Casomide

Company: Clonmel Healthcare Ltd.
Legal category: Prescription. HT. Sport permitted.
Active ingredient: Bicalutamide 50mg.
Description: White round biconvex film-coated tablet.
Presentation: 28, price available on request.
Indications: Advanced prostate cancer: In combination with LHRH analogue therapy or surgical castration. Locally advanced prostate cancer: Alone or as adjuvant therapy to radical prostactectomy or radiotherapy in patients at high risk for disease progression.

Pharmacology: Bicalutamide is a non-steroidal antiandrogen, devoid of other endocrine activity. It induces regression of prostate cancer by blocking the activity of androgens at receptor level.
Dosage: Adult: Advanced prostate cancer: 50mg, once daily. Start treatment at least 3 days before commencing treatment with LHRH analogue or at the same time as surgical castration. Locally advanced prostate cancer: 150mg once daily, continuously for at least 2 years or until disease progression. Elderly: As per adults.
Contraindications: Females and children. Hypersensitivity to bicalutamide or to any of the excipients. History of hepatic toxicity associated with bicalutamide.
Special precautions: Caution: Hepatic impairment, severe renal impairment (cc < 30ml/min). Hepatic damage may occur, discontinue if severe; monitor liver function periodically especially in the first 6 months. Monitor cardiac function in heart disease patients. Contains lactose.
Drug interactions: Contraindicated: Terfenadine, astemizole, cisapride. Caution: Ciclosporin, Ca++ channel blockers, medicinal products that inhibit the oxidation process in the liver (e.g. cimetidine, ketoconazole), coumarin anticoagulants (monitor prothrombin time).
Adverse drug reactions: Breast tenderness, gynaecomastia, GI disorders, hepatic changes (elevated transaminase levels, bilirubinemia, hepatomegaly, cholestasis and jaundice), hot flushes, asthenia, pruritus, dry skin, rash, maculopapular rash, sweating, hirsutism, alopecia, diabetes mellitus, weight gain, anaemia, dizziness, somnolence, oedema (face, extremities, trunk), general pain, pelvic pain, chills, decreased libido, erectile dysfunction, impotence.
Full prescribing information and references available from Clonmel Healthcare Ltd. Telephone (052) 77777. Fax: (052) 77791. E-mail: medicalinformation@clonmel-health.ie