Registration number in the Russian Federation P N015093/02 dated 03/22/2007
Tradename Hepa-Merz
International generic name
Dosage form
concentrate for the preparation of solution for infusion
Compound
1 ampoule contains 5g L- ornithine-L aspartate, water for injection up to 10 ml.
Description
Transparent solution of light yellow color.
Pharmacotherapeutic group
Hypoazotemic agent ATX code: A05BA
Pharmacological properties
Reduces increased level ammonia in the body, in particular in liver diseases. The effect of the drug is associated with its participation in the ornithine Krebs urea cycle (the formation of urea from
ammonia). Promotes insulin production and growth hormone. Improves protein metabolism for diseases requiring parenteral nutrition. Pharmacokinetics: Excreted by the kidneys.
Indications for use
Spicy and chronic diseases liver, accompanied by hyperammonemia. Hepatic encephalopathy incl. as part of complex therapy disturbances of consciousness (precoma and coma).
As a corrective additive to parenteral nutrition preparations in patients with protein deficiency.
Contraindications
Expressed renal failure if the creatinine level is more than 3 mg/100 ml. Hypersensitivity to the components of the drug, lactation period. With caution - pregnancy.
Directions for use and doses
Up to 4 ampoules per day are administered intravenously, dissolving the contents of the ampoules in 500 ml of infusion solution. For hepatic encephalopathy, depending on the severity of the condition, up to 8 ampoules per day are administered. The duration of infusion, frequency and duration of treatment are determined individually. Maximum speed intravenous administration - 5g per hour. Do not dissolve more than 6 ampoules in 500 ml of infusion solution!
Side effect
Allergic reactions, in some cases nausea and vomiting are possible.
Overdose
Symptoms: increased severity of side effects.
Interaction with other drugs
Not described
special instructions
When diagnosing hepatic encephalopathy due to an underlying disease, care must be taken when driving vehicles and engaging in other potentially dangerous species activities that require increased concentration and speed of psychomotor reactions.
If nausea or vomiting occurs, the rate of administration should be reduced.
Release form
Concentrate for solution for infusion, 500 mg/ml, 10 ml in dark glass ampoules type I, DAB 10 with two color marking rings and
white dot. 10 ampoules each (2 plastic pallets of 5 ampoules each) with instructions for use in a cardboard box.
Best before date
3 years. Do not use after expiration date.
Storage conditions
At a temperature not higher than 25 °C. Keep out of the reach of children.
Conditions for dispensing from pharmacies
On prescription.
Manufacturing company
Merz Pharma GmbH & Co. KGaA"
D-60318, Germany,
Frankfurt am Main
Send claims to
Address: Merz Pharma LLC
123242, Moscow,
lane Kapranova, d.Z, p. 2
Hepa-merz is an original German medicine that accelerates the elimination of toxins. It normalizes the high level of ammonia in the patient’s body, which is observed in liver pathologies. The drug belongs to the group of hepatoprotectors. It is produced by Merz, Germany.
Dosage form
Hepa-merz can be found on sale in dosage forms in the form of bags with granules for the preparation of a solution and a concentrate from which a solution for infusion is prepared.
Description and composition
The concentrate is a transparent light yellow liquid.
The sachet contains orange and white granules for preparing an oral solution.
The active component of the drug is L-ornithine L-aspartate. In addition to this, the granules contain the following formative substances:
- E 330;
- lemon and orange flavor;
- levulose;
- saccharin;
- E 952;
- E 110;
- povidone.
Contains concentrate additional component is water for injection.
Pharmacological group
The action of the drug is associated with its participation in the Krebs-Henseleit cycle, as a result of which urea is formed in the body from nitrogen-containing substances. It starts the cycle by normalizing the function of liver cell enzymes - ornithine carbamoyl transferase and carbamoyl phosphate synthetase.
The drug promotes the production of insulin and somatotropin, improves protein metabolism in pathologies that require intravenous nutrition.
Taking it reduces pain, asthenia, dyspepsia, and also normalizes weight in patients with steatosis and steatohepatitis.
L-ornithine-L-aspartate quickly breaks down in the body into ornithine and aspartate and begins to act within 15-25 minutes, having a short half-life. It is excreted in urine through the Krebs-Henseleit cycle.
Indications for use
for adults
The drug in the form of granules and concentrate is prescribed for the following disorders:
- spicy and chronic pathologies liver, which is accompanied by an increase in the level of free ammonium ions;
- asymptomatic or severe hepatic encephalopathy, including if it is accompanied by impaired consciousness.
