Ambisol-150/Ambisol-300

Ambisol-150/Ambisol-300

ursodeoxycholic acid

Manufacturer:

Sydler Remedies

Distributor:

Ambica
Concise Prescribing Info
Contents
Ursodeoxycholic acid
Indications/Uses
Primary biliary cirrhosis (PBC) & for dissolution of small to medium sized radiolucent, cholesterol-rich gall-stones in patients w/ functioning gall bladder.
Dosage/Direction for Use
PBC Adult & elderly 10-15 mg/kg/day in 2-4 divided doses. Childn Dosage should be related to body wt. Dissolution of gallstones Adult & elderly 6-12 mg/kg/day either as a single nighttime dose or in divided doses. Obese patients May be increased to 15 mg/kg/day if necessary. Childn Dosage should be related to body wt. Duration of treatment may be up to 2 yr depending on stone size & should be continued for 3 mth after apparent stone dissolution.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to ursodeoxycholic acid or bile acid. Radio-opaque calcified gall-stones; acute inflammation of gall bladder or biliary tract; biliary tract occlusion (occlusion of common bile duct or cystic duct); frequent episodes of biliary colic; impaired contractility of gall bladder; chronic liver disease, peptic ulcers or in those w/ inflammatory diseases of small intestine & colon. Women who may become pregnant. Pregnancy & lactation.
Special Precautions
Decompensation of hepatic cirrhosis. Discontinue in cases of persistent diarrhea. Visualize (oral cholecystography) gall bladder 6-10 mth after beginning of treatment. Do not use if gallbladder cannot be visualized on x-ray images or w/ calcified gallstones, impaired contractility of gallbladder or frequent episodes of biliary colic. Monitor AST, ALT & γ-glutamyl transferase every 4 wk during the 1st 3 mth of treatment, thereafter every 3 mth. Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
Drug Interactions
Inhibits absorption & efficacy w/ charcoal, colestyramine, colestipol or antacids containing Al hydroxide &/or smectite (Al oxide). Increased intestinal absorption of ciclosporin. Reduced Cmax & AUC of Ca antagonist nitrendipine. Reduced therapeutic effect of dapsone. May increase biliary lithiasis w/ OCs, estrogenic hormones & blood cholesterol lowering agents eg, clofibrate. May reduce absorption of ciprofloxacin.
ATC Classification
A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.
Presentation/Packing
Form
Ambisol-150 tab 150 mg
Packing/Price
30's
Form
Ambisol-300 tab 300 mg
Packing/Price
30's
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