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Potassium chloride

Registration certificate holder: GROTEX, LLC (Russia) ATX code: B05XA01 (Potassium chloride) Active substance: potassium chloride (potassium chloride) Ph.Eur. European Pharmacopoeia

Dosage form

Potassium chloride

Conc. d/prep. r-ra d/inf. 40 mg/1 ml: 10 ml amp. 10 pcs., 100 ml or 200 ml bottle. 1 piece reg. No.: LP-003059 dated 06/25/15 - Valid

Release form, packaging and composition

Concentrate for the preparation of a solution for infusion in the form of a clear, colorless or slightly yellowish liquid.

1 ml

potassium chloride 40 mg

Excipients: dextrose monohydrate - 334 mg, hydrochloric acid 1M solution - up to pH 3.0-4.0, water for injection - up to 1 ml.

10 ml - ampoules (10) - cardboard packs. 100 ml - polypropylene bottles (1) - cardboard packs. 200 ml - polypropylene bottles (1) - cardboard packs.

Clinical-pharmacological group: A drug that replenishes potassium deficiency in the body Pharmaco-therapeutic group: Potassium drug

pharmachologic effect

A remedy that replenishes potassium deficiency in the body. Helps maintain the necessary intra- and extracellular potassium levels. Potassium is the main intracellular ion and plays an important role in the regulation of various body functions. Participates in maintaining intracellular osmotic pressure, in the processes of conducting and transmitting nerve impulses to innervated organs, in the contraction of skeletal muscles and in a number of biochemical processes. Reduces the excitability and conductivity of the myocardium, in high doses it inhibits automatism.

Pharmacokinetics After oral administration, it is easily and in almost any quantity passively absorbed (70%), because its concentration (both food and released from the dosage form) is higher in the lumen of the small intestine than in the blood. In the ileum and colon, potassium is released into the intestinal lumen according to the principle of coupled exchange with sodium and is excreted with bile (10%). T1/2 in the absorption phase is 1.31 hours.

Indications for the drug Hypokalemia of various origins, incl. caused by vomiting, diarrhea, hyperaldosteronism, polyuria in chronic renal failure, taking certain medications, arrhythmias, incl. with glycoside intoxication, hypokalemic form of paroxysmal myoplegia. ICD-10 codes

Dosage regimen The method of administration and dosage regimen of a particular drug depend on its release form and other factors. The optimal dosage regimen is determined by the doctor. The compliance of the dosage form of a particular drug with the indications for use and dosage regimen should be strictly observed.

The daily dose for oral administration corresponds to 50-100 mEq of potassium, a single dose - 25-50 mEq of potassium, the frequency of administration and duration of use depend on the indications.

For intravenous administration, the dose and treatment regimen are determined individually.

Side effect

Possible symptoms of hyperkalemia: paresthesia in the upper and lower extremities, muscle weakness, arrhythmias, heart block, cardiac arrest, confusion.

After oral administration: nausea, vomiting, diarrhea, there are reports of ulcerative lesions of the stomach and small intestine, sometimes with bleeding, perforation, and subsequent formation of strictures.

After intravenous administration, hyperkalemia may manifest itself primarily by the development of cardiac dysfunction.

Contraindications for use Impaired renal excretory function, complete heart block, hyperkalemia of various etiologies, metabolic disorders (acidosis, hypovolemia with hyponatremia), gastrointestinal diseases in the acute phase, adrenal insufficiency.

Use during pregnancy and breastfeeding If use during pregnancy is necessary, the expected benefits for the mother should be weighed against the potential risk to the fetus; during lactation, the issue of stopping breastfeeding should be decided.

Use for renal impairment

Contraindicated in cases of impaired renal excretory function.

Patients with chronic kidney disease may develop hyperkalemia, which can potentially be fatal. Early clinical manifestations of hyperkalemia (sharpening of the P wave, disappearance of the U wave, lowering of the ST segment, and prolongation of the QT interval) usually appear at serum potassium concentrations of 7 to 8 mEq/L.

special instructions

Use with caution for AV conduction disorders, orally for gastrointestinal diseases. During treatment, it is necessary to monitor the level of potassium in the blood and ECG, and when treating potassium-deficient conditions, ASC should be carefully monitored.

