Salofalk 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 Side Effects Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Mesalazine

Indications/Uses

Gastro-resistant PR granules: Treatment of acute episodes & prevention of further episodes of mild to moderate ulcerative colitis. Enema: As monotherapy or, particularly in the acute phase, in combination w/ corticosteroids for the treatment of ulcerative colitis. Supp: Treatment of acute episodes & prevention of further episodes of chronic ulcerative colitis.

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Dosage/Direction for Use

Gastro-resistant PR granules Adult, elderly, & childn weighing >40 kg Treatment of acute episodes 3 sachets once daily (preferably in the morning) or 1 sachet tds (in the morning, at midday, in the evening). Prevention of further episodes if at increased risk for recurrence 3 sachets once daily preferably in the morning. Childn ≥6 yr Treatment of acute episodes Initially 30-50 mg/kg/day once daily preferably in the morning or in divided doses. Max dose: 75 mg/kg/day. Prevention of further episodes Initially 15-30 mg/kg/day in divided doses. Enema Adult & elderly Treatment of acute episodes Insert 1 enema into the rectum once daily preferably at bedtime. Supp Adult & elderly Treatment of acute symptoms of inflammation Insert 2 supp into the rectum tds (in the morning, at midday, at bedtime). Long-term treatment to prevent recurrences Insert 1 supp into the rectum tds.

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Overdosage

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Administration

Should be taken on an empty stomach: Gastro-resistant PR granules: Place directly on tongue, then swallow w/ plenty of liqd. Do not chew.

Contraindications

Hypersensitivity to mesalazine, salicylic acid, or salicylates (eg, ASA). Serious liver or kidney disease.

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Special Precautions

Caution in patients w/ history of lung problems, particularly bronchial asthma; history of allergy to sulphasalazine; liver or kidney problems; history of severe skin rash or skin peeling, blistering &/or mouth sores after using mesalazine. Perform regular blood & urine tests during treatment. Kidney stones may develop. Reports of serious skin reactions including DRESS, SJS, & TEN. May produce a harmless red-brown urine discoloration after contact w/ Na hypochlorite bleach. Should only be used during pregnancy & breast-feeding if necessary. Gastro-resistant PR granules: Contains aspartame, a source of phenylalanine, which may be harmful in patients w/ phenylketonuria. Contains sucrose, therefore caution in patients w/ intolerance to some sugars. Enema: Contains K metabisulphite, which may rarely cause severe hypersensitivity reactions & bronchospasm. Contains Na benzoate, which may cause local irritation. Enema/Supp: Little experience in childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

Rash, itching. Gastro-resistant PR granules: Headache.

Drug Interactions

Potential interaction w/ azathioprine, 6-mercaptopurine or thioguanine; blood-clotting inhibitors (eg, warfarin). Gastro-resistant PR granules: Potential interaction w/ lactulose or other prep that can change the acidity of stools.

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Caution For Usage

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Storage

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Description

View Salofalk description for details of the chemical structure and excipients (inactive components).

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

P₁S₁S₃

Presentation/Packing

Form

Salofalk gastro-resistant PR granules 1,000 mg

Packing/Price

50 × 1's

Form

Salofalk enema 4 g/60 mL

Packing/Price

7 × 1's

Form

Salofalk supp 250 mg

Packing/Price

30's

Salofalk

mesalazine

Manufacturer:

Dr Falk

Distributor:

Zuellig

Agencia Lei Va Hong

Marketer:

A. Menarini