Potassium chloride Kabi 0.04 meq/ml in glucose 3.3% and sodium chloride 0.3% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion

Potassium Chloride, Glucose, Sodium Chloride

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion is and what it is used for
2. What you need to know before using Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion
3. How to use Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion
4. Possible adverse effects
5. How to store Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion
6. Contents of the pack and other information

1. What Cloruro de potasio Kabi 0,04 mEq/ml en Glucosa 3,3% y Cloruro de sodio 0,3% Solución para perfusión is and what it is used for

This medicine contains the following active substances: potassium chloride, glucose (as monohydrate), and sodium chloride. This medicine is a solution for infusion and will be administered to you intravenously through a thin tube.

This medicine belongs to a group of medicines called intravenous solutions affecting electrolyte balance – electrolytes with carbohydrates (used to maintain body fluids in proper balance).

This medicine is indicated for the prevention or treatment of potassium deficiency (an electrolyte) in your body, when you require supplementation with water, electrolytes, and carbohydrates because dietary measures or oral medication are inadequate.

2. What you need to know before starting to use Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion

Do not use Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3%

• if you are allergic to potassium chloride, glucose, or sodium chloride, or to any of the other ingredients of this medicine (listed in section 6)
• if your blood potassium levels are high (hyperkalemia)
• if you have severe kidney disease with oliguria (reduced urine output), anuria (absence of urine production), or azotemia (excess nitrogenous waste in the blood due to kidney failure)
• if your blood chloride levels are high (hyperchloremia)
• if your blood sodium levels are high (hypernatremia)
• if you have hyperhydration states (excess water in the body)
• if you have hyperglycemic states (high blood glucose levels), such as hyperosmolar coma, uncontrolled diabetes, or other glucose intolerances, including metabolic stress conditions
• if you have renal tubular acidosis (a kidney function disorder)
• if you have acute ischemic stroke (sudden loss of brain function due to blocked blood flow)
• during the first 24 hours after head trauma.

Warnings and Precautions

Talk to your doctor or nurse before starting to use Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion.

Potassium administration must always be carried out under strict medical supervision. During treatment with this medicine, and in order to detect early signs of excessive potassium levels (hyperkalemia), your doctor will monitor your heart using electrocardiograms and perform periodic blood tests to determine your blood potassium levels, especially:

• if you have heart or kidney disease, or other conditions that may favor the development of hyperkalemia
• if you are taking other medicines that may increase blood potassium levels (see subsection below).

Your doctor must take special precautions if you are receiving digitalis glycosides, particularly when stopping potassium administration, since a rapid decrease in potassium levels may cause digitalis toxicity. In such cases, potassium treatment should not be discontinued abruptly.

Potassium solution should only be administered if you have adequate urine output. If not, you may need to receive a potassium-free solution.

Your doctor will perform frequent clinical and laboratory tests to monitor changes in fluid and acid-base balance, as well as electrolyte and blood glucose levels.

If you are in an emergency situation and your blood potassium levels are very low, or if you are taking digitalis glycosides, administration of glucose-containing solutions is not recommended, as glucose may prevent potassium levels from rising as quickly as needed.

If you experience episodes of increased intracranial pressure, your doctor will closely monitor your blood glucose levels.

Since this medicine contains glucose, it should be administered with caution if you have vitamin B1 deficiency or diabetes. Your doctor may administer this medicine provided that appropriate treatment has been initiated beforehand.

Since this medicine contains sodium, it should be administered with caution if you have hypertension, congestive heart failure, pulmonary or peripheral edema, renal insufficiency, preeclampsia (development of high blood pressure during pregnancy), or other conditions associated with sodium retention, as well as if you are taking corticosteroids or corticotropin (see subsection below).

This medicine should be administered with special caution if you are elderly, as you may be taking other medications (see subsection below), or may have impaired kidney or heart function, or other diseases that may affect your blood potassium levels.

If administration is prolonged, extravasation (leakage of the solution from the vein into surrounding tissue) or thrombophlebitis (vein inflammation associated with clot formation) may occur.

