Ursofalk suspension for children. Ursofalk - instructions for use. Dissolution of cholesterol gallstones

Description of the dosage form

Release form, composition and packaging

Capsules hard gelatin, size No. 0, white, opaque; the contents of the capsules are white powder or granules.

Excipients: corn starch, colloidal silicon dioxide, magnesium stearate, gelatin, sodium lauryl sulfate, titanium dioxide, purified water.

10 pieces. - blisters (1) - packs of cardboard.
25 pcs. - blisters (2) - packs of cardboard.
25 pcs. - blisters (4) - packs of cardboard.

Suspension for oral administration white, homogeneous, containing small air bubbles, with a lemon flavor.

Excipients: benzoic acid, xylitol, glycerol, microcrystalline cellulose, propylene glycol, sodium citrate, sodium cyclamate, anhydrous citric acid, sodium chloride, Givaudan PHL-134488 lemon flavor, purified water.

250 ml - dark glass bottles (1) complete with a measuring spoon - packs of cardboard.

Clinical and pharmacological group

pharmachologic effect

Hepatoprotector. Has a choleretic effect. It reduces the synthesis of cholesterol in the liver, its absorption in the intestines and its concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and excretion of bile. Reduces the lithogenicity of bile, increases the content of bile acids in it. Causes increased gastric and pancreatic secretion, increases the activity of lipase. It has a hypoglycemic effect.

Causes partial or complete dissolution of cholesterol stones when taken orally, reduces the saturation of bile with cholesterol, which contributes to the mobilization of cholesterol from gallstones.

It has an immunomodulatory effect, affects the immunological reactions in the liver: it reduces the expression of some antigens on the hepatocyte membrane, affects the number of T-lymphocytes, the formation of interleukin-2, and reduces the number of eosinophils.

Pharmacokinetics

Data on the pharmacokinetics of the drug Ursofalk are not provided.

Indications for the use of the drug

- dissolution of cholesterol gallstones;

- biliary reflux gastritis;

- primary biliary cirrhosis of the liver in the absence of signs of decompensation (symptomatic treatment).

Dosing regimen

Children and adults weighing less than 34 kg it is recommended to use Ursofalk in the form of a suspension.

For dissolution of cholesterol gallstones appoint in a dose of 10 mg/kg of body weight 1 time/day.

Capsules

Suspension for oral administration

The drug should be taken daily in the evening, at bedtime (capsules are not chewed), washed down with a small amount of liquid.

The duration of treatment is 6-12 months. For the prevention of recurrent cholelithiasis, it is recommended to take the drug for several months after the dissolution of the stones.

For treatment of biliary reflux gastritis appoint 1 caps. (1 measuring spoon) Ursofalk daily in the evening before going to bed with a small amount of water. The course of treatment - from 10-14 days to 6 months, if necessary - up to 2 years.

For symptomatic treatment of primary biliary cirrhosis the daily dose depends on body weight and ranges from 2 to 6 capsules (measuring spoons) (approximately 10-15 mg / kg of body weight).

Capsules

Suspension for oral administration

Side effect

From the digestive system: diarrhea, nausea, pain in the epigastric region and right hypochondrium, calcification of gallstones, increased activity of hepatic transaminases.

In the treatment of primary biliary cirrhosis, transient decompensation of liver cirrhosis may occur, which disappears after discontinuation of the drug.

Others: allergic reactions.

Contraindications to the use of the drug

- X-ray-positive (high in calcium) gallstones;

- non-functioning gallbladder;

- acute inflammatory diseases of the gallbladder, bile ducts and intestines;

- cirrhosis of the liver in the stage of decompensation;

- severe violations of kidney function;

- severe violations of liver function;

- severe violations of the function of the pancreas;

- pregnancy;

- lactation period (breastfeeding);

- Hypersensitivity to the components of the drug.

The use of the drug during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Application for violations of liver function

The drug is contraindicated in severe liver dysfunction.

Application for violations of kidney function

The drug is contraindicated in severe renal impairment.

special instructions

In cholelithiasis, the effectiveness of treatment is monitored every 6 months by X-ray and ultrasound examination of the biliary tract in order to prevent recurrence of cholelithiasis.

In cholestatic liver diseases, the activity of transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase in the blood serum should be periodically determined.

Overdose

Cases of overdose have not been identified. In case of overdose, symptomatic treatment is carried out.

drug interaction

Colestyramine, colestipol, and antacids containing aluminum hydroxide or smectite (aluminum oxide) reduce intestinal absorption of ursodeoxycholic acid and thus reduce its absorption and effectiveness. If the use of preparations containing at least one of these substances is still necessary, they should be taken at least 2 hours before taking Ursofalk.

