Kalidex (Solution) Instructions for Use

ATC Code

B05XA01 (Potassium chloride)

Active Substances

Potassium chloride (Ph.Eur.)

Dextrose (Ph.Eur.)

Clinical-Pharmacological Group

Drug replenishing potassium deficiency in the body

Pharmacotherapeutic Group

Potassium preparation

Pharmacological Action

The medicinal product contains glucose (dextrose) and electrolytes – potassium and chloride ions.

Potassium is the most important cation of the intracellular space; about 98% of the total potassium content in the body is found in the intracellular fluid.

Potassium is involved in the electrochemical processes of the cell, as well as in carbohydrate and protein metabolism. It is vital for maintaining the acid-base balance, isotonicity, and electrodynamic properties of the cell. This electrolyte is important and indispensable for a number of physiological processes, in particular, for the conduction of nerve impulses, contraction of cardiac, smooth and skeletal muscles, gastric secretion, kidney function, tissue formation, carbohydrate utilization and protein synthesis. During the synthesis of glycogen and proteins, potassium is consumed by the cells, and during the breakdown of these substrates, potassium is released (about 0.4-1 mmol of potassium /g of glycogen and about 2-3 mmol of potassium/g of excreted nitrogen).

Chlorides are the main anions of the extracellular fluid responsible for the physiological distribution of sodium and potassium in the body. Together with sodium and bicarbonates, chlorides play an important role in regulating the acid-base balance. A change in the concentration of chlorides in the blood serum, in turn, leads to a change in the acid-base balance.

Glucose is the main carbohydrate in the human body, vital for some organs. In the body, glucose and its derivatives are used as a source of energy, components of nucleic acids, as well as for the conversion of proteins and fats, the formation of glycosaminoglycans and lactose; in addition, glucose forms compounds for the excretion of various substances.

In the postoperative, post-traumatic periods and in other clinical cases, serious loss of fluid and electrolytes, and the predominance of catabolic processes are often observed.

This combination is indicated for such patients to restore water-electrolyte balance, provide energy and prevent further disruption of the body’s functions.

Pharmacokinetics

Bioavailability is 100%.

The concentration of potassium and the acid-base state of the blood plasma are closely related. Alkalosis is often accompanied by hypokalemia, and acidosis by hyperkalemia. A normal plasma potassium concentration in the presence of 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. The intracellular potassium concentration exceeds the extracellular concentration by up to 40 times.

Chlorides enter the extracellular space to a greater extent. The normal plasma chloride concentration usually ranges from 98 to 108 mmol/L.

The fasting plasma glucose level ranges from 3.9 to 5.6 mmol/L (70-100 mg/dL).

Plasma glucose levels are controlled by the liver, a number of hormones, and skeletal muscle. Normally, glucose is completely oxidized to carbon dioxide and water, but this metabolic process has its limitations. Excess glucose is stored as glycogen or converted to fat. The processes of glucose excretion, oxidation and reuse in the body are impaired in severe trauma and other clinical conditions, such as diabetes. In such situations, the solution should be administered with caution to avoid hyperglycemia.

Potassium and chlorides are mainly excreted by the kidneys in the urine (about 90%), but small amounts are lost in feces and through sweating (about 10%). The end products of complete glucose oxidation are excreted through the lungs (carbon dioxide) and through the kidneys (water). In particular, surgical interventions promote increased potassium excretion in the urine while retaining water and sodium. The mutual influence of individual electrolytes must be taken into account during replacement therapy and correction of water-electrolyte metabolism.

Indications

Treatment and prevention of hypokalemia of various origins (including arrhythmias caused by hypokalemia).

ICD codes

Dosage Regimen

Administer intravenously only.

Determine the dose based on the patient’s age, body weight, and clinical condition.

Base the regimen on serum potassium levels, acid-base status, and continuous ECG monitoring.

For adults, the maximum infusion rate is 20 mmol of potassium per hour, equivalent to 0.3 mmol/kg/hour.

Do not exceed a glucose administration rate of 5 ml/kg/hour (0.25 g glucose/kg/hour) due to the solution’s composition.

Use an infusion pump for controlled administration, particularly during corrective therapy for hypokalemia.

Monitor serum electrolytes, blood glucose, and fluid balance regularly throughout the infusion.

Ensure adequate sodium intake to prevent hyponatremia.

Adjust the dosage with extreme caution in patients with cardiac or renal impairment, and in those receiving cardiac glycosides.

