Archives: Products

Generic:

Ursodeoxycholic acid

Therapeutic Class:

Composition:

• Each capsule of Urso contains
• 250 mg or 500 mg Ursodeoxycholic acid as the active ingredient.
• Each 5 ml of Urso Suspension contains 250 mg of Ursodeoxycholic acid

Description:

Urso contains Ursodeoxycholic acid that has been used successfully for oral dissolution therapy of gallstones and in the treatment of bile reflux gastritis. It also reduces
the symptoms and improves hepatic enzyme levels in patients with primary biliary cirrhosis. There are number of cholestatic diseases (primary sclerosing cholangitis, the various forms of hepatitis including overlap syndrome, cholestasis occurring in patients receiving total parenteral nutrition and in cholestatic diseases of childhood such as cystic fibrosis) in which positive effects of treatment with Urso have been published.

Indications:

• For the dissolution of radiolucent cholesterol gallstones (no larger than 15 mm in diameter) in the patients with still functioning gall bladder despite the gallstones

• For the symptomatic therapy of primary biliary cirrhosis, provided there is no decompensated hepatic cirrhosis

• For the treatment of bile reflux gastritis

Dosage:

Dosage for Urso capsule:

For the dissolution of cholesterol gallstones:

The daily dosage amounts to 10 mg per kg body weight. Swallow the capsules whole with a little fluid, do not chew. Do take the capsules regularly. Gallstones generally take from 6 to 24 months to dissolve. If the gallstones have not become smaller after 12 months, do not continue treatment. The result of therapy should be mentioned by ultrasonography or X-ray every 6 months. At the follow-up examinations, a check should be made to see  whether calcification of the stones has occurred in the meantime. Should this be the case, the treatment must be ended.

For the treatment of primary biliary cirrhosis (PBC):

The daily dosage is 10-15 mg per kg body weight daily. For the first 3 months of treatment, Urso caps should be taken divided over the day. With improvement of the liver values the daily dose may be taken once daily in the evening. The use of Urso capsule in primary biliary cirrhosis may be  continued indefinitely. In patients with primary biliary cirrhosis, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g.  the itching may increase. Should this occur, therapy should first be continued with Urso caps 250 mg daily, and the therapy gradually increased until the dose indicated in the respective dosage regimen is reached again.

For the treatment of bile reflux gastritis: 

Urso caps 250 mg should normally be taken for 10-14 days. The attending physician will decide how long treatment should be continued.
Note: It is important for the result of treatment to take the capsules regularly. Liver function parameters should be monitored several times during treatment.

For the symptomatic treatment of primary biliary cirrhosis:

The daily dose depends on bodyweight and is approx. 2 to 6 capsule (10 to 15 mg Ursodeoxycholic acid per kg bodyweight)

Dosage for Urso Suspension:

There are no age restrictions on the use of Urso 250mg/5ml suspension

For the treatment of primary biliary cirrhosis (PBC):

The usual daily dose depends on body weight, and is approximately 14 ± 2 mg Ursodeoxycholic acid per kg of body weight. One Teaspoonful (= 5 ml oral suspension) contains 250 mg of Ursodeoxycholic acid.

For the first 3 months of treatment, Urso 250 mg/5 ml suspension should be taken divided over the day. When the liver function parameters improve, the daily dose can be administered once a day in the evening.

Urso 250 mg/5 ml suspension should be taken in accordance with the dosage regimen given above. The oral suspension must be taken regularly. The use of Urso 250 mg/5 ml suspension in primary biliary cirrhosis may be continued indefinitely. In patients with primary biliary cirrhosis, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. the itching may increase. Should this occur, therapy should first be
continued with a reduced daily dose of Urso suspension, and the dose then gradually increased (increase of the daily dose weekly) until the dose indicated in the respective dosage regimen is reached again.

Dissolution of Gallstones: 

Approximately 10 mg of Ursodeoxycholic acid per kg of body weight daily, equivalent to:
One Teaspoonful (= 5 ml oral suspension) contains 250 mg of Ursodeoxycholic acid. Urso suspension should be taken in the evening at bedtime. The oral suspension must be taken regularly. The time required for dissolution of gallstones is likely to range from 6 to 24 months depending on stone size and composition. Follow-up cholecystograms or ultrasound investigation may be useful at 6 month intervals until the gallstones have disappeared. Treatment should be continued until 2 successive cholecystograms and/or ultrasound investigations 4-12 weeks apart have failed to demonstrate gallstones. This is because these techniques do not permit reliable visualization of stones less than 2mm in diameter. The likelihood of recurrence of gallstones after dissolution by bile acid treatment has been estimated as up to 50% at 5 years. The efficiency of Urso in treating radio-opaque or partially radio-opaque gallstones has not been tested but these are generally thought to be less soluble than radiolucent stones. Non-cholesterol stones account for 10-15% of radiolucent stones and may not be dissolved by bile acids.

Elderly:

There is no evidenceto suggest that any alteration in the adult dose is needed but the relevant precautions should be taken into account.

Children: 

Cholesterol rich gallstones are rare in children but when they occur, dosage should be related to bodyweight.

Presentations:

• 250 mg caps 10’s,
• 500 mg caps 10’s,
• 250 mg/5 ml susp 120 ml,