Larnamin®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LARNAMIN® (LARNAMIN)

Composition:

Active substance: L-ornithine-L-aspartate;

1 sachet contains: L-ornithine-L-aspartate, calculated as 100 % substance – 3 g;

Excipients: citric acid anhydrous, orange flavor, lemon flavor, sodium saccharin, sodium cyclamate, tartrazine (E 110), povidone, maltitol (E 965).

Pharmaceutical form. Granules for oral solution.

Main physicochemical characteristics: a mixture of white and orange granules of different sizes.

Pharmacotherapeutic group.

Agents used in liver diseases, lipotropic substances. Hepatotropic agents. ATC code A05B A.

Pharmacological Properties

Pharmacodynamics

The in vivo action of L-ornithine-L-aspartate is mediated by the amino acids ornithine and aspartate, which participate in two key mechanisms 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 carbamoyl phosphate synthetase, as well as a substrate for urea synthesis.

Glutamine synthesis occurs in perivenous hepatocytes. In particular, under pathological conditions, aspartate and dicarboxylates, including metabolites of ornithine, are taken up by cells and used there for binding ammonia into glutamine.

Glutamate is an amino acid that binds ammonia under both physiological and pathological conditions. The resulting amino acid, glutamine, represents not only a non-toxic form for ammonia elimination, but also stimulates intracellular glutamine metabolism.

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

Animal experimental studies have shown that the ability of L-ornithine-L-aspartate to reduce ammonia levels is due to accelerated glutamine synthesis. In some clinical studies, this improvement has been demonstrated with respect to the ratio of branched-chain amino acids to aromatic amino acids.

Pharmacokinetics

L-ornithine-L-aspartate is rapidly absorbed and dissociated into ornithine and aspartate. The elimination half-life of both amino acids is short—0.3–0.4 hours. A portion of aspartate is excreted unchanged in urine.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to L-ornithine-L-aspartate or to any of the excipients.

Severe renal function impairment (renal failure) when creatinine levels exceed 3 mg/100 ml.

Interaction with other medicinal products and other forms of interaction.

Studies on interactions have not been conducted. Data are lacking.

Special precautions for use.

Prolonged use of the medicinal product Larnamin® may be harmful to teeth (development of dental caries).

The colouring agent Sunset Yellow FCF (E 110) may cause allergic reactions.

High-dose administration of Larnamin® may lead to increased plasma uric acid levels; therefore, monitoring of urea levels in blood plasma and urine is necessary.

Do not use in patients with phenylketonuria.

Use during pregnancy or breastfeeding.

There are no data on the use of Larnamin® granules during pregnancy. Animal studies with L-ornithine-L-aspartate to evaluate its toxic effects on reproductive function have not been conducted. Therefore, the use of Larnamin® granules during pregnancy should be avoided.

However, if treatment with Larnamin® is considered necessary during pregnancy due to life-threatening indications, the physician should carefully weigh the potential risk to the fetus/child against the expected benefit to the mother.

It is unknown whether L-ornithine-L-aspartate passes into breast milk. Therefore, the use of Larnamin® should be avoided during breastfeeding.

Ability to affect reaction rate while driving or operating machinery.

Due to liver disease, the ability to drive or operate machinery may be impaired during treatment with L-ornithine-L-aspartate. Therefore, such activities should be avoided during therapy.

Dosage and Administration.

Dissolve the contents of 1–2 packets of the medicinal product Larnamin® in a glass of water and take up to 3 times daily during or after meals.

The duration of treatment is determined by the physician depending on the patient's clinical condition.

Children.

Experience with use in children is limited; therefore, the drug should not be used in pediatric practice.

Overdose.

In case of overdose, increased levels of urea in blood and urine and intensification of adverse reactions may occur.

Signs of intoxication caused by overdose of L-ornithine-L-aspartate have not been observed to date.

Treatment. No specific antidote is known. Gastric lavage and symptomatic treatment are recommended.

Adverse reactions

The frequency of adverse reactions was defined as follows:

very common (≥ 1/10);

common (≥ 1/100, < 1/10);

uncommon (≥ 1/1000, < 1/100);

rare (≥ 1/10000, < 1/1000);

very rare (< 1/10000);

frequency not known: cannot be estimated based on available data.

Gastrointestinal disorders:

uncommon: nausea, vomiting, stomach pain, flatulence, diarrhea, constipation.

Musculoskeletal system disorders:

very rare: joint and muscle pain.

Skin and subcutaneous tissue disorders: skin rash, redness of the skin, itching, urticaria.

Nervous system disorders: dizziness.

Immune system disorders: hypersensitivity reactions, including angioedema, anaphylactic shock, sneezing, lacrimation.

Metabolic disorders: when used in high doses, increased plasma uric acid levels are possible.

These adverse reactions are usually transient and do not require discontinuation of the medicinal product.

Yellow FCF (E 110) may cause allergic reactions.

Shelf life

2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging

5 g per sachet. 10 or 30 sachets per pack.

Pharmaceutical category

Over-the-counter.

Manufacturer: JSC "Farmak".

Manufacturer's name and address of the place of business

74, Kyrylivska Street, Kyiv, 04080, Ukraine.