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Article: Population pharmacokinetics of oral diclofenac for acute pain in children

TitlePopulation pharmacokinetics of oral diclofenac for acute pain in children
Authors
KeywordsAcute pain
Children
Diclofenac
NONMEM
Population pharmacokinetics
Issue Date2008
PublisherBlackwell Publishing Ltd. The Journal's web site is located at http://www.blackwellpublishing.com/journals/BJCP
Citation
British Journal Of Clinical Pharmacology, 2008, v. 66 n. 6, p. 846-853 How to Cite?
AbstractAIMS: To develop a population pharmacokinetic model for a new diclofenac suspension (50 mg 5 ml -1) in adult volunteers and paediatric patients, and recommend a dose for acute pain in children. METHODS: Blood samples were drawn at the start and end of surgery, and on removal of the venous cannula from 70 children (aged 1 to 12 years, weight 9 to 37 kg) who received a preoperative oral 1 mg kg -1 dose; these were pooled with rich (14 post-dose samples) data from 30 adult volunteers. Population pharmacokinetic modelling was undertaken with NONMEM. The optimum adult dose of diclofenac for acute pain is 50 mg. Simulation from the final model was performed to predict a paediatric dose to achieve a similar AUC to 50 mg in adults. RESULTS: A total of 558 serum diclofenac concentrations from 100 subjects was used in the pooled analysis. A single disposition compartment model with first order elimination and dual absorption compartments was used. The estimates of CL/F and V D/F were 53.98 l h -1 70 kg -1 and 4.84 l 70 kg -1 respectively. Allometric size models appeared to predict adequately changes in CL and V D with age. Of the simulated doses investigated, 1 mg kg -1 gave paediatric AUC (0,12 h) to adult 50 mg AUC (0,12 h) ratios of 1.00, 1.08 and 1.18 for ages 1-3, 4-6 and 7-12 years respectively. CONCLUSIONS: This study has shown 1 mg kg -1 diclofenac to produce similar exposure in children aged 1 to 12 years as 50 mg in adults, and is acceptable for clinical practice; patients are unlikely to obtain further benefit from higher doses. © 2008 The Authors.
Persistent Identifierhttp://hdl.handle.net/10722/132929
ISSN
2015 Impact Factor: 3.83
2015 SCImago Journal Rankings: 1.486
PubMed Central ID
ISI Accession Number ID
Funding AgencyGrant Number
Rosemont Pharmaceuticals Ltd
Funding Information:

Competing interests: JFS received a PhD studentship sponsored by Rosemont Pharmaceuticals Ltd.

References

 

DC FieldValueLanguage
dc.contributor.authorStanding, JFen_HK
dc.contributor.authorHoward, RFen_HK
dc.contributor.authorJohnson, Aen_HK
dc.contributor.authorSavage, Ien_HK
dc.contributor.authorWong, ICKen_HK
dc.date.accessioned2011-04-04T07:58:02Z-
dc.date.available2011-04-04T07:58:02Z-
dc.date.issued2008en_HK
dc.identifier.citationBritish Journal Of Clinical Pharmacology, 2008, v. 66 n. 6, p. 846-853en_HK
dc.identifier.issn0306-5251en_HK
dc.identifier.urihttp://hdl.handle.net/10722/132929-
dc.description.abstractAIMS: To develop a population pharmacokinetic model for a new diclofenac suspension (50 mg 5 ml -1) in adult volunteers and paediatric patients, and recommend a dose for acute pain in children. METHODS: Blood samples were drawn at the start and end of surgery, and on removal of the venous cannula from 70 children (aged 1 to 12 years, weight 9 to 37 kg) who received a preoperative oral 1 mg kg -1 dose; these were pooled with rich (14 post-dose samples) data from 30 adult volunteers. Population pharmacokinetic modelling was undertaken with NONMEM. The optimum adult dose of diclofenac for acute pain is 50 mg. Simulation from the final model was performed to predict a paediatric dose to achieve a similar AUC to 50 mg in adults. RESULTS: A total of 558 serum diclofenac concentrations from 100 subjects was used in the pooled analysis. A single disposition compartment model with first order elimination and dual absorption compartments was used. The estimates of CL/F and V D/F were 53.98 l h -1 70 kg -1 and 4.84 l 70 kg -1 respectively. Allometric size models appeared to predict adequately changes in CL and V D with age. Of the simulated doses investigated, 1 mg kg -1 gave paediatric AUC (0,12 h) to adult 50 mg AUC (0,12 h) ratios of 1.00, 1.08 and 1.18 for ages 1-3, 4-6 and 7-12 years respectively. CONCLUSIONS: This study has shown 1 mg kg -1 diclofenac to produce similar exposure in children aged 1 to 12 years as 50 mg in adults, and is acceptable for clinical practice; patients are unlikely to obtain further benefit from higher doses. © 2008 The Authors.en_HK
dc.languageengen_US
dc.publisherBlackwell Publishing Ltd. The Journal's web site is located at http://www.blackwellpublishing.com/journals/BJCPen_HK
dc.relation.ispartofBritish Journal of Clinical Pharmacologyen_HK
dc.subjectAcute painen_HK
dc.subjectChildrenen_HK
dc.subjectDiclofenacen_HK
dc.subjectNONMEMen_HK
dc.subjectPopulation pharmacokineticsen_HK
dc.titlePopulation pharmacokinetics of oral diclofenac for acute pain in childrenen_HK
dc.typeArticleen_HK
dc.identifier.emailWong, ICK: wongick@hku.hken_HK
dc.identifier.authorityWong, ICK=rp01480en_HK
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1111/j.1365-2125.2008.03289.xen_HK
dc.identifier.pmid19032726-
dc.identifier.pmcidPMC2675780-
dc.identifier.scopuseid_2-s2.0-56549122658en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-56549122658&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume66en_HK
dc.identifier.issue6en_HK
dc.identifier.spage846en_HK
dc.identifier.epage853en_HK
dc.identifier.eissn1365-2125-
dc.identifier.isiWOS:000261133400012-
dc.publisher.placeUnited Kingdomen_HK
dc.identifier.scopusauthoridStanding, JF=8702431000en_HK
dc.identifier.scopusauthoridHoward, RF=7403674211en_HK
dc.identifier.scopusauthoridJohnson, A=7410015511en_HK
dc.identifier.scopusauthoridSavage, I=7004074225en_HK
dc.identifier.scopusauthoridWong, ICK=7102513915en_HK
dc.identifier.citeulike3689584-

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