In addition, granules for preparing a solution for oral use are prescribed for steatosis and steatohepatitis of various etiologies.
The drug, in the form of a concentrate, is used as a corrective additive to medications for parenteral nutrition in patients with protein deficiency.
for children
Hepa-Merz is contraindicated for persons under 18 years of age, as there is not enough experience in treating this group of patients.
During pregnancy, the drug should be used with caution. The medication is contraindicated in women who are breastfeeding.
Contraindications
Hepa-Merz should not be prescribed to patients if they have:
- intolerance to active and additional components;
- severe renal impairment, in which serum creatinine is > 3 mg/1 dl.
Applications and dosages
for adults
Hepa-Merz is taken orally, 1-2 sachets 3 times a day after meals. The granules must be dissolved in 200 ml of liquid before use.
The duration of therapy by the doctor is determined in each specific case individually depending on the severity of the pathology.
The drug is administered intravenously up to 40 ml (4 ampoules) per day; the concentrate must first be dissolved in 500 ml of infusion solution.
For hepatic encephalopathy (depending on the severity of the pathology), up to 80 ml (8 ampoules) per day is administered intravenously.
The duration of infusion, the interval between them and the course of therapy are determined individually. You can administer no more than 5 g/hour.
A maximum of 60 ml (6 ampoules) of concentrate is dissolved in 0.5 l of infusion solution.
for children
Hepa-Merz is not used in pediatrics.
for pregnant women and during lactation
During pregnancy, Hepa-Merz is prescribed as usual according to strict indications.
Side effects
On the background parenteral administration Nausea and allergies may occur.
Taking the drug in granules can provoke such unpleasant phenomena as:
- nausea, abdominal pain, bloating, diarrhea;
- pain in the limbs;
- an allergy that occurs due to the “Orange Yellow” dye included in the medication.
Interaction with other drugs
The compatibility of Hepa-Merz with other medications has not been studied.
special instructions
If a patient is diagnosed with hepatic encephalopathy, due to the underlying pathology, he needs to be careful when driving a car and engaging in other potentially hazardous activities that require increased concentration attention.
Overdose
Cases of overdose with infusion administration the medicine is not registered.
Storage conditions
The drug Hepa-merz should be stored in a place inaccessible to children, at a temperature environment 25 degrees. The shelf life of the drug in the form of granules is 5 years, in the form of a concentrate - 3 years. Granules can be purchased without a doctor's prescription; concentrate in ampoules can be purchased with a prescription.
Analogs
In addition to the drug Hepa-merz, there are many of its full and partial analogues on sale:
- Ornithine. This is a Russian drug that is available in the form of granules for the preparation of a solution for oral administration. It is a complete analogue of the drug Hepa-Merz and has the same indications, contraindications and adverse reactions.
- Ornithine Canon. Another complete analogue of the drug Hepa-merz Russian production. It is available only in the form of granules for the preparation of an oral solution.
- Ornilatex. The drug is produced by PharmFirma Sotex JSC (Russia) in the form of a concentrate for the preparation of a solution for infusion. It is a complete analogue of the drug Hepa-merz.
- Infezol 100. The drug is available in the form of a solution for infusion and contains a complex of amino acids and electrolytes. It is used in children over 2 years of age as a means of parenteral nutrition.
A substitute can be used instead of Hepa-Merz only after consultation with a specialist. It is the doctor who must make the decision to change the medication.
Price
The cost of Hepa-merz is on average 1006 rubles. Prices range from 2 to 3730 rubles.
Hepa-merz is a German original hepatoprotector used for the treatment of acute and chronic liver pathologies, as well as hepatic encephalopathy.
Over the past few decades, the incidence curve of liver pathologies has risen decisively. It can't be said that modern medicine sits with folded hands: a thorough study of the mechanisms of liver damage of viral, alcoholic and autoimmune etiology has made it possible to significantly advance in their diagnosis and treatment. However, liver diseases continue to be one of the main causes of disability, disability and mortality. The drug hepa-merz includes two active amino acids: diaminovaleric (ornithine) and aspartic (aspartate), which determine pharmacological properties of this medicine. Most often, Hepa-Merz is prescribed for hepatic encephalopathy, which complicates the course of liver diseases (usually cirrhosis) and worsens their prognosis. As is known, the 5-year survival rate of patients with liver cirrhosis complicated by hepatic encephalopathy is only 25%. The main factor in the development of hepatic encephalopathy is a high level of ammonia in the blood, which has a direct effect on the central nervous system and potentiates a number of others negative factors. High level ammonia is established due to an imbalance between its formation and disposal. Ammonia is formed in the body as a result of the removal of amino groups from amino acid molecules, the breakdown of urea and other nitrogenous compounds in the large intestine. Ammonia utilization occurs, for the most part, in the reactions of the Krebs-Henseleit cycle (the so-called ornithine cycle) in the liver and through the synthesis of glutamine in the liver and muscles. Liver diseases largely limit its ability to neutralize ammonia.
