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.
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