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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.

Studies establishing effectiveness included predominately patients with NYHA Functional Class II-III symptoms and etiologies of primary pulmonary hypertension (71%) or pulmonary hypertension associated with connective tissue disease (25%).

Limitation of Use

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

DOSAGE AND ADMINISTRATION

Pulmonary Arterial Hypertension (PAH)

REVATIO Tablets

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.

REVATIO Injection

REVATIO injection is for the continued treatment of patients with pulmonary arterial hypertension (PAH) who are currently prescribed oral REVATIO and who are temporarily unable to take oral medication.

The recommended dose is 10 mg (corresponding to 12.5 mL) administered as an intravenous bolus injection three times a day. The dose of REVATIO injection does not need to be adjusted for body weight.

A 10 mg dose of REVATIO injection is predicted to provide pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose.

DOSAGE FORMS AND STRENGTHS

REVATIO Tablets

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

REVATIO Injection

REVATIO injection is supplied as a single use vial containing 10 mg (12.5 mL) of sildenafil.

HOW SUPPLIED/STORAGE AND HANDLING

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

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

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

REVATIO Injection is supplied as a clear, colorless, sterile, ready to use solution containing 10 mg sildenafil (12.5mL) presented in a glass vial.

REVATIO Injection
Package Configuration Strength NDC
Vial individually packaged in a carton 10 mg (12.5 mL) 0069-0338-01

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

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