Acetaminophen controlled-release sprinkles versus acetaminophen immediate-release elixir in febrile children

John T. Wilson, Richard Helms, Bretten D. Pickering, Lori Donahue, R. Don Brown

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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 applesauce or one dose q 4 hours x 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. (C) 2000 the American College of Clinical Pharmacology.

Original languageEnglish (US)
Pages (from-to)360-369
Number of pages10
JournalJournal of Clinical Pharmacology
Volume40
Issue number4
DOIs
StatePublished - Jan 1 2000

Fingerprint

Acetaminophen
Fever
Antipyretics
Temperature
Area Under Curve
Child Care
Compliance
Multicenter Studies
Ear
Pharmacokinetics
Observation
Anti-Bacterial Agents

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

Cite this

Acetaminophen controlled-release sprinkles versus acetaminophen immediate-release elixir in febrile children. / Wilson, John T.; Helms, Richard; Pickering, Bretten D.; Donahue, Lori; Brown, R. Don.

In: Journal of Clinical Pharmacology, Vol. 40, No. 4, 01.01.2000, p. 360-369.

Research output: Contribution to journalArticle

Wilson, John T. ; Helms, Richard ; Pickering, Bretten D. ; Donahue, Lori ; Brown, R. Don. / Acetaminophen controlled-release sprinkles versus acetaminophen immediate-release elixir in febrile children. In: Journal of Clinical Pharmacology. 2000 ; Vol. 40, No. 4. pp. 360-369.
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