Ursodiol (USP34) 250 mg 20 capsules

Ursodiol USP34 250 mg 20 capsules

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.