Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
BICALUTAMIDE (UNII: A0Z3NAU9DP) (BICALUTAMIDE - UNII:A0Z3NAU9DP)
Bryant Ranch Prepack
BICALUTAMIDE
BICALUTAMIDE 50 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
BICALUTAMIDE- BICALUTAMIDE TABLET BRYANT RANCH PREPACK ---------- 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 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 prostate. Bicalutamide tablets 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 an 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 Baca dokumen lengkapnya