Concise Prescribing Info
Contents
Bicalutamide
Indications/Uses
Advanced prostate cancer in combination w/ LHRH analogue therapy or surgical castration.
Dosage/Direction for Use
Adult male including the elderly 1 tab once a day. Start at least 3 days prior to LHRH analogue treatment, or at the same time as surgical castration.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Co-administration of terfenadine, astemizole or cisapride. Females. Childn.
Special Precautions
Moderate to severe hepatic impairment. Consider periodic liver function testing due to the possibility of hepatic changes. Discontinue if changes are severe. Co-administration w/ drugs metabolised predominantly by CYP3A4. Closely monitor prothrombin time in patients who are receiving coumarin anticoagulants.
Adverse Reactions
Breast tenderness, gynaecomastia, hot flushes; diarrhoea, nausea, hepatic changes (elevated levels of transaminases, jaundice), asthenia, pruritus.
Drug Interactions
Increased AUC w/ drugs w/ a narrow therapeutic index (eg, terfenadine, astemizole & cisapride, cyclosporin & Ca-channel blockers. Cimetidine, ketoconazole may inhibit drug oxidation.
ATC Classification
L02BB03 - bicalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.
Presentation/Packing
Form
Diproca FC tab 50 mg
Packing/Price
2 × 14's (Rp1,000,000/boks)
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