Ursodez
Ursodez
(
Ursodez
) is a medicinal product, a hepatoprotector with choleretic and cholelitholytic effects.
Ursodez dosage forms and composition
Ursodez is available in the form of capsules, each of which contains 250 mg of the active substance - ursodeoxycholic acid. Excipients of Ursodez: gelatin, starch 1500, colloidal silicon dioxide, magnesium stearate, titanium dioxide.
Indications for use of Ursodez
- bile reflux gastritis and reflux esophagitis
- symptomatic treatment of primary biliary cirrhosis in the absence of signs of decompensation
- dissolution of small and medium-sized cholesterol stones with a functioning gallbladder
How to take Ursodez and dosage
Ursodez is taken orally with water, once a day, before bedtime (unless otherwise indicated below or by your doctor). It is not recommended to chew Ursodez capsules. The dose depends on the diagnosis:
- reflux gastritis and reflux esophagitis with bile reflux: Ursodez is taken one capsule at a time, the duration of therapy is determined by the doctor, it usually lasts from 10 days to 14 days, but can be up to two years
- symptomatic treatment of primary biliary cirrhosis: daily dose of two to six capsules (10 to 15 mg per kg of patient weight), duration of treatment - from 6 months to several years; Ursodez is taken with food and a sufficient amount of liquid.
- dissolution of cholesterol gallstones: the daily dose of Ursodez is from 10 to 15 mg per kg of patient weight; duration of treatment - from 6 to 12 months; To prevent the formation of new stones, it is recommended to take Ursodez for several months after the stones have dissolved.
Contraindications to the use of Ursodez
Ursodesis is contraindicated for use in the following cases:
- hypersensitivity to the components of Ursodez
- gallstones with high calcium content
- non-functioning gallbladder
- acute inflammatory diseases of the gallbladder, bile ducts and intestines
- liver cirrhosis in the stage of decompensation
- severe dysfunction of the kidneys, liver, pancreas
- patient weight less than 34 kg
- pregnancy and breastfeeding period.
Professional medical publications addressing the use of Ursodez
- Osadchuk A.M., Davydkin I.L. Optimization of treatment of refractory form of gastroesophageal reflux disease based on the use of Ursodez // Experimental and clinical gastroenterology. — 2012. - N 4. - pp. 74-75.
On the website gastroscan.ru in the literature catalog there is a section “Gastroprotectors, cytoprotectors, hepatoprotectors”, containing articles concerning the treatment of the gastrointestinal tract with ursodeoxycholic acid preparations.
Use of Ursodez by pregnant and nursing mothers
Ursodez (ursodeoxycholic acid) when used by pregnant women has a risk category for the fetus according to the FDA B (animal studies have not revealed the risk of negative effects on the fetus; there have been no adequate studies in pregnant women).
Due to the lack of data on the penetration of ursodeoxycholic acid into breast milk, breastfeeding should be discontinued during Ursodez therapy.
Pharmacokinetics
The pharmacokinetics of Ursodez and other properties are determined by its active substance, ursodeoxycholic acid, and are described in the article “Ursodeoxycholic acid”.
Interaction of Ursodez with other drugs
Ursodez is not used simultaneously with antacids containing aluminum and ion exchange resins, as they interfere with the absorption of ursodeoxycholic acid.
When used concomitantly, lipid-lowering drugs, estrogens, neomycin or gestagens (oral contraceptives) increase the saturation of bile with cholesterol and may reduce the ability of ursodeoxycholic acid to dissolve cholesterol gallstones.
Ursodesis may increase the absorption of cyclosporine from the intestine, which requires monitoring the concentration of cyclosporine in the blood and, if necessary, changing its dosage regimen.
Sometimes Ursodez can reduce the absorption of ciprofloxacin.
Side effects of Ursodez
When treating primary biliary cirrhosis with Ursodez, transient decompensation of liver cirrhosis is possible, which disappears after discontinuation of the drug.
The following complications are possible: calcification of gallstones, increased activity of liver transaminases, diarrhea, nausea, chest pain.
general information
According to the pharmacological index, Ursodez belongs to the groups “Hepatoprotectors” and “Cholagogues and bile preparations”.
By ATC - to group “A05. Drugs for the treatment of diseases of the liver and biliary tract" and has the code "A05AA02 Ursodeoxycholic acid". Ursodez is a prescription drug.
, Russia.
Other medicines
based on ursodeoxycholic acid: Grinterol, Livodexa, Urdoxa, Urso 100, Ursodex, Uroliv, Ursorom Rompharm, Ursorom S, Ursosan, Ursodeoxycholic acid, Ursofalk, Choludexan, Exhol.
