Composition, form of production and packaging
? Tablets covered with a film coat of white or almost white color, round, biconcave, with a slightly shiny and uneven surface, almost odorless.
1 tab.
potassium asparaginate hemihydrate 166.3 mg,
which corresponds to the content of potassium asparaginate 158 mg
magnesium aspartate tetrahydrate 175 mg,
which corresponds to the content of magnesium asparaginate 140 mg
Excipients: silicon dioxide colloid - 2 mg, povidone K30 - 3.3 mg, magnesium stearate - 4 mg, talc - 10 mg, corn starch - 86.1 mg, potato starch - 3.3 mg.
Sheath composition: Macrogol 6000 - 1.4 mg, titanium dioxide (E171) - 5.3 mg, butyl methacrylate, dimethylaminoethyl methacrylate and methacrylate copolymer [1: 2: 1] - 6 mg, talc - 7.3 mg.
50 pcs. - vials of polypropylene (1) - packs cardboard.
The solution for intravenous administration is colorless or slightly greenish, transparent, with no visible mechanical inclusions.
1 ml of 1 amp.
potassium aspartate (in the form of hemihydrate) 45.2 mg 452 mg,
which corresponds to the content of K + 10.33 mg 103.3 mg
magnesium aspartate (in the form of tetrahydrate) 40 mg 400 mg,
which corresponds to the content of Mg 2+ 3.37 mg 33.7 mg
Auxiliary substances: water d / and - up to 10 ml.
10 ml - ampoules of colorless glass (5) - plastic pallets (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
A drug that affects metabolic processes. The source of potassium and magnesium ions.
Potassium and magnesium are intracellular cations that play a major 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 has an effect on myocardial contractility. Endogenous aspartate acts as an ion conductor: it has a high affinity for cells, due to the insignificant dissociation of its salts, the ions enter the cell in the form of complex compounds. Potassium and magnesium aspartate improves myocardial metabolism. The lack of potassium and / or magnesium ions predisposes to the development of arterial hypertension, coronary artery atherosclerosis and the occurrence of metabolic changes in the myocardium.
One of the most important physiological functions of potassium is the maintenance of the membrane potential of neurons, myocytes and other excitable structures of myocardial tissue. Violation of the balance between intra- and extracellular potassium content leads to a decrease in myocardial contractility, arrhythmia, tachycardia, and increased cardiac glycoside toxicity.
Magnesium is an important cofactor of more than 300 enzymatic reactions, including energy metabolism and the synthesis of proteins and nucleic acids. In addition, magnesium plays an important role in the work of the heart: it improves contractility and heart rate, leading to a decrease in myocardial oxygen demand. Reduction of myocardial contractility of smooth muscles of arteriolar walls, incl. coronary, leads to vasodilation and increased coronary blood flow. Magnesium has an anti-ischemic effect on the tissue of the myocardium.
The combination of potassium and magnesium ions in one preparation is justified by the fact that potassium deficiency in the body is often accompanied by a deficiency of magnesium and requires simultaneous correction of the content in the body of both ions. With simultaneous correction of the levels of these electrolytes, an additive effect is observed (low potassium and / or magnesium levels have a pro-arrhythmic effect), in addition, potassium and magnesium reduce the toxicity of cardiac glycosides without affecting their positive inotropic effect.
PHARMACOKINETICS
Suction
When ingested, the absorption of the drug is high.
Excretion
It is excreted in the urine.
Data on the pharmacokinetics of the drug in the form of a solution for intravenous administration are not available.
INDICATIONS
- in the complex therapy of heart failure, acute myocardial infarction, cardiac arrhythmias (mainly ventricular arrhythmias, as well as arrhythmias caused by cardiac glycosides overdose);
- to improve the tolerability of cardiac glycosides;
- Replenishment of potassium and magnesium deficiency with a decrease in their content in the diet (for tablets).
DOSING MODE
For oral administration
Assign 1-2 tables. 3 times / day. The maximum daily dose is 3 tab. 3 times / day.
The drug should be used after a meal, tk. The acidic environment of the contents of the stomach reduces its effectiveness.
The duration of therapy and the need for repeated courses the doctor determines individually.
For intravenous administration
The drug is administered iv in the drip, in the form of a slow infusion (20 drops / min). If necessary, repeated administration is possible in 4-6 hours.
To prepare a solution for intravenous infusion, the contents of 1-2 amp. dissolved in 50-100 ml of a 5% solution of dextrose (glucose).
The drug is suitable for combination therapy.
SIDE EFFECT
Ingestion
From the side of the cardiovascular system: AV blockade is possible, paradoxical reaction (increase in the number of extrasystoles).
On the part of the digestive system: nausea, vomiting, diarrhea, a feeling of discomfort or burning in the pancreas (in patients with an anatomic gastritis or cholecystitis) is possible.
From the side of water-electrolyte balance: hyperkalemia is possible (nausea, vomiting, diarrhea, paresthesia), hypermagnia (reddening of face, thirst, lowering blood pressure, hyporeflexia, respiratory depression, convulsions.
