Sodium Chloride
Generic: SODIUM CHLORIDE
Basic Information
Manufacturer
B. Braun Medical Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
24a08a93-df23-474b-873e-c59ec8855f9f
Indications & Usage
INDICATIONS AND USAGE 0.9% Sodium Chloride Injection USP is indicated as pharmaceutic aid and diluent for the infusion of compatible drug additives.
Refer to prescribing information accompanying additive drugs.
Refer to prescribing information accompanying additive drugs.
Warnings
WARNINGS The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
The risk of dilutional states is inversely proportional to the electrolyte concentration.
The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.
Solutions containing sodium ions 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 is sodium retention with edema.
In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
Infusion of isotonic (0.9%) sodium chloride during or immediately after surgery may result in excessive sodium retention.
Use the patient’s circulatory system status as a guide.
The risk of dilutional states is inversely proportional to the electrolyte concentration.
The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.
Solutions containing sodium ions 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 is sodium retention with edema.
In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
Infusion of isotonic (0.9%) sodium chloride during or immediately after surgery may result in excessive sodium retention.
Use the patient’s circulatory system status as a guide.
Adverse Reactions
ADVERSE REACTIONS Reactions which may occur because of the solution, added drugs or the technique of reconstitution or administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
Carefully review the prescribing information for the diluted drug.
The physician should also be alert to the possibility of adverse reactions to drug additives.
Prescribing information for drug additives to be administered in this manner should be consulted.
Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.
Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume.
If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect.
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.
Carefully review the prescribing information for the diluted drug.
The physician should also be alert to the possibility of adverse reactions to drug additives.
Prescribing information for drug additives to be administered in this manner should be consulted.
Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.
Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume.
If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect.
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.