Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- PLASMA -LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) must not be used in patients with clinically significant hyperglycemia.
- PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is a hyper-osmotic solution, having an osmolarity of 363 mOsmol/L (calc). Administration of hypertonic solutions may cause venous irritation, including phlebitis. Hyperosmolar solutions should be administered with caution, if at all, to patients with hyperosmolar states.
* added a General subsection and information regarding air embolism
* remove Carcinogenesis, Mutagenesis, Impairment of Fertility subsection
* add instruction to monitor electrolyte concentrations and the risk for Hyponatremia; update Pediatric Use subsection and reorganize language regarding monitoring glucose and hyperglycemia
Labor and Delivery
* Added subsection and information regarding maternal and fetal hyperglycemia