Ursodez caps. 250mg 50 pieces

Description

Composition
Active substance:
ursodeoxycholic acid – 250 mg
Excipients:
pregelatinized starch (starch 1500) – 73.0 mg, colloidal silicon dioxide (Aerosil) – 5.0 mg magnesium stearate – 2.0 mg Capsule shell: a housing lid and titanium dioxide – 2.1118% gelatin – 100 %
Description:
Solid, white opaque gelatin capsule. Capsules Size – № 0. Content capsules – a powder of white or almost white color.
Product form:
Packaging 50 capsules.
Contraindications
Rentgenpolozhitelnye (high calcium) gallstones; violation contractility of the gallbladder, biliary tract blockage (occlusion of the common bile duct or cystic duct), frequent episodes of biliary colic; acute inflammatory diseases of the gall bladder and bile ducts; cirrhosis of the liver decompensation; expressed hepatic and / or renal insufficiency, hypersensitivity to the drug or other bile acids.
Pediatric population
Poorly executed portoenterostomiya or absences restore normal bile flow in children with Biliary atresia.
Ursodeoxycholic acid has no age restrictions in the application, but for children under 3 years, it is recommended to apply UDCA preparations in the form of a suspension, since there may be difficulty in swallowing capsules.
Dosage
250 mg
Indications
The dissolution of cholesterol gallstones, biliary reflux gastritis, primary biliary cirrhosis with no signs of decompensation, chronic hepatitis of various genesis, primary sclerosing cholangitis, muko- vistsidoz (cystic fibrosis), nonalcoholic steatohepatitis, alcoholic liver disease, biliary dyskinesia.
Interaction with other drugs
Cholestyramine, colestipol, antacids that contain aluminum hydroxide or smectite (aluminum oxide), reduce the absorption of UDCA in the intestine and thus reduce its effectiveness and goglaschenie. If the use of preparations containing at least one of these substances is still necessary, they must be taken at least 2 hours before receiving Ursodez® preparation.
Ursodeoxycholic acid can affect cyclosporine absorption from the intestine. Therefore, in patients receiving cyclosporine, your doctor should check the concentration of cyclosporine in the blood and adjust the dose of cyclosporine if necessary.
In some cases Ursodez® can reduce the absorption of ciprofloxacin. Estrogenic hormones and drugs that reduce blood cholesterol levels, such as clofibrate, increase secretion of cholesterol in the liver and, therefore, may promote the formation of gallstones, which eliminates the effect of ursodeoxycholic acid, which is used for dissolving gallstones.
Overdose
If overdose is possible diarrhea. Typically, other symptoms of an overdose are unlikely, because with increasing doses of UDCA absorption decreases and, consequently, a greater amount of it is excreted in the faeces. Need to apply specific measures in overdose there. Treatment of symptomatic effects of diarrhea, aimed at filling the volume of fluid and electrolyte balance recovery.
pharmachologic effect
Pharmacological group:
hepatoprotective agent
Pharmacodynamics:
Hepatoprotective agent has choleretic effect. Decreases cholesterol synthesis in the liver, its absorption in the intestine and bile concentration raises the solubility of cholesterol in the biliary system, stimulates the production and secretion of bile. Decreases lithogenicity bile, it increases the content of bile acids; causes increased gastric and pancreatic secretion, increases lipase activity, exerts hypoglycemic action. Causes a partial or complete dissolution of cholesterol calculi in enteral application, decreases the saturation of bile with cholesterol, which contributes to the mobilization of cholesterol gallstones. Has immunomodulatory effects, influences the immunological reaction in the liver: decrease the expression of certain antigens on the membrane of hepatocytes, affects the amount of T-lymphocytes, interleukin-2, reduces the number of eosinophils.
Pharmacokinetics:
After ingestion ursodeoxycholic acid is rapidly absorbed in the jejunum and proximal ileum by passive diffusion, and in the distal ileum – due to active transport. It absorbed approximately 60-80% of the dose. After absorption of ursodeoxycholic acid is almost fully conjugated in the liver with glycine and taurine, and excreted in the bile. The first passage through the liver is metabolized to 60%.
