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1.
Allergy Asthma Proc ; 29(4): 380-5, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18702885

RESUMO

Allergic rhinitis (AR) is a common chronic condition in children and may impact a child's quality of life. Increasing treatment compliance may improve quality of life. An oral suspension of fexofenadine hydrochloride (HCl) has been developed to ease administration to children and may, therefore, improve treatment compliance. The purpose of this study was to assess the pharmacokinetic behavior, safety, and tolerability of a single dose of fexofenadine HCl oral suspension administered to children aged 2-5 years with allergic rhinitis. Children (aged 2-5 years) with AR were recruited in a multicenter, open-label, single-dose study. Fexofenadine HCl (30 mg) was administered as a 6-mg/mL suspension (5 mL). Plasma samples were collected up to 24 hours postdose. Adverse events (AEs); electrocardiograms (ECGs); vital signs; and clinical laboratory tests for hematology, blood chemistry, and urinalysis were analyzed to evaluate safety and tolerability. Fifty subjects completed the study. Mean maximum plasma concentration of fexofenadine was 224 ng/mL, and mean area under the plasma concentration curve was 898 ng . hour/mL. Treatment-emergent AEs were mild in intensity and reported in a total of seven subjects. No trends or clinically meaningful changes in mean ECG, vital sign, or clinical laboratory test data occurred during the study. In children aged 2-5 years, the exposure after a 30-mg dose of fexofenadine HCl suspension was similar to the exposures previously seen after a 30- and 60-mg dose of fexofenadine HCl in children aged 6-11 years and in adults, respectively. The suspension was also well tolerated.


Assuntos
Antialérgicos/farmacocinética , Antagonistas não Sedativos dos Receptores H1 da Histamina/farmacocinética , Rinite Alérgica Perene/tratamento farmacológico , Rinite Alérgica Sazonal/tratamento farmacológico , Terfenadina/análogos & derivados , Administração Oral , Antialérgicos/administração & dosagem , Antialérgicos/efeitos adversos , Pré-Escolar , Antagonistas não Sedativos dos Receptores H1 da Histamina/administração & dosagem , Antagonistas não Sedativos dos Receptores H1 da Histamina/efeitos adversos , Humanos , Suspensões , Terfenadina/administração & dosagem , Terfenadina/efeitos adversos , Terfenadina/farmacocinética , Resultado do Tratamento , Estados Unidos
2.
J Clin Pharmacol ; 48(1): 108-16, 2008 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-18094223

RESUMO

The systemic exposure of fluticasone propionate with hydrofluoroalkane propellant compared with chlorofluoro-carbon propellant and the effect of fluticasone propionate hydrofluoroalkane on 24-hour urinary cortisol in children aged 4 to 11 years with asthma were evaluated. Study 1 was an open-label, 2-way crossover study in which 16 subjects were randomized to 7.5 days each of fluticasone propionate hydrofluoroalkane 88 mug twice a day or fluticasone propionate chlorofluorocarbon 88 mug twice a day. In study 2, 63 subjects received 13.5 days of placebo followed by 27.5 days of fluticasone propionate hydrofluoroalkane 88 mug twice a day. The main outcome measure for study 1 was the difference between fluticasone propionate hydrofluoroalkane and fluticasone propionate chlorofluorocarbon in fluticasone propionate AUC(last) (area under the plasma fluticasone propionate concentration-time curve from zero up to the last quantifiable plasma concentration), and for study 2, 24-hour overnight urinary cortisol excretion. In study 1, fluticasone propionate systemic exposure was significantly lower (55%) with hydrofluoroalkane metered dose inhaler compared with chlorofluorocarbon metered dose inhaler. Study 2 showed no statistically significant changes in 24-hour overnight urinary cortisol excretion and no relationship to fluticasone propionate systemic exposure at this dose. The results of these 2 studies showed that in children aged 4 to 11 years with asthma, fluticasone propionate hydrofluoroalkane has lower systemic exposure compared with chlorofluorocarbon and no hypothalamic-pituitary-adrenal axis effects as measured by 24-hour urinary cortisol excretion.


Assuntos
Androstadienos/uso terapêutico , Asma/tratamento farmacológico , Hidrocarbonetos Fluorados/química , Hidrocortisona/urina , Administração por Inalação , Propelentes de Aerossol/química , Androstadienos/sangue , Androstadienos/farmacocinética , Antiasmáticos/administração & dosagem , Antiasmáticos/efeitos adversos , Antiasmáticos/química , Área Sob a Curva , Asma/metabolismo , Criança , Pré-Escolar , Clorofluorcarbonetos/química , Tosse/induzido quimicamente , Estudos Cross-Over , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Febre/induzido quimicamente , Fluticasona , Meia-Vida , Cefaleia/induzido quimicamente , Humanos , Hidrocortisona/análogos & derivados , Masculino , Inaladores Dosimetrados , Náusea/induzido quimicamente , Infecções Respiratórias/induzido quimicamente
3.
J Agromedicine ; 9(2): 309-14, 2004.
Artigo em Inglês | MEDLINE | ID: mdl-19785224

RESUMO

Two clinical cases illustrate near-fatal reactions to fire ant venom encountered by an infant playing in the backyard, and by a pharmacist working indoors in a hospital setting under a ceiling ventilation duct.


Assuntos
Anafilaxia/etiologia , Venenos de Formiga/imunologia , Mordeduras e Picadas de Insetos/complicações , Mordeduras e Picadas de Insetos/imunologia , Adulto , Anafilaxia/imunologia , Anafilaxia/prevenção & controle , Animais , Dessensibilização Imunológica , Epinefrina/uso terapêutico , Feminino , Humanos , Lactente
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