Pms-Ursodiol C: Dosing, Side Effect & Interaction

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

Ursodiol

Indications/Uses

Management of cholestatic liver diseases eg, primary biliary cirrhosis.

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Dosage/Direction for Use

Adult 13-15 mg/kg/day in 2-4 divided doses.

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Overdosage

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Administration

Should be taken with food.

Contraindications

Hypersensitivity. Complete biliary obstruction of extrahepatic origin. Widespread intrahepatic obstruction.

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Special Precautions

Monitor serum LFTs & bilirubin levels every mth for 3 mth after start of therapy, & every 6 mth thereafter. Consider discontinuation when serum LFTs increase to a level considered clinically significant for patients w/ recent history of adequate biochemical response to treatment. Exercise caution to maintain bile flow of patients taking ursodiol. Very rare post-marketing reports of bezoars leading to obstructive symptoms that require surgical interventions in ursodiol-treated patients w/ medical conditions that predispose to intestinal stenosis or stasis. Caution in patients w/ variceal bleeding, hepatic encephalopathy, ascites, or patients in need of urgent liver transplant, & when administered in a setting of partial biliary obstruction of extrahepatic origin. Should not be used in women who are or may become pregnant. Potential hazard to fetus. Exercise caution when administered to a nursing mother. No authorized indication for ped or geriatric use.

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Use In Pregnancy & Lactation

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Adverse Reactions

Asthenia, dyspepsia, peripheral edema, HTN, nausea, GI disorders, chest pain, pruritus. Leukopenia, skin rash, diarrhea, increased blood creatinine, increased blood glucose, peptic ulcer.

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Drug Interactions

Reduced absorption w/ bile acid sequestrants (eg, cholestyramine, colestipol); Al-based antacids. Metabolic interaction w/ CYP3A substrates (eg, cyclosporine, nitrendipine, dapsone).

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view pms-Ursodiol C detailed prescribing information

Storage

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Description

View pms-Ursodiol C 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

pms-Ursodiol C tab 250 mg

Packing/Price

100's

pms-Ursodiol C

ursodeoxycholic acid

Manufacturer:

Pharmascience

Distributor:

T-BOMA