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Titolo:
The pharmacokinetics, electrocardiographic effects, and tolerability of loratadine syrup in children aged 2 to 5 years
Autore:
Salmun, LM; Herron, JM; Banfield, C; Padhi, D; Lorber, R; Affrime, MB;
Indirizzi:
Schering Plough Corp, Res Inst, Allergy Resp Dis Clin Res, Kenilworth, NJ 07033 USA Schering Plough Corp Kenilworth NJ USA 07033 es, Kenilworth, NJ 07033 USA
Titolo Testata:
CLINICAL THERAPEUTICS
fascicolo: 5, volume: 22, anno: 2000,
pagine: 613 - 621
SICI:
0149-2918(200005)22:5<613:TPEEAT>2.0.ZU;2-2
Fonte:
ISI
Lingua:
ENG
Soggetto:
ALLERGIC RHINITIS; DESCARBOETHOXYLORATADINE; ANTIHISTAMINES; COMPLICATIONS; ASTEMIZOLE;
Keywords:
allergic rhinitis; antihistamine; idiopathic urticaria; loratadine; pediatric; pharmacokinetics;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
12
Recensione:
Indirizzi per estratti:
Indirizzo: Salmun, LM Schering Plough Corp, Res Inst, Allergy Resp Dis Clin Res, 2000Galloping Hill Rd, Kenilworth, NJ 07033 USA Schering Plough Corp 2000 Galloping Hill Rd Kenilworth NJ USA 07033
Citazione:
L.M. Salmun et al., "The pharmacokinetics, electrocardiographic effects, and tolerability of loratadine syrup in children aged 2 to 5 years", CLIN THER, 22(5), 2000, pp. 613-621

Abstract

Objective: We assessed the pharmacokinetics and tolerability of 5 mg loratadine syrup (1 mg/mL) in children aged 2 to 5 years. Methods: Two studies were undertaken. A single-dose, open-label bioavailability study was performed to characterize the pharmacokinetic profiles of loratadine and its metabolite desloratadine. Plasma concentrations of loratadine and desloratadine were determined at 0, 1, 2, 4, 8, 12, 24, 48, and 72hours after a single administration of 5 mg loratadine syrup to 18 healthychildren (11 male, 7 female; 22 black, 5 white, 1 other; mean age +/- SD, 3.8 +/- 1.1 years; mean weight +/- SD, 17.4 +/- 4.4 kg). In addition, a randomized, double-blind, placebo-controlled, parallel-group study was performed to assess the tolerability of 5 mg loratadine syrup after multiple doses. Loratadine (n = 60) or placebo (n = 61) was given once daily for 15 days to children with a history of allergic rhinitis or chronic idiopathic urticaria. In the loratadine group, 27 boys and 33 girls (52 white, 8 black) were enrolled, with a mean age +/- SD of 3.67 +/- 1.13 years and a mean weight+/- SD of 17.2 +/- 3.8 kg. In the placebo group, 27 boys and 34 girls (53 white, 7 black, 1 Asian) were enrolled, with a mean age +/- SD of 3.52 +/- 1.12 years and a mean weight +/- SD of 17.3 +/- 2.9 kg. Tolerability was assessed based on electrocardiographic results, occurrence of adverse events,changes in vital signs, and results of laboratory tests and physical examinations. Results: The peak plasma concentrations of loratadine and desloratadine were 7.78 and 5.09 ng/mL, respectively, observed 1.17 and 2.33 hours after administration of loratadine; the areas under the plasma concentration-time curve to the last quantifiable time point for loratadine and desloratadine were 16.7 and 87.2 ng.h/ml, respectively. Single and multiple doses were well tolerated, with no adverse events occurring with greater frequency after multiple doses of loratadine than after placebo. Electrocardiographic parameters were not altered by loratadine compared with placebo. There were no clinically meaningful changes in other tolerability assessments. Conclusion: Loratadine was well tolerated in this small, selected group ofchildren aged 2 to 5 years at a dose providing exposure similar to that with the adult dose (ie, 10 mg once daily).

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 21/09/18 alle ore 07:36:46