Pentasa

Pentasa

mesalazine

Manufacturer:

Ferring

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Mesalazine
Indications/Uses
PR tab: Ulcerative colitis & Crohn's disease. PR granules: Mild to moderate ulcerative colitis. Supp: Ulcerative proctitis. Rectal susp: Ulcerative proctosigmoiditis.
Dosage/Direction for Use
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. PR granules Ulcerative colitis Adult Active disease: Individual dosage, up to 4 g daily in divided doses. Supp Ulcerative proctitis 1 supp once-bd. Insert in the rectum until resistance is felt & disappeared again. The supp can be moistured w/ water or moisture cream to facilitate administration. Rectal susp Ulcerative proctosigmoiditis Adult 1 rectal susp at bedtime. Insert tip into rectum, maintain steady pressure & content should be applied w/in max 30-40 sec.
Administration
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.
Contraindications
Hypersensitivity to mesalazine or salicylates. Severe hepatic or renal impairment.
Special Precautions
Hypersensitivity to sulphasalazine. Assess ALT or AST prior to & during treatment. Discontinue if mesalazine-induced cardiac hypersensitivity reactions & serious blood dyscrasias occur. Hepatic impairment. Not recommended in patients w/ renal impairment. 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. Pregnancy & lactation. Childn (6-18 yr). PR tab & PR granules: Carefully monitor pulmonary disease particularly asthma.
Adverse Reactions
Headache; diarrhoea, abdominal pain, nausea, vomiting, flatulence; rash (including urticaria, erythematous rash). Rectal form: Anal discomfort & application site irritation, pruritus (anal), rectal tenesmus.
ATC Classification
A07EC02 - mesalazine ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.
Presentation/Packing
Form
Pentasa PR granules 2 g
Packing/Price
60's
Form
Pentasa supp 1 g
Packing/Price
28's
Form
Pentasa reactal susp 1 g
Packing/Price
7 × 1's
Form
Pentasa PR tab 500 mg
Packing/Price
100's
Form
Pentasa PR tab 1 g
Packing/Price
60's
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