Pentasa

Pentasa

mesalazine

Manufacturer:

Ferring

Distributor:

Metro Drug
Concise Prescribing Info
Contents
Mesalazine
Indications/Uses
Tab/PR granules: Mild to moderate ulcerative colitis & Crohn's disease. Supp: Acute attacks of mild to moderate acute ulcerative proctitis. Maintenance of remission of ulcerative proctitis.
Dosage/Direction for Use
Tab Ulcerative colitis Adult Up to 4 g daily in divided doses. Maintenance: Up to 2 g daily in divided doses. Childn 20-30 mg/kg daily, ≥6 yr Initially 30-50 mg/kg/day in divided doses, max: 75 mg/kg/day in divided doses. Max total dose: 4 g/day. Maintenance: Initially 15-30 mg/kg/day in divided doses. Max total dose: 2 g/day. Crohn's disease Adult Up to 4 g daily in divided doses. Childn 20-30 mg/kg daily in divided doses, ≥6 yr Initially 30-50 mg/kg/day in divided doses, max: 75 mg/kg/day in divided doses. Max total dose: 4 g/day. Maintenance: Initially 15-30 mg/kg/day in divided doses. Max total dose: 4 g/day. PR granules Ulcerative colitis Adult Active disease: Individual dosage up to 4 g once daily or divided into 2-4 doses. Maintenance: 2 g once daily. Childn ≥6 yr Active disease: Initially 30-50 mg/kg/day in divided doses. Max: 75 mg/kg/day in divided doses. Do not exceed 4 g/day. Maintenance: Initially 15-30 mg/kg/day in divided doses. Do not exceed 2 g/day. Childn up to 40 kg ½ of the adult dose, >40 kg Normal adult dose. Crohn's disease Childn ≥6 yr Active disease: 30-50 mg/kg/day in divided doses. Max: 75 mg/kg/day in divided doses. Maintenance: 15-30 mg/kg/day in divided doses. Do not exceed 4 g/day total dose. Supp Ulcerative proctitis 1 supp once-bid.
Administration
May be taken with or without food: Tab: Swallow whole, do not chew/crush. If necessary, tab may also be halved along score-line or suspended in water/juice immediately before use. PR granules: Contents of sachet should be emptied on to the tongue & wash down w/ water/orange juice. Alternatively, can be taken with yogurt & consume immediately. Do not chew.
Contraindications
Hypersensitivity to mesalazine or salicylates. Severe liver or renal impairment.
Special Precautions
Patients allergic to sulphasalazine. Assess liver function parameters eg, ALT or AST & perform blood test for differential blood count prior to & during treatment. Regularly monitor renal function (eg, serum creatinine) especially during initial phase of treatment. Patients w/ pulmonary disease particularly asthma. Discontinue if hematological effects, inflammation of cardiac muscle, blood dyscrasias occur. Not recommended in patients w/ renal impairment. Impaired liver function. Pregnancy & lactation.
Adverse Reactions
Gastric discomfort (nausea & frequent urge to defecate), headache, rash, urticaria, eczema, hypersensitivity reactions. PR granules: Diarrhoea, abdominal pain, vomiting, flatulence. Supp: Anal discomfort & irritation at the application site, pruritus, rectal tenesmus.
Drug Interactions
May increase the risk of blood dyscrasia w/ azathioprine or 6-mercaptopurine or thioguanine.
MIMS Class
GIT Regulators, Antiflatulents & Anti-Inflammatories
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 × 1's
Form
Pentasa PR tab 1 g
Packing/Price
60's
Form
Pentasa PR tab 500 mg
Packing/Price
100's
Form
Pentasa supp 1 g
Packing/Price
28's
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