Asparkam

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ASPARKAM (ASPARKAM)

Composition:

Active substances: magnesium aspartate, potassium aspartate;

One tablet contains magnesium aspartate 175 mg (0.175 g) and potassium aspartate 175 mg (0.175 g);

Excipients: maize starch, calcium stearate, talc.

Pharmaceutical form. Tablets.

Main physicochemical properties: white tablets with a flat surface, a score line and bevelled edges.

Pharmacotherapeutic group.

Mineral supplements. Magnesium preparations. ATC code A12CC30.

Pharmacological properties.

Pharmacodynamics.

Asparkam belongs to medicinal products that regulate metabolic processes. Its mechanism of action is related to the ability of aspartates to carry magnesium and potassium ions into the intracellular space and to their participation in metabolic processes. Potassium and magnesium ions, as important intracellular cations, are involved in the function of various enzymes, in the binding of macromolecules to subcellular elements, and in the mechanism of muscle contraction at the molecular level. The ratio of extracellular and intracellular concentrations of potassium, calcium, sodium, and magnesium ions affects the contractile function of the myocardium. As a natural endogenous substance, aspartate acts as a carrier of potassium and magnesium ions and has a high 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. Magnesium aspartate and potassium aspartate improve myocardial metabolism. Deficiency of potassium and magnesium in the body increases the risk of developing hypertension, atherosclerotic damage to coronary vessels, cardiac arrhythmias, and myocardial pathology.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Adjunctive therapy in chronic heart diseases (in heart failure, post-infarction period), cardiac arrhythmias, primarily ventricular arrhythmias.

Adjunctive therapy in treatment with digitalis preparations.

As a supplement to increase dietary intake of magnesium and potassium.

Contraindications.

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

Special precautions.

The drug should be used with caution in patients with myasthenia gravis and in conditions that may lead to hyperkalemia, such as acute dehydration, extensive tissue damage, particularly in severe burns. In these patients, regular monitoring of serum electrolyte concentrations is recommended. Should not be prescribed to patients with gastroduodenal ulcers or obstruction.

During prolonged use of the drug, blood levels of potassium and magnesium should be monitored, and regular ECG monitoring is required.

Interaction with other medicinal products and other types of interactions.

Due to the presence of potassium ions in the formulation, concomitant use of Asparkam with potassium-sparing diuretics, ACE inhibitors, beta-blockers, and cyclosporine increases the risk of hyperkalemia (plasma potassium levels must be monitored) and enhances the inhibitory effect on intestinal peristalsis.

The drug inhibits the absorption of oral formulations of tetracycline, iron salts, and sodium fluoride (a 3-hour interval between administrations should be maintained).

Asparkam enhances the effect of medicinal agents that stimulate trophic processes in the myocardium; prevents hypokalemia induced by thiazide and loop diuretics, corticosteroids, and cardiac glycosides.

Asparkam reduces the cardiotoxic effects of cardiac glycosides.

When used concomitantly with non-depolarizing muscle relaxants, neuromuscular blockade is enhanced; when used with anesthetic agents (ketamine, hexenal, halothane), central nervous system depression is intensified.

Asparkam may reduce the efficacy of neomycin, polymyxin B, tetracycline, and streptomycin.

Special precautions.

Use during pregnancy or breastfeeding.

There are no data on the use of the drug during pregnancy or breastfeeding.

Ability to affect the reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

Asparcam tablets should be taken orally. The usual daily dose for adults is 1–2 tablets three times a day. The dose may be increased to 3 tablets three times a day. Gastric juice can reduce the effectiveness of the drug; therefore, it is recommended to take the tablets after meals.

The duration of treatment is determined by the physician depending on the nature and course of the disease.

Children.

There is no experience with the use of the drug in children; therefore, the drug should not be used in this patient population.

Overdose.

Cases of overdose have not been reported to date. Theoretically, overdose may lead to symptoms of hyperkalemia (nausea, vomiting, diarrhea, abdominal pain, metallic taste in the mouth, bradycardia, weakness, disorientation, muscle paralysis, limb paresthesia) and hypermagnesemia (nausea, vomiting, drowsiness, bradycardia, weakness, slurred speech, double vision, facial skin flushing, thirst, arterial hypotension, hyporeflexia, neuromuscular transmission disturbances, respiratory depression, arrhythmia, seizures; at very high plasma magnesium concentrations, muscle paralysis, respiratory arrest, and cardiac arrest may develop). On the electrocardiogram, increased T-wave amplitude, reduced P-wave amplitude, and QRS complex widening are observed. Extremely high plasma potassium concentrations may result in fatal outcomes due to cardiac suppression, arrhythmia, or cardiac arrest.

Treatment: discontinue the drug, symptomatic therapy (intravenous administration of calcium chloride solution at a dose of 100 mg/min); if necessary, hemodialysis.

Adverse reactions.

Adverse reactions develop very rarely:

Gastrointestinal system: nausea, vomiting, diarrhea, abdominal pain, discomfort or burning sensation in the epigastric region, gastrointestinal bleeding, mucosal ulcers of the gastrointestinal tract, dry mouth;

Cardiovascular system: myocardial conduction disturbances, decreased blood pressure, AV block;

Central and peripheral nervous system: paresthesia, hyporeflexia, seizures;

Allergic reactions: hypersensitivity reactions, including itching, facial skin redness, rash;

Respiratory system: possible respiratory depression (caused by hypermagnesemia);

Other: sensation of warmth.

Reporting suspected adverse reactions:

Reporting suspected adverse reactions after drug registration is highly important. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all cases of suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach and sight of children.

Packaging.

10 or 50 tablets in blisters.

10 tablets per blister; 1 or 10 blisters per cardboard pack.

50 tablets per blister; 1 blister per cardboard pack.

Prescription status.

Over-the-counter (without prescription).

Manufacturer.

JSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA"

Manufacturer's address and location of business activity.

1, Gordiienkivska Street, Kharkiv, Kharkiv Oblast, 61010, Ukraine.