Ursodeoxycholic acid may enhance the absorption of cyclosporine from the intestine. Therefore, in patients taking cyclosporine, the physician should check the concentration of cyclosporine in the blood and adjust the dose of cyclosporine if necessary.

In some cases, Ursofalk may reduce the absorption of ciprofloxacin.

Lipid-lowering drugs (especially clofibrate), estrogens, neomycin, or progestins increase bile saturation with cholesterol and may decrease the ability to dissolve cholesterol gallstones.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children at temperatures up to 25 ° C. The shelf life of capsules is 5 years, suspensions for oral administration are 4 years.

After opening the vial, the suspension should be used within 4 months.

Tradename: URSOFALC

International non-proprietary name:

Dosage forms: capsules, oral suspension.

COMPOUND

Capsules: One capsule contains 250 mg of ursodeoxycholic acid. Excipients: corn starch, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, purified water, sodium lauryl sulfate. Suspension: 5 ml suspension (1 scoop) contains 250 mg ursodeoxycholic acid.

Excipients: benzoic acid, purified water, xylitol, glycerol, microcrystalline cellulose, propylene glycol, sodium citrate, sodium cyclamate, anhydrous citric acid, sodium chloride, lemon flavor (GivaudanPHL-134488).

DESCRIPTION

Capsules: Hard, opaque gelatin capsules No. 0; White cap, white body. The contents of the capsule are white powder or granules.

Suspension: Homogeneous suspension of white color, containing small air bubbles, with lemon aroma.

PHARMACOTHERAPEUTIC GROUP
Hepatoprotective agent.

ATC Code: A05AA02

PHARMACOLOGICAL PROPERTIES

Hepatoprotective agent, has a choleretic effect. It reduces the synthesis of cholesterol in the liver, its absorption in the intestines and its concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and secretion of bile. Reduces the lithogenicity of bile, increases the content of bile acids in it; causes an increase in gastric and pancreatic secretion, enhances the activity of lipase, has a hypoglycemic effect. Causes partial or complete dissolution of cholesterol stones when administered enterally, reduces the saturation of bile with cholesterol, which contributes to the mobilization of cholesterol from gallstones. It has an immunomodulatory effect, affects the immunological reactions in the liver: it reduces the expression of some antigens on the hepatocyte membrane, affects the number of T-lymphocytes, the formation of interleukin-2, and reduces the number of eosinophils.

INDICATIONS FOR USE
Dissolution of cholesterol gallstones, biliary reflux gastritis, primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment).

CONTRAINDICATIONS
X-ray positive (high calcium) gallstones; non-functioning gallbladder; acute inflammatory diseases of the gallbladder, bile ducts and intestines; cirrhosis of the liver in the stage of decompensation; severe dysfunction of the kidneys, liver, pancreas; hypersensitivity to the components of the drug. Ursodeoxycholic acid has no age restrictions for use, but for children under the age of 3 years, it is recommended to use Ursofalk in suspension, as it may be difficult to swallow the capsules.

PREGNANCY AND LACTATION
The drug is contraindicated during pregnancy and lactation.

Children and adults weighing less than 34 kg are recommended to use Ursofalk in suspension.

Dissolution of cholesterol gallstones

Dosage and administration

Capsules 250 mg

Suspension for oral administration

The drug should be taken daily in the evening, at bedtime (capsules are not chewed), washed down with a small amount of liquid. The duration of treatment is 6-12 months. For the prevention of recurrent cholelithiasis, it is recommended to take the drug for several months after the dissolution of the stones.

Treatment of biliary reflux gastritis

1 capsule (1 scoop) Ursofalk daily in the evening before going to 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 capsules (measuring spoons) (approximately 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight).

Capsules 250 mg

Suspension for oral administration

SIDE EFFECTS
Diarrhea, nausea, pain in the epigastric region and right hypochondrium, calcification of gallstones, increased activity of "liver" transaminases, allergic reactions.

In the treatment of primary biliary cirrhosis, transient decompensation of liver cirrhosis may occur, which disappears after discontinuation of the drug.

OVERDOSE
Cases of overdose have not been identified. In case of overdose, symptomatic treatment is carried out.

INTERACTION WITH OTHER DRUGS
Colestyramine, colestipol, and antacids containing aluminum hydroxide or smectite (aluminum oxide) reduce intestinal absorption of ursodeoxycholic acid and thus reduce its absorption and effectiveness. If the use of drugs containing at least one of these substances is still necessary, they should be taken at least 2 hours before taking Ursofalk.

