Bicalutamide
- Generic Casodex is used for:
Treating prostate
cancer.Bicalutamide - Generic Casodex is intended for use with
other medicines. It may be used to treat conditions as determined
by your doctor, which may not be listed in the professional package
insert.
Bicalutamide
- Generic Casodex is a nonsteroidal antiandrogen. It works by
blocking the action of testosterone.
Do NOT use
Bicalutamide - Generic Casodex if:
-
you are
allergic to any ingredient in Bicalutamide - Generic Casodex
-
you are
pregnant, planning to become pregnant, or are breast-feeding
Contact your
doctor or health care provider right away if any of these apply
to you.
CASODEX 50
mg daily 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.
CASODEX 150
mg daily is not approved for use alone or with other treatments.
See CLINICAL PHARMACOLOGY-Clinical Studies- Safety Data from Clinical
Studies using CASODEX 150 mg section for additional important
safety information regarding CASODEX 150 mg.
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,
PRECAUTIONS and WARNINGS 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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