Gallstone dissolving agent.

How the Drug Works

Ursodiol helps dissolve cholesterol gallstones. It is most effective if the gallstones are small or "floatable." Patients must have a working gallbladder.

Uses

To dissolve cholesterol gallstones smaller than 20 mm in diameter in patients who are not good candidates for surgery because of systemic disease, advanced age, or reaction to general anesthesia.

For the prevention of gallstones in obese patients experiencing rapid weight loss.

Gallstone Recurrence: Treatment requires months of therapy. Complete dissolution does not always occur and recurrence with in 5 years has been observed in 50% or fewer patients. Consider alternative therapy if possible.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits outweigh the possible hazards to the fetus.

Breastfeeding: It is not known if ursodiol appears in breast milk. Consult your doctor before you begin breastfeeding.

Children: Safety and effectiveness have not been established.

Lab tests will be required during treatment. Tests include liver function; analysis.

Drug Interactions

Tell your doctor or pharmacist if you are taking or planning to take any over ­ the-counter or prescription medications or dietary supplements with this drug. Drug doses may need to be modified or a different drug prescribed. The following drugs and drug classes interact with this drug.

Antacids, Aluminum-based (eg, aluminum hydroxide)

Clofibrate (eg, Atromid-S)

Contraceptives, Oral (eg, Ortho-Novum)

Bile Acid Sequestrants (eg, cholestyramine)

Estrogens (eg, ethinyl estradiol)

Side Effects

Every drug is capable of producing side effects. Many patients experience no, or minor, side effects. The frequency and severity of side effects depend on many factors including dose, duration of therapy and individual susceptibility. Possible side effects include.

Digestive Tract: Nausea; vomiting; diarrhea; severe abdominal pain (especially in upper right side); indigestion; constipation; gas; gallbladder inflammation; inflammation of the mouth.

Nervous System: Headache; fatigue; anxiety; depression; sleep problems.

Skin: Rash; itching; hives; dry skin; sweating; hair thinning.

Other: Metallic taste; joint and muscle pain; cough; runny nose; back pain; mouth sores.

Guidelines for Use

Use exactly as prescribed. Otherwise, the gallstones may dissolve very slowly or not at all.

If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose in order to "catch up" (unless advised to do so by your doctor). If more than one dose is missed or it is necessary to establish a new dosage schedule, contact your doctor or pharmacist.

Carefully follow the diet your doctor has prescribed.

Contact your doctor if diarrhea, stomach pain, severe sudden pain in upper right side, nausea or vomiting occurs.

Therapy usually takes months. Complete dissolving of gallstones does not occur in all patients, and recurrence within 5 years occurs in up to 50% of patients.

The long-term effects (more than 24 months) of this medicine are not known.

Lab tests will be required to monitor therapy. Be sure to keep appointments.

Store below 86°F.