Ursodeoxycholic acid may enhance the absorption of cyclosporine from the intestine. Therefore, in patients taking cyclosporine, the physician should check the concentration of cyclosporine in the blood and adjust the dose of cyclosporine if necessary.

In some cases, Ursofalk may reduce the absorption of ciprofloxacin. Lipid-lowering drugs (especially clofibrate), estrogens, neomycin, or progestins increase bile saturation with cholesterol and may decrease the ability to dissolve cholesterol gallstones.

SPECIAL INSTRUCTIONS
In cholelithiasis, the effectiveness of treatment is monitored every 6 months by X-ray and ultrasound examination of the biliary tract in order to prevent recurrence of cholelithiasis. In cholestatic liver diseases, the activity of transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase in the blood serum should be periodically determined.

RELEASE FORM
Capsules 250 mg, 10 capsules in aluminum / PVC blister; 1 blister with instructions for use in a cardboard box.
Capsules 250 mg, 25 capsules in aluminum / PVC blister; 2 and 4 blisters together with instructions for use in a cardboard pack.
Suspension for oral administration 250 mg / 5 ml, 250 ml in a dark glass bottle with a screw cap with first opening control; 1 bottle together with a measuring spoon and instructions for use in a cardboard pack.

STORAGE CONDITIONS
Store at a temperature not exceeding 25°C. Keep out of the reach of children.

BEST BEFORE DATE
Capsules - 5 years.
Suspension - 4 years. After opening - 4 months.
Do not use after the expiry date stated on the packaging.

TERMS AND CONDITIONS OF DISCOUNT FROM PHARMACIES
By prescription.

OWNER OF THE REGISTRATION CERTIFICATE (ISSUING QUALITY CONTROL)
Dr. Falk Pharma GmbH
Leinenweberstr. 5, 79108 Freiburg, Germany

Claims and proposals should be sent to: 127055, Moscow, Butyrsky Val, 68/70, building 4,5

Ursofalk is a hepatoprotective drug that helps dissolve cholesterol gallstones.

The product is available in the form of hard gelatin capsules, which contain white granules or powder, as well as a suspension for oral administration. Ursofalk's main active ingredient is ursodeoxycholic acid.

In this article, we will consider why doctors prescribe Ursofalk, including instructions for use, analogues and prices for this drug in pharmacies. If you have already used Ursofalk, leave feedback in the comments.

Composition and form of release

Clinical and pharmacological group: hepatoprotector. A drug that helps dissolve cholesterol gallstones.

1. The capsules contain the active ingredient ursodeoxycholic acid, as well as inactive ingredients: corn starch, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulfate, gelatin, titanium dioxide, purified water.
2. Ursofalk suspension contains ursodeoxycholic acid as an active ingredient, as well as additional components: benzoic acid, xylitol, glycerol, MCC, sodium citrate, propylene glycol, anhydrous citric acid, sodium cyclamate, sodium chloride, flavor, water.

Ursofalk is produced in capsules of 250 mg and in suspension (250 ml vials, the content of urodeoxycholic acid is 250 mg / 5 ml).

What is Ursofalk used for?

Ursofalk is prescribed for various diseases that can be caused by both an improper lifestyle and the consequences of various infections, uncontrolled intake of complex medications, which caused damage to the liver cells.

What helps Ursofalk:

1. Biliary dyskinesia.
2. Cirrhosis (only biliary) of the primary form, provided there are no symptoms of decompensation.
3. Any disturbances in the functioning of the liver after prolonged alcohol abuse.
4. Chronic hepatitis (regardless of the cause).
5. Cystic fibrosis or sclerosing cholangitis of the primary form.
6. Steatohepatitis of non-alcoholic origin.

Ursofalk also has an indication for use in the presence of stones in the biliary and biliary organs.

pharmachologic effect

Ursofalk contains urodeoxycholic acid in its composition. It, as it were, delimits the smallest structures of bile acids with a structural shell - it forms the so-called mixed micelles.

Urodeoxycholic acid also interacts with the lipophilic structures of membranes, making them resistant to damage. Thus, it implements a cytoprotective (protective) effect. The drug protects the membranes of the cells of the liver and biliary tract from damage by toxic bile acids, and also prevents the growth of connective tissue in the liver in case of damage to hepatocytes.

