Panangin

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANANGIN

Composition:

Active substances: magnesium aspartamate, potassium aspartamate;

1 ml of concentrate for infusion solution contains 40 mg of magnesium aspartamate (corresponding to 3.37 mg of magnesium) and 45.2 mg of potassium aspartamate (corresponding to 10.33 mg of potassium);

Excipient: water for injections.

Pharmaceutical form. Concentrate for infusion solution.

Main physicochemical properties: colorless or slightly greenish, clear solution.

Pharmacotherapeutic group. Minerals. Magnesium preparations.

ATC code A12CC30.

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 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 the contractile ability of the myocardium. Aspartate, as an endogenous substance, 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. Magnesium and potassium aspartate improves the metabolism of cardiac muscle. Insufficient intake of potassium and magnesium promotes the development of arterial hypertension, sclerotic-type coronary vascular pathology, cardiac arrhythmias, and myocardial degeneration.

Pharmacokinetics.

Magnesium

The total magnesium store in the body of a 70 kg human averages 24 g (1000 mmol); more than 60% of magnesium is located in bone tissue, and about 40% in skeletal muscles and other tissues. Approximately 1% of the total body magnesium is found in the extracellular fluid, predominantly in blood serum. In healthy adults, serum magnesium concentration ranges from 0.7 to 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.

An increase in 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 leads to decreased magnesium excretion (< 0.5 mmol/day).

Potassium

The total potassium store in the body of a 70 kg human averages 140 g (3570 mmol). Total body potassium is slightly lower in women than in men and decreases slightly with age. 2% of the total body potassium is located outside the cells, while the remaining 98% is intracellular.

The optimal daily dietary intake of potassium is 3–4 g (75–100 mmol). The main 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 the exchange of potassium between intracellular and extracellular compartments.

Clinical characteristics.

Indications.

• As adjunctive therapy in chronic heart diseases (in heart failure, post-infarction period), cardiac arrhythmias, particularly ventricular arrhythmias.
• Adjunctive therapy in treatment with cardiac glycosides.

Contraindications.

• Hypersensitivity to the active substances of the drug.
• Acute and chronic renal failure.
• Addison's disease.
• Third-degree atrioventricular block.
• Cardiogenic shock (SBP < 90 mm Hg).

Interaction with other medicinal products and other forms of interaction.

Concomitant use of the drug with potassium-sparing diuretics and/or 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.

Panangin, a preparation containing potassium and magnesium, 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, and extensive tissue injury, particularly in severe burns. In these patients, regular monitoring of serum electrolyte levels is recommended.

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.

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 drug is suitable for use in combination therapy.

The treatment course is determined by the physician.

Children. Experience with the use of this medication in children is insufficient.

Overdose

Cases of overdose are unknown.

Due to the kidneys' ability to excrete large amounts of potassium, increased dosage of the drug 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 extremely rare.

In case of rapid intravenous administration, symptoms of hyperkalemia/hypermagnesemia may occur.

In overdose, symptoms of hyperkalemia and hypermagnesemia may be observed.

Symptoms of hyperkalemia: general weakness, paresthesia, bradycardia, paralysis. Extremely high plasma potassium concentrations may result in 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 rapidly, possible symptoms of hyperkalemia/hypermagnesemia should be taken into account.

Shelf life. 3 years.

Storage conditions. Store at a temperature not exceeding 30 ºC.

Keep out of reach of children.

Incompatibility. Unknown.

Packaging. 10 ml of solution in a colorless glass ampoule with a break point; 5 ampoules (5x1) in a blister pack; 1 blister pack in a cardboard box.

Prescription status. Prescription only.

Manufacturer.

JSC "Gedeon Richter".

Manufacturer's address.

19-21 Demre utca, H-1103 Budapest, Hungary.