Ursomax capsules are used for the following indications:
for the dissolution of radiopaque cholesterol gallstones no larger than 15 mm in diameter in patients with a functioning gallbladder, despite the presence of gallstone(s); for the treatment of biliary reflux gastritis; for the symptomatic treatment of primary biliary cirrhosis (PBC) in the absence of decompensated liver cirrhosis; for the treatment of hepatobiliary disorders in cystic fibrosis in children aged 6 to 18 years.
Composition
The active ingredient is ursodeoxycholic acid (one capsule contains 250 mg of ursodeoxycholic acid (calculated on 100% dry matter).
Excipients: corn starch, hydroxypropylcellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, gelatin.
Contraindication
Hypersensitivity to any of the ingredients of the drug; acute inflammation of the gallbladder or bile ducts; bile duct obstruction (obstruction of the common bile duct or cystic duct); frequent episodes of hepatic colic; radiopaque calcified gallstones; impaired gallbladder contractility; unsuccessful portoenterostomy outcome or lack of adequate bile outflow in children with biliary atresia.
Method of application
There are no age restrictions on the use of Ursomax. For patients whose body weight is less than 47 kg or who have difficulty swallowing Ursomax capsules, another dosage form of ursodeoxycholic acid is available - suspension.
To dissolve cholesterol gallstones
Approximately 10 mg ursodeoxycholic acid/kg body weight:
up to 60 kg - two capsules; 61-80 kg - 3 capsules; 81-100 kg - 4 capsules; over 100 kg - 5 capsules.
Capsules should be taken without chewing, with water, once a day in the evening before bedtime.
The drug should be taken regularly.
The time required for gallstones to dissolve is usually 6-24 months. If a reduction in the size of gallstones is not observed after 12 months of treatment, it is not advisable to continue therapy.
The effectiveness of the treatment should be checked every 6 months by ultrasound or X-ray. Additional studies should be performed to check whether calcification of the stones has occurred or not. If this occurs, treatment should be discontinued.
For the treatment of biliary reflux gastritis
One capsule of the drug "Ursomax" once a day with some liquid in the evening before bedtime.
Usually, for the treatment of gastritis with reflux, Ursomax bile capsules are taken for 10-14 days. The duration of treatment depends on the patient's condition. The doctor must decide on the duration of treatment in each case individually.
For symptomatic treatment of primary biliary cirrhosis
The daily dose depends on body weight and varies from 3 to 7 capsules (14 ± 2 mg ursodeoxycholic acid / kg body weight).
In the first 3 months of treatment, Ursomax capsules should be taken by dividing the daily dose into 3 doses during the day. With improvement in liver function, the daily dose can be taken once a day in the evening.
The capsules should be swallowed whole with liquid. It is necessary to observe regularity of administration.
The use of Ursomax capsules in primary biliary cirrhosis can be unlimited in time.
In patients with primary biliary cirrhosis, in some cases, clinical symptoms may worsen after the start of treatment, for example, itching may increase. If this occurs, therapy should be continued by taking one capsule of Ursomax per day, after which the dose should be gradually increased (increasing the daily dose by one capsule each week) until the prescribed dosage regimen is reached.
Use in children
For children with cystic fibrosis aged 6 to 18 years, the dose is 20 mg/kg/day and is divided into 2-3 doses, with a subsequent increase in the dose to 30 mg/kg/day if necessary.
Application features
Pregnant women
Ursomax capsules should not be used during pregnancy unless clearly necessary. Women of childbearing age should only take the drug if they are using reliable contraception.
According to several recorded cases of use of the drug by breastfeeding mothers, the content of ursodeoxycholic acid in breast milk was extremely low, so no adverse effects should be expected in children receiving such milk.
Drivers
No effect on the ability to drive and use machines was observed.
Overdose
In cases of overdose, diarrhea may occur. Other symptoms of overdose are unlikely, since the absorption of ursodeoxycholic acid decreases with increasing dose, and therefore most of it is excreted in the feces.
If diarrhea occurs, the dose should be reduced, and in cases of persistent diarrhea, therapy should be discontinued.
There is no need for specific measures, and the effects of diarrhea should be treated symptomatically, with restoration of fluid and electrolyte balance.
Side effects
Gastrointestinal disorders: Cases of pasty stools or diarrhea have been reported during treatment with ursodeoxycholic acid.
During the treatment of advanced stages of primary biliary cirrhosis, decompensation of liver cirrhosis is very rarely observed, which partially regresses after discontinuation of treatment.
Immune system disorders: very rarely, allergic reactions are possible, which include rash, urticaria.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 3 years.
