Potassium chloride solution 7.5 %

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT POTASSIUM CHLORIDE SOLUTION 7.5%

Composition:

Active substance: potassium chloride;

1 ml of solution contains potassium chloride 75 mg;

Ionic composition per 1 ml of product: K+ — 1 mmol, Cl− — 1 mmol;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Electrolyte solutions. Potassium chloride. ATC code B05XA01.

Pharmacological properties.

Pharmacodynamics. Potassium — the active substance of the medicinal product — is the main intracellular cation of most body tissues. Potassium ions are essential for many vital physiological processes. They participate in the regulation of excitability, contractility, conduction, and automaticity of the myocardium; are necessary for maintaining intracellular pressure, nerve impulse conduction and synaptic transmission, maintaining potassium concentration in the myocardium, skeletal muscles, and smooth muscle cells, as well as for maintaining normal kidney function. In small doses, potassium ions dilate coronary vessels, while in large doses they constrict them. Potassium promotes an increase in acetylcholine content and stimulates the sympathetic part of the central nervous system. It exerts a moderate diuretic effect. Elevated potassium levels reduce the risk of cardiotoxic effects of cardiac glycosides on the heart. Potassium also plays an important role in the development and correction of acid-base balance disorders.

Pharmacokinetics. Potassium is mainly excreted by the kidneys through secretion in the distal tubules, where sodium-potassium exchange also occurs. The kidney's ability to retain potassium is limited, and potassium excretion in urine continues even with a significant decrease in potassium levels in the body. Tubular secretion of potassium depends on several factors, including chloride ion concentration, hydrogen ion exchange, acid-base balance, and adrenal hormones. A certain amount of potassium is excreted in feces, and a small amount may be excreted in saliva, sweat, bile, or pancreatic juice.

Clinical characteristics.

Indications.

Hypokalemia; cardiac glycoside intoxication; arrhythmias of various origins, including paroxysmal tachycardia (mainly associated with electrolyte disturbances and absolute or relative hypokalemia).

Contraindications.

Impaired renal excretory function (potassium accumulates in blood plasma, which may lead to intoxication), acute and chronic renal failure (with oliguria or anuria, azotemia), retention uremic stage in chronic renal failure, atrioventricular conduction disturbances, hyperkalemia, hyperchloremia, systemic acidosis, diabetic acidosis, acute dehydration, severe burns, intestinal obstruction, Addison's disease, cerebral edema, heat cramps. The medicinal product must not be administered simultaneously with blood preparations.

Interaction with other medicinal products and other forms of interactions.

When potassium chloride is used concomitantly with potassium-sparing diuretics (amiloride, spironolactone, triamterene), angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, aliskiren, cyclosporine, tacrolimus (not for topical use), trimethoprim, and nonsteroidal anti-inflammatory drugs, the risk of developing severe hyperkalemia increases (monitoring of serum potassium levels is required). Particularly careful monitoring of blood potassium levels is necessary when using these medicinal products in conditions that may cause elevated blood potassium levels.

In patients with hypokalemia, glucose infusions may lead to further reduction in blood potassium levels, even with concomitant administration of potassium chloride (see section "Special precautions for use").

Under the influence of potassium preparations, the cardiac effect of quinidine and the adverse cardiovascular effects of disopyramide are enhanced. Potassium preparations improve tolerance to cardiac glycosides.

Special precautions for use.

During treatment, it is recommended to regularly monitor serum potassium levels to avoid the development of hyperkalemia, as well as blood acid-base balance, and to monitor cardiac activity using ECG, especially in patients with cardiovascular and kidney diseases.

At the beginning of treatment, do not use with glucose solutions, as glucose may further reduce blood potassium levels.

Magnesium deficiency, which may accompany potassium deficiency, should also be treated. In patients with chronic kidney disease or other conditions associated with impaired potassium excretion, or during very rapid intravenous administration of potassium chloride, hyperkalemia may develop, which could potentially lead to fatal outcomes. Use with caution in patients with cardiovascular diseases, conditions involving significant tissue destruction (e.g., burns), or when used concomitantly with potassium-sparing diuretics or other medicinal products that may increase serum potassium levels (see section "Interaction with other medicinal products and other forms of interaction"). Concurrent parenteral administration of calcium ions may cause arrhythmias.

Sudden discontinuation of potassium chloride when used concomitantly with cardiac glycosides requires particular caution, as hypokalemia developing in this case enhances the toxicity of digitalis preparations.

Use during pregnancy or breastfeeding.

The medicinal product may be used when clinically indicated, when the benefit outweighs the risk. It should be noted that potassium preparations reduce uterine tone.

The medicinal product should be used with caution in pregnant women with nephropathy.

Ability to influence reaction rate while driving or operating machinery.

The product should be administered only under hospital conditions. Data regarding the influence of the product on reaction rate while driving or operating machinery are lacking.

Administration and Dosage

Administer intravenously by infusion.

Do not administer undiluted!

