Posology
There are no age restrictions on the use of ursodeoxycholic acid in the treatment of PBC and for the dissolution of radiolucent gallstones. The following daily dose is recommended for the various indications:
For the treatment of primary biliary cholangitis (PBC)
The daily dose depends on body weight and is approximately 14 ± 2 mg UDCA per kg of body weight.
For the first 3 months of treatment, this medicinal product 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.
| Body weight (kg) | Daily dose (mg/kg BW) | Amount of Suspension (ml)* |
| First 3 months | Subsequently |
| Morning | Midday | Evening | Evening (1 x daily) |
| 8 – 11 | 12 – 16 | - | 1.25 ml | 1.25 ml | 2.5 ml |
| 12 – 15 | 12 – 16 | 1.25 ml | 1.25 ml | 1.25 ml | 3.75 ml |
| 16 – 19 | 13 – 16 | 2.5 ml | - | 2.5 ml | 5 ml |
| 20 – 23 | 13 – 15 | 1.25 ml | 2.5 ml | 2.5 ml | 6.25 ml |
| 24 – 27 | 13 – 16 | 2.5 ml | 2.5 ml | 2.5 ml | 7.5 ml |
| 28 – 31 | 14 – 16 | 1.25 ml | 2.5 ml | 5 ml | 8.75 ml |
| 32 – 39 | 12 – 16 | 2.5 ml | 2.5 ml | 5 ml | 10 ml |
| 40 – 47 | 13 – 16 | 2.5 ml | 5 ml | 5 ml | 12.5 ml |
| 48 – 62 | 12 – 16 | 5 ml | 5 ml | 5 ml | 15 ml |
| 63 – 80 | 12 – 16 | 5 ml | 5 ml | 10 ml | 20 ml |
| 81 – 95 | 13 – 16 | 5 ml | 10 ml | 10 ml | 25 ml |
| 96 – 115 | 13 – 16 | 10 ml | 10 ml | 10 ml | 30 ml |
| Over 115 | - | 10 ml | 10 ml | 15 ml | 35 ml |
This medicinal product should be taken in accordance with the dosage regimen given above. The oral suspension must be taken regularly.
The use of ursodeoxycholic acid in PBC may be continued indefinitely.
For dissolution of cholesterol gallstones:
Approximately 10 mg of UDCA per kg of body weight daily, equivalent to:
| Body Weight (kg) | Amount of Suspension (ml)* |
| 5 – 7 | 1.25 ml |
| 8 – 12 | 2.50 ml |
| 13 – 18 | 3.75 ml |
| 19 – 25 | 5 ml |
| 26 – 35 | 7.5 ml |
| 36 – 50 | 10 ml |
| 51 – 65 | 12.5 ml |
| 66 – 80 | 15 ml |
| 81 – 100 | 20 ml |
| Over 100 | 25 ml |
The 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 visualisation 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 ursodeoxycholic acid 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.
Older people
There is no evidence to suggest that any alteration in the adult dose is needed but the relevant precautions should be taken into account.
Paediatric population
Cholesterol rich gallstones and PBC are very rare in children but when they occur, dosage should be related to bodyweight. There are no adequate data on the efficacy and safety in this population.
Hepatobiliary disorders associated with cystic fibrosis
Paediatric population
Children with cystic fibrosis aged 1 month to 18 years: 20 mg/kg/day in 2-3 divided doses, with a further increase to 30 mg/kg/day if necessary.
Very rarely, children under 10 kg body weight are affected. In this case, a commercially available oral syringe should be used. Please note: a syringe is not provided in the pack.
Up to 10 kg body weight: Dosing 20 mg UDCA/kg/day
Measuring device: 2 ml graduated oral syringe (not provided)
| Body weight (kg) | Amount of Suspension (ml)* |
| Morning | Evening |
| 4 | 0.8 | 0.8 |
| 4.5 | 0.9 | 0.9 |
| 5 | 1.0 | 1.0 |
| 5.5 | 1.1 | 1.1 |
| 6 | 1.2 | 1.2 |
| 6.5 | 1.3 | 1.3 |
| 7 | 1.4 | 1.4 |
| 7.5 | 1.5 | 1.5 |
| 8 | 1.6 | 1.6 |
| 8.5 | 1.7 | 1.7 |
| 9 | 1.8 | 1.8 |
| 9.5 | 1.9 | 1.9 |
| 10 | 2.0 | 2.0 |
More than 10 kg body weight (BW): Dosing 20-25 mg UDCA/kg/day
Measuring device: Measuring spoon
| Body weight (kg) | Daily dose UDCA (mg/kg BW) | Amount of Suspension (ml)* |
| Morning | Evening |
| 11 – 12 | 21 – 23 | 2.5 ml | 2.5 ml |
| 13 – 15 | 21 – 24 | 2.5 ml | 3.75 ml |
| 16 – 18 | 21 – 23 | 3.75 ml | 3.75 ml |
| 19 – 21 | 21 – 23 | 3.75 ml | 5 ml |
| 22 – 23 | 22 – 23 | 5 ml | 5 ml |
| 24 – 26 | 22 – 23 | 5 ml | 6.25 ml |
| 27 – 29 | 22 – 23 | 6.25 ml | 6.25 ml |
| 30 – 32 | 21 – 23 | 6.25 ml | 7.5 ml |
| 33 – 35 | 21 – 23 | 7.5 ml | 7.5 ml |
| 36 – 38 | 21 – 23 | 7.5 ml | 8.75 ml |
| 39 – 41 | 21 – 22 | 8.75 ml | 8.75 ml |
| 42 – 47 | 20 – 22 | 8.75 ml | 10 ml |
| 48 – 56 | 20 – 23 | 11.25 ml | 11.25 ml |
| 57 – 68 | 20 – 24 | 13.75 ml | 13.75 ml |
| 69 – 81 | 20 – 24 | 16.25 ml | 16.25 ml |
| 82 – 100 | 20 – 24 | 20 ml | 20 ml |
| >100 | - | 22.5 ml | 22.5 ml |
* Conversion table:
| Amount of Suspension | Ursodeoxycholic Acid |
| 5 ml | 250 mg |
| 3.75 ml | 187.5 mg |
| 2.5 ml | 125 mg |
| 1.25 ml | 62.5 mg |
Method of administration
Oral use.
Shake well before use.
A 5ml measuring spoon with graduations of 1.25 ml, 2.5 ml, 3.75 ml and 5 ml is provided and can be used to deliver the majority of doses e.g. 6.25 ml is given as 1 x 5 ml and 1 x 1.25 ml and 8.75 ml is given as 1 x 5 ml and 1 x 3.75 ml. A measuring cup or oral syringe (not supplied) can also be used if available.
Doses under 2 ml for children with cystic fibrosis weighing under 10 kg should be administered with a 2 ml oral syringe (not supplied).
If necessary, this medicinal product can be administered via a gastric, duodenal or nasal feeding tube (see section 6.6). It is advised to rinse medium / larger bore tubes e.g. Fr14, twice with at least 10 ml of water following administration and to rinse smaller bore tubes e.g. Fr4, at least once with a minimum of 3 ml of water.
site
Find similar products:
