Potassium chloride B. Brown - instructions for use, dose, side effects, contraindications

Potassium is involved in the electrochemical processes of the cell, as well as in carbohydrate and protein metabolism. During the synthesis of glycogen and proteins, potassium is consumed by cells, and during the cleavage of these substrates, potassium is released (about 0.4-1 mmole of potassium / g glycogen and about 2-3 mmol of potassium / g of excreted nitrogen).

Therapeutic effect

The therapeutic effect of potassium chloride solutions for intravenous administration is the prevention or treatment of potassium deficiency, when oral intake (or enteral administration) is impossible or insufficient.

The daily requirement for potassium is about 1-1,5 mmol / kg body weight.

Potassium deficiency can be caused by increased renal excretion, increased losses through the gastrointestinal tract, for example, during vomiting, diarrhea or through fistulas, increased intracellular consumption, for example, in the treatment of acidosis or the administration of dextrose and insulin, and with insufficient potassium intake. Hypokalemia is accompanied by muscle weakness, atony of the smooth muscles of the gastrointestinal tract (from constipation to intestinal obstruction), loss of the ability of the kidneys to concentrate urine, ECG changes and cardiac arrhythmia.

Pharmacokinetics:

Suction

Since the drug is administered intravenously, its bioavailability is 100%.

Distribution

The ions of potassium and chlorine are included in the pool of body ions.

The concentration of potassium and the acid-base state of blood plasma are closely related. Alkalosis is often accompanied by hypokalemia, and acidosis - hyperkalemia. The concentration of potassium in the blood plasma within the norm with acidosis indicates a potassium deficiency.

The intracellular potassium concentration is about 140 - 150 mmol / l. The concentration of potassium in the blood plasma within the norm ranges from 3.5 to 5 mmol / l.

Biotransformation

Not applicable.

Excretion

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

Indications:

Treatment of hypokalemia of various genesis (including arrhythmias caused by hypokalemia), especially with concomitant hypochloraemic alkalosis.

Contraindications:

Potassium chloride B. Brown can not be administered under the following conditions:

- hypersensitivity to the components of the drug,

- hyperkalemia,

- hyperchloremia,

- concomitant therapy with potassium-sparing diuretics (eg triamterene, amiloride, spironolactone),

- disorders often associated with hyperkalemia, such as:

- dehydration,

- reduced renal excretion,

- complete atrioventricular (AV) heart block,

- Addison's disease,

- hereditary periodic paralysis (hyperkaliemic familial periodic paralysis, Gamstorp's syndrome),

- sickle-cell anemia.

Carefully:

Potassium chloride B. Brown should be applied with caution:

- in patients with heart failure,

- in patients taking cardiac glycosides, aldosterone antagonists, ACE inhibitors, tacrolimus, ciclosporin, long-acting heparin, suxamethonium or potentially nephrotoxic drugs (non-steroidal anti-inflammatory drugs, peripheral analgesics).

Pregnancy and lactation:

Pregnancy

Data from controlled clinical trials on drug use Potassium chloride B. Brown during pregnancy is absent. Animal studies on the determination of direct or indirect adverse effects on pregnancy, embryo / fetus, childbirth or postnatal development are also lacking. On the other hand, since potassium and chloride are contained in all living organisms, no harmful effect is expected upon their administration.

When the drug is prescribed Potassium chloride B. Brown, pregnant women should be careful. The drug should be used only with obvious indications for its use, if the expected benefit for the mother exceeds the risk to the fetus (if possible, drugs are prescribed for potassium intake).

Breastfeeding period

Data from systematic studies on the use of the drug Potassium chloride B. Brown in the period of breastfeeding absent.

When prescribing the drug, lactating women should be careful (if possible, they are prescribed potassium preparations for oral administration).

Dosing and Administration:

Intravenously.

Enter only by infusion after dilution in a compatible solution for infusion.

Concentration of potassium in solution for infusions usually should not exceed 40 mmol / l. If the concentration of potassium in the blood plasma is below 2 mmol / l, the potassium concentration in the solution for infusions can reach 80 mmol / l.

The following solutions can be used for dilution:

- dextrose solution 5%, 10%;

- solution of sodium chloride 0.9%;

- sodium lactate complex solution;

- other suitable solutions of electrolytes.

Before administration to the patient, the ready-to-use infusion solution must be thoroughly mixed.

Doses

The dose should be selected based on the actual concentration of electrolytes in the blood plasma and the acid-base state.

Adults and elderly patients:

The dose for the treatment of moderate, asymptomatic potassium deficiency and with maintenance therapy

The amount of potassium needed to correct moderate potassium deficiency and with maintenance therapy can be calculated using the following formula:

required amount of mmol TO⁺ = (MT * [kg] x 0.2)** x 2 x (target concentration K⁺ in blood plasma *** - the actual concentration of K⁺ in blood plasma [mmol / l])

* MT = body weight

** The value is the extracellular volume of the liquid

*** target concentration K⁺ in blood plasma should be equal to 4.5 mmol / l

The maximum daily dose (for example, in case of severe symptomatic hypokalemia or significant loss)

Up to 2 - 3 mmol / kg body weight.

Maximum injection rate

Up to 20 mmol potassium / hour in adults (corresponding to 0.3 mmol of potassium / kg of body weight / hour). If the potassium concentration in the blood plasma is less than 2 mmol / l, the infusion rate can reach 40 mmol potassium / hour.

Patients of childhood

The dose and speed of infusion depend on the needs of the patient of childhood. The daily dose should not exceed 2-3 mmol / kg body weight or 40 mmol / m² the surface of the body (if possible, preparations of potassium for oral administration are prescribed).

