Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride

5 WARNINGS AND PRECAUTIONS • Serious Risks with Inappropriate Use with Ceftriaxone : Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone. In patients older than 28 days, ceftriaxone and Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions. ( 4 , 5 . 1 , 8.4 ) • Air Embolism : Use a non-vented infusion set or close the vent on a vented set and use a dedicated line without any connections. Pressure infusion is not recommended to increase flow rates, but if necessary, remove all air from the bag prior to initiating infusion. ( 5.2 ) • Hypersensitivity Reactions : Stop the Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection infusion immediately if signs or symptoms of a hypersensitivity reaction develop. ( 5.3 ) • Potassium Imbalances, Hyponatremia, Neonatal Hypoglycemia, Hyperglycemia and Hyperosmolar Hyperglycemic State, Hypercalcemia, Fluid Overload, Acid-Base Imbalances, Interference with Interpretation of Serum Lactate Levels in Patients with Severe Metabolic Acidosis: See Full Prescribing Information for risk management recommendations. ( 5.4 , 5.5 , 5.6 , 5.7 , 5.8 , 5.9 , 5.10 , 5.11 ) 5.1 Serious Risk with Concomitant Use with Ceftriaxone Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing solutions, such as Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, in the same intravenous administration line. Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used. Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is contraindicated in neonates who receive ceftriaxone [see Contraindications (4) , Use in Specific Populations (8.4) ] . However, in patients older than 28 days, ceftriaxone and Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid. 5.2 Air Embolism Cases of air embolism have been reported with pressurized administration of intravenous fluids. Air embolism may result in stroke, organ ischemia and/or infarction, and death. Use a non-vented infusion set or close the vent on a vented set and use a dedicated line without any connections. If administration is controlled by a pumping device, care must be taken to discontinue the pumping action before the container is empty. If administration is controlled by a pumping device, care must be taken to discontinue the pumping action before the container is empty. Pressure infusion is not recommended to increase flow rates, but if necessary, ensure all air is removed from the bag before infusion. Refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container [see Dosage and Administration (2.2) ] . 5.3 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Lactated Ringer’s solution. Stop the Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated. 5.4 Potassium Imbalances Hyperkalemia Potassium-containing solutions, including Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, may increase the risk of hyperkalemia. This risk is increased in patients predisposed to hyperkalemia including those with severe renal impairment, acute dehydration, extensive tissue injury or burns, heart failure, or in those using concomitant drugs that are associated with hyperkalemia. Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients with, or at increased risk for, hyperkalemia. If use cannot be avoided in these patients, closely monitor serum potassium concentrations. 5.5 Hyponatremia Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. The risk of hospital-acquired hyponatremia is increased in younger pediatric patients, geriatric patients, patients treated with diuretics, patients with cardiac or pulmonary failure, or patients with the syndrome of inappropriate antidiuretic hormone (SIADH) (e.g., postoperative patients, patients concomitantly treated with arginine vasopressin analogs, or certain antiepileptic, psychotropic, or cytotoxic drugs) [see Drug Interactions (7.1) , Use in Specific Populations (8.4) ] . Avoid Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients with or at risk for hyponatremia. If use cannot be avoided in these patients, closely monitor serum sodium concentrations. Rapid correction of hyponatremia may result in serious neurologic complications such as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status. 5.6 Neonatal Hypoglycemia Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypoglycemia. Closely monitor blood glucose concentration during treatment with intravenous dextrose solutions to ensure adequate glycemic control in order to avoid potential long-term adverse effects. 5.7 Hyperglycemia and Hyperosmolar Hyperglycemic State Administration of solutions containing dextrose and lactate in patients with impaired glucose tolerance including those with diabetes mellitus may worsen hyperglycemia. Hyperglycemia is associated with an increase in serum osmolality, which can result in hypovolemia and electrolyte imbalances due to osmotic diuresis. Patients with underlying central nervous system disease or renal impairment who receive dextrose infusions may be at greater risk of developing hyperosmolar hyperglycemic state. While using Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, closely monitor blood glucose concentrations and treat hyperglycemia to maintain glucose concentrations within normal limits. Anti-diabetic drugs may need to be started or dosages of these drugs may need to be increased to maintain optimal blood glucose concentrations. 5.8 Hypercalcemia Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection contains calcium salts and may cause hypercalcemia. Avoid administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients with hypercalcemia, those with calcium-containing renal calculi or history of such calculi, those with conditions predisposing to hypercalcemia, or those treated with concomitant thiazide diuretics or vitamin D. 5.9 Fluid Overload Depending on the administered volume and the infusion rate, administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection can cause fluid overload, including pulmonary edema. Avoid Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients at risk for fluid and/or solute overload including patients with severe renal impairment. If use cannot be avoided in these patients, monitor fluid balance, electrolyte concentrations and acid base balance, especially during prolonged use. 5.10 Acid/Base Imbalances Because lactate is metabolized to bicarbonate, administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may result in, or worsen, metabolic alkalosis. Closely monitor the acid-base balance in patients with, or at risk of, alkalosis. In patients with severe hepatic impairment, decreased lactate metabolism may result in worsening anion gap metabolic acidosis. Avoid Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients with severe hepatic impairment. If use cannot be avoided in these patients, closely monitor serum bicarbonate levels. 5.11 Interference of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection with Interpretation of Serum Lactate Levels in Patients with Severe Metabolic Acidosis Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may result in interference with the interpretation of serum lactate levels in patients with severe metabolic acidosis, including lactic acidosis [see Drug Interactions (7.5)] .