Products

Livagoal

Ursodeoxycholic acid
 

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Active ingredient

Ursodeoxycholic acid 450 mg
 

Indications

  • Livagoal capsules are indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anaesthesia or for those patients who refuse surgery.
  • Safety of use of Livagoal capsules beyond 24 months is not established.
  • Livagoal capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

Dosage and Administration

  • The recommended Livagoal dose is 13-15 mg/Kg/d for adults with cholestatic disease.
  • Dosing regimen should be adjusted according to each patient’s need at the difference of the physician.
  • In other words average 2 capsules per day.

Contraindication

  • Livagoal capsules will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. Hence, patients with such stones are not candidates for Livagoal therapy.
  • Patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for Livagoal therapy.
  • Allergy to bile acids.

Side effects

Whole body:
• Allergy, Chest Pain, Fatigue, Infection Viral.
Digestive System:
• Abdominal Pain, Cholecystitis, Constipation, Diarrhea, Dyspepsia, Flatulence.
• Gastrointestinal Disorder: Nausea, Vomiting.
Musculoskeletal System:
• Arthralgia, Arthritis, Back Pain, Myalgia.
Nervous System:
• Headache, Insomnia.
Respiratory System:
• Bronchitis, Coughing, Pharyngitis, Rhinitis, Sinusitis, Upper Respiratory Tract Infection.
Urogenital System:
•Urinary Tract Infection.

Drug Interaction

  • Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of Livagoal by reducing its absorption.
  • Aluminum-based antacids have been shown to adsorb bile acids in vitro and may be expected to interfere with Livagoal in the same manner as the bile acid sequestering agents.
  • Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) increase hepatic cholesterol secretion, and encourage cholesterol gallstone formation and hence may counteract the effectiveness of Livagoal.

Pregnancy and Lactation

Pregnancy:
• There are no adequate or well-controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy.
Nursing Mothers:
• It is not known whether Livagoal is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Livagoal is administered to a nursing mother.

Warning and Precaution

  • Lithocholic acid is detoxified in the liver by sulfation and, although man appears to be an efficient sulfater, it is possible that some patients may have a congenital or acquired deficiency in sulfation, thereby predisposing them to lithocholate-induced liver damage.
  • Abnormalities in liver enzymes have not been associated with Livagoal therapy and, in fact, Livagoal has been shown to decrease liver enzyme levels in liver disease.
    However, patients given Livagoal should have SGOT (AST) and SGPT (ALT) measured at the initiation of therapy and thereafter as indicated by the particular clinical circumstances.
  • Improved serum liver tests do not always correlate with improved liver disease status.
  • Continue monitoring of GGT, alkaline phosphatase .AST, ALT & bilirubin every month for three months after start of therapy and every six months thereafter.
  • Treatment should be discontinued if the level of these parameters increase Long-term use of doses exceeding
    the recommended dose of Livagoal (i.e.,13-15mg/Kg/d) was associated improvement in serum liver tests but did not improve survival, and was associated with higher rates of serious adverse events (including death or liver transplantation) compared to placebo.
  • Patients with variceal bleeding, hepatic encephalopathy, and ascites or in need of an urgent liver transplant should receive appropriate specific treatment.

Package and Storage

  • Package: Carton box containing two strips each of 10 capsules & insert leaflet.
  • Storage: Store in a dry place at temperature not exceeding 30°C.

Mother Company

Manufactured by Marcyrl