Ursode Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Indications/Uses Dosage/Direction for Use Contraindications Warnings Use In Pregnancy & Lactation Adverse Reactions Drug Interactions MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Ursodeoxycholic acid

Indications/Uses

Treatment of chronic liver diseases w/ bile flow impairment (eg, primary biliary cirrhosis or sclerosing cholangitis, cystic fibrosis-related cholestasis). Dissolution of cholesterol gallstones in patients w/ uncomplicated radiolucent gallstone disease. Prevention of gallstone formation in obese patients experiencing rapid wt loss.

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Dosage/Direction for Use

Dissolution of cholesterol gallstone 8-10 mg/kg daily in 2-3 divided doses. Treatment duration: 6 mth to 2 yr of continuous dosing depending on size & composition of the stones. Monitor response by ultrasonograms performed at 6-mth interval during 1st yr of therapy. Continued for at least 3 mth after complete dissolution to promote dissolution of particles that are too small to image. Prevention of gallstone formation 300 mg bid.

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Administration

Should be taken with food.

Contraindications

Presence of calcified cholesterol & radiopaque stones, acute cholecystitis & biliary obstruction.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Ursode detailed prescribing information

Special Precautions

Discontinue therapy if non-visualizing gallbladder develops. Patient who have undergone cholecystectomy. Long-term use (>24 mth). Not to be used during pregnancy. Lactation.

Use In Pregnancy & Lactation

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Adverse Reactions

Pruritus, rash, urticaria, dry skin, sweating, hair-thinning; nausea, vomiting, dyspepsia, metallic taste, abdominal pain, biliary pain, cholecystitis, constipation, stomatitis, flatulence; headache, fatigue, anxiety, depression, sleep disorder, arthralgia, myalgia, back pain, cough, rhinitis.

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Drug Interactions

Impaired absorption & efficacy w/ cholestyramine, colestipol or Al hydroxide-containing antacids.

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Description

View Ursode description for details of the chemical structure and excipients (inactive components).

MIMS Class

Cholagogues, Cholelitholytics & Hepatic Protectors

ATC Classification

A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.

Thai FDA Category

Presentation/Packing

Form

Ursode cap 250 mg

Packing/Price

10 × 10's

Ursode

ursodeoxycholic acid

Manufacturer:

Charoon Bhesaj

Distributor:

Charoon Bhesaj