pms-Ursodiol C

pms-Ursodiol C

ursodeoxycholic acid

Manufacturer:

Pharmascience

Distributor:

T-BOMA
Concise Prescribing Info
Contents
Ursodiol
Indications/Uses
Management of cholestatic liver diseases eg, primary biliary cirrhosis (PBC).
Dosage/Direction for Use
Adult 13-15 mg/kg/day in 2-4 divided doses.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Complete biliary obstruction of extrahepatic origin. Widespread intrahepatic obstruction.
Special Precautions
Monitor serum liver function tests & bilirubin level every mth for 3 mth after start of therapy & every 6 mth thereafter. Not indicated for the treatment of decompensated cirrhosis. Patients w/ variceal bleeding, hepatic encephalopathy, ascites, or in need of urgent liver transplant. Caution when administered in a setting of partial biliary obstruction of extra-hepatic origin. Exercise caution to maintain bile flow of the patients taking ursodiol. Should not be used in women who are or may become pregnant. Lactation. Ped patients.
Adverse Reactions
Asthenia, dyspepsia, edema peripheral, HTN, nausea, GI disorder, peptic ulcer, chest pain, skin rash, pruritus, leukopenia, blood creatinine increased, blood glucose increased.
Drug Interactions
Reduced absorption w/ bile acid sequestering agents; Al-based antacids. Metabolic interaction w/ CYP3A substrates (eg, cyclosporine, nitrendipine, dapsone).
MIMS Class
Cholagogues, Cholelitholytics & Hepatic Protectors
ATC Classification
A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.
Presentation/Packing
Form
pms-Ursodiol C tab 250 mg
Packing/Price
100's
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