Take special care with Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion:

• If you are in critical conditions, experiencing pain, postoperative stress, infections, burns, or central nervous system disorders.
• If you have any type of heart, liver, or kidney disease and are being treated with a medicine that enhances the effect of vasopressin (a hormone regulating the body’s water retention), as this may increase the risk of developing hospital-acquired low blood sodium (hyponatremia). (see section "Use of Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion with other medicines").

All patients must be closely monitored. In cases where the normal regulation of blood water content is disrupted due to increased vasopressin secretion—also known as Antidiuretic Hormone (ADH)—infusion of fluids with low sodium chloride concentration (hypotonic fluids) may result in low blood sodium (hyponatremia). This can cause headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency. (See section 4. Possible side effects).

Children, women of childbearing age, and patients with brain disorders such as meningitis, cerebral hemorrhage, cerebral contusion, and cerebral edema are at special risk of developing severe and potentially fatal brain swelling due to acute hyponatremia.

Use of Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is particularly important to inform your doctor if you are taking:

• Medicines that may cause blood potassium levels to become too high due to additive effects, especially if kidney function is impaired:

  • Potassium-sparing diuretics (amiloride, triamterene, spironolactone, eplerenone)
  • Angiotensin-converting enzyme inhibitors (ACE inhibitors) (e.g., captopril, enalapril, lisinopril)
  • Angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan, valsartan)
  • Potassium-containing medicines such as potassium salts of penicillin
  • Non-steroidal anti-inflammatory drugs (NSAIDs) (diclofenac, indomethacin, piroxicam, mefenamic acid, celecoxib)
  • Heparin
  • Pentamidine, trimethoprim
  • Cyclosporine, tacrolimus
  • β-adrenergic blockers (propranolol, nadolol, atenolol)
  • Succinylcholine (suxamethonium)

• Medicines that may reduce blood potassium levels, which may require higher potassium doses:

  • Corticosteroids
  • Diuretics (loop diuretics, thiazides and related agents, osmotic diuretics, carbonic anhydrase inhibitors)
  • High doses of penicillins
  • Aminoglycosides
  • Cisplatin
  • Foscarnet
  • Amphotericin B
  • Theophylline
  • Insulin
  • Folic acid and vitamin B12
  • β2-adrenergic agonists

• Digitalis glycosides (digoxin and methyldigoxin) (high potassium levels may reduce their effect, and a sudden drop in potassium levels may cause digitalis toxicity)

• Antiarrhythmic medicines (such as quinidine, hydroquinidine, procainamide) (high potassium levels increase their activity, while low potassium levels reduce their effectiveness)

• Lithium carbonate (sodium may accelerate renal excretion of lithium, leading to reduced therapeutic effect)

• Mineralocorticoid-acting corticosteroids (e.g., fludrocortisone) or ACTH (corticotropin) (these medicines promote water and sodium retention)

• Glucocorticoid-acting corticosteroids (e.g., hydrocortisone) (these medicines may cause blood glucose levels to become too high)

• Insulin and oral antidiabetics (biguanides, sulfonylureas) (glucose may reduce their effect)

• Medicines that lead to increased vasopressin effect (see section Warnings and precautions), for example:

  • Medicines that stimulate vasopressin release (e.g., antipsychotics, narcotics)
  • Medicines that enhance the action of vasopressin (e.g., non-steroidal anti-inflammatory drugs)
  • Medicines that act like vasopressin, known as vasopressin analogs

Other medicines that increase the risk of hyponatremia, including diuretics in general and antiepileptic drugs.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The safety of this medicine during pregnancy and breastfeeding has not been established. Therefore, it should only be used when the beneficial effects clearly outweigh the potential risks to the fetus or infant.

This medicine should be administered with special caution in pregnant women during labor, especially if administered in combination with oxytocin (a hormone that may be given to induce labor and control bleeding), due to the risk of hyponatremia.

