Axialith 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 Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Ursodeoxycholic acid

Indications/Uses

Dissolution of cholesterol-rich gallstones in patients w/ functioning gallbladders. Primary biliary cirrhosis.

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Dosage/Direction for Use

Dissolution of cholesterol gallstones >100 kg 5 tab (equiv to 1,250 mg); 81-100 kg 4 tab (equiv to 1,000 mg); 61-80 kg 3 tab (750 mg); up to 60 kg 2 tab (equiv to 500 mg). Biliary cirrhosis Depends on body wt & is between 3 & 7 tab (14 ± 2 mg ursodeoxycholic acid/kg).

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Overdosage

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Administration

Film-coated tab: May be taken with or without food: Take in the evening before bedtime. Swallow whole w/ some liqd, do not chew.|Film-coated tab: Should be taken with food.

Contraindications

Hypersensitivity. Acute inflammation of the gallbladder & biliary tract; occlusion of the biliary tract (choledochal or cystic duct obstruction); frequent episodes of biliary colic; radio-opaque 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 enable early detection of potential hepatic dysfunction. Hepatic cirrhosis. Reduce dose if diarrhea occurs; discontinue in case of persistent diarrhea. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Pasty stools or diarrhea during treatment.

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Drug Interactions

Inhibition of absorption & efficacy w/ colestyramine, colestipol or antacids containing Al hydroxide &/or smectite (Al oxide). Increased/decreased absorption of ciclosporin. Reduce C_max & AUC of nitrendipine. Reduction of therapeutic effect of dapsone. May increase biliary lithiasis w/ oestrogenic hormones & blood cholesterol-lowering lowering substances eg, clofibrate.

Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Axialith 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

Axialith FC tab 250 mg

Packing/Price

100's (P4,564/box)

Form

Axialith FC tab 500 mg

Packing/Price

30's (P2,158.8/box)

Axialith

ursodeoxycholic acid

Manufacturer:

Lek S.A

Distributor:

Cathay Drug