Instructions for Caldium extended-release capsules 600 mg bottle No. 100
Composition
active ingredient: potassium chloride;
1 extended-release capsule contains 600 mg of potassium chloride;
excipients: microcrystalline cellulose, ethyl acrylate and methyl acrylate copolymer (1:1) (in the form of a 30% aqueous dispersion solution), dimethicone, talc, colloidal anhydrous silicon dioxide, indigo carmine (E 132);
composition of the gelatin capsule: gelatin, FD&C red (erythrosine (E 127)), FD&C blue (indigo carmine (E 132)).
Dosage form
Extended-release capsules.
Main physicochemical properties: gelatin capsules containing a mixture of blue and white or yellowish granules; capsule cap is blue, capsule body is transparent, colorless.
Pharmacotherapeutic group
Potassium preparations. Potassium chloride.
ATX code A12B A01.
Pharmacological properties
Pharmacodynamics.
Potassium is one of the most important intracellular cations, involved in many physiological processes; it ensures normal muscle contraction, transmission of nerve impulses and carbohydrate metabolism. The potassium cation is vital for the normal functioning of the body.
Pharmacokinetics.
Potassium chloride is rapidly absorbed after oral administration: approximately 90% of potassium ingested with food is absorbed. Potassium is mainly excreted by the kidneys, secreted by the distal tubules, where it is replaced by sodium or hydrogen ions. Renal excretion of sodium cannot be limited even when the concentration of its ions in the body decreases. A small amount of potassium is excreted in the feces and sweat.
Potassium chloride in extended-release capsules is contained in granules, which provides a slow release. After the capsule is broken, the granules disperse and gradually release the active substance as it passes through the digestive tract. These two factors prevent the creation of too high a temporary concentration of potassium chloride and thus reduce the likelihood of side effects on the digestive tract.
Indication
Prevention and treatment of hypokalemia.
Contraindication
Hypersensitivity to the active substance or any components of the drug.
Hyperkalemia caused by certain diseases and medications, for example, in the case of taking potassium-sparing diuretics or ACE inhibitors, in the case of adrenocortical insufficiency, renal insufficiency, acidosis, diabetic ketoacidosis, after tissue injury (see section "Interaction with other medicinal products and other types of interactions").
Oligoanuric and uremic stages of acute renal failure.
Retentional uremic stage of acute renal failure.
Adrenal insufficiency (Addison's disease).
Inhibition of the function of the gastrointestinal tract of organic or functional origin.
Structural or functional disorders that affect the passage of the drug through the digestive tract.
Interaction with other medicinal products and other types of interactions
When used concomitantly with other drugs that interact with the drug, serum potassium levels should be periodically checked.
An increase in serum potassium concentration may occur in the case of simultaneous use of Kaldium® with potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (e.g., captopril, enalapril), angiotensin II receptor inhibitors, proton pump inhibitors, indomethacin, glucocorticoids, heparin, cardiac glycosides, beta-adrenergic blockers, other drugs containing potassium, nephrotoxic drugs (cisplatin, aminoglycosides).
Potassium-sparing diuretics.
The concomitant use of potassium chloride with potassium-sparing diuretics such as amiloride, canrenone, spironolactone, triamterene (alone or in combination) is contraindicated (see section 4.3). In patients with renal insufficiency, the risk of fatal hyperkalemia is potentially increased.
Angiotensin-converting enzyme inhibitors.
The concomitant use of potassium chloride with angiotensin-converting enzyme (ACE) inhibitors is not recommended, except in cases of hypokalemia. The concomitant use of such drugs increases the risk of fatal hyperkalemia, especially in patients with renal insufficiency. In patients taking ACE inhibitors, potassium supplementation should be used only under close supervision.
Cardiac glycosides.
Potassium chloride should be used with extreme caution with cardiac glycosides, as hyperkalemia reduces the intropic activity of cardiac glycosides (digoxin) and may cause atrioventricular conduction disorders. Digitalis glycoside, P-blockers, heparin, cyclosporine require regular monitoring of potassium levels in the blood.
Nonsteroidal anti-inflammatory drugs.
Potassium chloride should be used with caution in conjunction with nonsteroidal anti-inflammatory drugs (NSAIDs), anticholinergic drugs, as gastrointestinal adverse reactions may be more pronounced. Serum potassium levels should be monitored when used concomitantly.
When potassium chloride is used together with parenteral calcium preparations, arrhythmias may occur.
Sodium chloride.
A diet rich in sodium chloride increases potassium excretion.
Concomitant use of angiotensin II receptor blockers, the direct renin inhibitor aliskiren, may cause an increase in blood potassium levels.
Simultaneous consumption of foods and plants rich in potassium (e.g., dandelion leaves and roots, banana, tomato, orange juice) may increase the risk of developing hyperkalemia.
Application features
The drug should be used with caution, since the level of potassium deficiency is not always determined correctly and excessive use of potassium preparations can cause potassium intoxication. Therefore, during treatment, it is recommended to regularly determine the level of potassium in the blood serum and perform an ECG, especially in patients with cardiovascular and renal diseases.
The use of Caldium during pregnancy requires a careful assessment of the risk/benefit ratio.
