- Approval Id
- 166bf6e1a0c9b558
- Drug Name
- CASODEX TABLET 150 mg
- Product Name
- CASODEX TABLET 150 mg
- Approval Number
- SIN11344P
- Approval Date
- 2000-07-08
- Registrant
- ASTRAZENECA SINGAPORE PTE LTD
- Licence Holder
- ASTRAZENECA SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **4.2 Posology and method of administration**
**Adult males including the elderly:** The dosage is one 150 mg tablet to be taken orally once a day.
CASODEX 150 mg should be taken continuously for at least 2 years or until disease progression.
**Renal Impairment:** No dosage adjustment is necessary for patients with renal impairment.
**Hepatic Impairment:** 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Therapeutic indications**
CASODEX 150 mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostrate cancer at high risk for disease progression (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
CASODEX 150 mg is also indicated for the management of patients with locally advanced, non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable.
- Contraindications
- **4.3 Contraindications**
CASODEX 150 mg is contraindicated in females and children (see section 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
CASODEX 150 mg must not be given to any patient who has shown a hypersensitivity to the active substance or to any of the excipients of this product.
Co-administration of terfenadine, astemizole or cisapride with Casodex is contraindicated (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Atc Code
- L02BB03
- Atc Item Name
- bicalutamide
- Pharma Manufacturer Name
- ASTRAZENECA SINGAPORE PTE LTD
- Company Detail Path
- /organization/astrazeneca-singapore-pte-ltd