In this regard, its responsibilities have to be shouldered by the muscles. The use of the drug Hepa-Merz leads to the activation of enzymes involved in the utilization of ammonia in the liver and muscles, increasing resistance to protein, which allows the patient to maintain a normal diet and prevent loss of muscle mass. In addition, hepa-merz helps to normalize the process of protein biosynthesis in the liver. As is known, for the liver to perform its protein-synthetic function, it needs amino acids and nucleic acids. Hepa-merz increases the content of both, plus stimulates the process of protein biosynthesis itself. Clinical trials of the drug have shown that it significantly increases protein synthesis in the muscles of patients suffering from liver cirrhosis. Therefore, the appointment of Hepa-Merz is justified in all hypercatabolic conditions, incl. chronic diseases liver, protein deficiency of any etiology, exhaustion, chronic infections. In addition, ornithine and aspartate are substrates for the Krebs-Henseleit cycle, during which ammonia is neutralized. This cycle is associated with the tricarboxylic acid cycle (an alternative name is the Krebs cycle, only without Henseleit), which is the main supplier of energy in the human body.
Thus, hepa-merz has a versatile pharmachologic effect: improves protein tolerance, has an anabolic effect, nourishes cells with energy, and aspartate, which is part of it, among other things, increases the permeability of cell membranes to magnesium, thereby providing a membrane-stabilizing, and therefore antioxidant effect. The latter is especially important for patients with chronic liver diseases of alcoholic etiology.
Pharmacology
Hypoammonemic drug. Reduces elevated levels of ammonia in the body, in particular in liver diseases. The effect of the drug is associated with its participation in the ornithine Krebs urea cycle (the formation of urea from ammonia).
Promotes the production of insulin and growth hormone. Improves protein metabolism in diseases requiring parenteral nutrition.
Pharmacokinetics
Ornithine aspartate dissociates into its constituent components - the amino acids ornithine and aspartate, which are absorbed into small intestine by active transport through the intestinal epithelium. It is excreted in urine through the urea cycle.Release form
Granules for the preparation of a solution for oral administration in the form of a mixture of orange and white.
| 1 pack (5 g) | |
| L-ornithine L-aspartate | 3 g |
Excipients: lemon acid anhydrous, lemon flavor, orange flavor, sodium saccharinate (sodium saccharin), sodium cyclamate, sunset yellow dye, polyvinylpyrrolidone (povidone), fructose (levulose).
5 g - bags (10) - cardboard boxes.
5 g - bags (30) - cardboard boxes.
Dosage
The drug is prescribed orally, 1 sachet of granules dissolved in 200 ml of liquid, 2-3 times a day, after meals.
Overdose
Symptoms: increased severity of side effects.
Treatment: gastric lavage, taking activated carbon, carry out symptomatic therapy.
Interaction
Drug interactions with Hepa-Merz have not been described.
Side effects
From the outside digestive system: in some cases - nausea, vomiting.
Other: allergic reactions.
Indications
- acute and chronic liver diseases accompanied by hyperammonemia;
- hepatic encephalopathy (latent or severe).
Contraindications
- severe renal failure (serum creatinine > 3 mg/100 ml);
- lactation period (breastfeeding);
- hypersensitivity to the components of the drug.
The drug should be prescribed with caution during pregnancy.
Features of application
Use during pregnancy and breastfeeding
The drug should be used with caution during pregnancy.
The drug is contraindicated for use during breastfeeding.
Use for liver dysfunction
The drug is used according to indications.Use for renal impairment
The drug is contraindicated in severe renal failure (creatinine level 3 mg/100 ml).special instructions
Impact on the ability to drive vehicles and operate machinery
In case of hepatic encephalopathy, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
cure pathological diseases liver disease is quite difficult, since in nature there are a small number of drugs that provide immediate assistance. Until relatively recently, a patient with a similar diagnosis had to prepare for long and very tedious treatment. However, the hepatoprotector Hepa-Merz came to the rescue.
Instructions for use and reviews are called this remedy the most effective and fastest-acting among the entire line of medications available on pharmacy counters aimed at working with the liver.
