INDICATIONS
CASODEX is indicated for use in combination therapy with
a luteinizing hormone-releasing hormone (LHRH) analogue
for the treatment of Stage D2 metastatic carcinoma of
the prostate.
DOSAGE AND ADMINISTRATION
The recommended dose for CASODEX therapy in combination
with an LHRH analogue is one 50 mg tablet once daily (morning
or evening), with or without food. It is recommended that
CASODEX be taken at the same time each day. Treatment
with CASODEX should be started at the same time as treatment
with an LHRH analogue.
Dosage Adjustment in Renal Impairment:
No dosage adjustment is necessary for patients with renal
impairment (See CLINICAL PHARMACOLOGY, Special Populations,
Renal Insufficiency).
Dosage Adjustment in Hepatic Impairment:
No dosage adjustment is necessary for patients with mild
to moderate hepatic impairment. Although there is a 76%
(5.9 and 10.4 days for normal and impaired patients, respectively)
increase in the half-life of the active enantiomer of
bicalutamide in patients with severe liver impairment
(n = 4), no dosage adjustment is necessary (see CLINICAL
PHARMACOLOGY, Special Populations, Hepatic Impairment
and PRECAUTIONS sections).
HOW SUPPLIED
50 mg Tablets. (NDC 0310-0705) White, film-coated
tablets (identified on one side with “CDX50”
and on the reverse with the “CASODEX logo”)
are supplied in unit dose blisters of 30 tablets per carton
(0310-0705-39), bottles of 30 tablets (0310-0705-30) and
bottles of 100 tablets (0310-0705-10).
Store at controlled room temperature, 20°-25°C
(68°-77°F).
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