Actigall: Effective Dissolution Therapy for Gallstones
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| Product dosage: 300mg | |||
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Synonyms | |||
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. As a hydrophilic secondary bile acid, it works by reducing the secretion of cholesterol from the liver and decreasing the cholesterol absorption in the intestine, thereby desaturating bile and promoting the gradual dissolution of radiolucent, non-calcified stones. This targeted pharmacological approach offers a non-invasive alternative for appropriately selected patients, providing a clinically validated option within a comprehensive gallbladder management strategy under specialist supervision.
Features
- Active ingredient: Ursodiol (ursodeoxycholic acid) 300 mg capsules
- Mechanism: Hydrophilic bile acid that reduces cholesterol saturation of bile
- Formulation: Oral capsules for systemic absorption and enterohepatic recirculation
- FDA-approved for radiolucent, non-calcified gallbladder stones ≤20 mm in diameter
- Also indicated for primary biliary cholangitis at different dosing regimens
- Requires confirmed gallbladder visualization and function via oral cholecystogram
Benefits
- Non-surgical alternative for cholesterol gallstone dissolution in appropriate candidates
- Reduces cholesterol saturation index in bile by up to 40-60% with chronic administration
- May prevent stone recurrence when used as maintenance therapy in susceptible patients
- Avoids surgical risks and recovery time for patients with contraindications to cholecystectomy
- Can provide symptomatic relief while awaiting elective surgical intervention
- Demonstrated hepatoprotective effects through displacement of toxic hydrophobic bile acids
Common use
Actigall is primarily prescribed for the dissolution of radiolucent, cholesterol-rich gallstones in functioning gallbladders, typically in patients who are poor surgical candidates due to comorbidities, advanced age, or personal preference. It is also used for the treatment of primary biliary cholangitis to improve liver enzyme levels and delay disease progression. The medication requires careful patient selection, including confirmation of stone composition and gallbladder patency through appropriate imaging studies. Treatment duration typically spans 6-24 months with regular monitoring via ultrasound to assess dissolution progress.
Dosage and direction
For gallstone dissolution: 8-10 mg/kg/day administered in two or three divided doses with meals to enhance absorption and maintain consistent bile acid levels. Treatment should continue for at least 3 months after stone dissolution is confirmed by ultrasound, with typical therapy duration of 6-24 months depending on stone size and response. For primary biliary cholangitis: 13-15 mg/kg/day administered in divided doses. Dosage should be individualized based on patient weight, with regular assessment of liver function tests and imaging studies to monitor therapeutic response and adjust treatment duration accordingly.
Precautions
Regular monitoring of liver function tests (ALT, AST, ALP, GGT) and bilirubin is essential throughout therapy. Ultrasound examinations should be performed at 6-month intervals to assess stone dissolution and detect possible calcification. Use with caution in patients with non-visualizing gallbladder, calcified stones, or chronic liver disease. Patients should be advised that complete dissolution occurs in approximately 30-40% of carefully selected cases, with higher success rates for smaller stones (<5 mm). Stone recurrence occurs in approximately 50% of patients within 5 years after discontinuation of therapy.
Contraindications
Radio-opaque (calcified) gallstones or stones >20 mm in diameter; non-functioning gallbladder or chronic cholestasis; acute cholecystitis, cholangitis, biliary obstruction, or biliary-gastrointestinal fistula; hypersensitivity to bile acids or any component of the formulation; inflammatory bowel diseases affecting bile acid absorption; pregnancy unless clearly needed (Category B); radioucent bile pigment stones; urgent need for cholecystectomy due to complications.
Possible side effects
- Gastrointestinal: Diarrhea (10-20%), constipation, dyspepsia, nausea, vomiting, abdominal pain
- Dermatological: Pruritus, rash, urticaria, hair thinning or changes in texture
- Hepatic: Transient elevation of liver enzymes (5-10%), rarely hepatitis
- Respiratory: Cough, pharyngitis, rhinitis
- Musculoskeletal: Back pain, arthralgia, myalgia
- Miscellaneous: Headache, fatigue, dizziness, metallic taste, sweating
Most side effects are mild and transient, often resolving with continued therapy or dose adjustment. Severe reactions requiring discontinuation are rare (<1%).
Drug interaction
- Cholestyramine, colestipol, colesevelam: Reduce absorption of ursodiol (separate administration by at least 2 hours)
- Aluminum-based antacids: May decrease ursodiol absorption
- Estrogens, oral contraceptives: May counteract ursodiol’s effect on cholesterol saturation
- Clofibrate: May increase cholesterol secretion into bile
- Cyclosporine: Ursodiol may increase absorption and blood levels
- Dapsone: Ursodiol may increase enterohepatic recirculation
- Nitrendipine: Ursodiol may increase bioavailability
Missed dose
If a dose is missed, take it as soon as remembered unless it is nearly time for the next scheduled dose. Do not double the dose to make up for a missed administration. Maintain regular dosing schedule to ensure consistent bile acid levels. If multiple doses are missed, contact healthcare provider for guidance on resumption of therapy.
Overdose
No specific antidote exists. Symptoms may include severe diarrhea, gastrointestinal discomfort, and potential electrolyte imbalances. Treatment should be symptomatic and supportive, including maintenance of hydration and electrolyte balance. Hemodialysis is not effective due to high protein binding and extensive enterohepatic recirculation. Contact poison control center for latest guidance.
Storage
Store at controlled room temperature (20-25°C or 68-77°F) in original container. Protect from light and moisture. Keep tightly closed and out of reach of children. Do not use after expiration date printed on packaging. Do not transfer capsules to other containers as moisture protection may be compromised.
Disclaimer
This information is for educational purposes only and does not constitute medical advice. Actigall should be used only under the supervision of a qualified healthcare professional. Treatment decisions must be based on individual patient assessment, including appropriate diagnostic testing and risk-benefit evaluation. Patient response varies, and not all gallstones will dissolve completely. Surgical intervention may still be required if complications develop or dissolution is inadequate.
Reviews
Clinical studies demonstrate complete dissolution rates of 30-40% in carefully selected patients with radiolucent stones <20 mm. Success rates are higher for smaller stones (<5 mm) and with longer treatment duration. In primary biliary cholangitis, Actigall has shown significant improvement in liver biochemistry and may delay disease progression. Patient satisfaction is generally good among those who achieve stone dissolution without surgery, though treatment duration and monitoring requirements are significant considerations. Many gastroenterologists consider it a valuable option in the appropriate clinical context despite the limitations of patient selection and potential for stone recurrence.