- Approval Id
- ccf87634aa454636
- Drug Name
- CASODEX TABLET 50 mg
- Product Name
- CASODEX TABLET 50 mg
- Approval Number
- SIN09772P
- Approval Date
- 1998-05-16
- Registrant
- ASTRAZENECA SINGAPORE PTE LTD
- Licence Holder
- ASTRAZENECA SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><strong>Adult males including the elderly:</strong> one tablet (50 mg) once a day. Treatment with CASODEX should be started at the same time as treatment with an LHRH analogue or surgical castration.</p>
<p><strong>Children:</strong> CASODEX is contraindicated in children.</p>
<p><strong>Renal impairment:</strong> No dosage adjustment is necessary for patients with renal impairment.</p>
<p><strong>Hepatic impairment:</strong> No dosage adjustment is necessary for patients with mild hepatic impairment. Increased accumulation may occur in patients with moderate to severe hepatic impairment (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Treatment of advanced prostate cancer in combination with luteinizing hormone-releasing hormone (LHRH) analogue therapy or surgical castration.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>CASODEX is contraindicated in females and children (see section 4.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>CASODEX must not be given to any patient who has shown a hypersensitivity reaction to the active substance or to any of the excipients of this product.</p>
<p>Co-administration of terfenadine, astemizole or cisapride with CASODEX is contraindicated.</p>
- Atc Code
- L02BB03
- Atc Item Name
- bicalutamide
- Pharma Manufacturer Name
- ASTRAZENECA SINGAPORE PTE LTD
