FDA label 965c65cb-0dd3-4337-998d-60723b67915a

WARNINGS Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% Sodium Chloride Injection, USP and may occur with 0.45% Sodium Chloride Injection, USP. Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Depending on the volume and rate of infusion, the intravenous administration of Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration/hypervolemia, congested states, pulmonary edema, or acid-base imbalance. The risk of dilutive states is inversely proportional to the electrolyte concentration 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. 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. Administer 0.9% Sodium Chloride Injection, USP with particular caution, to patients with or at risk for hypernatremia, hyperchloremia, or metabolic acidosis. The infusion of solutions with 0.45% Sodium Chloride Injection, USP may result in hyponatremia. Close clinical monitoring may be warranted. Hyponatremia can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death. The risk for hyponatremia is increased, for example, in children, elderly, women, postoperatively, in persons with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as certain antiepileptic and psychotropic medications). The risk for developing hyponatremic encephalopathy is increased, for example, in pediatric patients (≤16 years of age), women (in particular pre-menopausal women), in patients with hypoxemia, and in patients with underlying central nervous system disease. Acute symptomatic hyponatremic encephalopathy is considered a medical emergency. Administer Sodium Chloride Injection, USP with particular caution, to patients with or at risk for hypervolemia or with conditions that may cause sodium retention, fluid overload and edema; such as patients with primary hyperaldosteronism, or secondary hyperaldosteronism [e.g., associated with hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis) or pre-eclampsia]. Certain medications may increase risk of sodium and fluid retention, see Drug Interactions . Administer Sodium Chloride Injection, USP with particular caution, to patients with severe renal impairment. In such patients, administration of Sodium Chloride Injection, USP may result in sodium retention.

ADVERSE REACTIONS Post-Marketing Adverse Reactions The following adverse reactions have been identified during postapproval use of Sodium Chloride Injection, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been reported in the post-marketing experience during use of 0.9% Sodium Chloride Injection, USP and include the following: hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus. Also reported are infusion site reactions, such as infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria. The following adverse reactions have not been reported with 0.9% Sodium Chloride Injection, USP but may occur: hypernatremia, hyperchloremic metabolic acidosis, and hyponatremia, which may be symptomatic. Hyponatremia has been reported for 0.45% Sodium Chloride Injection, USP (see Pediatric Use section). The following adverse reactions have not been reported with 0.45% Sodium Chloride Injection, USP but may occur: hyperchloremic metabolic acidosis, hypersensitivity/infusion reactions (including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus), and infusion site reactions (such as infusion site erythema, injection site streaking, burning sensation, infusion site urticaria). If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.