Arginine - darnitsa

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ARGININE-DARNITSA (ARGININE-DARNITSA)

Composition:

Active substance: arginine glutamate;

1 ml of solution contains arginine glutamate 40 mg;

Excipients: water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: colorless clear liquid.

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

Pharmacological properties.

Pharmacodynamics.

The active ingredient of the medicinal product – arginine glutamate – plays an important role in supporting biochemical processes of neutralization and elimination from the body of highly toxic metabolite of nitrogenous compounds – ammonia. The hypoammonemic effects of the medicinal product are realized 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, general toxic effects, including neurotoxic effects of ammonia, are reduced.

The medicinal product positively influences energy supply processes in hepatocytes.

The medicinal product stimulates alcohol utilization in the hepatic monooxygenase system, prevents inhibition of the key enzyme in ethanol metabolism – alcohol dehydrogen enzyme; accelerates inactivation and elimination of ethanol metabolites due to increased formation and oxidation of succinic acid; reduces the depressant effect of alcohol on the CNS through excitatory neurotransmitter properties of glutamic acid. Due to these properties, the product exhibits a sobering effect.

In pregnancy pathology, due to endothelium-protective action of arginine glutamate, vascular permeability and thromboresistance are reduced, hypercoagulability is prevented, and vascular sensitivity to vasoconstrictive agents (endothelin, angiotensin, thromboxane) causing generalized vasospasm is decreased. After prior biotransformation into nitric oxide, arginine exhibits vasodilatory action, positively influences blood coagulation and functional properties of circulating blood elements. As a result of vasodilatory and antihypoxic effects, maternal-fetal hemodynamics are improved, and fetal intrauterine hypoxia is reduced. In pregnancy pathology, the medicinal product acts as a non-specific metabolic regulator of metabolic processes. Due to these properties, during pregnancy, the level of circulating immune complexes in blood is reduced, and compensatory-adaptive responses of the organism are enhanced.

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

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

• Hepatic encephalopathy, precoma and coma associated with hyperammonemia.
• Acute alcohol intoxication of moderate and severe degree, including alcoholic encephalopathy and coma. Postintoxication disorders caused by alcohol consumption.
• 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, including conditions associated with hyperammonemia.
• In complex therapy of acute and chronic hepatitis of various etiologies, including poisoning with hepatotropic toxins (death cap mushroom, chemical and medicinal substances), liver cirrhosis, leptospirosis, including conditions associated with hyperammonemia.

Contraindications.

• Hypersensitivity to the active substance or to other components of the medicinal product.
• Typhus.
• Increased excitability and psychotic reactions with stormy course.
• Severe impairment of renal filtration (nitrogen-excreting) function.

Interaction with other medicinal products and other types of interactions.

When this medicinal product is used concomitantly with other medicinal products, the following interactions are possible:

with aminophylline – enhanced effect of arginine glutamate on insulin secretion;

with antiplatelet agents – potentiation of the effect of the latter;

with vinblastine – reduction of the effect of the latter;

with isoniazid – prevention and reduction of isoniazid-induced neurotoxic effects.

Special precautions.

When prescribing to patients with endocrine gland function disorders, it should be taken into account that the medicinal product stimulates insulin and growth hormone secretion.

Arginine glutamate activates ammonia binding into urea, which may be accompanied by a transient increase in its blood levels.

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 affect reaction rate when driving or operating machinery.

Since adverse reactions from the central nervous system (headache, dizziness, tremor) may occur during treatment with this medicinal product, caution should be exercised when driving or operating machinery.

Method of administration and dosage.

The medicinal product should be administered intravenously to adults. Prior to administration, ampoules should be inspected for the presence of particles or discoloration of the solution.

Hepatitis, hyperammonemia. Administer intravenously by drip infusion twice daily, 50 ml (2 g) in 150–250 ml of 0.9% sodium chloride solution at a rate of 60–70 drops per minute. In severe cases, the daily dose may be increased to 150–200 ml (6–8 g). Treatment duration is 5–10 days. Maximum daily dose – 200 ml (8 g).

Alcohol intoxication. Administer 20 ml (0.8 g) twice daily by drip infusion in 150–250 ml of 0.9% sodium chloride solution at a rate of 60–70 drops per minute for 2–3 days, then reduce the dose to 10 ml (0.4 g) twice daily for 10 days. In severe cases (alcoholic coma), increase the daily dose to 50 ml (2 g) twice daily.

Pregnancy pathology (III trimester). Administer 1–2 times daily, 50 ml (2 g) per dose. Treatment duration – 5–7 days. Maximum daily dose – 100 ml (4 g).

Children.

The efficacy and safety of the medicinal product in children have not been studied.

Overdose.

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

Treatment: symptomatic therapy, intravenous administration of glucocorticosteroids.

Adverse reactions.

In rare cases, the following adverse reactions are possible.

Gastrointestinal disorders: nausea, epigastric pain.

Nervous system disorders: headache, dizziness, tremor, weakness.

Cardiovascular disorders: atrial fibrillation, decreased blood pressure, tachycardia.

Immune system, skin and subcutaneous tissue disorders: hypersensitivity reactions, including skin rashes, pruritus, hyperemia, urticaria, angioneurotic edema.

General disorders and administration site reactions: dyspnea, chest pain, increased body temperature, chills, local site reactions, phlebitis.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Incompatibility.

Data not available. Use only recommended solvents.

Packaging.

5 ml in a vial; 5 vials in a blister pack; 1 or 2 blister packs in a carton.

Prescription category. Prescription only.

Manufacturer: JSC "Pharmaceutical company "Darnytsia".

Manufacturer's address and location of business activity:

13, Borysplilska Street, Kyiv, 02093, Ukraine.