"The U.S. Food and Drug Administration announced its preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not "generally recognized as safe" for use in food. "...
3% and 5% Sodium Chloride Injection, USP 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 3% and 5% Sodium Chloride Injection, USP may result in sodium retention.
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.
Caution must be exercised in the administration of 3% and 5% Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.
Pregnancy: Teratogenic Effects
Pregnancy Category C. Animal reproduction studies have not been conducted with 3% and 5% Sodium Chloride Injection, USP. It is also not known whether 3% and 5% Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 3% and 5% Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed.
Safety and effectiveness of 3% and 5% Sodium Chloride Injection, USP in pediatric patients have not been established by adequate and well controlled trials, however, the use of sodium chloride solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.
Clinical studies of 3% and 5% Sodium Chloride Injection, USP, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Do not administer unless solution is clear and seal is intact.
Last reviewed on RxList: 10/3/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Hypertonic Saline Information
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