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Panangin® (Tablets, Concentrate) Instructions for Use

ATC Code

A12CX (Other mineral substances)

Active Substance

Potassium aspartate and magnesium aspartate

Clinical-Pharmacological Group

Drug replenishing potassium and magnesium deficiency in the body

Pharmacotherapeutic Group

Mineral supplements; other mineral supplements; other mineral substances

Pharmacological Action

The most important intracellular cations, potassium and magnesium, play a key role in the functioning of many enzymes, in the formation of bonds between macromolecules and intracellular structures, and in the mechanism of muscle contractility.

The intra- and extracellular ratio of potassium, magnesium, calcium, and sodium ions affects myocardial contractility.

Endogenous aspartate acts as a conductor of ions: it has a high affinity for cells, and due to the slight dissociation of its salts, ions in the form of complex compounds penetrate into the cell.

Magnesium and potassium aspartates improve myocardial metabolism.

A deficiency of potassium and/or magnesium ions predisposes to the development of arterial hypertension, atherosclerosis of the coronary arteries, arrhythmias, and the occurrence of metabolic changes in the myocardium.

Taking magnesium and potassium aspartates helps compensate for the deficiency of these electrolytes in the diet.

Pharmacokinetics

Magnesium

The total magnesium reserve in the human body weighing 70 kg averages 24 g (1000 mmol); more than 60% of magnesium is in bone tissue and about 40% in skeletal muscles and other tissues.

About 1% of the total magnesium reserve in the body is in the extracellular fluid, predominantly in the blood serum.

In healthy adults, the magnesium content in blood serum ranges from 0.7-1.10 mmol/L.

Magnesium is absorbed from the gastrointestinal tract by active transport. The kidneys are the main regulator of magnesium balance in the body. 3-5% of ionized magnesium is excreted by the kidneys.

An increase in urine volume (for example, during therapy with “loop” diuretics) leads to an increase in the excretion of ionized magnesium. If magnesium absorption in the small intestine decreases, subsequent hypomagnesemia leads to a decrease in its excretion (<0.5 mmol/day).

Potassium

The total potassium reserve in the human body weighing 70 kg averages 140 g (3570 mmol).

The total potassium reserve is somewhat lower in women than in men and decreases slightly with age.

2% of the total potassium reserve in the body is outside the cells, and the remaining 98% is inside the cells.

Potassium is absorbed in the gastrointestinal tract. The optimal daily intake of potassium from food is 3-4 g (75-100 mmol)/day. The main route of potassium excretion is renal (about 90% of potassium is excreted by the kidneys daily). The remaining 10% is excreted through the gastrointestinal tract. Thus, the kidneys are responsible for the long-term homeostasis of potassium, as well as for the potassium content in the blood plasma. In the short term, the blood potassium level is also regulated by the flow of potassium between the intracellular and extracellular space.

Indications

To eliminate potassium and magnesium deficiency as part of combination therapy for

  • Various manifestations of coronary artery disease (including acute myocardial infarction);
  • Chronic heart failure;
  • Cardiac rhythm disorders (including arrhythmias caused by an overdose of cardiac glycosides).

