Ursofalk release form. Ursofalk suspension for newborns: instructions for use. Why does jaundice occur

Physiological jaundice in newborns is quite common and normal if it lasts for several days. After 2-3 days, in most babies, the yellowness of the skin goes away.

However, in some crumbs, a relatively weak or moderate icterus remains for a long time. In this case, treatment is not prescribed, it passes by itself, subject to the recommendations of the doctor.

If the jaundice goes into severe stages, then medication is prescribed. Doctors recommend medicine Ursofalk for newborns from jaundice.

Ursofalk and jaundice in newborns

The drug Ursofalk belongs to the class of hepatoprotectors. It is intended to treat liver pathologies and protect the organ from external stimuli.

Under the influence of the drug, liver cells begin to work more actively and produce the right amount of enzymes that contribute to the removal of bilirubin from the body.

Ursofalk also copes well with the stagnation of bile in the liver and improves its outflow. Newborns still in the hospital must be under the supervision of a doctor.

In babies, an analysis is taken for bilirubin, which shows whether there is jaundice or not. If the norm of bilirubin in the blood exceeds, a course of complex treatment is prescribed, which includes: the use of the drug Ursofalk, phototherapy sessions.

It's important to know: Bilirubin is excreted in feces and urine. The body is cleared of toxic substances and jaundice in newborns disappears.

Indications for the use of the drug

The drug has a wide sector of action:

lowers cholesterol levels;
has an immunomodulatory effect;
improves the protective properties of cells;
improves gastric secretion;
breaks down cholesterol plaques and stones.

Ursofalk is used for the following diseases:

jaundice in newborns;
liver disease in children;
cirrhosis of the liver;
biliary dyskinesia;
hepatitis;
toxic liver damage;
reflux gastritis;
primary sclerosing cholangitis;
cystic fibrosis;
urinary tract dyskinesia;
atresia of intrahepatic bile streams.

The drug Ursofalk is prescribed for the prevention of oncology of the large intestine, with liver damage, while taking hormonal drugs.

The drug is contraindicated in: acute cholecystitis, cholangitis, blockage of the bile ducts, as well as with allergic reactions to the drug.

Ursofalk for newborns from jaundice - dosage

It's important to know: Outwardly, the yellowness of the skin of a newborn is associated with increased bilirubin and the child's body is unable to remove it, so the skin of newborns reacts in a certain way.

The drug is prescribed only by the attending physician after studying the appropriate analysis for bilirubin.

Also, in addition to suspensions, there are capsules that are usually contraindicated for newborns, they are prescribed for older children.

How to give Ursofalk to newborns?

Instructions for use for newborns:

The use of Ursofalk has a quick and positive effect.

It is recommended to take the drug in the evening, before the baby goes to sleep at night.
The duration of the medication is individual. Basically, the reception lasts until the jaundice passes.
Although Ursofalk has practically no side effects, it should be used as a last resort when non-drug therapy methods do not help.

It's important to know: Without consulting a specialist, you cannot prescribe the drug yourself!

Side effects

Despite the fact that the drug is highly effective, it is very rare for newborns to experience adverse reactions. In some cases, increased stools, regurgitation and allergic reactions have been noted.

In adults, after Ursofalk, gastrointestinal disorders (diarrhea) may occur and pain in the right hypochondrium may occur. All symptoms disappear if the dosage is reduced or the drug is stopped.

Ursofalk to a newborn from jaundice - reviews

Maria, 27 years old

The drug is really cool, but very strong! If jaundice is catastrophically severe, then Ursofalk should be taken. But I myself am a pharmacist and I think that it is quite possible to get by with lighter drugs that cope with jaundice. Yes, and vitamin D and the sun to help!

Anna, 32 years old

When my baby was almost a month old, she remained yellow. The doctor prescribed the drug to drink at home. It's better than lying in the hospital for such a crumb under drips.

We drank for 2 weeks, and pah-pah everything went away! And I want to say that the sun cannot always cope with the difficult form of jaundice! We had more than 200 bilirubin and jaundice appeared not immediately after birth, but only at 3 weeks.

Valentina, 29 years old

I gave in suspension. She poured ¼ of the cap and gave her son water from a pipette. So it is more convenient, he does not spit out! By the month we weighed about 4 kg. We underwent a course of treatment with Ursofalk - 10 days. Thank God everything is over!

The yellowness subsided noticeably, there was a barely noticeable tan. Plus, the doctor said to take vitamin D drop by drop and walk more in the fresh air. In the complex, the effect is probably good. But the drug, I think. He did no small thing.

Cheap analogues of the drug

There are many cheap analogues of Ursofalk on the market, namely:

Holacid;
Urdox;
Ursachol;
Urzofalk;
Ursilon;
Ursosan;
Solutrate
Delursan.

Ursofalk or Ursosan - what's better?

According to reviews, both Ursofalk and Ursosan are effective drugs and absolutely identical in composition. True, the first one is more convenient to give, since it comes in suspension, but it is much more expensive in price.

Reviews about Ursofalk are mostly the most positive. However, in rare cases, side effects are observed, so you should be careful and monitor the reaction of the child.

The baby can become capricious, tighten the legs. It is important to monitor the child for allergic reactions: skin itching, rashes in the form of urticaria. In this case, you should immediately consult a doctor or call an ambulance at home.

Ursofalk is a serious drug, but its effect has not been fully studied. This suggests that it is possible to do without a medicine by replacing it with less complex analogues.

In most cases, newborns with jaundice are helped by fresh air and sunbathing. However, it is more difficult for children born in the cold season to soak up the sun's rays. In this case, there are special physiotherapy procedures where the newborn is placed under artificial lamps.

In any case, if parents decide to treat the baby with medication, this is done only for the benefit of their beloved child. The child feels the care and love of dad and mom, and recovers faster. Be healthy!

One of the most effective drugs for the treatment of physiological jaundice is Ursofalk for newborns. It has a wide spectrum of action and copes not only with jaundice in infants, but also with other diseases and pathologies of the liver in children and adults.

Dosage form

The drug is available in two dosage forms, both intended for oral use - capsules and suspension.

Capsules are suitable for the treatment of adults and children over 3 years of age. For newborns and children weighing up to 34 kg, as well as adults weighing up to 47 kg. It is considered appropriate to take the drug in the form of a suspension.

Capsules are hard, white with a gelatinous shell, opaque. 250 mg. the main active ingredient in 1 capsule. The package may contain 10, 50 or 100 capsules.

Suspension of homogeneous consistency with good fluidity, sweetish taste. There may be bubbles. In 5 ml. suspension contains 250 mg. active substance. On sale there are bottles of 250 ml. with a measured spoon (5 ml.) in a set.

Description and composition of the drug

Ursofalk (Ursofalk) is a European drug belonging to the pharmacological group of hepatoprotectors. This means that this medicine is intended not only to treat, but also to protect the liver and biliary tract from various negative factors. Ursofalk effectively copes with the following tasks:

Stimulates the work of liver cells, which begin to more actively produce enzymes responsible for removing bilirubin from the body of a baby or an adult.
Prevents stagnation of bile, promotes its outflow.
Fights high cholesterol levels, cholesterol plaques and stones. Promotes the excretion of cholesterol along with bile.
Improves immunity, strengthens the defenses of the body of the newborn.
Stabilizes and improves the protective functions of the body at the cellular level.
Improves the secretion of gastric juice, pancreatic secretion.
Prevents the growth and increase of liver tissue.
Blocks the expansion of veins in the organs.
Negatively affects malignant neoplasms, slowing down their growth.

As part of the drug, the main active ingredient is ursodeoxycholic acid. There are also minor components that complement and enhance the effect of the active substance, as well as a flavor.

In the human body, ursodeoxycholic acid is also produced, it is the liver that is responsible for this process. If there are problems with the functioning of the liver, the synthesis of this acid is reduced. Ursofalk helps to fill the deficiency of the element, partially performs its functions.

Pharmacodynamics and pharmacokinetics

Drug absorption occurs in the small intestine. Absorption of the drug occurs slowly with an efficiency of 60-80%.

The breakdown of the active substance that enters the bloodstream occurs mainly in the liver and partly in the intestine.

The excretion of the substance occurs within 3-5 days along with the feces.

The drug during therapy partially accumulates in the body, its complete excretion is possible only after the end of treatment.

Indications for use

Due to its wide spectrum of action, Ursofalk is indicated for a variety of diseases / conditions:

Jaundice in newborns.
Liver disease in pediatric patients.
Cirrhosis of the liver and hepatitis.
Dyskinesia of the biliary or urinary tract.
Toxic damage to the liver, including due to alcohol intake.
Reflux gastritis.
cystic fibrosis.
Prevention and therapy of oncological diseases.
Liver damage due to treatment with hormonal drugs, antibiotics, hormonal contraceptives.
Various diseases of the digestive tract.
To eliminate stagnation of bile.
To restore the liver after surgery.

The drug is also used to treat cholesterol stones, if they are not X-ray positive.

Contraindications

Ursofalk has the following contraindications:

Individual hypersensitivity to the components of the drug, allergy to the composition of the drug.
Pregnancy, breastfeeding period (relative contraindications, see "Special Instructions").
Severe liver pathology.
Acute cholecystitis.
Cholangitis.
Bleeding, inflammation, blockage of the bile ducts.
Bleeding, inflammation of the gallbladder, intestines.
Gallbladder dysfunction.
Cirrhosis of the liver in the stage of decompensation.
Violations in the functioning of the pancreas or kidneys.
X-ray positive cholesterol stones.

Dosage and administration

Since Ursofalk is a prescription drug, it is forbidden to prescribe it to yourself or your child on your own. There is a standard dosage amount of the drug depending on the disease or condition of the patient. However, the doctor may, at his discretion, change the dosage and treatment regimen, based on his own experience, the clinical picture, the individual characteristics of the patient, the results of tests, research data and the dynamics of the patient's complaints.

The doctor prescribes the form of the drug that is most convenient for treatment in each case. Most often, the dosage is prescribed based on the patient's body weight. The amount of the drug per 1 kg. measured in a certain amount of mg. active substance.

Dosage calculation example: Patient weighing 60 kg, daily dose 10 mg/1 kg of body weight.

60kg. x 10 mg. = 600 mg.

600 mg. / 250 mg. = 2.4 doses. We round down - it turns out that you need to take 2 doses - this is either 2 capsules or 2 measuring spoons of the suspension.

Taking 1 capsule of the drug = taking 1 measuring spoon of the drug in the form of a suspension.

For some diseases, the dosage is indicated immediately in the number of capsules / suspension for daily intake, regardless of weight.

Treatment of jaundice in newborns.

Infants are prescribed only a suspension. It has a pleasant sweetish taste and children do not resist when the medicine gets into their mouths.

If the child's jaundice has turned into a complex form, Ursofalk is prescribed based on the child's body weight and these test results. Only a pediatrician can set an individual dosage. Approximately, for infants, the dosage is as follows:

The weight of the child is 3-5 kg. - daily dose of 0.5 ml. (or 1/10 scoop).
The weight of the child is 5-8 kg. - daily dose of 1.25 ml. (or ¼ scoop).

The intake of the suspension has nothing to do with food intake, but the time of day is of great importance in therapy. Most processes occur in the liver at night. At the same time, during sleep, the organ, being in a horizontal position, is as relaxed as possible and susceptible to the action of the drug. Therefore, it is recommended to give the drug to the baby once a day in the evening before going to bed.

The duration of the course of therapy is determined individually. Most often, Ursofalk is used until the child has symptoms of jaundice. Since the drug is highly effective, usually the level of bilirubin decreases quite quickly - within a few days. So for the entire course of therapy, 1 bottle of Ursofalk is more than enough.

To dissolve cholesterol stones and sand.

Ursofalk is prescribed according to the scheme of 10 mg. drug per 1 kg. body weight 1 time per day (before bedtime). Capsules are not chewed, washed down with plenty of liquid.

The course of treatment can take from 6 months to 1 year. To consolidate the result and prevention, it is recommended to additionally drink the drug for a few more months after the end of treatment.

Therapy for reflux gastritis.

Urosofalk should be taken 1 capsule (measuring spoon) every evening. The course of treatment is an average of 2 weeks, but can take from 6 to 24 months.

Therapy for cirrhosis of the liver.

Ursofalk is prescribed depending on body weight - 15 mg. per 1 kg. It turns out that the daily dose is 3-7 capsules (measuring spoons). During the first 3 months of therapy, the number of capsules should be divided into 3 doses during the day - morning, afternoon and evening. When the patient's condition improves, the entire daily dose of the drug can be taken once a day in the evening before bedtime. The course of therapy is not limited in time.

hepatitis therapy.

Ursofalk is prescribed depending on body weight - 10-15 mg. per 1 kg. Divide the number of capsules into 2 or 3 doses throughout the day. Hen therapy - from six months and longer.

Therapy for cystic fibrosis.

Ursofalk is prescribed depending on body weight - 12-15 mg. per 1 kg. - take 1 time per day.

The dose may be increased to 20-30 mg. per 1 kg. masses. In this case, divide the total number of capsules into 2-3 doses during the day.

The course of therapy is from six months to several years.

Regarding the treatment regimen and dosage of Ursofalk for other diseases, you should consult with your doctor.

Possible side effects

If the treatment is accompanied by the intake of alcohol in any form, the appearance of side effects is inevitable.

Interaction with other drugs

It has been proven that the simultaneous administration of the drug with certain medications can significantly impair the effectiveness of treatment. Therefore, if the patient takes any medicines other than Ursofalk, he must inform his doctor about this.

special instructions

Treatment should take place under the supervision and supervision of the attending physician.

During treatment, you must follow the doctor's recommendations regarding diet and daily routine.

The use of the drug during pregnancy is highly undesirable and is likely to harm the fetus. Use during lactation is highly undesirable, if treatment is unavoidable, breastfeeding should be discontinued.

During treatment (especially at the beginning of therapy), periodic monitoring of liver function and other organs, the effectiveness of therapy is required.

Taking the drug does not affect the degree of concentration and reaction speed.

Overdose

Cases of overdose have not been recorded. If the patient has taken a large amount of the drug, you need to inform the doctor. You may need symptomatic treatment.

Terms of sale and storage

Ursofalk is sold in pharmacies only with a prescription from a doctor.

The drug can be stored:

Capsules - 5 years.
Suspension (unopened package) - 4 years.
Suspension (opened package) - 4 months.

Storage conditions - room temperature, no direct sunlight, out of the reach of children.

Drug analogues

Instead of Ursofalk, the following drugs can be used:

Ukrliv is a Ukrainian drug that is a complete analogue of Ursofalk. Available in suspension and capsules, approved for use in children weighing over 5 kg. According to the indications, the medication can be used starting from the second trimester of pregnancy.
contains ursodeoxycholic acid as an active ingredient. Produced in capsules and suspensions, it can be used in children whose weight is 5 kilograms or more. In the case when the benefit to the mother is greater than the harm to the child, the medicine can be prescribed to pregnant women. Patients of childbearing age should use non-hormonal contraceptives. During the reception, you should stop breastfeeding.
for children, it is a substitute for Ursofalk according to the clinical and pharmacological group. The drug is produced in granules for the preparation of a solution for oral administration, which is recommended for children over the age of 1 month and up to 12 years. This is a herbal preparation that has a choleretic and antispasmodic effect.
is a homeopathic remedy that is recommended for pathologies of the liver and biliary tract. It is available in drops and sublingual tablets. The drug prevents the appearance, has a choleretic, hepatoprotective and anti-inflammatory effect. It can be used in patients of all ages, including women in position and breastfeeding.

The price of the drug

The cost of the drug is an average of 43 rubles. Prices range from 31 to 64 rubles

Ursofalk is a drug used to treat diseases associated with the destructive work of the gallbladder and liver. It is available in different variations and has positive and negative properties. Therefore, it is better to study the characteristics of the tool in more detail.

In pharmacies, Ursofalk is released as a suspension / capsule with powder inside. In the first case, the volume of the substance in a closed pack is 250 ml, which corresponds to 50 single doses of 250 mg of the active ingredient for every 5 ml of liquid (volume of a measuring spoon).

The capsule formulation is sold in 3 versions:

50 pcs. in 2 blisters;
100 pieces. in 4 blisters;
10 pieces.

The components of the medicinal product (PM):

Medicine is packed into a dense cardboard box. The package indicates the type of medicinal supply, volume, the manufacturer's annotation is enclosed inside. The suspension set includes a measuring spoon.

What is it used for

The tool has certain indications. These include:

biliary reflux gastritis;
biliary cirrhosis of the liver of the primary stages without decompensation manifestations (treatment according to symptoms);
the presence of cholesterol stones in the gallbladder (the remedy helps to soften and dissolve them);
hepatitis of the chronic stage, of various genesis;
cystic fibrosis (cystic fibrosis);
sclerosing cholangitis (primary stage);
liver dysfunction of an alcoholic nature;
non-alcoholic steatohepatitis;
dyskinesia of the bile ducts.

In the presence of other health problems, restrictions on the prescription of the drug are possible. In such cases, its use should be coordinated with the supervising physician.

pharmachologic effect

When ingested, ursodeoxycholic acid (UDCA) accumulates by passive diffusion on the walls of the small intestine. At the same time, the content of the substance in the blood increases.

During the therapeutic course, UDCA replaces the main acids of bile entering the blood (48%). With a daily intake of 10-20 mg/kg, UDCA replaces up to 75% of the acid composition of bile. Altered bile is involved in digestive and immune processes; in women it crosses the placenta. The greater the content of UDCA in the bile fluid, the more pronounced effect it gives.

The active substance Ursofalk has a membrane-stabilizing effect: direct cytoprotection on the membrane of cholangiocytes / hepatocytes is carried out. At the stages of its accumulation and entry into the natural intestinal processes, hydrophobic acids, probable toxins, are gradually replaced.

In the future, there is a deterioration in the intake of cholesterol by the intestines, the normalization of the microflora on the inner walls of the intestines and stomach. The natural process of rejection of toxins leading to cell death is launched.

This mechanism has positive side effects: inhibition of colon cancer cells, suppression of foci of inflammation on the intestinal walls.

Instructions for use

The main therapeutic substance (ursodeoxycholic acid) is allowed for use in all age categories. Due to the possibility of reducing a single dosage and a safe form of administration, a suspension is recommended for patients up to 36 months from birth (this applies to the weight category of patients up to 34 kg).

Method of use - oral. When removing cholesterol stones, portions of the medication are calculated based on weight. The optimal value is 10 mg / kg per day. For capsules, this corresponds to: 35-60 kg - 2 pcs., 61-80 kg - 3 pcs., 81-100 kg - 4 pcs., from 100 kg - 5 pcs. Scheme for calculating the daily dose of the suspension drug by weight of the patient:

Patient's weight, kg	Drug weight, mg	Suspension volume, ml	Number of measuring spoons, pcs.
5-7	62,5	1,25	0,25
8-12	125	2,5	0,5
13-18	187,5	3,75	0,75
19-25	250	5	1
26-34	375	7,5	1,5
35-50	500	10	2
51-65	625	12,5	2,5
66-80	750	15	3
81-100	1000	20	4
From 100	1250	25	5

Reception is made daily at bedtime with a small amount of water. If capsules are used, they are not chewed and swallowed whole. The course for removing stones is 6-12 months. In order to prevent recurrence, the medication is required to be used for another 2-3 months after recovery.

When diagnosing biliary reflux gastritis, Ursofalk is consumed daily in an amount of 250 mg. The average course is 0.3-6 months, in exceptional cases - 2 years. The elimination of symptoms of primary biliary cirrhosis must be approached carefully. The daily medicinal volume is calculated based on the weight of a person - for every 12-16 kg 250 mg of the medicinal substance.

At the initial stage of treatment (about 3 months), the daily intake of the drug is divided into several parts. If there is an improvement in the liver, it is reduced to one at bedtime. The remedy is used until complete recovery.

In some patients, when taking the drug at the initial stages of therapy, side effects may occur: itching, pain. Then the daily dose is reduced to 1 capsule / spoon, consumed in one evening dose. After the decline in the pronounced symptoms of the disease, the dosage and the number of daily doses gradually return to the required ones (5-7 days).

A list of other diseases, the daily calculation of Ursofalk and therapeutic periods are presented in the table:

Use for newborns

The treatment of infants must be approached carefully, in consultation with a doctor. Ursolfak's suspension is given with diluted water 1 time per day at bedtime. Medicinal share - 10 mg per 1 kg.

For convenience, you can use a medium syringe without playing: the drug is dosed with a measuring spoon and drawn into the syringe, then purified water is drawn into it up to about 4 cm 3, after which the mixture is shaken, air is removed by pressing the piston, and the liquid composition is fed to the baby.

Application for jaundice

Jaundice suffers little: the average period of disease activity is from a week to 10 days. In this case, the symptoms disappear completely in 14 days. Treatment should be carried out by a pediatrician based on blood tests for bilirubin.

Self-medication is allowed, but only in the absence of the possibility of contacting a specialist. But if the symptoms of the disease do not go away after 2 weeks, the child must be taken to the hospital.

Contraindications and side effects

Ursofalk should not be used if a patient has X-ray positive stones in the gallbladder (with an excessive level of calcium in their composition), in case of failure / atrophy of the gallbladder, in case of inflammation in the areas of formation, flow of bile.

Additional factors for refusing the drug may be:

infectious, viral or other suppuration in the intestinal area;
decompensation stage of cirrhosis;
dysfunction of the kidneys, pancreas or liver with severe symptoms;
individual intolerance or atypical reaction of the patient's body to the components of the drug;
pregnancy in all trimesters;
lactation period.

Possible side effects: pain in the right hypochondrium or epigastric zone, increased liver transaminases, allergic manifestations in the form of rashes and itching, nausea, bouts of diarrhea. Also, the treatment of biliary cirrhosis of the primary stage may be accompanied by transient decompensation. At the end of the use of the remedy, the symptom disappears.

special instructions

In the fight against cholelithiasis, the effectiveness of therapy is controlled after six months by X-ray and ultrasound studies.

drug interaction

UDCA absorption, digestibility and effect are reduced due to concomitant use with Colestipol, Colestyramine or antacids. In order to avoid a decrease in the effectiveness of Ursofalk, these substances are taken with a break of 2 hours or more.

Due to the likelihood of an increase in the absorption of Cyclosporine from the gastrointestinal system, its presence in the body is clarified through a blood test, and adjustments are made for admission. On an individual basis, the drug may inhibit (partially or completely) the absorption of Ciprofloxalin.

The use of lipid-lowering drugs (Clofibrate, etc.), Neomycin, estrogens or progestins increases the amount of cholesterol in bile, complicates the process of destruction of cholesterol seals under the influence of UDCA.

Analogues

Similar drugs based on UDCA are available on the market in a wide range. Substitutes for the drug in capsules / tablets:

Urso;
Livodex;
Urso 100;
Ursosan;
Ursor C;
Ursolit.

Substitutes are available in the form of a suspension:

Hofetol;
Heptor;
Pepopen;
Oveson;
Heptral.

Despite the similarity of the chemical composition, these drugs may differ in the concentration of the active substance, components and mechanism of action. Before using them, you need to study the attached instructions in detail or consult a doctor.

The price of the drug

The cost of Ursofalk depends on the manufacturer, the volume of the drug in the package and the point of sale. Its approximate cost in pharmacies of the Russian Federation:

Compound

active substance: ursodeoxycholic acid

1 film-coated tablet contains 500 mg ursodeoxycholic acid

Excipients: microcrystalline cellulose, povidone K 25, crospovidone (type A), talc, magnesium stearate, colloidal silicon dioxide, polysorbate 80, hypromellose, macrogol 6000.

Dosage form

Film-coated tablets.

Basic physical and chemical properties: white or almost white oblong tablets with a notch on both sides.

Pharmacological group

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

ATX code A05A A02.

Agents used in case of liver disease, lipotropic substances.

ATX code A05B.

Pharmacological properties

Pharmacological.

A small amount of ursodeoxycholic acid has been found in human bile. After oral administration, ursodeoxycholic acid 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 cholestasis 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 reverse hepatobiliary changes, if therapy is started early in 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 jejunum and upper 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

For the dissolution of X-ray negative cholesterol gallstones not more than 15 mm in diameter in patients with a functioning gallbladder, despite the presence of gallstone(s) in it(s).

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.

Contraindications

Hypersensitivity to any substance that is part of the drug.

Acute inflammation of the gallbladder or bile ducts.

Blockage of the bile duct (blockage of the common bile duct or duct).

Frequent episodes of hepatic colic.

Radiopaque calcified gallstones.

Violation of the contractility of the gallbladder.

Cirrhosis of the liver in the stage of decompensation.

Unsuccessful result of portoenterostomy or lack of adequate bile outflow in children with bile duct atresia.

Interaction with other medicinal products and other forms of interaction

Ursofalk should not be co-administered with cholestyramine, colestipol, or antacids containing aluminum hydroxide and/or smectite (aluminum oxide), as these drugs bind ursodeoxycholic acid in the intestine and thus interfere with its absorption and reduce efficacy. If the use of preparations containing one of these substances is necessary, they must be taken at least 2:00 before or 2:00 after taking Ursofalk.

Ursofalk may enhance the absorption of cyclosporine from the intestine. In patients taking cyclosporine, the doctor should check the concentration of this substance in the blood and, if necessary, adjust the dose of cyclosporine.

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

Ursodeoxycholic acid reduces the maximum plasma concentration (Cmax) and the area under the concentration-time curve (AUC) for the calcium antagonist nitredipine.

Based on this, as well as one case report of interaction with dapsone (reduced therapeutic effect) and studies in vitro, it can be concluded that ursodeoxycholic acid induces the cytochrome P450 3A enzyme, which is metabolized by drugs.

Therefore, in the case of the joint use of drugs that are metabolized with the participation of this enzyme, one should be especially careful and keep in mind that, if necessary, dose adjustment is possible.

Application features

Ursofalk tablets should be taken under medical supervision.

During the first 3 months of therapy, the physician should monitor liver function tests for AST (SGOT), ALT (SGPT), and γ-GT every 4 weeks. This allows determining 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

6-10 months after the start of treatment, using oral cholecystography, it is necessary to determine the general appearance of the stone and the type of blockage of the gallbladder in the patient's standing and lying position (ultrasound). This is necessary to assess therapeutic progress and to timely detect possible calcification of gallstones.

The drug should not be taken by patients with a gallbladder that is not visualized by X-ray methods, with calcified stones, impaired contractility of the gallbladder or those who have frequent biliary colic.

Treatment of patients with advanced PBC

Very rarely, cases of decompensated liver cirrhosis have been reported, which partially regressed after discontinuation of therapy.

In patients with PBC, it is very rare for symptoms to worsen at the beginning of treatment, for example, itching may increase. In such cases, the dose of Ursofalk 500 mg plive-coated tablets should be reduced to one tablet of Ursofalk 500 mg per day, then the dose should be gradually increased as described in the Dosage and Administration section.

If diarrhea develops, the dosage should be reduced; if diarrhea becomes persistent, treatment should be discontinued.

Use during pregnancy or lactation.

Animal studies have not shown an effect of ursodeoxycholic acid on fertility. Data on the effect on human fertility are not available.

There are insufficient data on the use of ursodeoxycholic acid in pregnant women. Animal studies have shown evidence of reproductive toxicity in the early stages of pregnancy. Ursofalk 500 mg film-coated tablets should not be used by pregnant women unless necessary. Women of childbearing age should only take the drug if they are using reliable contraception.

It is recommended to use non-hormonal contraceptives or low-estrogen oral contraceptives. Patients receiving Ursofalk 500 mg film-coated tablets 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 milk was extremely low, therefore, the development of any adverse events in infants 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 work with mechanisms.

Dosage and administration

For patients weighing less than 47 kg or for those who have difficulty swallowing tablets, it is possible to use Ursofalk in another dosage form (suspension).

To dissolve cholesterol gallstones:

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

Table 1

Tablets should be swallowed without chewing, with a small amount of liquid, in the evening before bedtime.

Tablets 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. Additional studies need to check whether the calcification of stones did not take place over time. If this happens, treatment should be discontinued.

For the symptomatic treatment of primary biliary cirrhosis (PBC)

The daily dose depends on body weight and varies from 1½ to 3½ tablets (14 ± 2 mg of ursodeoxycholic acid per kilogram of body weight), see table. 2.

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

table 2

Tablets should be swallowed with liquid. The drug must be used regularly.

The use of Ursofalk in primary biliary cirrhosis is possible for a long period.

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 by taking half a tablet of Ursofalk per day, after which the dose should be gradually increased (increasing the daily dose by half a tablet of Ursofalk every week until the indicated dosing regimen is reached).

application to children

Children with cystic fibrosis aged 6 to 18 years

The dose is 20 mg / kg / day and is divided into 2-3 doses, followed by an increase in dose to 30 mg / kg / day if necessary.

Table 3

body mass	daily dose	Ursofalk, film-coated tablets, 500 mg
body mass	daily dose

Jaundice in newborns, and especially in premature babies, is very common. This disease is associated with hyperbilirubinemia, that is, an increased level of bilirubin in the blood. It is due to the high concentration of this bile pigment that the skin and eye sclera can turn yellow.

Neonatal syndrome, as a rule, manifests itself already in the first week of life. Jaundice can be congenital or acquired. To make an accurate diagnosis, you need to conduct laboratory diagnostics.

The causes of the syndrome can be:

Squeezing of the bile ducts.
Thickening of bile.
Gilbert's syndrome.
Intrauterine infectious diseases.
Cystic fibrosis.
Galactosemia.
Kligler-Najjar syndrome.
Congenital diseases of the thyroid gland.
Congenital hepatitis or cirrhosis.
Banal disorders in the functioning of the organs of the hepatobiliary system, which arose as a result of stress, bad habits, infectious diseases or an unbalanced diet in the mother.

A characteristic symptom of jaundice is a change in the color of the skin, mucous membranes and eye sclera. But the patient may experience other signs, namely nausea, vomiting, lethargy, drowsiness, causeless crying, diarrhea. Possible biliary colic.

Maria, 27 years old

Anna, 32 years old

Valentina, 29 years old

Many newborns are diagnosed with jaundice. This common condition externally manifests itself in the form of yellowness of the skin and whites of the eyes.

A medical examination shows an increased level of bilirubin in the blood, with the removal of which the child's body is not yet able to cope.

With physiological (natural) jaundice, treatment is not provided, but if the bilirubin levels do not decrease after a week, then doctors may prescribe Ursofalk for newborns.

Ursofalk refers to drugs with a wide spectrum of action. The main active ingredient - ursodeoxycholic acid - has several useful properties:

embedded in the membrane of liver cells, protecting them from exposure to toxic enzymes;
activates the liver, as a result of which the organ begins to process indirect bilirubin into direct bilirubin faster, which is then excreted from the child's body with bile;
has an immunomodulatory effect, increasing the number of protective cells and accelerating their growth in the intestines and liver.

Suspension Ursofalk - a drug from the group of hepatoprotectors used in the treatment of jaundice in newborns

In addition to ursodeoxycholic acid, the drug also contains auxiliary components, the list of which depends on the form of release of the drug:

Capsules consist of:
- corn starch;
- magnesium stearate;
- titanium dioxide;
- distilled water;
- gelatin;
- sodium lauryl sulfate.
Suspension includes:
- cellulose;
- glycerol;
- benzoic and citric acids;
- sodium citrate;
- lemon flavor;
- distilled water.

In pediatrics, Ursofalk for newborns is used to treat jaundice that occurs in children due to poor liver function and a lack of enzymes that remove toxic bilirubin.

Jaundice in children occurs when there is an excess of bilirubin in the body.

If the symptoms of jaundice are observed after 14 days, the risk of negative consequences for the health of the baby increases significantly.

In addition to the jaundice of newborns, the drug is also prescribed for other pathological conditions. So, taking the suspension is justified if the baby suffers from:

hepatitis of different origin;
biliary dyskinesia;
cystic fibrosis.

Maria, 27 years old

Anna, 32 years old

Valentina, 29 years old

When Ursofalk (suspension) is prescribed:

cirrhosis, hepatitis;
the physiological form of jaundice in very young infants;
liver pathology;
cystic fibrosis, liver toxicity;
violation of the functions of the urinary, biliary tract.

The medicine Ursofalk is prescribed for preventive purposes if the child is at risk for the development of oncology of the large intestine.

The drug Ursofalk belongs to the class of hepatoprotectors. It is intended to treat liver pathologies and protect the organ from external stimuli.

Under the influence of the drug, liver cells begin to work more actively and produce the right amount of enzymes that contribute to the removal of bilirubin from the body.

Ursofalk also copes well with the stagnation of bile in the liver and improves its outflow. Newborns still in the hospital must be under the supervision of a doctor.

Important to know: Bilirubin is excreted in feces and urine. The body is cleared of toxic substances and jaundice in newborns disappears.

Read the full article on neonatal jaundice(amp)gt;(amp)gt;(amp)gt;

Important to know: Outwardly, the yellowness of the skin of a newborn is associated with increased bilirubin and the child's body is unable to remove it, so the skin of newborns reacts in a certain way.

The drug is prescribed only by the attending physician after studying the appropriate analysis for bilirubin.

The specialist also tells the exact dosage and time of taking the medicine, based on the individual characteristics of the newborn and the level of bilirubin. Read more about the norms of bilirubin in newborns(amp)gt;(amp)gt;(amp)gt;

Also, in addition to suspensions, there are capsules that are usually contraindicated for newborns, they are prescribed for older children.

Maria, 27 years old

Anna, 32 years old

Valentina, 29 years old

Immediately after birth, the baby's body is not yet strong, he has to adapt to new conditions. Fetal hemoglobin is replaced by adult. During its breakdown, bilirubin is formed. It is difficult for the baby's liver to cope with large volumes of this substance. Bilirubin that is not excreted from the body is deposited on the skin. The body of the child and the whites of the eyes turn yellow, hence the name of the disease.

Within two weeks, the baby's liver gets stronger and can independently produce the right amount of glucuronic acid. It combines with bilirubin, neutralizes it, making it non-toxic, and promotes excretion in the urine. If the jaundice has not passed, then the baby is prescribed hepatoprotectors. With jaundice in newborns, doctors often prescribe Ursofalk.

The main danger is that if the level of bilirubin is too high, then it is able to get to the brain cells and destroy them. This will lead to disruption of the brain and cause nuclear jaundice.

Maria, 27 years old

Anna, 32 years old

Valentina, 29 years old

What is included in the medicine

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:

The main component of the drug, thanks to which it has a therapeutic effect, is called ursodeoxycholic acid. The amount of such acid in 5 ml of suspension and in 1 capsule is 250 mg, and in one tablet - 500 mg. Additionally, liquid Ursofalk contains sodium cyclamate, lemon flavor, xylitol, sodium chloride, glycerol and other ingredients. Auxiliary components of the capsules are gelatin, sodium lauryl sulfate, corn starch and other substances.

