Instructions Tivortin Forte solution for infusion 84 mg/ml bottle 50 ml No. 1
Composition
active ingredient: arginine hydrochloride;
1 ml contains 84 mg of arginine hydrochloride;
excipient: water for injections.
Dosage form
Solution for infusion.
Main physicochemical properties: transparent colorless or slightly yellowish-brown solution. Theoretical osmolarity – 797 mosmol/l.
Pharmacotherapeutic group
Blood substitutes and perfusion solutions. Additional solutions for intravenous administration. Amino acids. Arginine hydrochloride.
ATX code B05X B01.
Pharmacological properties
Pharmacodynamics
Arginine (a-amino-d-guanidinovaleric acid) is an amino acid that belongs to the class of conditionally essential amino acids and is an active and versatile cellular regulator of numerous vital functions of the body, exerting important protective effects in critical conditions of the body.
The drug Tivortin® Forte exhibits antihypoxic, membrane-stabilizing, cytoprotective, antioxidant, antiradical, detoxification activity, manifests itself as an active regulator of intermediate metabolism and energy supply processes, plays a certain role in maintaining hormonal balance in the body. It is known that arginine increases the blood content of insulin, glucagon, somatotropic hormone and prolactin, participates in the synthesis of proline, polyamine, agmatine, is involved in the processes of fibrinogenolysis, spermatogenesis, and has a membrane depolarizing effect.
Arginine is one of the main substrates in the urea synthesis cycle in the liver. The hypoammonemic effect of the drug is realized by activating the conversion of ammonia into urea. It has a hepatoprotective effect due to its antioxidant, antihypoxic and membrane-stabilizing activity, and has a positive effect on the processes of energy supply in hepatocytes.
The drug Tivortin® Forte is a substrate for NO synthase, an enzyme that catalyzes the synthesis of nitric oxide in endothelial cells. The drug activates guanylate cyclase and increases the level of cyclic guanidine monophosphate (cGMP) in the vascular endothelium, reduces the activation and adhesion of leukocytes and platelets to the vascular endothelium, inhibits the synthesis of adhesion proteins VCAM-1 and MCP-1, thus preventing the formation and development of atherosclerotic plaques, inhibits the synthesis of endothelin-1, which is a powerful vasoconstrictor and stimulator of proliferation and migration of smooth myocytes of the vascular wall. Arginine hydrochloride also inhibits the synthesis of asymmetric dimethylarginine, a powerful endogenous stimulator of oxidative stress. The drug stimulates the activity of the thymus gland, which produces T-cells, regulates the content of glucose in the blood during physical exertion. It has an acid-forming effect and helps correct acid-base balance.
Pharmacokinetics
With continuous intravenous infusion, the maximum concentration of arginine hydrochloride in the blood plasma is observed 20-30 minutes after the start of administration. Arginine hydrochloride penetrates the placental barrier, is filtered in the renal glomeruli, but is almost completely reabsorbed in the renal tubules.
Indication
Metabolic alkalosis, hyperammonemia, atherosclerosis of the heart and brain vessels, atherosclerosis of peripheral vessels, including with manifestations of intermittent claudication, diabetic angiopathy, arterial hypertension, chronic heart failure, hypercholesterolemia, chronic obstructive pulmonary disease, pulmonary hypertension.
Contraindication
Hypersensitivity to the drug. Severe renal dysfunction, hyperchloremic acidosis; history of allergic reactions; use of potassium-sparing diuretics, as well as spironolactone. Myocardial infarction (including history).
Interaction with other medicinal products and other types of interactions
When using the drug Tivortin® Forte, it should be taken into account that it can cause severe and persistent hyperkalemia against the background of renal failure in patients who are taking or have taken spironolactone. Previous use of potassium-sparing diuretics can also cause an increase in the level of potassium concentration in the blood. When used simultaneously with aminophylline, an increase in insulin levels in the blood is possible.
Arginine is incompatible with thiopental.
Application features
In patients with renal insufficiency, diuresis and plasma potassium levels should be checked before starting the infusion, as the drug may cause the development of hyperkalemia.
The drug should be used with caution in cases of endocrine gland dysfunction. Tivortin® Forte may stimulate the secretion of insulin and growth hormone.
If dry mouth occurs, it is necessary to check your blood sugar level.
It should be used with caution in cases of electrolyte imbalance and kidney disease. If symptoms of asthenia develop while taking the drug, treatment should be discontinued.
The drug should be used with caution in patients with angina pectoris.
Use during pregnancy or breastfeeding
There are no data on the use of the drug during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Caution should be exercised when driving or operating other machinery, as the medicine may cause dizziness.
Method of administration and doses
The drug is administered intravenously drip at a rate of 5 drops per minute for the first 10-15 minutes, then the rate of administration can be increased to 15 drops per minute.
The daily dose of the drug is 50 ml of solution.
In case of severe circulatory disorders in the central and peripheral vessels, with pronounced symptoms of intoxication, hypoxia, and asthenic conditions, the dose of the drug can be increased to 100 ml per day.
The maximum rate of infusion solution administration should not exceed 20 mmol/h.
For the treatment of metabolic alkalosis, the dose can be calculated as follows:
arginine hydrochloride (mmol) ´ 0.3 ´ body weight (kg)
alkali excess (Be) (mmol/l)
Administration should begin with half the calculated dose. Any additional correction should be made after receiving the results of an updated acid-base balance.
Children
There is insufficient data on the use of the drug in children.
Overdose
Symptoms: renal failure, hypoglycemia, metabolic acidosis.
Treatment. In case of overdose, the infusion of the drug should be stopped. It is necessary to monitor physiological reactions and maintain vital functions of the body. If necessary, alkalizing agents and agents for establishing diuresis (saluretics), electrolyte solutions (0.9% sodium chloride solution, 5% glucose solution) are administered. Therapy is symptomatic.
Adverse reactions
General disorders: hyperthermia, feeling hot, body aches.
Musculoskeletal system: joint pain.
On the part of the digestive tract: dry mouth, nausea, vomiting.
Skin and subcutaneous tissue disorders: changes at the injection site, including hyperemia, itching, skin pallor, up to acrocyanosis.
Immune system disorders: anaphylactic shock, hypersensitivity reactions including rash, urticaria, angioedema.
Respiratory, thoracic and mediastinal disorders: dyspnea.
Cardiovascular system: fluctuations in blood pressure, changes in heart rhythm, pain in the heart area.
From the nervous system: headache, dizziness, feeling of fear, weakness, convulsions, tremor, more often when the rate of administration is exceeded.
Laboratory indicators: hyperkalemia.
Reporting of adverse reactions
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio 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 lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging. Keep out of the reach of children.
Incompatibility
The drug is incompatible with thiopental.
Packaging
50 ml in glass bottles. 1 bottle in a cardboard box. 100 ml in glass bottles. 1 bottle in a cardboard box.
Vacation category
According to the recipe.
Producer
LLC "Yuria-Pharm".
Location of the manufacturer and address of its place of business
Ukraine, 18030, Cherkasy region, Cherkasy city, Kobzarska st., 108. Tel.: (044) 281-01-01.