Patients with diabetes mellitus

The change in the acid-base state affects the concentration of potassium in the blood plasma.The need for potassium increases with the compensation of ketoacidosis in patients with diabetes mellitus, as well as with the introduction of short-acting dextrose / insulin.

Side effects:

Adverse side reactions can develop as symptoms of hyperkalemia only in the case of absolute or relative overdose and / or too high infusion rate.

The frequency of adverse adverse reactions depends on the dose.

Immune system disorders

Allergic reactions.

Disorders from the metabolism and nutrition

Acidosis, hyperchloremia, hyperkalemia.

Disturbances from the nervous system

Fatigue, muscle weakness, confusion, heaviness in the limbs, muscle cramps, paresthesia, ascending paralysis.

Heart Disease

Bradycardia, AV blockade, ventricular fibrillation, cardiac arrest.

Too high infusion rate can cause cardiac arrhythmia.

Vascular disorders

Reduction of blood pressure, centralization of blood circulation.

Disorders from the gastrointestinal tract

Nausea.

Overdose:

Symptoms

Overdose can lead to hyperkalemia, especially if associated with acidosis or kidney failure.

Symptoms of hyperkalemia are mainly disorders of the cardiovascular system. They can manifest as a bradycardia, AV blockade, ventricular fibrillation and cardiac arrest. On the ECG appear high, sharp, symmetrical teeth T and, with a very high concentration of potassium, expansion of the ventricular complex.

Symptoms from the side of blood vessels are lowering blood pressure and centralizing blood circulation.

Neuromuscular symptoms are fatigue, muscle weakness, confusion, heaviness in the limbs, muscle cramps, paresthesia and ascending paralysis.

The concentration of potassium in the blood plasma is 6.5 mmol / L and higher is life-threatening, higher than 8 mmol / L - often lethal.

Treatment

The first measure is the immediate cessation of infusion.

Further measures include oral or intravenous administration of 0.9% sodium chloride solution, slow intravenous administration of 10% calcium gluconate solution, intravenous 300-500 ml of 5% dextrose solution with 10-20 Short-acting insulin dose per 1 liter, diuresis stimulation, oral administration or rectal administration of cation-binding drugs, if necessary, correction of acidosis.

In severe cases, hemodialysis may be necessary.

Interaction:

- Cardiac glycosides

An increase in extracellular potassium concentration decreases the efficiency of cardiac glycosides, a decrease in extracellular potassium concentration leads to an increase in the arrhythmogenic effect of cardiac glycosides.

- drugs that reduce the excretion of potassium

They include:

- potassium-sparing diuretics (for example, triamterene, amiloride, spironolactone)

- antagonists of aldosterone

- ACE inhibitors

- tacrolimus

- ciclosporin

- nonsteroidal anti-inflammatory drugs

- analgesics of peripheral action

- heparin

When these drugs are administered together with potassium chloride, pronounced hyperkalemia can develop, which has a negative effect on the heart rhythm.

- suxamethonium

With the joint administration of suxamethonium with potassium, pronounced hyperkalemia may develop, which has a negative effect on the rhythm of the heart.

When mixed with other drugs, it is necessary to take into account the possibility of incompatibility.

Special instructions:

Infusion of potassium-containing solutions should be discontinued in case of symptoms of renal failure.

Due to a sharp cessation of the introduction of potassium, pronounced hypokalemia may develop, which may lead to an increase in the toxicity of the co-administered cardiac glycosides.

If the balance of potassium is disturbed (hypo- or hyperkalemia), characteristic ECG changes occur. However, there is no linear relationship between ECG changes and potassium concentration in the blood.

During the treatment it is necessary to monitor the ECG, the concentration of electrolytes in the blood plasma and the acid-base state.

It is necessary to ensure exclusively intravenous administration of the drug, since perennial administration can cause tissue necrosis.

Use the solution only if it is clear and the ampoule is not damaged.

The drug should only be diluted in a compatible solution for infusion. The preparation should be diluted immediately after opening the ampoule.

When diluting the drug requires strict adherence to the rules of asepsis.

In terms of microbiological safety, the diluted drug should be used immediately. If the drug is not used immediately, it can be used no later than 24 hours after dilution, and it is allowed to store it during this period at a temperature of 2 to 8 ° C, only if aseptic conditions are met when it is diluted.

The ampoule is for single use only. Remaining unused quantities of the drug are subject to destruction.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care must be taken when managing vehicles, mechanisms and occupations of potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Concentrate for the preparation of a solution for infusions 40 mg / ml.

Packaging:

10 ml per ampoule of polyethylene without additives, which meets the requirements of the European Pharmacopoeia for polyethylene for parenteral preparations. Ampoules are of two types. A type I - colorless polyethylene ampoules having a rectangular self-falling body with a twisting cap with a screw connection for needleless sampling of the preparation. A type II - colorless polyethylene ampoules, having a cylindrical self-falling body with a twisting cap without screw connection for needleless sampling of the preparation.

For 20 ampoules of 10 ml together with instructions for use in a cardboard pack.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002641

Date of registration:29.09.2014

Expiration Date:29.09.2019

The owner of the registration certificate:B. Brown Mehlungen AGB. Brown Mehlungen AG Germany

Manufacturer: & nbsp

B. BRAUN MELSUNGEN, AG Germany

Representation: & nbspB. Brown Medikal, Open CompanyB. Brown Medikal, Open Company

Information update date: & nbsp26.11.2017

Illustrated instructions

Instructions

Potassium chloride B. Brown (Potassium chloride B. Braun)