Patients with chronic kidney disease or any disease that impairs the excretion of potassium from the body, or if potassium chloride is administered too quickly intravenously, may develop hyperkalemia, which can potentially be fatal. Early clinical manifestations of hyperkalemia (sharpening of the P wave, disappearance of the U wave, lowering of the ST segment, and prolongation of the QT interval) usually appear at serum potassium concentrations of 7 to 8 mEq/L. More severe symptoms (including muscle paralysis and cardiac arrest) develop at potassium concentrations of 9-10 mEq/L. It should be borne in mind that hyperkalemia, which can be fatal, can develop quickly and be asymptomatic. In case of an overdose of potassium chloride, a sodium chloride solution is administered orally or intravenously, or intravenously 300-500 ml of dextrose solution containing 10-20 units of insulin per 1000 ml. If necessary, hemodialysis and peritoneal dialysis are performed.

The safety and effectiveness of potassium chloride in children have not been established.

Drug interactions When used simultaneously, potassium-sparing diuretics, potassium supplements, ACE inhibitors, and salt substitutes containing potassium increase the risk of developing hyperkalemia.

Potassium chloride 4%/10 ml No. 10 solution d/in.amp.

Instructions for medical use of the drug Potassium chloride Trade name Potassium chloride International nonproprietary name no Dosage form Solution for intravenous administration 40 mg/ml, 10 ml Composition 1 ml of the drug contains the active substance - potassium chloride 40 mg, excipients: dextrose monohydrate, hydrochloric acid 1 M solution – up to pH 3.0-4.0, water for injection. Description Transparent colorless to light yellow liquid Pharmacotherapeutic group Plasma replacement and perfusion solutions. Additives to solutions for intravenous administration. Electrolyte solutions. Potassium chloride ATC code B05XA01 Pharmacological properties Pharmacokinetics Potassium chloride is completely absorbed. In patients with normal potassium levels, approximately 90% of the administered potassium is excreted in the urine. Pharmacodynamics Potassium is the main intracellular ion. The drug normalizes water-electrolyte balance in the body and replenishes potassium deficiency. Activates many cytoplasmic enzymes, regulates intracellular osmotic pressure, protein synthesis, amino acid transport, conduction of nerve impulses, improves skeletal muscle contraction in muscular dystrophy, myasthenia gravis. Potassium ions cause a decrease in heart rate, reduce contractile activity, reduce conductivity, automaticity and excitability of the myocardium. In small doses, K+ dilates the coronary vessels, in large doses it narrows. Potassium helps to increase the content of acetylcholine and stimulate the sympathetic part of the central nervous system. Has a moderate diuretic effect. Increasing potassium levels reduces the risk of developing toxic effects of cardiac glycosides on the heart. Stimulates the adrenal glands and increases their release of epinephrine. Indications for use - treatment and prevention of hypokalemia arising from diabetes mellitus, prolonged diarrhea, vomiting, with the use of certain diuretics (thiazide, thiazide-like, loop), therapy with glucocorticosteroids, cardiac glycosides, antihypertensive drugs - treatment and prevention of digitalis intoxication - arrhythmias of various origins (associated with electrolyte disturbances and absolute or relative hypokalemia) - prevention of arrhythmia in patients with myocardial infarction (in the acute period). Method of administration and dosage: Administer intravenously by stream or drip. 1 ampoule (10 ml) 40 mg/ml potassium chloride solution contains 0.4 g of potassium chloride. 