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Potassium and Magnesium Asparaginate- infusion solution

INSTRUCTIONS FOR MEDICAL USE

POTASSIUM AND MAGNESIUM ASPARAGINATE

Trade name of the drug: Potassium and Magnesium Asparaginate.

Active ingredients (INN): potassium hydroxide, magnesium oxide, L-aspartic acid.

Dosage form: solution for infusion.

Contents:

1000 ml of the solution contains:

Active ingredients: potassium hydroxide – 3.854 g, magnesium oxide – 1.116 g, L-aspartic acid – 15.16 g.

excipients: xylitol, water for injection.

Description: clear, almost colorless liquid.

Pharmacotherapeutic group: Mineral drug, trace element.

ATX code: B05XA31.

Pharmacological properties

Source of potassium and magnesium ions. Prevents or eliminates hypokalemia. Improves metabolism in the myocardium. Improves tolerance to cardiac glycosides. Has antiarrhythmic activity. Asparaginate carries potassium and magnesium ions and promotes their penetration into the intracellular space. Asparaginate enters cells, it is involved in metabolic processes. Magnesium ion plays an important role in maintaining potassium and calcium homeostasis, has the properties of a calcium channel blocker, and participates in many enzymatic reactions, protein and carbohydrate metabolism.

Pharmacokinetics

Potassium asparaginate and magnesium asparaginate are intensively absorbed in intestine, mainly in small intestine. Excreted by the kidneys.

Indications for use

Potassium and magnesium deficiency therapy as combination therapy in various forms of CHD (including acute myocardial infarction), chronic heart failure, cardiac arrhythmias (including arrhythmias caused by overdose of cardiac glycosides).

Dosage and administration

Oral and intravenous (slow trickle or intravenous drop). Dosage and regimen of administration are determined individually depending on indications, clinical situation and dosage form.

Side effects

Digestive system: nausea, vomiting, diarrhea, discomfort or burning in the epigastrium (in patients with anacid gastritis or cholecystitis).

Cardiovascular system: AV-blockade; when administered intravenously – paradoxical reaction in the form of increased number of extrasystoles, BP decrease.

Metabolism: hyperkalemia (nausea, vomiting, diarrhea, paresthesia), hypermagnesemia (facial hyperemia, thirst, bradycardia, BP decrease, muscle weakness, fatigue, paresis, coma, areflexia, respiratory depression, seizures).

Local reactions: when administered intravenously – phlebitis, venous thrombosis.

Contraindications

Hypersensitivity to potassium asparaginate and magnesium asparaginate; children and teenagers under 18 years of age. Oral administration: acute and chronic renal failure, hyperkalemia, hypermagnesemia, Addison’s disease, AV-blockade of degree I-III, shock, including cardiogenic shock (BP less than 90 mm Hg), amino acid metabolism disorders, severe myasthenia, hemolysis, acute metabolic acidosis, dehydration state.

Caution: pregnancy (especially I trimester), breast-feeding.

For intravenous administration: hyperkalemia, hypermagnesemia, acute renal insufficiency, insufficiency of the adrenal cortex, AV-blockade of II and III degree, amino acid metabolism disorders, hemolysis, severe myasthenia, dehydration; Addison’s disease.

Caution: expressed liver dysfunction, metabolic acidosis, danger of edema development, chronic renal insufficiency – if it is impossible to monitor regularly the magnesium content in serum (danger of cumulation, toxic magnesium content), cardiogenic shock (systolic blood pressure less than 90 mm Hg), hypophosphatase. st), hypophosphatemia, urolithiasis associated with impaired calcium, magnesium and ammonium phosphate metabolism, AV-blockade of degree I.

Special indications

Strophantine or preparations of foxglove can be administered together with potassium and magnesium asparaginate, if necessary. Hyperkalemia and hypermagnesemia are possible during rapid I/V administration.

As part of a polarizing mixture (combined with dextrose and insulin) normalize the heart rhythm in myocardial infarction, ectopic arrhythmias and overdose of cardiac glycosides.

Use during pregnancy and lactation

Administration of this medicine orally during pregnancy (especially during the first trimester) is possible only if the potential benefit to the mother exceeds the possible risk to the fetus. Potassium and magnesium asparaginate penetrate into breast milk. If it is necessary to take this medicine during lactation, breastfeeding should be discontinued.

It is contraindicated by intravenous administration during pregnancy and lactation (breast-feeding). Caution should be exercised when using by mouth in patients with significant liver dysfunction. Use in renal dysfunction Contraindicated for oral administration in acute and chronic renal failure.

Contraindicated for intravenous administration in acute renal failure. Caution is required for chronic renal failure if it is not possible to monitor the magnesium content in serum on a regular basis (risk of cumulation and toxic levels of magnesium).

Administration for children

Administration for children and adolescents under 18 years of age is contraindicated.

Drug interactions

Simultaneous use with antiarrhythmic drugs increases the negative dromo- and batmotropic effects of antiarrhythmic drugs.

When concomitant use of beta-adrenoblockers, cyclosporine, ACE inhibitors, NSAIDs, potassium-saving diuretics, table salt substitutes containing potassium increase the risk of hyperkalemia.

Concomitant use with astringents and coagulants decreases absorption from the gastrointestinal tract, with anesthetics – possible increase in deprivative effect on the CNS, with atracurium besylate, suxamethonium chloride – possible increase in neuromuscular blockade.

Co-administration with potassium-saving diuretics (triamterene, spironolactone), beta-adrenoblockers, cyclosporine, heparin, ACE inhibitors, NSAIDs increases the risk of hyperkalemia up to arrhythmia and asystole.

Magnesium reduces the effects of neomycin, polymyxin B, tetracycline and streptomycin.

Overdose

Symptoms: conduction disorders (especially with previous pathology of cardiac conduction system).

Treatment: drug withdrawal, symptomatic therapy (intravenous injection of calcium chloride), if necessary – hemodialysis and peritoneal dialysis.

Form of production

Infusion solution 100 ml, 200 ml, 250 ml (vials).

Storage conditions

Store in a dry, dark place at temperatures not exceeding 25ºC. Keep out of the reach of children! Do not heat or freeze!

Shelf life

2 years. Do not use after the expiration date.

Conditions of dispensing from pharmacies

Released by a doctor’s prescription.

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