Drug Catalog - Product Detail
FLUTAMIDE, USP CP 125MG 180
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00591-2466-18 | ACTAVIS PHARMA | 180 | 125MG | CAPSULE |
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Description
DESCRIPTION: Flutamide Capsules contain flutamide, an acetanilid, nonsteroidal, orally active antiandrogen having the chemical name, 2-methyl- N -[4-nitro-3-(trifluoromethyl)phenyl] propanamide. The compound is a buff to Yellow powder and has the following structural formula: Each capsule, for oral administration, contains 125 mg flutamide and has the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and sodium lauryl sulfate. The ingredients in the capsule shell are black iron oxide, gelatin, red iron oxide, yellow iron oxide, and titanium dioxide. The ingredients in the imprinting ink are D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol, and synthetic black iron oxide. flutamide chemical structure C11H11F3N2O3 Molecular Weight: 276.2
How Supplied
HOW SUPPLIED: Flutamide Capsules, USP are available as: 125 mg: Brown opaque cap and white opaque body filled with yellow powder. Imprinted in black ink with “ WPI 2227 ”. Available in bottles of: 180 NDC-0591-2466-18 Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: July 2014 195814-2
Indications & Usage
INDICATIONS AND USAGE: Flutamide capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B 2 -C and Stage D 2 metastatic carcinoma of the prostate. Stage B 2 -C Prostatic Carcinoma: Treatment with flutamide capsules and the goserelin acetate implant should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy. Stage D 2 Metastatic Carcinoma: To achieve benefit from treatment, flutamide capsules should be initiated with the LHRH-agonist and continued until progression.
Dosage and Administration
DOSAGE AND ADMINISTRATION: The recommended dosage is 2 capsules 3 times a day at 8-hour intervals for a total daily dose of 750 mg.