Instructions for use

The drug is taken orally, if a single dose is prescribed, then it is advisable to take the drug in the evening. Capsules are taken whole, without chewing and drinking the necessary amount of water. Children and patients with difficulty swallowing are usually prescribed the drug in the form of a suspension for oral administration.

The duration of the course of treatment and the dose of the drug is calculated by the attending physician individually for each patient, depending on the nature of the disease and personal characteristics.

1. Patients with biliary cirrhosis and sclerosing cholangitis are usually prescribed the drug at a daily dose of 10-15 mg/kg of body weight. If necessary, the daily dose is increased to 20 mg/kg of body weight. The course of treatment is from 6 months to 2 years.
2. Patients suffering from cystic fibrosis are usually prescribed in a daily dose of 20-30 mg / kg of body weight. The course of treatment is from 6 months to 2 years.
3. In case of toxic liver damage, as well as in acute and chronic alcohol poisoning, a daily dose of 10-15 mg / kg of body weight is usually prescribed.
4. The duration of the course of treatment is individual, the average duration of the course of treatment is about 6-12 months.

Patients with acute and chronic liver diseases, including cholelithiasis, are usually prescribed the drug at a daily dose of 10-15 mg / kg of body weight. The course of treatment is usually from 6 months to 2 years, during the course of treatment it is not recommended to take breaks in taking the drug.

In the treatment of cholelithiasis, it is necessary to control the course of the disease, if the patient does not experience a decrease in calculi after 12 months of continuous therapy with the drug, then its administration is canceled. Patients with biliary reflux gastritis and reflux esophagitis are usually prescribed the drug at a dose of 250 mg 1 time per day, preferably in the evening. The duration of the course of treatment is 10-14 days.

Contraindications

Treatment with Ursofalk is prohibited in the presence of:

• cirrhosis of the liver occurring in the stage of decompensation;
• inflammatory diseases of the bile ducts, gallbladder, intestines, manifested in an acute form;
• acute cholecystitis;
• disorders of the pancreas, liver, kidneys;
• hypersensitivity to the constituent components of the drug;
• x-ray positive, as well as calcified gallstones;
• cholangitis.

Doctors do not prescribe Ursofalk to patients with a non-functioning gallbladder. Babies under three years of age are prohibited from prescribing this drug in the form of a suspension, since the possibility of difficulties when swallowing capsules is not excluded.

Side effects

According to reviews, Ursofalk can cause adverse reactions from the body. Most often, diarrhea, pain in the epigastric region and right hypochondrium, nausea, calcification of gallstones, vomiting, and increased activity of hepatic transaminases are observed.

During the treatment of primary biliary cirrhosis, Ursofalk, according to reviews, can provoke the development of primary decompensation of liver cirrhosis, which disappears immediately after discontinuation of the drug.

special instructions

In cholelithiasis, the effectiveness of treatment is monitored every 6 months by X-ray examination and ultrasound of the biliary tract in order to prevent recurrence of cholelithiasis.

In cholestatic liver diseases, the activity of transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase in the blood serum should be periodically determined.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Analogues

To date, the following analogues can be considered for treatment:

1. Ursosan - has a similar effect, its price is significantly different. So for 50 capsules you need to pay only 600-800 rubles, which is half the price of Ursofalk;
2. Urdoksa - also available in capsules, its price is even lower than the cost of the previous remedy and is within 450 rubles for 50 pieces;
3. Ursoliv is a good replacement and costs around 600 rubles for a pack of 50 capsules.

Attention: the use of analogues must be agreed with the attending physician.

Compound

active substance: ursodeoxycholic acid

5 ml suspension (one measuring cup) contains ursodeoxycholic acid 250 mg

Excipients: benzoic acid (E 210), avicel RC-591, sodium chloride, sodium citrate, citric acid, glycerin, propylene glycol, xylitol, sodium cyclamate, lemon flavor, purified water.

Dosage form

Suspension oral.

Basic physical and chemical properties: white homogeneous suspension with small air bubbles and lemon smell.

Pharmacological group

Means used to treat the liver and biliary tract. Means used in biliary pathology.

ATX code A05A A02.

Medications used in liver diseases, lipotropic substances.

ATX code A05B.

Pharmacological properties

Pharmacodynamics.

A small amount of ursodeoxycholic acid has been found in human bile.

After oral administration, it reduces the saturation of bile with cholesterol, inhibiting its absorption in the intestine and reducing the secretion of cholesterol in bile. Perhaps due to the dispersion of cholesterol and the formation of liquid crystals, the gradual dissolution of gallstones occurs.

