Zuellig Pharma
Concise Prescribing Info
50-mg FC tab: Advanced prostate cancer in combination w/ LH-releasing hormone analogue therapy or surgical castration. 150-mg FC tab: Monotherapy or as adjunct to radical prostatectomy or radiotherapy in patients w/ locally advanced prostate cancer at high risk for disease progression. Management of patients w/ locally advanced, non-metastatic prostate cancer where surgical castration or other medical intervention is not appropriate or acceptable.
Dosage/Direction for Use
Adult male including elderly 50-mg FC tab 1 tab once daily, treatment should be started at the same time as treatment w/ an LHRH analogue or surgical castration. 150-mg FC tab 1 tab once daily, should be taken continuously for at least 2 yr or until disease progression.
May be taken with or without food.
Hypersensitivity. Co-administration w/ terfenadine, astemizole or cisapride. Females. Pregnancy & lactation. Childn.
Special Precautions
Consider periodic liver function testing due to the possibility of hepatic changes. Discontinue use if severe hepatic changes & hepatic failure have been observed. Co-administration w/ drugs metabolised predominantly by CYP3A4. Patients should follow adequate contraception during & for 130 days after therapy. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Moderate to severe hepatic impairment. 50-mg FC tab: Occasional somnolence may impair the ability to drive or operate machinery. 150-mg FC tab: Consider cessation of therapy in patients w/ objective progression of disease together w/ elevated PSA. Avoid direct exposure to excessive sunlight or UV light.
Adverse Reactions
Anaemia; dizziness; hot flush; abdominal pain, constipation, nausea; breast tenderness, gynaecomastia; asthenia, oedema; decreased appetite; haematuria; decreased libido, depression; somnolence; dyspepsia, flatulence; hepatotoxicity, jaundice, hypertransaminasaemia; alopecia, hirsutism, rash, dry skin, pruritus; erectile dysfunction; chest pain; increased wt; decreased appetite; somnolence. 50-mg FC tab: Diarrhoea; MI, cardiac failure.
Drug Interactions
Increased AUC of midazolam. Contraindicated w/ terfenadine, astemizole & cisapride. Caution w/ ciclosporin & Ca channel blockers. Increased plasma conc w/ cimetidine & ketoconazole. May displace warfarin from its protein binding sites. Drugs known to prolong QT interval.
ATC Classification
L02BB03 - bicalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.
Casodex FC tab 50 mg
Casodex FC tab 150 mg
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