Pentasa Prolonged Release Tablets

/ Ferring Pharmaceuticals

Ulcerative Colitis
Adults: Active treatment: Individual dosage, up to 4 g mesalazine once daily or in two or three divided doses.
Maintenance treatment: Recommended dosage, 2 g mesalazine once daily.
Crohn’s Disease
Adults: Active treatment: Individual dosage, up to 4 g mesalazine daily in two or three divided doses.
Maintenance treatment: Individual dosage, up to 4 g mesalazine daily in two or three divided doses.
Paediatric population
The safety and efficacy in children below 6 years have not been established. There is only limited documentation for an effect in children (age 6-18 years)
Ulcerative colitis
Children 6 years of age and older: Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose). It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
Crohn’s disease
Treatment of active disease: Children 6 years of age and older: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
Maintenance treatment: Children 6 years of age and older: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 4g/day (recommended adult dose).
It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
Method of Administration: Pentasa® Tablets or Granules must not be chewed. To facilitate swallowing the tablets may be dispersed in 50ml of cold water. Stir and drink immediately. The contents of the sachet should be emptied onto the tongue and washed down with some water or juice.

Crohn’s disease, ulcerating colitis.

Hypersensitivity to mesalazine, any other component of the product or salicylates. Severe liver and/or renal impairment.

Patients allergic to sulphasalazine (risk of allergy to salicylates).

N/A

Aspirin, diphenhydramine, probenicid, isoniazide, rifamipicin.