s (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 ni-tric oxide donors, or nitrates in any form, is therefore contraindicated.
HOW SUPPLIED
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 |
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].