Source: FDA, National Drug Code (US) Revision Year: 2020
RAPAFLO, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)].
RAPAFLO is not indicated for the treatment of hypertension.
The recommended dose is 8 mg orally once daily with a meal.
Patients who have difficulty swallowing pills and capsules may carefully open the RAPAFLO capsule and sprinkle the powder inside on a tablespoonful of applesauce. The applesauce should be swallowed immediately (within 5 minutes) without chewing and followed with an 8 oz glass of cool water to ensure complete swallowing of the powder. The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing. Any powder/applesauce mixture should be used immediately (within 5 minutes) and not stored for future use. Subdividing the contents of a RAPAFLO capsule is not recommended [see CLINICAL PHARMACOLOGY (12.3)].
Renal impairment: RAPAFLO is contraindicated in patients with severe renal impairment (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) [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.2), USE IN SPECIFIC POPULATIONS (8.6) and CLINICAL PHARMACOLOGY (12.3)].
Hepatic impairment: RAPAFLO has not been studied in patients with severe hepatic impairment (Child-Pugh score 10) and is therefore contraindicated in these patients. No dosage adjustment is needed in patients with mild or moderate hepatic impairment [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.3), USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)].
RAPAFLO was evaluated at doses of up to 48 mg/day in healthy male subjects. The dose-limiting adverse event was postural hypotension.
Should overdose of RAPAFLO lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by maintaining the patient in the supine position. If this measure is inadequate, administration of intravenous fluid should be considered. If necessary, vasopressors could be used, and renal function should be monitored and supported as needed. Dialysis is unlikely to be of significant benefit since silodosin is highly (97%) protein bound.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature]. Protect from light and moisture.
Keep out of reach of children.
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