Sodium Chloride
Generic: SODIUM CHLORIDE
Basic Information
Manufacturer
Fresenius Kabi USA, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
c44b0fdb-33df-4747-b443-5fb4deb456cb
Indications & Usage
INDICATIONS AND USAGE Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake.
Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome.
Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.
Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome.
Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.
Warnings
WARNINGS WARNING: This product contains aluminum that may be toxic.
Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.
Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration.
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 exists edema with sodium retention.
In patients with diminished renal function, administration of solutions containing sodium may result in sodium retention.
The intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overloading resulting in dilution of other serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
Excessive administration of potassium free solutions may result in significant hypokalemia.
Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.
Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration.
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 exists edema with sodium retention.
In patients with diminished renal function, administration of solutions containing sodium may result in sodium retention.
The intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overloading resulting in dilution of other serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
Excessive administration of potassium free solutions may result in significant hypokalemia.
Adverse Reactions
ADVERSE REACTIONS None known.