Glutargin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLUTARGIN (GLUTARGIN)

Composition:

Active substance: arginine glutamate;

1 ml of the preparation contains 400 mg of arginine glutamate;

Excipient: water for injections.

Pharmaceutical form. Concentrate for solution for infusion.

Main physicochemical properties: clear yellowish solution.

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

Pharmacological Properties.

Pharmacodynamics. Glutargin is a combination of arginine and glutamic acid, which play an important role in supporting biochemical processes involved in the neutralization and elimination from the body of highly toxic metabolites of nitrogenous compounds—ammonia. The hypoammonemic 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 and its excretion from the body. Due to these properties, Glutargin reduces general toxic effects, including neurotoxic effects, of ammonia.

Glutargin also exerts hepatoprotective action due to its antioxidant, antihypoxic, and membrane-stabilizing properties, and positively influences energy supply processes in hepatocytes.

In alcohol intoxication, Glutargin stimulates alcohol utilization in the hepatic mono-oxygenase system, prevents inhibition of the key enzyme involved 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 central nervous system through the excitatory neurotransmitter properties of glutamic acid. Due to these properties, Glutargin demonstrates detoxifying and sobering effects.

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

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

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications. In complex therapy of acute and chronic hepatitis of various etiologies, including poisoning with hepatotropic toxins (death cap mushroom, chemicals, and drugs), liver cirrhosis, leptospirosis.

Hepatic encephalopathy, precoma, and coma associated with hyperammonemia.

Acute alcohol intoxication of moderate and 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.

Contraindications. Hypersensitivity to the components of the drug, porphyria, increased excitability, severe impairment of renal filtration (nitrogen-excreting) function.

Interaction with other medicinal products and other types of interactions. The effect of Glutargin on insulin secretion is enhanced when administered concomitantly with aminophylline. Glutargin may potentiate the effect of antiplatelet agents (dipyridamole). It prevents and reduces neurotoxic manifestations that may occur during isoniazid administration. It reduces the effect of vinblastine.

Special precautions.

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

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

Ability to affect reaction rate when driving or operating machinery. Since adverse reactions from the central nervous system (headache, dizziness, tremor) may occur during treatment with the drug, caution should be exercised when driving or operating machinery.

Administration and Dosage

The drug is intended for intravenous use in adults.

Hepatitis, hyperammonemia. Administer intravenously by drip infusion twice daily, 5 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 15–20 ml (6–8 g), divided into two doses.

Maximum daily dose – 20 ml (8 g). Treatment duration – 5–10 days.

Alcohol intoxication. Administer intravenously by drip infusion twice daily, 2 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 for 2–3 days, then reduce the dose to 1 ml (0.4 g) twice daily for 10 days. In severe cases (alcoholic coma), increase the daily dose to 5 ml (2 g) twice daily.

After completing the course of treatment with 40% Glutargin solution, if necessary, switch to oral Glutargin tablets.

Pregnancy complications. Administer by drip infusion 1–2 times daily, 5 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.

Maximum daily dose – 10 ml (4 g). Treatment duration – 5–7 days.

Children. The efficacy and safety of the drug in children have not been studied.

Overdose. Symptoms: intensification of adverse reactions, chest pain, atrioventricular block.

Treatment: intravenous administration of corticosteroids. Symptomatic therapy.

Adverse reactions.

Rarely possible:

General disorders: dyspnea, chest pain, increased body temperature, chills, local reactions at the site of administration, phlebitis;

Cardiovascular system: atrial fibrillation, decreased arterial pressure, tachycardia;

Gastrointestinal system: nausea, epigastric pain;

Nervous system: headache, dizziness, tremor, weakness;

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

Shelf life. 4 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Incompatibility. The drug should not be mixed with other medicinal products. Use only recommended solvents.

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

Prescription status. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and place of business. 22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.