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

    1 ml of the preparation contains:

    Active substance:

    Potassium chloride - 40 mg

    Excipients:

    Dextrose monohydrate (in terms of dextrose) - 334 mg

    1 M hydrochloric acid solution to pH 3.0-4.0

    Water for injection - up to 1 ml

    Description:

    Transparent colorless or slightly yellowish 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 about 1-1.5 mmol / kg body weight. Potassium deficiency can be caused by increased renal excretion,increased losses through the gastrointestinal tract, for example, with vomiting, diarrhea or through fistulas, increased intracellular intake, for example, in the treatment of acidosis or the administration of dextrose and insulin, as well as inadequate 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, including arrhythmias, caused by 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 impaired 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 nephrotoxic 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, nursing women should be careful (if possible, prescribe potassium preparations for oral administration).

    Dosing and Administration:

    The drug is administered intravenously drip. If possible, it is necessary to prescribe potassium preparations for oral administration, especially in children.

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

    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 maintenance therapy can be calculated by the following formula:

    the required amount of mmol K+ = (MT * [kg] x 0.2) ** x 2 x (target concentration K+ at blood plasma *** - the actual concentration of K+ in blood plasma [mmol / l]

    Where:

    * MT = body weight;

    ** The value is the extracellular volume of the fluid;

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

    At gipokaliemii with disturbances of a warm rhythm - on 1-1,5 g 4-5 times a day; after restoring the heart rhythm, the dose is reduced.

    To arrest seizures of paroxysmal tachycardia on the first day of 8-12 g, followed by a decrease to 3-6 g.

    The solution was administered intravenously - a rate of 2.5 g of potassium chloride in 500 ml of 0.9% isotonic sodium chloride solution or 5% dextrose solution.

    Dextrose is not used at the beginning of hypokalemia therapy, as it may lead to a decrease in potassium concentration in the blood.

    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 solution (short-acting insulin is added at the rate of 1 ND for 3-4 g of dry dextrose). The resulting solution is injected intravenously at a rate of 20-30 drops per minute. The rate of administration should not exceed 1.5 g per hour. With severe hypokalemia or ketoacidosis, a higher rate of administration may be required, which should be accompanied by mandatory ECG monitoring.

    Children with body weight less than 25 kg and newborns should not exceed 0.225 g / kg body weight daily. For children weighing more than 25 kg, doses correspond to those of adults.

    The procedure for working with a polymer ampoule:

    - Take the ampoule and shake it, holding it by the neck.

    - Press the ampoule with your hand, while the drug should not be isolated, and rotate and separate the valve with rotating movements.

    - Through the formed hole, immediately connect the syringe with the ampoule.

    - Turn the ampoule over and slowly put the contents into the syringe.

    - Put the needle on the syringe.

    Side effects:

    Adverse reactions candevelop 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.

    Impaired 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: reduction of blood pressure, centralization of blood circulation.

    Disorders from the gastrointestinal tract: nausea.

    Overdose:

    Symptoms: impaired excretory mechanism or too rapid intravenous administration of potassium can lead to fatal hyperkalemia (muscle hypotension, paresthesia of limbs, slowing of atrioventricular conduction, arrhythmias, cardiac arrest).Early clinical signs of hyperkalemia usually appear at a concentration of potassium ions in the serum of more than 6 meq / l: sharpening of the T wave, disappearance of the P wave, a decrease in the segment ST, interval lengthening QT, expansion of the complex QRS. More severe symptoms of hyperkalemia - muscle paralysis and cardiac arrest - develop at a concentration of potassium ions of 9-10 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 (with 10-20 units of short-acting insulin per 1 liter); Correction of acidosis (if available) by intravenous sodium bicarbonate 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 potassium concentration in the blood serum can lead to digitalis intoxication. In the treatment of overdose it is necessary to carry out continuous ECG monitoring,periodically determine urea, electrolytes and creatinine in blood plasma, control 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-adrenoblockers increased both the maximum serum potassium concentration and the time required to return it to the 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, may result in the cumulation of potassium with simultaneous use of potassium preparations with: 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 0.9% sodium chloride solution, 2.5%, 5%, 10%, 20% glucose (dextrose) solutions in water for injection, Ringer's solution for injections, Ringer's lactate for injection, 0.45 %, 0.9%, 3% solutions of sodium chloride.Pharmaceutically incompatible with dilution with solutions containing: amikacin sulfate, amphotericin B, amoxicillin sodium, benzylpenicillin, diazepam, dobutamine hydrochloride, ergotamine tartrate, etoposide with cisilantin 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 of hypokalemia should not be performed by simultaneous administration of potassium salts and potassium-sparing diuretics in order to avoid severe hyperkalemia.Treatment with potassium preparations should not be performed with diseases accompanied by heart blockages, as this can increase the degree of blockade. At the initial stage of treatment, simultaneous administration with glucose should be avoided, since it may further reduce the potassium concentration. It is necessary to ensure exclusively intravenous administration of the drug, since perennial administration can cause tissue necrosis. With the introduction of potassium chloride into the veins of a small diameter, it can be accompanied by soreness at the injection site. Use the solution only if it is clear, and the ampoule is not damaged. The drug should only be diluted in a compatible solution for infusion. The preparation should be diluted immediately after opening the ampoule. When diluting the drug requires strict adherence to the rules of asepsis. In terms of microbiological safety, the diluted drug should be used immediately. The ampoule is for single use only. Remaining unused quantities of the drug are subject to destruction.

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

    During the treatment period, care must be taken when driving vehicles and engaging in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

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

    Packaging:

    10 ml per ampoule of low density polyethylene or polypropylene. For 10 ampoules together with instructions for use in a pack of cardboard.

    For 100 or 200 ml in polypropylene bottles with a scale and holder loop, sealed with welded polypropylene caps. One bottle together with instructions for use in a pack of cardboard.

    For hospitals

    From 1 to 40 bottles but 100 or 200 ml together with instructions for use in an amount equal to the number of bottles in a corrugated box of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date!

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003059
    Date of registration:25.06.2015
    Expiration Date:25.06.2020
    The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp26.11.2017
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