ReviewerNo.

1Section3
ANTIALLERGICSANDMEDICINESUSEDINANAPHYLAXIS

Forproposedyellows:Arethesemedicinesforchildren?

Dothesemedicinesmeetapublichealth?

Chlorphenamine:Yes.

Dothesemedicinesmeetapublichealth?
Yes.Chlorphenamine

Aretheyregisteredforusein(allagecategoriesof)children?
No.

Chlorphenaminemaleateoral:
Dosesforchildrenare:1to2years,1mgtwicedaily;2to5years,1mgevery4to6hours
(maximum6mgdaily);6to12years,2mgevery4to6hours(maximum12mgdaily).
Martindale33ed.,P.412

Chlorphenaminemaleateoral:
Children<12yearoral:0,35mg/kg/dayindivideddosesevery46hoursorasanalternative
2to5years:1mgevery4to6hours
6to11years,2mgevery4to6hours,nottoexceed12mg/dayortimedrelease8mgevery12
hours.
PediatricDosageHandbookAmericanPharmaceuticalAssociation,2001/2002P.226.
ChlorphenaminemaleateI.M.,I.V.,S.C.;
Children<12years:0,0875mg/kgor2,5mg/m
2
4times/day

Arethereanyanaswered/unexpectedclinicalissueswithrespecttoeffectivesorsafety?
No.

Additionalcommentsifany:
nicomedicamentoantialrgicoexistentenalistacomdadossobreutilizaoemcrianas,
devendoteratenoespecialaoefeitoadversodapalpitao.

Rev.bras.cln.ter;14(1/2):479,jan.fev.1985.Tab,ilus.Comparativestudyofterfenadine
versusdextrochlorfeniramineinchronicurticaria

WannmacherL.Autacides.In:FuchsFD,WannmacherLeditorsFarmacologiaclnica.
Fundamentosdateraputicaracional.2nded.RiodeJaneiro:GuanabaraKoogan,1998.p.10513.
BrownNJ,RobertsIILJ.Histamine,bradykinin,andtheirantagonists.In:HardmanJG,
LimbirdLE,GilmanAGeditorsGoodmanandGilmansthepharmacologicalbasisof
therapeutics.10thed.NewYork:McGrawHill,2001.p.64567.

SimonsFER,SimonsKJ.Drugtherapy:thepharmacologyanduseofH(sub1)receptor
antagonistdrugs.NEnglJMed1994;330:166370.

RegistroCochranedeEnsaiosControlados(CENTRAL/CCTR)
Loratadineanddexchlorpheniramineinthetreatmentofperennialallergicrhinitisin
pediatricpatients]
Effectofallergymedicationonchildrensreadingcomprehension.
Efficacyandsafetyofloratadinesuspensioninthetreatmentofchildrenwithallergic
rhinitis.
Comparativestudyoftheefficacy,toleranceandsideeffectsofdexchlorpheniramine
maleate6mgb.i.d.withterfenadine60mgb.i.d.
ComparisonofCNSadverseeffectsbetweenastemizoleandchlorpheniramineinchildren:a
randomized,doubleblindstudy.

Anaphylaxis

Patientswithsevereanaphylacticoranaphylactoidreactionsshouldbegivenimmediate
treatmentwithadrenaline(seeAnaphylaxisandAnaphylacticShock,Adrenaline
Hydrochloride).Additionofaparenteralantihistaminesuchaschlorphenaminemaleateor
diphenhydraminehydrochlorideandacorticosteroidsuchashydrocortisoneaftertheacute
episodemaydecreasethedurationandseverityofsymptomsandpreventrelapse.