Administration of large volumes of glucose-containing solutions to the mother during labor, particularly in complicated deliveries, may cause hyperglycemia, hyperinsulinemia (high blood insulin levels), and acidosis in the fetus, and thus may be harmful to the newborn.

Due to the sodium chloride content of this medicine, extra precautions should be taken in cases of preeclampsia during pregnancy.

If you are pregnant or breastfeeding, your doctor should continuously monitor your heart function and blood potassium levels, as abnormalities could lead to serious cardiac disturbances in both mother and fetus or newborn.

Driving and use of machines

Not applicable.

3. How to use Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion

This medicine will be administered to you by a doctor or other healthcare professional via intravenous infusion (drip into a vein).

Your doctor will decide the dose you should receive, taking into account the severity of your hypokalaemia, your age, weight and clinical condition (especially if you have any heart or kidney disease), and how long you need to be treated.

The recommended maximum dose of potassium is 2–3 mEq/kg/day. In adults, the potassium dose should not exceed 200 mEq daily. The recommended dose to meet maintenance requirements is 40–80 mEq per day.

Your doctor will determine the volume of fluid you should receive. However, in general, you should not be given more than 40 mL/kg/day (maximum 3000 mL per day).

The amount of glucose administered with the solution should not exceed 4–5 mg/kg/min.

If your kidneys are not functioning properly, you will need to receive a lower dose.

As a general rule, the infusion rate should never exceed 20 mEq of potassium per hour when administered through a peripheral vein.

Use in children and adolescents

In children, the potassium dose should not exceed 3 mEq/kg/day, and daily maintenance requirements are 2–2.5 mEq/kg.

The recommended daily fluid dose in these patients is as follows:

• less than 10 kg body weight: 100 mL/kg
• between 10 and 20 kg body weight: 1000 mL + 50 mL/kg for each kg above 10 kg
• over 20 kg body weight: 1500 mL + 20 mL/kg for each kg above 20 kg

Oral potassium supplements or consumption of potassium-rich foods should replace intravenous administration of this medicine as soon as possible.

If you are given more Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion than you should

Excessive administration of potassium solutions may cause hyperkalaemia, which can be potentially fatal, especially if your kidneys are not functioning properly. In case of overdose, disturbances in fluid balance and serum electrolytes, swelling, and circulatory and cardiac disturbances may also occur (see symptoms in section 4. Possible side effects).

In case of hyperkalaemia, your doctor must stop the infusion and take the most appropriate measures to reduce blood potassium levels.

In case of overdose or accidental ingestion, contact your doctor or pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

After administration of this medicine, hyperhydration (fluid retention), hyperglycemia, hyperchloremic acidosis (high blood chloride levels), and hyperkalemia may occur, especially if the solution is administered too rapidly or in excess, or if your kidneys are not functioning properly. Symptoms of hyperkalemia mainly affect nerves, muscles, and the heart, and include itching or tingling in the extremities, muscle weakness, flaccid paralysis (in which muscles become limp), respiratory paralysis, intestinal paralysis, mental confusion, loss of reflexes, apathy, cold skin, pallor (grayish skin tone), weakness and heaviness in the legs, hypotension (low blood pressure), electrocardiogram abnormalities, irregular heartbeats, heart block, and cardiac arrest. It is very important that your doctor monitors your heart to assess the severity of possible hyperkalemia.

Adverse effects related to intravenous administration may also occur. These include fever, infection at the injection site, local pain, venous irritation, venous thrombosis (blood clot formation), inflammation, hardening or constriction of the vein, extravasation, and necrosis (tissue death).

The following adverse effects may occur in some people:

• Elevated levels of potassium and/or glucose in the blood, fluid retention, hyperchloremic acidosis
• Mental confusion, apathy
• Muscle weakness, itching or tingling in the extremities, loss of voluntary muscle movement (paralysis), loss of reflexes, sensation of weakness and heaviness
• Severe or complete weakness of respiratory muscles
• Intestinal obstruction due to lack of intestinal muscle movement
• Irregular heartbeats, heart block, cardiac arrest
• Infection at the injection site
• Fever
• Inflammation, hardening or constriction of the vein where the medicine is administered, venous thrombosis, cold skin, pallor (grayish skin tone), hypotension
• Pain, irritation, extravasation, and necrosis at the injection site
• Electrocardiogram abnormalities

Headache, nausea, seizures, and lethargy. These may be caused by low sodium levels in the blood. When blood sodium levels drop significantly, water enters the brain cells, causing them to swell. This may lead to increased intracranial pressure and hyponatremic encephalopathy.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for Infusion

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Once the container has been opened, the solution should be used immediately.