Depending upon the daily dosage, and type of disease state of the liver, bile accumulates in larger or smaller number of ursodeoxycholic acid. At the same time there is a relative decrease in the content of other more lipophilic bile acids.
Under the action of intestinal bacteria ursodeoxycholic acid partially decomposes to form the 7-keto lithocholic acid and lithocholic. Lithocholic acid hepatotoxicity; in some species, it causes damage to the liver parenchyma. In humans, it is absorbed only in small quantities. In the process of metabolism occurs in the liver it sulfation, whereby it is rendered harmless even before it happens excretion into the bile and excreted in the faeces. UDCA half-life is from 3.5 to 5.8 days.
Pregnancy and breast-feeding
According to studies in animal ursodeoxycholic acid has no effect on fertility. Data on the effect of treatment with ursodeoxycholic acid on fertility in humans.
Data on the use of ursodeoxycholic acid in pregnant women are limited or absent. Animal studies have shown the presence of reproductive toxicity in the early stages of pregnancy. Ursodez® during pregnancy should not be used except in cases where it is clearly needed. The use of the drug in women having childbearing potential, is only possible if they are using reliable methods of contraception. It is recommended to use a non-hormonal contraceptives or oral contraceptives with low estrogen. However, patients receiving Ursodez® for dissolving gallstones, effective use hormonal contraceptives as well as hormonal oral may enhance the formation of gallstones. The possibility of pregnancy must be excluded before starting treatment.
According to several documented cases of ursodeoxycholic acid level in breast milk of women is very low and, therefore, the occurrence of adverse reactions in children during breastfeeding is not expected.
Conditions of supply of pharmacies
Prescription.
side effects
Assessment of adverse events based on the following classification:
Very frequent (> 1/10)
Frequent (> 1 / 100-
special instructions
Ursodez® the drug must be used under medical supervision. During the first three months of treatment should monitor liver function parameters: transaminase, alkaline phosphatase and gamma-glutamyl serum every 4 weeks, and then every 3 months. Controlling these parameters allows to identify liver disorders early on. Also, this applies to patients in the later stages of primary biliary cirrhosis. In addition, because you can quickly determine if the patient reacts with primary biliary cirrhosis to treatment.
In the application for the dissolution of cholesterol gallstones:
In order to assess progress in the treatment and early detection of signs of calcification of stones, depending on the size of the stones, gall bladder should be visualized (oral cholecystography) with a tour of blackouts in the “standing” and “lying on his back” (ultrasound) through 6 10 months after starting treatment. If the gallbladder can not be visualized on X-rays, or in cases of calcification of stones, poor contractility of the gall bladder or frequent bouts of colic, the drug should not be used Ursodez®.
Patients receiving Ursodez® to dissolve gallstones is necessary to use an effective non-hormonal contraceptive methods, since hormonal contraceptives may increase the formation of gallstones (see. The sections “interaction with other drugs” and “Pregnancy and lactation”).
In the treatment of patients in the later stages of primary biliary cirrhosis:
Very rarely were cases of decompensated cirrhosis. After discontinuation of therapy, a partial regression of the manifestations of decompensation.
In patients with primary biliary cirrhosis, in rare cases, early treatment may increase the clinical symptoms, such as itching may increase. In this case the dose to be reduced, and then gradually increase again as described under “Dosage and Administration”.
When used in patients with primary sclerosing cholangitis:
Prolonged therapy with high-dose UDCA (28-30 mg / kg / day) of the patients with this disorder can cause serious side effects.
Patients with diarrhea should reduce the dosage of the drug. In persistent diarrhea should discontinue treatment.
Influence of control transport and other mechanisms
Ursodeoxycholic acid has no effect on the ability to operate vehicles and machinery, or this influence is minimal.
Storage conditions
In a dry, dark place at a temperature not higher than 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Children and adults with a body weight less than 47 kg are recommended UDCA preparations in 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:
60 kg – 2 capsules
61 – 80kg – 3 capsules
81 – 100 kg – 4 capsules
Over 100 kg – 5 Capsules
The drug should be taken daily in the evening, before going to bed (do not chew the capsule), washed down with a small amount of liquid.
