Asparcam Avexima (Tablets) Instructions for Use

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Contact Information

Avexima JSC (Russia)

ATC Code

A12CX (Other mineral substances)

Active Substance

Potassium aspartate and magnesium aspartate

Dosage Form

Asparcam Avexima

Tablets 175 mg+175 mg: 10, 20, 40, 48, 50, 56, 60, 80, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets are white, round, flat-cylindrical in shape, with a double-sided chamfer and a score on one side; slight marbling on the surface is allowed.

Excipients: potato starch – 88 mg, stearic acid – 5 mg, macrogol-4000 – 7 mg, colloidal silicon dioxide – 50 mg.

8 pcs. – contour cell packs (6) – cardboard packs.
8 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
12 pcs. – contour cell packs (4) – cardboard packs.
12 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – non-cell contour packs.
50 pcs. – polyethylene jars (1) – cardboard packs.

Clinical-Pharmacological Group

Drug replenishing potassium and magnesium deficiency in the body

Pharmacotherapeutic Group

Potassium and magnesium preparation

Pharmacological Action

ASPARCAM AVEKSIMA is a source of potassium and magnesium ions and regulates metabolic processes.

The mechanism of action is presumably associated with the role of aspartate as a transporter of magnesium and potassium ions into the intracellular space and the participation of aspartate in metabolic processes.

Thus, ASPARCAM AVEKSIMA eliminates electrolyte imbalance and reduces myocardial excitability and conductivity (moderate antiarrhythmic effect).

Pharmacokinetics

It is easily absorbed when taken orally and is relatively quickly excreted by the kidneys.

Indications

Used in complex therapy

• Chronic heart failure;
• Coronary artery disease;
• Hypokalemia;
• Cardiac arrhythmias (including in myocardial infarction, overdose of cardiac glycosides).

ICD codes

Dosage Regimen

Administer orally after meals to minimize gastrointestinal irritation.

For adults, the standard dosage is 1-2 tablets taken three times daily.

The total daily dose is typically 3 to 6 tablets.

Adhere to a standard treatment course of 3 to 4 weeks.

If clinically indicated, repeat the treatment course after consultation with a physician.

Adjust the dosage based on individual patient requirements and plasma potassium levels.

For patients with concomitant cardiac conditions, individualize the dosing regimen.

Do not exceed the recommended daily dosage without medical supervision.

Adverse Reactions

Nausea, vomiting, diarrhea, discomfort or burning in the epigastric region (in patients with anacid gastritis or cholecystitis), AV block, paradoxical reaction (increase in the number of extrasystoles), hyperkalemia (nausea, vomiting, diarrhea, paresthesia), hypermagnesemia (facial skin redness, feeling of thirst, decreased blood pressure, muscle weakness, increased fatigue, paresis, coma, areflexia, respiratory depression, convulsions) are possible.

Contraindications

• Hypersensitivity to the drug;
• Impaired amino acid metabolism;
• Acute and chronic renal failure;
• Hyperkalemia;
• Hypermagnesemia;
• Adrenal insufficiency;
• Impaired AV conduction (AV block I-III degree);
• Severe myasthenia gravis;
• Hemolysis;
• Arterial hypotension (systolic blood pressure less than 90 mm Hg);
• Age under 18 years.

With caution pregnancy, lactation period.

Use in Renal Impairment

Use is prohibited in patients with acute and chronic renal failure.

Pediatric Use

Use of the drug in children under 18 years of age is prohibited.

Special Precautions

Control of plasma potassium ion levels is necessary.

Effect on the ability to drive vehicles and operate machinery

No clinical studies have been conducted to assess the effect of the drug on the ability to drive vehicles and operate machinery.

Overdose

Symptoms: hyperkalemia, hypermagnesemia.

Treatment: intravenous calcium chloride, if necessary – hemodialysis and peritoneal dialysis.

Drug Interactions

Pharmacodynamic: concomitant use with potassium-sparing diuretics (triamterene, spironolactone), beta-blockers, cyclosporine, heparin, angiotensin-converting enzyme inhibitors, non-steroidal anti-inflammatory drugs increases the risk of hyperkalemia up to the development of arrhythmia and asystole.

The use of potassium preparations together with glucocorticosteroids eliminates the hypokalemia caused by the latter. Due to the content of potassium ions, it reduces the undesirable effects of cardiac glycosides. Due to the content of magnesium ions, it reduces the effect of neomycin, polymyxin B, tetracycline and streptomycin. It may enhance the neuromuscular blockade caused by depolarizing muscle relaxants (atracurium besilate, decamethonium bromide, suxamethonium (chloride, bromide, iodide). Calcitriol increases the concentration of magnesium ions in blood plasma, calcium preparations reduce the effect of magnesium.

Pharmacokinetic: astringent and enveloping agents reduce the absorption of the drug in the gastrointestinal tract (a 3-hour interval between their intake must be observed).

Storage Conditions

The drug should be stored in a dry place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Do not use after the expiration date.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.