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Glutargin alkoclean (Tablets, Powder) Instructions for Use

ATC Code

A05BA01 (Arginine glutamate)

Active Substance

Arginine glutamate

Clinical-Pharmacological Group

Hypoammonemic drug

Pharmacotherapeutic Group

Hepatoprotective agent

Pharmacological Action

Arginine glutamate is a compound of arginine and glutamic acid, which play an important role in providing biochemical processes for the neutralization and elimination of a highly toxic metabolite of nitrogen-containing substance metabolism — ammonia.

The hypoammonemic effect of the drug is realized through the activation of ammonia detoxification processes in the ornithine cycle of urea synthesis, the binding of ammonia into non-toxic glutamine, as well as the enhancement of ammonia elimination from the CNS and its excretion from the body. Due to these properties, Arginine glutamate reduces the general toxic and neurotoxic effects of ammonia.

Arginine glutamate also has a hepatoprotective effect, possesses antioxidant, antihypoxic, and membrane-stabilizing activity, positively influencing the energy supply of hepatocytes. In alcohol intoxication, Arginine glutamate stimulates the utilization of alcohol in the liver monooxygenase system, prevents the inhibition of the key enzyme of ethanol utilization — alcohol dehydrogenase; accelerates the inactivation and elimination of toxic ethanol metabolism products by increasing the formation and oxidation of succinic acid; reduces the inhibitory effect of alcohol on the CNS due to the neurotransmitter properties of glutamic acid.

Indications

Acute and chronic hepatitis of various etiologies; poisoning with hepatotropic poisons (poison of the death cap mushroom, chemicals and medicinal products); liver cirrhosis; liver damage in leptospirosis; hepatic encephalopathy; precoma and coma caused by hyperammonemia; condition of acute alcohol poisoning of moderate and severe degree, including alcoholic encephalopathy and coma; post-intoxication disorders caused by alcohol consumption.

ICD codes

ICD-10 code Indication
A27 Leptospirosis
B15 Acute hepatitis A
B16 Acute hepatitis B
B17.1 Acute hepatitis C
B18.0 Chronic viral hepatitis B with delta-agent
B18.1 Chronic viral hepatitis B without delta-agent
B18.2 Chronic viral hepatitis C
G31.2 Degeneration of nervous system caused by alcohol (including alcoholic encephalopathy)
K70 Alcoholic liver disease
K71 Toxic liver disease
K72 Hepatic failure, not elsewhere classified (including hepatic coma, hepatic encephalopathy)
K73 Chronic hepatitis, not elsewhere classified
K74 Fibrosis and cirrhosis of liver
T51 Toxic effect of alcohol
T62.0 In mushrooms eaten
T65.9 Unspecified substance
ICD-11 code Indication
1B91 Leptospirosis
1E50.0 Acute hepatitis A
1E50.1 Acute hepatitis B
1E50.2 Acute hepatitis C
1E51.0Z Chronic hepatitis B, unspecified
1E51.1 Chronic viral hepatitis C
1E51.2 Chronic hepatitis D
4A85.00 Drug hypersensitivity-induced liver disease
8D43.1 Cognitive impairments due to toxic effects
8D43.2Y Other specified neuropathy due to toxic effect
8D43.2Z Neuropathy due to toxic effect, unspecified
8D43.3 Myopathy due to toxic effect
8D43.4 Movement disorders due to toxic effect
8D43.Y Other specified neurological disorders due to toxic effect
8D44.Z Neurological disorders associated with alcohol, unspecified
DB91.Z Unspecified acute or subacute liver failure
DB93 Fibrosis or cirrhosis of liver
DB94.Z Alcoholic liver disease, unspecified
DB95.Z Drug-induced or toxic liver disease, unspecified
DB97.2 Chronic hepatitis, not elsewhere classified
DB99.7 Hepatic failure, not specified as acute or chronic
DB99.8 Chronic hepatic failure
DB9Z Liver diseases, unspecified
NE61 Toxic effect of poisonous substances, chiefly nonmedicinal, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets, Powder

Orally administered to adults, 3 tablets (0.75 g) 3 times/day for 15 days, regardless of food intake. If necessary, the drug dose and course of treatment can be increased to 20 days. The highest single dose is 2 g, the highest daily dose is 8 g.

Intravenously by drip, administered 2 times/day, 2 g in 150-250 ml of isotonic sodium chloride solution at a rate of 60-70 drops per 1 min. The course of treatment is 5-10 days. The highest daily dose is 8 g.

Adverse Reactions

When taken orally: rarely — a feeling of mild discomfort in the stomach and intestines, nausea immediately after taking the drug, which disappear on their own.

Contraindications

Febrile conditions; increased excitability; acute psychosis; severe renal impairment.

Use in Pregnancy and Lactation

There are no data on the use of the drug during pregnancy and lactation, so use during these periods is highly undesirable.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Pediatric Use

Experience of use in children is insufficient.

Special Precautions

In patients with endocrinological disorders, it should be taken into account that Arginine glutamate can stimulate the secretion of insulin and growth hormone.

Drug Interactions

The effect of arginine glutamate on insulin secretion increases with simultaneous use of aminophylline.

It can potentiate the effect of antiplatelet agents (including dipyridamole).

Prevents and alleviates neurotoxic phenomena that may occur when using isoniazid.

Weakens the effect of vinblastine.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Atrapak, LLC (Russia)

Manufactured By

Pharmamed, LLC (Russia)

Dosage Form

Bottle OTC Icon Glutargin alkoclean Tablets 1 g: 2 or 10 pcs.

Dosage Form, Packaging, and Composition

Tablets white, biconvex, oblong in shape with a score.

1 tab.
Arginine glutamate 1 g

Excipients: microcrystalline cellulose (MCC 101) – 0.11 g, crospovidone – 0.02 g, calcium stearate – 0.01 g.

1 pc. – blister packs (2) – cardboard boxes.
10 pcs. – blister packs (1) – cardboard boxes.

Marketing Authorization Holder

Atrapak, LLC (Russia)

Manufactured By

Pharmaceutical Company Zdorovye, LLC (Ukraine)

Dosage Form

Bottle OTC Icon Glutargin alkoclean Powder for oral solution 1 g: sachets 2, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for oral solution from white to white with a yellowish tint, with a fruity smell.

1 sachet
Arginine glutamate 1 g

Excipients: glycine, mannitol (E421), citric acid (anhydrous), aspartame (E951), lemon flavor.

3 g – sachets (2) – cardboard boxes.
3 g – sachets (5) – cardboard boxes.
3 g – sachets (10) – cardboard boxes.

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