Orniprim (Granules) Instructions for Use

Marketing Authorization Holder

Aliym, JSC (Russia)

Manufactured By

Pharmproekt, JSC (Russia)

ATC Code

A05BA (Drugs for the treatment of liver diseases)

Active Substance

Ornithine (Rec.INN registered by WHO)

Dosage Form

Orniprim

Granules for oral solution 3 g: 5 g sachets 1, 5, 10, or 30 pcs.

Dosage Form, Packaging, and Composition

Granules for oral solution in the form of a mixture of powder and granules from light yellow to orange in color, with a characteristic faint orange odor; the presence of white and colorless inclusions is allowed.

Excipients: anhydrous citric acid, lemon flavor, orange flavor, sodium saccharin, sodium cyclamate, sunset yellow FCF dye, povidone K30, fructose.

5 g – sachets (1) – cardboard packs.
5 g – sachets (5) – cardboard packs.
5 g – sachets (10) – cardboard packs.
5 g – sachets (30) – cardboard packs.

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 synthesis (the Krebs urea cycle).

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 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 synthesis cycle.

Indications

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

Steatoses 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

Use orally as a solution prepared from granules.

Dissolve the entire contents of one 5 g sachet in one glass (200 ml) of water immediately before use.

For acute and chronic liver diseases with hyperammonemia, take one sachet (3 g of ornithine aspartate) three times daily after meals.

For the management of hepatic encephalopathy, adhere to the prescribed dosage, typically one to two sachets administered three times daily.

For steatoses and steatohepatitis, the usual adult dose is one sachet three times a day with meals.

The daily dosage should generally not exceed 18 grams of ornithine aspartate (six sachets).

Adjust the dosage and duration of therapy based on the severity of the condition and individual patient response.

For intravenous administration, use only the appropriate parenteral formulation under strict medical supervision.

Discontinue use and consult a physician if severe nausea, vomiting, or allergic reactions occur.

Adverse Reactions

Immune system disorders: frequency unknown – allergic reactions.

Gastrointestinal disorders: rarely – nausea, vomiting, abdominal pain, flatulence, diarrhea.

Musculoskeletal and connective tissue disorders: 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 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 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

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.