Ursofalk suspension is a drug that has a wide spectrum of action. It is used to treat many diseases, including helminthic invasions. Ursofalk can be used as a body cleanser.
The international non-proprietary name (INN) is ursodeoxycholic acid. It is included in the Register of Medicines in Russia (RLS). Available in two forms:
- capsules;
- suspension.
Ursofalk capsules are small gelatinous tablets. The cap itself is white. Inside contains powder in the form of small granules. Each tablet contains 250 mg of active ingredient.
Ursofalk in suspension is a homogeneous liquid with a white color. Air bubbles are visible after opening. Pleasant in smell, as it has a lemon scent.
What does it consist of
Ursodeoxycholic acid is the main component of the drug. This substance acts as a choleretic agent, effectively lowers blood cholesterol levels. The use of Ursofalk is able to enhance pancreatic and gastric secretions. In addition to destroying worms, the drug is able to dissolve cholesterol stones.
Regardless of the form of release of Ursofalk, the drug can be used to treat many disorders of the human body. The medicine in capsules has a wide spectrum of action, and also helps to get rid of many types of helminths. Indications for use of Ursofalk:
After entering the body, the drug Ursofalk helps to improve the protective properties of cells.
The medicine can be beneficial as well as harm. Especially if the patient does not follow the basic recommendations for use. Contraindications Ursofalk:
- Disorders in the urinary system.
- Poor kidney function.
- Infections in the intestines, as well as in the gallbladder.
- Non-functioning gallbladder.
- Diseases of the pancreas.
- Lactation period in women.
- Intolerance to individual components of the drug.
If the patient has at least one of the listed diseases, then the medicine is not recommended to be used. It does not matter whether it is a suspension or tablets. The composition of the drug may not be suitable for the patient, which will affect his general condition.
Application
The instructions for use of Ursofalk contain detailed information, including only important nuances. So how to take Ursofalk correctly? It all depends on the age, weight and disease of the patient. For children weighing more than 50 kg, use Ursofalk 250 mg capsules.
Babies are usually prescribed a medicine in the form of a suspension. This is done to make it easier for the child to swallow the drug this way. If the patient is unable to take a pill, then a syrup is prescribed. In this case, the dosage must be observed.
In no case should you self-medicate, especially if the patient is a small child.
The standard treatment regimen involves the following dosage. There are 14 mg of active ingredient per 1 kg of patient weight. This scheme must be adhered to during the first three months of treatment. If during this time the person feels an improvement, the dose is changed. To achieve the maximum therapeutic effect, one capsule per day will be sufficient.
With dyskinesia of the biliary tract, the patient is prescribed 10 mg of ursodeoxycholic acid per 1 kg of body weight. The medicine is drunk twice a day. Likewise, DVP is treated from 1.5 weeks to 2 months.
Compatibility
A medicine like Ursofalk is not an antibiotic. But in some cases, its use is prohibited in parallel with other drugs. Why is this happening? Ursofalk is not prescribed simultaneously with medicines, which include aluminum hydroxide and smectite.
These substances prevent absorption of the drug in the intestine, thereby reducing its medicinal effectiveness. At least 2 hours should pass between the receptions of these components. If smectite and aluminum hydroxide cannot be abandoned for the period of treatment, therapy is carried out under the strict supervision of a physician. 
For babies
Ursofalk for newborns is an advantage due to which the drug is very popular. Instructions for use for newborns are very simple and require attention from parents first of all. Regular use of the drug immediately gives a positive effect. So, how to give the drug to the baby?
They drink the medicine, if it is a baby, always at night. If the disease is difficult to tolerate, then at least 10 ml of ursodeoxycholic acid should go per 1 kg of weight. Treatment depends on many factors. The patient's weight, the state of the immune system, as well as the individual characteristics of the organism are taken into account.
In a newborn, each new case has its own characteristics. The drug must be taken until the symptoms of the disease go away and the child is much better. It is better for a newborn to choose a form of release in a liquid state, in other words - a suspension. According to the doctor's recommendations, the medicine is absorbed better when taken at night.
Ursofalk is used to cleanse the body last. Usually, after a person is unable to remove the worms with drug-free therapy.
Babies under one year old cannot easily drink the drug. As a rule, they are capricious and vomit it. In this case, there is an excellent solution to how to drink the drug. You should use a regular injection syringe.
To do this, collect the required amount of funds and pour everything into the child's mouth. Press on the cheeks so that the baby opens his mouth and slowly injects the medicine, directing the stream to the inside of the cheek. This will create drops. This method is a success among many parents.
There are no instructions for newborns in the Ursofalk kit. In rare cases, minor side effects may occur. It can be burning, itching, and increased stool frequency.
During pregnancy
The description of the drug does not contain complete information about its effect on the body of pregnant women and the fetus. When taking Ursofalk 250 mg, it does not affect the baby's body from a mutagenic point of view. Ursofalk (indications) is not a provoking factor in the onset of cancer. Annotation to the drug suggests that the drug is prohibited for pregnant women. Despite this, gynecologists, together with therapists, are confident that it does not have any negative effects if you follow the basic recommendations for use.
It contains components that can behave unpredictably. Therefore, before you start taking Ursofalk, you must undergo a complete examination. If a woman begins to drink medicine, then she should be ready for numerous ultrasounds and monitoring the state of the body.
Only the attending physician decides whether to take the drug for a pregnant woman or not. A similar conclusion is made on the results of analyzes.
A worthy analogue
If during pregnancy Ursofalk was prescribed as a treatment for worms, the patients who drank it noted a good result. But in some cases it is more expedient to use Ursofalk analogs.
Popular Ursofalk substitutes:
- Urdoks;
- Ursosan;
- Exhol;
- Ursodez.
The doctor writes the prescription, so it is up to him to decide which drug to use for treatment. An interesting fact is that the name of the analogs sounds about the same.
Consequences of application
When using the medication, you must adhere to the doctor's recommendations. Depending on the state of the body, it is prescribed before or after meals. It is allowed to use the drug with food. The scheme is simple: we eat and after that we drink Ursofalk. Regardless of how the medication was taken - with food or not, side effects may appear:
- indigestion;
- pains of various kinds (in the abdomen);
- allergic rash on skin areas.
Side effects always go away on their own. Thus, the body reacts to the ingress of certain components. In any case, a person should monitor the state of the body after drinking Ursofalk, the side effects of which are described above. As a rule, a serious condition appears if the patient is given too much medicine.
If a person needs to drink a double dose (Ursofalk 500 mg), it is recommended to split it into several doses. As experts say, you give your body the opportunity to easily transfer treatment. Therefore, drink it only in specially selected doses.
Storage
Adults and children tolerate the suspension well. It has a pleasant smell and interesting taste. The tablets can cause a gag reflex if swallowed. The shelf life of Ursofalk ranges from 4 years. Once opened, the bottle will remain usable for 4 months. After this time, the components can harm the body, which cannot be avoided after swallowing the medicine.
The drug Ursofalk belongs to the group of hepatoprotectors. It contains ursodeoxycholic acid. Forms of drug release:
- Capsules - 250 mg of active substance in each;
- Oral suspension, 250 ml - 250 mg of active substance in every 5 ml.
Indications for the use of Ursofalk are quite extensive:
- Liver cirrhosis, primary biliary;
- Sclerosing cholangitis;
- ZhKB (cholesterol stones, no more than 15 mm in diameter);
- Hepatitis of any origin;
- Alcoholic liver disease;
- Acute alcohol poisoning;
- Non-alcoholic steatohepatitis;
- Dyskinesia of the bile ducts and gallbladder;
- Liver damage with cystic fibrosis;
- Consequences of liver transplant surgery;
- Long-term use of hepatotoxic and cholestatic drugs (hormones, including contraceptives, some antibiotics, etc.);
- Atresia of the bile ducts inside the liver.
Contraindications
Conditions of the patient in which the reception of Ursofalk is contraindicated:
- Allergy to the drug and its components;
- Acute cholecystitis;
- Acute cholangitis;
- ZhKB with a stone size of more than 15 mm;
- Obturation of the biliary tract (stone overlap);
- Hypomotor disorders in the gallbladder (decrease in motor activity);
- Biliary colic;
- Lactation period;
- Children under 3 years of age (for the drug in the form of capsules);
- Liver cirrhosis, decompensation;
- Renal failure;
- Liver failure.
Operating principle
Getting into the systemic circulation, Ursofalk has hepatoprotective, cholelitic and immunomodulatory effects. The active ingredient of the drug reduces bile acids in bile and removes them through the intestines, which reduces the stagnation of bile in the liver and gallbladder. Also, the drug restores the membrane of hepatocytes, improves its ability to defend itself against toxins and other harmful substances. Ursofalk reduces inflammation in the liver, gallbladder and biliary tract. In addition, Ursofalk helps dissolve soft cholesterol stones.
Mode of application
Ursofalk capsule
Ursofalk capsules should be taken orally, without chewing, with a sufficient amount of liquid. The dosage is usually selected individually, depending on the weight of the patient, his pathology and its severity. Average calculations of dosages:
- Dissolution of stones - with a patient weighing up to 60 kg - 2 capsules in the evening; 60-80 kg - 3 capsules; 80-100 kg - 4 capsules; from 100 kg - 5 capsules. The course of treatment is from 6 months to 1 year
- Biliary cirrhosis: with a weight of 45-60 kg - 1 capsule three times a day; 60-80 kg - 4 capsules per day, divided into 3 doses; 80-95 kg - 5 capsules per day, divided into 3 doses; 95-110 kg - 2 capsules three times a day; more than 110 kg - 7 capsules per day, divided into 3 doses. The course of treatment is long, possibly lifelong
- Hepatitis of any origin - 10-15 mg for each kg of the patient's weight, divided into 2-3 doses. The course of treatment is about 1 year. If necessary, you can extend
Ursofalk in suspension form
Ursofalk in the form of a suspension is recommended for children under 3-6 years old and for patients who have impaired swallowing processes. Average calculations of dosages for specific pathologies, given that 5 ml contains 250 mg of the drug, and 1 ml - 50 mg, respectively:
- Dissolving stones: weight 5-7 kg - 1.25 ml; 8-12 kg - 2.5 ml; 13-18 kg - 3.75 ml; 19-25 kg - 5 ml; 26-35 kg - 7.5 ml; 36-50 kg - 10 ml; 51-65 kg - 12.5 ml; 66-80 kg - 15 ml; 81-100 kg - 20 ml; from 100 kg - 25 ml. The course of treatment is from 6 months to 1 year
- Biliary cirrhosis: with a weight of 5-7 kg - 1.25 ml once a day, in the evening; 8-12 kg - 1.25 ml each day and evening; 13-18 kg - 1.25 ml three times a day; 19-25 kg - 2.5 ml each morning and evening; 26-35 kg - 2.5 ml three times a day; 36-50 kg - 5 ml each morning and evening; 51-65 kg - 5 ml three times a day; 66-80 kg - 5 ml in the morning and afternoon and 10 ml in the evening; 81-100 kg - 5 ml in the morning and 10 ml each afternoon and evening; from 100 kg - 10 ml three times a day. The course of treatment is long, possibly lifelong
- Hepatitis - 10-15 mg for each kg of the patient's weight, divided into 2-3 doses. The course of treatment is about 1 year. If necessary, you can extend
- Cholangitis and liver damage in cystic fibrosis - from 12 to 30 mg for each kg of the patient's weight, dividing the intake by 2-3 times. The course of treatment is on average about 6 months, but can be extended to 2-3 years
- Steatohepatitis and alcoholic liver disease - 10-15 mg for each kg of patient weight, divided into 2-3 doses. The course of treatment is 6-18 months
- Biliary dyskinesia - 10 mg for each kg of weight, divided into 2 doses. The course of treatment is from 2 weeks to 2 months
Side effects of Ursofalk
Ursofalk causes side effects extremely rarely, and they all disappear after reducing the dosage of the drug or after canceling it:
- Pain in the abdomen;
- Loose stools;
- Itchy skin rash;
- Nausea.
No cases of overdose with this tool have been reported.
special instructions
During pregnancy, the drug can be used, it does not affect the development of the fetus and the formation of organs. During lactation for the entire period of treatment, it is recommended to stop breastfeeding, because there is no reliable data on the effect of the drug on the body of a healthy infant.
Alcohol does not affect the properties of the drug, but it aggravates the liver.
gepatus.ru
Our liver is daily exposed to many loads, and the work of all organs and systems largely depends on its correct activity. In certain situations, the liver can be disrupted, and it begins to require increased attention and certain therapeutic measures. So to eliminate and prevent a number of problems with this organ, special medicinal composition - hepatoprotectors can be used. One of the drugs of this type is Ursofalk. Today we will talk about the features of using this medication.
What is the action of Ursofalk?
According to these instructions, this medicinal composition has an effective choleretic effect, it destroys cholesterol-type stones and eliminates excess "bad" cholesterol in the body.
The consumption of the drug has a protective effect on the cell membrane of hepatocytes, as well as on the cells of the biliary tract, protecting them from injury by toxic bile acids. In addition, this medicine prevents connective tissue from growing inside the liver if, for some reason, its cells have been damaged.
What is the use of Ursofalk?
The drug is prescribed for the treatment of the primary type of biliary cirrhosis, if it is in a compensated state. It also stops biliary reflux gastritis, dissolves cholesterol formations inside the gallbladder. Also, Ursofalk can be prescribed for cholestasis, if it is accompanied by parenteral nutrition, and as part of the complex therapy of cystic fibrosis and biliary dyskinesias. This medicinal composition is used to prevent the development of colon cancer in those people who belong to high-risk groups for this disease.
Urosofalk can be applied to different age groups without restrictions. It is often used to lower the amount of indirect bilirubin in the blood of newborn babies with a diagnosis of conjugated hyperbilirubinemia.
The medicine is taken once a day (just before bedtime) by mouth with some liquid. The drug is available in capsules that do not need to be opened. To calculate the average daily dose, it is necessary to carry out a calculation - ten milligrams of the drug is used for each kilogram of body weight. In the event that the dosage exceeds the average, it can be divided into two or three consumptions.
Ursofalk suspension is intended for the treatment of children from the age of three and those who weigh less than thirty-four kilograms, or for patients with difficulty swallowing. The use of this drug composition should be continued for a long time - from a couple of months to two years, without taking breaks in therapy.
If Ursofalk is designed to dissolve the stones inside the gallbladder, then before starting therapy, you need to make sure of their cholesterol composition (they are not visible on X-ray examination). In addition, the size of the formations should not exceed twenty millimeters, they should fill the gallbladder less than half, and not interfere with the patency of the biliary tract. It is worth considering that Ursofalk instructions for use do not recommend consuming in parallel with drugs that increase cholesterol levels in bile (such properties are possessed by clofibrate, estrogens, etc.). In addition, antacids noticeably impair the absorption of the drug composition.