Existing or history of gastrointestinal ulceration requires special caution, as in some cases, gastrointestinal bleeding, ulcers, intestinal perforation, and stenosis may occur after taking slow-release potassium chloride preparations.
For elderly patients or patients with impaired renal function, the drug should be prescribed with caution: a dose reduction may be necessary; regular monitoring of potassium in the blood is particularly important.
Abrupt withdrawal of Kaldium during combination therapy with digitalis glycosides requires special caution, since the developing hypokalemia increases the toxicity of digitalis glycosides.
In some rare cases, when hypokalemia is combined with metabolic acidosis, other (alkalizing) potassium salts are recommended to replenish potassium levels (e.g., citrate, gluconate, bicarbonate).
In some patients, magnesium deficiency caused by diuretic use prevents the correction of intracellular potassium deficiency, so hypomagnesemia should be corrected simultaneously with hypokalemia.
Use during pregnancy or breastfeeding
Pregnancy
Pregnancy is not an absolute contraindication for the use of the drug. The drug is used during pregnancy only in cases where, in the opinion of the doctor, the expected benefit to the mother outweighs the possible risk to the fetus.
Controlled clinical trials during pregnancy have not been conducted, but based on experience, the drug can be taken during pregnancy if the risk/benefit ratio is carefully assessed (see section Special warnings and precautions for use).
Due to the inhibition of gastrointestinal function during pregnancy, solid oral potassium dosage forms should be administered to pregnant women with great caution and only in carefully selected cases. Kaldium, a solid oral potassium dosage form, rapidly releases a large number of micropellets from the primary dosage form, which are then gradually distributed in the intestinal contents. This limits the risk associated with the administration of solid dosage forms that retain their relatively large size during passage through the gastrointestinal tract (i.e. matrix tablets) and can cause gastrointestinal adverse reactions caused by the local release of a large amount of active substance and/or the mechanical impact of the unchanged dosage form.
Breast-feeding
The drug is used during breastfeeding only in cases where, in the opinion of the doctor, the expected benefit to the mother outweighs the possible risk to the child.
The concentration of potassium ions in breast milk is about 13 mmol per liter. As long as the body's potassium level is not too high, potassium supplementation has little or no effect on the potassium content of breast milk. There is no evidence that oral potassium supplementation causes any adverse effects in breastfed infants.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive or operate other mechanisms.
Method of administration and doses
The dose and duration of treatment should be selected individually for each patient.
The usual daily dose for adults is 2-3 capsules (16-24 mmol K+) for prevention and 5-12 capsules (40-96 mmol K+) for treatment of hypokalemia with regular monitoring of serum potassium levels.
If the daily dose exceeds 2 capsules, it should be divided into several doses.
Capsules should be swallowed whole during or after meals.
Elderly patients
It is not necessary to change the dosage for elderly patients.
Caution is required in patients with renal or hepatic impairment. Studies in patients with hepatic impairment have not been conducted.
Children.
The drug is not recommended for use in children.
Overdose
In case of overdose, symptoms of hyperkalemia may occur. Symptoms of potassium chloride overdose may include: muscle weakness, sensory disturbances, paresthesias of the extremities, apathy, confusion, difficulty breathing, atonic paralysis, decreased blood pressure, shock, cardiac arrhythmias and heart blocks (e.g. atrioventricular block). In severe overdose (over 6.0 mmol/l), cardiac arrest is possible. Elevated potassium levels produce a characteristic ECG pattern (tall, sharp T wave, ST segment depression, disappearance of P wave, QT segment prolongation, QRS complex widening).
Treatment
Treatment of overdose may include gastric lavage, administration of saline, glucose, insulin, or forced diuresis, peritoneal dialysis, or hemodialysis.
Side effects
There is no current clinical documentation that would allow the side effects of this drug to be grouped by frequency of occurrence.
Metabolism and digestive disorders
Not known: hyperkalaemia (with risk of sudden death). Hyperkalaemia should be prevented by constant monitoring of serum potassium levels (see section 4.4).
Cardiovascular system
Rarely, tachycardia may occur.
From the digestive tract
Nausea, vomiting, flatulence, abdominal pain, discomfort, diarrhea, burning sensation in the stomach and esophagus, constipation, minor erosive changes in the small intestine. In some cases, gastrointestinal bleeding, gastroduodenal ulcers (for solid oral forms of potassium chloride), perforation and obstruction may occur, mainly in the presence of predisposing risk factors (see sections "Contraindications" and "Special instructions for use"). The risk of gastroduodenal ulcers increases with the use of high doses of potassium chloride.
If such factors are suspected, the drug should be discontinued immediately and the causes of the symptoms should be investigated.
These symptoms, as a result of intestinal irritation, can be reduced mainly by taking food and the drug at the same time.
Skin and skin derivatives
Not known: hypersensitivity reactions, including skin rashes.
Skeletal muscle and connective tissue disorders
Muscle weakness may rarely occur.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
50 or 100 capsules in a bottle of colorless transparent glass; 1 bottle in a cardboard pack.
Vacation category
According to the recipe.
Producer
CJSC Pharmaceutical Plant EGIS.
Location of the manufacturer and its address of place of business/location of the applicant and/or representative of the applicant.
9900, Kermend, 65 Matyas Kirai Street, Hungary.
