Glutargin

INSTRUCTIONS for medical use of the medicinal product GLUTARGIN (GLUTARGIN)

Composition:

Active substance: arginine glutamate;

1 ml of solution contains arginine glutamate 200 mg;

Excipients: water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: clear, colorless or slightly yellowish solution.

Pharmacotherapeutic group. Agents used in liver diseases, lipotropic agents. Arginine glutamate. ATC code A05BA01.

Pharmacological properties.

Pharmacodynamics.

Glutargin is a salt of arginine and glutamic acid, both of which play an important role in supporting biochemical processes involved in neutralizing and eliminating from the body the highly toxic metabolite of nitrogenous substance metabolism – ammonia. The hypoammonaemic effects of the drug are achieved through activation of ammonia detoxification in the ornithine cycle of urea synthesis, binding of ammonia into non-toxic glutamine, as well as enhanced removal of ammonia from the central nervous system (CNS) and its excretion from the body. Due to these properties, the general toxic, including neurotoxic, effects of ammonia are reduced.

Glutargin also exhibits hepatoprotective activity, which is attributed to its antioxidant, anti-hypoxic, and membrane-stabilizing properties, and positively influences energy supply processes in hepatocytes.

In alcohol intoxication, the drug stimulates ethanol utilization in the hepatic monooxygenase system, prevents inhibition of the key enzyme in ethanol metabolism – alcohol dehydrogenase; accelerates inactivation and elimination of toxic ethanol metabolites by increasing the formation and oxidation of succinic acid; reduces the depressant effect of alcohol on the CNS due to the excitatory neurotransmitter properties of glutamic acid. Thanks to these properties, the drug demonstrates antitoxic and sobering effects.

In pregnancy-related disorders, due to its endothelioprotective action, the drug reduces impaired vascular permeability and thromboresistance, prevents hypercoagulation, and decreases vascular sensitivity to vasoconstrictive agents (endothelin, angiotensin, thromboxane) that cause generalized vasospasm. After prior biotransformation into nitric oxide, arginine exerts vasodilatory effects, positively influences blood coagulation and functional properties of circulating blood elements. As a result of the drug's vasodilatory and anti-hypoxic effects, maternal-fetal hemodynamics improve and intrauterine fetal hypoxia decreases. In pregnancy-related disorders, the drug also demonstrates antitoxic and hepatoprotective activity and acts as a non-specific metabolic regulator of metabolic processes. Due to these properties, during pregnancy the levels of circulating immune complexes in the blood are reduced, the severity of the "metabolic" intoxication and immunotoxicosis syndromes decreases, and the body's compensatory and adaptive responses are activated.

Glutargin does not exhibit embryotoxic, gonadotoxic, mutagenic, or teratogenic effects and does not cause allergic or immunotoxic reactions.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications. As part of complex therapy for acute and chronic hepatitis of various etiologies, including poisoning with hepatotropic toxins (e.g., Amanita phalloides, chemical and medicinal substances), liver cirrhosis, leptospirosis, including conditions accompanied by hyperammonemia.

Hepatic encephalopathy, precoma and coma accompanied by hyperammonemia.

Acute alcohol intoxication of moderate to severe degree, including alcoholic encephalopathy and coma.

Complications in the third trimester of pregnancy: late gestosis, including its severe forms—preeclampsia and eclampsia, fetoplacental insufficiency, chronic pathologies of the hepatobiliary system in pregnant women, including conditions accompanied by hyperammonemia.

Contraindications. Hypersensitivity to the components of the medicinal product. Comatose state, increased excitability and psychotic reactions with agitated course. Severe impairment of renal filtration (nitrogen-excreting) function.

Interaction with other medicinal products and other types of interactions. The effect of the drug on insulin secretion is enhanced when administered concurrently with aminophylline. Glutargin may enhance the effect of anti-aggregation agents (dipyridamole). Prevents and reduces neurotoxic manifestations that may occur during isoniazid administration. Reduces the effect of vinblastine.

Special precautions.

When prescribing to patients with endocrine gland disorders, it should be taken into account that the drug stimulates insulin and growth hormone secretion. The drug activates ammonia binding into urea, which may be accompanied by a transient increase in its blood levels.

After completing a course of treatment with Glutargin solution, if necessary, transition to Glutargin tablets may be performed.

Use during pregnancy or breastfeeding. The clinical safety of the drug has not been studied during the first and second trimesters of pregnancy or during breastfeeding.

Ability to affect reaction rate when driving or operating machinery. The indications for use of the drug do not imply that the patient may drive vehicles or operate machinery. If driving vehicles or operating machinery becomes necessary during treatment, caution should be exercised, since adverse reactions from the central nervous system (headache, dizziness, tremor) may occur during therapy.

Dosage and Administration

The medication is intended for intravenous and intramuscular use in adults. Before administration, the solution in ampoules should be visually inspected for the presence of particles or discoloration.

Hepatitis, hyperammonemia. Administer intravenously by drip infusion 1–2 times daily, 10 ml (2 g) in 150–250 ml of 0.9% sodium chloride solution or 5% glucose solution, at a rate of 60–70 drops per minute. In severe cases, the daily dose may be increased to 30–40 ml (6–8 g), divided into two administrations. The treatment course is 5–10 days. The maximum daily dose for intravenous administration is 40 ml (8 g).

For intramuscular administration, inject the medication slowly and deeply into the gluteal muscle 1–2 times daily, 5 ml (1 g). If necessary, the dose may be increased to 10 ml (2 g) 1–2 times daily. The treatment course is 5–10 days. The maximum daily dose for intramuscular administration is 20 ml (4 g).

Alcohol intoxication. Administer intravenously by drip infusion twice daily, 4 ml (0.8 g) in 150–250 ml of 0.9% sodium chloride solution or 5% glucose solution, at a rate of 60–70 drops per minute. After 2–3 days, reduce the dose to 2 ml (0.4 g).

For intramuscular administration, inject the medication slowly and deeply into the gluteal muscle, 4 ml (0.8 g) twice daily for 2–3 days, then reduce the dose to 2 ml (0.4 g) twice daily for 5–10 days. In severe cases (alcoholic coma), increase the daily dose to 10 ml (2 g) twice daily for either intravenous or intramuscular administration.

Pregnancy-related disorders. Administer the medication intravenously by drip infusion 1–2 times daily, 10 ml (2 g) in 150–250 ml of 0.9% sodium chloride solution. The maximum daily dose is 20 ml (4 g).

Preparation of solution for intravenous drip infusion: under aseptic conditions, dilute 2 ampoules of 5 ml each (10 ml, or 2 g of arginine glutamate) in 150–250 ml of 0.9% sodium chloride solution. Shake gently to ensure uniform mixing. The resulting solution should be clear, colorless, and free of visible particles.

Infuse the prepared solution by drip at a rate of 60–70 drops per minute. If adverse reactions occur, discontinue the infusion.
The treatment course is 5–7 days.

Children. The efficacy and safety of the medication in pediatric and adolescent populations have not been studied.

Overdose.

Symptoms: intensification of adverse reactions; possible glutamic acid-related symptoms such as chest pain and atrioventricular block.

Treatment: intravenous administration of corticosteroids.

Side effects.

Rarely possible:

General disorders: dyspnea, chest pain, hyperthermia, chills;

Cardiovascular system: cardiac arrhythmias in the form of atrial fibrillation, arterial hypotension, tachycardia;

Gastrointestinal tract: nausea, epigastric pain;

Nervous system: headache, dizziness, tremor, weakness;

Immune system: hypersensitivity reactions, including skin rashes, pruritus, hyperemia, urticaria, angioneurotic edema.

Local reactions: injection site reactions, phlebitis.

Shelf life. 4 years.

Storage conditions.

Incompatibility. The medicinal product should not be mixed with other medicinal agents. Use only recommended solvents.

Packaging. 5 ml in ampoules, 10 in a box; 5×2 in blisters in a box.

Prescription status. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "KORPORATSIYA "ZDOROVO".

Address of manufacturer and location of its business activities.

22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.