Ursodez has contraindications, side effects and application features; consultation with a specialist is necessary.
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Ursodez caps 250 mg N100 (Northern Star)
Children and adults weighing less than 47 kg are recommended to use ursodeoxycholic acid preparations in the form of a suspension.
Dissolution of cholesterol gallstones
The recommended dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight per day, which corresponds to:
| Body mass | Capsules |
| Up to 60 kg | 2 |
| 61-80 kg | 3 |
| 81-100 kg | 4 |
| Over 100 kg | 5 |
The drug must be taken daily in the evening, before bed (the capsules are not chewed), with a small amount of liquid.
Duration of treatment is 6-12 months. To prevent recurrent cholelithiasis, it is recommended to take the drug for several months after the stones have dissolved.
Treatment of biliary reflux gastritis
1 capsule of Ursodez® daily in the evening before bed, without chewing and with a small amount of water.
The course of treatment is from 10-14 days to 6 months, if necessary - up to 2 years.
Treatment of primary biliary cirrhosis
The daily dose depends on body weight and will range from 3 to 7 capsules (approximately 14 ± 2 mg ursodeoxycholic acid per 1 kg of body weight).
In the first 3 months of treatment, taking Ursodez® 250 mg capsules should be divided into several doses throughout the day. After improvement of liver parameters, the daily dose of the drug can be taken once in the evening.
The following mode of application is recommended:
| Body mass | Ursodez® capsules 250 mg | |||
| First 3 months of treatment | Subsequently | |||
| Morning | Day | Evening | Evening (1 per day) | |
| 47-62 kg | 1 | 1 | 1 | 3 |
| 63-78 kg | 1 | 1 | 2 | 4 |
| 79-93 kg | 1 | 2 | 2 | 5 |
| 94-109 kg | 2 | 2 | 2 | 6 |
| Over 110 kg | 2 | 2 | 3 | 7 |
Capsules should be taken regularly, without chewing, with a small amount of liquid.
The use of Ursodez® for the treatment of primary biliary cirrhosis can be continued indefinitely.
In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may worsen at the beginning of treatment, for example, itching may become more frequent. In this case, treatment should be continued, taking one capsule daily, then the dosage should be gradually increased, increasing the daily dose by one capsule weekly, until the recommended dosage regimen is achieved again.
Symptomatic treatment of chronic hepatitis of various origins is a daily dose of 10-15 mg/kg in 2-3 doses. Duration of treatment is 6-12 months or more.
Primary sclerosing cholangitis - daily dose 12-15 mg/kg; if necessary, the dose can be increased to 20-30 mg/kg in 2-3 doses. The duration of therapy ranges from 6 months to several years (see section: “Special instructions”).
Cystic fibrosis (cystic fibrosis) - daily dose of 20 mg/kg/day in 2-3 doses, with a further increase to 30 mg/kg/day if necessary
| Body weight (kg) | Daily dose (mg/kg body weight) | Ursodez® capsules 250 mg | ||
| Morning | Day | 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 | |
Non-alcoholic steatohepatitis - average daily dose of 10-15 mg/kg in 2-3 doses. The duration of therapy ranges from 6-12 months or more.
Alcoholic liver disease - average daily dose of 10-15 mg/kg in 2-3 doses. The duration of therapy ranges from 6-12 months or more.
Biliary dyskinesia - average daily dose of 10 mg/kg in 2 divided doses for 2 weeks to 2 months. If necessary, it is recommended to repeat the course of treatment.
Ursodez®
Children and adults weighing less than 47 kg are recommended to use ursodeoxycholic acid preparations in the form of a suspension.
Dissolution of cholesterol gallstones
The recommended dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight per day, which corresponds to:
| Body mass | Capsules |
| Up to 60 kg | 2 |
| 61-80 kg | 3 |
| 81-100 kg | 4 |
| Over 100 kg | 5 |
The drug must be taken daily in the evening, before bed (the capsules are not chewed), with a small amount of liquid.
Duration of treatment is 6-12 months. To prevent recurrent cholelithiasis, it is recommended to take the drug for several months after the stones have dissolved.
Treatment of biliary reflux gastritis
1 capsule of Ursodez® daily in the evening before bed, without chewing and with a small amount of water.
The course of treatment is from 10-14 days to 6 months, if necessary - up to 2 years.
Treatment of primary biliary cirrhosis
The daily dose depends on body weight and will range from 3 to 7 capsules (approximately 14 ± 2 mg ursodeoxycholic acid per 1 kg of body weight).
