Instructions Larnamin concentrate for solution for infusion 500 mg/ml ampoule 10 ml No. 10
Composition
active ingredient: L-ornithine-L-aspartate;
1 ml of the drug contains 500 mg of L-ornithine-L-aspartate in terms of 100% substance;
excipient: water for injections.
Dosage form
Concentrate for solution for infusion.
Main physicochemical properties: transparent solution from colorless to light yellow.
Pharmacotherapeutic group
Drugs used in liver diseases, lipotropic substances. Hepatotropic drugs. ATX code A05B A.
Pharmacological properties
Pharmacodynamics.
In vivo, the action of L-ornithine-L-aspartate is mediated by the amino acids ornithine and aspartate through two key methods of ammonia detoxification: urea synthesis and glutamine synthesis.
Urea synthesis occurs in periportal hepatocytes, where ornithine 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. 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 pathological 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 for 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.
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 to other components of the drug.
Severe renal failure (creatinine level above 3 mg/100 ml is considered as an indicative value).
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted. Interactions are unknown to date.
Application features
Larnamin®, concentrate for solution for infusion, should not be administered into an artery.
When administering high doses of Larnamin®, it is necessary to monitor the level of urea in blood plasma and urine.
In case of impaired liver function, the infusion rate should 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 Larnamin® during pregnancy. Animal studies with Larnamin® to study its toxic effects on reproductive function have not been conducted. Therefore, the use of Larnamin® during pregnancy should be avoided.
However, if treatment with Larnamin® during pregnancy is considered necessary for life-threatening indications, the physician should carefully weigh the potential risk to the fetus/child against the expected benefit to the mother.
It is not known whether Larnamin® passes into breast milk, so the use of the drug should be avoided during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
As a result of the disease, the ability to drive or operate other machinery may deteriorate during treatment with Larnamin®, 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 Larnamin® 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 Larnamin® have been observed. Side effects may be exacerbated. In case of overdose, symptomatic treatment is recommended.
Side effects
Gastrointestinal tract
Very rare (<1/10,000): nausea.
These symptoms are generally short-lived and do not require discontinuation of the drug. They disappear when the dose or rate of administration of the drug is reduced.
Allergic reactions are possible.
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Incompatibility
Since incompatibility studies have not been performed, this drug should not be mixed with other drugs.
Larnamin® can be mixed with common infusion solutions. However, no more than 6 ampoules should be dissolved in 500 ml of infusion solution.
Packaging
10 ml in an ampoule.
5 or 10 ampoules in a pack.
5 ampoules in a blister. 1 or 2 blisters in a pack.
Vacation category
According to the recipe.
Producer
JSC "Farmak".
Address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
