Ursodiol (USP34) 250 mg 20 capsules
Sedico Pharma
Sedico Pharma
Composition
Ursodeoxycholic acid 250 mg
Product Description
Hard gelatin capsules (containing the active ingredient in the form of powder or microgranules)
Indications for use
Dissolution of radiolucent (cholesterol) gallstones measuring no more than 15 mm in diameter in patients with a functioning gallbladder;
Treatment of primary biliary cholangitis (PBC) in the absence of decompensated liver cirrhosis
Method of administration and dosage
Oral, capsules should be swallowed whole, washed down with a sufficient amount of water.
The dosage is determined individually by the attending physician:
For dissolving stones, it is usually prescribed at a rate of 8–10 mg/kg of body weight per day;
For primary biliary cholangitis — 13–15 mg/kg/day
Contraindications
Hypersensitivity or allergic reactions to the components of the drug.
Severe conditions and diseases requiring surgical intervention.
Pronounced liver cell diseases, bile duct anomalies, or concomitant inflammatory bowel disease.
Presence of calcified (radiopaque) gallstones, impaired gallbladder function, or chronic liver disease.
Presence of gastrointestinal (galactoneal) fistulas.
Conditions requiring urgent surgical intervention (for example, cholecystectomy for acute inflammation or infection of the gallbladder)
Precautions
Use must be carried out strictly under medical supervision; during the first 3 months of treatment, liver function parameters (transaminases, alkaline phosphatase, bilirubin) should be monitored every 4 weeks, and thereafter every 3 months
Adverse reaction / Side effects
Gastrointestinal disorders (pain in the upper right part of the abdomen, diarrhea or stool softening), transient increase in the activity of liver transaminases, in rare cases — allergic reactions
Pregnancy and lactation
Ursodeoxycholic acid should not be used during pregnancy.
Use of the drug by women of childbearing potential is possible only if they use reliable methods of contraception.
It is recommended to use non-hormonal contraceptives or oral contraceptives with a low estrogen content, since hormonal oral contraceptives can enhance gallstone formation.
Possible pregnancy should be excluded before starting treatment.
Use during the breastfeeding period is possible according to indications, in recommended doses.
Storage conditions
Store in a dry, dark place at a temperature not exceeding 30°C
Packaging
A cardboard carton containing 20 hard gelatin capsules.