Potassium Chloride, Dextrose Monohydrate

1 INDICATIONS AND USAGE Potassium Chloride in 5% Dextrose Injection is indicated as a source of water, electrolytes and calories. Potassium Chloride in 5% Dextrose Injection is indicated as a source of water, electrolytes and calories. ( 1 )

6 ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride in 5% Dextrose Injection were identified in post marketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity reactions : including anaphylaxis and chills [see Warnings and Precautions ( 5.1 )] .

8.1 Pregnancy Risk Summary Appropriate administration of Potassium Chloride in 5% Dextrose 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 5% Dextrose 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.

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.1 ) Hyperkalemia : May result in cardiac arrhythmias. Avoid use in patients with, or at risk for, hyperkalemia. If use cannot be avoided, use a product with a low amount of potassium chloride, infuse slowly and monitor serum potassium concentrations and ECGs. ( 5.2 ) Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed. ( 5.3 , 8.4 ) Hyponatremia : Avoid in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. ( 5.4 , 8.4 ) Hypokalemia: Avoid in patients with or at risk for hypokalemia. If use cannot be avoided, monitor serum potassium levels. 4 CONTRAINDICATIONS Potassium Chloride in 5% Dextrose Injection is contraindicated in patients with: known hypersensitivity to potassium chloride and/or dextrose [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 or de...