Source: FDA, National Drug Code (US) Revision Year: 2020
RAPAFLO is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)- 5-[(2R)2({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 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.
| Dosage Forms and Strengths |
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The 8 mg capsules are white, opaque, hard #1 gelatin capsules imprinted with “WATSON 152” in green on the cap and “8 mg” in green on the body. The 4 mg capsules are white, opaque, hard #3 gelatin capsules imprinted with “WATSON 151” in gold on the cap and “4 mg” in gold on the body. |
| How Supplied |
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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:
Bottles of 30 and 90 capsules are supplied with child-resistant closures. White, opaque, hard gelatin 4 mg capsules: Cap is imprinted with “WATSON 151” in gold. Body is imprinted with “4 mg” in gold. 4 mg capsules are supplied in unit of use HDPE bottles of:
Bottles of 30 capsules are supplied with child-resistant closures. Distributed by: Allergan USA, Inc., Madison, NJ 07940 Under license from: Kissei Pharmaceutical Co., Ltd., Nagano, Japan |
| Drug | Countries | |
|---|---|---|
| RAPAFLO | Canada, United States |
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