In the treatment of urolithiasis, the duration of dissolution of stones can be from six months to two years, however, if the consumption of Ursofalk does not lead to the appearance of positive dynamics within one year, then treatment with it is considered inappropriate. In order to control the processes of removing stones, it is worth systematically (once every six months) to conduct an X-ray and ultrasound examination of the liver, as well as the biliary tract.
To correct biliary reflux gastritis or reflux esophagitis, the duration of consumption should be ten to fourteen days.
In the treatment of cystic fibrosis, Ursofalk is prescribed twenty to thirty milligrams of the drug for each kilogram of body weight (this is the daily amount). If the patient has a primary form of biliary cirrhosis, then the recommended dosage can range from fifteen to twenty milligrams per kilogram of weight.
What are Ursofalk's analogues?
Such medicinal compositions as Livodexa, Urdoksa, Urso 100, Ursodez, Ursodeoxycholic acid, Ursodex, Ursoliv, Ursor Rompharm, Ursor S, Ursosan, Choludexin, Exhol have a similar composition and effect.
If you plan to change the composition assigned to you with a similar one, do not forget to consult a doctor.
What are the contraindications for Ursofalk?
This medicinal composition should not be used if the patient has an individual intolerance to its components. Ursofalk is not prescribed if the gallbladders are visible on x-rays, this indicates a high calcium content in them. Also, this drug is contraindicated if the patient has inflammatory lesions of the biliary tract or intestines, decompensated cirrhosis of the liver, dysfunctional gallbladder, malfunctioning of the kidneys, liver or pancreas.
What are the side effects of Ursofalk?
Nausea, diarrhea, pain in the right hypochondrium or epigastric region, allergic reactions, calcification of gallstones.
As you can see, the use of Ursofalk should be carried out exclusively under doctor's supervision.
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Pharmacological action Ursofalk
Ursofalk according to the instructions has a choleretic, destroying cholesterol stones, cholesterol-lowering effect.
The drug protects the membranes of the cells of the liver and biliary tract from damage by toxic bile acids, and also prevents the proliferation of connective tissue in the liver in case of damage to hepatocytes.
Ursofalk contains urodeoxycholic acid. It, as it were, delimits the smallest structures of bile acids with a structural shell - forms the so-called mixed micelles. Urodeoxycholic acid also interacts with lipophilic membrane structures, making them resistant to damage. Thus, it implements a cytoprotective (protective) effect.
Like its counterparts, Ursofalk enhances the secretion of the stomach and pancreas.
The drug has an immunological effect - it affects the content of different classes of immune cells in the body, and at the liver level it slows down the development of fibrosis in patients with cystic fibrosis, primary biliary cirrhosis, alcoholic liver damage, and reduces the likelihood of esophageal varicose veins. There are positive reviews about Ursofalk when it is included in the program for the treatment of malignant diseases of the colon (cancer), it is able to delay the growth of tumor cells.
Release form
Ursofalk is produced in capsules of 250 mg and in suspension (vials of 250 ml, the content of urodeoxycholic acid is 250 mg / 5 ml).
Indications for use of Ursofalk
The drug is prescribed for the treatment of primary biliary cirrhosis under the condition of a compensated state, biliary reflux gastritis, for dissolving cholesterol stones in the gallbladder and in the case of cholestasis with parenteral nutrition, in the complex treatment of cystic fibrosis, biliary dyskinesias. It is also recommended to prevent the development of colon cancer in high-risk groups for this disease.
There is no age limit. So, the use of Ursofalk as a means of reducing the level of indirect bilirubin in the blood is possible in newborns with conjugated hyperbilirubinemia (jaundice).
Contraindications
According to the instructions, Ursofalk is not used in case of individual intolerance, in the case of X-ray-positive gallstones (they contain a lot of calcium), in inflammatory diseases of the biliary tract and intestines, decompensated cirrhosis of the liver, non-functioning gallbladder, in case of disorders in the functioning of the kidneys, liver or pancreas.
Instructions for use of Ursofalk
The drug is taken once a day (at night) inside. The capsule is swallowed without opening the shell, washed down with water. The average daily dose of Ursofalk is calculated on the patient's body weight and is 10 mg / kg / day. If the dosage exceeds the average, you can divide the daily dose into 2 - 3 doses. Ursofalk suspension is recommended for the treatment of children under 3 years of age and patients weighing less than 34 kg, as well as for swallowing difficulties. It is recommended to take the drug for a long time - from several months to 2 years, without interruptions in treatment.
To dissolve stones in the gallbladder, before starting treatment, you should make sure that they are cholesterol (they are not visible on the roentgenogram), no more than 20 mm, fill the gallbladder no more than half, while maintaining the patency of the biliary tract. Like its analogues, Ursofalk is not recommended to be used simultaneously with drugs that increase cholesterol in bile (clofibrate, estrogens, etc.). Antacids impair drug absorption. 
In the case of cholelithiasis, the duration of dissolution of stones is from 6 to 24 months, but if no positive dynamics is noted after 12 months from the start of the intake, Ursofalk can be canceled, since further treatment is inappropriate for them. To monitor the effectiveness of treatment, the liver and bile ducts should be examined every six months using ultrasound and X-ray.
With biliary reflux gastritis and reflux esophagitis, the course of administration lasts an average of 10-14 days.
With cystic fibrosis, the daily dose of Ursofalk reaches 20-30 mg / kg / day, with primary biliary cirrhosis up to 15-20 mg / kg / day.
Ursofalk's analogues are Ursosan, Urdoksa and Ursodez.
Side effects
According to reviews, Ursofalk sometimes causes allergic reactions, diarrhea, dyspepsia, calcification of gallstones.
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Composition and properties
The drug is available in the form of capsules and oral suspension.
The active substance of one capsule is ursodeoxycholic acid - 250 mg. Additional components:
- gelatin,
- titanium dioxide,
- magnesium stearate,
- purified water,
- maize starch,
- sodium dodecyl sulfate,
- silica.
The active ingredient of 5 ml of suspension is ursodeoxycholic acid - 250 mg. Additional substances:
- xylitol,
- benzoic acid,
- sodium chloride,
- purified water,
- avicel RC 591,
- sodium citrate,
- glycerol,
- sodium cyclamate,
- propylene glycol.
lemon flavoring,
The drug has the properties of a wide range of actions:
- lowers blood cholesterol levels and dissolves the formed cholesterol gallstones,
- has a hepatoprotective, immunomodulatory effect,
- has a choleretic effect,
- reduces the absorption of toxins in the ileum,
- improves the protective properties of the cell membrane,
- reduces the amount of cholesterol in bile,
- prophylactically affects the development of varicose veins of the esophagus.
Indications and contraindications
Indications for the use of the drug "Ursofalk" are the following violations:
- primary biliary cirrhosis,
- acute hepatitis,
- cholestasis with parenteral nutrition,
- primary sclerosing cholangitis,
- biliary dyskinesia,
- cholesterol stones in the gallbladder (if they cannot be removed surgically),
- alcoholic liver damage,
- chronic active hepatitis,
- prevention of liver diseases,
- atresia of the intrahepatic biliary tract,
- prevention of colon cancer,
- liver damage with cholestasis in children.
cystic fibrosis,
Taking a drug for the treatment of gallstone disease, it is necessary to be examined by a doctor every six months.
Contraindications for use medicinal product:
- high calcium gallstones
- hypersensitivity to the components of the drug,
- cirrhosis of the liver in the stage of decompensation,
- pregnancy and breastfeeding,
- non-functioning gallbladder
- dysfunction of the liver, kidneys, pancreas,
- inflammatory diseases of the intestines, gallbladder, bile ducts in the acute stage.
