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HEPTOR-PHARMEX concentrate for solution for infusion 500 mg/ml
Instruction
For medical use of the medicinal product
Heptor-Pharmex
(Heptor-pharmex)
Composition:
Active ingredient: l-ornithine-l-aspartate;
1 ml of concentrate contains L-ornithine-L-aspartate 500 mg (calculated as 100% anhydrous substance);
excipient: water for injections.
Dosage form
. concentrate for solution for infusion.
Main physicochemical properties: transparent colorless or yellowish solution.
Pharmacotherapeutic group.
Drugs used in liver diseases, lipotropic substances. hepatotropic drugs. ATC code a05b a.
Pharmacological properties.
Pharmacodynamics.
The in vivo action of L-ornithine-L-aspartate is due to the amino acids ornithine and aspartate and consists in the detoxification of ammonia through the synthesis of urea and the synthesis of glutamine.
Urea synthesis occurs in periportal hepatocytes, where ornithine acts as an activator of two enzymes: ornithine carbamoyl transferase and carbamoyl phosphate synthetase, and also as a substrate for urea synthesis.
Glutamine synthesis occurs in perivenous hepatocytes. In particular, under pathological conditions, aspartate and dicarboxylate, including products of ornithine 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 pathophysiological conditions. The resulting amino acid glutamine is not only 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 shown to be relative to branched-chain amino acids/aromatic amino acids.
Pharmacokinetics.
The half-life of both ornithine and aspartate is short - 0.3-0.4 hours. A small part of aspartate is excreted in the urine unchanged.
Clinical characteristics.
Indication.
Treatment of concomitant diseases and complications caused by impaired liver detoxification function (e.g., cirrhosis) with symptoms of latent or severe hepatic encephalopathy, especially impaired consciousness (precoma, coma).
Contraindication.
Hypersensitivity to l-ornithine-l-aspartate or other components of the drug.
Severe renal failure (creatinine level above 3 mg/100 ml is considered as an indicative value).
Interaction with other drugs and other types of interactions.
Interaction studies have not been conducted. Interactions are unknown to date.
Application features.
When administering high doses of Heptor-Pharmex, it is necessary to monitor the level of urea in blood plasma and urine.
In case of impaired liver function, the infusion rate must be adjusted according to the individual patient's condition to prevent nausea and vomiting.
Use during pregnancy or breastfeeding.
There are no data on the use of l-ornithine-l-aspartate during pregnancy. Animal studies with l-ornithine-l-aspartate to investigate its toxic effects on reproductive function have not been conducted. Therefore, the use of l-ornithine-l-aspartate during pregnancy should be avoided.
However, if treatment with L-ornithine-L-aspartate during pregnancy is considered necessary for vital indications, the doctor should carefully weigh the ratio of the possible risk to the fetus/child - the expected benefit to the woman.
It is not known whether L-ornithine-L-aspartate passes into breast milk. Therefore, the use of L-ornithine-L-aspartate should be avoided during breastfeeding.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
Due to the disease, the ability to drive or operate other machinery may be impaired during treatment with l-ornithine-l-aspartate, so such activities should be avoided during the treatment period.
Method of administration and doses.
Administer intravenously.
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.
Before administration, add the contents of the ampoules to 500 ml of infusion solution, but do not dissolve more than 6 ampoules 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 is determined by the doctor depending on the patient's clinical condition.
Children.
Experience in children is limited, so the drug should not be used in pediatric practice.
Overdose.
To date, no signs of intoxication due to an overdose of l-ornithine-l-aspartate have been observed. Side effects may be increased. In case of overdose, symptomatic treatment is recommended.
Adverse reactions.
Gastrointestinal tract
Very rarely (
Rarely (1/10,000,
These symptoms are generally short-lived and do not necessarily require discontinuation of treatment with the drug. They disappear when the dose or rate of administration of the drug is reduced.
Allergic reactions are possible.
Expiration date.
2 years.
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Incompatibility.
Since incompatibility studies have not been performed, this drug should not be mixed with other drugs.
Heptor-Pharmex can be mixed with conventional infusion solutions. However, no more than 6 ampoules should be dissolved in 500 ml of solution.
Packaging.
10 ml in a bottle. 5 bottles in a blister. 1 or 2 contour blister packs in a cardboard pack.
Vacation category
. by prescription.
Producer.
LLC "Pharmex group".
Location of production and its address of place of business.
Ukraine, 08300, Kyiv region, Boryspil city, Shevchenko st., 100.
