Instruction for use: Hepa-Merz

Active substance Ornithine

ATX code A05BA Preparations for the treatment of liver diseases

Pharmacological group

Proteins and amino acids

Hepatoprotectors

Nosological classification (ICD-10)

E72.2 Disruption of the urea cycle metabolism

Argininemia, Arginine Succinatemia, Hyperammonemia, Ornithine transcarbamylase deficiency, Urea cycle enzyme deficiency, Citrullinemia

K70.0 Alcoholic fatty liver [fatty liver]

Alcohol steatohepatitis, Fatty degeneration of the liver of alcoholic origin, Steatosis

K72.9 Hepatic insufficiency, unspecified

Latent hepatic encephalopathy, Acute liver failure, Liver failure, Hepatic precoma, Acute hepatic-renal failure

K76.0 Fatty liver degeneration, not elsewhere classified

Fatty hepatosis, Hepatosis fat, Dystrophy of fatty liver, Fatty liver infiltration, Fatty liver degeneration, Fatty degeneration of the liver, Steathepatitis, Fatty degeneration of the liver, Non-alcoholic steatohepatitis, Disorders of lipid metabolism of the liver, Steatosis, Steatosis states, Lipidoses, Acute yellow atrophy of the liver

K76.9 Liver disease, unspecified

Change in liver function in heart failure, Restoration of impaired liver function, Severe liver function disorders, Hepatitis, Hepatosis, Hepatopathy, Liver dysfunction, Diseases of the liver, Impaired liver function, Dysfunction of the liver, Infringements of function of a liver of an inflammatory etiology, Functional liver failure, Functional disorders of the liver, Chronic liver disease, Chronic diffuse liver disease, Enterogenic diseases of the gallbladder and liver

Composition

Granules for the preparation of oral solution 5 g

active substance:

L-ornithine-L-aspartate 3 g

excipients: anhydrous citric acid - 0.55 g; lemon flavor - 0.02 g; orange flavor - 0.2 g; sodium saccharinate (sodium saccharin) - 0.0045 g; sodium cyclamate - 0.0405 g; the dye “Sunset” yellow - 0.0005 g; polyvinylpyrrolidone (povidone) - 0.05 g; fructose (levulose) - 1.1345 g

Description of the dosage form

Granules for oral solution: a mixture of orange and white granules.

pharmachologic effect

Pharmacological action - hepatoprotective.

Pharmacodynamics

It has a detoxification effect, reducing the increased level of ammonia in the body, in particular for liver diseases. The action of the drug is associated with its participation in the ornithine Krebs urea-forming cycle (it activates the work of the cycle, restoring the activity of the enzymes of the liver cells: ornithine-carbamoyl transferase and carbamoyl-phosphate synthetase). Promotes the production of insulin and somatotropic hormone.

Improves protein metabolism in diseases requiring parenteral nutrition.

It contributes to the reduction of asthenic, dyspeptic and pain syndromes, as well as the normalization of increased body weight (with steatosis and steatohepatitis).

Pharmacokinetics

L-ornithine-L-aspartate quickly dissociates into ornithine and aspartate and takes effect within 15–25 min, having a short T1 / 2. Excreted in the urine through the urea cycle.

Indications

acute and chronic liver disease, accompanied by hyperaemonemia;

hepatic encephalopathy (latent and severe);

steatosis and steatohepatitis (of various genesis).

Contraindications

hypersensitivity to the drug;

severe renal failure with a creatinine index of more than 3 mg / 100 ml;

lactation period;

children's age (due to insufficient data).

With care: pregnancy.

Side effects

On the part of the gastrointestinal tract: infrequently - nausea, vomiting, abdominal pain, flatulence, diarrhea.

From the musculoskeletal and connective tissue: very rarely - pain in the limbs.

Dye “Sunset” yellow can cause allergic reactions.

Interaction

Not described.

Dosage and administration

Inside, after eating, 1-2 pack. granules, pre-dissolved in 200 ml of liquid, 3 times a day. The course of treatment depends on the severity of the disease.

Overdose

Symptoms: increased severity of side effects.

Treatment: gastric lavage, the appointment of activated carbon, symptomatic therapy.

special instructions

Impact on the ability to drive vehicles and engage in other potentially hazardous activities. When making a diagnosis of hepatic encephalopathy due to the underlying disease, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and psychomotor speed.

Release form

Granules for the preparation of a solution for oral administration, 3, 10 or 30 packs. (5 g) granules for the preparation of an oral solution containing 3 g of L-ornithine-L-aspartate are packed in a cardboard box.

Pharmacy sales terms

Over the counter.

Storage conditions

At temperatures not above 25 ° C.

Keep out of the reach of children.

Shelf life

5 years.

Do not use after the expiration date printed on the package.