Y36-003-064 LD-710-2

Prescribing Information

EXCEL® CONTAINER

Potassium Chloride for Injection Concentrate USP
500 mEq/250 mL (2 mEq/mL)

PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION

FOR INTRAVENOUS INFUSION ONLY

MUST BE DILUTED PRIOR TO INJECTION

Rx only

A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion. 

Potassium Chloride for Injection Concentrate USP is a sterile, nonpyrogenic, concentrated solution of Potassium Chloride USP in Water for Injection USP to be administered by intravenous infusion only after dilution in a larger volume of fluid. No bacteriostatic or antimicrobial agent has been added.

Each 100 mL of Potassium Chloride contains:

Potassium Chloride USP 14.9 g; Water for Injection USP qs

pH: 5.4 (4.0–8.0); Calculated Osmolarity: 4000 mOsmol/liter

Concentration of Electrolytes (mEq/mL): Potassium 2; Chloride 2

The formula of the active ingredient is:

Potassium chloride injection (approximately diluted) is a parenteral fluid and electrolyte replenisher.

Excel container not made with natural rubber latex, PVC or DEHP.

The plastic container is made from a multi-layered film specifically developed for parenteral drugs. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during admixing. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

The closure system has two ports; the one for the suitable transfer device or compounding set has a tamper evident plastic protector and the other is a non-accessible blocked port. Refer to the Directions for Use of the container.

Potassium is the chief cation of body cells (160 mEq/liter of intracellular water) and is concerned with the maintenance of body fluid composition and electrolyte balance. Potassium participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. Chloride, the major extracellular anion, closely follows the metabolism of sodium and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

Normally about 80 to 90% of the potassium intake is excreted in the urine, the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting, or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion. A deficiency of either potassium or chloride will lead to a deficit of the other.

Potassium Chloride for Injection Concentrate USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.

This is a concentrated solution which is intended for use in a pharmacy admixture service and is restricted to the preparation of admixtures for intravenous infusion.

Potassium Chloride for Injection Concentrate USP is contraindicated in diseases where high potassium levels may be encountered, in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present, or where additives of potassium and chloride could be clinically detrimental.

Reactions which may occur because of the potassium-containing solutions or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection or extravasation, hypervolemia, and hyperkalemia.

To rapid infusion of hypertonic solutions may cause local pain and, rarely, vein irritation. Rate of administration should be adjusted according to tolerance.

Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation.

If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect.

Potassium-containing solutions are intrinsically irritating to tissues. Therefore, extreme care should be taken to avoid perivascular infiltration. Local tissue necrosis and subsequent sloughing may result if extravasation occurs. Chemical phlebitis and venospasm have also been reported.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

In the event of fluid overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment.

In the event of overdosage with potassium-containing solutions, discontinue the infusion immediately and institute corrective therapy to reduce serum potassium levels.

Treatment of hyperkalemia includes the following:

1. Dextrose Injection USP, 10% or 25%, containing 10 units of crystalline insulin per 20 grams of dextrose administered intravenously, 300 to 500 mL per hour.
2. Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema.
3. Hemodialysis and peritoneal dialysis. The use of potassium-containing foods or medications must be eliminated. However, in cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity.

Not for direct patient injection. Potassium Chloride for Injection Concentrate USP, Pharmacy Bulk Package is for preparation of intravenous admixtures only and must be diluted before administration. Care must be taken to ensure there is complete mixing of the potassium chloride with the large volume fluid, particularly if soft or bag type containers are used.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dosage and rate of administration are to be directed by the physician and are dependent upon the specific conditions of each patient (e.g., age, weight, clinical condition of the patient and laboratory determinations). Frequent laboratory determinations and clinical evaluation are essential to monitor changes in electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

If the serum potassium level is greater than 2.5 mEq/liter, potassium can be given at a rate not to exceed 10 mEq/hour and in a concentration of up to 40 mEq/liter. The 24 hour total dose should not exceed 200 mEq.

If urgent treatment is indicated (serum potassium level less than 2.0 mEq/liter and electrocardiographic changes and/or muscle paralysis), potassium chloride may be infused very cautiously at a rate of up to 40 mEq/hour. In such cases, continuous cardiac monitoring is essential. As much as 400 mEq may be administered in a 24 hour period. In critical conditions, potassium chloride may be administered in saline (unless contraindicated) rather than in dextrose containing fluids, as dextrose may lower serum potassium levels.

Potassium Chloride for Injection Concentrate USP 500 mEq/250 mL (2 mEq/mL) is supplied sterile and nonpyrogenic in 250 mL Excel® container with clear overwrap, Pharmacy Bulk Packages, packaged 24 per case.

Revised: November 2022

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Prepared in USA. API from Germany.

Fatal If Given By Direct Infusion

Potassium Chloride for
Injection Concentrate USP
500 mEq/250 mL (2 mEq/mL)

WARNING: Pharmacy Bulk Package
Not for Direct Infusion
Concentrated solution: MUST BE DILUTED
For preparation of intravenous admixtures only.

Y94-003-477 LD-709-2

NDC 0264-1944-20

250 mL

Each 100 mL contains: Potassium Chloride USP 14.9 g; Water for Injection USP qs;
4000 mOsmol/liter; Electrolytes (mEq/mL): Potassium 2; Chloride 2

Pharmacy Bulk Package. Sterile, nonpyrogenic. No antimicrobial or bacteriostatic
agent has been added. Contains no more than 25 mcg/L of aluminum.

Store at 20°-25°C. [See USP Controlled Room Temperature.]
Avoid excessive heat (40°C/104°F). Protect from freezing.

Dosage and Directions for Use: See Prescribing Information.
Do not remove overwrap until ready for use.
Withdraw contents within 4 hours of initial puncture. Use aseptic technique.

Not made with natural rubber latex, PVC or DEHP.

Affix accompanying label for date and time of expiry

          Expiration date: __ / __ / ____

          Expiration time: ___________ AM/PM

          Discard ___ hours after initial entry

           Y37-002-586
           LD-736-2

REF P9402

Rx only

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y94-003-476 LD-708-2

EXP

LOT

Container Label

Fatal if Given By Direct Infusion

Potassium Chloride for
Injection Concentrate USP

500 mEq/250 mL (2 mEq/mL)

WARNING: PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION

Y37-002-584 LD-747-2

Auxiliary Label