Bazer

Tasnif

Trade name of the drug: Bazer
Active substances (XPN): L-arginine, levocarnitine
Dosage form: solution for infusion
Contents:
1 ml of solution contains:
active substances: L-arginine hydrochloride – 42 mg, levocarnitine – 20 mg;
excipient: water for injection – up to 1 ml.
Description: clear, colorless solution.
Pharmacotherapeutic group: amino acids. A metabolic tool.
ATX code: B05XB

Pharmacological properties
Pharmacodynamics
The drug contains active substances of amino acids levocarnitine and arginine hydrochloride.
Arginine hydrochloride has an antihypoxic, membrane-stabilizing, cytoprotective, antioxidant, antiradical, detoxifying effect, appears as an active regulator of intermediate exchange and energy supply processes, plays a certain role in maintaining hormonal balance in the body. It is known that arginine increases the amount of insulin, glucagon, somatotropic hormone and prolactin in the blood, participates in the synthesis of proline, polyamine, agmatine, enters the processes of fibrinogenolysis, spermatogenesis, has a membrane depolarizing effect.
The drug has a hepatoprotective effect due to its antioxidant, antihypoxic and membrane stabilizing activity. In the liver, arginine is one of the main substrates in the cycle of urea synthesis.
The hypoammonemic effect of the drug is expressed by the activation of the conversion of ammonia into urea.
Arginine hydrochloride is a substrate for the enzyme NO-synthase, which catalyzes the synthesis of nitric oxide in endotheliocytes.
The drug activates guanylate cyclase and has a cardioprotective effect by increasing the amount of cyclic guanosine monophosphate (tsGMF) in the endothelium of blood vessels, reduces the activity and adhesion of platelets and leukocytes to the endothelium of blood vessels, reduces the synthesis of adhesion proteins VCAM-1 and MSR-1, and thus the formation of atherosclerotic deposits and prevents its development, suppresses the synthesis of endothelin-1, which is a stimulator of migration and proliferation of smooth myocytes in the walls of blood vessels and a strong vasoconstrictor.
Arginine hydrochloride also suppresses the synthesis of asymmetric dimethylarginine, a strong endogenous stimulator of oxidative stress.
The drug stimulates the activity of the thyroid gland, which produces T-cells, controls the amount of glucose in the blood during physical exertion.
Levocarnitine is a natural agent involved in energy metabolism and metabolism of ketone bodies. The L-isomer of carnitine is biologically active. Levocarnitine is involved in metabolic processes as a transporter of fatty acids through cell membranes to mitochondria, where these acids undergo beta oxidation, generating a large amount of metabolic energy (in the form of ATF). Fatty acids are used as energy substrates in all tissues except the brain. In skeletal muscle and myocardium, fatty acids are the main substrate for energy.

