Ursodiol 250mg Tab, 100ct Bottle

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Description

What is Ursodiol and how is it used?

Ursodiol is a prescription medicine used to prevent and to treat the symptoms of Gallstones. Ursodiol may be used alone or with other medications.

Ursodiol belongs to a class of drugs called Gallstone Solubilizing Agents.

What are the possible side effects of Ursodiol?

Ursodiol may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • weakness,
  • swelling of the ankles or feet,
  • increased thirst and urination,
  • fever,
  • persistent sore throat,
  • easy bleeding or bruising, and
  • severe dizziness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Ursodiol include:

  • stomach upset,
  • nausea,
  • diarrhea,
  • dizziness,
  • back pain,
  • hair loss, and
  • cough

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Ursodiol. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SPECIAL NOTE

Gallbladder stone dissolution with Ursodiol treatment requires months of therapy. Complete dissolution does not occur in all patients and recurrence of s tones within 5 years has been observed in up to 50% of patients who do dissolve their s tones on bile acid therapy. Patients should be carefully s elected for therapy with ursodiol, and alternative therapies should be considered.

INDICATIONS

  1. Ursodiol is 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 anesthesia, or for those patients who refuse surgery. Safety of use of Ursodiol beyond 24 months is not established.
  2. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

DOSAGE AND ADMINISTRATION

Gallstone Dissolution

The recommended dose for Ursodiol treatment of radiolucent gallbladder stones is 8 – 10 mg/kg/day given in 2 or 3 divided doses.

Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of Ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, Ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of Ursodiol therapy, the likelihood of success is greatly reduced.

Gallstone Prevention

The recommended dosage of Ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).

Storage

Store at 20-25°C (68-77°F). [See USP controlled room temperature.]

Dispense in a tight container (USP).

Keep out of reach of children.