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 gallstones in patients for whom surgery is not a preferred or viable option. It works by reducing the amount of cholesterol released by the liver into bile and by slowly dissolving cholesterol-rich gallstones. This oral therapy is indicated for patients with radiolucent, non-calcified gallbladder stones who are symptomatic yet unable or unwilling to undergo cholecystectomy. Proper patient selection and adherence to treatment protocols are critical to achieving therapeutic success.
Features
- Contains ursodeoxycholic acid as the active pharmaceutical ingredient
- Available in 300 mg capsules for oral administration
- Functions by desaturating bile and reducing cholesterol secretion
- Specifically targets radiolucent, non-calcified gallstones
- Requires prescription and ongoing medical supervision
- Typically administered in divided doses with meals
Benefits
- Non-surgical alternative for eligible gallstone patients
- Reduces biliary cholesterol saturation and lithogenicity
- Can prevent recurrence of stones in susceptible individuals
- Avoids risks associated with invasive procedures
- Allows for outpatient management with periodic monitoring
- May improve digestive symptoms related to gallstone disease
Common use
Actigall is primarily prescribed for the dissolution of cholesterol-rich gallstones in functioning gallbladders. It is most effective in patients with small to medium-sized (typically less than 20 mm in diameter), floating, radiolucent stones. The medication is also used off-label for certain cholestatic liver conditions, including primary biliary cholangitis, where it helps improve liver enzyme levels and may slow disease progression. Treatment duration typically ranges from 6 to 24 months, with regular ultrasound monitoring to assess stone dissolution progress.
Dosage and direction
The recommended dosage for gallstone dissolution is 8-10 mg/kg/day administered in two or three divided doses with meals. For a 70 kg patient, this translates to approximately 600-700 mg daily, typically given as two 300 mg capsules in the morning and two in the evening. Administration with food enhances bioavailability and therapeutic effect. Treatment should continue for at least 3 months after stone dissolution is confirmed by ultrasound to ensure complete clearance. Liver function tests and ultrasound examinations should be performed at 6-month intervals to monitor efficacy and safety.
Precautions
Patients should be advised that complete dissolution may require months of therapy and is not guaranteed. Those with calcified stones, radiopaque stones, or stones exceeding 20 mm diameter are unlikely to benefit. Regular monitoring of liver enzymes (ALT, AST, ALP) is essential throughout treatment. Women of childbearing potential should use effective contraception during therapy, as safety during pregnancy hasn’t been fully established. Patients with chronic liver disease require careful assessment before initiation. Diarrhea or mild gastrointestinal discomfort may occur initially but often resolves with continued use.
Contraindications
Actigall is contraindicated in patients with radio-opaque (calcified) gallstones, acute cholecystitis, cholangitis, biliary obstruction, or biliary-gastrointestinal fistula. It should not be used in patients with non-functioning gallbladders or chronic liver disease with decompensation. Hypersensitivity to ursodiol or any component of the formulation prohibits use. Patients with frequent biliary colic requiring analgesic intervention are generally poor candidates for dissolution therapy. Those with inflammatory bowel diseases affecting bile acid metabolism should avoid this medication.
Possible side effects
The most commonly reported adverse reactions include diarrhea (occurring in approximately 10-20% of patients), nausea, vomiting, dyspepsia, and abdominal discomfort. These gastrointestinal effects are typically mild and transient. Less frequently, patients may experience constipation, headache, dizziness, or hair thinning. Elevated liver enzymes (transaminases) may occur but usually normalize with continued treatment or dose adjustment. Rare cases of urticaria, pruritus, and allergic reactions have been reported. Calcification of gallstones during therapy occurs in approximately 5% of cases.
Drug interaction
Actigall may interact with several medications including aluminum-based antacids, which can reduce ursodiol absorption. Cholestyramine, colestipol, and colesevelam may decrease efficacy by binding ursodiol in the intestine. Estrogens, oral contraceptives, and clofibrate may counteract the cholesterol-desaturating effects. Cyclosporine blood levels may be affected, requiring monitoring. Drugs that increase cholesterol secretion into bile (such as certain hypolipidemic agents) may reduce therapeutic effectiveness. Clinicians should review all concomitant medications before initiation.
Missed dose
If a dose is missed, patients should take it as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Doubling doses to make up for missed medication is not recommended. Consistent daily administration is important for maintaining adequate bile acid concentrations. Patients should be educated about the importance of adherence and advised to develop routine administration habits, such as taking doses with breakfast and dinner.
Overdose
No specific antidote exists for ursodiol overdose. Reported cases of overdose have been rare and generally associated with diarrhea as the primary symptom. Management should be supportive and symptomatic. Activated charcoal may be administered if ingestion occurred within the previous hour. Electrolyte imbalance from persistent diarrhea should be corrected. Hemodialysis is not expected to be effective due to high protein binding. Medical attention should be sought for significant overdoses, particularly in pediatric patients or those with comorbid conditions.
Storage
Actigall capsules should be stored at controlled room temperature (20-25°C or 68-77°F) in their original container. Protection from moisture, light, and excessive heat is essential. The medication should not be stored in bathrooms or other humid environments. Keep tightly closed and out of reach of children. Do not use capsules that appear discolored, damaged, or beyond their expiration date. Proper storage ensures stability and potency throughout the treatment period.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions should be made in consultation with a qualified healthcare professional based on individual patient characteristics. The prescribing physician should be familiar with complete prescribing information, including boxed warnings and precautions. Efficacy and safety profiles may vary among patient populations. Patients should report any adverse reactions to their healthcare provider promptly.
Reviews
Clinical studies demonstrate complete dissolution rates of approximately 30-40% in appropriately selected patients after 6 months of therapy, increasing to 60-70% after 12-24 months. Many gastroenterologists report satisfactory outcomes in motivated patients who adhere to treatment protocols. Some practitioners note that patient selection remains the most critical factor for success, with better outcomes in patients with small, floating stones and functioning gallbladders. The non-surgical nature of the treatment is frequently cited as a significant advantage for suitable candidates. Long-term follow-up indicates recurrence rates of 10-15% per year, emphasizing the need for maintenance therapy in some cases and ongoing monitoring.