50 ml of a 40 mg/ml solution of potassium chloride (2.0 g of potassium chloride) is diluted with water for injection 10 times (up to 500 ml) to obtain an isotonic solution (the concentration of the resulting solution is 4 mg/ml) and administered intravenously, drip (20- 30 drops per minute). For drip intravenous administration, you can prepare a solution at the rate of up to 2.5 g of potassium chloride (up to 62.5 ml of potassium chloride solution 40 mg/ml) in 500 ml of 0.9% sodium chloride solution or 5% dextrose solution (the concentration of the resulting potassium solution chloride 5 mg/ml). Side effects - nausea, vomiting, diarrhea, flatulence, abdominal pain, ulceration of the gastrointestinal mucosa, gastrointestinal bleeding, perforation and intestinal obstruction - paresthesia, muscle weakness, confusion - decreased blood pressure, arrhythmias, slowdown of atrioventricular conduction until complete AV blockade, cardiac arrest (in case of overdose) - hyperkalemia, allergic reactions. Contraindications - hypersensitivity to the components of the drug - acute and chronic renal failure - complete atrioventricular block - adrenal insufficiency - concomitant therapy with potassium-sparing diuretics - hyperkalemia - metabolic disorders (acidosis, hypovolemia with hyponatremia) - erosive and ulcerative diseases of the gastrointestinal tract - childhood and adolescence up to 18 years of age (efficacy and safety have not been established) - pregnancy and lactation. Drug interactions Pharmaceutically compatible with solutions of cardiac glycosides (improves their tolerability). Strengthens the negative dromo- and bathmotropic effect of antiarrhythmic drugs. As part of a polarizing mixture (in combination with dextrose and insulin), it helps to normalize heart rhythm during myocardial infarction, ectopic arrhythmias and overdose of cardiac glycosides. Beta-blockers, cyclosporine, heparin, potassium-sparing diuretics, potassium supplements, ACE inhibitors, non-steroidal anti-inflammatory drugs increase the risk of developing hyperkalemia. Enhances the effect of quinidine, a side effect of disopyramide. Special instructions Use with caution in case of atrioventricular block I-II degree. During the treatment period, it is necessary to monitor the content of potassium ions in the blood serum, ECG; when treating hypokalemia, monitoring of the acid-base state is necessary. It should be borne in mind that hypokalemia, leading to death, can develop quickly and be asymptomatic. The safety and effectiveness of potassium chloride in children has not been established. Pregnancy and lactation Due to insufficient experience of use, it is not prescribed to pregnant women. If it is necessary to use it during lactation, the issue of stopping breastfeeding should be decided. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Considering the possible side effects, care must be taken when driving a vehicle and performing work that requires precise coordination of movements. Overdose Symptoms: hyperkalemia (increased concentration of potassium ions in the blood serum from 5.5 to 6.5 mEq/l), which manifests itself in the form of: muscle hypotonia, paresthesia in the extremities, slowing of atrioventricular conduction, arrhythmia, cardiac arrest. Early changes in the electrocardiogram are a tall T wave with a pointed apex and a narrow base, most pronounced in chest leads V2-V4. With moderate hyperkalemia (concentration of potassium ions in the blood serum 6.5-8.0 meq/l), electrocardiographic signs are: decreased P wave amplitude, lengthened PQ interval, widened QRS complex, decreased R wave amplitude, ventricular extrasystole. More severe symptoms of hyperkalemia - muscle paralysis and cardiac arrest (changes in the electrocardiogram - slow or accelerated idioventricular rhythm, ventricular fibrillation, asystole) develop when the concentration of potassium ions in the blood serum is 9-14 mEq/l. Treatment: orally or intravenously - sodium chloride solution; IV - 300-500 ml of dextrose solution with 10-20 units of insulin per 1000 ml; if necessary, hemodialysis and peritoneal dialysis. Release form and packaging 10 ml in neutral glass ampoules. 10 ampoules in a cardboard box. Each box contains instructions for medical use in the state and Russian languages, a knife for opening ampoules or an ampoule scarifier. When packaging ampoules with a break ring or break point, do not insert a knife for opening ampoules or an ampoule scarifier. Storage conditions Store at temperatures between 15 °C and 25 °C. Keep out of the reach of children! Shelf life 4 years Do not use after the expiration date indicated on the package Conditions for dispensing from pharmacies By prescription 630028, Russia, Novosibirsk, st. Dekabristov, 275 tel., fax Registration certificate holder Novosibkhimpharm OJSC, Russia Address of the organization receiving claims on the territory of the Republic of Kazakhstan from consumers regarding the quality of products (goods) Valenta Asia LLP, Almaty, Abay Ave., corner st. . Radostovtsa, 151/115, business office No. 1102 Tel./fax, E-mail