Instructions for use Argitec solution for infusion 8 mg/ml bottle 250 ml No. 1
Composition
active ingredient: arginine glutamate;
1 ml of solution contains 8 mg of arginine glutamate;
excipients: sodium chloride, sodium hydroxide, water for injections.
Dosage form
Solution for infusion.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group
Drugs used in liver diseases, lipotropic substances. Arginine glutamate. ATX code A05B A01.
Pharmacological properties
Pharmacodynamics
Argitec is a combination of arginine and glutamic acid, which play an important role in ensuring the biochemical processes of neutralization and excretion of the highly toxic metabolite of nitrogenous metabolism - ammonia. The hypoammonemic effects of the drug are realized by activating the neutralization of ammonia in the ornithine cycle of urea synthesis, binding ammonia to non-toxic glutamine, as well as enhancing the removal of ammonia from the central nervous system and its excretion from the body. Due to these properties of Argitec, the general toxic, including neurotoxic effects of ammonia, are reduced.
Argitec also has a hepatoprotective effect due to its antioxidant, antihypoxic and membrane-stabilizing properties, and has a positive effect on energy supply processes in hepatocytes.
In case of alcohol intoxication, Argitec stimulates the utilization of alcohol in the monooxygenase system of the liver, prevents the inhibition of the key enzyme for ethanol utilization - alcohol dehydrogenase; accelerates the inactivation and elimination of toxic products of ethanol metabolism as a result of increased formation and oxidation of succinic acid; reduces the inhibitory effect of alcohol on the central nervous system due to the neurotransmitter properties of excitatory glutamic acid. Due to these properties, Argitec exhibits antitoxic and sobering effects.
Argitec does not exhibit embryotoxic, gonadotoxic, mutagenic and teratogenic effects, and does not cause allergic and immunotoxic reactions.
Pharmacokinetics
Not studied.
Indication
In the complex therapy of acute and chronic hepatitis of various etiologies, poisoning with hepatotropic poisons (pale toadstool, chemicals and drugs), cirrhosis of the liver, leptospirosis, hepatic encephalopathy, precoma and coma, accompanied by impaired nitrogen metabolism and hyperammonemia. Acute alcoholic poisoning of moderate and severe severity, including alcoholic encephalopathy and coma, as well as as part of the complex therapy of post-intoxication disorders after acute alcohol poisoning.
Contraindication
Hypersensitivity to the components of the drug, fever, increased excitability, severe impairment of filtration (nitrogen excretion) function of the kidneys.
Interaction with other medicinal products and other types of interactions
The effect of Argitec on insulin secretion is enhanced by the simultaneous use of aminophylline. Argitec may enhance the effect of antiaggregants (e.g. dipyridamole). Prevents and attenuates neurotoxic effects that may occur with isoniazid. Attenuates the effect of vinblastine.
Application features
When prescribing to patients with endocrine gland dysfunction, it should be taken into account that the drug stimulates the secretion of insulin and growth hormone. Argitec activates the binding of ammonia into urea, which may naturally be accompanied by a short-term increase in its level in the blood.
Excipients.
This medicinal product contains 0.1 M sodium hydroxide. Caution should be exercised when administering it to patients on a controlled sodium diet.
Ability to influence reaction speed when driving vehicles or other mechanisms
Since adverse reactions from the CNS (headache, dizziness, tremor) may occur during treatment, caution should be exercised when driving or operating other mechanisms.
Use during pregnancy or breastfeeding
The safety of clinical use of the drug during pregnancy in the I and II trimesters of pregnancy and during breastfeeding has not been studied.
Method of administration and doses
The drug is administered intravenously to adults.
Administer intravenously by drip 2 times a day, 1 vial (2 g) at a rate of 60–70 drops per minute.
In severe cases, the daily dose of the drug should be increased to 3–4 vials (corresponding to 6–8 g), divided into 2 administrations.
Alcohol poisoning. Intravenously administered drip 2 times a day, 100 ml (0.8 g) at a rate of 60-70 drops per minute.
In severe cases (alcoholic coma), the daily dose is increased to 1 vial (2 g) 2 times a day.
The maximum daily dose is 8 g. The course of treatment is 5–10 days.
Children
The efficacy and safety of the drug in children have not been studied.
Overdose
Symptoms: increased manifestations of adverse reactions, chest pain, atrioventricular block.
Treatment: intravenous corticosteroids. Symptomatic therapy.
Adverse reactions
Rarely possible:
Gastrointestinal: nausea, epigastric pain.
From the nervous system: headache, dizziness, tremor, weakness.
From the cardiovascular system: atrial fibrillation, decreased blood pressure, tachycardia.
Immune system disorders: hypersensitivity reactions, including skin rash, itching, flushing, urticaria, angioedema.
General disorders and administration site conditions: dyspnea, chest pain, fever, chills, injection site changes, phlebitis.
Expiration date
1.5 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of reach of children.
Packaging
250 ml in a bottle; 1 bottle in a pack.
Vacation category
According to the recipe.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and its business address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
