Lupibile 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 Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing Brand Resources

Concise Prescribing Info

Contents

Ursodeoxycholic acid

Indications/Uses

Tab: Suppression of synthesis & secretion of cholesterol by the liver & inhibits intestinal absorption of cholesterol; dissolution of cholesterol-rich gallstones in patients w/ functioning gallbladders. FC tab: Management of cholestatic liver disease, eg, primary biliary cirrhosis (PBC).

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Dosage/Direction for Use

Tab 6-12 mg/kg daily as single bedtime dose or in 2 or 3 divided doses; obese patient Up to 15 mg/kg daily. Treatment should be continued for 3-4 mth after radiological disappearance of the stones. Prevention of gallstones in patient undergoing rapid wt loss 300 mg bid. PBC 10-15 mg/kg daily in 2-4 divided doses. FC tab PBC Adult 13-15 mg/kg daily in 2-4 divided doses.

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Overdosage

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Administration

Should be taken with food.

Contraindications

Tab: Hypersensitivity to ursodeoxycholic acid. FC tab: Hypersensitivity to ursodiol or to ursodeoxycholic acid. Patients w/ complete biliary obstruction of extrahepatic origin, widespread intrahepatic obstruction.

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Special Precautions

FC tab: Patients w/ variceal bleeding, hepatic encephalopathy, ascites, or in need of urgent liver transplant. Caution in patients w/ partial biliary obstruction of extra-hepatic origin. Monitor γ-GT, alkaline phosphatase, AST, ALT & bilirubin levels every mth for 3 mth after start of therapy & every 6 mth thereafter. Not to be use during pregnancy. Women of childbearing potential should use an effective non-hormonal method of contraception. Safety & effectiveness in childn have not been established.

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Use In Pregnancy & Lactation

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Adverse Reactions

Tab: Nausea, vomiting & other GI disturbances. Pruritus. FC tab: Pasty stools or diarrhea.

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Drug Interactions

Tab: Not be used w/ drugs that increase bile cholesterol eg, oestrogenic hormones & cholesterol-lowering drugs eg, clofibrate. Avoid concomitant use w/ bile-acid binding drugs including antacids, charcoal & colestyramine since this may reduce effectiveness. FC tab: Should not be concomitantly administered w/ colestyramine, colestipol or antacids containing Al hydroxide &/or smectite due to inhibition of absorption & efficacy. May affect absorption of ciclosporin. Reduced absorption of ciprofloxacin. Reduced plasma peak conc C_max & AUC of nifedipine. Reduced therapeutic effect of dapsone. Increase hepatic cholesterol secretion & may encourage biliary lithiasis w/ clofibrate; increased plasma levels w/ rosuvastatin.

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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

Lupibile FC tab 500 mg

Packing/Price

100's

Form

Lupibile tab 300 mg

Packing/Price

100's

Lupibile

ursodeoxycholic acid

Manufacturer:

Globela Pharma

Sydler Remedies

Distributor:

Multicare

Multicare