Composition:
Ursodex-150 : Each film-coated tablet contains Ursodeoxycholic Acid BP 150 mg.
Ursodex-300 : Each film-coated tablet contains Ursodeoxycholic Acid BP 300 mg.
Description:
Ursodeoxycholic acid (Ursodex) reduces elevated liver enzyme levels by facilitating bile flow through the liver and
protecting liver cells. The main mechanism if anticholelithic. Although the exact process of ursodiol’s anticholelithic
action is not completely understood, it is thought that the drug is concentrated in bile and decreases biliary
cholesterol by suppressing hepatic synthesis and secretion of cholesterol and by inhibiting its intestinal absorption. The
reduced cholesterol saturation permits the gradual solubilization of cholesterol from gallstones, resulting in their
eventual dissolution.
Indications and usage:
Ursodex is a superior drug for the treatment of Cholestasis (Jaundice), Acute Viral Hepatitis, Viral Hepatitis, Chronic Hepatitis,
Chronic Hepatitis C, Alcoholic Fatty Liver, Primary Billiary Cirrhosis (PBC), Primary Sclerosing Cholangitis (PSC), Dissolution
of gallstones and Non-alcoholic steato hepatitis (NASH).
Dosage & Administration:
Primary biliary cirrhosis: The recommended adult dosage for Ursodex in the treatment of PBC is 13-15 mg/kg/day
administered in two to four divided doses with food.
Dissolution of gallstones: The recommended adult dose is 6-12 mg/kg/day as a single dose at bedtime. Dosing regimen should
be adjusted according to each patient’s need at the discretion of the physician.
Contraindication:
Non-functioning gall-bladder calcified and pigmented gallstones, inflammatory bowel disease.
Use in pregnancy and lactation: PregnancyPregnancy
Category-B.
No evidence of harm has been reported in pregnancy. It has been effectively used for the treatment of cholestasis of
pregnancy during the last trimester without any side effects.
Lactation: Problems have not been documented in humans regarding breast feeding. So patients taking the drug during
breast-feed to consults with doctors.
Pediatric use: Cholesterol rich gallstones are rare in children. Dosage should be related to body weight.
Geriatric use: There is no evidence which suggests the alteration in the adult dose but caution is advised.
Precaution:Â Caution should be exercised in patients with history of liver, gallbladder, pancreas, or bile duct disorders, during
pregnancy and breastfeeding.
Side-effect :Â Diarrhoea, constipation, stomach upset, indigestion, dizziness, vomiting, cough, sore throat, runny nose, back
pain, muscle and joint pain, hair loss.
Ursodex 300mg 1pcs
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Description
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