Safety of desloratadine syrup in children

Bloom, M.; Staudinger, Heribert; Herron, Jerry

doi:10.1185/030079904x14148

Cited by 58 publications

(36 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Median C max values for the 2-5 years old and 6-11 years old groups were 2.28 and 2.05 ng ml -1 , respectively, at t max of 2 h for both age groups. Median AUC(0,last) was 38.8 and 38.2 ng ml -1 h for the 2-5 and 6-11 years old, respectively, and these values were similar to those in adults, who received 5 mg doses of desloratadine [7].…”

Section: Introductionsupporting

confidence: 53%

Desloratadine dose selection in children aged 6 months to 2 years: comparison of population pharmacokinetics between children and adults

Gupta¹,

Kantesaria²,

Banfield³

et al. 2007

Brit J Clinical Pharma

View full text Add to dashboard Cite

What is already known about this subject • According to recent literature, the pathophysiologies of allergic rhinitis and chronic idiopathic urticaria are thought to be similar in adults and children. In addition, the response to antihistamine treatment is similar in adults and children, suggesting a similar concentration-response relationship.• However, an appropriate dose selection and the pharmacokinetics of desloratadine in children of Ն6 months-Յ2 years old have never been addressed in the literature. What this study adds• This study demonstrated that desloratadine syrup offers a safe treatment option for allergic conditions in young children.• A suitable dose for children aged Ն6 months-<1 year is 1.0 mg, while the corresponding predicted dose for children aged Ն1 year-Յ2 years is 1.25 mg. These paediatric doses yielded similar systemic desloratadine exposures (AUC) to those seen with a typical adult dose of 5.0 mg. AimsThe aim of this study was to identify the dose of desloratadine in children aged Ն6 months-Յ2 years that would yield a single-dose target exposure (AUC) comparable with that in adults taking 5 mg desloratadine as syrup. MethodsIn a phase 1, single-dose, open-label, pharmacokinetic study in 58 children aged Ն6 months-<1 year and Ն1 year-Յ2 years were randomly assigned to desloratadine syrup 0.625 mg (1.25 ml) and 1.25 mg (2.5 ml), respectively. Because the volume of blood that could be collected from individual subjects was limited, a population pharmacokinetic approach was used to estimate the pharmacokinetics of desloratadine. Safety was assessed based on results of screening and postdose physical examinations, laboratory safety tests, vital signs, and adverse events. ResultsThe apparent clearance (CL/F) of desloratadine, population estimate (%CV), in children aged Ն6 months-<1 year was 27.8 l h -1 (35) and corresponding values in children Ն1 year-Յ2 years was 35.5 l h -1 (51), compared with 137 l h -1 (58) for adults. The CL/F ratios (children to adults) indicated that doses of 1 mg for Ն6 months-<1 year and 1.25 mg for Ն1 year-Յ2 years would result in similar systemic exposure to that observed in adults receiving the recommended 5 mg dose. Desloratadine was well tolerated with no safety issues. ConclusionsDoses of 1.0 and 1.25 mg in children aged Ն6 months-Յ2 years should result in an exposure to desloratadine similar to that of adults receiving doses of 5 mg.

show abstract

Section: Introductionsupporting

confidence: 53%

Desloratadine dose selection in children aged 6 months to 2 years: comparison of population pharmacokinetics between children and adults

Gupta¹,

Kantesaria²,

Banfield³

et al. 2007

Brit J Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…Tratase de um composto bem tolerado, com mínima incidência de efeitos adversos, comparáveis ao placebo [31][32][33]36 .…”

Section: Os Anti-histamínicos Mais Recentesunclassified

“…A DL não induz alterações clinicamente relevantes no intervalo QTc 34,36 , mesmo em indivíduos que utilizam drogas que usam a mesma via de metabolização hepáti-ca 22,23 . Apesar de seu potencial de interação com receptores muscarínicos, efeitos anticolinérgicos importantes não têm sido relatados 37 .…”

Section: Os Anti-histamínicos Mais Recentesunclassified

New antihistamines: a critical view

Camelo-Nunes¹

2006

J Pediatr (Rio J)

