Active substancePotassium chloridePotassium chloride
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  • Dosage form: & nbsptooncentrate for solution for infusion
    Composition:

    Active substance: potassium chloride 40 mg;

    Excipient: water for injection up to 1 ml.

    Description:A clear, colorless liquid.
    Pharmacotherapeutic group:Potassium preparation
    ATX: & nbsp

    B.05.X.A   Electrolyte solutions

    B.05.X.A.01   Potassium chloride

    Pharmacodynamics:

    Mechanism of action

    Potassium is the most important cation of intracellular space, about 98% of the total potassium content in the body is in the intracellular fluid. Potassium is involved in the electrochemical processes of the cell, as well as in carbohydrate and protein metabolism. During the synthesis of glycogen and proteins, potassium is consumed by cells, and during the cleavage of these substrates, potassium is released (about 0.4-1 mmol of potassium / g glycogen and about 2-3 mmol of potassium / g of excreted nitrogen).

    Therapeutic effect

    The therapeutic effect of potassium chloride solutions for intravenous administration is the prevention or treatment of potassium deficiency, when oral intake (or enteral administration) is impossible or insufficient. The daily requirement for potassium is 1-1,5 mmol / kg body weight. Potassium deficiency can be caused by increased renal excretion, increased losses through the gastrointestinal tract, for example, during vomiting, diarrhea or through fistulas, increased intracellular consumption, for example, in the treatment of acidosis or the administration of dextrose and insulin, and with insufficient potassium intake.Hypokalemia is accompanied by muscle weakness, atony of the smooth muscles of the gastrointestinal tract (from constipation to intestinal obstruction), loss of the ability of the kidneys to concentrate urine, ECG changes and cardiac arrhythmia.

    Pharmacokinetics:

    Suction

    Since the drug is administered intravenously, its bioavailability is 100%.

    Distribution

    The ions of potassium and chlorine are included in the total pool of the organism. The concentration of potassium and the acid-base state of blood plasma are closely related. Alkalosis is often accompanied by hypokalemia, and acidosis - hyperkalemia. The concentration of potassium in the blood plasma within the norm with acidosis indicates a potassium deficiency. The intracellular potassium concentration is about 140-150 mmol / l. The concentration of potassium in the blood plasma within the norm ranges from 3.5 to 5 mmol / l.

    Biotransformation

    Not applicable.

    Excretion

    Potassium is mainly excreted by the kidneys with urine (about 90%), about 10% is excreted from the body through the gastrointestinal tract. Even in conditions of potassium deficiency 10-50 mmol of potassium per day is excreted by the kidneys.

    Indications:Hypokalemia of various genesis; arrhythmias due to hypokalemia.
    Contraindications:

    Hypersensitivity to the drug components, hyperkalemia or hyperchloremia of any etiology, complete atrioventricular or intraventricular blockade, renal insufficiency with oliguria or azotemia, ventricular fibrillation, Addison's disease, hyperadrenalism associated with adrenogenital syndrome, extensive tissue decay (including with severe burns) , acute dehydration, thermal convulsions, conditions with increased sensitivity to the introduction of potassium (including hereditary episodic adynamia or congenital paramyot Nia), concomitant therapy potassium salts and potassium-sparing diuretics.

    Carefully:

    Atrioventricular block I-II degree, heart failure, sickle-cell anemia, diseases and conditions accompanied by a violation of potassium excretion, incl. chronic renal failure, adrenal insufficiency.

    In patients taking cardiac glycosides, aldosterone antagonists, ACE inhibitors, tacrolimus, ciclosporin, long-acting heparin, suxamethonium or potentially nephrotic drugs (non-steroidal anti-inflammatory drugs, peripheral analgesics).

    Pregnancy and lactation:

    Care should be taken when prescribing pregnant women. The drug should be used only with obvious indications for its use, if the expected benefit for the mother exceeds the potential risk to the fetus (if possible, prescribe potassium preparations for oral administration).

    Potassium is excreted in breast milk. When prescribing the drug, lactating women should be careful (if possible, they are prescribed potassium preparations for oral administration).

    Dosing and Administration:

    The drug is injected intravenously only after diluting the concentrate 10 times.

    10 ml of potassium chloride concentrate 40 mg / ml is diluted 10 times with water for injection (up to 100 ml) to obtain an isotonic solution (potassium chloride concentration is 4 mg / ml or 0.4%) and injected intravenously at a rate of 20-30 drops per minute). At the same time, no more than 100 ml of the prepared solution is administered per infusion. If necessary, the infusion can be repeated, but the total daily dose should not exceed 300-500 ml of the prepared solution with a potassium chloride concentration of 4 mg / ml (0.4%).

    For intravenous drip, a solution can be prepared for up to 2.5 g of potassium chloride in 500 ml of an isotonic 0.9% solution of sodium chloride or a 5% solution of dextrose (glucose).

