Ornitin (Granules) Instructions for Use

ATC Code

A05BA (Drugs for the treatment of liver diseases)

Active Substance

Ornithine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug for the treatment of liver diseases

Pharmacotherapeutic Group

Drugs for the treatment of liver diseases

Pharmacological Action

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

The action is associated with participation in the ornithine cycle of urea formation (Krebs cycle), which is the 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 reduce asthenic, dyspeptic, and pain syndromes, as well as normalize elevated 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

For oral administration, dissolve the contents of one 5 g sachet in a glass of water or juice immediately before use.

Administer the solution orally, typically 1 to 3 times daily after meals.

For the treatment of hepatic encephalopathy and hyperammonemia, the usual adult dose is 3 to 6 sachets (15 g to 30 g) per day, divided into 2 or 3 doses.

For steatosis and steatohepatitis, the typical dose is 1 to 2 sachets (5 g to 10 g) taken 2 to 3 times daily.

Adjust the dosage and duration of therapy individually based on the severity of the condition and the patient’s response to treatment.

For intravenous infusion, administer only as a slow drip infusion; do not inject rapidly.

Dilute the concentrate for solution for infusion in a suitable large-volume parenteral solution prior to administration.

The typical intravenous dose for adults ranges from 20 g to 40 g per day, infused over several hours.

In severe hepatic impairment, strictly monitor the patient and reduce the infusion rate if nausea or vomiting occurs.

The maximum daily intravenous dose should not exceed 40 g.

Continue treatment until clinical and laboratory parameters indicate normalization.

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 level 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 discontinuing 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 adjustment 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 level more than 3 mg/100 ml).

Pediatric Use

The use in children and adolescents under 18 years of age is contraindicated.

Special Precautions

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

When using a specific dosage form of ornithine, compliance with 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

Over-the-Counter

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.