The U.S. Food and Drug Administration has approved the pediatric use of Protopam Chloride (pralidoxime chloride), a drug used to treat poisoning by organophosphate pesticides and chemicals (e.g., nerve agents). The drug is approved to be administered either by intravenous (IV) or intramuscular (IM) injections.
"We know this drug has been widely used for many years to treat poisoning in pediatric patients in emergency situations," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Improving the drug's label with new dosing information for children will give health care professionals better guidance on how to use this drug safely and effectively."
"It can be difficult to use IV drugs in children, particularly in emergency situations, so having the new option of IM injection may help health care professionals use this medicine quickly and accurately," said Dianne Murphy, M.D., director of the FDA's Office of Pediatric Therapeutics..........& more