REVATIO is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability.

The efficacy of REVATIO has not been evaluated in patients currently on bosentan therapy.

The recommended dose of REVATIO is 20 mg three times a day (t.i.d.). 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 t.i.d. is not recommended. Dosages lower than 20 mg t.i.d. were not tested. Whether dosages lower than 20 mg t.i.d. are effective is not known.

In general, dose selection for elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see CLINICAL PHARMACOLOGY)

No dose adjustments are required for renal impaired patients (including severe renal impairment, creatinine clearance <30 mL/min), or for hepatic impaired patients (Child Pugh class A and B).

No dose adjustments are required for the co-administration of REVATIO with erythromycin or saquinavir.

Co-administration of REVATIO with CYP3A4 inducers (including bosentan; and more potent inducers such as barbiturates, carbamazepine, phenytoin, efavirenz, nevirapine, rifampin, rifabutin) may alter plasma levels of either or both medications. Dosage adjustments may be necessary (see PRECAUTIONS: DRUG INTERACTIONS).

Co-administration of potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) with REVATIO substantially increases serum concentrations of sildenafil and is therefore not recommended (see WARNINGS and PRECAUTIONS: DRUG INTERACTIONS).

Sildenafil 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.

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

REVATIO Tablets

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

Distributed by: Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. Revised October 2007. FDA rev date: 12/18/2007

Bookmark this page: