Pentasa

Pentasa

mesalazine

Manufacturer:

Ferring

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Mesalazine
Indications/Uses
Tab/Sachet Mild to moderate ulcerative colitis & Crohn's disease. Enema Proctosigmoiditis & left-sided colitis. Supp Ulcerative proctitis.
Dosage/Direction for Use
Tab/Sachet Ulcerative colitis Adult Up to 4 g once daily, or in divided doses. Maintenance dose: 2 g once daily, or in divided doses. Childn ≥6 yr Initially w/ 30-50 mg/kg/day in divided doses. Max: 75 mg/kg/day in divided doses. Total dose should not exceed 4 g/day. Maintenance: Initially 15-30 mg/kg/day in divided doses. Total dose not to exceed 2 g/day. Crohn's disease Adult Active disease & maintenance dose: Up to 4 g daily in divided doses. Childn ≥6 yr Initially 30-50 mg/kg/day in divided doses. Max: 75 mg/kg/day in divided doses. Total dose should not exceed 4 g/day. Enema Adult 1 enema at bedtime. Supp Adult 1 supp once daily or bid.
Administration
May be taken with or without food: Tab: Swallow whole, do not chew/crush. If necessary, tab may also be halved along the score-line or dispersed in 50 mL cold water. Stir and drink immediately. Sachet: Empty contents onto the tongue immediately after opening. Wash down all the granules w/ water or juice so that none remain in the mouth. Do not chew the granules.
Contraindications
Hypersensitivity to mesalazine or salicylates. Severe renal or hepatic impairment.
Special Precautions
Patients allergic to sulphasalazine. Discontinue treatment if abdominal cramps, acute abdominal pain, fever, severe headache & rash; blood dyscrasias occurs. Assess liver function parameters ie, ALT or AST prior to, & during treatment. Regularly monitor renal function eg, serum creatinine especially during the initial phase of treatment & in concurrent use of other known nephrotoxic agents. Determine urinary status prior to, & during treatment. Carefully monitor patients w/ pulmonary disease especially those w/ asthma. Perform blood test for differential blood count prior to, & during treatment; follow-up tests 14 days after commencement of treatment, then a further 2-3 tests at intervals of 4 wk, & every 3 mth thereafter. Pregnancy & lactation.
Adverse Reactions
Headache; diarrhoea, abdominal pain, nausea, vomiting, flatulence; rash (including urticaria, erythematous rash). Enema/supp: Anal discomfort & irritation at the application site, anal pruritus, rectal tenesmus.
Drug Interactions
Concomitant use w/ azathioprine or 6-mercaptopurine or thioguanine may produce myelosuppressive effects. May decrease anticoagulant effect of warfarin.
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 1 g
Packing/Price
50 × 1's
Form
Pentasa enema 1 g/100 mL
Packing/Price
7 × 1's
Form
Pentasa PR granules 2 g
Packing/Price
60 × 1's
Form
Pentasa SR tab 500 mg
Packing/Price
10 × 10's
Form
Pentasa supp 1 g
Packing/Price
4 × 7's
Form
Pentasa PR tab 1 g
Packing/Price
6 × 10's
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