Axialith Special Precautions

Axialith should be taken under medical supervision.
During the first 3 months of treatment, liver function parameters AST (SGOT), ALT (SGPT) and gamma-GT should be monitored by the physician every 4 weeks, thereafter every 3 months. This monitoring would enable early detection of potential hepatic dysfunction, particularly in patients with advanced stage of primary biliary cirrhosis.
In addition, it will be detected in good time whether a patient with primary biliary cirrhosis responds to treatment.
When used for dissolution of cholesterol gallstones: In order to assess therapeutic progress and for timely detection of any calcification of the gallstones, depending on stone size, the gallbladder should be visualized (oral cholecystography) with overview and occlusion views in standing and supine positions (ultrasound control) 6-10 months after the beginning of treatment.
If the gallbladder cannot be visualized on x-ray images, or in cases of calcified gallstones, impaired contractibility of the gallbladder and or frequent episodes of biliary colic, Axialith should not be used.
When used for the treatment of patients with primary biliary cirrhosis in advanced stage: In very rare cases, decompensation of hepatic cirrhosis has been observed, which partially regressed after the treatment was discontinued.
If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued.
Interaction with other medicinal products and other forms of interaction: Axialith should not be administered concomitantly with colestyramine, colestipol or antacids containing aluminum hydroxide and/or smectite (aluminum oxide), because these preparations bind ursodeoxycholic acid in the intestines and thereby inhibits 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.
Axialith can increase the absorption of ciclosporin from the intestine. In patients receiving ciclosporin treatment, blood concentrations of these substances should therefore be checked by the physician and the ciclosporin dose adjusted if necessary.
In isolated cases, Axialith can reduce the absorption of ciclosporin.
Ursodeoxycholic acid has been shown to reduce the plasma peak concentration (C_max) and the area under the curve (AUC) of the calcium antagonist nitrendipine. A reduction in the therapeutic effect of dapsone was also reported.
These observations together with in vitro findings could indicate a potential for ursodeoxycholic acid to induce cythochrome P450 3A enzymes. Controlled clinical trials have shown, however, that ursodeoxycholic acid does not have a relevant induction effect on cythochrome P450 3A enzymes.
Oestrogenic hormones and blood cholesterol-lowering substances such as clofibrate may increase biliary lithiasis, which is a counter effect to ursodeoxycholic acid used for dissolution of gallstones.
Effects on the Ability to Drive and Use Machines: No effects on the ability to drive and use machines have been observed.