Asparkam arterium

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ASPARCAM Arterium (ASPARCAM Arterium)

Composition:

Active substances: 1 ml of solution contains magnesium aspartate anhydrous – 40.0 mg (3.37 mg of magnesium), potassium aspartate anhydrous – 45.2 mg (10.33 mg of potassium);

Excipients: sorbitol (E 420), water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: clear colorless liquid or with a slight yellowish tint.

Pharmacotherapeutic group. Minerals. Magnesium preparations.

ATC code A12C C30.

Pharmacological Properties

Pharmacodynamics. Potassium and magnesium ions, as important intracellular cations, are involved in the function of numerous enzymes, in the binding of macromolecules to subcellular structures, and in the mechanism of muscle contraction at the molecular level. The ratio of extracellular to intracellular concentrations of potassium, calcium, sodium, and magnesium ions influences the contractile capacity of the myocardium. As a natural substance, aspartate acts as a carrier of potassium and magnesium ions and has a pronounced affinity for cells; its salts undergo dissociation only to a minor extent. As a result, these ions penetrate into the intracellular space in the form of complex compounds. Potassium and magnesium aspartate improves myocardial metabolism. Insufficient intake of potassium and magnesium into the body may lead to the development of arterial hypertension, sclerotic-type coronary vascular pathology, cardiac arrhythmias, and myocardial degeneration.

Pharmacokinetics.

Magnesium

The total magnesium reserve in the body of a 70 kg human averages 24 g (1000 mmol); more than 60% of magnesium is located in bone tissue, and approximately 40% in skeletal muscles and other tissues. About 1% of the body's total magnesium is found in the extracellular fluid, predominantly in blood serum. In healthy adults, serum magnesium concentration ranges between 0.7 and 1.1 mmol/L.

The recommended daily dietary intake of magnesium is 350 mg for men and 280 mg for women. Magnesium requirements increase during pregnancy and lactation.

Magnesium is absorbed from the gastrointestinal tract via active transport. The kidneys are the main regulators of magnesium balance in the body. 3–5% of ionized magnesium is excreted by the kidneys.

Increased urine volume (e.g., during therapy with high-efficacy loop diuretics) leads to increased excretion of ionized magnesium. If magnesium absorption in the small intestine is reduced, subsequent hypomagnesemia results in decreased magnesium excretion (< 0.5 mmol/day).

Potassium

The total potassium reserve in the body of a 70 kg human averages 140 g (3570 mmol). Total potassium reserves are slightly lower in women than in men and decrease slightly with age. Only 2% of the body's total potassium is located extracellularly, while the remaining 98% is intracellular.

The optimal daily dietary intake of potassium is 3–4 g (75–100 mmol). The primary route of potassium elimination is renal (approximately 90% of potassium is excreted daily by the kidneys). The remaining 10% is excreted via the gastrointestinal tract. Thus, the kidneys are responsible for long-term potassium homeostasis and for maintaining serum potassium levels. In the short term, blood potassium levels are also regulated by potassium exchange between intracellular and extracellular compartments.

Clinical characteristics.

Indications.

• As adjunctive therapy in chronic heart diseases (in heart failure, post-infarction period), in cardiac arrhythmias, primarily ventricular arrhythmias;
• adjunctive therapy in treatment with digitalis preparations.

Contraindications.

• Hypersensitivity to the components of the drug;
• acute and chronic renal failure;
• Addison's disease;
• third-degree atrioventricular block;
• cardiogenic shock (BP <90 mmHg).

Interaction with other medicinal products and other types of interactions.

Concomitant use of the drug with potassium-sparing diuretics and/or angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, cyclosporine, heparin, nonsteroidal anti-inflammatory drugs increases the risk of developing hyperkalemia.

Special precautions for use.

Rapid administration may cause facial hyperemia.

With prolonged use of the drug, it is necessary to monitor potassium and magnesium levels in blood, as well as perform regular monitoring of electrolyte balance parameters and ECG data.

As a drug containing potassium and magnesium, Asparkam Arterium should be used with caution in patients with myasthenia gravis and in conditions that may lead to hyperkalemia, such as impaired renal function, acute dehydration, extensive tissue damage, particularly in severe burns. In these patient groups, regular assessment of serum electrolyte levels is recommended.

Since Asparkam Arterium contains sorbitol, the drug must not be used in patients with hereditary fructose intolerance.

Use during pregnancy or breastfeeding.

To date, no risk has been reported associated with using the drug in these patient groups.

Ability to affect reaction rate when driving or operating machinery.

The drug does not impair the ability to drive or operate machinery.

Method of Administration and Dosage

The medication is intended for intravenous use only. For adults, administer slowly by intravenous infusion – 10–20 mL (the contents of one or two ampoules diluted in 50–100 mL of 5% glucose solution). If necessary, the dose may be repeated after 4–6 hours. The medication is suitable for use in combination therapy.

The treatment course is determined by the physician.

Children.

Experience with the use of the medication in children is insufficient; therefore, it is not administered to this age group of patients.

Overdose.

Cases of overdose are unknown.

Due to the kidneys' ability to excrete large amounts of potassium, increased dosage of the medication may lead to hyperkalemia only if associated with acute or pronounced impairment of potassium excretion.

The therapeutic index of magnesium is wide, and in the absence of renal insufficiency, severe adverse 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, paresthesia, bradycardia, paralysis. Extremely high plasma potassium concentration may lead to fatal outcome due to suppression of cardiac activity, arrhythmia, or cardiac arrest.

Symptoms of hypermagnesemia: nausea, vomiting, drowsiness, arterial hypotension, bradycardia, weakness, slurred speech, double vision. At very high plasma magnesium concentrations, hyporeflexia, muscle paralysis, respiratory arrest, and cardiac arrest may develop.

In case of overdose, K⁺-, Mg²⁺-aspartate must be discontinued and symptomatic treatment initiated (calcium chloride 100 mg/min intravenously, dialysis if necessary).

Side effects.

When administering the drug intravenously at a rapid rate, consider the possible occurrence of symptoms of hyperkalemia, for example: nausea, vomiting, diarrhea, paresthesia; and/or hypermagnesemia, for example: facial flushing, hyporeflexia, seizures, sensation of warmth, respiratory depression.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Incompatibility. Unknown.

Packaging.

5 ml in an ampoule, 5 ampoules in a blister, 2 blisters in a carton;
10 ml in an ampoule, 5 ampoules in a blister, 2 blisters in a carton.

Prescription status. Prescription only.

Manufacturer.

JSC "Halychpharm".

Manufacturer's address and location of its business activity.

6/8 Opryshkivska Street, Lviv, 79024, Ukraine.