Actigall (ursodiol) is a bile acid medication specifically formulated to dissolve certain types of cholesterol gallstones in patients for whom surgery poses an unacceptable risk. It works by reducing the amount of cholesterol secreted into bile and gradually dissolving existing cholesterol-rich stones. This oral therapy represents a non-surgical option for a carefully selected patient population, offering a targeted approach to managing symptomatic gallstone disease under appropriate medical supervision.

Features

• Active ingredient: Ursodiol (ursodeoxycholic acid)
• Available in 300 mg capsules
• Synthetic bile acid analog
• Hydrophilic, non-cytotoxic properties
• Cholesterol-desaturating action on bile
• FDA-approved for gallstone dissolution therapy
• Requires prescription-only access

Benefits

• Non-surgical alternative for cholesterol gallstone dissolution
• Reduces biliary cholesterol saturation index
• May prevent formation of new cholesterol stones
• Can provide symptomatic relief for appropriate candidates
• Avoids risks associated with cholecystectomy
• Preserves gallbladder function in responsive patients

Common use

Actigall is primarily indicated for the dissolution of radiolucent, cholesterol-rich gallstones in patients with functioning gallbladders who are not candidates for surgical intervention. The medication is specifically appropriate for stones that are non-calcified and typically less than 20 mm in diameter. Treatment is generally reserved for symptomatic patients who experience biliary pain or complications related to stone presence. Patient selection is critical, as dissolution therapy requires months of continuous treatment and carries variable success rates depending on stone characteristics and patient compliance.

Dosage and direction

The recommended dosage for gallstone dissolution is 8-10 mg/kg/day administered in two or three divided doses with food. Treatment typically continues for 6-24 months, with regular monitoring via ultrasound every 6 months to assess stone dissolution. Patients should take capsules whole with adequate fluids, preferably with meals to enhance absorption and minimize gastrointestinal discomfort. Dosage adjustments may be necessary based on patient weight changes or treatment response. Therapy should be discontinued if partial stone dissolution hasn’t occurred within 12 months or if complete dissolution isn’t achieved within 24 months.

Precautions

Liver function tests should be monitored every 3-6 months during treatment, as ursodiol metabolism may be affected by hepatic impairment. Patients with chronic liver disease require careful supervision. Gallstone calcification during therapy may reduce treatment efficacy and should prompt reevaluation. Women of childbearing potential should use effective contraception during treatment, as safety in pregnancy hasn’t been fully established. Patients should report any worsening abdominal symptoms, jaundice, or signs of cholangitis immediately. Concomitant use of cholesterol-lowering medications or other hepatotoxic drugs requires careful monitoring.

Contraindications

Actigall is contraindicated in patients with radio-opaque (calcified) gallstones, non-functioning gallbladders, or acute cholecystitis. It should not be used in individuals with known hypersensitivity to ursodiol or bile acids. Patients with chronic liver disease with decompensated hepatic function, biliary tract obstruction, or frequent biliary colic episodes are not candidates for therapy. The medication is contraindicated in those requiring emergency surgical intervention for gallstone complications.

Possible side effects

Common side effects (occurring in >1% of patients) include diarrhea, constipation, nausea, vomiting, abdominal discomfort, and headache. Less frequently reported effects include dyspepsia, flatulence, skin rash, pruritus, and elevated liver enzymes. Rare but serious adverse reactions may include acute pancreatitis, worsening of pre-existing liver disease, or calcification of gallstones. Most gastrointestinal side effects are dose-related and often diminish with continued therapy. Patients should report persistent or severe symptoms to their healthcare provider.

Drug interaction

Actigall may interact with aluminum-based antacids, cholestyramine, colestipol, and estrogen-containing medications, which can reduce its absorption and efficacy. Concurrent use with cyclosporine may increase cyclosporine absorption. Clofibrate and other lipid-lowering agents may counteract ursodiol’s cholesterol-desaturating effects. The medication may reduce the absorption of chenodiol if administered concomitantly. Healthcare providers should review all medications, including over-the-counter products and supplements, before initiating therapy.

Missed dose

If a dose is missed, patients should take it as soon as remembered unless it’s nearly time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should not double the dose to make up for a missed administration. Consistent daily dosing is important for maintaining adequate bile acid concentrations necessary for gallstone dissolution. Healthcare providers should discuss strategies for adherence with patients before initiating long-term therapy.

Overdose

There are no documented cases of serious adverse events from ursodiol overdose. Based on the medication’s mechanism of action, potential symptoms might include severe diarrhea, gastrointestinal discomfort, or nausea. Treatment should be supportive and symptomatic. Activated charcoal may be considered if ingestion occurred recently. Patients experiencing suspected overdose should seek medical attention, though the medication’s favorable safety profile suggests serious consequences are unlikely.

Storage

Actigall capsules should be stored at controlled room temperature (20-25°C or 68-77°F) in their original container. The medication should be protected from light, moisture, and excessive heat. Keep out of reach of children and pets. Do not use capsules that appear discolored, damaged, or beyond their expiration date. Proper storage ensures medication stability and efficacy throughout the extended treatment period.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Actigall should only be used under the supervision of a qualified healthcare professional who can assess individual patient suitability. Treatment decisions should be based on comprehensive medical evaluation, including appropriate diagnostic imaging and consideration of alternative therapies. Patients should not initiate or discontinue medication without consulting their healthcare provider.

Reviews

Clinical studies demonstrate that approximately 30-40% of carefully selected patients achieve complete gallstone dissolution with Actigall therapy within 6-24 months. Success rates are highest in patients with small (<5 mm), floating, cholesterol-rich stones and functioning gallbladders. Many gastroenterologists report satisfactory outcomes in appropriate candidates, particularly those who cannot undergo surgery. However, stone recurrence rates of up to 50% within 5 years following dissolution necessitate ongoing monitoring and possible maintenance therapy in some cases. Patient satisfaction is generally good among those who achieve successful dissolution without requiring surgical intervention.