"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
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 Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP may result in sodium retention.
Do not connect flexible plastic containers of intravenous solutions in series connections. Such use could result in air embolism due to residual air being drawn from one container before administration of the fluid from a secondary container is completed. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.
Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.
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.
Carcinogenesis and Mutagenesis and Impairment of Fertility
Studies with Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Pregnancy Category C
Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP. It is also not known whether Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP should be given to a pregnant woman only if clearly needed.
Labor and Delivery
Studies have not been conducted to evaluate the effects of Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP on labor and delivery. Caution should be exercised when administering this drug during labor and delivery.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP is administered to a nursing woman.
Safety and effectiveness of Sodium Chloride (sodium chloride (sodium chloride injection) injection) Injection, USP in pediatric patients have not been established by adequate and well controlled trials, however, the use of sodium chloride (sodium chloride (sodium chloride injection) injection) 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 Sodium Chloride (sodium chloride (sodium chloride injection) injection) 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 the responses between 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.
Last reviewed on RxList: 12/2/2010
This monograph has been modified to include the generic and brand name in many instances.
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