Dextrose, Potassium chloride and Sodium chloride

Potassium Chloride in Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories.

Potassium Chloride in Dextrose and Sodium Chloride Injection is a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

• Only for intravenous infusion. • See full prescribing information for information on preparation, administration, dosing considerations and instructions for use.

Potassium Chloride in Dextrose and Sodium Chloride Injection is contraindicated in patients with: • known hypersensitivity to potassium chloride, dextrose and/or sodium chloride • clinically significant hyperkalemia • clinically significant hyperglycemia • Known hypersensitivity to potassium chloride, dextrose, or sodium chloride. • Clinically significant hyperkalemia. • Clinically significant hyperglycemia

• Hypersensitivity Reactions: monitor for signs and symptoms and discontinue infusion if reactions occur. • 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. • Hyperglycemia or Hyperosmolar Hyperglycemic State: Monitor blood glucose and administer insulin as needed. • Hyponatremia, Hypernatremia and Hyperchloremia: Avoid in patients with or at risk for hypo-/hypernatremia. If use cannot be avoided, monitor serum sodium concentrations. • Fluid Overload: Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance and electrolyte, concentrations and acid-base balance, as needed and especially during prolonged use.

The following adverse reactions associated with the use of Potassium Chloride in Dextrose and Sodium Chloride Injection were identified in postmarketing 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: anaphylaxis, rash and pruritus. • Metabolism and Nutrition Disorders: hyperkalemia, hyperglycemia and hyperosmolar hyperglycemic state, hyponatremia and hyponatremic encephalopathy, fluid overload and refeeding syndrome. Hypernatremia and hyperchloremia acidosis have been observed in solutions containing 0.9% sodium chloride.

• Other Products that Cause Hyperkalemia: Avoid use in patients receiving such products. If use cannot be avoided, monitor serum potassium concentrations. • Lithium: Decreased lithium concentrations with concomitant use, monitor serum lithium concentrations. • 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.

Store at room temperature (25°C), brief exposure up to 40°C does not adversely affect the product.