Pentasa

Mesalazine

PR tab: Ulcerative colitis & Crohn's disease. PR granules: Mild to moderate ulcerative colitis. Supp: Ulcerative proctitis. Rectal susp: Ulcerative proctosigmoiditis.

PR tab Ulcerative colitis Adult Active disease: Individual dosage, up to 4 g in divided doses. Maintenance: Individual dosage, usually 2 g daily in divided doses. Childn ≥6 yr Active disease/maintenance: Individual dosage, usually 20-30 mg/kg daily in divided doses. Crohn's disease Active disease/maintenance: Adult Individual dosage, up to 4 g daily in divided doses. Childn ≥6 yr Individual dosage, 20-30 mg/kg daily in divided doses. PR granules Ulcerative colitis Adult Active disease: Individual dosage, up to 4 g once daily or in divided doses. Supp Ulcerative proctitis 1 supp once-bd. Insert in the rectum until resistance is felt & disappeared again. Supp can be moistured w/ water or moisture cream to facilitate administration. If supp is discharged w/in 1st 10 min, another can be inserted. Rectal susp Ulcerative proctosigmoiditis Adult 1 rectal susp at bedtime. Insert tip into rectum, maintain steady hand pressure & content should be applied w/in max 30-40 sec. Remain relaxed in the administration position for 5-10 min or until the urge to pass the rectal susp has disappeared, try to retain the rectal susp overnight.

May be taken with or without food: Empty contents of sachet onto the tongue & wash down w/ some water/orange juice. Do not chew granules.

Hypersensitivity to mesalazine or salicylates. Severe liver &/or renal impairment.

Hypersensitivity to sulphasalazine (risk of allergy to salicylates). Possible severe cutaneous AR (SCARs) including DRESS, SJS & TEN. Immediately discontinue therapy in case of acute intolerance reactions eg, abdominal cramps, acute abdominal pain, fever, severe headache &/or 1st appearance of signs & symptoms of severe skin reactions (eg, rash, mucosal lesions, or any other hypersensitivity signs). Assess ALT or AST prior to & during treatment. Regularly monitor renal function especially during initial phase of treatment. Consider mesalazine-induced nephrotoxicity in patients developing renal dysfunction during treatment. Concurrent use w/ other nephrotoxic agents. Carefully monitor patients w/ pulmonary disease particularly asthma. Concomitant treatment w/ azathioprine or 6-mercaptopurine or thioguanine. Discontinue use if mesalazine-induced cardiac hypersensitivity reactions (myo- & pericarditis) &/or serious blood dyscrasias occur. Patients w/ inflammatory bowel disease are at risk of developing nephrolithiasis. Ensure adequate fluid intake during treatment. Follow-up tests are recommended 14 days after treatment commencement then a further 2-3 tests at 4-wk intervals; follow-up tests should be carried out every 3 mth if findings are normal; immediately perform these tests if additional symptoms occur. May produce red-brown urine discoloration after contact w/ Na hypochlorite bleach (eg, in toilets cleaned w/ Na hypochlorite contained in certain bleaches). Patients w/ impaired liver function. Not recommended in patients w/ renal impairment. Pregnancy & lactation. Childn (6-18 yr).

Headache; diarrhoea, abdominal pain, nausea, vomiting, flatulence; rash (including urticaria, erythematous rash). SCARs including DRESS, SJS & TEN. Rectal form: Anal discomfort & application site irritation, anal pruritus, rectal tenesmus.

Possible higher frequency of myelosuppressive effects in combination w/ azathioprine, 6-mercaptopurine or thioguanine. Regularly monitor WBC & adjust dosage regimen of thiopurines accordingly.

GIT Regulators, Antiflatulents & Anti-Inflammatories

A07EC02 - mesalazine ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.

POM