The following addendum from the Committee on Drugs was prepared in response to numerous requests for reference material or rationale to support the dosage of naloxone for infants and children1 currently recommended by the Committee on Drugs.

The currently recommended dose of naloxone is 0.1 mg/kg for infants and children from birth to 5 years of age or 20 kg of body weight. Children olden than 5 years of age or weighing more than 20 kg may be given 2.0 mg. These doses may be repeated as needed to maintain opiate reversal.1 The higher dose recommendation is based, in part, on a concern that 0.01 mg/kg, currently recommended in approved labeling, may not provide optimal opiate reversal in some infants.2 In addition, it is intended to simplify naloxone dosing and provide greater probability of optimal opiate reversal in most patients.

Because doses as high as 0.4 mg/kg have been administered to newborns without ill effect,3 it is felt that the higher dose poses no increased risk. Naloxone doses ranging from 0.005 to 0.4 mg/kg have been reported in the pediatric literature.2-10 Individual doses up to 0.4 mg/kg3 and constant intravenous infusion of 0.16 mg/kg/h for 5 days4 have not been associated with naloxone-related adverse effects. The average half-life of naloxone in premature newborns is 70 minutes.5

The Committee's naloxone dosing recommendation has been incorporated recently into the joint American Heart Association (AHA)/American Academy of Pediatrics (AAP) textbook on neonatal resuscitation11 and the accompanying test materials. However, a discrepancy persists between the routes of administration recommended by the Committee and the routes of administration recommended in the AHA/AAP neonatal resuscitation guidelines.

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