PALM BEACH GARDENS, Fla., May 19, 2011 /PRNewswire/ -- Underscoring the importance of weight-based dosing for over-the-counter (OTC) children's acetaminophen medications, AccuDial Pharmaceutical, Inc. made seven recommendations to the Food & Drug Administration (FDA) at the meeting of the Joint Pediatric Advisory Committee and Non-Prescription Drugs Advisory Committee meeting on Tuesday, May 17, 2011 concerning children's single-ingredient acetaminophen products.
Bob Terwilliger, Chairman and CEO of AccuDial said, "AccuDial supports all recommendations made by the Consumer Healthcare Product Association (CHPA) to the Joint Advisory Committee. A majority of healthcare professional groups including the American Association of Pediatricians support the recommendations made by CHPA and AccuDial."
"Dosing by age is a core issue of the safety and efficacy of acetaminophen products for children," Terwilliger said. "Many pharmaceutical manufacturers and various FDA websites state, 'if possible, dose by weight.' Dosing instructions by age or weight ranges are very confusing for many parents. For example, when dosing by age or weight ranges, only the smallest or youngest child in each group receives 15 milligrams per kilogram, the optimal dose. The remainder are under-dosed by 17-50% depending on where they fall in the age or weight ranges," said Terwilliger.
AccuDial Pharmaceutical is an OTC children's medication manufacturer whose business is premised upon the weight-based dosing of children's OTC drug products. At the meeting, AccuDial Pharmaceutical supported and recommended the following to the panel:
Dr. Brian Kaplan, M.D. gave AccuDial's recommendations to the committee and added, "I have treated over 15,000 children in my career as a physician and I believe these recommendations will resolve all the issues and problems relevant to dosing acetaminophen to children."
Wednesday morning the FDA Advisory Committee approved the following:
ABOUT ACCUDIAL PHARMACEUTICAL
Children's AccuDial® is a revolutionary line of OTC medications designed to give your child an accurate dose of medicine. The weight of children in the same age group can vary greatly, and they should not always be given the same amount of medicine. According to the American Medical Association, 72% of children are dosed inaccurately with OTC medications. Using the patented AccuDial rotating dosing system, a caregiver simply turns the label of the bottle and matches the child's weight with the correct dose listed in milliliters.
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|SOURCE AccuDial Pharmaceutical, Inc.|
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