Calubia

Calubia

bicalutamide

Manufacturer:

Salutas

Distributor:

Cathay Drug

Marketer:

Sandoz
Concise Prescribing Info
Contents
Bicalutamide
Indications/Uses
Advanced prostate cancer in combination w/ luteinizing hormone-releasing hormone (LHRH) analogue therapy or surgical castration. Monotherapy or as adjuvant to radical prostatectomy or radiotherapy in patients w/ locally advanced prostate cancer at high risk for disease progression.
Dosage/Direction for Use
Adult including elderly 50 mg once daily either 3 days before or at the same time w/ LHRH analogue or surgical castration. Monotherapy 150 mg once daily taken continuously for at least 2 yr or until progression.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Terfenadine, astemizole or cisapride. Females. Childn.
Special Precautions
May prolong the QT interval. Reduced glucose tolerance. Somnolence may occur. Co-administration w/ CYP3A4, coumarin anticoagulants. Patients w/ moderate to severe hepatic impairment.
Drug Interactions
Closely monitor w/ ciclosporin. Other medicinal products inhibiting drug oxidation eg, cimetidine & ketoconazole. Increased effect of warfarin & other coumarin anticoagulants. May induce torsade de pointes eg, class IA (quinidine, disopyramide) or class III (amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic products, methadone, moxifloxacin, antipsychotics.
MIMS Class
Cancer Hormone Therapy
ATC Classification
L02BB03 - bicalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.
Presentation/Packing
Form
Calubia FC tab 50 mg
Packing/Price
30's (P4,670.4/box)
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