ICD codes

ICD-10 code Indication
E61.2 Magnesium deficiency
E87.6 Hypokalemia
I21 Acute myocardial infarction
I47.0 Recurrent ventricular arrhythmia
I47.1 Supraventricular tachycardia
I47.2 Ventricular tachycardia
I47.9 Paroxysmal tachycardia, unspecified
I49.0 Ventricular fibrillation and flutter
I49.3 Premature ventricular depolarization
I49.4 Other and unspecified premature depolarization
I49.8 Other specified cardiac arrhythmias
I49.9 Cardiac arrhythmia, unspecified
I50.0 Congestive heart failure
I50.1 Left ventricular failure
I50.9 Heart failure, unspecified
T46.0 Poisoning by cardiac glycosides and drugs of similar action
ICD-11 code Indication
5C64.41 Magnesium deficiency
5C77 Hypokalemia
8D40.2 Myopathy due to nutritional deficiency
BA41.Z Acute myocardial infarction, unspecified
BC62 Accessory pathway
BC64 Sudden arrhythmic death syndrome
BC65.0 Long QT syndrome
BC65.1 Brugada syndrome
BC65.2 Short QT syndrome
BC65.3 Early repolarization syndrome
BC65.4 Idiopathic ventricular fibrillation
BC65.5 Catecholaminergic polymorphic ventricular tachycardia
BC65.Z Cardiac arrhythmia associated with genetic anomalies, unspecified
BC70 Premature ventricular depolarization
BC71.0Z Ventricular tachycardia, unspecified
BC71.1 Ventricular fibrillation
BC71.2 Ventricular arrhythmia due to re-entry mechanism
BC71.Z Ventricular tachyarrhythmia, unspecified
BC81.0 Ectopic atrial tachycardia
BC81.1 Nodal ectopic tachycardia
BC81.20 CTI [cavotricuspid isthmus]-dependent atrial tachycardia by “macro re-entry” mechanism
BC81.21 Atrial tachycardia by “macro re-entry” mechanism not associated with scar or cavotricuspid isthmus
BC81.2Z Atrial tachycardia by “macro re-entry” mechanism, unspecified
BC81.5 Sinoatrial reentrant tachycardia
BC81.6 Inappropriate sinus tachycardia
BC81.7Z Atrioventricular reentrant tachycardia, unspecified
BC81.8 Atrioventricular nodal reentrant tachycardia
BC81.Z Supraventricular tachyarrhythmia, unspecified
BC8Z Supraventricular arrhythmia, unspecified
BC90 Atrioventricular nodal rhythm
BD10 Congestive heart failure
BD11.Z Left ventricular failure, unspecified
BD1Z Heart failure, unspecified
BE2Y Other specified diseases of the circulatory system
MC81.3 Paroxysmal tachycardia
NE60 Poisoning by drugs, medicaments or biological substances, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Concentrate

The drug is intended for intravenous administration only.

The contents of 1-2 ampoules should be diluted in 50-100 ml of a 5% dextrose (glucose) solution and administered intravenously as a slow drip infusion (20 drops/min). If necessary, repeated administration after 4-6 hours is possible.

The drug can be used as part of combination therapy.

Tablets

Before use, the patient should consult a doctor.

Orally, without chewing and with a sufficient amount of water. The drug should be taken after meals, as the acidic environment of the stomach reduces its effectiveness.

The usual daily dose is 1-2 tablets 3 times/day. The maximum daily dose is 2 tablets 3 times/day.

The duration of treatment and the need for repeated courses are determined by the doctor.

Data on the safety and efficacy of Panangin® in children and adolescents are not available.

Adverse Reactions

From the digestive system nausea, vomiting, diarrhea, discomfort or burning in the epigastrium (in patients with anacid gastritis or cholecystitis) are possible.

From the cardiovascular system AV block, paradoxical reaction (increase in the number of extrasystoles) are possible.

From the water-electrolyte balance hyperkalemia (nausea, vomiting, diarrhea, paresthesia), hypermagnesemia (facial flushing, feeling of thirst, decreased blood pressure, hyporeflexia, respiratory depression, convulsions) are possible.

Contraindications

  • Hypersensitivity to potassium aspartate, magnesium aspartate or to any of the excipients included in the drug;
  • Acute and chronic renal failure;
  • Hyperkalemia;
  • Hypermagnesemia;
  • Addison’s disease;
  • AV block of I-III degree;
  • Shock, including cardiogenic (BP less than 90 mm Hg);
  • Impaired amino acid metabolism;
  • Severe myasthenia;
  • Hemolysis;
  • Acute metabolic acidosis;
  • Dehydration;
  • Breastfeeding period;
  • Age under 18 years (efficacy and safety have not been established).

With caution pregnancy (especially in the first trimester) and the period of breastfeeding.

Use in Pregnancy and Lactation

Adequate and strictly controlled studies of the use of the drug during pregnancy and breastfeeding have not been conducted.

Pregnancy

Use is possible if the potential benefit to the mother outweighs the possible risk to the fetus.

Breastfeeding period

Potassium and magnesium aspartate pass into breast milk. If it is necessary to take the drug during breastfeeding, breastfeeding should be discontinued.

Use in Renal Impairment

The use of the drug is contraindicated in acute and chronic renal failure.

Special Precautions

Special attention is required for patients with diseases accompanied by hyperkalemia: regular monitoring of plasma potassium levels is necessary.

Each Panangin® tablet contains 36.2 mg of potassium. This must be taken into account in patients with reduced renal function and in patients on a potassium-restricted diet.

Effect on the ability to drive vehicles and mechanisms

Studies have not been conducted. No effect on the ability to drive vehicles and engage in activities requiring increased concentration and speed of psychomotor reactions is expected.

Overdose

The risk of symptoms of hyperkalemia and hypermagnesemia increases.