The 7.5% concentrated potassium chloride solution must be diluted before administration and thoroughly mixed. The concentration of the ready-to-use solution must not exceed 3 g/L or 40 mmol/L. As a diluent, 0.9% sodium chloride solution or 5% glucose solution may be used. The dose and rate of administration depend on the individual patient's condition. The required dose should be determined based on serum potassium levels. Potassium deficit should be calculated using the following formula:

Potassium = body weight × 0.2 × 2 × (4.5 — K+plasma),

where: potassium — calculated in mmol, body weight — in kg, 4.5 — normal potassium level in mmol/L in blood serum, K+plasma — actual potassium concentration (mmol/L) in the patient's blood serum.

The result obtained represents the required amount of potassium (in mmol) for an organism with potassium deficiency. To determine the volume of medication to be used, note that the 7.5% potassium chloride solution contains 1 mmol of K+ ions per 1 mL.

If serum potassium concentration is above 2.5 mmol/L, the infusion rate should not exceed 10 mmol/hour, and the daily potassium dose should not exceed 200 mmol.

If urgent treatment of severe hypokalemia is indicated (serum potassium concentration below 2 mmol/L, ECG changes, muscle paralysis), potassium chloride may be administered very cautiously at a rate of up to 40 mmol/hour. In this case, up to 400 mmol of potassium may be infused over 24 hours. Continuous cardiac monitoring and serum potassium concentration control are required to prevent hyperkalemia and cardiac arrest. In critical conditions, potassium chloride should be administered in 0.9% sodium chloride solution (if not contraindicated), rather than in glucose-containing solutions, as glucose may reduce serum potassium levels.

Children.

There is no available data on the use of this medicinal product in children.

Overdose.

Overdose may remain asymptomatic for a long time until serum potassium concentration reaches high levels (6.5–8 mmol/L). Hyperkalemia and hyperhydration may develop.

Clinical symptoms of potassium overdose: limb paresthesia, muscle weakness or heaviness in legs, flaccid paralysis, abdominal pain, frequent shallow breathing, cardiac rhythm and conduction disturbances, pale and cold skin, peripheral vascular collapse, lethargy, confusion, possible loss of consciousness, elevated body temperature, apathy, decreased blood pressure and body weight, psychiatric disorders. Electrocardiogram (ECG) shows peaked T waves, ST segment depression, widened QRS complex, reduced P wave amplitude, prolonged PQ interval. Extremely high plasma potassium concentration (8–11 mmol/L) may lead to fatal outcome due to cardiac depression, development of arrhythmias, and cardiac arrest.

Treatment: immediately discontinue potassium chloride administration. All potassium-containing medications and potassium-sparing diuretics should be discontinued immediately. Symptomatic treatment should be directed toward supporting vital functions.

Plasma potassium concentration may be reduced by infusing 300–500 mL/hour of 10% glucose solution containing up to 10 units of insulin per 20 g of glucose, or by infusing sodium bicarbonate solution.

Plasma potassium concentration above 6.5 mmol/L or cardiac arrhythmia requires urgent intravenous injection of 10–20 mL of 10% calcium gluconate solution over 1–5 minutes under ECG monitoring. In severe cases, hemodialysis or peritoneal dialysis is indicated.

During overdose treatment, ECG monitoring is required; plasma levels of urea, electrolytes, and creatinine should be determined; potassium levels should be checked (if necessary, every 2–3 hours). Patients without symptoms of overdose should be observed for 6 hours.

Too rapid reduction of serum potassium concentration during hyperkalemia treatment in patients taking cardiac glycosides may lead to digitalis intoxication.

Adverse reactions.

Electrolyte imbalance: hypophosphatemia; hypomagnesemia; hyperkalemia; hyponatremia.

Gastrointestinal disorders: dyspeptic disorders (nausea, abdominal pain).

Cardiovascular system: bradycardia; cardiac conduction disorders, arrhythmia, extrasystole; arterial hypotension, cardiac arrest.

Immune system: allergic reactions (hyperthermia, skin rashes, angioneurotic edema, shock).

Nervous system: in isolated cases, when high doses are administered, muscle weakness, paresthesia, paralysis, confusion may occur.

General reactions: hypervolemia; dyspnea; sore throat.

Local reactions at site of administration: pain, redness, phlebitis (during intravenous infusion of solutions containing 30 mmol/L or more potassium).

If adverse reactions occur, administration of the solution should be discontinued. Symptomatic treatment is recommended.

Reporting of suspected adverse reactions

Reporting of adverse reactions following drug registration is important. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions. Store at temperatures not exceeding 25 °C, in a place inaccessible to children. Do not freeze.

Incompatibilities.

Do not mix with other medicinal products. For reconstitution, do not use any medicinal products other than those specified in the section “Directions for use and dosage”.

Packaging. 10 ml or 20 ml in glass vials.

Prescription status. Prescription only.

Manufacturer. Private Joint Stock Company "Infuziya".

Manufacturer's address and location of operations.

Vinnitski Khotory, Nemirovskе Highway, 84A, Vinnitsa district, Vinnitsa region, 23219, Ukraine.