- Approval Id
- 1a0836db9957802f
- Drug Name
- PENTASA PROLONGED RELEASE TABLETS 1G
- Product Name
- PENTASA PROLONGED RELEASE TABLETS 1G
- Approval Number
- SIN14479P
- Approval Date
- 2014-01-09
- Registrant
- FERRING PHARMACEUTICALS PRIVATE LIMITED
- Licence Holder
- FERRING PHARMACEUTICALS PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET
- Dosage
- <p><strong>POSOLOGY AND METHOD OF ADMINISTRATION</strong><br>
Posology:<br>
<strong>Ulcerative colitis</strong><br>
Treatment of active disease:<br>
Adults: Individual dosage, up to 4 g daily in divided doses.<br>
Children 6 years of age and older: Individual dosage, usually 20–30 mg/kg bodyweight daily in divided doses.</p>
<p>Maintenance treatment:<br>
Adults: Individual dosage, usually 2 g daily in divided doses.<br>
Children 6 years of age and older: Individual dosage, usually 20–30 mg/kg bodyweight daily in divided doses.</p>
<p><strong>Crohn’s disease</strong><br>
Treatment of active disease and maintenance treatment:<br>
Adults: Individual dosage, up to 4g daily in divided doses.<br>
Children 6 years of age and older: Individual dosage, usually 20–30 mg/kg bodyweight daily in divided doses.</p>
<p>Paediatric population:<br>
There is only limited documentation for an effect in children (age 6–18 years).</p>
<p>Method of administration:<br>
PENTASA® tablets must not be chewed. To facilitate swallowing, the tablets may be dispersed in 50 ml of cold water. Stir and drink immediately.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>THERAPEUTIC INDICATIONS</strong><br>
Treatment of ulcerative colitis and Crohn’s disease.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
Hypersensitivity to mesalazine, any of the excipients, or salicylates.<br>
Severe liver or renal impairment.</p>
- Atc Code
- A07EC02
- Atc Item Name
- mesalazine
- Pharma Manufacturer Name
- FERRING PHARMACEUTICALS PRIVATE LIMITED
