Potassium chloride

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)

Composition:

Active substance: potassium chloride;

1 ml of solution contains potassium chloride 75 mg;

Excipient: water for injections.

Pharmaceutical form. Concentrate for infusion solution.

Main physico-chemical properties: clear, colorless liquid;

ionic composition: potassium ion – 1.01 mmol/ml; chloride ion – 1.01 mmol/ml.

Pharmacotherapeutic group. Electrolyte solutions. Potassium chloride.

ATC code B05XA01.

Pharmacological Properties

Pharmacodynamics

A medicinal product that restores potassium deficiency. It helps maintain adequate intracellular and extracellular potassium levels. Potassium is the main intracellular ion and plays an important role in cellular metabolism and regulation of various body functions. Potassium ions activate a large number of cytoplasmic enzymes, regulate intracellular osmotic pressure, enhance the tone of the sympathetic division of the autonomic nervous system, increase adrenaline production by the adrenal glands, stimulate the synthesis of adenosine triphosphate (ATP), glycogen, proteins, and acetylcholine. Potassium reduces heart rate, decreases myocardial contractility, conductivity, automaticity, and excitability. In low doses, potassium dilates coronary vessels; in high doses, it constricts them. The drug corrects electrolyte imbalance in the body, improves myocardial metabolism and energy supply, and has antiarrhythmic properties. It reduces increased sensitivity to cardiac glycosides and diminishes their cardiotoxic effects.

Pharmacokinetics

After intravenous infusion, the drug enters cells, particularly cardiomyocytes, in the form of potassium ions. Potassium participates in cellular metabolism. It is excreted in urine.

Clinical characteristics.

Indications.

Tachycardia, extrasystolic arrhythmia caused by hypokalemia, including cardiac glycoside intoxication. Severe hypokalemia (serum potassium concentration less than 2.5 mmol/L).

Contraindications.

Acute and chronic renal failure (with oliguria, anuria, azotemia), complete heart block, atrioventricular (AV) conduction disturbances, hyperkalemia (serum potassium concentration greater than 5 mmol/L), hyperchloremia, metabolic disorders (hypovolemia with hyponatremia), hyperhydration, systemic acidosis, diabetic ketoacidosis, acute dehydration, severe burns, intestinal obstruction, cerebral edema, Addison's disease, heat cramps.

The medicinal product must not be administered simultaneously with blood preparations.

Interaction with other medicinal products and other types of interactions.

The drug improves tolerance of cardiac glycosides, allowing simultaneous administration of strophanthin or digitalis preparations if necessary.

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

During simultaneous infusions of glucose solutions and potassium chloride, further reduction in blood potassium levels may occur (see section "Special precautions for use").

Concomitant use of potassium chloride with nonsteroidal anti-inflammatory drugs (NSAIDs) increases the risk of hyperkalemia (serum potassium levels should be monitored). Under the influence of potassium preparations, the cardiac effect of quinidine and the adverse cardiovascular effects of disopyramide are enhanced.

Special precautions for use.

Do not administer undiluted!

Use only as directed by a physician.

High concentrations of potassium may cause serious cardiotoxicity; therefore, the solution concentration should not exceed 3 g (40 mmol)/L, and the diluted solution must be administered slowly (maximum rate 20 mmol/hour).

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

Use with caution in patients with impaired AV conduction. It should be noted that the toxicity of potassium salts increases in adrenal insufficiency. The drug should be used cautiously in patients with intracranial and intraspinal hemorrhages.

Magnesium deficiency, which may accompany potassium deficiency, should also be corrected.

Hyperkalemia, which may be fatal, can develop in patients with chronic kidney disease or other conditions associated with impaired potassium excretion or impaired cellular potassium uptake, as well as in cases of very rapid intravenous administration of potassium chloride (75 mg/mL).

During treatment, it is recommended to regularly monitor serum potassium levels, acid-base balance, and perform ECG monitoring, especially in patients with cardiovascular or renal diseases.

Dehydration should be corrected to ensure adequate urine output (and potassium excretion).