Release form and composition of the drug
Human health, such an ephemeral state of his body, in the presence of problems and failures, requires taking medications. Hepa-Merz is one of them, and its use helps to cope with a fairly large number of problems that arise in the liver.
It is available on the market in 2 types:
The drug is based on 2 main active ingredients. They themselves are amino acids: L-ornithine, as well as L-aspartate. Their total weight in 1 sachet is 3 grams out of five.
The rest of the composition of Hepa-Merz includes: orange or lemon flavors, citric acid, sodium saccharin, sodium cyclamate, yellow and orange dyes, levulose and saccharin.
Ampoules, in addition to the amino acids themselves, which fill half of the composition, as excipient filled with injection fluid.
Ampoules and sachets are packed only in white cardboard packaging with a pattern. It shows the liver in pink. The name Hepa-Merz is written in black font.
Pharmacology and pharmacokinetics
Hepa-Merz - detoxifies the body, simultaneously affecting 2 main pathways of ammonia formation in the body - urea and glutamine.
This is precisely what the amino acids contained in the drug allow you to avoid.
The constant participation of ornithine, biosynthesizing urea from ammonia, ensures the continuous ornithine Krebs cycle.
The body produces insulin and somatropic hormone, which allows for maximum therapeutic effect on the liver with relatively few side effects.
There is a gradual activation of the liver’s own cells, which have undergone cleansing and degreasing, and protein metabolism increases.
In general, after entering the body, both amino acids are quickly absorbed and broken down into their components. Act active substances start in just 10-15 minutes. The remains of Hepa-Merz, which were not absorbed by the intestines and transferred to the blood, are excreted unchanged in the urine quite quickly.
If previously it took more than 3 months of constant use to improve your health with other medications, then Hepa-Merz allows you to achieve the same result much faster.
Indications for use
By carefully studying the instructions, you can clearly find out all the diseases for which Hepa-Merz can be used.
Basically, this hepatoprotector is intended for all acute and chronic diseases that always go along with hyperammonemia. With its help, you can easily suppress diseases associated with liver cirrhosis and hepatitis.
Hepa-Merz can also be used in for preventive purposes, especially for people who abuse the amount of food and alcohol to relieve hangover symptoms.
In general, the drug has many indications:
Contraindications
In general, the most important contraindications include:
- hypersensitivity or individual intolerance to any of the components of the product;
- the presence of a thermal stage of renal failure, that is, severe illness;
- if there is more than 3 mg of creatine in 100 ml of blood.
Directions for use according to instructions
Since there are 2 versions of Hepa-Merz: solution in ampoules and granulate in bags, they should be used differently. Each one is best suited for different stages liver diseases, so for serious conditions it is best to focus on injections.
In general, it is best to leave the choice of drug and duration of treatment entirely to the doctor, since the main emphasis is on the individual characteristics of the patient:
- Hepa-Merz in the form of granules is intended for internal use. Before use, it is dissolved in water. It is best to use 200 ml of water per 1 sachet, however, the dosage of water has no actual effect on the effect of the medicine. Normal single dose– no more than 2 packages per appointment. It is taken immediately after meals 2-3 times a day. To prevent overeating and get rid of the consequences of alcohol abuse, in order to prevent the development of liver pathologies, you should take 1 sachet dissolved in water immediately after these events.
- Injection Hepa-Merz is intended for intravenous administration. For correct use it is dissolved in half a liter of infusion fluid. On average, about 4 ampoules are used per dropper, but in very serious situations their number can increase to 8. Such droppers last for the whole day, since you should carefully monitor the rate of entry of Hepa-Merz and the infusion solution into the blood - their volume should not exceed 4 g per hour.
Use during breastfeeding and pregnancy
Generally special contraindications the drug does not have. It is also allowed to be used during pregnancy, but only under the careful attention of a doctor and with the understanding that the risks from taking it are much less than from possible refusal.
However, in general, clinical trials It has not been used on pregnant women, so if possible, it would be best to avoid it.
The same applies to the lactation period. However, when feeding, it would be better to completely abandon the drug, since it penetrates into the blood and milk that the child consumes. The entry of drug components into his body can lead to various consequences.
Use of the drug for disorders of the renal and hepatic systems
Hepa-Merz is indicated for use in the treatment of numerous liver diseases. Its girth is truly amazing in its breadth. However, renal failure is one of the contraindications, so if it is present, you should completely stop using the medicine.
Side effects and complications
Side effects this drug little studied due to their rarity.
They mainly focus on disorders in the gastrointestinal tract.
