Larnamin^® (Concentrate) Instructions for Use

Marketing Authorization Holder

Farmak, JSC (Ukraine)

ATC Code

A05BA (Drugs for the treatment of liver diseases)

Active Substance

Ornithine (Rec.INN registered by WHO)

Dosage Form

Larnamin®

Concentrate for solution for infusion 500 mg/1 ml: amp. 10 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion in the form of a transparent solution from colorless to light yellow.

Excipients: water for injections – up to 1 ml.

10 ml – ampoules of dark glass (5) – cardboard boxes.
10 ml – ampoules of dark glass (10) – cardboard boxes.
10 ml – ampoules of dark glass (5) – blisters (1) – cardboard boxes.
10 ml – ampoules of dark glass (5) – blisters (2) – cardboard boxes.

Clinical-Pharmacological Group

Hypoammonemic drug

Pharmacotherapeutic Group

Hypoazotemic agent

Pharmacological Action

Hypoammonemic agent. It reduces the elevated level of ammonia in the body, particularly in liver diseases.

The action is associated with participation in the ornithine cycle of urea formation (Krebs cycle) (formation of urea from ammonia).

It promotes the production of insulin and somatotropic hormone.

It improves protein metabolism in diseases requiring parenteral nutrition.

It helps to reduce asthenic, dyspeptic and pain syndromes, as well as normalization of increased body weight (in steatosis and steatohepatitis).

Pharmacokinetics

In the body, it dissociates into the amino acids ornithine and aspartate, which are absorbed in the small intestine by active transport through the intestinal epithelium.

It is excreted in the urine through the urea cycle.

Indications

Acute and chronic liver diseases accompanied by hyperammonemia. Hepatic encephalopathy.

Steatosis and steatohepatitis of various origins (for oral administration).

As a corrective additive to drugs for parenteral nutrition in patients with protein deficiency (for parenteral use).

ICD codes

Dosage Regimen

Administer orally or by slow intravenous infusion. Determine the dose, route, and duration of therapy individually based on the clinical indication and severity of the patient’s condition.

For intravenous infusion, dilute the concentrate before administration. Do not administer undiluted. Dilute each 10 ml (5 g) ampoule in a minimum of 500 ml of appropriate infusion solution, such as 0.9% sodium chloride or 5% glucose.

For acute liver conditions with severe hyperammonemia, the typical daily intravenous dose is 20-40 g. Administer as a slow infusion, with a maximum infusion rate of 5 g per hour to minimize adverse effects.

For chronic liver diseases and maintenance therapy, the typical daily intravenous dose is 10-20 g. Adjust the dose based on plasma ammonia levels and clinical response.

For oral administration, use the appropriate dosage form. The typical daily oral dose is 3-6 g, divided into 2-3 doses, taken with meals.

Adjust the infusion rate carefully. If nausea or vomiting occurs, reduce the infusion rate immediately. In patients with severe hepatic impairment, strictly monitor the patient’s condition and correct the infusion rate to prevent gastrointestinal side effects.

The duration of treatment is not fixed. Continue therapy until clinical symptoms resolve and plasma ammonia levels normalize. For long-term management, follow the prescribed maintenance regimen.

Adverse Reactions

From the immune system: frequency unknown – allergic reactions.

From the digestive system: rarely – nausea, vomiting, abdominal pain, flatulence, diarrhea.

From the musculoskeletal system: very rarely – pain in the extremities.

Contraindications

Hypersensitivity to ornithine; severe renal failure (serum creatinine content more than 3 mg/100 ml); lactation period (breastfeeding); children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

During pregnancy, it should be used only in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use during lactation, the issue of stopping breastfeeding should be decided.

Use in Hepatic Impairment

With parenteral use in patients with severe liver dysfunction, strict monitoring of the patient’s condition and correction of the ornithine infusion rate are necessary to prevent the development of nausea and vomiting.

Use in Renal Impairment

Contraindicated in severe renal failure (serum creatinine content more than 3 mg/100 ml).

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

If nausea or vomiting occurs, the infusion rate should be optimized.

When using a specific dosage form of ornithine, the correspondence to specific indications should be observed.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.