According to current knowledge, it is believed that the effect of ursodeoxycholic acid in liver diseases and cholestatic diseases is due to the relative replacement of lipophilic, similar washing toxic bile acids with hydrophilic cytoprotective non-toxic ursodeoxycholic acid, an improvement in the secretory capacity of hepatocytes and immunoregulatory processes.

application to children

cystic fibrosis

The user from clinical reports concerns the long-term use of ursodeoxycholic acid (for a period of up to 10 years) in the treatment of children with hepatobiliary disorders associated with cystic fibrosis. There is evidence that the use of ursodeoxycholic acid can reduce proliferation in the bile ducts, stop the progression of histological changes, and even eliminate hepatobiliary changes, provided that therapy is started in the early stages of cystic fibrosis. For best results, treatment with ursodeoxycholic acid should be initiated as soon as the diagnosis of cystic fibrosis has been established.

Pharmacokinetics.

When administered orally, ursodeoxycholic acid is rapidly absorbed in the empty and superior ileum by passive transport, and in the terminal ileum by active transport. The absorption rate is usually 60-80%. After absorption, bile acid is subject to almost complete conjugation in the liver with the amino acids glycine and taurine and is then excreted in the bile. Clearance of the first passage through the liver is up to 60%.

Depending on the daily dose and the underlying disorder or condition of the liver, the more hydrophilic ursodeoxycholic acid accumulates in the bile. At the same time, there is a relative decrease in other more lipophilic bile acids.

Under the influence of intestinal bacteria, there is a partial degradation to 7 ketolithocholic and lithocholic acids. Lithocholic acid is hepatotoxic and causes damage to the liver parenchyma in some animal species. In humans, only a small amount is absorbed, which is sulfated in the liver and thus detoxified before being excreted in the bile and finally in the feces.

The biological half-life of ursodeoxycholic acid is 3.5-5.8 days.

Indications

Symptomatic treatment of primary biliary cirrhosis (PBC) in the absence of decompensated liver cirrhosis.

For the dissolution of X-ray negative cholesterol gallstones no larger than 15 mm in diameter in patients with a functioning gallbladder, despite the presence of gallstone(s) in it(s).

For the treatment of hepatobiliary disorders in cystic fibrosis in children aged 1 month to 18 years.

Contraindications

Hypersensitivity to bile acids or any of the excipients included in the formulation.

Acute cholecystitis or acute cholangitis.

Obstruction of the bile ducts (blockade of the common bile duct or duct).

Frequent attacks of biliary (hepatic) colic.

The presence of radiopaque calcified gallstones.

Excited contractility of the gallbladder.

Unsuccessful outcome of portoenterostomy or lack of adequate biliary outflow in children with biliary atresia.

Interaction with other medicinal products and other forms of interaction

Ursofalk, oral suspension, (250 mg / 5 ml) should not be used simultaneously with cholestyramine, colestipol or antacids containing aluminum hydroxide or Smectite (aluminum oxide), as these drugs bind ursodeoxycholic acid in the intestine and thus interfere with its absorption and reduce efficiency. If the use of a preparation containing one of these substances is necessary, then it must be taken at least 2:00 before or 2:00 after taking Ursofalk, oral suspension, 250 mg / 5 ml.

Ursofalk, suspension, may affect the absorption of cyclosporine from the intestine. In this regard, in patients taking cyclosporine, the concentration of this substance in the blood should be checked and, if necessary, the dose should be adjusted.

In some cases, Ursofalk, oral suspension, 250 mg / 5 ml may reduce the absorption of ciprofloxacin.

In a clinical study in healthy volunteers, the combined use of ursodeoxycholic acid (500 mg/day) and rosuvastatin (20 mg/day) resulted in a slight increase in plasma concentrations of rosuvastatin. The clinical significance of this interaction, as well as the significance in other statins, has not been established.

Ursodeoxycholic acid has been shown to reduce the peak plasma concentration (Cmax) and area under the curve (AUC) of the calcium antagonist nitrendipine in healthy volunteers. Careful monitoring of the result of the combined use of nifedipine and ursodeoxycholic acid is recommended. An increase in the dose of nifedipine may be required. In addition, a decrease in the therapeutic effect of dapsone has been reported.

This information, as well as data obtained in vitro, suggest that ursodeoxycholic acid can potentially cause the induction of cytochrome P450 3A enzymes. But in a well-designed interaction study with budesonide, which is a proven cytochrome P450 3A substrate, no such effect was observed.

