Indications And Usage

Ursodeoxycholic acid is indicated in the treatment of primary biliary cirrhosis (PBC) and for the dissolution of radiolucent gallstones in patients with a functioning gall bladder.

Administration

There are no age restrictions on the use of Ursodeoxycholic acid 250 mg hard gelatin capsules in the treatment of PBC and for the dissolution of radiolucent gallstones. For patients weighting less than 47 kg or patients who are unable to swallow Ursodeoxycholic acid capsules, Ursodeoxycholic acid suspension is available.

The following daily dose is recommended for the various indications:

Treatment of Primary biliary cirrhosis (PBC):

The daily dose depends on body weight, and ranges from 3 to 7 capsules (14 ±2 mg ursodeoxycholic acid per kg of body weight).

For the first 3 months of treatment, Ursodeoxycholic acid should be taken divided over the day.

With improvement of the liver values the daily dose may be taken once daily in the evening.

Contraindications

Ursodeoxycholic acid 250 mg hard gelatin capsules should not be used in patients with:

- Hypersensitivity to bile acids or to any of the excipients of the formulation

- Acute inflammation of the gall bladder or the biliary tract

- Occlusion of the biliary tract (occlusion of the common bile duct or a cystic duct)

- Frequent episodes of biliary colic

- Radio-opaque calcified gallstones

- Impaired contractility of the gall bladder

When used in hepatobiliary disorders associated with cystic fibrosis in children aged 6 to 18 years.

- Unsuccessful portoenterostomy or without recovery of good bile flow in children with biliary atresia.

Precautions

Ursodeoxycholic acid capsules should be taken under medical supervision. During the first 3 months of treatment, liver function parameters ASAT (SGOT), ALAT (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 late stage primary biliary cirrhosis.

Adverse Reactions

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Pregnancy and lactation

Pregnancy

There are no or limited amounts of data from the use of UDCA in pregnant women. Studies in animals have shown reproductive toxicity during the early phase of gestation .Ursodeoxycholic acid capsules must not be used during pregnancy unless clearly necessary.

Breastfeeding

According to few documented cases of breastfeeding women, milk levels of UDCA are very low and probably no adverse reactions are to be expected in breastfed infants.

Renal and liver Impairment

Subchronic toxicity studies in monkeys showed hepatotoxic effects in the groups given high doses, including functional changes (e.g. liver enzyme changes) and morphological changes such as bile duct proliferation, portal inflammatory foci and hepatocellular necrosis

Clinical experience confirms that the described hepatotoxic effects are of no apparent relevance in humans

Laboratory Tests