After taking the drug, patients experience:
- severe nausea and vomiting;
- abdominal pain;
- diarrhea and constant flatulence.
Pathological problems arising in the bone and muscular systems Even more rare, pain in the arms and legs can manifest itself at times.
However, most a common complication are allergic reactions, affecting the skin and forming urticaria on the dermis.
Overdose
If side effects begin to be severe, this may indicate an overdose of Hepa-Mertz.
In such a situation, you should immediately stop using the drug and consult a doctor.
Standard treatment includes complete gastric lavage and detoxification of the body using regular activated carbon or other sorbent. All other signs are treated symptomatically.
Interaction with other drugs
On this moment no clinical trials have been conducted to detect the interaction of Hepa-Merz with any other medications, so there is no clear and structured data on this issue.
The influence of Hepa-Merz on the body when driving and operating machinery
Gepa-Merz does not have sedative qualities, so it is not capable of dulling the driver’s reaction in any way. However, some liver diseases, such as encephalopathy, are dangerous in themselves because they affect concentration and suppress the usual speed of response to external distractions.
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Drug interactions
No special tests have been carried out on the relationship between Hepa-Merz and other drugs. However, doctors still do not recommend taking it with a number of medications.
These include:
special instructions
There are a number of rules that it is advisable to obey in order to achieve best effect from taking Hepa-Mertz:
- When administering Hepa-Merz injections should not be dissolved in infusion solution more than 6 ampoules at once, otherwise there is a high risk of overdose. During this period, you should definitely monitor the level of urea in the blood and urine. Not allowed to be injected into arteries.
- The drug solution should not be administered when diabetes mellitus Due to the presence of fructose, it is better to limit yourself to granulate.
- Long-term use of Hepa-Merz has a strong effect on teeth, increasing the rate of caries spread.
- At the moment, there have been no cases of counterfeit Hepa-Merz. The authenticity can be traced to the series and appearance packaging and drug. If in doubt, you should ask the pharmacy for a declaration of conformity; the pharmacist is obliged to provide the information of interest.
- Because Hepa-Merz allows the liver to function normally again, then the drug affects liver function indicators - ALT and AST - it normalizes them to an optimal state.
Release from pharmacy
To purchase Hepa-Merz, the pharmacist does not need to present a special prescription, so it is sold in the public domain.
Storage conditions and shelf life
When stored correctly: in a dark place where a child cannot reach it, in an intact shell at a temperature no higher than 25 degrees, that is room temperature Hepa-Merz will be usable for 60 months, or 5 years.
Price
Hepa-Merz can be bought in almost any pharmacy in the country; the price will depend on the packaging and region of sale. average price 5 g ampoules – 2500 rubles for 10 pieces, sachets are much cheaper - 30 bags will cost 1600 rubles.
Analogues and synonyms of Hep-Merz
- Ornitsetil – analog medicine. The composition is the same as in Hepa-Mertz, so the action and indications for use are equivalent. Out of production since 2008.
- Ornithine– more cheap analogue, produced in granules, active substance– ornithine. It has an effect on the liver, healing it. Price – from 400 rubles .
- Antraliv– a drug based on phospholipids simultaneously helped treat not only the liver, but also the bile ducts. Not produced in Russia since 2015.
- Berlition– helps cope with the consequences of alcohol consumption and toxic diseases liver. Production closed in 2005.
- Brenziale forte– a hepatoprotector that allows you to improve not only the liver, but also treat psoriasis and accidental poisoning. Not produced since 2008.
- Vitanorm– mainly acts as choleretic agent, helping to enhance metabolism and correct urodynamics. Available in capsules - price from 450 rubles, homeopathic remedy.
- Gepabene– used to treat the liver after toxic effects and during a course of radiotherapy and chemotherapy. Effectiveness is provided by fume and milk thistle extract. Price – from 410 rubles.
- Hepatosan– has a hepatoprotective effect and detoxifies the body. Active ingredient– cells pork liver, fully compatible with human body. Price – from 370 rubles.
- Hepatofalk planta– helps treat diseases formed in the biliary tract, fights varicose veins veins in the esophagus. Has an antispasmodic effect. Not produced since 2006.
- Hepaphor– used not only to treat the liver, but also tuberculosis and poisoning. Their milk thistle capsules cost from 170 rubles.
- Heptor– helps fight mainly alcohol and drug poisoning. Used against depression and liver diseases. Price – from 800 rubles .
- Heptral– hepatoprotector with antidepressant and antioxidant properties. Good in the fight against cirrhosis. Price – from 1500 rubles.
