Actigall: Effective Dissolution Therapy for Gallstones
Actigall
| Product dosage: 150mg | |||
|---|---|---|---|
| Package (num) | Per tab | Price | Buy |
| 30 | $2.00 | $60.00 (0%) | 🛒 Add to cart |
| 60 | $1.83 | $120.00 $110.00 (8%) | 🛒 Add to cart |
| 90 | $1.64 | $180.00 $148.00 (18%) | 🛒 Add to cart |
| 120 | $1.56 | $240.00 $187.00 (22%) | 🛒 Add to cart |
| 180 | $1.47 | $360.00 $264.00 (27%) | 🛒 Add to cart |
| 360 | $1.38
Best per tab | $720.00 $495.00 (31%) | 🛒 Add to cart |
| Product dosage: 300mg | |||
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| 30 | $4.00 | $120.00 (0%) | 🛒 Add to cart |
| 60 | $3.30 | $240.00 $198.00 (18%) | 🛒 Add to cart |
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| 120 | $2.96 | $480.00 $355.00 (26%) | 🛒 Add to cart |
| 180 | $2.89
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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 cholesterol absorption in the intestine, thereby desaturating bile and promoting the gradual dissolution of existing radiolucent stones. This oral therapy represents a non-surgical option for appropriately selected patients, offering a targeted biochemical approach to managing symptomatic gallbladder disease under careful medical supervision.
Features
- Contains ursodeoxycholic acid as the active pharmaceutical ingredient
- Available in 300mg strength capsules for precise dosing
- Hydrophilic properties reduce cytotoxicity compared to endogenous bile acids
- Manufactured under strict pharmaceutical quality controls
- FDA-approved for gallstone dissolution therapy
- Stable formulation with consistent bioavailability
Benefits
- Non-surgical alternative for patients who are poor candidates for cholecystectomy
- Effectively dissolves radiolucent cholesterol gallstones in functioning gallbladders
- Reduces cholesterol saturation index in bile by up to 40-60%
- May prevent stone recurrence when used as maintenance therapy
- Improves biliary lipid composition and hepatobiliary function
- Minimal systemic absorption with primarily local action in the enterohepatic circulation
Common use
Actigall is primarily indicated for the dissolution of radiolucent, non-calcified cholesterol gallstones in patients with a functioning gallbladder who are unable or unwilling to undergo cholecystectomy. The medication is particularly suitable for stones smaller than 20mm in diameter that are floating in non-obstructed bile ducts. Beyond gallstone dissolution, Actigall is also prescribed for the treatment of primary biliary cholangitis (PBC) to improve liver enzyme levels and delay disease progression. Off-label uses include prevention of gallstone formation in patients undergoing rapid weight loss and management of certain cholestatic liver conditions. Patient selection is critical, as success rates vary significantly based on stone characteristics and patient compliance with long-term therapy.
Dosage and direction
For gallstone dissolution: The typical adult dosage is 8-10 mg/kg/day administered in two or three divided doses with food to enhance absorption and tolerance. Treatment should continue for several months until stones are dissolved, typically requiring 6-24 months of continuous therapy. For primary biliary cholangitis: The recommended dosage is 13-15 mg/kg/day divided into two to four doses. Dosage should be individualized based on patient weight, with regular monitoring of liver function tests and gallbladder imaging every 6 months during treatment. Capsules should be swallowed whole with water and not crushed or chewed. Administration with meals improves bioavailability and reduces gastrointestinal side effects. Treatment duration must be sufficient to achieve complete dissolution, followed by monitoring for potential stone recurrence.
Precautions
Regular monitoring of liver function tests (ALT, AST, alkaline phosphatase) is essential throughout therapy. Patients should undergo gallbladder ultrasound every 6 months to assess treatment efficacy and stone dissolution progress. Use with caution in patients with non-functioning gallbladders, calcified stones, or chronic liver disease. Pregnancy Category B: Use during pregnancy only if clearly needed, as safety data is limited. Nursing mothers should exercise caution, as ursodiol is excreted in human milk. Pediatric use has not been established for gallstone dissolution. Elderly patients may require dosage adjustments based on renal and hepatic function. Patients should be advised that complete dissolution may not occur in all cases, and stones may recur after treatment cessation.