With iv introduction
With rapid on / in the introduction, it is possible to develop symptoms of hyperkalemia (fatigue, myasthenia gravis, paresthesia, confusion, cardiac arrhythmia / bradycardia, AV blockade, arrhythmias, cardiac arrest) and hypermagnesia (decreased neuromuscular excitability, vomiting, vomiting, lethargy , decrease in blood pressure). It is also possible to develop phlebitis, AV blockade and paradoxical reaction (increase in the number of extrasystoles).
CONTRAINDICATIONS
For oral administration
acute and chronic renal failure;
- Hyperkalemia;
- hypermagnesia;
- Addison's disease;
- AV blockade of I-III degree;
- cardiogenic shock (BP <90 mmHg);
- Myasthenia gravis;
- a violation of the exchange of amino acids;
- hemolysis;
- Acute metabolic acidosis;
dehydration of the body.
With caution: during pregnancy (especially in the first trimester) and during lactation.
For intravenous administration
acute and chronic renal failure;
- Hyperkalemia;
- hypermagnesia;
- Addison's disease;
- AV-blockade of II-III degree;
- cardiogenic shock (BP <90 mmHg);
- Myasthenia gravis;
- dehydration;
- Insufficiency of the adrenal cortex;
- age under 18 years (effectiveness and safety not established);
- Pregnancy;
- lactation period;
- Hypersensitivity to the components of the drug.
With caution: with AV blockade of the I degree, expressed violations of the liver function, metabolic acidosis, the risk of edema, renal dysfunction in the event that the regular monitoring of the magnesium content in the blood serum is impossible (risk of development of cumulation, toxic content of magnesium) , hypophosphatemia, urolithic diathesis, associated with a violation of the exchange of calcium, magnesium and ammonium phosphate.
PREGNANCY AND LACTATION
Data on the negative effect of the drug in the form of a solution for intravenous administration during pregnancy and lactation (breastfeeding) are absent.
With caution should be used inside the drug during pregnancy (especially in the first trimester) and during lactation (breastfeeding).
APPLICATION FOR FUNCTIONS OF THE LIVER
Acute and chronic renal failure, oliguria, anuria.
SPECIAL INSTRUCTIONS
Caution is necessary to prescribe the drug to patients with an increased risk of hyperkalemia. In this case, it is necessary to regularly monitor the level of potassium ions in the blood plasma.
Before taking the drug, the patient should consult a doctor.
With rapid IV injection of the drug may develop skin hyperemia.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the ability to drive and engage in activities that require increased concentration and speed of psychomotor reactions.
OVERDOSE
To date, cases of overdose have not been described. Overdose increases the risk of hyperkalemia and hypermagnesemia.
Symptoms of hyperkalemia: fatigue, myasthenia gravis, paresthesia, confusion, violation of the heart rhythm (bradycardia, AV blockade, arrhythmias, cardiac arrest).
Symptoms of hypermagnesemia: decreased neuromuscular excitability, urge for vomiting, vomiting, lethargy, lowering blood pressure. With a sharp increase in the content of magnesium ions in the blood - the suppression of tendon reflexes, respiratory paralysis, coma.
When administered orally - a violation of conduction of the heart (especially with the previous pathology of the conduction system of the heart).
Treatment: withdrawal of the drug, symptomatic therapy (iv administration of 100 mg / min calcium chloride solution), if necessary - hemodialysis and peritoneal dialysis.
DRUG INTERACTION
When used simultaneously with potassium-sparing diuretics (triamterene, spironolactone), beta adrenoblockers, cyclosporine, heparin, ACE inhibitors, NSAIDs, the risk of developing hyperkalemia increases up to the appearance of arrhythmia and asystole.
The use of potassium preparations together with GCS eliminates the hypokalemia caused by them.
Under the influence of potassium, there is a decrease in the undesirable effects of cardiac glycosides.
The drug enhances the negative dromo- and batmotropic effect of antiarrhythmic drugs.
In connection with the presence of potassium ions in the use of Panangin with ACE inhibitors, beta-adrenoblockers, cyclosporine, potassium-sparing diuretics, heparin, NSAIDs, it is possible to develop hyperkalemia up to the development of extrasystole.
Magnesium preparations reduce the effectiveness of neomycin, polymyxin B, tetracycline and streptomycin.
Calcium preparations reduce the effect of magnesium preparations.
Anesthetics increase the inhibitory effect of magnesium on the central nervous system.
When used with atracurium, dexamethonium, suxamethonium, neuromuscular blockade may increase; with calcitriol - an increase in the level of magnesium in the blood plasma.
Astringent and enveloping agents reduce the absorption of the drug in the digestive tract. It is necessary to observe a 3-hour interval between ingestion of Panangin В®preparation with the above-mentioned agents.
The solution for intravenous administration is compatible with solutions of cardiac glycosides (improves their tolerability, reduces undesirable effects of cardiac glycosides).
TERMS OF RELEASE FROM PHARMACY
The drug in the form of a solution for intravenous administration is dispensed by prescription.
Panangin in the form of tablets is approved for use as an OTC product.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored at a temperature of 15 В° to 30 В° C, out of the reach of children. Shelf life for tablets is 5 years, for a solution for intravenous administration is 3 years.
