Drug Catalog - Product Detail
RAPAFLO CAPSULE 8MG 30 X 1
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 52544-0152-30 | ALLERGAN | 30 | 8MG | CAPSULE |
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Description
11 DESCRIPTION RAPAFLO is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2 R )-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1 H -indole-7-carboxamide and the molecular formula is C 25 H 32 F 3 N 3 O 4 with a molecular weight of 495.53. The structural formula of silodosin is: Silodosin is a white to pale yellowish white powder that melts at approximately 105 to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each RAPAFLO 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #1 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing FD&C Blue No. 1 Aluminum Lake and yellow iron oxide. Each RAPAFLO 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing yellow iron oxide. structural formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING White, opaque, hard gelatin 8 mg capsules . Cap is imprinted with “WATSON 152” in green. Body is imprinted with “8 mg” in green. 8 mg capsules are supplied in unit of use HDPE bottles of: 30 capsules ( NDC 52544-152-30 ) 90 capsules ( NDC 52544-152-19 ) NDC 69189-0169-1 single dose pack with 1 capsule as repackaged by Avera McKennan Hospital Bottles of 30 and 90 capsules are supplied with child-resistant closures. Storage 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.
Indications & Usage
1 INDICATIONS AND USAGE 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. 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. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 8 mg capsules taken orally once daily with a meal. ( 2.1 ) 4 mg capsules taken orally once daily with a meal for those with moderate renal impairment [Creatinine Clearance (CCr) 30-50 mL/min]. ( 2.2 ) 2.1 Dosing Information 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 ) ]. 2.2 Dosage Adjustment in Special Populations 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 ) ].