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

Composition:

Active substance: arginine glutamate;

1 sachet (3 g) contains arginine glutamate 1 g;

Excipients: glycine, mannitol (E 421), citric acid anhydrous, aspartame (E 951); lemon flavor containing maltodextrin, gum arabic, citric acid.

Pharmaceutical form. Powder for oral solution.

Main physicochemical characteristics: white to off-white powder with a fruity odor.

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

Pharmacological properties.

Pharmacodynamics. Glutarjin Alkoclin is a salt of arginine and glutamic acid.

In alcohol intoxication, the medicinal product stimulates alcohol utilization in the hepatic monooxygenase system and prevents inhibition of the key enzyme in ethanol metabolism – alcohol dehydrogenase. It accelerates inactivation and elimination of toxic ethanol metabolites by increasing the formation and oxidation of succinic acid. It reduces the depressant effect of alcohol on the central nervous system (CNS) due to the excitatory neurotransmitter properties of glutamic acid. Because of these properties, the drug exerts antidotal and sobering effects.

The drug also possesses hepatoprotective and hypoammonemic properties. The hepatoprotective action is due to its antioxidant, antihypoxic, and membrane-stabilizing effects, as well as its positive influence on energy supply processes in hepatocytes. The hypoammonemic effects are achieved through activation of ammonia detoxification in the ornithine cycle of urea synthesis, binding of ammonia into non-toxic glutamine, and enhanced removal of ammonia from the CNS and its excretion from the body. Due to these properties, the drug reduces general toxicity, including the neurotoxic effects, of ammonia.

In experimental animal studies, the drug did not show embryotoxic, gonadotoxic, mutagenic, or teratogenic effects and did not cause allergic or immunotoxic reactions.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications. Prevention of intoxication and hepatotoxic effects of alcohol. Treatment of mild to moderate acute alcohol intoxication, as well as as part of complex therapy of post-intoxication disorders following severe acute alcohol poisoning.

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

Interaction with other medicinal products and other forms of interactions. The drug's effect on insulin secretion is enhanced when administered concurrently with aminophylline. The drug may enhance the effect of antiplatelet agents (dipyridamole). Prevents and reduces neurotoxic symptoms that may occur during administration of isoniazid. Reduces the effect of vinblastine.

Special precautions for use

When administered on a long-term basis to patients with endocrine gland disorders, it should be borne in mind that the drug stimulates insulin and growth hormone secretion. The drug enhances ammonia binding into urea, which may be accompanied by a transient increase in blood urea levels.

Aspartame is a derivative of phenylalanine and therefore poses a risk for patients with phenylketonuria.

Use during pregnancy or breastfeeding. Experience with use during pregnancy or breastfeeding is insufficient; therefore, the drug should not be used during pregnancy. If use of the drug is necessary, breastfeeding should be discontinued.

Ability to affect reaction rate when driving or operating machinery. Has no effect.

Dosage and Administration

The drug is intended for oral administration to adults, after dissolving the contents of the sachet in ¼–½ glass of water.

For prevention of alcohol intoxication and alcohol-induced hepatotoxic effects, take 2 g (2 sachets) 1–2 hours before alcohol consumption, or 1 g (1 sachet) 1 hour before alcohol consumption and another 1 g (1 sachet) within 0.5 hours after alcohol consumption.

For treatment of mild to moderate acute alcohol intoxication, take 1 g (1 sachet) 4 times daily at 1–2.5-hour intervals. During the following 2–3 days, reduce the dose to 1 g (1 sachet) twice daily. In cases of severe alcohol intoxication, administer 1 g (1 sachet) twice daily for 20 days as part of complex therapy, following a course of treatment with Glutargin injection preparations.

Children. The efficacy and safety of the drug in children have not been studied; therefore, the drug should not be used in this age group.

Overdose.

Symptoms: nausea, vomiting, abdominal pain, diarrhea, chills, transient hyperthermia and/or hypotension, central nervous system excitation, insomnia, chest pain, atrioventricular block.

Treatment: symptomatic therapy. Depending on the severity of clinical symptoms, administer activated charcoal; if necessary, antihistamine therapy and intravenous corticosteroids.

Side effects.

Rarely possible:

Gastrointestinal tract: a feeling of mild discomfort in the gastrointestinal area and nausea immediately after administration of the drug, which resolve spontaneously.

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

Shelf life. 2 years.

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

Keep out of reach of children.

Packaging. 3 g in sachets: 1×2, 1×5, 1×10, or paired sachets 2×5 in a box.

Availability. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's location and address of business activity.

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