Potassium Chloride Injection, Solution, Concentrate
FDA Label NDC 0264-1944

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.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements, or the use of electrolyte-free dextrose solutions to which individualized electrolyte supplements may be added.

Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended.

Solutions containing potassium in a greater concentration than 40 mEq/liter may result in significant irritation to peripheral or central veins.

For peripheral administration of solutions containing potassium, slowly infuse the solution through a small bore needle, placed well within the lumen of a large vein. Carefully avoid infiltration.

Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason.

If the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.

Use only if solution is clear and container and seals are intact. Discard container within 4 hours after initial puncture.

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:

• 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.
• Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema.
• 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.

Warning: Not for direct infusion. For preparation of admixtures for intravenous infusion.

The Pharmacy Bulk Package is for use in a Pharmacy Admixture Service only. Use of this product is restricted to a suitable work area, such as a laminar flow hood (or an equivalent clean air compounding area).

Additives should not be made to Pharmacy Bulk Packages.

Caution: Do not use plastic containers in series connection.

To Open

Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired.

NOTE: Before use, perform the following checks:

Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.

Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used.

Use only if solution is clear and container and seals are intact.

Preparation for Admixing
1. Remove plastic protector from sterile set port at bottom of container.
2. Attach suitable transfer device or compounding set. Refer to complete directions accompanying device.

Do Not Add Medication
Transfer individual dose(s) to appropriate intravenous infusion solutions. Use of a syringe with needle is not recommended. Multiple entries increase the potential of microbial and particulate contamination. The container closure may be penetrated only one time, utilizing a suitable sterile dispensing set which allows measured dispensing of the contents.

For Pharmacy Bulk Packages: 

• The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar air flow hood (or an equivalent clean air compounding area).
• For compounding only. Do not use for direct infusion.
• Do not use/penetrate blocked port.
• Attach suitable transfer device or compounding set. Refer to complete directions accompanying device.
• Hang container on suitable fixture.
• Once container closure has been penetrated, withdrawal of contents should be completed within 4 hours. Discard any unused portion.

Important Admixing Instructions

• The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.
• Additives may be incompatible with the fluid withdrawn from this container. Consult with pharmacist.
• When compounding admixtures, use aseptic technique, mix thoroughly and discard unused portion.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (See Warnings and Precautions, General).

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

MUST BE DILUTED BEFORE USE

Potassium Chloride for
Injection Concentrate USP
(2 mEq K⁺/mL)

WARNING: PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION

Y94-003-427 LD-709-1

REF P9402
NDC 0264-1944-20

250 mL
EXCEL^® CONTAINER

Each 100 mL contains: Potassium Chloride USP 14.9 g;
Water for Injection USP qs;

pH: 5.4 (4.0-8.0); Calc. Osmolarity: 4000 mOsmol/liter

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

 Contains no more than 25 mcg/L of aluminum.

Sterile, nonpyrogenic. Pharmacy Bulk Package.

No antimicrobial or bacteriostatic agent has been added.

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

Usual Dosage and Directions for Use: See Package Insert.

WARNING: Not for direct infusion. For preparation of intravenous admixtures only. Concentrated solution: dilute in suitable fluid prior to administration.

Do not remove overwrap until ready for use. After removing the overwrap, check for leaks by squeezing container firmly. If leaks are found, discard solution.

Use only if solution is clear and container and seals are intact. A single-entry through the set port should be made with a sterile dispensing set. Transfer individual doses to appropriate intravenous infusion solutions under a laminar flow hood using aseptic technique.

Not made with natural rubber latex, PVC or DEHP.

Affix accompanying label for date and time of entry

Discard container within 4 hours after initial puncture.

          Date of Entry: __ / __ / ____

           Time of Entry: ___________ AM/PM

           Discard ___ hours after initial entry

           Y37-002-578

           LD-736-1

Rx only

Y94-003-426 LD-708-1

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

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

EXP

LOT

Container/entry Label (Potassium Chloride For Injection Concentrate Usp I 1)