In the first 3 months of treatment, taking Ursodez® 250 mg capsules should be divided into several doses throughout the day. After improvement of liver parameters, the daily dose of the drug can be taken once in the evening.
The following mode of application is recommended:
| Body mass | Ursodez® capsules 250 mg | |||
| First 3 months of treatment | Subsequently | |||
| Morning | Day | Evening | Evening (1 per day) | |
| 47-62 kg | 1 | 1 | 1 | 3 |
| 63-78 kg | 1 | 1 | 2 | 4 |
| 79-93 kg | 1 | 2 | 2 | 5 |
| 94-109 kg | 2 | 2 | 2 | 6 |
| Over 110 kg | 2 | 2 | 3 | 7 |
Capsules should be taken regularly, without chewing, with a small amount of liquid.
The use of Ursodez® for the treatment of primary biliary cirrhosis can be continued indefinitely.
In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may worsen at the beginning of treatment, for example, itching may become more frequent. In this case, treatment should be continued, taking one capsule daily, then the dosage should be gradually increased, increasing the daily dose by one capsule weekly, until the recommended dosage regimen is achieved again.
Symptomatic treatment of chronic hepatitis of various origins -
daily dose 10-15 mg/kg in 2-3 doses. Duration of treatment is 6-12 months or more.
Primary sclerosing cholangitis
— daily dose 12-15 mg/kg; if necessary, the dose can be increased to 20-30 mg/kg in 2-3 doses. The duration of therapy ranges from 6 months to several years (see section: “Special instructions”).
Cystic fibrosis (cystic fibrosis) -
daily dose 20 mg/kg/day in 2-3 divided doses, with a further increase to 30 mg/kg/day if necessary
| Body weight (kg) | Daily dose (mg/kg body weight) | Ursodez® capsules 250 mg | ||
| Morning | Day | 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 | |
Non-alcoholic steatohepatitis -
the average daily dose is 10-15 mg/kg in 2-3 doses. The duration of therapy ranges from 6-12 months or more.
Alcoholic liver disease -
the average daily dose is 10-15 mg/kg in 2-3 doses. The duration of therapy ranges from 6-12 months or more.
Biliary dyskinesia -
the average daily dose is 10 mg/kg in 2 divided doses for 2 weeks to 2 months. If necessary, it is recommended to repeat the course of treatment.
Ursodez, 250 mg, capsules, 10 pcs.
Inside.
Dissolution of cholesterol gallstones.
The recommended (approximate) dose of UDCA is 10 mg/kg/day. The drug should be taken without chewing, with a small amount of liquid, in the evening, before bedtime. It usually takes 6–24 months for gallstones to dissolve. If after 12 months of treatment the size of the stones does not decrease, then treatment should be stopped.
The effectiveness of treatment should be assessed every 6 months with ultrasound or radiography. During the interim examination, it is necessary to assess whether calcification of the stones has occurred during the intervening period. If stones become calcified, treatment should be discontinued.
To prevent recurrent cholelithiasis, it is recommended to take the drug for several months after the stones have dissolved.
Treatment of biliary reflux gastritis.
1 caps. (250 mg) of Ursodez® daily in the evening before bed, with a small amount of water. The course of treatment is from 10–14 days to 6 months, if necessary – up to 2 years.
Symptomatic treatment of primary biliary cirrhosis.
The daily dose depends on body weight and ranges from 2 to 6 caps. 250 mg or 1-3 caps. 500 mg (approximately 10 to 15 mg/kg UDCA) in 2-3 doses for the first 3 months of treatment. After improving the functional parameters of the liver, the daily dose can be used 1 time, in the evening. The duration of treatment is not limited. In rare cases, at the beginning of treatment, clinical symptoms may worsen (itching may become more frequent). In this case, the daily dose should be reduced (to 250 mg), and then gradually increased (increasing the daily dose weekly) until the recommended dosage regimen is achieved.
Chronic hepatitis of various origins, non-alcoholic steatohepatitis and alcoholic liver disease.
The average daily dose is 10 to 15 mg/kg UDCA in 2–3 divided doses. The duration of therapy is 6–12 months or more.
Primary sclerosing cholangitis.
12–15 mg/kg/day (up to 20 mg/kg/day) in 2–3 divided doses. Duration of use - from 6 months to several years.
Cystic fibrosis (cystic fibrosis).
20–30 mg/kg/day in 2–3 divided doses. Duration of use - from 6 months to several years.
Biliary dyskinesia.
The average daily dose is 10 mg/kg UDCA in 2 divided doses for 2 weeks to 2 months. If necessary, the course of treatment is repeated. The daily dosage regimen is determined by the doctor.