- Galstena– drops and tablets based on medicinal herbs– milk thistle and dandelion, completely homeopathic. Price – from 250 rubles .
- Sirepar– hepatoprotector based on vitamin B12 and cattle liver extract. Recommended for the first stages of cirrhosis and hepatitis, available in liquid form. Not sold in Russia due to lack of registration.
- Phosphogliv– capsules or lyophysilate help cope with liver and skin diseases. Reacts well with corticosteroids. Price – about 500 rubles.
- Phosphogliv Forte– in addition to the hepatoprotective effect, they improve immunity and help fight viral diseases. Price – from 900 rubles .
- Karsil– hepatoprotector in capsules based on milk thistle fruits. It works on the basis of silymarin, affecting toxins in the body. Price – from 330 rubles.
- Liv 52- an analogue of Karsil, helps treat hepatitis and cirrhosis, is used in the fight against anorexia. Price – from 300 rubles.
- Resalut about– a phospholipid from Germany that helps heal the liver. Analogous to Essentiale Forte. Price – 450 rubles.
- Urdoxa– has choleretic and hepatoprotective properties, helps with cystic fibrosis and cholelithiasis. Price – from 650 rubles. Produced in Russia.
- Ursosan– helps disperse bile, increase immunity and cope with liver damage. Price – from 189 rubles.
- Ursofalk– hepatoprotector based on ursodeoxycholic acid. Capsules help with cirrhosis and fibrosis. Price – about 2000 rubles.
- Essentiale N– injections based on soybeans help increase the liver’s resistance to disease, simultaneously improving its work in detoxifying the body. Price – 669 rubles.
- Essentiale Forte– used to treat hepatitis and other liver diseases, stones in bile duct and as a prophylaxis during radiotherapy. Price – from 587 rubles.
The mechanism of action of the drug Hepa-Merz differs significantly from other medications in the class of hepatoprotectors. The main therapeutically active ingredient is ornithine (in the form of aspartate). It is an amino acid that breaks down into two separate compounds after absorption. Each one is different in how it works, but final result manifests itself in the form of detoxification of the body, reducing the load on the liver and gradually restoring the structure of the organ.
Hepa-Merz is prescribed not only for hepatitis C. The drug is suitable for complex therapy various manifestations liver diseases. They are combined under the term hepatic encephalopathy. The syndrome is especially common in cirrhosis, prolonged exposure to alcohol, fatty hepatosis and a number of other diseases. It is believed that one of the main reasons for the progression of hepatic encephalopathy and damage internal organs serves to increase ammonia levels.
Pathogenetic causes of nitrogen metabolism disorders consist in disruption of the processes of biochemical reactions occurring not only in the liver, but also in digestive tract, muscles. But the increase in ammonia levels exceeds physiological norm negatively affects the condition of the body as a whole.
Hepa-Merz contains amino acids that restore the activity of enzymatic reactions necessary for the full functioning of the Krebs cycle. In addition to regulating nitrogen metabolism, the drug also restores energy potential hepatocytes, protects them from the influence of free radical oxidation products. This is also important for the prevention of cirrhosis with chronic alcohol consumption.
Manufacturer
Manufacturer Hepa-Merz - pharmaceutical company Merz Pharma GmbH&Co, Germany. The company was founded in 1908, and is currently engaged in the production of medicinal drugs and cosmetic products. Medicines produced by Merz Pharma are used in neurology, dermatology, and for various types of metabolic disorders. The company is known for its development and implementation of drugs designed to facilitate and improve the quality of life in patients with Alzheimer's disease (regardless of the severity of the pathology).
Instructions for use
Self-treatment of Hepa-Merz is not recommended. The possibility of administration, dosage and duration of the course (including in a hospital setting) must be discussed with a doctor, especially if therapy is carried out in parallel with the use of targeted drugs. Instructions for use will help the patient clarify the main nuances of taking the medication.
Pharmacological group
According to the Vidal reference book, Hepa-Merz is included in the list of medications prescribed both for monotherapy and as part of complex treatment various types of liver damage. According to the RLS (registry of medicines) it belongs to the group of hepatoprotectors.
Dosage form
The drug is available in the form of granules packaged in sachets. The powder is dissolved and taken orally. In a hospital setting, the medicine is used in the form of ampoules filled with a solution for infusion. The product is not produced in tablets or capsules.
Description and composition
The main component of the drug is L-ornithine-L-aspartate (ornithine). The drug is available in several dosages: 5 g sachets contain 3 g of active ingredient, 10 g sachets contain 6 g of active ingredient. In 1 ampoule (10 ml of solution) - 5 g of ornithine.