The effect of the drug on the course of pregnancy is not fully understood, however, the acid in the composition penetrates the placental barrier.
Instructions for use
The method of application of "Ursofalk" depends on the patient's weight:
- children weighing 5 to 7 kg - 1.25 milligrams (0.25 measuring spoon),
- from 8 to 12 kg - 2.5 milligrams,
- from 13 to 18 kg - 3.75 milligrams,
- from 19 to 25 kg - 5 milligrams,
- from 26 to 35 kg - 7.5 milligrams,
- from 36 to 50 kg - 10 milligrams (2 capsules morning and evening),
- adults from 51 to 65 kg - 12.5 ml (3 capsules three times a day),
- from 66 to 80 kg - 15 milligrams (4 capsules three times a day),
- from 81 to 100 kg - 20 milligrams (5 capsules three times a day),
- over 100 kg - 25 milligrams (6 capsules three times a day),
- usually the drug is prescribed once a day, preferably in the evening, shortly before bedtime,
- the capsule should not be chewed, but swallowed with water,
- drink the suspension with a little water,
- the course of treatment is from 6 months to two years, depending on the disease and the appointment of the attending physician.
children and adults weighing less than 34 kilograms can only take a suspension,
If, during the treatment of gallstone disease, the size and number of stones does not decrease after a year, the use of the drug should be canceled.
The following adverse reactions are rarely possiblethat disappear when the drug is discontinued:
- nausea, diarrhea,
- pain in the stomach
- calcification of gallstones,
- stool disorders,
- allergic reactions in the form of hives or itching,
- deterioration of the general condition.
There is no data on drug overdose, if any inappropriate body reactions appear, you should consult a doctor. Especially if the treatment does not give any effect, the disease has worsened or adverse reactions have occurred.
ladyvenus.ru
Active-active substance: ursodeoxycholic acid;
Ursofalk - hepatoprotector with choleretic, cholelitholytic, hypocholesterolemic and immunomodulatory effects. Neutralizes toxic bile acids. It stabilizes the membrane structures of hepatocytes. Causes the dissolution of cholesterol gallstones. Delays the progression of liver fibrosis. It is used for cholelithiasis (to dissolve cholesterol stones), biliary cirrhosis, sclerosing cholangitis, liver fibrosis, hepatitis, toxic (including alcoholic) liver damage, biliary reflux gastritis / esophagitis, biliary dyskinesia, cholestatic liver disease (cholestasis), for the prevention of iatrogenic liver damage.
Latin name:
URSOFALK / URSOFALK.
Composition and form of release:
Ursofalk capsules of 10, 50 or 100 pcs. packaged.
1 capsule Ursofalk
Ursofalk suspension for oral administration in bottles of 250 ml, 1 or 2 pcs. in a package, complete with a measuring spoon.
5 ml suspension Ursofalk contains: ursodeoxycholic acid 250 mg.
Properties / Action:
Ursofalk - hepatoprotector with choleretic, cholelitholytic, hypocholesterolemic, immunomodulating and antifibrotic effects.
Ursofalk has a direct cytoprotective effect on the membrane of hepatocytes and cholangiocytes. Suppresses cell death caused by toxic bile acids.
Ursofalk reduces the saturation of bile with cholesterol, increases the solubility of cholesterol in bile, and reduces the lithogenic index of bile. It causes partial or complete dissolution of cholesterol gallstones and the prevention of the formation of new stones.
Ursofalk influences immunological reactions in the liver. Delays the progression of fibrosis in patients with primary biliary cirrhosis, cystic fibrosis and alcoholic steatohepatitis, reduces the risk of developing esophageal varicose veins.
Ursofalk has an antitumor effect against colon cancer. Inhibits the growth of colorectal cancer cells.
Indications: primary biliary cirrhosis; primary sclerosing cholangitis; chronic active hepatitis, chronic hepatitis of various etiology with signs of cholestasis; cholesterol gallstones in the gallbladder; biliary reflux gastritis; biliary reflux esophagitis; cystic fibrosis of the liver (cystic fibrosis); alcoholic and toxic liver damage; atresia of the intrahepatic bile ducts, cholestatic liver disease in children; cholestasis with parenteral nutrition; biliary dyskinesia; acute hepatitis; prevention of liver damage when using hormonal contraceptives, cytostatics; cholestasis after liver transplantation; prevention of colon cancer in patients at high risk of developing it.
Method of administration and dosage:
Ursofalk is taken daily, once a day, before bedtime. The daily dose of Ursofalk more than 10 mg / kg / day can be divided into 2-3 doses. The capsules are not chewed with a small amount of liquid. The suspension is recommended for use in children and patients with difficulty swallowing.
Acute and chronic liver diseases: 10 mg / kg / day, continuously for a long time. In the treatment of chronic liver diseases, the duration of treatment with Ursofalk can be from several months to 2 years.
Gallstone disease (dissolution of cholesterol gallstones): 10 mg / kg / day, continuously for a long time. The duration of the process of dissolving gallstones is from 6 months to 2 years. If, after 12 months from the beginning of the use of Ursofalk, there is no decrease in gallstones, then it is impractical to continue treatment.
Biliary reflux gastritis and reflux esophagitis: 250 mg at bedtime. The duration of Ursofalk's use is usually 10-14 days.
Toxic and alcoholic liver damage: 10-15 mg / kg / day for 6 months to several years.
Primary biliary cirrhosis, primary sclerosing cholangitis: 10-15 mg / kg / day; if necessary - up to 20 mg / kg for 6 months to several years.
Cystic fibrosis (cystic fibrosis of the liver): up to 20-30 mg / kg / day for 6 months to several years.
Overdose:
No cases of Ursofalk overdose have been reported.
Contraindications: individual intolerance (including a history of hypersensitivity) to the components of Ursofalk; acute inflammatory diseases of the gallbladder and bile ducts.
Side effect:
When using Ursofalk, the following are possible: dyspeptic symptoms, diarrhea, calcification of gallstones, allergic reactions.
Special instructions and precautions:
When prescribing Ursofalk for the successful dissolution of gallstones, it is necessary that: the stones are purely cholesterol (do not give a shadow on the roentgenogram); their size did not exceed 15-20 mm; the gallbladder is not more than half filled with stones; the patency of the cystic duct must be preserved; the common bile duct must be free of stones; the bile ducts and the gallbladder fully retained their function.
To prevent recurrence of cholelithiasis, treatment with Ursofalk should be continued for several months after the dissolution of gallstones.
To monitor the effectiveness of treatment of gallstone disease, it is recommended to conduct an X-ray and ultrasound examination of the biliary tract every 6 months.
When prescribing Ursofalk in order to dissolve cholesterol stones, you should not simultaneously use drugs that increase the cholesterol content in bile (for example, estrogens, clofibrate).
In cholestatic liver diseases, the activity of transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase in the blood serum should be determined periodically.
There is evidence of the use of Ursofalk for cholestasis in pregnant women. The efficacy and safety of Ursofalk's use during pregnancy have not been finally established. There are currently no data on the penetration of Ursofalk into breast milk.
Drug interaction:
Cholestyramine, colestipol or antacids containing aluminum hydroxide (Maalox, etc.) reduce the effectiveness of Ursofalk. Taking these funds at the same time as Ursofalk is inappropriate.
With simultaneous use with Ursofalk, an increase in the absorption of cyclosporine is possible.
