| Multiple-dose pharmacokinetics and safety of an ibuprofen-pseudoephedrine cold suspension in children. | |
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MedLine Citation:
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PMID: 20356918 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Two studies were conducted to characterize multiple-dose pharmacokinetics and potential drug interactions of ibuprofen and pseudoephedrine combined in a suspension and to evaluate safety of this combination in children with common cold, flu, or sinusitis. In the pharmacokinetic study, 24 healthy children aged 4-11 years were administered ibuprofen -pseudoephedrine suspension at 7.5 and 1.125 mg/kg, respectively, every 6 hours for 5 doses. Serial blood samples were drawn over 6 hours after final dose for assessment of steady-state pharmacokinetics. In the open-label, multicenter safety study, more than 100 children aged 2-11 years experiencing symptomatic rhinitis were enrolled. Ibuprofen -pseudoephedrine suspension was administered as needed at similar mg/kg doses every 6-8 hours for up to 3 days. Subjects enrolled in the pharmacokinetic study showed no accumulation of either drug; their weight-adjusted clearances were independent of age, and results were comparable with those from previous single-ingredient studies. For ibuprofen, oral clearance (Cl/F) was 77.5 + or - 16.4 mL/kg/h and volume of distribution (Vd/F) was 0.147 + or - 0.037 L/kg. For pseudoephedrine, Cl/F was 12.3 + or - 2.2 mL/kg/min and Vd/F was 2.52 + or - 0.47 L/kg. In the safety study, adverse events were reported for 18.4% of subjects; most were mild to moderate intensity. There was little difference in incidence of adverse events among different age and weight groups. In conclusion, administration of combined ibuprofen and pseudoephedrine in children demonstrated similar pharmacokinetics when compared with reports of the pharmacokinetics for the single-ingredient products, consistent with no apparent drug interactions. The combination suspension was generally well tolerated. |
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Authors:
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Cathy K Gelotte; Mary Jane Prior; Charles Pendley; Brenda Zimmerman; Bernard J Lavins |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't Date: 2010-03-31 |
Journal Detail:
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Title: Clinical pediatrics Volume: 49 ISSN: 1938-2707 ISO Abbreviation: Clin Pediatr (Phila) Publication Date: 2010 Jul |
Date Detail:
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Created Date: 2010-06-28 Completed Date: 2010-10-13 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0372606 Medline TA: Clin Pediatr (Phila) Country: United States |
Other Details:
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Languages: eng Pagination: 678-85 Citation Subset: AIM; IM |
Affiliation:
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McNeil Consumer Healthcare, Fort Washington, PA, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Oral Age Factors Area Under Curve Case-Control Studies Child Child, Preschool Common Cold / diagnosis, drug therapy* Dose-Response Relationship, Drug Drug Administration Schedule Drug Combinations Drug Interactions Drug Toxicity Female Humans Ibuprofen / administration & dosage, pharmacokinetics* Male Pseudoephedrine / administration & dosage, pharmacokinetics* Reference Values Rhinitis / diagnosis, drug therapy* Suspensions / administration & dosage, pharmacokinetics Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Drug Combinations; 0/Suspensions; 15687-27-1/Ibuprofen; 90-82-4/Pseudoephedrine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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