Casodex Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Bicalutamide

Indications/Uses

50 mg: Advanced prostate cancer in combination w/ LH-releasing hormone (LHRH) analogue therapy or surgical castration. 150 mg: Monotherapy or as adjunct to radical prostatectomy or RT in patients w/ locally advanced prostate cancer at high risk for disease progression. Management of patients w/ locally advanced, non-metastatic prostate cancer for whom surgical castration or other medical intervention is not appropriate or acceptable.

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Dosage/Direction for Use

Adult male including elderly 50 mg: 1 FC tab once daily, should be started at the same time as treatment w/ an LHRH analogue or surgical castration. 150 mg: 1 FC tab once daily, should be taken continuously for at least 2 yr or until disease progression.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Co-administration w/ terfenadine, astemizole or cisapride. Females. Pregnancy & lactation. Childn.

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Special Precautions

Consider periodic liver function testing due to the possibility of hepatic changes. Discontinue use if severe hepatic changes & hepatic failure are observed. Co-administration w/ drugs metabolised predominantly by CYP3A4. Patients w/ history of or w/ QT prolongation risk factors & those concomitantly receiving medicinal products that may prolong QT interval. Patients &/or their partners should follow adequate contraception during & for 130 days after therapy. Contains lactose monohydrate. Concomitant therapy w/ coumarin. Moderate to severe hepatic impairment. 50 mg: Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Occasional somnolence may impair ability to drive or operate machinery. 150 mg: Consider cessation of therapy in patients w/ objective disease progression together w/ elevated PSA. Avoid direct exposure to excessive sunlight or UV light.

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Use In Pregnancy & Lactation

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Adverse Reactions

Anaemia; dizziness; hot flush; abdominal pain, constipation, nausea; haematuria; breast tenderness, gynaecomastia; asthenia, oedema. Decreased appetite; decreased libido, depression; somnolence; dyspepsia, flatulence; hepatotoxicity, jaundice, hypertransaminasaemia; alopecia, hirsutism, rash, dry skin, pruritus; erectile dysfunction; chest pain; increased wt. 50 mg: Diarrhoea; MI, cardiac failure.

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Drug Interactions

Increased AUC of midazolam. Contraindicated w/ terfenadine, astemizole & cisapride. Co-administration w/ ciclosporin & Ca channel blockers. Possible increased plasma conc w/ cimetidine & ketoconazole. May displace warfarin from its protein binding sites. Possible increased effect of warfarin & other coumarin anticoagulants. Carefully evaluate concomitant use w/ drugs known to prolong QT interval or able to induce Torsade de Pointes.

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Cancer Hormone Therapy

ATC Classification

L02BB03 - bicalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.

Regulatory Classification

POM

Presentation/Packing

Form

Casodex FC tab 150 mg

Packing/Price

28's

Form

Casodex FC tab 50 mg

Packing/Price

28's

Casodex

bicalutamide

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma