Argitek
Ukraine
Table of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ARGITET (ARGITEC)
Composition:
Active substance: arginine glutamate;
1 ml of solution contains 8 mg of arginine glutamate;
Excipients: sodium chloride, sodium hydroxide, water for injections.
Pharmaceutical form. Infusion solution.
Main physicochemical properties: clear, colorless liquid.
Pharmacotherapeutic group. Agents used in liver diseases, lipotropic substances. Arginine glutamate. ATC code A05BA01.
Pharmacological Properties
Pharmacodynamics
Argitek is a compound of arginine and glutamic acid, both of which play a crucial role in supporting biochemical processes involved in the neutralization and elimination from the body of highly toxic metabolites of nitrogenous substances—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 (CNS) and its excretion from the body. Due to these properties, Argitek reduces general toxic, particularly neurotoxic, effects of ammonia.
Argitek also exerts hepatoprotective effects due to its antioxidant, anti-hypoxic, and membrane-stabilizing properties, and positively influences energy supply processes in hepatocytes.
In alcohol intoxication, Argitek stimulates alcohol 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 enhancing 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, Argitek demonstrates antitoxic and sobering effects.
In pregnancy-related disorders, due to its endothelioprotective action, Argitek reduces abnormal 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 vasodilatory and anti-hypoxic effects of Argitek, 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 Argitek reduces levels of circulating immune complexes in the blood, diminishes the severity of the "metabolic" intoxication and immunotoxicosis syndromes, and enhances the body's compensatory and adaptive responses.
Argitek 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, poisoning with hepatotropic toxins (death cap mushroom, chemicals and drugs), liver cirrhosis, leptospirosis, hepatic encephalopathy, precoma and coma accompanied by impaired nitrogen metabolism and hyperammonemia. Moderate to severe acute alcohol intoxication, 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 components of the drug, tyrosinemia, increased excitability, severe impairment of renal filtration (nitrogen-excreting) function.
Interaction with other medicinal products and other types of interactions.
The effect of Argitec on insulin secretion is enhanced when used concomitantly with aminophylline. Argitec may potentiate the effect of antiaggregant agents (e.g., dipyridamole). It prevents and alleviates 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 medicinal product stimulates the secretion of insulin and growth hormone. Argitex activates ammonia binding into urea, which may be accompanied by a transient increase in its blood concentration.
Excipients.
This medicinal product contains 0.1 M sodium hydroxide. Caution should be exercised when administering to patients on a sodium-controlled diet.
Use during pregnancy or breastfeeding.
The safety of clinical use of the medicinal product during the first and second trimesters of pregnancy and during breastfeeding has not been studied.
Ability to influence reaction rate when driving or operating machinery.
Since adverse reactions from the central nervous system (headache, dizziness, tremor) may occur during treatment, caution should be exercised when driving or operating machinery.
Dosage and Administration
The medicinal product should be administered intravenously to adults.
Hepatitis, hyperammonemia. Administer intravenously by drip infusion twice daily, 1 vial (2 g) at a rate of 60–70 drops per minute.
In severe cases, increase the daily dose to 3–4 vials (6–8 g), divided into two administrations.
Alcohol intoxication. Administer intravenously by drip infusion twice daily, 100 ml (0.8 g) at a rate of 60–70 drops per minute for 2–3 days; then reduce the dose to 50 ml (0.4 g) twice daily for 10 days.
In severe cases (alcoholic coma), increase the daily dose to 1 vial (2 g) twice daily.
Maximum daily dose – 4 vials (8 g). Treatment duration – 5–10 days.
Pregnancy-related disorders. Administer by drip infusion 1–2 times daily, 250 ml (2 g) at a rate of 60–70 drops per minute.
Maximum daily dose — 500 ml (4 g). Treatment duration — 5–7 days.
Administration method
Do not insert the needle(s) into any part of the polymer vial other than the designated sterile ports!
For infusion therapy, follow this procedure:
- Remove the protective plastic cap with tamper-evident seal (if present).
- Remove protective closure(s) № 1 as shown in Figures 1 and 2 (the manufacturer may use different types and materials for protective closures).
- Remove the needle cap and insert the needle into any of the designated sterile ports № 2 of the infusion vial (see Figures 1 and 2).
- The other sterile port may be used either for adding other medicinal products into the infusion vial (№ 4, see Figure 3) or, in case of insufficient flow rate, for a venting needle (№ 4, see Figure 3).
- Hang the vial using the special ring № 3 located at the bottom of the vial (see Figure 3).
Children.
The efficacy and safety of the medicinal product in children have not been studied.
Overdose.
Symptoms: intensified adverse reactions, chest pain, atrioventricular block.
Treatment: intravenous administration of corticosteroids. Symptomatic therapy.
Adverse Reactions.
Rarely possible:
Gastrointestinal disorders: nausea, epigastric pain.
Nervous system disorders: headache, dizziness, tremor, weakness.
Cardiovascular disorders: atrial fibrillation, decreased blood pressure, tachycardia.
Immune system disorders: hypersensitivity reactions, including skin rash, pruritus, hyperemia, urticaria, angioneurotic edema.
General disorders and administration site conditions: dyspnea, chest pain, increased body temperature, chills, changes at the injection site, phlebitis.
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions after registration of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and/or lack of efficacy of the medicinal product through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.
Shelf life. 3 years.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.
Keep out of reach of children.
Incompatibilities.
The medicinal product must not be mixed with other medicinal products.
Packaging.
250 ml in a vial; 1 vial in a carton.
Prescription category. Prescription only.
Manufacturer. JSC "Pharmaceutical Company "Darnytsia".
Manufacturer's address and location of its business activity.
13, Boryspilska Street, Kyiv, 02093, Ukraine.