This medicine is for single use only. Discard any unused solution.

Do not use this medicine if you notice that the solution is not clear, contains particles, or if the container is damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Potassium Chloride Kabi 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion

• The active substances are potassium chloride, glucose and sodium chloride. Each 100 ml of this medicinal product contains 0.3 g of potassium chloride, 3.3 g of glucose (as monohydrate) and 0.33 g of sodium chloride.
• The other components (excipients) are hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections.

Appearance of the product and contents of the container

Potassium Chloride Kabi 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion is a clear, colourless solution.

This medicinal product is available in polyethylene bottles (Kabipac). Cartons containing 10 bottles of 500 ml or 10 bottles of 1000 ml.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España, S.A.U.
Marina 16-18,
08005 Barcelona
Spain

Manufacturer

Labesfal – Laboratórios Almiro, S.A.
Zona Industrial do Lagedo
3465-157 Santiago de Besteiros
Portugal

Date of the most recent review of this summary: March 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Potassium Chloride Kabi 0.04 mEq/ml in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion is a ready-to-use solution that must be administered by slow infusion.

The theoretical osmolarity of the solution is 376 mOsm/L.

Given the potassium concentration of the solution (40 mEq/L), this medicinal product is suitable for administration via peripheral vein. If a central vein is used, the femoral vein is recommended and the jugular and subclavian veins should be avoided.

In general, it is recommended not to exceed 40 mEq/L via peripheral route.

Dosage:

The dose and duration of treatment must be individualized for each patient, depending on the severity of hypokalemia, age, weight and clinical condition, especially in cases of cardiac or renal failure.

The dose and rate of administration should be determined by electrocardiographic monitoring and plasma potassium measurements.

In adults, the recommended maximum dose of potassium is 2–3 mEq/kg/day, without exceeding 200 mEq/day; the recommended dose for maintenance therapy is 40–80 mEq/day.

Fluid administration should be calculated for each patient according to rehydration or maintenance requirements. However, in general, no more than 40 ml/kg/day (maximum 3000 ml per day) should be administered.

The amount of glucose administered with the solution should not exceed 4–5 mg/kg/min.

In children, the potassium dose should not exceed 3 mEq/kg/day, and daily maintenance requirements are 2–2.5 mEq/kg.

The recommended daily fluid dose in these patients is as follows:

• < 10 kg body weight: 100 ml/kg
• between 10 and 20 kg body weight: 1000 ml + 50 ml/kg for each kg above 10 kg

• 20 kg body weight: 1500 ml + 20 ml/kg for each kg above 20 kg

Patients with renal impairment should receive lower doses due to the risk of developing hyperkalemia.

Intravenous potassium administration at a rate of 10 mEq/h is considered safe. When the administration rate exceeds 10 mEq/h, close patient monitoring with ECGs and periodic plasma potassium concentration measurements is required. As a general rule, the infusion rate via peripheral route must never exceed 20 mEq/h. Higher administration rates may be achieved via central route.

General recommendations for the administration of intravenous potassium solutions:

Preparation and handling precautions:

The contents of each container are for single use only. Any unused portion must be discarded.

The solution should be clear and free from particles. Do not administer if this is not the case.

Use aseptic technique when administering the solution, as well as when adding medications to the solution, if necessary.

As with all parenteral solutions, before adding medications to the solution or administering concomitantly with other drugs, compatibility must be verified to ensure there are no incompatibilities between the added drugs and the solution or container. The product information leaflet of the added medication should also be consulted.

