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Ursodeoxycholic Acid BP
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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.
Ursodex-150: Each film-coated tablet contains Ursodeoxycholic Acid BP 150 mg. Ursodex-300: Each film-coated tablet contains Ursodeoxycholic Acid BP 300 mg.
Indications And Uses
"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 And 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.
Diarrhoea, constipation, stomach upset, indigestion, dizziness, vomiting, cough, sore throat, runny nose, back pain, muscle and joint pain, hair loss.
Caution should be exercised in patients with history of liver, gallbladder, pancreas, or bile duct disorders, during pregnancy and breastfeeding.
Use In Pregnancy Lactation
Pregnancy 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.
Ursodeoxycholic acid should not be used with drugs, such as estrogenic hormones that increase bile cholesterol. Concomitant administration with bile-acid binding drugs including antacids, charcoal and cholestyramine should be avoided since this may reduce the effectiveness of therapy with Ursodeoxycholic acid.
Store at room temperature away from light and moisture.
Non-functioning gall-bladder calcified and pigmented gallstones, inflammatory bowel disease.
Ursodex-150: Each box contains 4 X 10 Tablets in blister pack. Ursodex-300: Each box contains 2 x 10 Tablets in blister pack.