FDA label e9151721-2279-44e6-88e9-b67d9bc26bcf

WARNINGS Hypersensitivity Reactions Hypersensitivity and infusion reactions have been reported with PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP). See ADVERSE REACTIONS . Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Institute appropriate therapeutic countermeasures as clinically indicated. Electrolyte Imbalances Fluid Overload Depending on the volume and rate of infusion, the intravenous administration of PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) can cause electrolyte disturbances such as overhydration and congested states, including pulmonary congestion and edema. Avoid PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, 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. Hyponatremia PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, 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 hypotonic PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP). Avoid PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) in hypervolemic or overhydrated patients. If use cannot be avoided, monitor serum sodium concentrations. Hypernatremia Hypernatremia may occur with PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP). Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia. Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see PRECAUTIONS . Avoid PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) in patients with, or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations. Hypermagnesemia Avoid solutions containing magnesium, including PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) in patients with or predisposed to hypermagnesemia, including patients with severe renal impairment and those patients receiving magnesium therapy (e.g., treatment of eclampsia and myasthenia gravis). PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is not indicated for the treatment of hypomagnesemia. Acidosis PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is not for use for the treatment of lactic acidosis or severe metabolic acidosis in patients with severe liver and/or renal impairment. Alkalosis Excess administration of PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) can result in metabolic alkalosis. Avoid PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) in patients with alkalosis or at risk for alkalosis. PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is not indicated for the treatment of hypochloremic hypokalemic alkalosis. Avoid use in patients with hypochloremic hypokalemic alkalosis. Hypocalcemia PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) contains no calcium, and an increase in plasma pH due to its alkalinizing effect may lower the concentration of ionized (not-protein bound) calcium. Avoid PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) in patients with hypocalcemia. Hyperkalemia Potassium-containing solutions, including PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) 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 PRECAUTIONS ). Avoid PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) in patients with, or at risk for hyperkalemia If use cannot be avoided, monitor serum potassium concentrations. Although PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) has a potassium concentration similar to the concentration in plasma, it is insufficient to produce a useful effect in case of severe potassium deficiency; therefore, it is not indicated for correction of severe potassium deficiency.

ADVERSE REACTIONS Post-marketing Adverse Reactions The following adverse reactions associated with the use of PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) were identified in clinical trials or postmarketing reports. Because postmarketing reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Hypersensitivity and Infusion Reactions : tachycardia, palpitations, chest pain, chest discomfort, dyspnea, flushing, hyperemia, asthenia, feeling abnormal, piloerection, edema peripheral, pyrexia, hypotension, wheezing, urticaria, cold sweat, chills. General Disorders and Administration Site Conditions : infusion site pain, burning sensation. Metabolism and nutrition disorders : hyperkalemia, hyponatremia. Nervous System Disorders : hyponatremic encephalopathy. Overdose Excessive administration of PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) can cause: • fluid overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired. • hypernatremia and hyperkalemia, especially in patients with severe renal impairment. • hypermagnesemia. See WARNINGS and ADVERSE REACTIONS • metabolic alkalosis with or without hypokalemia and decreased ionized serum calcium and magnesium concentrations. When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment. Interventions include discontinuation of PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP), dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).