BICALUTAMIDE tablet film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Golden State Medical Supply, Inc.

INN (Nama Internasional):

Bicalutamide

Komposisi:

Bicalutamide 50 mg

Jenis Resep:

PRESCRIPTION DRUG

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

BICALUTAMIDE- BICALUTAMIDE TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY, 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 injury and fatal hepatic failure have been observed.
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