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Bicalutamide (Bicalutamide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Bicalutamide Tablets, USP 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.

Bicalutamide Tablets, USP 150 mg daily are not approved for use alone or with other treatments [see Clinical Studies].

DOSAGE AND ADMINISTRATION

The recommended dose for Bicalutamide Tablets, USP therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that Bicalutamide Tablets, USP be taken at the same time each day. Treatment with Bicalutamide Tablets, USP should be started at the same time as treatment with an LHRH analog.

Dosage Adjustment in Renal Impairment

No dosage adjustment is necessary for patients with renal impairment [see Use in Specific Populations].

Dosage Adjustment in Hepatic Impairment

No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. In patients with severe liver impairment (n=4), although there was a 76% increase in the half-life (5.9 and 10.4 days for normal and impaired patients, respectively) of the active enantiomer of bicalutamide no dosage adjustment is necessary [see Use in Specific Populations].

DOSAGE FORMS & STRENGTHS

Bicalutamide Tablets, USP 50 mg Tablets for oral administration.

HOW SUPPLIED/STORAGE AND HANDLING

Bicalutamide Tablets, USP, 50 mg are white, round, biconvex, film-coated tablets with "BCM 50" debossed on one side. They are supplied as follows:

NDC 51991-560-01, Bottles of 100

Storage and Handling

Store at controlled room temperature, 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). See USP Controlled Room Temperature.

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