ProUrsan Forte 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 the gall bladder. Symptomatic treatment of primary biliary cholangitis (PBC); biliary reflux gastritis; cholestatic liver disease. Hepatobiliary disorder associated w/ cystic fibrosis in childn 6 yr-<18 yr.

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Dosage/Direction for Use

Dissolution of cholesterol gallstones Approx 10 mg/kg corresponding to: >100 kg 2½ FC tab, 81-100 kg 2 FC tab, 61-80 kg 1½ FC tab, up to 60 kg 1 FC tab. Symptomatic treatment of PBC Depends on body wt & ranges from 1½-3½ FC tab (14±2 mg/kg). 1st 3 mth of treatment: Should be divided over the day. May be taken once daily in the evening if liver values improve. Childn w/ cystic fibrosis 6 yr-<18 yr 20 mg/kg/day in 2-3 divided doses, w/ further increase to 30 mg/kg/day if necessary.

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Overdosage

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Administration

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

Contraindications

Hypersensitivity to bile acids. Acute inflammation of the gallbladder & biliary tract; occlusion of biliary duct (occlusion of the common bile duct or a cystic duct); frequent episodes of biliary colic; radiopaque calcified gallstones; impaired contractility of the gallbladder. Unsuccessful portoenterostomy or w/o recovery of good bile flow in childn w/ biliary atresia.

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Special Precautions

Monitor liver function parameters every 4 wk during the 1st 3 mth, thereafter every 3 mth. Visualize gallbladder w/ overview (oral cholecystography) & occlusion views in standing & supine positions (ultrasound control) 6-10 mth after the beginning of treatment. Should not be used if gallbladder cannot be visualised on x-ray images or in cases of calcified gallstones, impaired contractility of the gallbladder or frequent episodes of biliary colic. Decompensation of the hepatic cirrhosis (very rare); discontinue if persistent diarrhea occurs. Long-term high dose therapy in patients w/ primary sclerosing cholangitis. Female patients should use an effective non-hormonal method of contraception. Pregnancy.

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Use In Pregnancy & Lactation

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Adverse Reactions

Pasty stools or diarrhoea.

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Drug Interactions

May inhibit absorption & efficacy w/ cholestyramine, colestipol or antacids containing Al hydroxide &/or smectite (Al oxide). May affect the absorption of ciclosporin. May reduce the absorption of ciprofloxacin. Slightly elevate plasma levels of rosuvastatin. Reduce peak plasma conc (C_max) & AUC of nitrendipine. Reduced therapeutic effect of dapsone. Increase hepatic cholesterol secretion & biliary lithiasis w/ oestrogenic hormones & blood cholesterol lowering agents eg, clofibrate.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view ProUrsan Forte detailed prescribing information

Storage

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Description

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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 Forte FC tab 500 mg

Packing/Price

100's;50's (P3,435/box)

ProUrsan Forte

ursodeoxycholic acid

Manufacturer:

Natrapharm

Distributor:

Natrapharm