Synthon Hispania


Macropharma Corp
Concise Prescribing Info
Treatment of advanced prostate cancer in combination w/ LHRH analogue therapy or surgical castration.
Dosage/Direction for Use
Adult male including older people 1 tab (50 mg) once daily. Start treatment at least 3 days before commencing treatment w/ an LHRH analogue or at the same time as surgical castration.
May be taken with or without food.
Hypersensitivity. Co-administration w/ terfenadine, astemizole or cisapride. Females & childn.
Special Precautions
Caution when co-administered w/ drugs metabolized predominantly by CYP3A4. Diabetes or loss of glycaemic control in pre-existing diabetes. Monitoring blood glucose when in combination w/ LHRH agonists. May prolong QT interval. Patients w/ history of or risk factors for QT prolongation & those in concomitant w/ drugs that might prolong the QT interval. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Periodic liver function testing in patients w/ moderate to severe hepatic impairment. Discontinue severe hepatic changes and hepatic failure.
Adverse Reactions
Anaemia; dizziness; hot flush; abdominal pain, constipation, nausea; haematuria; gynaecomastia & breast tenderness; asthenia, oedema; decreased appetite; decreased libido, depression; somnolence; MI, cardiac failure; dyspepsia, flatulence; hepatotoxicity, jaundice, hypertransaminasaemia; alopecia, hirsutism/hair re-growth, dry skin, pruritus, rash; erectile dysfunction; chest pain; wt increased.
Drug Interactions
Increases of mean midazolam exposure AUC. Contraindicated in concomitant w/ terfenadine, astemizole & cisapride. Caution in co-administration w/ ciclosporin & Ca channel blockers. Increased side effects w/ drugs which may inhibit drug oxidation eg, cimetidine & ketoconazole. May displace coumarin anticoagulant, warfarin from protein binding sites.
ATC Classification
L02BB03 - bicalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.
Prosmide FC tab 50 mg
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