Levocarnitine plays a key role in heart metabolism, because the oxidation of fatty acids depends on a sufficient amount of this substance.
Experimental studies show that in conditions such as stress, acute ischemia, myocarditis, there is a possibility of a decrease in the level of levocarnitine in myocardial tissue.
It has a positive effect on the heart in acute and chronic ischemia, cardiac decompensation, heart failure as a result of myocarditis, drug-induced cardiotoxicity (taxanes, adriamycin, etc.). Excluding coenzyme-A from complex thioethers, levocarnitine increases the oxidation of carbohydrates in the Krebs cycle of tricarbonic acids and stimulates the oxidation of chain amino acids in skeletal muscles. Thus, levocarnitine directly or indirectly participates in many energy processes, its presence is important for the oxidation of fatty acids, amino acids, carbohydrates and ketone bodies.
Pharmacokinetics
With continuous intravenous infusion, the maximum concentration of arginine hydrochloride in blood plasma is observed 20-30 minutes after the start of administration. Arginine hydrochloride passes through the placental barrier, is filtered in the renal tubules, but is almost completely reabsorbed in the renal tubules.
Levocarnitine is excreted in the urine. The rate of excretion is directly proportional to the concentration of carnitine in the blood. Levocarnitine is almost not metabolized in the body.
Application
 Cardiology: cardiovascular diseases (hypertension, coronary heart disease, atherosclerosis and its complications, UIK).
 Pulmonology: chronic obstructive pulmonary disease, idiopathic pulmonary hypertension, chronic postembolic pulmonary hypertension.
 Hepatology: acute chronic hepatitis of various etiologies, acute and chronic toxic liver damage.
 Metabolic disorders: hyperammonemia, metabolic alkalosis, hypercholesterolemia.
 Obstetrics: arterial hypertension, fetal development delay and preeclampsia in pregnant women.
 Endocrinology: as a diagnostic tool for stimulation of the release of growth hormone from the pituitary gland, as well as in the complex treatment of 2 types of diabetes, diabetic angiopathy, and growth disorders.
 In complex treatment of infertility.
 Prevention and treatment of hypoxic and ischemic conditions, used in asthenic syndrome.
Method of administration and doses
In adults:
For the first 10-15 minutes, the drug is injected intravenously at a rate of 10 drops per minute, then the rate of administration can be increased to 30 drops per minute.
The daily dose of the drug is 100 ml of solution.
In children:
There is no information on the use of the drug in children.
Side effects
General changes: hyperthermia, feeling of heat, pain in the body.
From the musculoskeletal system: pain in the joints.
From the digestive system: dry mouth, nausea, vomiting, abdominal pain, diarrhea.
From the skin and subcutaneous tissue: changes at the injection site, including hyperemia, itching, skin pallor, up to acrocyanosis.
From the immune system: hypersensitivity reactions, including rashes, urticaria, angioneurotic edema.
From the cardiovascular system: changes in arterial pressure, changes in heart rhythm, pain in the heart area.
On the part of the nervous system: headache, dizziness, feeling of fear, weakness, twitching, tremor, tremors, often occur when the rate of administration of the drug is increased.
Laboratory parameters: hyperkalemia may be observed.
Circumstances that cannot be used
Hypersensitivity to the drug.
Severe disorders of kidney function, hyperchloremic acidosis, allergic reactions in the anamnesis, potassium-sparing diuretics, including spironolactone, cannot be used.
Drug interactions
When the drug is used, it should be taken into account that the drug can cause pronounced and stable hyperkalemia in patients who are taking or have received spironolactone against the background of kidney failure.
Previous use of potassium-sparing diuretics can also increase the level of potassium concentration in the blood.
Simultaneous use with aminophylline can increase the amount of insulin in the blood.
The simultaneous use of glucocorticoids leads to the accumulation of levocarnitine in body tissues (except the liver).
Special instructions
In patients with renal insufficiency, the amount of potassium in the blood plasma and diuresis should be checked before the infusion, because the drug can contribute to the development of hyperkalemia.
The drug is used with caution in endocrine gland dysfunction.
The drug can stimulate the secretion of insulin and growth hormone. When dry mouth is observed, it is necessary to check the level of sugar in the blood. It is used with caution when electrolyte metabolism is disturbed and in kidney diseases. If symptoms of asthenia increase while taking the drug, treatment with the drug should be discontinued. Levocarnitine improves glucose absorption, so it can cause hypoglycemia in patients with diabetes. In such cases, to correct the level of glucose in the blood plasma, its amount should be monitored regularly.
Use during pregnancy and lactation. The drug passes through the placental barrier, so it can be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus. There is no information on the use of the drug during lactation.
Effects on the ability to drive a car and complex mechanisms. In some cases, adverse reactions of the central nervous system may affect the ability to operate vehicles or other mechanisms.
Overdose
Symptoms: renal failure, hypoglycemia, metabolic acidosis, large doses of preapart can cause diarrhea.
Treatment.
In case of drug overdose, its infusion should be stopped. It is necessary to control the physiological reactions and maintain the vital activities of the body.
Release form
Solution for infusion in a 100 ml polypropylene vial. 1 vial in a cardboard box with instructions for medical use.
Storage conditions
Store in a dry place, protected from light, at a temperature not higher than 25 0С.
Keep the drug out of the reach of children.
Expiry date
2 years.
Do not use after the expiration date.
Dispensing procedure from pharmacies
According to the doctor’s prescription.
Name and address of the manufacturer/organization receiving objections (proposals) on the quality of medicinal products in the territory of the Republic of Uzbekistan:
LLC “Samarkand-England Eco-Medical” JV,
Republic of Uzbekistan, 140163, Samarkand district, Farkhod district, 9.
Tel/Fax: +998662307700
E-mail: info@seem.uz Web: www.seem.uz