Storage conditions:
List B. Store in a dry, dark place at room temperature (18-25 ° C).
Expiration date: 5 years.
Terms of dispensing from a pharmacy - by prescription.
Description of the active-active substance of the drug Ursofalk: pharmacology, indications, application, etc.
P N014714 / 02-050309Tradename: URSOFALK
International non-proprietary name:
Ursodeoxycholic acid.Dosage forms: capsules, oral suspension.
COMPOSITION
Capsules: One capsule contains 250 mg of ursodeoxycholic acid. Excipients:corn starch, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, purified water, sodium lauryl sulfate. Suspension: 5 ml of suspension (1 scoop) contains 250 mg of ursodeoxycholic acid.
Excipients: benzoic acid, purified water, xylitol, glycerol, microcrystalline cellulose, propylene glycol, sodium citrate, sodium cyclamate, anhydrous citric acid, sodium chloride, lemon flavor (GivaudanPHL-134488).
DESCRIPTION
Capsules: Hard, opaque gelatin capsules # 0; white lid, white body. The contents of the capsule are white powder or granules.
Suspension:A homogeneous white suspension containing fine air bubbles, with a lemon scent.
PHARMACOTHERAPEUTIC GROUP
Hepatoprotective agent.
ATX code: A05AA02
PHARMACOLOGICAL PROPERTIES
Hepatoprotective agent, has a choleretic effect. Reduces the synthesis of cholesterol in the liver, its absorption in the intestine 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 the content of bile acids in it; causes an increase in gastric and pancreatic secretion, enhances lipase activity, has a hypoglycemic effect. It causes partial or complete dissolution of cholesterol stones when administered enterally, reduces the saturation of bile with cholesterol, which contributes to the mobilization of cholesterol from gallstones. It has an immunomodulatory effect, affects immunological reactions in the liver: reduces the expression of some antigens on the membrane of hepatocytes, affects the number of T-lymphocytes, the formation of interleukin-2, and reduces the number of eosinophils.
INDICATIONS FOR USE
Dissolution of cholesterol stones of the gallbladder, biliary reflux gastritis, primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment).
CONTRAINDICATIONS
X-ray positive (high calcium) gallstones; non-functioning gallbladder; acute inflammatory diseases of the gallbladder, bile ducts and intestines; cirrhosis of the liver in the stage of decompensation; severe violations of the kidneys, liver, pancreas; hypersensitivity to drug components. Ursodeoxycholic acid has no age restrictions for use, but for children under 3 years of age, it is recommended to use Ursofalk in suspension, as it may be difficult to swallow capsules.
PREGNANCY AND LACTATION
The drug is contraindicated during pregnancy and lactation.
Children and adults weighing less than 34 kg are recommended to use Ursofalk in suspension.
Dissolving cholesterol gallstones
Method of administration and dosage
The recommended dose is 10 mg ursodeoxycholic acid per 1 kg of body weight per day, which corresponds250 mg capsules
Oral suspension
The drug must be taken daily in the evening, before bedtime (do not chew the capsules) with a small amount of liquid. Duration of treatment is 6-12 months. For the prevention of recurrent cholelithiasis, it is recommended to take the drug for several months after the stones dissolve.
Treatment of biliary reflux gastritis
1 capsule (1 scoop) of Ursofalk daily in the evening before going to bed with a little water. The course of treatment is from 10-14 days to 6 months, if necessary - up to 2 years.
Symptomatic treatment of primary biliary cirrhosis
The daily dose depends on body weight and ranges from 2 to 6 capsules (measuring spoons) (approximately 10 to 15 mg ursodeoxycholic acid per 1 kg of body weight).
250 mg capsules
Oral suspension
| Body mass | Daily dose | In the morning | In the afternoon | In the evening | |
| Measured spoons |
Corresponding (ml) |
(dimensional spoons) |
(dimensional spoons) |
(dimensional spoons) |
|
| 5-7 kg | ¼ | 1,25 | - | - | ¼ |
| 8 - 12 kg | ½ | 2,50 | - | ¼ | ¼ |
| 13-18 kg | ¾ | 3,75 | ¼ | ¼ | ¼ |
| 19 - 25 kg | 1 | 5,00 | ½ | 1 | ½ |
| 26 - 35 kg | 1½ | 7,50 | ½ | ½ | ½ |
| 36 - 50 kg | 2 | 10,00 | 1 | - | 1 |
| 51-65 kg | 3 | 15,00 | 1 | 1 | 1 |
| 66 - 80 kg | 4 | 20,00 | 1 | 1 | 2 |
| 81-100 kg | 5 | 25,00 | 1 | 2 | 2 |
| Over 100 kg | 6 | 30,00 | 2 | 2 | 2 |
SIDE EFFECTS
Diarrhea, nausea, pain in the epigastric region and right hypochondrium, calcification of gallstones, increased activity of "hepatic" transaminases, allergic reactions.
In the treatment of primary biliary cirrhosis, transient decompensation of liver cirrhosis may occur, which disappears after the drug is discontinued.
OVERDOSE
Overdose cases have not been identified. In case of an overdose, symptomatic treatment is performed.
INTERACTION WITH OTHER MEDICINAL PRODUCTS
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 must be taken at least 2 hours before taking Ursofalk.
Ursodeoxycholic acid can enhance the absorption of cyclosporine from the intestine. Therefore, in patients taking cyclosporine, the doctor should check the concentration of cyclosporine in the blood and adjust the dose of cyclosporine if necessary.
In some cases, Ursofalk can reduce the absorption of ciprofloxacin. Lipid-lowering drugs (especially clofibrate), estrogens, neomycin, or progestins increase the saturation of bile with cholesterol and may decrease the ability to dissolve cholesterol gallstones.
SPECIAL INSTRUCTIONS
In case of gallstone disease, the effectiveness of treatment is monitored every 6 months by means of X-ray and ultrasound examination of the biliary tract in order to prevent recurrence of cholelithiasis. In cholestatic liver diseases, the activity of transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase in the blood serum should be determined periodically.
RELEASE FORM
Capsules 250 mg, 10 capsules in aluminum / PVC blister; 1 blister with instructions for use in a cardboard box.
Capsules 250 mg, 25 capsules in aluminum / PVC blister; 2 and 4 blisters together with instructions for use in a cardboard box.
Oral suspension 250 mg / 5 ml, 250 ml in a dark glass bottle with a screw cap with first opening control; 1 bottle with a measuring spoon and instructions for use in a cardboard box.
STORAGE CONDITIONS
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
SHELF LIFE
Capsules - 5 years.
Suspension - 4 years. After opening - 4 months.
Do not use after the expiration date printed on the package.
TERMS OF RELEASE FROM PHARMACIES
With a doctor's prescription.
REGISTRATION CERTIFICATE OWNER (RELEASE QUALITY CONTROL)
Dr. Falk Pharma GmbH
Leinenweberstr. 5, 79108 Freiburg, Germany
Claims and suggestions should be sent to: 127055, Moscow, Butyrskiy Val, 68/70, building 4.5
Due to the rapid development of pharmaceutical science, there are fewer and fewer “old-fashioned” brands that have been tested by time on the world pharmaceutical market, which are being replaced by new modern drugs in orderly rows. The active component of the drug Ursofalk - ursodeoxycholic acid - was extracted from the bile of a brown bear at the beginning of the last century, and synthesized under artificial conditions for a long time too - more than 60 years ago. The original drug based on this substance was named "urso" and began to be produced by the Japanese pharmaceutical industry, but over time it could not withstand competition with numerous generics. The German drug Ursofalk is one of such generics, which, along with the Czech Ursosan, has staked out the leadership in the category "quality and safety". Its main but significant disadvantage is the high price, and therefore many consumers in Russia prefer cheaper Indian generics (by the way, domestic generic drugs of ursodeoxycholic acid are not produced at the moment).
