BICALUTAMIDE tablet film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Avera McKennan Hospital

INN (Միջազգային անվանումը):

BICALUTAMIDE

Կազմը:

BICALUTAMIDE 50 mg

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

BICALUTAMIDE- BICALUTAMIDE TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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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
RECENT MAJOR CHANGES
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 TEVA USA,
PHARMACOVIGILANCE AT 1-866-832-8537
OR [e-mail]; OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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Dosage and Administration (2.1) 02/2015
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 .
2
Bicalutamide tablets USP, 150 mg daily are 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
dysfunction. Use bicalutamide with caution in patients
with hepatic impairment. (5.1)
Gynec