Contraindications
Actigall is contraindicated in patients with radio-opaque (calcified) gallstones that are visible on plain abdominal radiography. Additional contraindications include patients with non-functioning gallbladders, acute cholecystitis, cholangitis, biliary obstruction, biliary-gastrointestinal fistula, or inflammatory bowel disease involving the terminal ileum. Hypersensitivity to ursodiol or any component of the formulation prohibits use. The medication is not recommended for patients with chronic liver disease severe enough to impair bile acid metabolism. Those with frequent biliary colic requiring analgesic medication typically are not suitable candidates for dissolution therapy.
Possible side effect
Common side effects (occurring in >1% of patients) include diarrhea, constipation, nausea, vomiting, dyspepsia, and abdominal pain. These gastrointestinal effects are usually mild and often diminish with continued therapy. Less frequent adverse reactions (<1%) may include headache, dizziness, fatigue, hair thinning or alopecia (typically reversible upon discontinuation), pruritus, and skin rash. Laboratory abnormalities may include elevated serum cholesterol transiently during initial treatment phases. Rare but serious side effects include acute pancreatitis, worsening liver function tests, and calcification of gallstones during therapy. Patients should report persistent diarrhea, severe abdominal pain, jaundice, or dark urine promptly to their healthcare provider.
Drug interaction
Actigall may interact with several medication classes. Bile acid sequestrants (cholestyramine, colestipol) and aluminum-based antacids may reduce ursodiol absorption and efficacy—administer at least 2 hours apart. Estrogens, oral contraceptives, and clofibrate may counteract ursodiol’s effects by increasing biliary cholesterol secretion. Cyclosporine blood levels may be reduced, requiring monitoring and potential dosage adjustment. Ursodiol may enhance the absorption of fat-soluble vitamins (A, D, E, K) and potentially increase the effects of hypoglycemic agents. Concomitant use with drugs that cause cholestasis (such as some psychotropic medications) may reduce efficacy. 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 is 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 effective stone dissolution. Occasional missed doses are unlikely to significantly impact long-term efficacy, but frequent missed doses may compromise treatment outcomes. Patients should maintain a dosing diary or use pill organizers to improve adherence to the prescribed regimen, particularly given the extended duration of therapy required.
Overdose
There is limited experience with ursodiol overdose, but reported cases have been associated with diarrhea as the primary symptom. Management should be supportive and symptomatic, with attention to maintaining hydration and electrolyte balance. There is no specific antidote for ursodiol overdose. Dialysis is unlikely to be effective due to ursodiol’s high protein binding and extensive enterohepatic recirculation. Activated charcoal may be considered if ingestion occurred within the previous 1-2 hours. Patients experiencing severe or persistent diarrhea should receive appropriate fluid and electrolyte replacement. Medical attention should be sought for ingestion of significantly large quantities or if severe symptoms develop.
Storage
Store Actigall capsules at controlled room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep the container tightly closed and protect from moisture and light. Do not store in bathroom cabinets where humidity levels fluctuate. Keep out of reach of children and pets. Do not use capsules that show signs of damage, discoloration, or that have expired. Proper storage ensures stability and potency throughout the shelf life. Dispense in original container with child-resistant closure. Do not transfer to other containers that may not provide adequate protection from moisture and light.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Individual patient responses to Actigall may vary based on specific medical conditions, stone characteristics, and adherence to therapy. Treatment should be initiated and monitored by a qualified healthcare professional familiar with biliary disorders. The prescriber should review full prescribing information, including boxed warnings and complete adverse reaction data, before initiating therapy. Patients should discuss potential benefits and risks with their healthcare provider and report any concerning symptoms during treatment. This information is not exhaustive and may not include all possible precautions, interactions, or adverse effects.
Reviews
Clinical studies demonstrate that Actigall achieves complete gallstone dissolution in approximately 30-40% of carefully selected patients after 6-24 months of therapy. Success rates are highest in patients with small (<5mm), floating, radiolucent stones in functioning gallbladders. In primary biliary cholangitis, Actigall has shown significant improvement in liver biochemistry and may delay disease progression to cirrhosis. Patient satisfaction varies, with some appreciating the non-surgical approach despite the extended treatment duration, while others express frustration with the slow response and potential for recurrence. Healthcare providers generally regard Actigall as a valuable option for appropriate candidates, emphasizing the importance of proper patient selection and ongoing monitoring for optimal outcomes.