URSODEOXYCHOLIC ACID 150 Milligram Tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

URSODEOXYCHOLIC ACID

Tillgänglig från:

Teva B.V.

ATC-kod:

A05AA02

INN (International namn):

URSODEOXYCHOLIC ACID

Dos:

150 Milligram

Läkemedelsform:

Tablets

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

Bile acid preparations

Bemyndigande status:

Authorised

Tillstånd datum:

2017-11-10

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ursodeoxycholic Acid 150 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg of ursodeoxycholic acid.
Also contains 142.50 mg of lactose monohydrate.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white, round tablet, 11 mm diameter with a break line.
The tablets are marked with ‘URS 150’.
The break line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The dissolution of radiolucent (i.e. non-radio opaque) cholesterol
gallstones in patients with a functioning gallbladder.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and the elderly
Dissolution of gallstones:
A daily dose of 8 to 12mg/kg ursodeoxycholic acid will produce
cholesterol desaturation in the majority of cases. The
measurement of the lithogenic index on bile-rich duodenal drainage
fluid after 4-6 weeks of therapy may be useful for
determining the minimum effective dose. The lowest effective dose has
been found to be 4 mg/kg. The daily dose for
most patients is 3 or 4 tablets,
according to body weight.
The dose should be divided into two administrations after
meals, with one administration always after the evening meal.
The duration of treatment needed to achieve dissolution will not
usually exceed 2 years, and should be monitored with
regular
cholecystograms.
Treatment
should be continued for
3-4 months
after
the radiological
disappearance of
gallstones.
Any temporary discontinuation of treatment,
if prolonged for 3-4 weeks,
will
allow the bile to return to a state of
supersaturation,
and will
extend the total
time taken for litholysis.
In some cases stones may recur after successful
treatment.
Children and adolescents
Not recommended
For oral administration.
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