title: Multiple-dose pharmacokinetics and safety of an ibuprofen-pseudoephedrine cold suspension in children.
abstract: 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.
authors.affiliation: McNeil Consumer Healthcare, Fort Washington, PA, USA.
authors.forename: Cathy K
authors.initials: CK
authors.lastname: Gelotte
authors.forename: Mary Jane
authors.initials: MJ
authors.lastname: Prior
authors.forename: Charles
authors.initials: C
authors.lastname: Pendley
authors.forename: Brenda
authors.initials: B
authors.lastname: Zimmerman
authors.forename: Bernard J
authors.initials: BJ
authors.lastname: Lavins
mesh_terms: D000284:Administration, Oral; D000367:Age Factors; D019540:Area Under Curve; D016022:Case-Control Studies; D002648:Child; D002675:Child, Preschool; D003139:Common Cold / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage / Q000493:pharmacokinetics*; D008297:Male; D054199:Pseudoephedrine / Q000008:administration & dosage / Q000493:pharmacokinetics*; D012016:Reference Values; D012220:Rhinitis / Q000175:diagnosis / Q000188:drug therapy*; D013535:Suspensions / Q000008:administration & dosage / Q000493:pharmacokinetics; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D013535:Suspensions; D054199:Pseudoephedrine; D007052:Ibuprofen