In pediatric and geriatric patients, administer under constant supervision due to increased risk of fluid and electrolyte disturbances.

Discontinue administration gradually to avoid rebound shifts in potassium concentration.

Adverse Reactions

Local reactions local pain, irritation at the injection site, thrombophlebitis.

Contraindications

Hyperkalemia; severe hyperchloremia; severe renal failure with oligo- and anuria; head injury (first 24 hours); hyperhydration; hyperglycemia requiring insulin administration in an amount of more than 6 units/hour; disorders often associated with hyperkalemia, such as: complete heart AV block, Addison’s disease, hereditary periodic paralysis (hyperkalemic familial periodic paralysis, Gamstorp syndrome), sickle cell anemia.

With caution

In patients suffering from heart disease, especially heart failure accompanied by edema or pulmonary edema; in patients taking cardiac glycosides, aldosterone antagonists, ACE inhibitors, tacrolimus, cyclosporine, long-acting heparin, suxamethonium or potentially nephrotoxic drugs (NSAIDs, peripheral analgesics); should be administered with caution to patients with diabetes, as well as to patients with other glucose tolerance disorders; in all cases of carbohydrate metabolism disorders, blood glucose levels should be monitored.

Use in Pregnancy and Lactation

Used only for clear indications, if the expected benefit to the mother outweighs the risk to the fetus.

Caution should be exercised when prescribing to nursing women.

Use in Hepatic Impairment

There are no special instructions for use restrictions.

Use in Renal Impairment

Contraindication: severe renal failure with oligo- and anuria.

Pediatric Use

In children, intravenous infusion therapy should be carried out under constant supervision due to possible disturbances in water and electrolyte balance. Special caution is required when administering low-salt solutions to children, as well as careful monitoring of water and electrolyte balance.

Geriatric Use

Constant monitoring is recommended during the treatment of elderly patients prone to heart and kidney failure, as well as strict adherence to the dose to avoid complications from the circulatory system and kidneys due to hypervolemia.

Special Precautions

This combination affects the water-electrolyte balance. This must be taken into account during therapy.
Clinical monitoring should include ECG, as well as regular monitoring of water balance, serum electrolyte levels and blood glucose.

The maximum rate of potassium administration in adults is up to 20 mmol of potassium/hour (corresponding to 0.3 mmol of potassium/kg body weight/hour). When using this combination, the maximum rate of administration is limited by the glucose contained in it and is up to 5 ml/kg body weight/hour, which corresponds to 0.25 g of glucose/kg body weight/hour.

To prevent hyponatremia, sufficient sodium intake must be ensured, taking into account the volume of the administered medicinal product.

Glucose-containing solutions are not recommended to be administered simultaneously with blood products, as well as immediately before and after such a procedure, using the same equipment due to the risk of pseudoagglutination.

Measures should be taken to prevent a sharp decrease in serum sodium concentration, as this may entail the risk of osmotic damage to the central nervous system.

It is not recommended to administer glucose-containing solutions after acute ischemic strokes, since it is known that hyperglycemia aggravates ischemic brain damage and slows down recovery processes.

Hyperkalemia often provokes the development of disorders such as Addison’s disease or sickle cell anemia.
An infusion pump is recommended for the administration of potassium as part of corrective therapy.

Effect on the ability to drive vehicles and mechanisms

During the treatment period, caution must be exercised when driving vehicles, operating machinery, and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Cardiac glycosides

An increase in the extracellular potassium concentration reduces the effectiveness of cardiac glycosides, while a decrease in the extracellular potassium concentration enhances the arrhythmogenic effect of cardiac glycosides and can cause cardiac glycoside intoxication.

Therefore, when treating patients receiving cardiac glycosides, a constant potassium concentration must be maintained. Potassium administration should be discontinued very carefully in such patients.
The medicinal product may interact with antiarrhythmic drugs in case of their simultaneous use.

Drugs that reduce potassium excretion

The use of potassium-containing preparations and drugs that promote hyperkalemia, such as: potassium-sparing diuretics, for example, spironolactone, triamterene, amiloride; ACE inhibitors; AT1 receptor blockers; NSAIDs; cyclosporine; tacrolimus; suxamethonium; long-acting heparin, should be combined with caution.
When these drugs are administered together with potassium chloride, severe hyperkalemia may develop, which has a negative effect on heart rhythm.

Drugs that cause a decrease in serum potassium levels

ACTH, corticosteroids and “loop” diuretics may increase renal potassium excretion.

Storage Conditions

Store at 2°C (36°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.