Asparkam arterium

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

Composition:

Active substances: 1 tablet contains magnesium aspartate 0.175 g; potassium aspartate 0.175 g;

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

Pharmaceutical form. Tablets.

Main physico-chemical properties: white tablets with a smooth surface, flat cylindrical shape, with a score line, with a specific odor. Marbling on the tablet surface is permissible.

Pharmacotherapeutic group. Mineral supplements. Magnesium preparations.

ATC code A12C.

Pharmacological Properties.

Pharmacodynamics.

Potassium and magnesium ions, as important intracellular cations, are involved in the function of various enzymes, in the binding process of macromolecules to subcellular elements, 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 affects myocardial contractility. Aspartate, as an endogenous substance, 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, the ions penetrate into the intracellular space in the form of complex compounds. Magnesium aspartate and sodium aspartate improve myocardial metabolism. Insufficient levels of potassium and magnesium in the body increase the risk of developing arterial hypertension, atherosclerotic damage to coronary vessels, cardiac arrhythmias, and myocardial pathology.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

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

Additional therapy in the treatment with digitalis preparations.

In conditions associated with hypokalemia and hypomagnesemia (including diuretic overdose).

Contraindications.

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

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

Arterium Asparkam, as a drug containing potassium and magnesium, should be used with caution in patients with myasthenia gravis; in conditions that may lead to hyperkalemia, such as acute dehydration, widespread tissue damage, including severe burns. For these patients, regular monitoring of plasma electrolyte concentrations is recommended.

Arterium Asparkam should not be administered to patients with gastroduodenal ulcers or obstruction.

Interaction with other medicinal products and other types of interactions.

Due to the presence of potassium ions in the formulation, when Arterium Asparkam is used concomitantly with potassium-sparing diuretics, ACE inhibitors, beta-blockers, or cyclosporine, the risk of developing hyperkalemia increases (monitoring of plasma potassium levels is required), and the inhibitory effect on intestinal peristalsis is enhanced. The drug inhibits the absorption of oral formulations of tetracycline, iron salts, and sodium fluoride (a three-hour interval between administrations should be maintained).

Arterium Asparkam enhances the effects of medicinal agents that stimulate trophic processes in the myocardium; prevents the development of hypokalemia induced by diuretics, corticosteroids, and cardiac glycosides. Arterium Asparkam reduces the cardiotoxic effects of cardiac glycosides.

When used concomitantly with depolarizing neuromuscular blockers, neuromuscular blockade is enhanced; when used with anesthetic agents (ketamine, hexanediol, halothane), central nervous system depression is potentiated.

Arterium 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 adverse effects of the drug during pregnancy or breastfeeding. However, the drug may be used if, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to influence the reaction rate while driving or operating machinery.

Aspamag Arterium does not affect the reaction rate while driving or operating machinery.

Dosage and Administration

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

The duration of treatment is determined by the physician.

Children. There is no experience with the use of the drug in children.

Overdose.

Currently, cases of overdose have not been reported. Theoretically, overdose may lead to symptoms of hyperkalemia (nausea, vomiting, diarrhea, abdominal pain, metallic taste in the mouth, bradycardia, weakness, disorientation, muscle paralysis, limb paresthesias) and hypermagnesemia (facial skin flushing, thirst, arterial hypotension, hyporeflexia, impaired neuromuscular transmission, respiratory depression, arrhythmia, seizures). Electrocardiogram shows increased T-wave amplitude, reduced P-wave amplitude, and widened QRS complex.

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 tract: 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 arterial pressure, AV block;

Central and peripheral nervous system: possible paresthesias, hyporeflexia, seizures;

Allergic reactions: itching, facial skin redness, rash;

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

Other: sensation of warmth.

Shelf life. 3 years.

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

Packaging. 50 tablets in blisters; 50 tablets in a blister, 1 blister per pack; 10 tablets in a blister, 5 blisters per pack.

Availability category. Over-the-counter.

Manufacturer. JSC "Galychpharm".

Manufacturer's location and address of business activity.

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