Hepa-Merz granules 3 g/5 g each 5 g bag of 30 pcs

Pharmacodynamics. The in vivo action of l-ornithine-l-aspartate is mediated by the amino acids ornithine and aspartate via two key ammonia detoxification pathways: urea synthesis and glutamine synthesis.

Urea synthesis occurs in periportal hepatocytes, where ornithine aspartate acts as an activator of two enzymes: ornithine carbamoyltransferase and carbamoylphosphate synthetase, as well as a substrate for urea synthesis.

Glutamine synthesis occurs in perivenous hepatocytes. Especially under pathological conditions, aspartate and dicarboxylate, including the products of ornithine aspartate metabolism, are absorbed into the cells and used there to bind ammonia in the form of glutamine.

Glutamate is an amino acid that binds ammonia under both physiological and pathological conditions. The resulting amino acid glutamine not only provides a non-toxic form for ammonia excretion, but also activates the important urea cycle (intracellular glutamine metabolism).

Under physiological conditions, ornithine and aspartate do not limit urea synthesis.

Experimental animal studies have shown that the ammonia-lowering properties of L-ornithine-L-aspartate are due to increased glutamine synthesis. In some clinical studies, this improvement has been found in relation to branched-chain amino acids/aromatic amino acids.

Pharmacokinetics. L-ornithine-L-aspartate is rapidly absorbed and split into ornithine and aspartate. T _½ of both ornithine and aspartate is short – 0.3-0.4 hours. A small part of aspartate is excreted in the urine unchanged.

Treatment of concomitant diseases and complications caused by impaired liver detoxification function (for example, in liver cirrhosis) with symptoms of latent or pronounced hepatic encephalopathy.

Inside. Dissolve the contents of 1-2 packets of Hepa-Merz in a large amount of liquid (for example, in a glass of water or juice) and take during or after meals up to 3 times a day.

In / in. Usually the dose is up to 4 ampoules (40 ml) per day.

In case of precoma or coma, administer up to 8 ampoules (80 ml) within 24 hours, depending on the severity of the condition.

Hepa-Merz infusion concentrate can be mixed with conventional infusion solutions. The contents of the ampoules should be mixed with infusion solutions immediately before use. Before administration, the contents of the ampoule should be added to 500 ml of solution, but no more than 6 ampoules should be dissolved in 500 ml of infusion solution.

The maximum rate of administration of L-ornithine-L-aspartate is 5 g/h (corresponding to the contents of 1 ampoule).

The course of treatment with Hepa-Merz is determined by the doctor depending on the patient’s clinical condition.

Hypersensitivity to l-ornithine-l-aspartate, sunset yellow dye or to any of the excipients; severe renal impairment (chronic or acute renal failure); do not use Hepa-Merz granules if creatinine levels are above 3 mg/100 ml.

The following are adverse reactions observed during clinical trials and post-marketing use of Hepa-Merz, concentrate for solution for infusion. The frequency categories are defined as follows: very common (≥1/10); common (≥1/100 to 1/10); uncommon (≥1/1000 to 1/100); rare (≥1/10,000 to 1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data).

On the part of the immune system: unknown – hypersensitivity, anaphylactic reactions.

Gastrointestinal tract: infrequently – nausea, rarely – vomiting.

In general, gastrointestinal symptoms are short-lived and do not require discontinuation of treatment. They disappear when the dose or rate of administration of the drug is reduced.

When using Hepa-Merz granules, adverse reactions were observed from the gastrointestinal tract: rarely – nausea, vomiting, stomach pain, flatulence, diarrhea; from the musculoskeletal system: very rarely – pain in the joints.

These side effects are usually short-lived and do not require discontinuation of the drug. Allergic reactions are possible.

Hepa-Merz, concentrate for solution for infusion, should not be administered into an artery.

When administering Hepa-Merz intravenously in high doses, the level of urea in blood plasma and urine should be monitored.

In case of impaired liver function, the infusion rate should be adjusted according to the patient’s condition to prevent nausea or vomiting.

Hepa-Merz granules contain 1.13 g of fructose in each packet (equivalent to 0.11 XO), which must be taken into account by diabetics. Do not use in patients with congenital fructose intolerance. Long-term use may be harmful to teeth (development of caries).

Use during pregnancy or breastfeeding. There are no data on the use of Hepa-Merz during pregnancy. Animal studies with L-ornithine-L-aspartate to study its toxic effects on reproductive function have not been conducted. Therefore, use of the drug during pregnancy should be avoided.

However, if treatment with Hepa-Merz during pregnancy is considered necessary for vital indications, the doctor should carefully weigh the ratio of the possible risk to the fetus/child and the expected benefit to the pregnant woman/mother.

It is not known whether L-ornithine-L-aspartate passes into breast milk. Use of the drug should be avoided during breastfeeding.

Children: Experience in children is limited, so the drug should not be used in pediatric practice.

Ability to influence the reaction rate when driving or operating other mechanisms. The ability to drive or operate other mechanisms may be impaired during treatment with L-ornithine-L-aspartate, so this type of activity should be avoided during treatment.

No studies have been conducted, no data are available.

Incompatibility. Since incompatibility studies have not been conducted, the drug should not be mixed with other drugs when administered intravenously.

Hepa-Merz can be mixed with conventional infusion solutions. However, no more than 6 ampoules should be dissolved in 500 ml of infusion solution.

No signs of intoxication due to an overdose of l-ornithine-l-aspartate were observed. Side effects may be increased. In case of overdose, symptomatic treatment is recommended.

At a temperature not exceeding 25 °C.