Asparkam-zdorovya

INSTRUCTIONS for medical use of the medicinal product ASPARKAM–ZDOROVYE

Composition:

Active substances: 1 tablet contains magnesium aspartate tetrahydrate 175 mg, potassium aspartate hemihydrate 175 mg;

Excipients: corn starch, copovidone, polysorbate 80, calcium stearate, talc.

Pharmaceutical form. Tablets.

Main physico-chemical properties: white tablets with a flat surface, a score line and beveled edges.

Pharmacotherapeutic group. Minerals. Magnesium preparations. ATC code A12C C30.

Pharmacological properties.

Pharmacodynamics.

An antiarrhythmic agent that corrects magnesium and potassium deficiency. The drug restores electrolyte balance in the body, improves myocardial metabolism and coronary circulation, possesses antiarrhythmic properties, slightly suppresses atrioventricular conduction, and also reduces increased sensitivity to cardiac glycosides and decreases manifestations of their toxicity.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

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.

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

Contraindications.

• Hypersensitivity to the components of the medicinal product;
• acute and chronic renal failure;
• Addison's disease;
• hyperkalemia, hypermagnesemia;
• atrioventricular block of II–III degree;
• cardiogenic shock (arterial pressure <90 mm Hg);
• oliguria;
• anuria.

Interaction with other medicinal products and other types of interactions.

Oral tetracyclines, iron salts, and sodium fluoride inhibit absorption of the drug from the gastrointestinal tract. When used concomitantly with the above-mentioned medicinal products, an interval of at least 3 hours between administrations is required.

Concomitant use of the drug with potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, beta-adrenoblockers, cyclosporine increases the risk of hyperkalemia (monitoring of plasma potassium levels is required) and enhances the inhibitory effect on intestinal peristalsis.

The drug enhances the effect of medicinal agents stimulating trophic processes in the myocardium; prevents development of hypokalemia caused by the use of saluretics, corticosteroids, cardiac glycosides.

The drug reduces cardiotoxic effects of cardiac glycosides.

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

The medicinal product may reduce the efficacy of neomycin, polymyxin B, tetracycline, and streptomycin.

Special precautions for use.

The medicinal product should be used with caution in patients with myasthenia gravis; in conditions that may lead to hyperkalemia, such as acute dehydration, extensive tissue damage, including severe burns. In these patients, regular monitoring of serum electrolyte concentrations is recommended.

The drug should not be prescribed to patients with gastroduodenal ulcers or obstruction.

Use during pregnancy or breastfeeding.

To date, no harmful effects have been reported with the use of this drug in these patient groups.

Ability to affect reaction speed when driving or operating machinery.

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

Method of Administration and Dosage.

The usual daily dose for adults is 1–2 tablets taken 3 times daily. The dose may be increased to 3 tablets 3 times daily. Gastric juice may 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.

Children.

The use of the drug in children is not recommended due to insufficient experience with its administration.

Overdose.

Cases of overdose are unknown.

In case of overdose, symptoms of hyperkalemia and hypermagnesemia may occur.

Symptoms of hyperkalemia: general weakness, nausea, vomiting, diarrhea, abdominal pain, metallic taste in the mouth, disorientation, limb paresthesias, bradycardia, muscle paralysis. Extremely high potassium concentration in plasma may lead to fatal outcome due to suppression of cardiac activity, arrhythmia, or cardiac arrest.

Symptoms of hypermagnesemia: nausea, vomiting, drowsiness, hypotension, bradycardia, weakness, slurred speech, double vision, facial skin flushing, thirst, neuromuscular transmission disturbances, arrhythmia, seizures. With very high plasma magnesium concentrations, hyporeflexia, muscle paralysis, respiratory arrest, and cardiac arrest may develop.

Electrocardiogram shows increased T-wave amplitude, reduced P-wave amplitude, and widened QRS complex.

Treatment: in case of overdose, the drug should be discontinued. Symptomatic treatment is recommended (calcium chloride 100 mg/min intravenously, dialysis if necessary).

Adverse reactions.

Gastrointestinal tract disorders: when high doses of the drug are used, increased defecation frequency may be observed.

According to some data, nausea, vomiting, abdominal pain, epigastric discomfort or burning sensation, gastrointestinal bleeding, mucosal ulcers of the digestive tract, and dry mouth may occur.

Cardiovascular system disorders: myocardial conduction disturbances, decreased arterial pressure, atrioventricular block.

Central and peripheral nervous system disorders: paresthesia, hyporeflexia, seizures.

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

Respiratory system disorders: respiratory depression (caused by hypermagnesemia).

Other: sensation of warmth.

Shelf life. 3 years.

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

Keep out of reach of children.

Packaging. Tablets, 10×5, 50 in a blister pack in a box; 50 in a blister pack.

Dispensing category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's location and address of business activity.

22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.