Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
During the first 3 months of treatment, this medicine should be taken in the morning, at midday and in the evening. As liver function values improve, the total daily dose may be taken once a day in the evening. The recommended dose is as follows:
Body Weight 8–11 kg
Daily dose: 12–16 mg per kg body weight
- First 3 months:
- Morning: None
- Midday: 1.25 ml
- Evening: 1.25 ml
- Subsequently:
- Evening (once daily): 2.5 ml
Body Weight 12–15 kg
Daily dose: 12–16 mg per kg body weight
- First 3 months:
- Morning: 1.25 ml
- Midday: 1.25 ml
- Evening: 1.25 ml
- Subsequently:
- Evening (once daily): 3.75 ml
Body Weight 16–19 kg
Daily dose: 13–16 mg per kg body weight
- First 3 months:
- Morning: 2.5 ml
- Midday: None
- Evening: 2.5 ml
- Subsequently:
- Evening (once daily): 5 ml
Body Weight 20–23 kg
Daily dose: 13–15 mg per kg body weight
- First 3 months:
- Morning: 1.25 ml
- Midday: 2.5 ml
- Evening: 2.5 ml
- Subsequently:
- Evening (once daily): 6.25 ml
Body Weight 24–27 kg
Daily dose: 13–16 mg per kg body weight
- First 3 months:
- Morning: 2.5 ml
- Midday: 2.5 ml
- Evening: 2.5 ml
- Subsequently:
- Evening (once daily): 7.5 ml
Body Weight 28–31 kg
Daily dose: 14–16 mg per kg body weight
- First 3 months:
- Morning: 1.25 ml
- Midday: 2.5 ml
- Evening: 5 ml
- Subsequently:
- Evening (once daily): 8.75 ml
Body Weight 32–39 kg
Daily dose: 12–16 mg per kg body weight
- First 3 months:
- Morning: 2.5 ml
- Midday: 2.5 ml
- Evening: 5 ml
- Subsequently:
- Evening (once daily): 10 ml
Body Weight 40–47 kg
Daily dose: 13–16 mg per kg body weight
- First 3 months:
- Morning: 2.5 ml
- Midday: 5 ml
- Evening: 5 ml
- Subsequently:
- Evening (once daily): 12.5 ml
Body Weight 48–62 kg
Daily dose: 12–16 mg per kg body weight
- First 3 months:
- Morning: 5 ml
- Midday: 5 ml
- Evening: 5 ml
- Subsequently:
- Evening (once daily): 15 ml
Body Weight 63–80 kg
Daily dose: 12–16 mg per kg body weight
- First 3 months:
- Morning: 5 ml
- Midday: 5 ml
- Evening: 10 ml
- Subsequently:
- Evening (once daily): 20 ml
Body Weight 81–95 kg
Daily dose: 13–16 mg per kg body weight
- First 3 months:
- Morning: 5 ml
- Midday: 10 ml
- Evening: 10 ml
- Subsequently:
- Evening (once daily): 25 ml
Body Weight 96–115 kg
Daily dose: 13–16 mg per kg body weight
- First 3 months:
- Morning: 10 ml
- Midday: 10 ml
- Evening: 10 ml
- Subsequently:
- Evening (once daily): 30 ml
Body Weight over 115 kg
Daily dose: Not specified
- First 3 months:
- Morning: 10 ml
- Midday: 10 ml
- Evening: 15 ml
- Subsequently:
- Evening (once daily): 35 ml
Duration of treatment
Take this medicine regularly. Ursodeoxycholic acid may be continued indefinitely in cases of primary biliary cholangitis.
To dissolve cholesterol gallstones
The recommended dose is approximately 10 mg per kg body weight daily as follows:
Body Weight 5-7 kg:
Body Weight 8-12 kg:
Body Weight 13-18 kg:
Body Weight 19-25 kg:
Body Weight 26-35 kg:
Body Weight 36-50 kg:
Body Weight 51-65 kg:
Body Weight 66-80 kg:
Body Weight 81-100 kg:
Body Weight Over 100 kg:
Take the suspension in the evening at bedtime. Take the suspension regularly.
Duration of treatment
It generally takes 6-24 months to dissolve gallstones. If there is no reduction in the size of the gallstones after 12 months, therapy should be stopped.
Every 6 months, your doctor should check whether the treatment is working. At each of these follow-up examinations, it should be checked whether a build-up of calcium causing hardening of the stones has occurred since the last time. If this happens, your doctor will stop the treatment.
Both indications:
Use in children and adolescents:
The administration of ursodeoxycholic acid is based on body weight and the condition being treated.
Use in children (1 month to 18 years) for treatment of liver disease associated with cystic fibrosis
The recommended daily dose is 20 mg per kg body weight, divided in 2-3 doses. Your doctor may want to increase the dose further to 30 mg per kg body weight daily if necessary.
Single doses for children with a body weight up to 10 kg should be given with an oral syringe as the spoon provided does not cover volumes below 1.25 ml. Use a 2 ml oral syringe with a graduation of 0.1 ml.
Please note: Oral syringes are not included in the pack but may be purchased from your pharmacist.
To administer the required dose by syringe:
1. Shake the bottle well before opening
2. Pour a small amount of suspension into a glass
3. Draw the appropriate volume into the syringe
4. Tap against the barrel of the syringe to remove any large air bubbles
5. Check the appropriate volume of suspension is in the syringe, adjust if necessary
6. Carefully dispense the syringe contents directly into the child’s mouth
7. Wash the syringe with water after each use and allow it to dry completely before you next use it.
Do NOT put the syringe into the bottle. Do NOT put unused suspension from the syringe or the glass back into the bottle.
