ProUrsan Dosage/Direction for Use

Posology: Adults: Dissolution of cholesterol gallstones: The recommended dose in adult patients is 2 to 5 capsules daily dependent on the body weight (10 mg/kg/day).
The total daily dose should be administered as one single dose, in the evening before going to bed. ProUrsan needs to be taken regularly. (See table.)

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The duration and efficacy of treatment are dependent on the size of gallstones and compliance of patient and it usually lasts from 6 to 24 months. If no reduction of the size of gallstones occurs within one year of treatment, it is recommended not to continue the treatment. During the first 3 months of treatment it is necessary to regularly monitor serum aminotransferases in regular 4-week intervals. If abnormal values are found, it is recommended to temporarily reduce ProUrsan dosage. Dissolution of gallstones has to be ultrasonically monitored at least in 6-month intervals. After the gallstones are dissolved, it is recommended to continue the treatment for another 3 months to ensure total dissolution of gallstones.
Primary biliary cirrhosis stage I and II and other conditions associated with intrahepatic cholestasis: The daily dose depends on the body weight and usually is 10-15 mg/kg/day (i.e. 2-6 capsules) taken in 2-3 divided doses.
Reactive gastritis in duodenogastric reflux: The recommended dose is 1 capsule (250 mg) daily, administered in the evening before going to bed. The recommended duration of ProUrsan treatment in this indication is 10-14 days.
Dosage regimen in children over the age of 2 years is individual. The usual recommended dose is 10-20 mg/kg/day. Slightly increased dose is necessary to compensate for reduced intestinal absorption. A different drug form is suitable for children younger than 6 years.
Paediatric population: Children and adolescents with cystic fibrosis aged 6 years to 18 years: 20 mg/kg/day should be administered in 2 to 3 divided doses, with a further increase to 30 mg/kg/ day if necessary.
Method of administration: The capsules should be swallowed whole and not chewed, with a sufficient amount of fluids.