- Approval Id
- 8d296f505138c18e
- Drug Name
- XATRAL SR TABLET 5 mg
- Product Name
- XATRAL SR TABLET 5 mg
- Approval Number
- SIN09546P
- Approval Date
- 1997-11-21
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, EXTENDED RELEASE
- Dosage
- **Dosage and method of administration**
Oral use.
The tablet must be swallowed whole with a glass of water
_(see Special warnings and special precautions for use_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)._
_Adults_
One XATRAL SR 5 mg tablet morning and evening.
_In elderly patients or patients treated for hypertension:_ as a systematic precaution, it is recommended that treatment be started with one XATRAL SR 5 mg tablet in the evening and that the dosage then be increased on the basis of the patient’s individual response, without exceeding the maximum dosage of one XATRAL SR 5 mg tablet morning and evening.
_Patients with impaired liver function:_ it is recommended that treatment be started with one XATRAL 2.5 mg tablet per day and that the dosage then be increased on the basis of the patient’s individual response, without exceeding one XATRAL 2.5 mg tablet twice daily.
- Route Of Administration
- ORAL
- Indication Info
- **Therapeutic indications**
Treatment of functional symptoms of benign prostatic hyperplasia.
- Contraindications
- **Contraindications**
This medicinal product must not be administered in the following situations:
- hypersensitivity to alfuzosin and/or any of the other ingredients;
- postural hypotension;
- severe liver failure (class C in the Child-Pugh classification);
- severe kidney failure (creatinine clearance <30 ml/min),
- in combination with ritonavir
- concomitant administration with potent CYP3A4 inhibitors
- Atc Code
- G04CA01
- Atc Item Name
- alfuzosin
- Pharma Manufacturer Name
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/sanofi-aventis-singapore-pte-ltd