Estrogen hormones, as well as cholesterol-lowering drugs, can increase the secretion of cholesterol by the liver and thus promote gallstone formation, which is the opposite effect of the ursodeoxycholic acid used to dissolve them.

Application features

Ursofalk suspension should be taken under medical supervision.

During the first three months of treatment, it is necessary to check the liver function of AST (SGOT), ALT (SGPT) and g-GT every 4 weeks, and then every 3 months. It also makes it possible to determine the presence or absence of response to treatment in patients with PBC, as well as timely detection of potential liver dysfunction, especially in patients with advanced PBC.

Use to dissolve cholesterol gallstones

In order to evaluate the effectiveness of treatment and detect in advance any calcification of gallstones, depending on the size of the stone, it is necessary to conduct an examination of the general appearance of the gallbladder (oral cholecystography) and possible obstruction in the standing and supine position (ultrasound control) after 6-10 months from the start of treatment .

It is not recommended to use Ursofalk, oral suspension, 250 mg / 5 ml, if the gallbladder is not visualized on x-rays or in case of calcification of stones, impaired contractility of the gallbladder or frequent hepatic colic.

Women taking Ursofalk oral suspension 250 mg/5 ml to dissolve gallstones should use an effective non-hormonal method of contraception, as hormonal contraceptives may increase the formation of gallstones.

Treatment of patients with advanced PBC

Very rarely, there have been cases of decompensation of cirrhosis of the liver, which may partially regress after discontinuation of therapy.

In patients with PBC, it is extremely rare for symptoms to worsen at the start of treatment, for example, itching may increase. In such cases, the dose of Ursofalk, oral suspension, 250 mg / 5 ml should be reduced to one glass of Ursofalk, oral suspension, 250 mg / 5 ml per day, then the dose should be gradually increased, as described in the section "Method of administration and doses".

One measuring cup (equivalent to 5 ml) of Ursofalk, oral suspension, 250 mg/5 ml contains 0.50 mmol (11.39 mg) sodium. Patients on controlled sodium intake (low sodium diet) should be aware of this fact.

Use during pregnancy and lactation.

Animal studies have shown no effect of ursodeoxycholic acid on fertility. Data on the effect on fertility in humans are not available.

There are insufficient data on the use of ursodeoxycholic acid in pregnant women. The results of animal studies indicate the presence of reproductive toxicity in the early stages of pregnancy. Ursofalk oral suspension 250 mg/5 ml should not be used during pregnancy unless absolutely necessary. Women of reproductive age can only take the drug if they use reliable contraceptives.

It is recommended to use non-hormonal contraceptives or low-estrogen oral contraceptives. Patients receiving Ursofalk oral suspension 250 mg/5 ml to dissolve gallstones should use effective non-hormonal contraception, as hormonal oral contraceptives may increase gallstone formation. Before starting treatment, the possibility of pregnancy should be excluded.

According to several recorded cases of the use of the drug by breastfeeding, the content of ursodeoxycholic acid in breast milk was extremely low, therefore, the development of any adverse events in children receiving such milk should not be expected.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms.

There was no effect on the ability to drive a car and use mechanisms.

Dosage and administration

Opening a bottle with a child-resistant cap

To open the bottle, firmly press the cap down and twist to the left.

To dissolve cholesterol gallstones

Approximately 10 mg ursodeoxycholic acid / kg body weight per day (see Table 1)

Table 1

Ursofalk suspension should be taken in the evening, before going to bed. The suspension should be taken regularly.

The time needed to dissolve gallstones is usually 6-24 months. If a decrease in the size of gallstones is not observed after 12 months of administration, therapy should not be continued.

The success of the treatment should be checked every 6 months by ultrasound or X-ray. With the help of additional studies, it is necessary to check whether the calcification of stones did not take place over time. If this happens, treatment must be stopped.

For the symptomatic treatment of primary biliary cirrhosis (PBC)

The daily dose depends on body weight and is approximately 14 ± 2 mg ursodeoxycholic acid / kg body weight.

In the first 3 months of treatment, Ursofalk suspension should be taken throughout the day, distributing the daily dose into several doses. With improvement in liver function, the dose can be taken 1 time per day, in the evening.

table 2

* 1 measuring cup (= 5 ml suspension) contains 250 mg ursodeoxycholic acid.

Ursofalk's suspension should be taken in accordance with the dosing regimen given in Table 2. It is necessary to observe the regularity of reception.

The use of Ursofalk suspension in primary biliary cirrhosis can be unlimited in time.

