البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
Bicalutamide (UNII: A0Z3NAU9DP) (Bicalutamide - UNII:A0Z3NAU9DP)
Golden State Medical Supply, Inc.
Bicalutamide
Bicalutamide 50 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
BICALUTAMIDE- BICALUTAMIDE TABLET, FILM COATED GOLDEN STATE MEDICAL SUPPLY, INC. ---------- 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 INDICATIONS AND USAGE 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 . Bicalutamide Tablets, USP 150 mg daily are not approved for use alone or with other treatments. (1) DOSAGE AND ADMINISTRATION The recommended dose for Bicalutamide Tablets, USP 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 Tablets, USP, 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, USP with caution in patients with hepatic impairment. (5.1) Gynecomastia and breast pain have been reported during treatment with Bicalutamide Tablets, USP 150 mg when used as a single agent. (5.2) Bicalutamide Tablets, USP are 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 Tablets, USP 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 اقرأ الوثيقة كاملة