Indications/Uses
Listed in Dosage.
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Dosage/Direction for Use
Adult: PO Palliation of advanced prostate cancer 50 mg once daily, w/ gonadotropin-releasing hormone (GnRH) agonist or surgical castration. Monotherapy or adjuvant therapy to surgery or radiotherapy in locally advanced prostatic cancer 150 mg once daily.
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Administration
May be taken with or without food.
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Contraindications
Females, childn. Pregnancy and lactation. Concomitant use of terfenadine, astemizole or cisapride.
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Special Precautions
Patient w/ decreased bone density, history of or risk factors for QT prolongation, diabetes, Moderate to severe hepatic and severe renal impairment (CrCl <30 mL/min). Patient CounsellingThis drug may cause somnolence, if affected, do not drive or operate machinery. Monitoring Parameters Perform LFT at baseline and regularly (particularly during the 1st 6 mth of therapy), then periodically thereafter. Monitor CBC, ECG, echocardiograms, serum testosterones, LH and serum prostate specific antigen.
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Adverse Reactions
Anaemia; angioedema, urticaria; decreased appetite, DM, wt gain, dehydration, gout; decreased libido, depression, anxiety, hypertonia, confusion, neuropathy, nervousness, dizziness, somnolence; hot flush; abdominal pain, constipation, nausea, dyspepsia, flatulence, anorexia, rectal haemorrhage, dry mouth, melaena; hepatotoxicity, jaundice, hypertransaminasaemia; alopecia, hirsutism, dry skin, pruritus/rash, photosensitivity; haematuria, dysuria, urinary retention, impaired urination, urinary frequency; gynaecomastia, breast tenderness, erectile dysfunction; asthenia, oedema, chest pain, neck pain, fever, sepsis, chills, neoplasm; cough, pharyngitis, bronchitis, pneumonia, rhinitis.
Potentially Fatal: MI, cardiac failure, QT prolongation, interstitial lung disease, hepatic failure. |
Drug Interactions
May induce torsade de pointes or QT prolongation if co-administered w/ class IA (e.g. quinidine) or class III (e.g. amiodarone) antiarrhythmic agents, methadone, antipsychotics, moxifloxacin. Enhanced anticoagulant effect of warfarin. Increased adverse effects when used w/ drugs that may inhibit oxidation (e.g. cimetidine, ketoconazole). May increase serum levels of ciclosporin and Ca channel blockers.
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CIMS Class
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ATC Classification
L02BB03 - bicalutamide ; Belongs to the class of anti-androgens.
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