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Composition:


active ingredient: phosphocreatine;


1 bottle contains 1 g of sodium phosphocreatine.


Dosage form. Powder for infusion solution.


Basic physical and chemical properties: white crystalline powder.


Pharmacotherapeutic group. Cardiological preparations. Phosphocreatine.


ATX code C01E B06.


Pharmacological properties.


Pharmacodynamics.


Phosphocreatine plays a fundamental role in the energy processes that accompany muscle contraction, and is used for resynthesis of ATP, an energy source for myocardial and skeletal muscle contraction. Insufficient energy supply due to a slowdown in oxidative metabolism is the main cause of myocyte damage.


Pharmacological studies of phosphocreatine have shown that:


1) preliminary intramuscular administration of phosphocreatine to animals in a dose-dependent manner counteracts various myocardial damage caused by chemicals (such as isoprenaline, emetin, thyroxine, P-nitrophenol);


2) phosphocreatine has a positive inotropic effect, which is manifested on an isolated heart in animals under hypodynamic conditions caused by glucose or calcium deficiency or potassium overdose;


3) in isolated guinea pig Atria, phosphocreatine counteracts the negative inotropic effect caused by anoxia;


4) the addition of phosphocreatine to cardioplegic solutions promotes myocardial protection in many experimental models, both on isolated organs and in vivo;


5) phosphocreatine has a protective effect in experimental models of infarction and arrhythmia caused by coronary occlusion.


The cardioprotective effect of phosphocreatine is due to the phenomena of sarcolemma stabilization, preservation of the cellular pool of adenine nucleotides, which is provided by inhibition of enzymes involved in nucleotide catabolism, inhibition of phospholipid breakdown in the ischemic myocardium and possible improvement of microcirculation in the ischemic area due to inhibition of ADP-induced platelet aggregation.


Pharmacokinetics.


In humans, the average Half − Life of phosphocreatine after intravenous administration is 0.09-0.2 hours. After intramuscular administration of 500 mg of phosphocreatine, it could be detected in the bloodstream after 5 minutes; maximum concentrations of phosphocreatine, approximately 10 nmol/ML, were reached 30 minutes after administration, after which they decreased and reached the level of 4-5 nmol/ml after 1 hour. 2 hours after administration, the concentrations remained within the measurement range and were 1-2 nmol/ML.


40 minutes after drip infusion of 5 g of the drug, serum phosphocreatine levels fall below 5 nmol/ML, and after administration of 10 g of the drug, they are approximately 10 nmol/ML.


Clinical characteristics.


Indications.


Intraoperative myocardial ischemia; intraoperative limb ischemia; metabolic disorders of the myocardium in hypoxia: myocardiosclerosis, senile heart, cardiomyopathy due to hypertension, chronic ischemic cardiomyopathy; complex therapy:

- acute myocardial infarction;


- acute and chronic heart failure;


- acute cerebrovascular accident, encephalopathy, as well as hypoxic, ischemic, traumatic and toxic lesions of the central nervous system.


Contraindications.


Individual hypersensitivity to the drug.


The drug in high doses (5-10 G per day) is contraindicated in patients with chronic renal failure.


Interactions with other drugs and other types of interactions.


As part of complex therapy, the drug can increase the effectiveness of antiarrhythmic, antianginal drugs, as well as drugs that positively affect the contractile function of the myocardium.


Application features.


Rapid intravenous administration of doses exceeding 1 g can lead to a temporary sharp decrease in blood pressure.


Administration of high doses of the drug (5-10 G/Day) leads to the absorption of large amounts of phosphates, which affects calcium metabolism and the secretion of hormones involved in the regulation of homeostasis, renal function and purine metabolism. High doses of the drug can only be prescribed to individual patients and for a short period of time.


Use during pregnancy or lactation.


There are no contraindications for the use of the drug during pregnancy or lactation.


Ability to influence the reaction rate when driving vehicles or other mechanisms.

As of today, there is no information available.


Dosage and administration.


The drug is administered intravenously by drip or jet. Before Administration, the powder is dissolved in a solvent; water for injection, 0.9% sodium chloride solution or 5% glucose solution can be used as a solvent. When using the drug during surgical procedures, it is recommended to add it to cardioplegic solutions.


In acute myocardial infarction, on the first day, the drug is administered to adults at a dose of 2 − 4 g intravenously in a jet, followed by a 2-hour drip infusion of a solution containing 8-16 g of the drug in 200 ml of water for injection, 0.9% sodium chloride solution or 5% glucose solution. On the second day, the drug is administered at a dose of 2 − 4 g intravenously drip 2 times a day. On the third day, the drug is administered at a dose of 2 g intravenously drip 2 times a day. If necessary, in the future, a 6-day course of infusions is carried out at a dose of 2 g of the drug 2 times a day. The best results of treatment can be obtained if it is started no later than 6 to 8 hours after the appearance of clinical manifestations of the disease.


Acute and chronic heart failure. In acute heart failure, the drug is administered to adults in the form of 2-hour intravenous infusions at a dose of 5-10 G per day for 3 to 5 days. The appropriate amount of the drug powder is dissolved in 200 ml of water for injection, 0.9% sodium chloride solution or 5% glucose solution. In case of chronic heart failure, the drug should be administered to adults in the form of intravenous infusions at a dose of 1-2 G twice a day for 10-14 days. Each dose of the drug should be dissolved in 50 ml of water for injection, 0.9% sodium chloride solution or 5% glucose solution and administered within 30 to 60 Minutes.


In acute cerebral circulatory disorders, encephalopathy, as well as in hypoxic, ischemic, traumatic and toxic lesions of the central nervous system, it is recommended to introduce daily infusions of the drug to adults at a dose of 120 mg/kg of body weight for 3 days.


In intraoperative myocardial ischemia, the drug is administered as part of a conventional cardioplegic solution at a concentration of 10 mmol/L (2.5 g/l). NEOTON is added to the cardioplegic solution immediately before Administration. It is recommended to conduct a course of infusions of the drug solution at a dose of 2 g twice a day for 3 to 5 days before the operation and for 1 to 2 days after it.


In case of intraoperative limb ischemia, adult patients are recommended to inject a solution of 2-4 g of the drug in 50 ml of solvent intravenously for 30-60 minutes before surgery. During surgery and the reperfusion period, NEOTON should be administered as intravenous infusions at a dose of 8-10 G, dissolved in at least 200 ml of solvent.


In case of metabolic disorders of the myocardium with hypoxia, the drug is administered to adults intravenously in a jet at a dose of 1 − 2 g per day (the dose is dissolved in 10 ml of solvent) or drip (the dose is dissolved in 50 ml of solvent and administered for 30 − 60 Minutes); the recommended duration of treatment is 2 − 4 weeks.


Children.


There is limited information about the use of the drug for the treatment of a pediatric group of patients.


Overdose.


In case of a sharp decrease in blood pressure caused, among other things, by an overdose of the drug, symptomatic treatment is recommended, including the use of vasoconstrictor drugs. The specific antidote to phosphocreatine is unknown.


Adverse reactions.


In some cases, during rapid intravenous administration of the drug in doses exceeding 1 g, a moderate and short-term decrease in blood pressure was observed.


Hypersensitivity reactions may develop, including anaphylactic reactions, angioedema.


Expiration date. 3 years.


Do not use after the expiration date indicated on the package.


Storage conditions.


Store at a temperature not exceeding 25 °C.


Keep out of reach of children.


Incompatibility. There is no information available.

Tags: Neoton® [Phosphocreatine]