Use with particular caution in patients with cardiovascular diseases, conditions involving significant tissue destruction (e.g., burns), and when co-administering 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").

Concomitant parenteral administration of calcium ions may cause arrhythmias.

Particular caution is required when abruptly discontinuing potassium chloride during concomitant use with cardiac glycosides, as the resulting hypokalemia may potentiate digitalis toxicity.

The contents of a vial should be used for only one patient; any unused portion must be discarded.

Use during pregnancy or breastfeeding.

There are no known contraindications for use during pregnancy or breastfeeding; however, it should be remembered that potassium preparations reduce uterine tone. Potassium chloride should be used during pregnancy or breastfeeding only if deemed necessary by a physician and under medical supervision. In pregnant women with nephropathy, the drug should be used cautiously if there are life-threatening indications.

Ability to influence reaction rate while driving or operating machinery.

Since this medicinal product is intended for use in a hospital setting, data on such effects are not available.

Dosage and Administration.

The dosage regimen and duration of treatment are determined individually by a physician based on electrocardiography results and serum potassium levels. Generally, adults should be administered 0.5 to 2 g of potassium chloride per day. As a solvent, 200–250 mL of 0.9% sodium chloride solution or 5% glucose solution may be used. The infusion rate is 20–30 drops per minute.

Children.

There are no data available regarding the use of this medicinal product in children.

Overdose.

Overdose often remains asymptomatic until serum potassium concentration reaches high levels (6.5–8 mmol/L). It manifests as an intensification of adverse reactions. Hyperkalemia and hyperhydration may develop. Patients may experience muscle weakness or heaviness in the legs, limb paresthesia, flaccid paralysis, abdominal pain, lethargy, pale and cold skin, confusion, peripheral vascular collapse, rapid shallow breathing, cardiac arrhythmias and conduction disturbances, possible loss of consciousness, elevated body temperature, apathy, decreased arterial pressure and body weight, and psychiatric disorders. The above-mentioned adverse reactions may lead to a significant deterioration in the patient's condition.

Electrocardiogram (ECG) findings include increased T-wave amplitude, ST-segment depression, and QRS complex widening.

An extremely high plasma potassium level (8–11 mmol/L) may result in fatal outcomes due to suppression of cardiac activity, development of arrhythmias, and cardiac arrest.

All medicinal products containing potassium, as well as potassium-sparing diuretics, must be discontinued immediately.

In case of overdose, symptomatic treatment aimed at supporting vital functions should be administered. Parenterally administer 300–500 mL/hour of 10% glucose solution (with the addition of 10 units of regular insulin per 20 g of glucose) or sodium bicarbonate solution.

Plasma potassium concentration exceeding 6.5 mmol/L or the presence of cardiac arrhythmia requires urgent intravenous injection of 10–20 mL of 10% calcium gluconate solution over 1–5 minutes under ECG monitoring.

If necessary, perform hemodialysis or peritoneal dialysis.

During treatment of overdose, continuous ECG monitoring is required, along with determination of blood urea, electrolytes, and creatinine levels in plasma, and frequent checks of potassium levels (if necessary, every 2–3 hours). Patients without symptoms of overdose should be observed for at least 6 hours.

Side effects.

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 rare cases, when high doses are administered, the following may occur:

• muscle weakness;
• paresthesia;
• paralysis;
• confusion.

General reactions:

• hypervolemia;
• jaundice;
• sore throat.

Local reactions at the 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. Treatment is symptomatic.

Shelf life. 2 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Do not freeze. Keep out of reach of children.

Incompatibility.

Do not mix with other medicinal products. Do not use other medicinal products as solvents except those specified in the section "Administration and dosage".

Packaging.

10 ml or 20 ml in glass vials.

Prescription category. Prescription only.

Manufacturer.

LLC "Yuria-Pharm".

Manufacturer's address and location of business activity.

108, Kozbirska St., Cherkasy, Cherkasy region, 18030, Ukraine. Tel.: (044) 281-01-01.