It is the responsibility of the user to evaluate potential incompatibilities of the added drug with Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion, monitoring for possible changes in color and/or formation of precipitates, insoluble complexes, or crystals.

Prior to administration of the mixture, the stability and osmolarity of the final solution should be verified.

When compatible medication is added to this formulation, the solution should be administered immediately, unless dilution has been performed under controlled and validated aseptic conditions.

Incompatibilities:

No studies describing incompatibilities related to this medicinal product have been found, although incompatibilities related to the active substances of the solution have been reported.

Potassium chloride in intravenous mixtures has been shown to be incompatible with sodium amoxicillin, amphotericin B, dobutamine hydrochloride, and sodium penicillin G. Furthermore, administration via Y-site is not recommended for the following drugs when potassium-containing mixtures are being administered: azithromycin, promethazine hydrochloride, diazepam, sodium phenytoin, sodium methylprednisolone succinate, or ergotamine tartrate.

The glucose-saline solution containing 3.3% glucose and 0.3% sodium chloride has been reported to be incompatible with mitomycin due to the low pH of this solution. In addition, incompatibility has been observed with various glucose-saline solutions for the following drugs: sodium phenytoin, sodium heparin, haloperidol lactate, sodium imipenem-cilastatin, and meropenem. However, some of these drugs may be compatible with glucose-saline solutions depending on various factors such as drug concentration in the solution (sodium heparin) or the time elapsed between dissolution and administration of the solution (sodium imipenem-cilastatin and meropenem).

In addition, signs of incompatibility have been described when certain drugs are diluted in solutions containing glucose, including sodium amoxicillin/clavulanic acid, sodium ampicillin, interferon alfa-2b, and procainamide hydrochloride. However, it should be noted that some of these drugs, such as sodium amoxicillin/clavulanic acid, may be directly injected into the injection site while these infusion solutions are being administered.

Signs of incompatibility have also been described when certain drugs are diluted in solutions containing chloride, including amsacrine and trimetrexate glucuronate.

Emergency treatment in case of hyperkalemia:

Treatment of hyperkalemia depends on its severity. Various treatment regimens have been established, involving administration of calcium to counteract the adverse cardiac effects of hyperkalemia, use of insulin and glucose or sodium bicarbonate to promote intracellular shift of extracellular potassium, and/or use of diuretics, cation-exchange resins, or dialysis to enhance potassium excretion:

• In the presence of cardiac manifestations: intravenous administration of calcium salts (10–20 mL of 10% calcium gluconate). In some cases, a second dose may be required.

• To rapidly reduce plasma potassium levels: intravenous administration of insulin and glucose (e.g., 5–15 units of insulin with 50 mL of 50% glucose). Alternatively or additionally, in acidotic patients, intravenous sodium bicarbonate (40–160 mEq administered over 5 minutes) may be given.

• To eliminate excess potassium from the body: use of diuretics, particularly loop diuretics (furosemide), cation-exchange resins (sodium or calcium polystyrene sulfonate) administered orally or rectally, or hemodialysis or peritoneal dialysis in severe cases of renal failure and hypercatabolism.

Rapid reduction of plasma potassium levels in digitalized patients may precipitate digitalis-related cardiac toxicity.

Preventive measures to avoid thrombophlebitis:

Prolonged administration may lead to extravasation or thrombophlebitis. To prevent thrombophlebitis, it is recommended to rotate the catheter insertion site every 24–48 hours.

General advice

Monitoring of fluid balance, serum glucose, serum sodium, and other electrolytes may be necessary before and during administration, particularly in patients with increased non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant medications that are vasopressin agonists, due to the risk of hyponatremia.

Monitoring of serum sodium is especially important with products having a lower sodium concentration compared to serum sodium concentration. After infusion of Potassium Chloride Kabi 0.04 mEq/mL in Glucose 3.3% and Sodium Chloride 0.3% Solution for infusion, rapid and active transport of glucose into body cells occurs. This condition promotes an effect equivalent to free water administration and may lead to severe hyponatremia.