Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: The following are packaged in plastic vials. Product Code Unit of Sale Total Potassium Ion Potassium Chloride per mL Each 96505 NDC 63323-965-05 Unit of 25 10 mEq (0.39 g) 149 mg NDC 63323-965-01 5 mL in a 10 mL Single Dose Vial 96510 NDC 63323-965-10 Unit of 25 20 mEq (0.78 g) 149 mg NDC 63323-965-03 10 mL Single Dose Vial 96520 NDC 63323-965-20 Unit of 25 40 mEq (1.56 g) 149 mg NDC 63323-965-02 20 mL Single Dose Vial These are Single Dose Vials, no preservative added, packaged 25 vials per tray. Unused portion of vial should be discarded. Product Code Unit of Sale Total Potassium Ion Potassium Chloride per mL Each 96730 NDC 63323-967-30 Unit of 25 60 mEq (2.35 g) 149 mg NDC 63323-967-01 30 mL Multiple Dose Vial This is a Multiple Dose Vial, preserved with 0.05% methylparaben and 0.005% propylparaben, packaged 25 vials per tray. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Use only if solution is clear, seal intact and undamaged. Vial stoppers do not contain natural rubber latex.; PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 5 mL Single Dose Vial Label NDC 63323-965-01 96505 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 10 mEq per 5 mL (2 mEq per mL) 5 mL Single Dose Vial Rx only 5mlvial; PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 5 mL Single Dose Vial Tray Label NDC 63323-965-05 96505 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 10 mEq per 5 mL (2 mEq per mL) Rx only 25 x 5 mL Single Dose Vials 5mltray; PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 10 mL Single Dose Vial Label NDC 63323-965-03 96510 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 20 mEq per 10 mL (2 mEq per mL) 10 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 10 mL Single Dose Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 10 mL Tray Label NDC 63323-965-10 96510 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 20 mEq per 10 mL (2 mEq per mL) 25 x 10 mL Single Dose Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 10 mL Tray Label; PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 20 mL Single Dose Vial Label NDC 63323-965-02 96520 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 40 mEq per 20 mL (2 mEq per mL) 20 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 20 mL Single Dose Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 20 mL Tray Label NDC 63323-965-20 96520 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 40 mEq per 20 mL (2 mEq per mL) 25 x 20 mL Single Dose Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 20 mL Tray Label; PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 30 mL Multiple Dose Vial Label NDC 63323-967-01 96730 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 60 mEq per 30 mL (2 mEq per mL) 30 mL Multiple Dose Vial Rx only 30mlvial; PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 30 mL Multiple Dose Vial Tray Label NDC 63323-967-30 96730 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 60 mEq per 30 mL (2 mEq per mL) Rx only 25 x 30 mL Multiple Dose Vials 30mltray
- HOW SUPPLIED: The following are packaged in plastic vials. Product Code Unit of Sale Total Potassium Ion Potassium Chloride per mL Each 96505 NDC 63323-965-05 Unit of 25 10 mEq (0.39 g) 149 mg NDC 63323-965-01 5 mL in a 10 mL Single Dose Vial 96510 NDC 63323-965-10 Unit of 25 20 mEq (0.78 g) 149 mg NDC 63323-965-03 10 mL Single Dose Vial 96520 NDC 63323-965-20 Unit of 25 40 mEq (1.56 g) 149 mg NDC 63323-965-02 20 mL Single Dose Vial These are Single Dose Vials, no preservative added, packaged 25 vials per tray. Unused portion of vial should be discarded. Product Code Unit of Sale Total Potassium Ion Potassium Chloride per mL Each 96730 NDC 63323-967-30 Unit of 25 60 mEq (2.35 g) 149 mg NDC 63323-967-01 30 mL Multiple Dose Vial This is a Multiple Dose Vial, preserved with 0.05% methylparaben and 0.005% propylparaben, packaged 25 vials per tray. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Use only if solution is clear, seal intact and undamaged. Vial stoppers do not contain natural rubber latex.
- PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 5 mL Single Dose Vial Label NDC 63323-965-01 96505 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 10 mEq per 5 mL (2 mEq per mL) 5 mL Single Dose Vial Rx only 5mlvial
- PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 5 mL Single Dose Vial Tray Label NDC 63323-965-05 96505 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 10 mEq per 5 mL (2 mEq per mL) Rx only 25 x 5 mL Single Dose Vials 5mltray
- PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 10 mL Single Dose Vial Label NDC 63323-965-03 96510 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 20 mEq per 10 mL (2 mEq per mL) 10 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 10 mL Single Dose Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 10 mL Tray Label NDC 63323-965-10 96510 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 20 mEq per 10 mL (2 mEq per mL) 25 x 10 mL Single Dose Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 10 mL Tray Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 20 mL Single Dose Vial Label NDC 63323-965-02 96520 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 40 mEq per 20 mL (2 mEq per mL) 20 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 20 mL Single Dose Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 20 mL Tray Label NDC 63323-965-20 96520 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 40 mEq per 20 mL (2 mEq per mL) 25 x 20 mL Single Dose Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 20 mL Tray Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 30 mL Multiple Dose Vial Label NDC 63323-967-01 96730 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 60 mEq per 30 mL (2 mEq per mL) 30 mL Multiple Dose Vial Rx only 30mlvial
- PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 30 mL Multiple Dose Vial Tray Label NDC 63323-967-30 96730 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 60 mEq per 30 mL (2 mEq per mL) Rx only 25 x 30 mL Multiple Dose Vials 30mltray
Overview
Potassium Chloride for Injection Concentrate, USP is a sterile, nonpyrogenic concentrated solution of Potassium Chloride, USP in Water for Injection to be administered by intravenous infusion only after dilution in a larger volume of fluid. Each mL of Potassium Chloride for Injection Concentrate contains 2 mEq of K + and Cl – equivalent to 149 mg of potassium chloride and has an osmolarity of 4000 mOsmol/L (calc). A more concentrated Potassium Chloride for Injection Concentrate is also available. Each mL of this injection contains 3 mEq of K + and Cl – equivalent to 224 mg of potassium chloride and has an osmolarity of 6000 mOsmol/L(calc). pH (4.0-8.0) may have been adjusted with hydrochloric acid and if necessary, potassium hydroxide. Some packages are intended for multiple dose use and contain preservatives (0.05% methylparaben and 0.005% propylparaben). A summary of the available products is presented in the HOW SUPPLIED section. Potassium Chloride for Injection Concentrate (appropriately diluted) is a parenteral fluid and electrolyte replenisher.
Indications & Usage
: Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.
Dosage & Administration
: Potassium Chloride for Injection Concentrate 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. The dose and rate of administration are dependent upon the specific condition of each patient. If the serum potassium level is greater than 2.5 mEq/L, potassium can be given at a rate not to exceed 10 mEq/hour and in a concentration of up to 40 mEq/L. The 24 hour total dose should not exceed 200 mEq. If urgent treatment is indicated (serum potassium level less than 2 mEq/L 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. Prior to entering a vial, cleanse the rubber closure with a suitable antiseptic agent. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Warnings & Precautions
WARNINGS: Potentially Fatal Cardiac Adverse Reactions with Undiluted Intravenous Administration Direct patient injection of potassium chloride at this concentration may be instantaneously fatal. Potassium Chloride for Injection Concentrate must be diluted before administration. Fatal cardiac arrhythmia and cardiac arrest have occurred when potassium chloride was administered in an undiluted form. To avoid potassium intoxication, do not infuse these solutions rapidly. In patients with renal insufficiency, administration of potassium chloride may cause potassium intoxication and life-threatening hyperkalemia. The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. In patients with diminished renal function, administration of solutions containing potassium ions may result in potassium retention. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Contraindications
: Potassium Chloride for Injection Concentrate is contraindicated in diseases where high potassium levels may be encountered, and in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present.
Adverse Reactions
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, hypervolemia, and hyperkalemia. Too 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 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.
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