In patients with primary biliary cirrhosis, rarely at the beginning of treatment, worsening of clinical symptoms is possible, for example, itching may increase. In this case, treatment should be continued, first taking a reduced dose of Ursofalk suspension, then gradually increasing the dose (increasing the daily dose every week) until the indicated dosing regimen is reached.

For the treatment of hepatobiliary disorders in cystic fibrosis

For children with cystic fibrosis aged 1 month to 18 years, the dosage is 20 mg / kg / day and divided into 2-3 doses, followed by an increase in dose to 30 mg / kg / day if necessary.

Children weighing less than 10 kg are very rarely affected. In such cases, it is recommended to use commercially available disposable syringes to administer the oral suspension.

Single doses for children weighing up to 10 kg should be taken with a syringe from the measuring cup that comes with the kit, to a volume of 1.25 ml. To do this, use a syringe for single use with a volume of 2 ml with a graduation of 0.1 ml. Please note that disposable syringes are not included in the package, but are freely sold in pharmacies.

In order to inject the required dose with a syringe:

1. Before opening a glass bottle, shake it.

3. Draw a little more suspension into the syringe than needed.

4. Press the plunger of the syringe with your finger to remove air bubbles from the collected suspension.

5. Check the volume of the suspension in the syringe, adjust if necessary.

6. Gently inject the contents of the syringe directly into the child's mouth.

Do not draw the syringe directly from the bottle. Do not pour the unused suspension from the measuring cup or syringe back into the bottle.

Table 3

Dosing regimen for children weighing less than 10 kg: 20 mg ursodeoxycholic acid / kg / day (volume measuring device - disposable syringe)

Table 4

Dosing regimen for children weighing more than 10 kg: 20-25 mg ursodeoxycholic acid / kg / day (volume measuring device - measuring cup)

Many children are born with pathologies. This is due to hereditary predisposition, peculiarities of intrauterine development and insufficient development of body systems. Physiological jaundice occurs in about 70% of newborns. The main symptom of the disease is a change in skin color. As a rule, this condition resolves without medical treatment within 10 days after birth. However, there are cases when a baby needs help to fight the disease. Most often, pediatricians prescribe Ursofalk for the treatment of jaundice.

Dosage form and composition of the drug

Ursofalk is a drug that belongs to the group of hepatoprotectors. The drug provides protection to the liver from the harmful effects of bilirubin. Available in the form of capsules and suspensions. Capsules must be swallowed completely, without chewing or dissolving in water, so this form of release is suitable for the treatment of children over 3 years of age.

For newborns and babies under the age of three, a suspension is prescribed. It is a thick liquid of homogeneous consistency, which has ductility. The suspension is sold in glass bottles of 250 ml. Each box comes with instructions for use and a measuring spoon.

The main active ingredient of Ursofalk is ursodeoxycholic acid. This substance is also part of the bile. Auxiliary components in the preparation:

pharmachologic effect

Ursofalk for newborns is used to treat physiological jaundice, to dissolve cholesterol gallstones and to protect the liver from various negative environmental factors. The drug has the following actions:

Instructions for use

Ursofalk is prescribed to newborns when signs of jaundice appear. The drug is prescribed by a pediatrician, taking into account the need for use, the development of the disease and the age of the baby. The doctor determines the required dosage and duration of treatment. You can not independently increase or decrease the rate of the drug and interrupt the course of therapy.

If symptoms of adverse reactions or the development of allergies are found, it is necessary to consult a pediatrician about the possibility of further use of the drug.

Ursofalk against jaundice

After birth, the baby's body needs to improve the functioning of the respiratory system. In the process of intrauterine development, fetal cells received oxygen from the mother using a special protein - fetal hemoglobin. Since the first breath, this substance is excreted from the body. Cells are saturated with other hemoglobin, which is responsible for supplying the body with oxygen throughout life. During the destruction of fetal hemoglobin, bilirubin is formed, which is excreted in the urine.

If this process in the baby's body is pathological, and the newborn's liver cannot cope with the amount of bilirubin, the pigment enters the bloodstream and accumulates in the tissues of the body. As a result, the following symptoms appear:

• yellow color of the skin and eyeball;
• lethargy;
• convulsions.

In the first weeks of life, the baby's liver begins to produce glucuronic acid. It reacts with bilirubin, reduces its toxic effects and promotes rapid elimination. If the body cannot cope with the amount of bilirubin, the use of a photolamp is prescribed. Most often, treatment is prescribed in the maternity hospital and lasts about 2 weeks (for premature babies - at least 3 weeks). The photolamp can also be used after discharge, after consulting with the doctor.

