BICALUTAMIDE tablet film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

BICALUTAMIDE (UNII: A0Z3NAU9DP) (BICALUTAMIDE - UNII:A0Z3NAU9DP)

제공처:

AvKARE, Inc.

INN (국제 이름):

BICALUTAMIDE

구성:

BICALUTAMIDE 50 mg

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

BICALUTAMIDE- BICALUTAMIDE TABLET, FILM COATED
AVKARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
BICALUTAMIDE TABLETS USP
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 50 mg is 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 prostate.
Bicalutamide 150 mg daily is not approved for use alone or with other
treatments. ( 1)
DOSAGE AND ADMINISTRATION
The recommended dose for bicalutamide 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, at regular intervals for the first four
months of treatment and periodically thereafter, and
for symptoms or signs suggestive of hepatic dysfunction. Use
bicalutamide with caution in patients with hepatic
impairment. ( 5.1)
Gynecomastia and breast pain have been reported during treatment with
bicalutamide 150 mg when used as a single
agent. ( 5.2)
Bicalutamide is 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 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 that occurred in more than 10% of patients receiving
bicalutamide plus an LHRH-A were: hot flashes