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warnings
WARNINGS Sodium Lactate Injection, USP is not for use for the treatment of lactic acidosis or severe metabolic acidosis. The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Depending on the volume and rate of infusion, the intravenous administration of these injections can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, pulmonary edema or acid-base imbalance. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection. Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation. Excessive administration of Sodium Lactate Injection, USP may result in hypokalemia. Sodium Lactate Injection, USP should be administered with particular caution, if at all, to patients with alkalosis or at risk for alkalosis. Because lactate is metabolized to bicarbonate, administration may result in, or worsen, metabolic alkalosis. Sodium Lactate Injection, USP should be administered with particular caution, if at all, to patients with severe renal impairment, hypervolemia, overhydration, or conditions that may cause sodium retention, fluid overload, or edema.
ADVERSE REACTIONS Post-Marketing Adverse Reactions The following adverse reactions have been reported in the post-marketing experience, listed by MedDRA System Organ Class (SOC). Immune System Disorders: Hypersensitivity/infusion reactions manifested by: blood pressure decreased, pyrexia General Disorders and Administration Site Conditions: Infusion site burning Class Reactions Other symptoms of hypersensitivity/infusion reactions: anaphylactic/anaphylactoid reactions, and the following manifestations: angioedema, chest pain, chest discomfort, decreased heart rate, tachycardia, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthaesias, hypesthesia oral, dysgeusia, nausea, anxiety and headache Hypervolemia Infusion site reactions, including infection at the site of injection, phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site anesthesia (numbness) Overdose An excessive volume or too high a rate of administration of Sodium Lactate Injection, USP may lead to fluid and sodium overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired. Excessive administration of lactate may lead to metabolic alkalosis. Metabolic alkalosis may be accompanied by hypokalemia. 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.