BICALUTAMIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Sandoz 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
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BICALUTAMIDE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BICALUTAMIDE
TABLETS.
BICALUTAMIDE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Dosage and Administration (2.1) 02/2015
INDICATIONS AND USAGE
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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
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Adverse reactions that occurred in more than 10% of patients receiving
bicalutamide plus an LHRH-A were: hot flashes,
pain (including general, back, pelvic and abdominal), asthenia,
constipation, infection, nausea, peripheral edema, dyspnea,
diarrhea, hematuria, nocturia and anemia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
Pediatric patients: Efficacy has not been demonstrated for the
treatment of familial male-limited precocious puberty
(testotoxicosis). (8.4)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
Bicalutamide tablets 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
pros tate .
2
Bicalutamide tablets 150 mg daily is not approved for use alone or
with other treatments. (1)
Hypersensitivity (4.1)
Women (4.2)
Pregnancy (4.3 and 8.1)
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
dysfun