Dosing By Weight - White Paper
》For almost four decades, dozens of studies corroborate the safety and efficacy of acetaminophen for use in pediatrics. The data demonstrated in those studies highlight that for an antipyretic dose to be achieved, a minimum dose of 10.00 mg per kg or 4.54 mg per lb. should be administered.
》These studies also included the Boston University Fever Study that took place during 1991-to-1993, which is regarded as one of the largest pediatric drug trials ever conducted. This practitioner-based randomized clinical trial involved over twenty thousand children and was conducted at a dose of 12 mg/kg of acetaminophen.
》Multiple large scale clinical trials have continued to demonstrate the effectiveness of a dose between this range; including within 12 unpublished clinical trials of 560 children receiving doses between 10-15 mg/kg, with average dose of 12.5 mg/kg, as submitted by Dr. Temple to the FDA in 2009.
》On January 13, 1995, a Nonprescription Drugs Advisory Committee Meeting was convened by the FDA to discuss pediatric dosing in general. The committee determined its preference for weight-based dosing over age, height/length, or body-surface area, based dosing. The committee also accepted the requirement for age-based dosing, providing for an additional dosing method should the weight of the child not be known at the time of dosing. It was concluded at this meeting that pediatric dosing should be labeled by weight and by age, with the instructions to use weight for dosing, if known, and age if weight is not known.
》On September 18, 1997, yet another committee was convened for the purpose to discuss dosing and labeling of OTC pediatric analgesic/antipyretic drug products. At this Nonprescription Drug and Arthritis Advisory Committee Meeting, the committee reiterated its preference of a primary weight-based dosing, but also recommended age-based dosing directions be additionally provided on the label.
》During a May 17-18, 2011, of the FDA Joint Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee, the panel voted unanimously that weight-based dosing directions be added to the existing age-based labeled dosing directions for children ages 2-12.
》Over the past decade the U.S. FDA has continued to promote and publish guidance for the industry intended to limit and encourage the safer use and dosing of Acetaminophen.
》A set dose of 5 mL of the single-ingredient acetaminophen product for Infants 2-3 years of age (24-35 lb.) population, provides for highly variable dosing that may increase the prospect of a subtherapeutic or supratherapeutic dose due to dosing at the near extremes of a minimum therapeutic dose of 10 mg and maximum of 15 mg.
》The Dose-2-Weight Syringe provides a set dose based on the near minimum efficacious dose of 4.57 mg per lb. (10.07 mg per kg) according to all infants’ and children’s individual weight under 3 years of age with no variable dosing whatsoever.