Abbreviated Prescribing Information of PENTASA – All Formulations
Indications
PR granules Mild to moderate ulcerative colitis. PR tab Ulcerative colitis & Crohn’s disease. Supp Ulcerative proctitis. Rectal susp Ulcerative proctosigmoiditis.
Dosage & Administration
PR granules Ulcerative colitis Adult Active disease: Individual dosage, up to 4 g once daily or in divided doses. PR tab Ulcerative colitis Adult Active disease: Individual dosage, up to 4 g daily in divided doses. Maintenance treatment: Individual dosage, usually 2 g daily in divided doses. Childn ≥6 yr Active disease/maintenance treatment: Individual dosage, usually 20-30 mg/kg daily in divided doses. Crohn’s disease Active disease/maintenance treatment: Adult Individual dosage, up to 4 g daily in divided doses. Childn ≥6 yr 20-30 mg/kg daily in divided doses. Supp Ulcerative proctitis 1 supp once daily or twice daily. Rectal susp Ulcerative proctosigmoiditis Adult 1 rectal suspension at bedtime.
Contra-indications
Hypersensitivity to mesalazine, any of the excipients, or salicylates; Severe liver or renal impairment.
Special Warning or Precautions
Caution in patients allergic to sulphasalazine (risk of allergy to salicylates). Severe cutaneous adverse reactions (SCARS), including Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment; Assess ALT/AST prior to & during treatment in patients with impaired liver function; Drug is not recommended for use in patients with renal impairment. Monitor renal function regularly during initial treatment, increase monitoring if concurrent use with other nephrotoxic agents; Consider mesalazine induced nephrotoxicity in patients developing renal dysfunction during treatment; Patients with inflammatory bowel disease are at risk of developing nephrolithiasis; Mesalazine-induced cardiac hypersensitivity reactions (myo- and pericarditis); Serious blood dyscrasias; Blood test for differential blood count recommended prior to & during treatment; Increased risk of blood dyscrasia with concurrent azathioprine, or 6-mercaptopurine or thioguanine treatment; Pregnancy and lactation; Monitor patients with pulmonary disease (esp. asthma).
Undesirable Effects
The most frequent adverse reactions seen in clinical trials are diarrhoea, nausea, abdominal pain, headache, vomiting, flatulence and rash (including urticaria, erythematous rash). Local reactions of pruritus, rectal discomfort, irritation and urge are reported with rectal administration. Hypersensitivity reactions and drug fever may occasionally occur and severe cutaneous adverse reactions, including DRESS, SJS and TEN, have been reported in association with mesalazine treatment.
Full prescribing information is available upon request.
* PR tab – Prolonged Release Tablets, PR granules – Prolonged Release Granules, Supp – Suppositories, Rectal susp- Rectal Suspension/Enema