FDA Talk Paper - FDA Approves Pediatric Doses of Atropen
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The Food and Drug Administration today approved new dosage forms of the Atropen (atropine autoinjector) for use in children and adolescents exposed to certain nerve agents or insecticides. The Atropen has been approved since 1973 for use in adults.
FDA Commissioner Mark B. McClellan has placed a high priority in making available safe and effective countermeasures against potential terrorist acts. Today's approval of the Atropen for children and adolescents is part of those efforts.
The Atropen is indicated for use by persons who have been adequately trained in recognizing and treating nerve agent or insecticide intoxication in patients poisoned by these susceptible nerve agents or insecticides.
This product is not considered primary protection against exposure to chemical nerve agents and insecticide poisoning; primary protection consists of protective garments including masks designed specifically for this use. The labeling further states that antidotes such as atropine and pralidoxime should not be considered as complete protection from chemical nerve agents and insecticide poisoning.
The doses approved today for use in children and adolescents with mild symptoms of nerve agent poisoning include 0.5mg for children weighing between 15 and 40 lbs, 1 mg for children weighing between 40 and 90 lbs, and 2 mg doses for adults and children weighing over 90 lbs. For children with symptoms of severe nerve agent poisoning, doses up to three times these doses may be given.
Expected adverse events with atropine can include tachycardia (fast heart rate), dry mouth, decreased sweating, and decreased intestinal functioning.
Atropen is manufactured by Meridian Medical Technologies of Columbia, MD, a wholly owned subsidiary of King Pharmaceuticals, Bristol, TN.