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.
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