INDICATIONS AND USAGE RAPAFLO, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). RAPAFLO is not indicated for the treatment of hypertension.
DOSAGE AND ADMINISTRATION 8 mg capsules taken orally once daily with a meal. 4 mg capsules taken orally once daily with a meal for those with moderate renal impairment [Creatinine Clearance (CCr) 30-50 mL/min].
DOSAGE FORMS AND STRENGTHS Capsules: 8 mg and 4 mg.
Renal impairment: RAPAFLO is contraindicated in patients with severe renal impairment (Creatinine Clearance - CCr < 30 mL/min). In patients with moderate renal impairment (CCr 30-50 mL/min), the dose should be reduced to 4 mg once daily taken with a meal. No dosage adjustment is needed in patients with mild renal impairment (CCr 50-80 mL/min)
Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula.
RAPAFLO is contraindicated in patients with severe renal impairment (Creatinine Clearance - CCr < 30 mL/min).
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here.