A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Casodex Indications, Dosage, Storage, Stability - Bicalutamide
Casodex Indications, Dosage, Storage, Stability - Bicalutamide
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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