Potassium chloride (Concentrate) Instructions for Use

ATC Code

B05XA01 (Potassium chloride)

Active Substance

Potassium chloride (Ph.Eur.)

Clinical-Pharmacological Group

Drug replenishing potassium deficiency in the body

Pharmacotherapeutic Group

Blood substitutes and perfusion solutions; additives to solutions for intravenous administration; electrolyte solutions

Pharmacological Action

A means of replenishing potassium deficiency in the body. It helps maintain the necessary intra- and extracellular potassium levels. Potassium is the main intracellular ion and plays an important role in regulating various body functions.

It is involved in maintaining intracellular osmotic pressure, in the processes of conduction and transmission of nerve impulses to innervated organs, in the contraction of skeletal muscles, and in a number of biochemical processes.

It reduces the excitability and conductivity of the myocardium, and in high doses, it suppresses automaticity.

Pharmacokinetics

After intravenous administration, the bioavailability is 100%. Potassium and chloride ions enter the general pool of ions in the body. The concentration of potassium and the acid-base state of the blood plasma are closely interrelated.

Alkalosis is often accompanied by hypokalemia, and acidosis by hyperkalemia. A normal plasma potassium concentration during acidosis indicates a potassium deficiency. The intracellular potassium concentration is about 140-150 mmol/l. The normal plasma potassium concentration ranges from 3.5 to 5 mmol/l.

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

Indications

Hypokalemia of various origins, including that caused by vomiting, diarrhea, hyperaldosteronism, polyuria in chronic renal failure, intake of certain medications; arrhythmias, including in glycoside intoxication; hypokalemic form of paroxysmal myoplegia.

ICD codes

Dosage Regimen

Administer intravenously only after dilution. Determine the dose, rate, and duration of infusion individually based on the severity of the potassium deficit and the patient’s clinical condition.

Calculate the required dose based on serum potassium concentration. Adjust the regimen according to repeated laboratory measurements and continuous ECG monitoring, especially in high-risk patients.

For adult patients, the usual intravenous infusion concentration is 20-60 mmol of potassium per liter of solution. The maximum recommended concentration for peripheral infusion is 40 mmol per 1000 ml. For more concentrated solutions, use a large central vein.

Do not exceed an infusion rate of 10-20 mmol per hour as a general rule. In severe hypokalemia with cardiac manifestations, rates up to 40 mmol per hour may be used under continuous ECG monitoring in an intensive care setting.

The total 24-hour dose typically should not exceed 200-400 mmol. Monitor serum potassium levels frequently to avoid hyperkalemia. Discontinue infusion immediately if signs of hyperkalemia, such as peaked T-waves on ECG, appear.

Dilute the concentrate in a compatible intravenous fluid before administration. Common diluents include 0.9% Sodium Chloride or 5% Dextrose solutions. Ensure thorough mixing.

Inspect the final infusion solution for particulate matter and discoloration prior to administration. Do not administer if crystals are present or the solution is cloudy.

Adverse Reactions

Immune system disorders allergic reactions.

Metabolism and nutrition disorders acidosis, hyperchloremia, hyperkalemia.

Nervous system disorders fatigue, muscle weakness, confusion, heaviness in the limbs, muscle cramps, paresthesia, ascending paralysis.

Cardiac and vascular disorders bradycardia, AV block, ventricular fibrillation, cardiac arrest, decreased blood pressure, centralization of circulation; too high infusion rate may cause cardiac arrhythmia.

Gastrointestinal disorders nausea.

Contraindications

Hypersensitivity to potassium chloride; hyperkalemia or hyperchloremia of any etiology, complete AV or intraventricular block; renal failure with oliguria or azotemia; ventricular fibrillation; Addison’s disease; hyperadrenalism associated with adrenogenital syndrome; extensive tissue breakdown (including severe burns); acute dehydration; heat cramps; conditions with increased sensitivity to potassium administration (including hereditary episodic adynamia or congenital paramyotonia); concomitant therapy with potassium salts and potassium-sparing diuretics; age under 18 years (efficacy and safety not established).

With caution AV block I-II degree, heart failure; sickle cell anemia; diseases and conditions accompanied by impaired potassium excretion, including chronic renal failure; adrenal insufficiency; in patients taking cardiac glycosides, aldosterone antagonists, ACE inhibitors, tacrolimus, cyclosporine, long-acting heparin, suxamethonium, or potentially nephrotoxic drugs (NSAIDs, peripheral analgesics).

Use in Pregnancy and Lactation

During pregnancy, it should be used with caution, strictly according to indications, in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

Potassium is excreted in breast milk. Use is indicated only in cases where the intended benefit to the mother outweighs the potential risk to the infant.

Use in Renal Impairment

Contraindicated in renal failure with oliguria or azotemia. Use with caution in chronic renal failure.

Pediatric Use

Use in children and adolescents under 18 years of age is contraindicated.

Special Precautions

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

Hyperkalemia develops rapidly and is asymptomatic, potentially leading to intraventricular conduction block and death. Early signs of hyperkalemia are limb hypotonia and paresthesia.

Treatment of hypokalemia should not be carried out simultaneously with the administration of potassium salts and potassium-sparing diuretics to avoid severe hyperkalemia.

Treatment with potassium preparations should not be carried out in diseases accompanied by heart block, as this may increase the degree of block.

At the initial stage of treatment, the administration of potassium chloride simultaneously with glucose should be avoided, as this may contribute to a further decrease in potassium concentration. It is necessary to ensure exclusively intravenous administration, since perivenous administration may cause tissue necrosis.

Administration of potassium chloride into small-diameter veins may be accompanied by pain at the injection site.

Effect on ability to drive vehicles and operate machinery

During the use of potassium chloride, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

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

ACE inhibitors – risk of hyperkalemia, since ACE inhibitors reduce aldosterone secretion, leading to potassium retention in the body.

Beta-blockers increased both the maximum serum potassium concentration and the time required for it to return to baseline in patients who received an emergency intravenous potassium loading dose.

NSAIDs – risk of hyperkalemia due to the development of secondary hyperaldosteronism after inhibition of prostaglandin synthesis in the kidneys.

Heparin reduces aldosterone synthesis, which may lead to the development of hyperkalemia, especially in the presence of renal failure or other conditions that impair potassium excretion from the body.

Administration of potassium preparations is not recommended in patients with severe and complete heart block who are simultaneously taking cardiac glycosides. In case of using potassium preparations to correct hypokalemia, careful monitoring of the patient’s condition is required.

Simultaneous use with insulin, sodium bicarbonate reduces serum potassium levels.

The following medicinal products containing potassium, or predisposing to the development of hyperkalemia, may lead to potassium accumulation when used simultaneously with potassium preparations: aliskiren, angiotensin II receptor antagonists, cyclosporine, tacrolimus.

Potassium chloride is 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 (dextrose) solution in Ringer’s lactate for injection, glucose (dextrose) solution in combination with sodium chloride, 5% glucose (dextrose) solution in 0.9% sodium chloride solution, 2.5%, 5%, 10%, 20% glucose (dextrose) solutions in water for injection, Ringer’s solution for injection, Ringer’s lactate solution for injection, 0.45%, 0.9%, 3% sodium chloride solutions.

Potassium chloride is pharmaceutically incompatible when diluted 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, sterile fat emulsion containing soybean oil and lecithin.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.