial Hypertension (PAH)

The recommended dose of REVATIO is 20 mg three times a day (TID). REVATIO tablets should be taken approximately 4—6 hours apart, with or without food.

In the clinical trial no greater efficacy was achieved with the use of higher doses. Treatment with doses higher than 20 mg TID is not recommended. Dosages lower than 20 mg TID were not tested. Whether dosages lower than 20 mg TID are effective is not known.

DOSAGE FORMS AND STRENGTHS

REVATIO is supplied as white, film-coated, round tablets engraved with "RVT20" containing sildenafil citrate equivalent to 20 mg of sildenafil.

HOW SUPPLIED/STORAGE AND HANDLING

REVATIO is supplied as white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:

REVATIO Tablets

Package Configuration	Tablet Strength (mg)	NDC	Engraving on Tablet
Bottle of 90	20 mg	0069-4190-68	RVT20

Recommended Storage: Store at 25°C (77°F); excursions permitted to 15—30°C (59—86°F) [see USP Controlled Room Temperature].