Safety

Plasma-Lyte 56 and Dextrose 5 percent in Plastic Container

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

March 2016

Summary View

CONTRAINDICATIONS

  • 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.

PRECAUTIONS

  • 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.

 

December 2014

Summary View

PRECAUTIONS

* added a General subsection and information regarding air embolism

* remove Carcinogenesis, Mutagenesis, Impairment of Fertility subsection

Pediatric Use

* 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

Page Last Updated: 04/15/2016
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