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Acetaminophen Controlled‐Release Sprinkles versus Acetaminophen Immediate‐Release Elixir in Febrile Children
Author(s) -
Wilson John T.,
Helms Richard,
Pickering Bretten D.,
Donahue Lori,
Brown R. Don
Publication year - 2000
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/00912700022009062
Subject(s) - acetaminophen , elixir (programming language) , anesthesia , medicine , antipyretic , analgesic , computer science , programming language
Current acetaminophen (APAP) formulations approved for antipyretic use in children require up to five doses/day, which compromise compliance and risk breakthrough fever over 4 hours after dosing. A total of 112 evaluable febrile children received oral APAP‐equivalent doses of either one dose of APAP controlled release (CR) as sprinkles on apple sauce or one dose q 4 hours × 2 of APAP immediate‐release (IR) elixir in an 8‐hour, double‐blind, double‐dummy, randomized, multicenter study. Prior or concurrent antibiotic use did not significantly affect either the magnitude or the pattern of temperature reduction during the 8‐hour observation period. Significantly greater aural temperature reductions were found with APAP‐CR than with APAP‐IR at 4 and 5 hours. However, the 8‐hour AUCs of temperature reduction were not significantly different between treatments. Pharmacokinetic/pharmacodynamic modeling of APAP was performed in 8 patients with values in both treatments similar to previous results, except for expected differences in AUC 0‐∞ . Similar 8‐hour temperature reduction for APAP‐CR (one dose) and APAP‐IR (two doses) demonstrates the efficacy of APAP‐CR as an antipyretic in children 2 to 11 years of age. A decrease in the number of APAP daily doses and the prolonged antipyretic effect of APAP‐CR may assist those who care for febrile children at home.