Baxter 0.9% Sodium Chloride

Baxter 0.9% Sodium Chloride Warnings

sodium chloride

Manufacturer:

Baxter Healthcare

Distributor:

Baxter Healthcare
Full Prescribing Info
Warnings
0.9% Sodium Chloride Injection should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.
In patients with diminished renal function, administration of Sodium Chloride Injection may result in sodium retention.
Hypersensitivity reactions: Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus, have been reported with Sodium Chloride Injection.
Stop the infusion immediately if signs or symptoms of hypersensitivity/infusion reactions develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Risk of Fluid and/or Solute Overload and Electrolyte Disturbances: Depending on the volume and rate of infusion, intravenous administration of Sodium Chloride Injection can cause: fluid and/or solute overload resulting in overhydration/hypervolemia and, for example, congested states, including central and peripheral edema; clinically relevant electrolyte disturbances and acid-base imbalance.
In general, the risk of dilutional states is inversely proportional to the electrolyte concentrations of 0.9% Sodium Chloride Injection and additions. The risk of solute overload causing congested states is directly proportional to the electrolyte concentrations of 0.9% Sodium Chloride Injection and additions.
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.
Use in patients at risk for sodium retention, fluid overload and edema: Sodium Chloride Injection should be used with particular caution, if at all, in patients with or at risk for: Hypernatremia, Hyperchloremia, Metabolic acidosis, Hypervolemia, Medications that may increase the risk of sodium and fluid retention, such as corticosteroids.
Conditions that may cause sodium retention, fluid overload and edema (central and peripheral), such as 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) or pre-eclampsia.
Risk of Hyponatremia: Monitoring of serum sodium is important for all fluids. 0.9% Sodium Chloride Injection has an osmolarity of 308 mOsmol/L (calc).
High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia.
Acute hyponatremia can lead to acute hyponatremic encephalopathy (brain edema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury.
Use in Patients with Severe Renal Impairment: Sodium Chloride Injection should be administered with particular caution, if at all, to patients with severe renal impairment. In such patients, administration of Sodium Chloride Injection may result in sodium retention.
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