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Urso

Urso

Generic:

Ursodeoxycholic acid

 

Therapeutic Class:

Bile Stone Therapy

 

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 evidence
to 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,