Ursofalk is, first of all, a hepatoprotector that protects hepatocytes from harmful inclinations of various negative factors of the internal environment of the body. The drug has a choleretic effect, reduces the production of cholesterol in the liver, its absorption in the intestine and its content in bile, promotes the dissolution of cholesterol in the gallbladder and ducts, stimulates the production and passage of bile.
At the same time, the lithogenicity of the latter decreases (the tendency to form stones), and the content of bile acids in it increases. The secretion of gastric and pancreatic juice increases, and lipase activity increases. Ursofalk partially or completely dissolves cholesterol stones, cleans cholesterol from bile and "pulls" it out of existing gallstones. Another positive point associated with the use of Ursofalk is its immunomodulatory effect, which manifests itself in the effect on immune reactions occurring in the liver: the drug reduces the expression of a number of antigens on the surface of hepatic cells, regulates the number of T-lymphocytes and interleukin-2 production, and reduces the number of eosinophils.
Ursofalk is available in two dosage forms, both of which are oral: capsules and suspension. The dose of the drug depends on body weight (in the instructions for the use of Ursofalk, there are even special tables by which you can determine the recommended dose). But it is categorically not recommended to independently determine the dose and mode of administration, because Ursofalk is a prescription drug, and, therefore, it is not intended for self-medication under any circumstances. For pediatric patients and slender adults (weighing up to 47 kg), the preferred dosage form is suspension.
Pharmacology
Hepatoprotector. It has a choleretic effect. Reduces the synthesis of cholesterol in the liver, its absorption in the intestine and its concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and excretion of bile. Reduces the lithogenicity of bile, increases the content of bile acids in it. It causes an increase in gastric and pancreatic secretion, enhances the activity of lipase.
Has a hypoglycemic effect.
Causes partial or complete dissolution of cholesterol stones when taken orally, reduces the saturation of bile with cholesterol, which helps to mobilize cholesterol from gallstones.
It has an immunomodulatory effect, affects the immunological reactions in the liver: reduces the expression of some antigens on the membrane of hepatocytes, affects the number of T-lymphocytes, the formation of interleukin-2, reduces the number of eosinophils.
Pharmacokinetics
Data on the pharmacokinetics of the drug Ursofalk are not provided.Release form
Hard gelatin capsules, size No. 0, opaque, white; the contents of the capsules are white powder or granules.
Excipients: corn starch - 73 mg, colloidal silicon dioxide - 5 mg, magnesium stearate - 2 mg, titanium dioxide - 1.94 mg, gelatin - 80.51 mg, sodium lauryl sulfate - 0.2 mg, purified water - 14.55 mg.
10 pieces. - blisters (1) - cardboard packs.
25 pcs. - blisters (2) - cardboard packs.
25 pcs. - blisters (4) - cardboard packs.
Dosage
Children and adults weighing less than 47 kg are recommended to use Ursofalk in the form of a suspension.
To dissolve cholesterol gallstones, it is prescribed in a dose of 10 mg / kg of body weight 1 time / day.
The drug must be taken daily in the evening, before bedtime (do not chew the capsules) with a small amount of liquid.
Duration of treatment is 6-12 months. For the prevention of recurrent cholelithiasis, it is recommended to take the drug for several months after the stones dissolve.
For the treatment of biliary reflux gastritis, 1 capsule is prescribed. Ursofalka daily in the evening before going to bed with a little 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 3 to 7 capsules (approximately 14 ± 2 mg / kg body weight).
In the first 3 months of treatment, taking the drug Ursofalk 250 mg capsules should be divided into several doses throughout the day. After improvement of liver function indicators, the drug can be taken 1 time / day, in the evening. The following dosing regimen is recommended:
The use of Ursofalk for the treatment of primary biliary cirrhosis can be continued indefinitely.
In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may worsen at the beginning of treatment, for example, itching may become more frequent. In this case, treatment should be continued, taking 1 capsule daily, then the dose should be gradually increased (increasing the daily dose by 1 capsule weekly) until the recommended dosage regimen is reached again.
Symptomatic treatment of chronic hepatitis of various origins - a daily dose of 10-15 mg / kg in 2-3 doses. The duration of treatment is 6-12 months or more.
Primary sclerosing cholangitis - daily dose 12-15 mg / kg. If necessary, the dose can be increased to 20-30 mg / kg in 2-3 doses. The duration of therapy is from 6 months to several years.
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 is from 6 months to several years.
Non-alcoholic steatohepatitis - an average daily dose of 10-15 mg / kg in 2-3 doses. The duration of therapy is 6-12 months or more.
Alcoholic liver disease - the average daily dose is 10-15 mg / kg in 2-3 doses. The duration of therapy is 6-12 months or more.
Biliary dyskinesia - an average daily dose of 10 mg / kg in 2 divided doses for 2 weeks to 2 months. If necessary, the course of treatment is recommended to be repeated.
Capsules should be taken regularly, without chewing, with a small amount of liquid.
Overdose
Overdose cases have not been identified. In case of an overdose, symptomatic treatment is performed.
Interaction
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 can enhance the absorption of cyclosporine from the intestine. Therefore, in patients receiving cyclosporine, the physician should check the concentration of cyclosporine in the blood and adjust the cyclosporine dose if necessary.
In some cases, Ursofalk can 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.
Side effects
Determination of the frequency of adverse reactions: very often (≥1 / 10), often (≥1 / 100-<1/10), нечасто (≥1/1000-<1/100), редко (≥1/10 000-<1/1000), очень редко (<1/10 000).
From the digestive system: often in clinical studies - loose stools or diarrhea; very rarely in the treatment of primary biliary cirrhosis - acute pain in the right upper abdomen.
From the liver and biliary tract: very rarely - calcification of gallstones, in the treatment of advanced stages of primary biliary cirrhosis - decompensation of liver cirrhosis, which disappears after discontinuation of the drug.
On the part of the skin and subcutaneous tissues: very rarely - urticaria.
If any of these adverse reactions are aggravated, or any other adverse reactions occur, the patient should inform the doctor about it.
Indications
- dissolution of cholesterol stones of the gallbladder;
- 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) gallstones;
- non-functioning gallbladder;
- acute inflammatory diseases of the gallbladder, bile ducts and intestines;
- cirrhosis of the liver in the stage of decompensation;
- severe renal dysfunction;
- severe liver dysfunction;
- severe dysfunction of the pancreas;
- pregnancy;
- lactation period (breastfeeding);
- hypersensitivity to drug components.
Application features
Application during pregnancy and lactation
The drug is contraindicated during pregnancy and lactation (breastfeeding).Application for violations of liver function
The drug is contraindicated in severe liver dysfunction, cirrhosis in the stage of decompensation.Application for impaired renal function
The drug is contraindicated in severe renal impairment.special instructions
Taking the drug Ursofalk is carried out under the supervision of a doctor.
During the first 3 months of treatment, liver function indicators should be monitored: the activity of transaminases, alkaline phosphatase and GGT in the blood serum every 4 weeks, and then every 3 months. Monitoring of these parameters allows you to identify violations of liver function in the early stages. This also applies to patients with advanced stages of primary biliary cirrhosis. In addition, in this way it is possible to quickly determine whether a patient with primary biliary cirrhosis is responding to the treatment.
When used to dissolve cholesterol gallstones
In order to assess the progress in treatment and for the timely detection of signs of calcification of stones, depending on the size of the stones, the gallbladder should be visualized (oral cholecystography) with an examination of the darkening in the standing and supine position (ultrasound) 6-10 months after the onset treatment.
If the gallbladder cannot be visualized on x-rays or in cases of calcification of stones, weak contractility of the gallbladder, or frequent attacks of colic, the drug Ursofalk should not be used.
When treating patients with advanced stages of primary biliary cirrhosis
Cases of liver cirrhosis decompensation were extremely rare. After discontinuation of therapy, there was a partial reverse development of manifestations of decompensation.
In patients with diarrhea, the dose should be reduced. If diarrhea persists, treatment should be discontinued.
Influence on the ability to drive vehicles and use mechanisms
No effect on the ability to drive vehicles and moving machinery was found.
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The site provides background information for informational purposes only. Diagnosis and treatment of diseases must be carried out under the supervision of a specialist. All drugs have contraindications. A specialist consultation is required!
Ursofalk is a drug of the group hepatoprotectors with choleretic, immunomodulatory, cholelitholytic (dissolving gallbladder stones) and hypocholesterolemic (lowering blood cholesterol) action. Ursofalk makes the liver cell membranes stronger and more resistant, which prevents the destruction of liver cells, stops the development of fibrosis and, in general, normalizes the condition and functioning of the liver. The drug is used to dissolve stones in cholelithiasis, as well as to normalize the state of the liver with biliary cirrhosis, with sclerosing cholangitis, with fibrosis, with hepatitis, with toxic damage (poisons, drugs, alcohol) of the liver, with biliary dyskinesia, with biliary reflux - gastritis or esophagitis, with stagnation of bile in the liver against the background of any pathologies. In addition, Ursofalk is used for the prevention of drug damage to the liver during courses of therapy with drugs that negatively affect the liver.General information about the drug
Description and release forms
Currently, the drug Ursofalk is available in three dosage forms - capsules, tablets and suspension. All three dosage forms of the drug (tablets, capsules and suspension) are intended for oral administration.Ursofalk capsules consist of a hard, opaque gelatinous lid and a body, painted white. The capsule contains white powder or granules inside. The capsules are packed in blisters (konvaluta) of 10 pieces, and the blisters, in turn, are packed in a cardboard box along with a leaflet with instructions for use. Currently in Russia Ursofalk capsules are sold in packs of 10, 50 and 100 pieces.
Ursofalk tablets are covered with a white film shell, have an oblong biconvex shape and a risk on both sides. The tablets are packaged in blisters (konvalyuta) of 25 pieces, which, in turn, are placed in cardboard boxes with a leaflet with instructions for use. The tablets are sold in cartons of 25, 50 and 100 pieces.
Suspension Ursofalk It is a homogeneous white liquid containing fine air bubbles and has a distinct lemon scent. The suspension is available in 250 ml dark glass vials. Vials are packed in cardboard boxes complete with a measuring cup and a leaflet with instructions for use.
The shelf life of Ursofalk tablets and suspension is 4 years, and of capsules - 5 years from the date of manufacture indicated on the package. It is necessary to store the medicine in any form in a dry dark place at an air temperature not exceeding 25 o C. Violation of storage conditions entails a decrease in the therapeutic efficacy of the drug.
Once opened, the suspension can be stored in the refrigerator for 4 months. If after this period the suspension has not been used, then it should be discarded and not used.
Composition and dosage
All dosage forms of the drug Ursofalk contain as an active, active substance ursodeoxycholic acid... In the accompanying instructions, this active substance is usually indicated under the abbreviation INN (international non-proprietary name). Ursofalk capsules contain an active substance in a dosage of 250 mg, and tablets - 500 mg. The suspension contains ursodeoxycholic acid at a concentration of 250 mg / 5 ml (2.5%).The auxiliary components of Ursofalk capsules, tablets and suspensions are different, therefore we present them in the table below.
| Auxiliary components of Ursofalk tablets | Auxiliary components of Ursofalk capsules | Auxiliary components of the Ursofalk suspension |
| Povidone K-25 | Corn starch | Benzoic acid |
| Crospovidone type A | Magnesium stearate | Xylitol |
| Talc | Titanium dioxide | Glycerol |
| Colloidal silicon dioxide | Microcrystalline cellulose | |
| Magnesium stearate | Gelatin | Propylene glycol |
| Polysorbate 80 | Sodium lauryl sulfate | Sodium citrate |
| Colloidal silicon dioxide | Purified water | Sodium cyclamate |
| Hypromellose | Lemon acid | |
| Macrogol 6000 | Lemon flavor | |
| Purified water |
Ursofalk 100 and 250
In practice, a number is usually added to the name of a medicinal product, which means the dosage of the active substance in a tablet, capsule, ampoule, etc. This allows doctors, pharmacists and patients to quickly navigate what kind of medicine is needed and in what dosage. Accordingly, the designation "Ursofalk 250" means capsules with a dosage of 250 mg ursodeoxycholic acid. But the designation "Ursofalk 100", contrary to the described, usual and standard scheme, does not mean a dosage of 100 mg, since there is simply no such thing, but the number of tablets or capsules in the package.Therapeutic action and effects
Ursofalk has hepatoprotective, choleretic, anticholestatic, cholelitholytic, anti-lithogenic, hypocholesterolemic, antifibrotic and immunomodulatory effects. Hepatoprotective effect the drug lies in the fact that under its action liver cells become more resistant to negative influences, are destroyed in a smaller amount, which minimizes the activity of the pathological process in the organ. Thanks to this, the progression of chronic liver diseases is slower, the organ has time to recover, thereby reducing the risk of complications and the development of cirrhosis or cancer. Also, thanks to Ursofalk, exacerbations of chronic liver diseases are prevented, as a result of which a person does not suffer from the periodic appearance of clinical symptoms of hepatic pathologies. Such a hepatoprotective effect of Ursofalk is ensured by the fact that the ursodeoxycholic acid in its composition binds the excess of bile acids found in the liver, and thereby prevents them from destroying the liver cells due to their chemical aggressiveness and toxicity. In addition, Ursofalk increases the strength of the liver cell membranes, making them resistant to damage from free radicals and other toxic substances.
Choleretic and anticholestatic (eliminating bile stasis) action Ursofalk consists in increasing the fluidity of bile, so that it does not stagnate, but flows freely from the hepatic ducts and gallbladder, without causing damage to these organs due to cholestasis. The choleretic effect of Ursofalk is ensured by the fact that the drug blocks the absorption of fatty acids in the intestine, from where they enter the liver, as a result of which the liver cells must synthesize them again, and this is what stimulates active bile secretion. Also, increased formation and excretion of bile leads to the elimination of its stagnation in the hepatic ducts.
In addition, Ursofalk reduces the synthesis of cholesterol by liver cells ( hypocholesterolemic action) and its absorption in the intestine, and also increases the solubility of cholesterol in the gallbladder and ducts, which improves the fluidity of bile and eliminates its stagnation. By increasing the concentration of fatty acids and reducing the cholesterol content in bile, Ursofalk helps dissolve gallstones ( cholelitholytic action). In addition, by providing better fluidity and lower viscosity of bile, Ursofalk prevents the formation of new gallstones ( anti-lithogenic action).
Also, Ursofalk enhances the production of enzymes by the pancreas, hydrochloric acid and enzymes - by the stomach, which allows the drug to eliminate digestive disorders and lower blood sugar levels.