    For the prevention and treatment of ectopic arrhythmias in myocardial infarction - a polarizing mixture is used: potassium chloride solution 2-2.5 g in 500 ml of 5-10% dextrose (glucose), to which short-acting insulin is added at the rate of 1 unit for 3-4 g of dry dextrose (glucose).

    Doses

    The dose for the treatment of potassium deficiency should be selected in accordance with the actual concentration of electrolytes in the blood plasma and the acid-base state.

    Adults and elderly patients:

    The dose for the treatment of moderate, asymptomatic potassium deficiency and with maintenance therapy:

    The amount of potassium needed to correct moderate potassium deficiency and with maintenance therapy can be calculated using the following formula:

    the required amount of mmol K+ = (MT * [kg] x 0,2)** x 2 x (target concentration K+ in blood plasma *** - the actual concentration of K+ in blood plasma [mmol / l])

    Where:

    * MT = body weight;

    ** value is the extracellular volume of the fluid;

    *** target concentration K+ in blood plasma should be equal to 4.5 mmol / l.

    The maximum daily dose (for example, in case of severe symptomatic hypokalemia or significant loss):

    Up to 2-3 mmol / kg body weight.

    Maximum injection rate:

    Up to 20 mmol potassium / hour in adults (corresponding to 0.3 mmol of potassium / kg of body weight / hour). If the potassium concentration in the blood plasma is less than 2 mmol / l, the infusion rate can reach 40 mmol potassium / hour.

    Patients of childhood:

    The dose and speed of infusion depend on the needs of the patient of childhood. The daily dose should not exceed 2-3 mmol / kg of body weight or 40 mmol / m of body surface (if possible, preparations of potassium for oral administration are prescribed).

    Patients with diabetes mellitus:

    The change in the acid-base state affects the concentration of potassium in the blood plasma. The need for potassium increases with the compensation of ketoacidosis in patients with diabetes mellitus, as well as with the introduction of short-acting dextrose / insulin.

    Side effects:

    Adverse side reactions can develop as symptoms of hyperkalemia only in the case of absolute or relative overdose and / or too high infusion rate. The frequency of adverse adverse reactions depends on the dose.

    Immune system disorders: allergic reactions.

    Disorders from the metabolism and nutrition: acidosis, hyperchloremia, hyperkalemia.

    Disturbances from the nervous system: fatigue, muscle weakness, confusion, heaviness in the limbs, muscle cramps, paresthesia, ascending paralysis.

    Heart Disease: bradycardia, AV blockade, ventricular fibrillation, cardiac arrest. Too high infusion rate can cause cardiac arrhythmia.

    Vascular disorders: lowering blood pressure, centralizing blood circulation.

    Disorders from the gastrointestinal tract: nausea.

    Overdose:

    Symptoms: a violation of the excretory mechanism or too rapid intravenous administration of potassium can lead to fatal hyperkalemia (an increase in the serum potassium levels in the serum above 5.5 meq / l), which manifestations are: muscle hypotension, paresthesia of limbs, slowing of atrioventricular conduction, arrhythmias, cardiac arrest. Early changes in the electrocardiogram are a high T wave with a pointed apex and a narrow base, most pronounced in the thoracic leads V2-V4 are manifested when the concentration of potassium ions in the blood serum increases to 5.5-6.5 meq / l. With moderate hyperkalemia (the content of potassium ions in the blood serum 6.5-8.0 meq / l), electrocardiographic signs are: a decrease in the amplitude of the P wave, an elongation of the interval QT, expansion of the complex QRS, decrease in the amplitude of the tooth R, ventricular extrasystole.

    More severe symptoms of hyperkalemia - muscle paralysis and cardiac arrest (a change in the electrocardiogram - slow or accelerated idioventricular rhythm, ventricular fibrillation, asystole) develop with a potassium ion content in the blood serum 9-14 meq / l.

    Treatment: discontinuation of infusion of potassium chloride. Inside or intravenously - a solution of sodium chloride; intravenously 300-500 ml of a 5% solution of dextrose (c 10-20 A short-acting insulin dose per 1 liter); Correction of acidosis (if available) by intravenous sodium hydrogencarbonate, if necessary - hemodialysis and peritoneal dialysis.

    Arrhythmia or serum potassium concentration above 6.5 mmol / L requires immediate treatment by intravenous administration of 10-20 ml of 10% calcium gluconate solution for 1-5 minutes.

    In the treatment of hyperkalemia in patients treated with cardiac glycosides, a rapid decrease in serum potassium concentration can lead to digitalis intoxication.

    In the treatment of overdose, continuous ECG monitoring, periodic determination of urea, electrolytes and creatinine in the blood plasma, monitoring the potassium concentration (if necessary, every 2-3 hours), asymptomatic patients should be observed for 6 hours.

    Interaction:

    Simultaneous administration with potassium-sparing diuretics (including triamterene, spironolactone, amiloride) can lead to severe hyperkalemia due to decreased renal excretion of potassium ions.

