- Approval Id
- fda8802b67d8352e
- Drug Name
- PENTASA PROLONGED RELEASE GRANULES 2G/SACHET
- Product Name
- PENTASA PROLONGED RELEASE GRANULES 2G/SACHET
- Approval Number
- SIN14456P
- Approval Date
- 2013-12-10
- Registrant
- FERRING PHARMACEUTICALS PRIVATE LIMITED
- Licence Holder
- FERRING PHARMACEUTICALS PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- GRANULE, DELAYED RELEASE
- Dosage
- **POSOLOGY AND METHOD OF ADMINISTRATION**
**Posology:**
**Ulcerative colitis**
Treatment of active disease:
Adults: Individual dosage, up to 4 g given once daily or in divided doses.
Paediatric population:
There is only limited documentation for an effect in children (age 6–18 years).
**Method of administration:**
PENTASA® granules must not be chewed. The contents of the sachet should be emptied onto the tongue and washed down with some water or orange juice. Alternatively the entire content of the sachet can be taken with yogurt and consumed immediately.
- Route Of Administration
- ORAL
- Indication Info
- **THERAPEUTIC INDICATIONS**
Treatment of mild to moderate ulcerative colitis.
- Contraindications
- **CONTRAINDICATIONS**
Hypersensitivity to mesalazine, any of the excipients, or salicylates.
Severe liver or renal impairment.
- Atc Code
- A07EC02
- Atc Item Name
- mesalazine
- Pharma Manufacturer Name
- FERRING PHARMACEUTICALS PRIVATE LIMITED
- Company Detail Path
- /organization/ferring-pharmaceuticals-private-limited