BICALUTAMIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Bicalutamide (UNII: A0Z3NAU9DP) (Bicalutamide - UNII:A0Z3NAU9DP)

Available from:

Synthon Pharmaceuticals, Inc.

INN (International Name):

Bicalutamide

Composition:

Bicalutamide 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 (14.2)]. Bicalutamide Tablets, USP are contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet's components. Hypersensitivity reactions including angioneurotic edema and urticaria have been reported [see Adverse Reactions (6.2)] . Bicalutamide Tablets, USP have no indication for women, and should not be used in this population. Bicalutamide Tablets, USP may cause fetal harm when administered to a pregnant woman. Bicalutamide Tablets, USP are contraindicated in women, including those who are or may become pregnant. There are no studies in pregnant women using Bicalutamide Tablets, USP. If this drug is used during pregnancy, or if the pat

Product summary:

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 63672-0005-1, Bottles of 30 NDC 63672-0005-3, Bottles of 100 NDC 63672-0005-4, Bottles of 500 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BICALUTAMIDE- BICALUTAMIDE TABLET, FILM COATED
SYNTHON PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BICALUTAMIDE TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BICALUTAMIDE
TABLETS, USP.
BICALUTAMIDE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Bicalutamide Tablets, USP 50 mg are an androgen receptor inhibitor
indicated for use in combination therapy with a
luteinizing hormone-releasing hormone (LHRH) analog for the treatment
of Stage D metastatic carcinoma of the
pros tate .
Bicalutamide Tablets, USP 150 mg daily are not approved for use alone
or with other treatments. (1)
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). (2)
DOSAGE FORMS AND STRENGTHS
50 mg tablets (3)
CONTRAINDICATIONS
Hypersensitivity (4.1)
Women (4.2)
Pregnancy (4.3 and 8.1)
WARNINGS AND PRECAUTIONS
Severe hepatic changes and hepatic failure have been observed rarely.
Monitor serum transaminase levels prior to
starting treatment with Bicalutamide Tablets, USP, at regular
intervals for the first four months of treatment and
periodically thereafter, and for symptoms or signs suggestive of
hepatic dysfunction. Use Bicalutamide Tablets, USP
with caution in patients with hepatic impairment. (5.1)
Gynecomastia and breast pain have been reported during treatment with
Bicalutamide Tablets, USP 150 mg when used
as a single agent. (5.2)
Bicalutamide Tablets, USP are used in combination with a LHRH agonist.
LHRH agonists have been shown to cause a
reduction in glucose tolerance in males. Consideration should be given
to monitoring blood glucose in patients
receiving Bicalutamide Tablets, USP in combination with LHRH agonists.
(5.3)
Monitoring Prostate Specific Antigen (PSA) is recommended. Evaluate
for clinical progression if PSA increases. (5.4)
ADVERSE REACTIONS
Adverse reactions th