BICALUTAMIDE tablet film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Mylan Pharmaceuticals Inc.

INN (Nome Internazionale):

Bicalutamide

Composizione:

Bicalutamide 50 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

BICALUTAMIDE- BICALUTAMIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS 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
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
The recommended dose for bicalutamide tablets 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 tablets 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 MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) 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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Bicalutamide tablets 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
prostate. (1)
2
Bicalutamide tablets 150 mg daily are not approved for use alone or
with other treatments. (1)
Hypersensitivity (4)
Women (4)
Pregnancy (4 and 8.1)
Severe hepatic injury and fatal hepatic failure have been observed.
Monitor serum transaminase levels prior to
starting treatment with bicalutamide tablets, 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 with caution in
patients with hepatic impairment. (5.1)
Gynecomastia and breast pain have been reported during treatmen