Potassium chloride, dextrose, and sodium chloride

FDA label, Baxter Healthcare Company, intravenous, effective 2019-02-21. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

Renal Impairment Administration of Potassium Chloride in Dextrose and Sodium Chloride Injection in patients with renal impairment may result in hyponatremia, hyperkalemia and/or fluid overload. Monitor patients with renal impairment for development of these adverse reactions [see Warnings and Precautions (5.2 , 5.5 , 5.6 )].

Preparation and administration

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Basis

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Important Administration Instructions

Potassium Chloride in Dextrose and Sodium Chloride Injection is only for intravenous infusion [see Warnings and Precautions ].

The osmolarity of Potassium Chloride in Dextrose and Sodium Chloride Injection, ranges from 361 to 641 mOsmol/L (calc). Peripheral administration is generally acceptable; however; consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain especially with higher potassium concentrations.

Do not administer Potassium Chloride in Dextrose and Sodium Chloride Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.

To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry.

Prior to infusion, visually inspect the solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged.

Use of a final filter is recommended during administration of parenteral solutions, where possible.

Drug interactions

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Label text (5 paragraphs)

7 DRUG INTERACTIONS • Other Products that Cause Hyperkalemia : Avoid use in patients receiving such products. If use cannot be avoided, monitor serum potassium concentrations. ( 7.1 ) • Lithium : Decreased lithium concentrations with concomitant use; monitor serum lithium concentrations. ( 7.2 ) • Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance : Monitor blood glucose concentrations, fluid balance serum electrolyte concentrations and acid-base balance. ( 7.3 )

7.1 Other Products that Cause Hyperkalemia Administration of Potassium Chloride in Dextrose and Sodium Chloride Injection in patients treated concurrently or recently with other products that can cause hyperkalemia or increase the risk of hyperkalemia (e.g., potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia [see Warnings and Precautions (5.2) ]. Avoid use of Potassium Chloride in Dextrose and Sodium Chloride Injection in patients receiving such products.

If use cannot be avoided, monitor serum potassium concentrations.

7.2 Lithium Renal sodium and lithium clearance may be increased during administration of Potassium Chloride in Dextrose and Sodium Chloride Injection resulting in decreased serum lithium concentrations. Monitor serum lithium concentrations during concomitant use.

7.3 Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance Potassium Chloride in Dextrose and Sodium Chloride Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions (5.3 , 5.4 , 5.5 , 5.6 )]. Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Potassium Chloride in Dextrose and Sodium Chloride Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.

Contraindications

Potassium Chloride in Dextrose and Sodium Chloride Injection is contraindicated in patients with: • known hypersensitivity to potassium chloride, dextrose and/or sodium chloride [see Warnings and Precautions 5.1) ] • clinically significant hyperkalemia [see Warnings and Precautions (5.2) ] • clinically significant hyperglycemia [see Warnings and Precautions (5.3) ] • Known hypersensitivity to potassium chloride, dextrose, or sodium chloride ( 4 , 5.1 ) • Clinically significant hyperkalemia ( 4 , 5.2 ) • Clinically significant hyperglycemia ( 4 , 5.3 )

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary Appropriate administration of Potassium Chloride in Dextrose Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Potassium Chloride in Dextrose Sodium Chloride Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

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