Indications 
• Primary biliary cirrhosis (PBC) 
• Cholesterol-rich gall-stones in patients with a functioning gall bladder.

Contraindications 
AGELIV-300 (Ursodeoxycholic acid 300) is contraindicated in patients with radio-opaque calcified gall-stones, acute inflammation of the gall bladder or biliary tract, occlusion of the biliary tract, frequent episodes of biliary colic, impaired contractability of the gall bladder, hypersensitivity to bile acids or any excipient of the formulation, pregnant or breastfeeding, chronic liver disease, peptic ulcers or in those with inflammatory diseases of the small intestine and colon.

Warnings & Precautions 
During the first 3 months of treatment, the liver function parameters AST (SGOT), ALT (SGPT) and γ-GT should be monitored by the physician every 4 weeks, thereafter every 3 months. Apart from allowing for identification of responders and non-responders in patients being treated for primary biliary cirrhosis, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advanced stage primary biliary cirrhosis.

Drug Interaction 
AGELIV-300 (Ursodeoxycholic acid) should not be administered concomitantly with charcoal, colestyramine, colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium oxide), because these preparations bind ursodeoxycholic acid in the intestine and thereby inhibit its absorption and efficacy. Should the use of a preparation containing one of these substances be necessary, it must be taken at least 2 hours before or after ursodeoxycholic acid.

AGELIV-300 (Ursodeoxycholic acid) can increase the absorption of ciclosporin from the intestine. In patients receiving ciclosporin treatment, blood concentrations of this substance should therefore be checked by the physician and the ciclosporin dose adjusted if necessary.

In isolated cases AGELIV-300 (ursodeoxycholic acid) can reduce the absorption of ciprofloxacin.
Oral contraceptives, oestrogenic hormones and blood cholesterol lowering agents such as clofibrate may increase biliary lithiasis, which is a counter-effect to AGELIV-300 (Ursodeoxycholic acid) used for dissolution of gallstones.

Dosage & Administration 
Primary Biliary Cirrhosis (Adults & Elderly): 10 - 15mg ursodeoxycholic acid per kg per day in two to four divided doses.
Children: Dosage should be related to bodyweight.
Dissolution of gallstones (Adults and Elderly): The usual dose is 6 - 12mg/kg/day either as a single night time dose or in divided doses. This may be increased to 15mg/kg/day in obese patients, if necessary.
The duration of treatment may be up to two years, depending on the size of the stone(s), and should be continued for three months after the apparent dissolution of the stone(s).
Children: Dosage should be related to bodyweight.
Paediatric population: Children with cystic fibrosis aged 6 year to less than 18 years: 20 mg/kg/day in 2-3 divided doses, with further increase to 30 mg/kg/day if necessary.

Presentation
AGELIV-300: Alu Alu of 10s