Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: AS Grindeks, Krustpils Iela 53, Riga, 1057, Latvia
Dissolution of cholesterol gallstones in patients:
Primary biliary cholangitis (PBC, also known as primary biliary cirrhosis).
Hepatobiliary disorders as a result of cystic fibrosis in children and adolescents aged 6 to 18 years.
The recommended daily dose is 8‑10 mg/kg body weight of ursodeoxycholic acid, equivalent to 2‑4 capsules, to be taken with a meal as follows:
OR
take a daily dose of 2-4 capsules in the evening before bedtime.
The duration of the dissolution process with this medicinal product is 6 months to 2 years, depending on the initial size of the stones. For a proper assessment of the therapeutic outcome, it is necessary, at the start of treatment, to accurately determine the size of the existing stones and subsequently to monitor them regularly, for example, every 3‑4 months, via new X-rays and/or ultrasound scans.
In patients whose stones have not decreased in size after 6 months of treatment at the dosage stated, it is recommended that the biliary lithogenic index be determined via duodenal drainage. If the bile has an index of >1.0, it is unlikely that a favourable outcome can be obtained and it is better to consider a different form of treatment for gallstones. Treatment must be continued for 3 to 4 months after ultrasound follow-up has confirmed complete dissolution of the gallstones.
Discontinuation of treatment for 3‑4 weeks leads to a return of bile supersaturation and prolongs the overall duration of therapy. Discontinuation of treatment after dissolution of the gallstones may be followed by a relapse.
The daily dose depends on body weight and ranges from 12‑16 mg/kg body weight of ursodeoxycholic acid (3‑7 capsules). During the first 3 months of treatment this medicinal product should be taken in divided doses throughout the day. If liver function improves, the total daily dose can be taken once daily in the evening.
In combination with increased serum bilirubin levels (>40 microg/L; conjugated), only half the normal dosage (see dosage for stages I‑III) should initially be given (6‑8 mg/kg/day of ursodeoxycholic acid, equivalent to about 2‑3 capsules).
Thereafter, liver function should be properly monitored for several weeks (once every 2 weeks for 6 weeks). If there is no deterioration in liver function (AP, ALAT, ASAT, gamma-GT, bilirubin) and if no increase in pruritus occurs, the dosage can be increased further to the usual level. However, liver function should again be closely monitored for several weeks. Once again, if there is no deterioration in liver function, the patient can be maintained at the normal dosage over the long term.
Patients with primary biliary cholangitis (stage IV) without increased serum bilirubin levels are permitted to receive the normal starting dose immediately (see dosage stages I‑III).
However, close monitoring of liver function, as described above, is likewise applicable in such cases; treatment of PBC will need to be regularly assessed on the basis of liver parameters (laboratory) and clinical findings. The use of this medicinal product in PBC is not limited in term of time.
Children and adolescents with cystic fibrosis aged 6 to 18 years: 20 mg/kg/day of ursodeoxycholic acid in 2 to 3 divided doses, with an increase up to 30 mg/kg/day if necessary.
| Body weight (kg) | Daily dose (mg/kg body weight) | Ursogrix 250 mg hard capsules | ||
|---|---|---|---|---|
| Morning | Afternoon | Evening | ||
| 20‑29 | 17‑25 | 1 | -- | 1 |
| 30‑39 | 19‑25 | 1 | 1 | 1 |
| 40‑49 | 20‑25 | 1 | 1 | 2 |
| 50‑59 | 21‑25 | 1 | 2 | 2 |
| 60‑69 | 22‑25 | 2 | 2 | 2 |
| 70‑79 | 22‑25 | 2 | 2 | 3 |
| 80‑89 | 22‑25 | 2 | 3 | 3 |
| 90‑99 | 23‑25 | 3 | 3 | 3 |
| 100‑109 | 23‑25 | 3 | 3 | 4 |
| >110 | 3 | 4 | 4 | |
For oral use.
The capsules should be swallowed whole with some liquid. The medicine should be used regularly. For patients weighing less than 47 kg or patients who are unable to swallow <Product name>, other formulations with ursodeoxycholic acid are available.
Diarrhoea may occur in the event of overdose. In general, other symptoms of overdose are unlikely, as the absorption of this medicinal product decreases with increasing dose and therefore more is excreted with the faeces.
No specific measures are needed and the consequences of diarrhoea must be treated symptomatically with restoration of the fluid and electrolyte balance.
Long-term use of high this medicinal product doses (28-30 mg/kg/day) in patients with primary sclerosing cholangitis (off-label use) was associated with an increase in severe adverse reactions.
4 years.
Do not store above 30°C.
Store in the original packaging material in order to protect from moisture.
The capsules are packed in PVC/aluminium blisters.
10 capsules per blister. 5, 6 or 10 blisters (50, 60 or 100 capsules) are packed per cardboard box.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