    ACE inhibitors are a risk of developing hyperkalemia, because ACE inhibitors reduce the secretion of aldosterone, which leads to a delay in potassium in the body.

    Beta-blockers were increased as the maximum potassium concentration in the blood serum, and the time required for it to return to baseline in patients who were urgently given a loading dose of potassium intravenously.

    Non-steroidal anti-inflammatory drugs - the risk of hyperkalemia due to the development of secondary hyperaldosteronism after inhibition of prostaglandin synthesis in the kidneys.

    Heparin reduces the synthesis of aldosterone, which can lead to the development of hyperkalemia, especially if there is renal failure or other conditions worsening the excretion of potassium from the body.

    The introduction of potassium preparations is not recommended in patients with severe and complete heart block, using simultaneously cardiac glycosides. If potassium preparations are used to correct hypokalemia in such patients, careful monitoring is required.

    Simultaneous use of insulin, sodium bicarbonate reduces the potassium content in the blood serum.

    The following medicines containing potassium, or predisposing to the development of hyperkalemia, can result in the cumulation of potassium with simultaneous application with potassium preparations: aliskiren, angiotensin II receptor antagonists, ciclosporin, tacrolimus.

    Pharmaceutically compatible with the following solutions for intravenous administration: Ringer's solution in combination with glucose (dextrose) for injection, Ringer's lactate solution in combination with glucose (dextrose) for injection, 5% glucose solution (dextrose) in Ringer's lactate solution for injection,glucose solution (dextrose) in combination with sodium chloride, 5% glucose solution (dextrose) in a 0.9% solution of sodium chloride, 2.5%, 5%, 10%, 20% glucose (dextrose) solutions in water for injection, Ringer's injection, Ringer's lactate for injection, 0.45%, 0.9%, 3% sodium chloride solutions.

    Pharmaceutically incompatible with dilution with solutions containing: amikacin sulfate, amphotericin B, amoxicillin sodium, benzylpenicillin, diazepam, dobutamine hydrochloride, ergotamine tartrate, etoposide with cisplatin and mannitol, methylprednisolone sodium succinate, phenytoin sodium, promethazine hydrochloride, sodium nitroprusside, streptomycin sulfate, mannitol, a sterile fat emulsion containing soybean oil and lecithin (this list is not exhaustive).

    Special instructions:

    During the treatment it is necessary to monitor the potassium concentration in the blood serum during the administration and to adjust the dose in a timely manner. In addition (especially with heart disease, kidneys, or the presence of acidosis), it is recommended to control the acid-base balance, serum electrolytes, ECG and the clinical state of the patient.

    Hyperkalemia develops rapidly and is asymptomatic and can potentially lead to blockade of intracardiac conduction and death. Early signs of hyperkalemia are hypotension and paresthesia of the extremities.

    Treatment should hypokalemia not performed simultaneous introduction of the potassium salt and potassium-sparing diuretics to prevent severe hyperkalemia.

    Potassium Treatment with drugs should be carried out in cases involving heart block, because it can increase the degree of blockade.

    At the initial stage of treatment should avoid introducing simultaneously with glucose, as it can further reduce the concentration of potassium. It is necessary to ensure exclusively intravenous administration of the drug, since perennial administration can cause tissue necrosis.

    Introduction of potassium chloride in small diameter veins may be accompanied by morbidity at the injection site.

    The solution should only be used if it is transparent, and the vial is not damaged.

    The drug should only be diluted in a compatible solution for infusion.

    The preparation should be diluted immediately after opening the vial.When diluting the drug requires strict adherence to the rules of asepsis.

    In terms of microbiological safety, the diluted drug should be used immediately.

    Effect on the ability to drive transp. cf. and fur:

    During drug treatment, care should be taken when carrying out potentially dangerous activities requiring increased concentration and speed of psychomotor reactions (vehicle management, working with moving mechanisms, dispatcher and operator work).

    Form release / dosage:

    Concentrate for the preparation of a solution for infusions, 40 mg / ml.

    Packaging:

    For 100 ml in bottles of glass with a capacity of 250 ml.

    24 bottles with an equal number of instructions for use are placed in a box of corrugated cardboard (for hospitals).

    Storage conditions:

    In dry, the dark place at a temperature of 0 to 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:For hospitals
    Registration number:LP-003891
    Date of registration:07.10.2016
    Expiration Date:07.10.2021
    The owner of the registration certificate:RUSSIAN CARDIOLOGICAL NPK FGU ROSMEDTEKHNOLOGIY - EXPERIMENTAL PRODUCTION OF MEDICAL AND BIOLOGICAL PREPARATIONS RUSSIAN CARDIOLOGICAL NPK FGU ROSMEDTEKHNOLOGIY - EXPERIMENTAL PRODUCTION OF MEDICAL AND BIOLOGICAL PREPARATIONS Russia
    Manufacturer: & nbsp
    Information update date: & nbsp26.11.2017
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