Hypersensitivity reactions, including anaphylaxis, have been reported with Lactated Ringer's Injection, USP (see ADVERSE REACTIONS). Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Lactated Ringer's Injection, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury.

The risk of hospital acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of Lactated Ringer's Injection, USP.

The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). See PRECAUTIONS, Drug Interactions and Pediatric Use.

Patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in particular, premenopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. Avoid Lactated Ringer's Injection, USP in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations.

Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications.

Fluid Overload

Depending on the volume and the rate of infusion, the intravenous administration of Lactated Ringer's Injection, USP can cause electrolyte disturbances such as overhydration and congested states, including pulmonary congestion and edema.

Avoid Lactated Ringer's Injection, USP in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations and acid base balance, as needed and especially during prolonged use.

Hyperkalemia

Potassium-containing solutions, including Lactated Ringer's Injection, USP, may increase the risk of hyperkalemia.

Patients at increased risk of developing hyperkalemia include those:

Avoid use of Lactated Ringer's Injection, USP in patients with, or at risk for, hyperkalemia. If use cannot be avoided, monitor serum potassium concentrations.

Alkalosis

Because lactate is metabolized to bicarbonate, administration of Lactated Ringer's Injection, USP may result in, or worsen, metabolic alkalosis. Avoid intravenous administration of Lactated Ringer's Injection, USP in patients with alkalosis or at risk for alkalosis.