Bicadex

Bicadex

bicalutamide

Manufacturer:

Sandoz

Distributor:

Zuellig
Concise Prescribing Info
Contents
Bicalutamide
Indications/Uses
Monotherapy in patients w/ locally advanced, non-metastatic prostate cancer.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Co-administration w/ terfenadine, astemizole or cisapride. Females & childn.
Special Precautions
Moderate to severe hepatic impairment; preexisting diabetes. Periodic liver function test & monitor blood glucose. Co-administration w/ drugs metabolized predominantly by CYP3A4. Patients w/ a history of/or risk factors for QT prolongation. Patients receiving medicinal products that might prolong the QT interval. May impair ability to drive or operate machinery.
Adverse Reactions
Anemia, anorexia, decreased libido, depression, dizziness somnolence, hot flush, abdominal pain, constipation, dyspepsia, flatulence, nausea, hepatic changes (including elevated levels of transaminases, jaundice), hepatobiliary disorders, rash, alopecia, hirsutism/hair regrowth, dry skin, pruritus, hematuria, gynecomastia, breast tenderness, impotence, asthenia, chest pain, edema, wt gain, interstitial lung disease.
Drug Interactions
Midazolam, terfenadine, astemizole, cisapride, cyclosporin, Ca-channel blockers, drugs which may inhibit drug oxidation eg, cimetidine & ketoconazole; coumarin anticoagulant, warfarin, medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes eg, class IA (eg, quinidine, disopyramide) or class III (eg, amiodarone, sotalol, dofetilide, ibutilide), antiarrhythmic medicinal 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
Bicadex film-coated tab 50 mg
Packing/Price
30's (P4,200/pack)
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