ProUrsan 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

Ursodeoxycholic acid

Indications/Uses

Dissolution of cholesterol gallstones in patients w/ a high risk for surgery & after lithotripsy. Primary biliary cirrhosis stage I & II & sclerosing cholangitis. Hepatitis of various aetiologies w/ cholestatic syndrome. Reactive gastritis in duodenogastric reflux. Hepatobiliary disorder associated w/ cystic fibrosis in childn 6 yr to <18 yr.

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Dosage/Direction for Use

Dissolution of cholesterol gallstones Adult >100 kg 5 cap (1,250 mg); 81-100 kg 4 cap (1,000 mg); 61-80 kg 3 cap (750 mg); up to 60 kg 2 cap (500 mg). Primary biliary cirrhosis stage I & II & other conditions associated w/ intrahepatic cholestasis 10-15 mg/kg daily (2-6 cap) in 2-3 divided doses. Reactive gastritis in duodenogastritis reflux Adult 1 cap (250 mg) daily for 10-14 days. Childn >2 yr 10 mg/kg daily. Childn & adolescents w/ cystic fibrosis 6-18 yr 20 mg/kg daily in 2-3 divided doses, w/ further increase to 30 mg/kg daily if necessary.

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Overdosage

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Administration

May be taken with or without food: Swallow whole w/ sufficient amount of liqd. Do not chew.

Contraindications

Hypersensitivity. Acute inflammation of the gallbladder or bile ducts; occlusion of extrahepatic bile duct (choledochus or cystic duct); frequent episodes of biliary colics; radiopaque calcified gallstones; impaired contractility of the gallbladder.

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Special Precautions

Monitor AST, ALT & γ-GT every 4 wk, thereafter every 3 mth to allow timely detection of a potential hepatic damage especially in patients w/ advanced stage of primary biliary cirrhosis. Reduce treatment if diarrhoea occurs. Discontinue therapy in case of persistent diarrhoea. Should not be used if the gallbladder cannot be imagined using radiography & in cases of calcified gallstones. Women of childbearing potential. Pregnancy & lactation. Not suitable for childn <6 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Loose stools or diarrhoea during therapy.

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Drug Interactions

Inhibition of absorption & efficacy w/ cholestyramine, colestipol or antacids containing Al hydroxide &/or smectite (Al oxide). Affect the absorption of ciclosporin. Reduce the absorption of ciprofloxacin. Decreased C_max & AUC of nitrendipine. Decreased therapeutic effect of dapsone. May increase hepatic cholesterol secretion & biliary lithiasis w/ oestrogenic hormones & blood cholesterol-lowering agents eg, clofibrate.

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Caution For Usage

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Storage

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Description

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

Action

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MIMS Class

Cholagogues, Cholelitholytics & Hepatic Protectors

ATC Classification

A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.

Regulatory Classification

Presentation/Packing

Form

ProUrsan cap 250 mg

Packing/Price

100's;30's (P1,350/box);50's

ProUrsan

ursodeoxycholic acid

Manufacturer:

Natrapharm

Distributor:

Natrapharm