Calculation of the daily number of capsules depending on the patient’s body weight and the recommended dose of the drug per 1 kg of body weight
| Body weight, kg | Number of capsules per dose, pcs. | ||||
| 10 mg/kg/day | 12 mg/kg/day | 15 mg/kg/day | 20 mg/kg/day | 30 mg/kg/day | |
| 34–35 | 1 caps. 250 mg | 2 caps. 250 mg or 1 capsule. 500 mg each | 2 caps. 250 mg or 1 capsule. 500 mg each | 3 caps. 250 mg each | 4 caps. 250 mg or 2 caps. 500 mg each |
| 36–40 | 2 caps. 250 mg or 1 capsule. 500 mg each | 2 caps. 250 mg or 1 capsule. 500 mg each | 2 caps. 250 mg or 1 capsule. 500 mg each | 3 caps. 250 mg each | 5 caps. 250 mg each |
| 41–45 | 2 caps. 250 mg or 1 capsule. 500 mg each | 2 caps. 250 mg or 1 capsule. 500 mg each | 3 caps. 250 mg each | 4 caps. 250 mg or 2 caps. 500 mg each | 5 caps. 250 mg each |
| 46–50 | 2 caps. 250 mg or 1 capsule. 500 mg each | 2 caps. 250 mg or 1 capsule. 500 mg each | 3 caps. 250 mg each | 4 caps. 250 mg or 2 caps. 500 mg each | 6 caps. 250 mg or 3 caps. 500 mg each |
| 51–55 | 2 caps. 250 mg or 1 capsule. 500 mg each | 3 caps. 250 mg each | 3 caps. 250 mg each | 4 caps. 250 mg or 2 caps. 500 mg each | 7 caps. 250 mg each |
| 56–60 | 2 caps. 250 mg or 1 capsule. 500 mg each | 3 caps. 250 mg each | 4 caps. 250 mg or 2 caps. 500 mg each | 5 caps. 250 mg each | 7 caps. 250 mg each |
| 61–65 | 3 caps. 250 mg each | 3 caps. 250 mg each | 4 caps. 250 mg or 2 caps. 500 mg each | 5 caps. 250 mg each | 8 caps. 250 mg or 4 caps. 500 mg each |
| 66–70 | 3 caps. 250 mg each | 3 caps. 250 mg each | 4 caps. 250 mg or 2 caps. 500 mg each | 6 caps. 250 mg or 3 caps. 500 mg each | 8 caps. 250 mg or 4 caps. 500 mg each |
| 71–75 | 3 caps. 250 mg each | 4 caps. 250 mg or 2 caps. 500 mg each | 5 caps. 250 mg each | 6 caps. 250 mg or 3 caps. 500 mg each | 9 caps. 250 mg each |
| 76–80 | 3 caps. 250 mg each | 4 caps. 250 mg or 2 caps. 500 mg each | 5 caps. 250 mg each | 6 caps. 250 mg or 3 caps. 500 mg each | 10 caps. 250 mg or 5 caps. 500 mg each |
| 81–85 | 3 caps. 250 mg each | 4 caps. 250 mg or 2 caps. 500 mg each | 5 caps. 250 mg each | 7 caps. 250 mg each | 10 caps. 250 mg or 5 caps. 500 mg each |
| 86–90 | 4 caps. 250 mg or 2 caps. 500 mg each | 4 caps. 250 mg or 2 caps. 500 mg each | 5 caps. 250 mg each | 7 caps. 250 mg each | 11 caps. 250 mg each |
| 91–95 | 4 caps. 250 mg or 2 caps. 500 mg each | 5 caps. 250 mg each | 6 caps. 250 mg or 3 caps. 500 mg each | 8 caps. 250 mg or 4 caps. 500 mg each | 11 caps. 250 mg each |
| 96–100 | 4 caps. 250 mg or 2 caps. 500 mg each | 5 caps. 250 mg each | 6 caps. 250 mg or 3 caps. 500 mg each | 8 caps. 250 mg or 4 caps. 500 mg each | 12 caps. 250 mg or 5 caps. 500 mg each |
| 101–105 | 4 caps. 250 mg or 2 caps. 500 mg each | 5 caps. 250 mg each | 6 caps. 250 mg or 3 caps. 500 mg each | 8 caps. 250 mg or 4 caps. 500 mg each | 13 caps. 250 mg each |
| 106–110 | 4 caps. 250 mg or 2 caps. 500 mg each | 5 caps. 250 mg each | 7 caps. 250 mg each | 9 caps. 250 mg each | 13 caps. 250 mg each |
For children from 3 years old.
Individually, at the rate of 10–20 mg/kg/day.