Duration of treatment 6-12 months. For prevention of recurrence of cholelithiasis is recommended taking the drug for several months after the dissolution of stones.
Treatment of biliary reflux gastritis
1 capsule daily Ursodeza® evening before bedtime, not liquid, and with a little water.
The course of treatment 10-14 days to 6 months, if necessary – up to 2 years.
Treatment of primary biliary cirrhosis
The daily dose depends on the body weight and the amount of 3 to 7 capsule (about 14 + 2 mg of ursodeoxycholic acid per 1 kg body weight)
In the first 3 months of treatment with the drug capsule 250 mg Ursodez® be divided into several doses throughout the day. After the improvement of liver counts daily dose can be taken once in the evening.
We recommend the following application conditions:
In the first 3 months
47-62 kg – 1 capsule (morning, afternoon and evening)
63-78 kg – 1 capsule (morning and afternoon), the capsule 2 (evening)
79-93 kg – 1 capsule (morning): 2 capsules (day and night)
94-109 kg – 2 capsules (in the morning, afternoon and evening)
Over 110 kg – 2 capsules (morning and afternoon), 3 capsules (evening)
Subsequently (1 per day – in the evening)
47-62 kg – 3 capsules
63-78 kg – 4 capsules
79-93 kg – 5 Capsules
94-109 kg – 6 capsules
Over 110 kg – 7 Capsules
Capsules should be taken regularly, not liquid, squeezed small amounts of liquid.
Application to the treatment of primary Ursodeza® biliarogo cirrhosis can be continued indefinitely. In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may worsen at the start of treatment, for example, may be more frequent itching. In this case, treatment should be continued, taking one capsule daily, followed by gradually increase the dose, increasing the daily dose every week by one capsule, as long as the new will not reach the recommended dosing regimen.
Symptomatic treatment of chronic hepatitis of various genesis – a daily dose of 10-15 mg / kg 2-3 hours. The duration of treatment, 6-12 months or more.
Primary sclerosing cholangitis – a daily dose of 12-15 mg / kg; if necessary, the dose may be increased to 20-30 mg / kg 2-3 hours. Duration of therapy is from 6 months to several years (see section “Special Instructions”).
Cystic fibrosis (cystic fibrosis), – a daily dose of 20 mg / kg / day in 2-3 doses, with the further uvlicheniem to 30 mg / kg / day, if necessary
20-29 kg – 17-25 mg / kg body weight (daily dose) – 1 capsule (morning and evening);
30-39 kg – 19-25 mg / kg body weight (daily dose) – p 1 capsule (morning, afternoon and evening);
40-49 kg – 20-25 mg / kg body weight (daily dose) – PA1 capsule (morning and afternoon), the capsule 2 (evening);
50-59 kg – 21-25 mg / kg body weight (daily dose) – 1 capsule (morning): 2 capsules (day and night);
60-69 kg – 22-25 mg / kg body weight (daily dose) – 2 capsules (morning, afternoon and evening)
70-79 kg – 22-25 mg / kg body weight (daily dose) – 2 capsules (morning and afternoon), 3 capsules (evening);
80-89 kg – 22-25 mg / kg body weight (daily dose) – 2 capsules (in the morning), 3 capsules (day and night);
90-99 kg – 23-25 ​​mg / kg body weight (daily dose) – 3 capsules (morning, afternoon and evening)
100-109 kg – 23-25 ​​mg / kg body weight (daily dose) – 3 capsules (morning and afternoon), 4 capsule (evening);
110 kg – 3 capsules (in the morning), four capsules (day and night)
Nonalcoholic steatohepatitis – average daily dose of 10-15 mg / kg 2-3 hours. The duration of therapy is 6-12 months or more.
Alcoholic liver disease – the average daily dose of 10-15 mg / kg 2-3 hours. The duration of therapy is 6-12 months or more.
Biliary dyskinesia – average daily dose of 10 mg / kg in 2 hours for 2 weeks to 2 months. If necessary, treatment must be repeated.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist