Registration number: P N014714/02-030614
Tradename: URSOFALC
International generic name:
Ursodeoxycholic acid.
Dosage forms:
suspension for oral administration.
COMPOUND
5 ml of suspension (1 measuring cup) contains 250 mg of ursodeoxycholic acid.
Excipients: benzoic acid 7.5 mg, purified water 2875.5 mg, xylitol 1600 mg, glycerol 500 mg, microcrystalline cellulose 100 mg, propylene glycol 50 mg, sodium citrate 25 mg, sodium cyclamate 25 mg, anhydrous citric acid 12.5 mg, sodium chloride 3 mg, lemon flavor (Givaudan РНL-134488) 1.5 mg.
DESCRIPTION
Homogeneous suspension white, containing small air bubbles, with a lemon aroma.
PHARMACOTHERAPEUTIC GROUP
Hepatoprotective agent.
ATX code: A05AA02
PHARMACOLOGICAL PROPERTIES
Hepatoprotective agent, has a choleretic effect. Reduces cholesterol synthesis in the liver, its absorption in the intestines and 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 its content bile acids; causes increased gastric and pancreatic secretion, enhances lipase activity, and has a hypoglycemic effect. Causes partial or complete dissolution of cholesterol stones when administered enterally, reduces the saturation of bile with cholesterol, which promotes the mobilization of cholesterol from gallstones. It has an immunomodulatory effect, affects immunological reactions in the liver: it reduces the expression of certain 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 of the liver in the absence of signs of decompensation ( symptomatic treatment)
chronic hepatitis of various origins
primary sclerosing cholangitis, cystic fibrosis(cystic fibrosis)
non-alcoholic steatohepatitis,
alcoholic liver disease,
biliary dyskinesia
CONTRAINDICATIONS
X-ray positive (high calcium content) gallstones; non-functional gallbladder; spicy inflammatory diseases gallbladder, bile ducts and intestines; liver cirrhosis in the stage of decompensation; severe dysfunction of the kidneys, liver, pancreas; increased sensitivity to the components of the drug.
Ursodeoxycholic acid has no age restrictions for use, but children under 3 years of age are recommended to use Ursofalk in suspension, as difficulties may arise when swallowing capsules.
PREGNANCY AND LACTATION
The drug is contraindicated during pregnancy. The drug can be used during pregnancy only in cases where the potential benefit to the mother exceeds possible risk for the fetus.
Data on the release of ursodeoxycholic acid from breast milk none. If it is necessary to use ursodeoxycholic acid during lactation, breastfeeding should be stopped.
METHOD OF APPLICATION AND DOSES
Children and adults weighing less than 34 kg are recommended to use Ursofalk in suspension.
Dissolution of cholesterol gallstones
| Body mass | Measuring cup | Compliant (ml) |
| 5-7 kg | 1/4 | 1,25 |
| 8-12 kg | 1/2 | 2,50 |
| 13-18 kg | 3/4 | 3,75 |
| 19-25 kg | 1 | 5,00 |
| 26-35 kg | 1 1/2 | 7,50 |
| 36-50 kg | 2 | 10,00 |
| 51-65 kg | 2 1/2 | 12,50 |
| 66-80 kg | 3 | 15,00 |
| 81-100 kg | 4 | 20,00 |
| Over 100 kg | 5 | 25,00 |
The drug must be taken daily in the evening, before bedtime.
Duration of treatment is 6-12 months. To prevent recurrent cholelithiasis, it is recommended to take the drug for several months after the stones have dissolved.
Treatment of biliary reflux gastritis
1 measuring cup of Ursofalk daily in the evening before bed.
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 7 measuring cups (approximately 14 mg ± 2 mg ursodeoxycholic acid per 1 kg of body weight).
The following mode of application is recommended:
| Body weight (kg) | Measuring cups Ursofalk suspension orally 250 mg / 5 ml |
|||
| First 3 months of treatment | Subsequently | |||
| Morning | During the day | Evening | Evening (1 time per day) | |
| 8-11 | - | 1/4 | 1/4 | 1/2 |
| 12-15 | 1/4 | 1/4 | 1/4 | 3/4 |
| 16-19 | 1/2 | - | 1/2 | 1 |
| 20-23 | 1/4 | 1/2 | 1/2 | 1 1/4 |
| 24-27 | 1/2 | 1/2 | 1/2 | 1 1/2 |
| 28-31 | 1/4 | 1/2 | 1 | 1 3/4 |
| 32-39 | 1/2 | 1/2 | 1 | 2 |
| 40-47 | 1/2 | 1 | 1 | 2 1/2 |
| 48-62 | 1 | 1 | 1 | 3 |
| 63-80 | 1 | 1 | 2 | 4 |
| 81-95 | 1 | 2 | 2 | 5 |
| 96-115 | 2 | 2 | 2 | 6 |
| More than 115 | 2 | 2 | 3 | 7 |
Symptomatic treatment chronic hepatitis of various origins - daily dose 10-15 mg/kg in 2-3 doses. Duration of treatment is 6-12 months or more.
Primary sclerosing cholangitis- daily dose 12-15 mg/kg; if necessary, the dose can be increased to 20 mg/kg in 2-3 doses. The duration of therapy ranges from 6 months to several years (see section: “Special instructions”).
Cystic fibrosis (cystic fibrosis)- daily dose 12-15 mg/kg; if necessary, the dose can be increased to 20-30 mg/kg in 2-3 doses. The duration of therapy ranges from 6 months to several years.
Non-alcoholic steatohepatitis- average daily dose 10-15 mg/kg in 2-3 doses. The duration of therapy ranges from 6-12 months or more.
Alcoholic liver disease- average daily dose 10-15 mg/kg in 2-3 doses. The duration of therapy ranges from 6-12 months or more.
Biliary dyskinesia- average daily dose of 10 mg/kg in 2 divided doses for 2 weeks to 2 months. If necessary, it is recommended to repeat the course of treatment.
SIDE EFFECTS
The assessment of adverse events is based on the following classification:
Very common (≥1/10)
Frequent (≥1/100 -<1/10)
Uncommon (≥1/1,000 -<1/100)
Rare (≥1/1 0.000 -<1/1,000)
Very rare (<1/10,000).
Gastrointestinal disorders:
In clinical studies, loose stools or diarrhea were frequently observed during treatment with ursodeoxycholic acid.
During the treatment of primary biliary cirrhosis, acute pain in the right upper abdomen was very rarely observed.
Disorders of the liver and biliary tract:
In very rare cases, calcification of gallstones may occur during treatment with ursodeoxycholic acid.
When treating advanced stages of primary biliary cirrhosis, in very rare cases, decompensation of liver cirrhosis was observed, which disappears after discontinuation of the drug.
Disorders of the skin and subcutaneous tissues:
In very rare cases, urticaria may occur.
If any of the side effects indicated in the instructions get worse, or you notice other side effects not listed in the instructions, please tell your doctor about it.
OVERDOSE
No cases of overdose have been identified. In case of overdose, symptomatic treatment is carried out.
INTERACTION WITH OTHER MEDICINES
Cholestyramine, colestipol and antacids containing aluminum hydroxide or smectite (aluminum oxide) reduce the absorption of ursodeoxycholic acid in the intestine 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 the saturation of bile with cholesterol and may reduce the ability to dissolve cholesterol gallstones.
SPECIAL INSTRUCTIONS
Ursofalk should be taken under medical supervision.
During the first three months of treatment, liver function parameters should be monitored: transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase in the blood serum every 4 weeks and then every 3 months. Monitoring these parameters makes it possible to identify liver dysfunction in the early stages. This also applies to patients in the later stages of primary biliary cirrhosis. In addition, it can quickly determine whether a patient with primary biliary cirrhosis is responding to treatment.
When used to dissolve cholesterol gallstones:
In order to assess progress in treatment and to promptly detect signs of calcification of stones depending on the size of the stones, the gallbladder should be visualized (oral cholecystography) with examination of opacities in the standing and supine position (ultrasound) 6-10 months after the start of treatment .
If the gallbladder cannot be visualized on x-rays or in cases of calcified stones, poor contractility of the gallbladder or frequent attacks of colic, Ursofalk should not be used.
When treating patients in the later stages of primary biliary cirrhosis:
Cases of decompensation of liver cirrhosis have been reported extremely rarely. After cessation of therapy, a partial reverse development of the manifestations of decompensation was noted.
When used in patients with primary sclerosing cholangitis:
Long-term therapy with high doses of ursodeoxycholic acid (28-30 mg/kg/day) in patients with this pathology can cause serious side effects.
In patients with diarrhea, the dosage of the drug should be reduced. If diarrhea persists, treatment should be discontinued.
One measuring cup (equivalent to 5 ml) of Ursofalk oral suspension 250 mg / 5 ml contains 0.50 mmol (11.39 mg) sodium. Patients monitoring their sodium intake should take this fact into account.
In this article you can read the instructions for use of the drug Ursofalk. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Ursofalk in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Ursofalk in the presence of existing structural analogues. Use for the treatment of liver cirrhosis and jaundice in adults, children (including infants and newborns), as well as during pregnancy and breastfeeding. Composition of the drug.
Ursofalk- hepatoprotector. Has a choleretic effect. Reduces cholesterol synthesis in the liver, its absorption in the intestines and concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and excretion of bile. Reduces the lithogenicity of bile and increases the content of bile acids. Causes increased gastric and pancreatic secretion, enhances lipase activity. Has a hypoglycemic effect.
Causes partial or complete dissolution of cholesterol stones when taken orally, reduces the saturation of bile with cholesterol, which promotes the mobilization of cholesterol from gallstones.
It has an immunomodulatory effect, affects immunological reactions in the liver: it reduces the expression of certain antigens on the hepatocyte membrane, affects the number of T-lymphocytes, the formation of interleukin-2, and reduces the number of eosinophils.
Compound
Ursodeoxycholic acid + excipients.
Indications
- dissolution of cholesterol gallstones;
- biliary reflux gastritis;
- primary biliary cirrhosis of the liver in the absence of signs of decompensation (symptomatic treatment).
Release forms
250 mg capsules (sometimes mistakenly called tablets).
Suspension for oral administration (sometimes mistakenly called syrup).
Instructions for use and dosage
Children and adults weighing less than 34 kg are recommended to use Ursofalk in the form of a suspension.
To dissolve cholesterol gallstones, a dose of 10 mg/kg body weight is prescribed once a day.
Capsules
- body weight up to 60 kg - 2 capsules per day;
- body weight 61-80 kg - 3 capsules per day;
- body weight 81-100 kg - 4 capsules per day;
- body weight over 100 kg - 5 capsules per day.
Oral suspension
- body weight 8-12 kg - number of measuring spoons 0.50 per day;
- body weight 51-65 kg - number of measuring spoons 2.5 per day;
- body weight 66-80 kg - number of measuring spoons 3 per day;
- body weight 81-100 kg - number of measuring spoons 4 per day;
- body weight over 100 kg - the number of measuring spoons is 5 per day.
The drug must be taken daily in the evening, before bed (the capsules are not chewed), with a small amount of liquid.
Duration of treatment is 6-12 months. To prevent recurrent cholelithiasis, it is recommended to take the drug for several months after the stones have dissolved.
For the treatment of biliary reflux gastritis, 1 capsule (1 scoop) of Ursofalk is prescribed every evening before bed, with a small amount of water. The course of treatment is from 10-14 days to 6 months, if necessary - up to 2 years.
For the 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 body weight).
Capsules
- body weight 34-50 kg - 2 capsules per day;
- body weight 51-65 kg - 3 capsules per day;
- body weight 66-85 kg - 4 capsules per day;
- body weight 86-110 kg - 5 capsules per day;
- body weight over 110 kg - 6 capsules per day.
Oral suspension
- body weight 5-7 kg - number of measuring spoons 0.25 per day;
- body weight 8-12 kg - number of measuring spoons 0.5 per day;
- body weight 13-18 kg - number of measuring spoons 0.75 per day;
- body weight 19-25 kg - number of measuring spoons 1 per day;
- body weight 26-35 kg - number of measuring spoons 1.5 per day;
- body weight 36-50 kg - number of measuring spoons 2 per day;
- body weight 51-65 kg - number of measuring spoons 3 per day;
- body weight 66-80 kg - number of measuring spoons 4 per day;
- body weight 81-100 kg - number of measuring spoons 5 per day;
- body weight over 100 kg - number of measuring spoons 6 per day.
Side effect
- diarrhea;
- nausea;
- pain in the epigastric region and right hypochondrium;
- calcification of gallstones;
- allergic reactions.
Contraindications
- X-ray positive (high calcium) gallstones;
- non-functioning gallbladder;
- acute inflammatory diseases of the gallbladder, bile ducts and intestines;
- liver cirrhosis in the stage of decompensation;
- severe renal dysfunction;
- severe liver dysfunction;
- severe dysfunction of the pancreas;
- pregnancy;
- lactation period (breastfeeding);
- hypersensitivity to the components of the drug.
Use during pregnancy and breastfeeding
The drug is contraindicated during pregnancy and lactation (breastfeeding).
Use in children
Perhaps, according to the dosage regimen.
special instructions
In case of cholelithiasis, the effectiveness of treatment is monitored every 6 months by conducting x-ray and ultrasound examination of the biliary tract in order to prevent relapses of cholelithiasis.
In case of cholestatic liver diseases, the activity of transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase in blood serum should be periodically determined.
When treating primary biliary cirrhosis, transient decompensation of liver cirrhosis may occur, which disappears after discontinuation of the drug.
During treatment, women of childbearing age should use reliable methods of contraception.
Drug interactions
Cholestyramine, colestipol and antacids containing aluminum hydroxide or smectite (aluminum oxide) reduce the absorption of ursodeoxycholic acid in the intestine 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 the saturation of bile with cholesterol and may reduce the ability to dissolve cholesterol gallstones.
Analogues of the drug Ursofalk
Structural analogues of the active substance:
- Livodex;
- Urdoxa;
- Urso 100;
- Ursodez;
- Ursodeoxycholic acid;
- Ursodex;
- Ursoliv;
- Ursorom Rompharm;
- Ursor S;
- Ursosan;
- Choludexan;
- Exhol.
If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.
Instructions for use of Ursofalk tell about the mechanism of action and properties of a popular hepatoprotective agent used to maintain liver function, dissolve cholesterol gallstones and reduce blood cholesterol levels. Due to its wide range of therapeutic effects, this drug is prescribed for many diseases of the liver, gall bladder and conditions associated with obstruction of the bile ducts.
Ursofalk: description, principle of operation
Ursofalk is a drug from the group of hepatoprotectors, the action of which is aimed at normalizing the production of bile and eliminating pathological conditions associated with its stagnation in the biliary system. The active component of the drug is ursodeoxycholic acid, which has choleretic properties, reduces synthesis by liver tissue, reduces its concentration in the composition and prevents absorption in the intestine.
Taking the drug allows you to normalize the process of production and excretion of bile, reduces its viscosity, which helps eliminate congestion. Due to this, the secretion of gastric juice and pancreatic enzymes increases, metabolic processes and functions of the digestive system improve. In addition, Ursofalk has a local immunomodulatory effect, helping the liver to resist the toxic effects of various adverse factors.
The direct effect of ursodeoxycholic acid is aimed at dissolving cholesterol stones and reducing the concentration of cholesterol in bile. As a result, cholesterol does not precipitate and does not form gallstones, but is excreted from the body naturally.
Thus, the therapeutic effect of the drug helps to avoid many complications - stagnation of bile, deterioration of the patency of the bile ducts, inflammatory processes in or the formation of stones in the gall bladder.
Composition and release forms of Ursofalk
Today, Ursofalk is produced in two dosage forms: capsules and suspension.
Gelatin capsules are opaque and hard, containing white granules or powder. The basis of each capsule is 250 mg of the active substance (ursodeoxycholic acid) + auxiliary components such as silicon dioxide, starch, magnesium stearate, etc. Capsules of 10 pieces are placed in blisters and packaged in cardboard packs.
Ursofalk suspension is white in color, homogeneous consistency, with the smell of lemon. The standard dose (5 ml of suspension) contains the same amount of active substance as in capsules (250 mg) and a number of additional ingredients. The suspension is produced in dark glass bottles of 250 ml. The kit includes a measuring spoon to facilitate dosage and use of the drug.
When is Ursofalk prescribed?
The main indications for the use of Ursofalk are diseases of the liver and gall bladder, cholestasis (decreased bile production), as well as an increase in the concentration of “bad” cholesterol in the blood. In addition, the hepatoprotector is prescribed as part of complex therapy for the following diseases:
- biliary liver (primary);
- hepatitis (acute chronic) of various origins, accompanied by cholestasis;
- reflux esophagitis and reflux gastritis (biliary);
- formation of cholesterol stones in the gall bladder;
- manifestations of cystic fibrosis;
- toxic liver damage (drugs, alcohol);
- biliary dyskinesia.
In addition, Ursofalk drugs are recommended to be prescribed to patients who have undergone liver transplant surgery, and also to be used to prevent toxic liver damage. Another direction of use is the appointment of Urfsofalk as a means of preventing cancer of the rectum.
Instructions for use
If it is necessary to dissolve cholesterol stones formed in the gallbladder, Ursofalk capsules are prescribed taking into account body weight. The required dose of the drug is selected by the doctor at the rate of 10 mg/1 kg of weight. This dose should be taken once a day, preferably in the evening, before bedtime.
The capsule is swallowed whole, without chewing, and washed down with a small amount of liquid. The duration of treatment required to completely dissolve the stones ranges from 6 months to one year. In order to prevent the re-formation of stones, the doctor may recommend taking the drug for several months after the end of the main course of therapy.
Ursofalk suspension is intended for the treatment of children and adults. And in this case, the dosage regimen depends on the age and body weight of the patient. The smallest patients, whose weight ranges from 5 to 7 kg, receive 1/4 scoop of suspension per day.
Older children with a body weight of up to 25 kg are prescribed 1 scoop of the drug, and the dose of medication for adults is from 3 to 6 spoons per day with a body weight of 60 to 100 kg. In any case, the exact regimen and duration of treatment should be determined by a specialist, taking into account the severity of the disease and possible contraindications.
For biliary cirrhosis, taking the drug can alleviate the symptoms of the disease. The daily dose is also calculated based on the age and weight of the patient, and is 10-15 mg/1 kg of body weight.
When treating reflux gastritis, 1 capsule (measuring spoon) of the drug per day is usually prescribed. It is recommended to drink the medicine before going to bed. The duration of therapy ranges from 14 days to several months and depends on the severity of symptoms and the general condition of the patient.
Ursofalk suspension for newborns
Ursofalk for newborns is prescribed in the form of a suspension. Treatment is carried out under the supervision of a pediatrician; the dose of the drug in this case should be minimal, no more than 0.25 scoop per dose.
For what purpose is Ursofalk prescribed to infants? The fact is that many newborn babies experience physiological jaundice. The coloring of the skin and mucous membranes in a yellow tint provokes an excess of bilirubin, which the child’s body cannot eliminate due to imperfect liver function and a lack of certain enzymes.
However, the accumulation of toxic bilirubin in the body negatively affects the baby’s condition, and if this situation persists for a long time, the use of Ursofalk suspension helps cleanse the body of harmful substances and eliminate jaundice in newborns.
Contraindications
The use of any form of the drug based on ursodeoxycholic acid is contraindicated in the following conditions:
- period and breastfeeding;
- acute inflammatory process in the gallbladder, bile ducts and intestines;
- severe pathologies of the liver, pancreas and kidneys;
- non-functioning gallbladder;
- the presence of gallstones, the basis of which are calcifications;
- liver cirrhosis at the stage of decompensation;
- individual intolerance to the components of the drug.
There are no age restrictions for the use of Ursofalk; it is prescribed even to newborn children. However, up to 3 years of age, the drug is used in the form of a suspension, since small children cannot yet swallow the entire capsule.
Despite the fact that scientists have proven the absence of mutagenic and teratogenic effects of the active component of the drug on the fetus, there is no accurate data on the possibility of this substance penetrating the hemocetal barrier and its effect on the course of pregnancy. Therefore, Ursofalk is prohibited for use during pregnancy.
Side effects
During treatment with Ursofalk, the following adverse reactions may occur:
On the part of the digestive system, nausea, pain in the right hypochondrium and in the epistrium, and loose stools (diarrhea) often appear.
On the part of the biliary tract and liver, it is possible to increase liver transaminases and calcify gallstones, but such a reaction is quite rare. If the drug is prescribed during the treatment of biliary cirrhosis, decompensation of cirrhosis is possible, which disappears after the drug is discontinued.
Allergic reactions to the use of the drug are manifested by skin symptoms - itching, rashes like urticaria.
If treatment with Ursofalk is prescribed to a woman of childbearing age, it is necessary to use reliable methods of contraception to avoid pregnancy while using the drug.
Good to know
When treating cholelithiasis, it is necessary to monitor the effectiveness of treatment every six months using ultrasound and x-ray examination of the biliary tract.
In case of liver cholestasis, during the use of the drug, the activity of transaminases and alkaline phosphatase in the blood serum is periodically determined.
Analogs
Structural analogues of Ursofalk, which contain the same active ingredient, are the following drugs:
- Urdoxa;
- Ursodez;
- Ursosan;
- Livodex;
- Choludexan.
If there is a need to replace the drug, the doctor can select an analogue for the patient from this list. Most often, patients ask to change the drug not because there are contraindications to its use or unwanted side effects occur, but because of the high cost of this drug.
Ursofalk price
The cost of the drug cannot be called affordable.
- The price for a pack of 10 capsules is about 250 rubles, and the cost of a pack of the drug containing 100 capsules averages 2,200 rubles.
- A bottle of Ursofalk suspension can be purchased at a pharmacy from 1,200 rubles.
Considering that the medication will have to be taken for a long time, the total cost of treatment will be an impressive amount.
Included capsules contains the active component, as well as inactive components: corn starch, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulfate, gelatin, titanium dioxide, purified water.
Ursofalk suspension contains as an active component ursodeoxycholic acid , as well as additional components: benzoic acid, xylitol, glycerol, MCC, sodium citrate, propylene glycol, anhydrous citric acid, sodium chloride, flavoring, water.
Release form
The medicine is produced in the form of capsules and suspension.
- Capsules gelatinous, hard, white, opaque. Inside the capsules there is white powder or granules. There are 10 capsules in a blister; the blisters fit into cardboard packs.
- Suspension homogeneous consistency, white in color, it may contain small bubbles. Has a lemon scent. Contained in 250 ml dark glass bottles, a 5 ml measuring cup is also included in the cardboard box.
pharmachologic effect
This drug is hepaprotector , that is, a medicine that helps dissolve cholesterol gallstones, significantly reducing cholesterol levels in the blood. It has a wide range of effects, in particular, it acts as a hepatoprotective, cholelitholytic, immunomodulatory agent. A hypoglycemic effect is also noted.
Ursodeoxycholic acid - the active substance contained in the drug Ursofalk is also present in certain quantities in bile. But if certain liver functions are impaired, the synthesis of this substance and its content in the bile decreases. Positively affects immunological reactions in the liver.
The following effects of ursodeoxycholic acid are highlighted:
- provides choleretic effect , reducing the amount of bile acids in bile and increasing their excretion into the intestinal lumen, also reducing the absorption of toxic bile hydrophobic acids;
- manifests itself cytoprotective effect , which consists in the ability of this substance to be incorporated into the lipid layer of the cell membrane, which leads to stabilization of the cell membrane and strengthening of its protective properties;
- noted and immunomodulatory effect and a decrease in the synthesis of pro-inflammatory cytokines;
- produces hypercholesterolemic effects due to decreased absorption in the ileum, reducing the synthesis of cholesterol in the liver, as well as activating the process of its excretion with bile.
Also, under the influence of ursodeoxycholic acid, lithogenicity decreases . As a consequence, the transformation of cholesterol compounds leads to a decrease in the formation of cholesterol and to the dissolution of cholesterol stones.
Under the influence of the drug Ursofalk, gastric and pancreatic secretion increases.
Pharmacokinetics and pharmacodynamics
After taking the medicine in the form of a suspension or capsules orally, the process of absorption of ursodeoxycholic acid occurs in the small intestine. Approximately 60-80% of the dose that was taken is determined in the general bloodstream. Metabolism of the active component occurs in the liver. The active ingredient is partially broken down in the intestines, resulting in the formation of toxic 7-keto-lithocholic acid. This substance is slightly absorbed into the general bloodstream; its detoxification occurs in the liver.
A characteristic feature of this drug is the effect of first passage through the liver. The half-life is 3-5 days. Excretion occurs in feces mainly in the form of metabolites, and a small part is excreted unchanged.
Indications for use
Those indications for the use of the drug Ursofalk, which are indicated in the instructions, are associated with use for diseases of the liver and gallbladder, in which cholestasis, an increase in blood cholesterol levels, as well as a decrease in a number of liver functions are noted. The medicine is prescribed for the following diseases:
- primary biliary;
- primary sclerosing cholangitis;
- hepatitis of different origins (acute and chronic), accompanied by cholestasis ;
- reflux esophagitis and biliary reflux gastritis;
- the presence of cholesterol stones in the gallbladder (provided that the stones are X-ray negative, their diameter is no more than 15 mm, and the person does not have gallbladder dysfunction);
- cystic fibrosis ;
- toxic liver damage (including alcohol poisoning);
- atresia of the intrahepatic bile ducts.
Also, tablets and suspension are prescribed to eliminate bile stagnation in people on parenteral nutrition. It is advisable to prescribe them to patients who have undergone liver transplantation in order to prevent liver damage in the case of treatment with drugs with a cholestatic effect and taking hormonal contraceptives. Ursofalk is also prescribed for the purpose of preventing colon cancer in those people who are considered at risk.
Contraindications
The instructions indicate the following contraindications to the use of tablets and suspensions:
- X-ray positive gallstones (that is, stones with a high calcium content);
- acute inflammatory diseases of the bile ducts, intestines, gall bladder;
- liver cirrhosis in the decompensation stage;
- non-functioning gallbladder;
- severe disturbances in the functions of the liver, pancreas, kidneys;
- pregnancy and lactation;
- pronounced sensitivity to drug components.
Side effects
During treatment, the following side effects may occur:
- digestive system: , manifestation of acute pain in the upper abdomen on the right during treatment of primary biliary cirrhosis ;
- liver and bile ducts: in rare cases - calcification of stones, decompensation liver cirrhosis in those undergoing treatment for primary biliary cirrhosis ;
- skin, subcutaneous tissue: in rare cases – .
If the above side effects worsen or if any other negative symptoms appear during treatment, the patient must inform the specialist.
Instructions for use of Ursofalk (Method and dosage)
Instructions for use of capsules
The drug for dissolving gallstones should be used in a dose of 10 mg per 1 kg of patient weight once a day.
For a patient weighing up to 60 kg, 2 capsules per day is recommended, for a weight from 61 to 80 kg - 3 capsules, for a weight from 81 to 100 kg - 4 capsules, for a weight over 100 kg - 5 capsules. You need to take the tablets in the evening, before going to bed. It is not recommended to chew the capsules.
The duration of taking the drug is from 6 to 12 months. To ensure quality prevention repeated cholelithiasis , it is recommended to take the product for several months after the stones have dissolved.
During treatment biliary reflux gastritis 1 Ursofalk capsule should be used every day in the evening for 10 days to 6 months, sometimes up to 2 years.
In case of symptomatic therapy primary biliary cirrhosis The dose of the medicine depends on the person’s weight. It can range from 2 to 7 tables. For the first three months of therapy, capsules should be taken several times throughout the day; then, when liver parameters improve, it is enough to drink 1 capsule. Ursofalk in the evening. Treatment of primary biliary cirrhosis can continue for an unlimited period of time. Please note that in rare cases, people with this condition may experience a worsening of symptoms when starting to take the drug. In this situation, you need to reduce the dose to 1 capsule per day, and after the condition improves, you need to gradually increase the dosage.
For symptomatic treatment chronic hepatitis of various origins The dose of the drug per day is 10-15 mg per 1 kg of weight, it should be taken in 2-3 doses. Reception lasts from 6 to 12 months.
In patients with primary sclerosing cholangitis , cystic fibrosis the dose is 12-15 mg of the drug per 1 kg of weight. If necessary, the dosage is increased to 20-30 mg per 1 kg of weight. Treatment lasts from 6 months to several years.
In people with non-alcoholic steatohepatitis , and also with alcoholic liver disease use a dose of 10-15 mg per 1 kg of weight. Treatment lasts 6-12 months or longer.
Patients with biliary dyskinesia Prescribe 10 mg of the drug per 1 kg of weight per day, you need to take the medicine for 2 weeks. up to 2 months Treatment can be repeated if necessary.
Ursofalk suspension, instructions for use
For newborns, children and adults whose weight does not exceed 47 kg, the drug is prescribed in the form of a suspension. To dissolve cholesterol stones , you need to take a suspension at a dose of 10 mg per 1 kg of weight once a day. Children weighing 5-7 kg receive 0.25 scoop; 8-12 kg – half a measuring spoon; 13-18 kg - 0.75 spoons; 19-25 kg – 1 spoon; 26-35 kg – 1.5 spoons; 36-50 kg – 2 spoons; 51-65 kg - 2.5 spoons; 66-80 kg – 3 spoons; 81-100 kg – 4 spoons; more than 100 kg – 4 spoons.
When treating other diseases, it should be taken into account that the content of 1 measuring spoon corresponds to the content of the active substance in one capsule. How to take it - before or after meals - does not matter significantly.
Overdose
There have been no recorded cases of drug overdose. If necessary, symptomatic therapy is practiced.
Interaction
The absorption of ursodeoxycholic acid in the intestine and, accordingly, the effectiveness of the drug is reduced when taking colestipol, cholestyramine, as well as antacids that contain aluminum oxide. If it is necessary to use these medications, they should be taken at least two hours before taking Ursofalk.
Ursodeoxycholic acid enhances absorption cyclosporine from the intestines. That is, if it is necessary to take cyclosporine, you need to control the concentration of cyclosporine in the blood and adjust the dose of the drug.
There is a possibility that absorption may be reduced when taking Ursofalk .
It should be borne in mind that when taking lipid-lowering drugs (especially clofibrate), neomycin, estrogens, progestins, the saturation of bile with cholesterol increases, so the ability of the active substance to dissolve cholesterol gallstones may decrease.
Terms of sale
Ursofalk can be purchased with a prescription.
Storage conditions
Keep capsules and suspension away from children and store at a temperature of no more than 25°C.
Best before date
Capsules can be stored for 5 years, suspension - 4 years. After the bottle of Ursofalk has been opened, the suspension can be used for 4 months.
special instructions
Ursofalk should be taken under the supervision of a specialist.
In the first 3 months of use, it is very important to monitor liver function indicators, first every 4 weeks, then once every three months. It is important to identify liver dysfunction at the earliest stages. It is also important to determine as quickly as possible whether people with primary biliary cirrhosis .
To determine whether there is any progress in the treatment of calcification of stones, it is necessary to conduct an oral cholecystography with examination in a standing position, as well as in a supine position, 6-10 months after the start of therapy.
Ursofalk should not be prescribed if it is not possible to visualize the gallbladder using an x-ray, if there is calcification of stones, or attacks of colic.
In very rare cases, cases of decompensation of liver cirrhosis have been reported.
To people suffering diarrhea , you need to reduce the dose of the drug. Patients with persistent diarrhea therapy must be suspended.
Analogues of Ursofalk
Level 4 ATX code matches:Analogues of this medicine are means Ursolite , Ursobil , Ursolvan , Holacid , , Ursosan , Delursan and etc.
The price of Ursofalk analogues depends on the manufacturer and packaging. The most optimal drug is prescribed by the attending physician individually.
Which is better: Ursofalk or Ursoliv?
Medicine as an active component it contains, like Ursofalk, ursodeoxycholic acid. Therefore, their effect on the human body is similar. However, sometimes these medications can act differently depending on your individual body. Therefore, the choice of drug should be made by a doctor after careful research.
For children
For children, it is prescribed in the form of a suspension; it must be used strictly according to the scheme described in the instructions.
Ursofalk for newborns
Reviews indicate that Ursofalk for newborns is prescribed for physiological jaundice, which appears a few days after the birth of the child. However, the instructions do not contain data on such use of the drug. It should be noted that such treatment can only be carried out under the constant supervision of a specialist.
During pregnancy and lactation
It has been proven that the active component of Ursofalk does not have a mutagenic, teratogenic or embryotoxic effect, but there is still no accurate data on its penetration through the hematoplacental barrier, and on the effect of the drug on the course of pregnancy. Therefore, during pregnancy it is prescribed only if indicated. There are no data on effects during breastfeeding.
Ursofalk is considered the best imported hepatoprotector based on ursodeoxycholic acid. The instructions say that the drug has hepatoprotective, choleretic, hypolipidemic, immunomodulatory, cholelitholytic effects.
The medicine is available in three dosage forms - tablets, oral suspension and capsules. The suspension is mainly prescribed to children. In some cases, it is even prescribed to infants suffering from jaundice.
The manufacturer of the drug is Losan Pharma GmbH (Germany). Also in pharmacies you can find Ursofalk produced by Vifor AG (Switzerland). The drug is dispensed by prescription. A 250 ml suspension costs about 3000-3200 rubles. For 100 tablets you will have to pay 6-7 thousand rubles, and the price of 100 capsules is about 2.5-3 thousand rubles.
Let's take a closer look at the action, indications, contraindications, side effects and analogues of the hepatoprotector and also find out what dosage regimen patients should follow.
Composition and action of Ursofalk
Bile acids are a group of hepatoprotectors. Mostly these medications are prescribed for diseases of the gallbladder, as well as for the formation of cholesterol stones in the gallbladder.
In the initial stages of cholelithiasis, ursodeoxycholic acid helps dissolve the calculus and prevent its enlargement. Also, the active component of Ursofalk has a positive effect on the physico-chemical properties, flow and synthesis of bile.
So, as noted above, Ursofalk has hepatoprotective, choleretic, hypolipidemic, cholelitholytic and immunomodulatory effects. According to doctors, this drug even has a mild hypoglycemic effect.
The suspension, tablets and capsules contain the same active ingredient – ursodeoxycholic acid. The suspension, tablets and capsules also contain excipients, including magnesium stearate, sodium cyclamate, flavorings, purified water, titanium dioxide, etc.
Ursofalk:
- It has a pronounced cholelitholytic effect. This means that when using the medicine, the bile lithogenicity index decreases. The higher this indicator, the higher the likelihood of cholesterol stones forming in the gallbladder.
- Normalizes carbohydrate metabolism and slightly reduces blood sugar levels.
- Reduces the saturation of bile with cholesterol. Hepatologists also note that Ursofalk helps stabilize lipid metabolism and even prevent the development of atherosclerosis and.
- Restores the integrity of liver cell membranes, protects hepatocytes from the effects of free radicals, toxins, heavy metal salts, and alcohol breakdown products. In general, Ursofalk stabilizes the detoxification function of the liver.
- Restores normal synthesis and passage of bile through the bile ducts. Doctors also claim that long-term use of Ursofalk leads to the stabilization of the physicochemical parameters of bile and a decrease in the activity of liver transaminases.
- Stimulates the excretion of toxic bile acids.
- Reduces the ability of gastric reflux to damage cell membranes against the background of chronic reflux esophagitis or reflux gastritis.
- Has a positive effect on the functioning of the immune system. The instructions say that this is achieved due to the fact that ursodeoxycholic acid inhibits the expression of HLA antigens, and at the same time normalizes the natural killer activity of lymphocytes.
- Prevents the development of fibrosis, a process characterized by the transformation of healthy liver cells into connective tissue.
- Reduces the likelihood of developing varicose veins of the esophagus.
- Dissolves cholesterol stones and prevents their re-formation.
Now a few words about pharmacokinetics. After taking the suspension, tablets or capsules orally, the process of absorption of ursodeoxycholic acid occurs in the small intestine. Studies show that about 60-80% of the dose taken by the patient is found in the general bloodstream. Metabolism of UDCA occurs directly in the liver. The partially active component of Ursofalk disintegrates in the intestines.
The hepatoprotector has a “first pass through the liver” effect. The half-life of UDCA is about 3-5 days. Excretion is carried out through the intestines. Bile acid is excreted in the form of metabolites, and a small part of it is excreted unchanged.
Instructions for use of the drug
Tablets, suspension and capsules are also often prescribed to people who have cholesterol stones in their gallbladder.
But the instructions stipulate that the drug is used provided that the gallbladder is functioning normally, the patency of the bile ducts is maintained and the size of the stone is small, and the stone itself does not contain a lot of calcium.
The list of indications for use also includes:
- Primary biliary cirrhosis of the liver.
- Sclerosing cholangitis.
- Acute and chronic hepatitis. Moreover, Ursofalk is used for viral, autoimmune, medicinal, and alcoholic etiologies of inflammatory processes.
- Reflux esophagitis.
- Reflux gastritis.
- Cystic fibrosis.
- Artresia of the intrahepatic bile ducts.
- Toxic liver damage.
- Fatty liver degeneration.
- Non-alcoholic steatohepatitis.
- Dyskinesia of the bile ducts.
- Noncalculous cholecystitis.
- Alcoholic liver disease.
You can take Ursofalk to prevent liver damage if a person has been consuming cytostatics, anabolic steroids, tuberculosis pills, hormonal drugs and any other hepatotoxic drugs for a long time.
Sometimes the suspension and capsules are prescribed to people who have recently had a liver transplant or gallbladder removal (cholecystectomy). You can take a hepatoprotector for bile stagnation if the patient is on parenteral nutrition.
Dosage regimen and rules of administration:
- Tablets/capsules. It is best to take them after meals or at night. The dosage is selected based on the patient’s body weight and the severity of the specific disease. The daily dose can be from 10 to 30 mg per 1 kg of patient body weight. The frequency of administration is 1-3 times a day. The duration of therapy is selected individually. When choosing the duration of the course, the severity of the underlying disease is taken into account. Sometimes the course lasts only 2-3 weeks, sometimes up to 2 years.
- Suspension. The dosage regimen and duration of administration are also selected individually, based on the patient’s body weight and the severity of the underlying disease. A measuring spoon is included with the suspension. The dose can be ¼-4 scoops. The syrup can be taken both before and after meals.
It is not recommended to take the suspension and tablets/capsules at the same time.
Contraindications and side effects
Let's consider contraindications to the use of the medicine. There are actually a lot of them. Firstly, the drug should not be taken by persons who have hypersensitivity or intolerance to ursodeoxycholic acid.
The list of contraindications includes decompensated cirrhosis of the liver, acute inflammatory diseases of the liver/bile ducts/intestines, gallbladder dysfunction, blockage of the bile ducts, severe disturbances in the functioning of the pancreas or kidneys. Ursofalk is not prescribed if a person has large stones in the gallbladder that contain a lot of calcium.
Pregnant women can take a hepatoprotector, but first consult a doctor. The physician must assess all possible risks to the fetus and the expected benefits to the mother.
During lactation, you can take capsules, tablets or suspension, but in this case you should stop breastfeeding. As for children, they are recommended to take the suspension, and tablets and capsules are prescribed mainly to adult patients.
Side effects:
- Allergic reactions - urticaria, itching, burning, hyperemia, redness of the skin, Quincke's edema. Even anaphylactic reactions are possible.
- Calcification of gallstones.
- Decompensation of liver cirrhosis.
- Digestive disorders. Ursofalk often causes nausea, diarrhea, vomiting, and pain in the abdominal area. There may be discomfort in the right hypochondrium.
- There may be a decrease in hemoglobin levels. This is not stated in the instructions, but there have been cases where long-term use of Ursofalk led to a decrease in Hb levels.
Cases of overdose with Ursofalk have not been registered and, accordingly, are not described in the instructions. Aluminum-containing drugs may reduce the effectiveness of Ursofalk, since such drugs reduce the level of absorption of ursodeoxycholic acid. During therapy, it is better not to take products that contain aluminum oxide or hydroxide at all.
The description also says that Ursofalk is able to enhance the rate of absorption of Cyclosporine from the intestine, and bile acid sometimes reduces the absorption of Ciprofloxacin.
Special instructions:
- Drinking alcohol during therapy is not recommended. Alcohol has normal compatibility with UDCA, however, ethanol has a detrimental effect on the liver and gall bladder, and accordingly, the effectiveness of therapeutic measures may be reduced.
- In the first 3 months of treatment, people who have cholesterol gallstones should undergo an ultrasound and biochemical blood test every 4 weeks to monitor.
- Therapy should be interrupted if liver enzymes increase, calcification of cholesterol stones occurs, or decompensation of cirrhosis develops.
- If diarrhea occurs, the dose should be reduced, and if diarrhea persists, the course should be interrupted.
Ursofalk does not affect the reaction rate, so you can drive vehicles and other potentially dangerous mechanisms while taking the drug.
