Urdafalk Forte Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Adverse Reactions Drug Interactions MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Ursodeoxycholic acid

Indications/Uses

Dissolution of cholesterol gallstones in the gallbladder (gallstones must not show as shadows on X-ray images & should not exceed 10 mm in diameter; gallbladder function must not be significantly impaired despite the gallstones). Primary biliary cirrhosis (PBC) in patients w/o decompensated hepatic cirrhosis.

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Dosage/Direction for Use

Dissolution of cholesterol gallstones Approx 10 mg/kg. PBC The daily dose depends on body wt & ranges from 1½ to 3½ FC tab (14±2 mg/kg).

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity to bile acids. Acute inflammation of gallbladder or biliary tract. Biliary tract occlusion (occlusion of the common bile duct or a cystic duct). Frequent episodes of biliary colic. Radio-opaque calcified gallstones. Impaired contractility of gallbladder. Calcified cholesterol stones, radiopaque or radiolucent bile pigment stones. Unremitting acute cholecystitis, cholangitis, biliary obstruction, pancreatitis or biliary GI fistula. Inflammatory disease & other conditions of small intestine. Colon & liver which interfere w/ enterohepatic circulation of bile salt. Pregnancy.

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Special Precautions

Ped <18 yr.

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Adverse Reactions

Gout flares, liver function abnormalities, diarrhoea, nausea, headache, arthralgia, rash & oedema.

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Drug Interactions

Concomitant use w/ cholestyramine, colestipol or antacids containing Al hydroxide &/or smectite (Al oxide).

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