Up to 10 kg body weight: Dosing 20 mg ursodeoxycholic acid/kg/day
Measuring device: 2 ml graduated oral syringe (not provided).
Body Weight 4 kg:
- Morning: 0.8 ml
- Evening: 0.8 ml
Body Weight 4.5 kg:
- Morning: 0.9 ml
- Evening: 0.9 ml
Body Weight 5 kg:
- Morning: 1.0 ml
- Evening: 1.0 ml
Body Weight 5.5 kg:
- Morning: 1.1 ml
- Evening: 1.1 ml
Body Weight 6 kg:
- Morning: 1.2 ml
- Evening: 1.2 ml
Body Weight 6.5 kg:
- Morning: 1.3 ml
- Evening: 1.3 ml
Body Weight 7 kg:
- Morning: 1.4 ml
- Evening: 1.4 ml
Body Weight 7.5 kg:
- Morning: 1.5 ml
- Evening: 1.5 ml
Body Weight 8 kg:
- Morning: 1.6 ml
- Evening: 1.6 ml
Body Weight 8.5 kg:
- Morning: 1.7 ml
- Evening: 1.7 ml
Body Weight 9 kg:
- Morning: 1.8 ml
- Evening: 1.8 ml
Body Weight 9.5 kg:
- Morning: 1.9 ml
- Evening: 1.9 ml
Body Weight 10 kg:
- Morning: 2.0 ml
- Evening: 2.0 ml
The spoon provided can be used for children over 10 kg body weight.
More than 10 kg body weight: Dosing 20-25 mg ursodeoxycholic acid/kg/day
Measuring device: Spoon
Body Weight 11–12 kg
Daily dose: 21–23 mg per kg body weight
- Morning: 2.5 ml
- Evening: 2.5 ml
Body Weight 13–15 kg
Daily dose: 21–24 mg per kg body weight
- Morning: 2.5 ml
- Evening: 3.75 ml
Body Weight 16–18 kg
Daily dose: 21–23 mg per kg body weight
- Morning: 3.75 ml
- Evening: 3.75 ml
Body Weight 19–21 kg
Daily dose: 21–23 mg per kg body weight
- Morning: 3.75 ml
- Evening: 5 ml
Body Weight 22–23 kg
Daily dose: 22–23 mg per kg body weight
- Morning: 5 ml
- Evening: 5 ml
Body Weight 24–26 kg
Daily dose: 22–23 mg per kg body weight
- Morning: 5 ml
- Evening: 6.25 ml
Body Weight 27–29 kg
Daily dose: 22–23 mg per kg body weight
- Morning: 6.25 ml
- Evening: 6.25 ml
Body Weight 30–32 kg
Daily dose: 21–23 mg per kg body weight
- Morning: 6.25 ml
- Evening: 7.5 ml
Body Weight 33–35 kg
Daily dose: 21–23 mg per kg body weight
- Morning: 7.5 ml
- Evening: 7.5 ml
Body Weight 36–38 kg
Daily dose: 21–23 mg per kg body weight
- Morning: 7.5 ml
- Evening: 8.75 ml
Body Weight 39–41 kg
Daily dose: 21–22 mg per kg body weight
- Morning: 8.75 ml
- Evening: 8.75 ml
Body Weight 42–47 kg
Daily dose: 20–22 mg per kg body weight
- Morning: 8.75 ml
- Evening: 10 ml
Body Weight 48–56 kg
Daily dose: 20–23 mg per kg body weight
- Morning: 11.25 ml
- Evening: 11.25 ml
Body Weight 57–68 kg
Daily dose: 20–24 mg per kg body weight
- Morning: 13.75 ml
- Evening: 13.75 ml
Body Weight 69–81 kg
Daily dose: 20–24 mg per kg body weight
- Morning: 16.25 ml
- Evening: 16.25 ml
Body Weight 82–100 kg
Daily dose: 20–24 mg per kg body weight
- Morning: 20 ml
- Evening: 20 ml
Body Weight >100 kg
Daily dose: Not specified
- Morning: 22.5 ml
- Evening: 22.5 ml
Conversion table:
5 ml is equivalent to 250 mg of ursodeoxycholic acid
3.75 ml is equivalent to 187.5 mg of ursodeoxycholic acid
2.5 ml is equivalent to 125 mg of ursodeoxycholic acid
1.25 ml is equivalent to 62.5 mg of ursodeoxycholic acid
Take your medicine two to three times per day, as advised. Take this medicine regularly.
Duration of treatment
Treatment can be continued long term (up to 18 years) in children with cystic fibrosis associated hepatobiliary disorders.
If you feel that the effect of this medicine is too strong or too weak, please talk to your doctor or pharmacist.
Method of administration
For oral administration.
Always shake the closed bottle 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. Pour the suspension into the spoon to the required dose – see diagram below – and then swallow the medicine. Repeat as required for further doses. Ensure you rinse the spoon with water after each use and allow to dry. 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).
This medicine can be administered via a gastric, duodenal or nasal feeding tube if required. Larger tubes should be rinsed twice with at least 10 ml of water following administration while smaller tubes should be rinsed at least once with a minimum of 3 ml of water.
If you take more DEOXXA than you should, you are likely to suffer from diarrhoea. If you or anyone else take more of this medicine than you should, contact your doctor or nearest hospital casualty department as soon as possible. Take the bottle and this leaflet with you so the medical staff will know what you have taken.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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