In addition to the active substance, the tablets contain talc, polysorbate 80, MCC, hypromellose and other compounds.

Ursofalk belongs to the medicinal group of hepatoprotectors. Its main active ingredient is ursodeoxycholic acid. Auxiliary components include distilled water, cellulose, benzoic and citric acids, sodium citrate. The preparation also includes glycerol and lemon flavor.

The drug has a positive effect, improves the dynamics of treatment:

Protects the liver from harmful and toxic enzymes;
Activates the liver, contributing to the rapid removal of bilirubin from the body;
Accelerates the growth of protective cells that will protect the liver and intestines;
Reduces the load on the brain, thereby preventing the development of nuclear jaundice.

The drug is embedded in the liver cells. Thanks to him, the production of enzymes that remove toxic substances from the body is stimulated. This explains the effectiveness of the drug in the treatment of newborns.

The drug is available in the form of capsules and suspensions. But newborns are prescribed a remedy in liquid form. Capsules need to be swallowed, therefore, they can be prescribed to children who are 3 years old. The main active ingredient of the drug is ursodeoxycholic acid. This substance is found in bile.

Also, the drug consists of:

Water.
Glycerol. This component acts as a sweetener. Thanks to him, the substances present in the suspension are dissolved. Glycerol is considered safe for the child's body, so it is often used during the manufacture of food for children.
Xylitol. This substance is considered a natural sweetener that reacts with other substances without changing their composition.
sodium chloride. Thanks to him, other components of the drug dissolve.
Benzoic acid. It is a preservative that provides a long shelf life of the drug.
sodium citrate. This food additive is considered an additive, due to which the taste is enhanced, the consistency of the drug is preserved.
propylene glycol. It is a thinner, which in its pure form does not have any aroma and taste.
Anhydrous citric acid. Because of this component, the medicine acquires a sour taste.
Lemon flavor.

This medicinal product can be stored for up to 4 months after opening the bottle.

Ursofalk suspension for newborns contains the main component - ursodeoxycholic acid.

It has a wide spectrum of action and has a complex effect on the body:

protects liver cells from the negative effects of toxic enzymes;
has immunomodulatory properties by stimulating the growth of protective cells in the liver and intestines;
activates the liver, due to which bilirubin begins to be processed quickly and easily excreted from the baby's body;
reduces the load on the brain, preventing the transformation of jaundice into a severe form.

Among the additional components in the composition of Ursofalk are:

water;
glycerol is a substance often used to prepare infant formulas, as it is completely safe, it helps to dissolve all the components of the drug, guaranteeing a pleasant taste;
xylitol, a natural sugar substitute that has a choleretic effect;
microcrystalline cellulose, used as a thickener without changing the beneficial properties of the drug;
sodium chloride helps to make the consistency homogeneous;
benzoic acid is a preservative that allows you to save the beneficial properties of the suspension for a long time (4 years);
sodium citrate serves as a flavor enhancer;
propylene glycol is used as a diluent, odorless and tasteless;
flavors;
citric acid is used as an acidifier;
Sodium cyclamate is a sweetener that is not absorbed by the body and is easily excreted in the urine.

Treatment of jaundice with Ursofalk

The action of the drug

Ursofalk with jaundice of newborns is used very often. You can give the drug even to a child who is on HB (breastfeeding) or parenteral nutrition. This hepatoprotector is recommended for use even by the notorious doctor Komarovsky. According to him, Ursofalk will be the best solution for jaundice, since the baby tolerates the drug well, and the therapeutic effect of UDCA is much more noticeable than that of hepatoprotectors of plant and homeopathic origin.

We have already mentioned above that only Ursofalk syrup is used. It is better not to give the same name tablets and capsules to newborns, since the child simply will not be able to swallow the medication. Doctors recommend giving tablets and capsules only after reaching the age of 6.

So, let's look at how the drug works. Ursodeoxycholic acid:

Strengthens immunity. The baby becomes less susceptible to infections and all kinds of viruses.
Breaks down small cholesterol stones in the gallbladder. Above, we talked about the fact that one of the causes of jaundice is cholelithiasis. If the calculus is small in size and does not contain a lot of calcium, then Ursofalk will be very useful, since the medication not only destroys stones, but also prevents their re-formation.
It has a positive effect on the flow and synthesis of bile. Stagnant processes in the biliary tract are very dangerous. It is because of them that cholangitis, cholecystitis and jaundice can develop. Ursodeoxycholic acid increases bile production and normalizes its passage. Due to this, digestion is greatly improved. In addition, Ursofalk has the ability to reduce the toxicity of bile acids, which will be very useful for the baby.
Stops inflammatory processes in the organs of the hepatobiliary system. This means that the use of UDCA will also be useful in cases where jaundice has developed as a result of chronic hepatitis, including viral etiology.
Slows down the progression of fibrosis - the degeneration of hepatocytes into connective tissue. This is a very important aspect, since untimely therapy for fibrosis is fraught with cirrhosis and even hepatic coma.
Reduces the saturation of bile with cholesterol and, accordingly, the index of lithogenicity. Due to this, even after stopping taking Ursofalk, it is possible to avoid the formation of stones in the gallbladder.