Antigall 300 Tablet 1 Strip

✔️ Dosage & Administration

Primary Biliary Cirrhosis (PBC)

The recommended adult dose is 13–15 mg/kg/day, administered in 2–4 divided doses with food.

Dissolution of Gallstones

Adults and elderly: The usual dose is 6–12 mg/kg/day, given either as a single dose at bedtime or in divided doses. In obese patients, the dose may be increased to 15 mg/kg/day when clinically appropriate.

Treatment may be required for up to 2 years, depending on the size of the gallstones. Therapy should generally be continued for 3 months after apparent dissolution of the stones.

Prevention of Gallstones

For patients undergoing rapid weight loss, the recommended dose is 600 mg daily, given as 300 mg twice daily.

Elderly Patients

No specific adjustment of the adult dosage is generally indicated. However, appropriate precautions should be considered based on the patient's clinical condition.

Children with Cystic Fibrosis (6 to <18 years)

The recommended dose is 20 mg/kg/day, divided into 2–3 doses. If necessary, the dose may be increased to 30 mg/kg/day.

Use in Special Populations

Hepatic and Renal Impairment

There are no specific dosage recommendations for patients with hepatic or renal impairment. Ursodeoxycholic Acid therapy has not generally been associated with liver damage; however, patients should be monitored appropriately.

✔️ Side Effects

• Diarrhea
• Pasty or soft stools
• Nausea
• Vomiting
• Pruritus (itching)

Rare adverse effects may include:

• Calcification of gallstones
• Urticaria (hives)

✔️ Pregnancy & Lactation

Adequate clinical data regarding the use of Ursodeoxycholic Acid during pregnancy, particularly during the first trimester, are limited. Animal studies have indicated potential teratogenic effects during early pregnancy. Therefore, Ursodeoxycholic Acid should only be used during pregnancy when clearly necessary. Treatment should be stopped if pregnancy occurs unless continued treatment is specifically advised by a physician.

It is not established whether Ursodeoxycholic Acid passes into human breast milk. Therefore, it should generally not be used during breastfeeding unless medically necessary. If treatment is considered essential, discontinuation of breastfeeding may be required.

✔️ Ursodeoxycholic Acid should not be taken at the same time as:

• Activated charcoal
• Cholestyramine
• Colestipol
• Antacids containing aluminium hydroxide and/or smectite

These medicines may reduce the absorption and effectiveness of Ursodeoxycholic Acid.

Ursodeoxycholic Acid may increase the intestinal absorption of ciclosporin. In some cases, it may decrease the absorption of ciprofloxacin.

It may also reduce the peak plasma concentration (Cmax) and overall exposure (AUC) of the calcium-channel blocker nitrendipine. A reduction in the therapeutic effect of dapsone has also been reported.

Oral contraceptives, estrogenic hormones, and cholesterol-lowering medicines such as clofibrate may increase the risk of biliary stone formation, which may counteract the intended effect of Ursodeoxycholic Acid when used for gallstone dissolution.

✔️ Overdose

Diarrhea may occur following an overdose. Other symptoms are generally unlikely because absorption of Ursodeoxycholic Acid decreases as the dose increases, resulting in greater elimination through the feces.

Specific treatment is usually not required. If diarrhea occurs, treatment should focus on maintaining adequate fluid and electrolyte balance. Ion-exchange resins may be considered to bind bile acids in the intestine. Monitoring of liver function may also be recommended.

✔️ Ursodeoxycholic Acid is contraindicated in patients with:

• Known hypersensitivity to Ursodeoxycholic Acid or any component of the formulation
• Radiopaque or calcified gallstones
• Acute inflammation of the gallbladder or biliary tract
• Biliary tract obstruction
• Frequent episodes of biliary colic
• Impaired gallbladder contractility
• Chronic liver disease
• Peptic ulcer disease
• Inflammatory diseases of the small intestine or colon

✔️ Storage:

Store in a cool, dry place and protect from light. Keep the medicine out of the reach of children