Aspangin solution for infusions 100 ml




Instructions Aspangin solution for infusions 100 ml
Composition
active ingredients: magnesium DL-aspartate tetrahydrate, potassium DL-aspartate hemihydrate;
100 ml of solution contain magnesium DL-aspartate tetrahydrate (calculated as magnesium DL-aspartate anhydrous) 0.7987 g (corresponds to 67.3 mg of magnesium); potassium DL-aspartate hemihydrate (calculated as potassium DL-aspartate anhydrous) 0.9996 g (corresponds to 228.3 mg of potassium);
Excipients: xylitol, water for injection.
Dosage form
Solution for infusion.
Main physicochemical properties: clear, colorless or slightly yellowish liquid; theoretical osmolarity 310 mosmol/l, pH 6.0–7.4.
Pharmacotherapeutic group
Mineral substances. Magnesium preparations.
ATX code A12C SZ0.
Pharmacological properties
Pharmacodynamics.
Aspangin has antiarrhythmic properties and compensates for the deficiency of magnesium and potassium ions.
Magnesium activates sodium-potassium ATPase, resulting in a decrease in intracellular sodium content and an increase in potassium entry into the cell. When the sodium concentration in the cell decreases, sodium-calcium metabolism in vascular smooth muscles is inhibited, which leads to their relaxation, potassium ions stimulate the synthesis of ATP, glycogen, proteins, acetylcholine; potassium and magnesium support the polarization of cell membranes.
Asparaginate promotes the entry of ions into the cell and participates in energy metabolism. The antiarrhythmic effect is realized due to the ability of the drug to eliminate electrolyte imbalance and reduce myocardial excitability and conductivity.
Pharmacokinetics.
When administered by infusion, the drug enters the cardiomyocytes and vascular smooth muscle cells from the blood in the form of K+, Mg2+ and asparaginate ions and is included in cellular metabolism. The pharmacokinetics of the drug has not been studied due to the fact that the ions that make up its composition are present in the human body, which makes it impossible to conduct research.
Indication
Additional therapy for chronic heart diseases (heart failure, post-infarction period), heart rhythm disorders, primarily ventricular arrhythmias;
additional therapy in the treatment of digitalis drugs.
Contraindication
Hypersensitivity to the components of the drug;
acute and chronic renal failure;
Addison's disease;
atrioventricular block III degree;
cardiogenic shock (BP < 90 mm Hg).
Interaction with other medicinal products and other types of interactions
The drug improves the tolerance of cardiac glycosides, enhances the effect of drugs that stimulate trophic processes in the myocardium; prevents the development of hypokalemia caused by the use of saluretics, corticosteroids, cardiac glycosides. With simultaneous use with potassium-sparing diuretics, ACE inhibitors, beta-blockers, cyclosporine, heparin, nonsteroidal anti-inflammatory drugs, the risk of developing hyperkalemia increases (it is necessary to monitor the level of potassium in the plasma).
The drug reduces the cardiotoxic effect of cardiac glycosides. The appointment of the drug may require an increase in the individual maintenance dose of cardiac glycosides.
When used simultaneously with antidepolarizing muscle relaxants, neuromuscular blockade is enhanced, and with anesthetics (ketamine, hexanal, fluorotan) - the central nervous system is depressed.
Application features
Rapid administration may cause facial flushing.
With prolonged use of the drug, the level of potassium and magnesium in the blood should be monitored, and regular monitoring of electrolyte hemostasis indicators and electrocardiogram data is also necessary.
Aspangin, as a potassium and magnesium-containing drug, should be used with caution in patients with myasthenia gravis; in conditions that may lead to hyperkalemia, such as decreased renal function, acute dehydration, extensive tissue damage, in particular in the case of severe burns. In this category of patients, it is recommended to regularly examine the level of electrolytes in the blood serum.
Since xylitol has choleretic properties, the drug should be administered to patients with gallstone disease under the supervision of a physician. The drug should be administered to patients with diabetes under the control of blood sugar levels.
Use during pregnancy or breastfeeding
To date, no danger has been reported when using the drug for this category of patients.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive vehicles and operate other mechanisms.
Method of administration and doses
The drug is intended for intravenous administration only.
Adults are administered slowly intravenously by drip 200–300 ml 1–2 times a day, but not more than 600 ml per day. The rate of administration is 20–25 drops per minute. The drug is suitable for combination therapy. The course of treatment is determined by the doctor.
Children.
There is insufficient experience with the use of the drug in children, so it is not used in this age group of patients.
Overdose
Cases of overdose are unknown.
Given the ability of the kidneys to excrete large amounts of potassium from the body, increasing the dose of the drug may lead to hyperkalemia only if it is associated with acute or severe impairment of potassium excretion.
The therapeutic index of magnesium is wide, and in the absence of renal failure, severe side effects are very rare.
In case of rapid intravenous administration, symptoms of hyperkalemia/hypermagnesemia may occur.
In case of overdose, symptoms of hyperkalemia and hypermagnesemia may be observed.
Symptoms of hyperkalemia: general weakness, paresthesias, bradycardia, paralysis. Extremely high plasma potassium concentrations can lead to death from cardiac depression, arrhythmia, or cardiac arrest.
Symptoms of hypermagnesemia: nausea, vomiting, drowsiness, hypotension, bradycardia, weakness, slurred speech, double vision. At very high plasma concentrations of magnesium, hyporeflexia, muscle paralysis, respiratory arrest and cardiac arrest may develop.
In case of overdose, K+-, Mg2+-aspartate should be discontinued; symptomatic treatment is recommended (calcium chloride 100 mg/min intravenously, dialysis if necessary).
Side effects
On the part of the digestive tract: dyspeptic phenomena, nausea, vomiting, diarrhea, stomach pain, flatulence, thirst.
From the cardiovascular system: impaired intraventricular conduction, decreased blood pressure.
From the nervous system: asthenia, disorientation, hyporeflexia, dizziness, paresthesia, convulsions.
Skin: allergic reactions are possible, including hyperemia, itching, rash, edema.
Respiratory system: respiratory depression, dyspnea.
Changes at the injection site: phlebitis, venous thrombosis.
General disorders: muscle weakness, feeling hot, increased sweating.
With rapid intravenous administration - hyperkalemia, hypermagnesemia. Symptoms: muscle hypotension, paresthesia of the extremities, slowing of AV conduction, arrhythmias, cardiac arrest.
Expiration date
5 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Packaging
100 ml, 200 ml or 400 ml in a bottle, 1 bottle in a pack.
Vacation category
According to the recipe.
Producer
Private Joint Stock Company "Infusion".
Location of the manufacturer and address of its place of business.
Ukraine, 23219, Vinnytsia region, Vinnytsia district, village Vinnytskie Khutory, Nemyrivske highway st., bldg. 84A.
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