Symptoms of hyperkalemia increased fatigue, myasthenia, paresthesia, confusion, cardiac rhythm disturbances (bradycardia, AV block, arrhythmias, cardiac arrest).

Symptoms of hypermagnesemia decreased neuromuscular excitability, nausea, vomiting, lethargy, decreased blood pressure. With a sharp increase in the level of magnesium ions in the blood – inhibition of deep tendon reflexes, respiratory paralysis, coma.

Treatment symptomatic therapy – intravenous administration of calcium chloride at a dose of 100 mg/min, if necessary – hemodialysis.

Drug Interactions

Pharmacodynamic interaction

Concomitant use with potassium-sparing diuretics (triamterene, spironolactone), beta-blockers, cyclosporine, heparin, ACE inhibitors, NSAIDs increases the risk of hyperkalemia up to the development of arrhythmia and asystole.

Simultaneous use of potassium preparations with corticosteroids eliminates the hypokalemia caused by the latter.

Potassium reduces the undesirable effects of cardiac glycosides.

Panangin® enhances the negative dromotropic and bathmotropic effects of antiarrhythmic drugs.

Magnesium reduces the effect of neomycin, polymyxin B, tetracycline and streptomycin.

Anesthetics increase the inhibitory effect of magnesium preparations on the central nervous system; with simultaneous use with atracurium, decamethonium, succinylcholine and suxamethonium, an increase in neuromuscular blockade is possible; calcitriol increases the magnesium content in blood plasma, calcium preparations reduce the effect of magnesium preparations.

Pharmacokinetic interaction

Drugs with astringent and enveloping action reduce the absorption of magnesium aspartate and potassium aspartate in the gastrointestinal tract, so it is necessary to observe a three-hour interval between the oral administration of Panangin® and the above-mentioned drugs.

Storage Conditions

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

Shelf Life

Shelf life – 5 years (when packaged in vials), 5 years (when packaged in blisters). Do not use after the expiration date indicated on the packaging.

Dispensing Status

The drug is available without a prescription.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Gedeon Richter, Plc. (Hungary)

Manufactured By

Gedeon Richter, Plc. (Hungary)

Or

Pharmfirma Sotex, CJSC (Russia)

Contact Information

GEDEON RICHTER Plc. (Hungary)

Dosage Form

Bottle Rx Icon Panangin® Concentrate for solution for infusion 45.2 mg+40 mg/1 ml: 10 ml ampoule 5 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion colorless or slightly greenish, transparent solution.

1 amp. (10 ml)
Potassium aspartate (in the form of potassium aspartate hemihydrate) 452 mg,
   Equivalent to potassium ion content 103.3 mg
Magnesium aspartate (in the form of magnesium aspartate tetrahydrate) 400 mg,
   Equivalent to magnesium ion content 33.7 mg

Excipients : water for injections – up to 10 ml, potassium hydroxide solution, 10% – to pH 6.0-7.5 (pH corrector, used to adjust pH if necessary, not contained in all batches).

10 ml – ampoules of colorless glass (5) – plastic trays (1) – cardboard packs.
10 ml – ampoules of colorless glass (5) – plastic trays with or without polymer film (1) – cardboard packs.

Marketing Authorization Holder

Gedeon Richter, Plc. (Hungary)

Manufactured By

Gedeon Richter, Plc. (Hungary)

Or

Gedeon Richter-Rus, JSC (Russia)

Packaging and Quality Control Release

GEDEON RICHTER, Plc. (Hungary)

Or

GEDEON RICHTER-RUS, JSC (Russia)

Contact Information

GEDEON RICHTER Plc. (Hungary)

Dosage Form

Bottle OTC Icon Panangin® Film-coated tablets, 158 mg+140 mg: 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with a slightly shiny and uneven surface, almost odorless.

1 tab.
Potassium aspartate 158 mg
   In the form of potassium aspartate 1/2 H2O 166.3 mg
Magnesium aspartate 140 mg
   In the form of magnesium aspartate 4 H2O 175 mg

Excipients : colloidal anhydrous silicon dioxide, povidone K30, magnesium stearate, talc, corn starch, potato starch.

Film coating composition macrogol 6000, titanium dioxide (E171), basic butyl methacrylate copolymer, talc.

25 pcs. – blisters (2) – cardboard packs.
25 pcs. – blisters (4) – cardboard packs.
50 pcs. – polypropylene bottles (1) with a first-opening control cap – cardboard packs.

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