warnings
WARNINGS Hypersensitivity Hypersensitivity reactions, including anaphylaxis, have been reported with Ringer’s Injection. Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Electrolyte Imbalances Hyperkalemia Potassium-containing solutions, including Ringer’s Injection, may increase the risk of hyperkalemia. Patient’s at increased risk of developing hyperkalemia include those: • With conditions predisposing to hyperkalemia and/or associated with increased sensitivity to potassium, such as patients with severe renal impairment, acute dehydration, extensive tissue injury or burns, certain cardiac disorders such as congestive heart failure • Treated concurrently or recently with agents or products that cause or increase the risk of hyperkalemia (see DRUG INTERACTIONS ). Avoid use of Ringer’s Injection in patients with, or at risk for, hyperkalemia. If use cannot be avoided, monitor serum potassium concentrations. Hypernatremia and Hyperchloremia Electrolyte imbalances such as hypernatremia, hyperchloremia, and metabolic acidosis may occur with Ringer’s Injection. Conditions that may increase the risk of hypernatremia, fluid overload and edema (peripheral and/or pulmonary), include patients with aldosteronism; hypertension, congestive heart failure, liver disease, and pre-eclampsia. Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see DRUG INTERACTIONS . Avoid Ringer’s Injection in patients with, or at risk for, hypernatremia or hyperchloremia. Administration of Ringer’s Injection may result in acute kidney injury (AKI) in patients with or at risk for hyperchloremia. If use cannot be avoided, monitor serum sodium and chloride concentrations acid-base balance, and renal function. Hyponatremia Ringer’s Injection may lead to hyponatremia in at-risk patients. 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 hypotonic Ringer’s Injection. 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 DRUG INTERACTIONS . 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 Ringer’s Injection 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 rate of infusion, the patient’s underlying clinical condition, the intravenous administration of Ringer’s Injection can cause electrolyte disturbances such as overhydration and congested states including pulmonary congestion and edema. Avoid Ringer’s Injection 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. Hypercalcemia Ringer’s Injection may cause hypercalcemia. Avoid intravenous administration of Ringer’s Injection in patients with: hypercalcemia or conditions predisposing to hypercalcemia; and in patients with calcium renal calculi or a history of such calculi.