Antifibrous Ursofalk's action is that the drug reduces the rate of degeneration of liver cells into connective tissue and the formation of cirrhotic tracts.
Separately, it should be said that Ursofalk has immunomodulatory action, which is provided by the fact that ursodeoxycholic acid normalizes the number of immune cells and their production of biologically active substances.
In order to prevent damage to the central nervous system with prolonged jaundice of newborns, when it does not go away on its own within two to three weeks after discharge from the maternity hospital, pediatricians recommend taking medications that have hepatoprotective and choleretic effects and promote the elimination of bilirubin from the blood. Under the influence of such drugs, the neutralization of bilirubin in the liver is activated, it is removed from the body faster, the jaundice passes, and the baby acquires a normal color of the skin and sclera of the eyes.
One of the effective hepatoprotectors with a choleretic effect, which are used to treat the jaundice of newborns, is Ursofalk. The drug should be given to babies exclusively in the form of a suspension of 1 - 2 ml, once a day, before bedtime. It is better to measure the required amount of the drug with a syringe, and not with a measuring cup, since the latter has no divisions into 1 and 2 ml. The duration of taking Ursofalk depends on the rate of disappearance of the jaundice.
Overdose
An overdose of Ursofalk is possible, and is manifested by the development of diarrhea (diarrhea). Other symptoms of an overdose usually do not appear, since an increase in the dosage of the drug leads to the fact that the absorption of ursodeoxycholic acid in the intestine simply decreases, and it is excreted in the feces.When diarrhea occurs, it is necessary to replenish the loss of fluid and salts by taking special rehydrating solutions, such as Trisol, Humana Electrolyte, Regidron, etc. If it is impossible to buy special rehydrating solutions in a pharmacy for some reason, then they are made independently, for which a tablespoon of salt, a tablespoon of soda and two tablespoons of sugar are poured into 1 liter of water. If it is impossible to make a rehydrating solution on your own, then they drink tea, fruit drinks, juices, compotes. You need to drink 300 - 500 ml of liquid after each trip to the toilet. No other treatment for Ursofalk overdose is required. It is also not necessary to cancel the drug - it is enough to reduce the dose.
Use during pregnancy and breastfeeding
Ursofalk in any form (tablets, capsules and suspension) is undesirable for use during pregnancy and during breastfeeding. In experiments on animals, the negative effect of Ursofalk was revealed in early pregnancy. But when Ursofalk is taken by non-pregnant women, it does not negatively affect their fertility (that is, the ability to conceive in the future). Thus, the drug is undesirable for pregnant women, but in the rest of life it can be taken without fear of fertility using reliable contraception (so that pregnancy does not occur during the course of therapy).
Of course, if necessary, Ursofalk can be used by pregnant women, but it should be taken only when indicated.
Contraindication to the use of Ursofalk during breastfeeding is due to the fact that ursodeoxycholic acid penetrates into milk, and together with it it can enter the child's body. Although the concentration of the active substance in milk is low, and the occurrence of side effects in a child due to feeding with such milk is unlikely, nevertheless, Ursofalk should not be taken during breastfeeding.
special instructions
During the first three months of treatment with Ursofalk, a monthly blood test for AST, ALT, alkaline phosphatase and gamma-glutamyltranspeptidase should be taken. These parameters reflect the state of the liver, allow detecting violations of its functioning in the early stages, and also assess the effectiveness of the therapy. If taking Ursofalk lasts more than three months, then in the remaining time you need to take the same tests every three months.The use of Ursofalk for the treatment of sclerosing cholangitis can cause severe side effects. If a person develops diarrhea, then the dosage of Ursofalk should be reduced. If the diarrhea is persistent, does not stop when the dosage is lowered, then Ursofalk should be discontinued and another therapy option should be chosen.
Impact on the ability to control mechanisms
Ursofalk does not affect mental processes and the central nervous system, therefore it does not impair the ability to control mechanisms, as a result of which, against the background of its use, it is possible to engage in any activity, including those requiring a high speed of reactions and concentration of attention (for example, driving a car).Interaction with other medications
Cholestyramine, Colestipol and aluminum hydroxide antacids.The simultaneous use of Ursofalk and Rosuvastatin leads to an increase in the concentration of the latter in the blood, however, the applied clinical significance of this phenomenon is unknown.
The simultaneous administration of Ursofalk with CCB-nitrendipine and Dapsone leads to a decrease in the concentration of the latter in the blood. Therefore, with the simultaneous use of these drugs, an increase in the dosage of nitrendipine and Dapsone may be necessary.
Estrogen hormones and drugs that lower blood cholesterol levels (Clofibrate, etc.), neomycin and progestins increase the secretion of cholesterol in the liver, which contributes to the formation of gallstones. Accordingly, if Ursofalk is used in conjunction with these drugs, then its effect of dissolving stones in the gallbladder is completely leveled. This means that if Ursofalk is planned to be taken for the purpose of dissolving stones, it cannot be combined with estrogen hormones and lipid-lowering agents.
., liver and pancreas;
For Ursofalk suspension, there are also the following contraindications:
- Violation of the contractility of the gallbladder;
- Blockage of the common bile duct or cystic duct;
- Frequent biliary colic;
- Severe hepatic or renal impairment;
- Unsuccessful portoenterostomy operation or lack of normal bile flow in children with biliary atresia.
What is better than Ursofalk?
In medical practice, there is no concept of the best drug; instead, the term "optimal" is used. The optimal drug is considered to be the one that best provides the therapeutic effect in this particular patient at the current time. This means that completely different drugs may be optimal for the same person with a chronic disease at different periods of his life. Therefore, it cannot be said that it is better than Ursofalk. Indeed, for one person, Ursofalk will be an ideal remedy as a choleretic and hepatoprotector, and for another - a completely different drug.Ursosan or Ursofalk - which is better?
Ursofalk and Ursosan are synonymous drugs, as they contain the same active substance, but are produced by different companies. Therefore, from this point of view, there is no difference between them. According to patients and doctors, both drugs have approximately the same efficacy and tolerability - in this respect, they really do not differ from each other. However, the cost of Ursosan is significantly lower than Ursofalk, therefore, if you want to save money, you can opt for the first drug. Analogues, price and reviews
Drug analogues
Currently, there are two categories of analog drugs on the pharmaceutical market - these are synonyms and, in fact, analogs. Synonyms are medicines that contain the same active substance. Analogs are drugs with different active ingredients, but with similar therapeutic effects.Accordingly, in relation to Ursofalk, we can say that its synonyms will be drugs that also contain ursodeoxycholic acid as an active substance. And analogues of Ursofalk will be other hepatoprotectors with a choleretic effect.
So, the following medicines belong to the synonyms of Ursofalk:
- Livodexa;
- Ursodeoxycholic acid;
- Ursodex;
- Ursoliv;
- Ursor;
- Ursor C;
- Ursosan;
- Urso 100;
- Ursodez;
- Choludexan;
- Exhol.
- Ademetionine-Vial;
- Altan;
- Astaxanthin;
- Betulin HEPATO;
- Bongigar;
- VG-5;
- Gepabel;
- Hepavit;
- Gepanorm;
- Heparetta;
- Hepatofalk plant;
- Dipana;
- Zixorin;
- Kavehol;
- Curcumin;
- Liv-52;
- Lohein;
- Maksar;
- Penopen;
- Transgepar;
- Tykveol;
- Febichol;
- Holyver;
- Tsinarin;
- Entophyte Hepato.