Sunlight has a positive effect on the body. Under the influence of the sun, bilirubin in the upper layers of the skin turns into a soluble substance that is excreted from the body with waste products. The optimal time for sunbathing is no later than 11 o'clock in the afternoon, since at other hours the rays can harm the thin skin of a newborn.

If these measures do not help reduce symptoms, mandatory treatment with hepatoprotectors is prescribed, since with a significant increase in bilirubin, it enters the brain and causes cell destruction. The drug cleanses the liver of toxins and accelerates the formation of enzymes involved in the excretion of bilirubin.

In what other cases is Ursofalk appointed?

In addition to the treatment of jaundice, Ursofalk is also used in the treatment of other serious diseases:

When is the drug contraindicated?

Contraindications for use:

• individual intolerance to individual components of the drug;
• serious disorders in the liver;
• cholecystitis in acute form;
• cholangitis;
• diseases of the bile ducts, gallbladder and intestines (bleeding, inflammation, blockage);
• gallbladder dysfunction;
• cholesterol stones with a high content of calcium.

When using several types of drugs together, their interaction must be taken into account. Ursofalk is taken with caution with the following drugs:

1. Smectite, Colestyramine - hydroxide and aluminum oxide, which are included in the composition, significantly reduce the effect of the anti-jaundice agent;
2. Cyclosporine - Ursofalk enhances the excretion of the drug;
3. Ciprofloxacin - the absorption of the drug is impaired.

Method of application and dosage

For the treatment of newborns and children under 3 years old, Ursofalk is used in the form of a suspension. It has a pleasant taste, so the kids are happy to take the medicine. The dosage depends on the age, weight of the baby and the degree of development of the disease. The average dose is not more than 10 mg of the drug per 1 kg of body weight. Dosage according to the instructions:

• children from 3 to 5 kg - 0.5 ml 1 time per day (1/10 measuring spoon);
• children from 5 to 8 kg - 1.25 ml 1 time per day (1/4 measuring spoon).

Shake the bottle before use as sediment may form at the bottom. It is allowed to pre-mix the suspension with breast milk.

You can give medicine to a child with a pipette or syringe without a needle, dripping the solution on the inside of the cheek. If the drug gets into the throat, the baby may choke or start a gag reflex due to irritation of the root of the tongue. The drug can be given before and after meals.

Ursofalk is taken 1 time per day at bedtime. This is due to the fact that the liver mainly works at night. In addition, at this time, the body is in a relaxed state, therefore it is most susceptible to the effects of the drug.

As a rule, the course of treatment lasts a week. Therapy can be extended if there is no improvement, or reduced if the symptoms have disappeared earlier, but after consulting a doctor.

Can the child experience adverse reactions?

Despite the wide therapeutic effect, the drug is easily tolerated by the child's body, does not cause the development of side effects. Most often, reactions can occur if the required dosage is not observed or the course of treatment is increased. Possible complications:

• allergies in the form of skin rashes;
• nausea, vomiting, diarrhea;
• profuse regurgitation;
• pain in the abdomen.

Ursofalk's analogues

Ursofalk has a high cost and a number of contraindications, therefore, in some cases, pediatricians prescribe other means, for example, Ursosan. Which of these remedies is best for the baby is decided by the doctor, who takes into account the individual characteristics of the child and the nature of the disease.

The following effective analogues can be distinguished:

1. Ursosan. Drug based on ursodeoxycholic acid. Available in the form of syrup and capsules. Eliminates cholesterol stones and removes bilirubin. The dosage of Ursosan depends on body weight, the average rate is 10-15 mg per 1 kg of weight. Causes adverse reactions in the form of rash, diarrhea, nausea.
2. Hofitol (more in the article:). A French remedy that has a choleretic effect, the main substance is an extract of the leaves of the field artichoke. The drug restores liver cells, reduces the amount of urea in the blood, promotes the normal metabolism of fats and cholesterol. It is used to treat various diseases of the liver and other organs.
3. Ukrliv. The Ukrainian analogue of Ursofalk is used to eliminate the symptoms of physiological jaundice in newborns and other liver diseases. The required rate is prescribed by the doctor depending on the body weight of the child.
4. Choludexan. Effective for cholesterol stones, gastritis with bile reflux and jaundice. Children can be given from the first months of life.
5. Flamin. Available in the form of granules for newborns and tablets for children over 12 years old. To prepare the suspension, it is necessary to dissolve the contents of the sachet in water. Used for hepatitis, cholecystitis and jaundice.