Additionally, the description of the medicine contains a list of auxiliary ingredients. They do not have therapeutic activity, but provide the proper pharmacokinetic properties of the drug. Thus, the granulate contains citric acid, fructose, povidone, flavorings and dyes; in ampoules - sterile water for injection.
Pharmacodynamics
The effect of the active ingredient is due to the influence on the main links of biochemical reactions “responsible” for neutralizing the products of nitrogen metabolism through the production of urea and glutamine. Both ornithine and aspartate serve as substrates for the synthesis of these compounds. As a result, ammonia, which is toxic to the liver and internal organs, binds with amino acids, turning into a safe substance. These same biochemical reactions restore the Krebs cycle and other stages of nitrogen metabolism.
Pharmacokinetics
Absorption. Regardless of the method of administration (orally or in the form of injections), Hepa-Merz quickly enters the systemic circulation.
Distribution. The active components of the medicine are distributed throughout all organs and tissues.
Biotransformation. The main ingredient of the medication is split into two amino acids - ornithine and aspartate, which are “included” in physiological metabolic processes.
Elimination. The drug is distinguished fast period half-life (does not exceed 40 minutes). The main routes of excretion are unknown. However, small amounts of aspartate are found in urine in its original form.
Pharmacokinetic profile of the drug in individual categories patients. It is assumed that age does not affect the pharmacological properties of the drugs. But no clinical studies have been conducted regarding the safety of prescribing the drug to children. There are no data on the pharmacokinetics of Hepa-Merz in patients with liver damage. Considering possible way eliminations suggest that renal disease may affect the pharmacological profile of the drug.
Active ingredients
The international nonproprietary name (INN) of the active substance is ornithine. Hepa-Merz is included in the form of aspartate. The empirical formula is C5H12N2O2. Externally it is a white crystalline powder. ATX code - A05BA17.
Indications for use
Granules are prescribed for hepatic encephalopathy, regardless of etiology and pathogenesis. Taking the medication is good for the liver and promotes rapid detoxification.
Therefore, the list of indications for use may include:
- viral hepatitis C and B;
- alcoholic hepatitis;
- cirrhosis;
- fibrosis;
- malignant neoplasms liver (exclusively as part of complex therapy and with the permission of a doctor).
Hepa-Merz is often prescribed for alcohol poisoning, with fatty hepatosis. On forums there are often recommendations regarding taking the drug for a hangover, especially when alcohol intoxication. The active components of the drug accelerate the elimination of toxins and protect hepatocytes from the effects of ethanol breakdown products.
Some recommend using the drug in combination with other measures to cleanse the liver. But such procedures should be carried out with caution and only after consulting a doctor. Otherwise, the detoxification course is fraught side effects and complications. After removal acute symptoms The doctor explains how to use the medicine in the future.
Prescribing Hepa-Merz in the form of injections is advisable when severe forms hepatic encephalopathy (cirrhosis due to hepatitis, HIV, etc.). Sometimes droppers with a solution are recommended after drinking large quantities of alcohol. But they are placed either in a hospital setting or at home, but under the supervision of qualified medical personnel.
Contraindications
Absolute contraindications to the use of Hepa-Merz are individual intolerance and severe kidney damage.
Experience of use during pregnancy and breastfeeding limited. No clinical studies have been conducted. Data on experiments involving animals are also not provided. Therefore, it is unknown whether the active ingredient of the drug can harm the child. Accordingly, the use of the medicine during pregnancy and lactation is contraindicated.
There are no pediatric forms of Hepa-Merz, so the use of the drug in pediatrics is limited (due to the lack of data on the ratio of possible therapeutic effect and the risk of possible complications).
Dosage and how to take
If you drink the drug in powder, daily dosage makes up 6 sachets of granulate. This amount is divided into 3 doses throughout the day. Patients are often interested in whether to take medicine before or after meals. Experts emphasize that the medication should be taken either directly during or immediately after a meal.
How to dilute a bag. The contents of one or two (according to the doctor’s recommendations) sachets must be dissolved in 150-200 ml of liquid. Plain water, juice or unsweetened warm tea will do. The resulting solution should be drunk immediately after preparation.
The method of using the injection solution is described in the annotation. However, the use of this form of Hepa-Merz is possible only under conditions medical institution. Daily dose- up to 80 ml within 24 hours (corresponds to 8 ampoules). The contents are diluted in a solution for infusion (no more than 60 ml of medicine per 500 ml of solvent) and administered intravenously using a dropper. The rate of administration should not exceed 5 g of ornithine per hour. Intramuscular and intraarterial injections are contraindicated.
How many days the course of treatment lasts is determined by the doctor depending on general condition patient. As a rule, intravenous administration of the drug is required for several days. Then, after feeling better, the patient is transferred to oral form. At the same time, the doctor explains in detail how to take the granules and determines the duration of the course of therapy, as well as the timing of diagnostic tests.
Treatment course for hepatitis C
Hepa-Merz for hepatitis C (regardless of the genotype and the presence of co-infections) is taken according to the standard regimen:
Take the drug only after consulting a doctor. But Hepa-Merz does not affect the causative agent of hepatitis C, but is only a means to maintain the functional activity of the liver. Additionally in mandatory Requires appropriate antiviral drugs(in tablets, capsules or liquid dosage form).
Side effects
The drug is usually well tolerated, and adverse reactions occur extremely rarely. But patients are warned about the possibility of the following side effects:
- digestive disorders;
- weakness and increased fatigue;
- systemic pain syndrome;
- nausea, in isolated cases - vomiting;
- increased gas formation.
With infusion intravenous administration possible development of severe allergic reactions, therefore, when using the Hepa-Merz solution for the first time, you should prepare the necessary means to relieve anaphylaxis.
Interaction
Research on the possibility and safety of combining Hepa-Merz with other medicines were not carried out. But it has been established that the drug is combined with medications for the treatment of hepatitis C and other causes of hepatic encephalopathy. Combination with other hepatoprotectors is possible. Hepa-Merz and Heptral can be taken simultaneously. There are no contraindications to this combination, but these drugs have a similar mechanism of action and therapeutic effect.
Alcohol compatibility
There is no data on whether Hepa-Merz and alcohol are compatible; the consequences of such a combination are also unknown. But alcoholic drinks are extremely toxic to the liver, especially when its functions are impaired as a result of hepatitis or other pathology. Therefore, doctors strongly recommend completely eliminating alcohol or the treatment will not make sense.
Pregnancy and lactation
When carrying a child and breastfeeding, the drug is not prescribed due to the lack of safety data.
Special instructions and precautions
The granulate contains fructose, which should be taken into account if you have diabetes.
When administering the drug infusion, monitoring of urea concentration indicators is necessary. If nausea and vomiting occur, the rate of intravenous infusion is reduced until symptoms disappear.
Both infusion and oral forms of the drug should be used immediately after opening the package and preparing the solution (or infusion).
Overdose
Symptoms are unknown. Risk severe complications if the recommended dose is exceeded, it is minimal.
Storage conditions
Store in original packaging at room temperature.
Shelf life
It is 5 years for granules and 3 years for ampoules (provided the original packaging is intact).
Discontinuation of therapy
Analogs
The attending physician decides what to replace Hepa-Merz with. Analogues containing ornithine in the form of aspartate:
- Larnamin (available as a solution for infusion), Farmak, Ukraine;
- Ornilatex (available in liquid dosage form), Sotex JSC, Russia;
- Ornithine Canon is a generic Hepa-Merz and the most complete substitute for the original product, as it is produced both in the form of ampoules and in the form of granules.
Trying to find cheaper analogues, many patients select drugs from the group of hepatoprotectors. The question arises, is it possible to replace Hepa-Merz with such drugs as Ursosan, Phosphogliv, Essentiale, Heptral and which of them is better?
How does Hepa-Merz differ from its analogues?
All hepatoprotectors can be divided into several groups: herbal remedies based on milk thistle, preparations containing essential phospholipids and synthetic medicines. Thus, Ursosan contains ursodeoxycholic acid, which reduces cholesterol levels in bile and prevents the growth and formation of stones. Essentiale helps restore damaged hepatocyte membranes, accelerating the regeneration of liver tissue. Phosphogliv has a similar effect.
Similar action Only Heptral has it, but this drug contains other amino acids. The product also has a detoxifying effect, but to a much lesser extent. That is why experts call Hepa-Merz one of the best means, which are taken against the background of liver diseases.
Price and where to buy
Hepa-Merz is registered in Russia, therefore it is available in all forms of release in pharmacies in Moscow, St. Petersburg and other cities of the country. If the medicine is not in stock, delivery is possible upon pre-order.
You can find out how much the medicine costs either on the pharmacy’s website or check by phone. The cost of the drug may vary in different pharmacy chains. You can order a package of Hepa-Merz ampoules (10 pieces) for 2700-3000 rubles. The price for a box with 30 sachets of granulate (5 g each) is approximately 1800-1900 rubles.
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