View full text Add to dashboard Cite

Objective: To perform a critical evaluation of the more recent H1 antihistamines and the various terms used to describe them, based on a review of evidence on their role in the treatment of allergic disorders.Sources: Original articles, reviews and consensus documents published from 1998 to 2006 and indexed in the MEDLINE and PubMed databases. Keyword: antihistamines.Summary of the findings: Second-generation antihistamines differ from first-generation ones because of their elevated specificity and affinity for peripheral H1 receptors and because of their lower penetration of the central nervous system (CNS), having fewer sedative effects as a result. Whilst second-generation antihistamines are in general better tolerated than their predecessors, some adverse effects, principally cardiotoxicity, have been observed with some of them. Over the last 20 years, new compounds with different pharmacokinetic properties have been synthesized. The majority of these exhibit antiinflammatory properties that are independent of their action on the H1 receptor. More recent improvements, generally in the form of active metabolites, led to the use of the term third-generation antihistamines. This term emerged spontaneously, with no clear definition of its meaning or clinical implications, creating great confusion among healthcare professionals. Conclusions:On the basis of the evidence on H1 antihistamines, none of them deserve the title third-generation antihistamine. As the Consensus Group on New Generation Antihistamines concluded, to merit this definition, a new class of antihistamines would have to demonstrate distinct clinical advantages over existing compounds and fulfill at least three prerequisites: they should be free from cardiotoxicity, drug interactions and effects on the CNS. J Pediatr (Rio J). 2006;82(5 Suppl):S173-80: Antihistamines, desloratadine, fexofenadine, levocetirizine, rupatadine. ResumoObjetivo: Avaliar criticamente os mais novos anti-histamínicos anti-H1 e os diferentes termos utilizados para denominá-los, com base na revisão de evidências sobre o papel dos anti-H1 no tratamento das doenças alérgicas.Fontes dos dados: Artigos originais, revisões e consensos indexados nos bancos de dados MEDLINE e PUBMED de 1998 a 2006. Palavra chave: anti-histamínicos.

show abstract

“…34,35 Desloratadine was shown to be safe and effective for the treatment of AR and chronic idiopathic urticaria in children aged 2 to 5 years and 6 to 11 years at dosages of 1.25 mg and 2.5 mg, respectively. 36 This is a welltolerated compound, with a minimal incidence of adverse effects that is comparable with placebo. [31][32][33]36 Desloratadine does not induce clinically relevant alterations to the QTc interval, 34,36 even in individuals given drugs that employ the same hepatic metabolism route.…”

Section: More Recent Antihistaminesmentioning

confidence: 99%

“…36 This is a welltolerated compound, with a minimal incidence of adverse effects that is comparable with placebo. [31][32][33]36 Desloratadine does not induce clinically relevant alterations to the QTc interval, 34,36 even in individuals given drugs that employ the same hepatic metabolism route. 22,23 Despite its potential for interaction with muscarinic receptors, no significant anticholinergic effects have been reported.…”

Section: More Recent Antihistaminesmentioning

confidence: 99%

Novos anti-histamínicos: uma visão crítica

Camelo-Nunes¹

2006

J. Pediatr. (Rio J.)

View full text Add to dashboard Cite

Objective: To perform a critical evaluation of the more recent H1 antihistamines and the various terms used to describe them, based on a review of evidence on their role in the treatment of allergic disorders.Sources: Original articles, reviews and consensus documents published from 1998 to 2006 and indexed in the MEDLINE and PubMed databases. Keyword: antihistamines.Summary of the findings: Second-generation antihistamines differ from first-generation ones because of their elevated specificity and affinity for peripheral H1 receptors and because of their lower penetration of the central nervous system (CNS), having fewer sedative effects as a result. Whilst second-generation antihistamines are in general better tolerated than their predecessors, some adverse effects, principally cardiotoxicity, have been observed with some of them. Over the last 20 years, new compounds with different pharmacokinetic properties have been synthesized. The majority of these exhibit anti-inflammatory properties that are independent of their action on the H1 receptor. More recent improvements, generally in the form of active metabolites, led to the use of the term third-generation antihistamines. This term emerged spontaneously, with no clear definition of its meaning or clinical implications, creating great confusion among healthcare professionals.Conclusions: On the basis of the evidence on H1 antihistamines, none of them deserve the title third-generation antihistamine. As the Consensus Group on New Generation Antihistamines concluded, to merit this definition, a new class of antihistamines would have to demonstrate distinct clinical advantages over existing compounds and fulfill at least three prerequisites: they should be free from cardiotoxicity, drug interactions and effects on the CNS. J Pediatr (Rio J). 2006;82(5 Suppl):S173-80: Antihistamines, desloratadine, fexofenadine, levocetirizine, rupatadine.

show abstract

Safety of desloratadine syrup in children

Abstract: These studies demonstrate the safety of desloratadine syrup in children aged 2 years-11 years with AR or CIU.

Cited by 58 publications

References 22 publications

Desloratadine dose selection in children aged 6 months to 2 years: comparison of population pharmacokinetics between children and adults

Desloratadine dose selection in children aged 6 months to 2 years: comparison of population pharmacokinetics between children and adults

New antihistamines: a critical view

Novos anti-histamínicos: uma visão crítica

Contact Info

Product

Resources

About