Pentasa Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Mesalazine

Indications/Uses

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

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Dosage/Direction for Use

PR tab/PR granules Ulcerative colitis Adult Up to 4 g once daily or in divided doses. Maintenance: 1.5-2 g PR tab or 2 g PR granules once daily or in divided doses. Childn ≥6 yr Initially 30-50 mg/kg daily in divided doses. Max: 75 mg/kg daily in divided doses. Total dose: 4 g daily. Maintenance: Initially 15-30 mg/kg daily in divided doses. Total dose: 2 g daily. Crohn's disease Adult Up to 4 g daily in divided doses. Maintenance: Up to 4 g daily in divided doses. Childn ≥6 yr Initially 30-50 mg/kg daily in divided doses. Max: 75 mg/kg daily in divided doses. Total dose: 4 g daily. Maintenance: Initially 15-30 mg/kg daily in divided doses. Total dose: 4 g daily. Supp Adult 1 supp once-bd. Enema Adult 1 enema at bedtime.

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Overdosage

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Administration

May be taken with or without food: PR tab: Do not chew. May be dispersed in 50 mL cold water to facilitate swallowing. Stir & drink immediately. PR granules: Empty contents onto the tongue & wash w/ some water/juice or yoghurt & consume immediately. Do not chew.

Contraindications

Hypersensitivity to mesalazine or salicylates. Severe hepatic or renal impairment.

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Special Precautions

Hypersensitivity to sulphasalazine. Discontinue use if acute intolerance reactions occur. Pulmonary disease, asthma, inflammatory bowel disease. Increased risk of blood dyscrasia in patients receiving azathioprine, 6-mercaptopurine or thioguanine. Mesalazine-induced cardiac hypersensitivity reactions (myo- & pericarditis). Assess liver function parameters ie, ALT/AST, determine urinary status & perform differential blood count prior to & during treatment. Ensure adequate fluid intake during treatment. Regularly monitor renal function during initial phase of treatment. Concurrent use of other known nephrotoxic agents. Not recommended in renal impairment. Hepatic impairment. Pregnancy & lactation. Supp/enema: Childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headache; diarrhoea, abdominal pain, nausea, vomiting, flatulence; rash including urticaria, erythematous rash. Supp/enema: Anal discomfort & irritation at application site, anal pruritis, rectal tenesmus.

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Drug Interactions

Higher frequency of myelosuppressive effects w/ azathioprine, 6-mercaptopurine or thioguanine. Increased risk of renal reactions w/ other known nephrotoxic agents eg, NSAIDs, azathioprine. Decreased anticoagulant effect of warfarin.

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Caution For Usage

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Storage

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Description

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Action

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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.

Regulatory Classification

Presentation/Packing

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 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

4 × 7's

Pentasa

mesalazine

Manufacturer:

Ferring

Distributor:

Zuellig Pharma