MARTINDALETheCompleteDrugReferenceacessoem28/05/2007
Indicationsanddose
Symptomaticreliefofallergysuchashayfever,urticaria
Bymouth
Child1month2years
1mgtwicedaily
Child26years
1mgevery46hours,max.6mgdaily
Child612years
2mgevery46hours,max.12mgdaily
Child1218years
4mgevery46hours,max.24mgdaily
Symptomaticreliefofallergy,emergencytreatmentofanaphylacticreactions

Bysubcutaneous,intramuscularorintravenousinjection
Child1month1year
250micrograms/kg(max.2.5mg),repeatedifrequiredupto4timesin24hours
Child16years
2.55mg,repeatedifrequiredupto4timesin24hours
Child612years
510mg,repeatedifrequiredupto4timesin24hours
Child1218years
1020mg,,repeatedifrequiredupto4timesin24hours(max.40mgin24hours)
NOTE
Intravenous route recommended for anaphylaxis; subcutaneous and intramuscular injections
rarely act quicker than oral administration

Licenseduse
syrupnotlicensedforuseinchildrenunder1year;tabletsnotlicensedforuseinchildren
under6years;injectionnotlicensedforuseinneonates

Administration

forintravenousinjection,giveover1minute;ifsmalldoserequired,dilutewithSodium
Chloride0.9%

Antihistaminesshouldbeusedwithcautioninhepaticimpairment,andthedosemayneed
tobereducedinrenalimpairment;also,usewithcautioninchildrenwithepilepsy.Most
antihistaminesshouldbeavoidedinporphyria,butsome(e.g.chlorphenaminearethought
tobesafe.Sedatingantihistaminesshouldnotbegiventochildrenunder2years,excepton
specialistadvice,becausethesafetyofsuchusehasnotbeenestablished.Sedating
antihistamineshavesignificantantimuscarinicactivitytheyshouldnotbeusedinneonates
andshouldbeusedwithcautioninchildrenwithurinaryretention,glaucoma,or
pyloroduodenalobstruction.
Hepaticimpairment

Sedatingantihistaminesshouldbeavoidedinchildrenwithsevereliverdiseaseincreased
riskofcoma.

Sideeffects
Drowsinessisasignificantsideeffectwithmostoftheolderantihistaminesalthough
paradoxicalstimulationmayoccurrarelyinchildren,especiallywithhighdoses.Drowsiness
maydiminishafterafewdaysoftreatmentandisconsiderablylessofaproblemwiththe
newerantihistamines(seealsonotesabove).Sideeffectsthataremorecommonwiththe
olderantihistaminesincludeheadache,psychomotorimpairment,andantimuscariniceffects
suchasurinaryretention,drymouth,blurredvision,andgastrointestinaldisturbances.
Otherraresideeffectsofantihistaminesincludehypotension,extrapyramidaleffects,
dizziness,confusion,depression,sleepdisturbances,tremor,convulsions,palpitation,
arrhythmias,hypersensitivityreactions(includingbronchospasm,angioedema,anaphylaxis,
rashes,andphotosensitivityreactions),blooddisorders,andliverdysfunction.

Sideeffects
Alsoexfoliativedermatitisandtinnitusreported;injectionsmaycausetransienthypotension
orCNSstimulationandmaybeirritant

CDBNFC,2006.
Forgreens:Isthereanyreasonnottoendorsetheseasessentialmedicinesforchildren?

Dexamethasone

Dothesemedicinesmeetapublichealth?Yes?TEMOSDVIDAS

Aretheyregisteredforusein(allagecategoriesof)children?Yes
Neonates:I.V.Usual:0,25mg/kg/dosegiven~4hourspriortoscheduledextubationandthen
every8hoursfor3dosestotal;range:0,251mg/kg/dosefor13doses;maximumdose
1mg/kg/day.
Children:I.V.,I.M:0,52mg/kg/doseindivideddosesevery6hours;begin24hourspriorto
extubationandcontinuefor46dosesafterextubation.
PediatricDosageHandbookAmericanPharmaceuticalAssociation,2001/2002P.308.

Aretheyanyunanswered/unexpectedclinicalissueswithrespecttoeffectivenessor
safety?No.

Aretherespecialrequirementsortrainingneededforsafe/effectiveuse?
No.

Additionalcommentsifany:

ActionproposedfortheCommitteetotake:
PERGUNTAAOSPEDIATRAS:NECESSRIODEXAMETAZONAPARAUSOEM
ANAFILAXIA,ALERGIAS?

Epinephrine

Dothesemedicinesmeetapublichealth?Yes

Aretheyregisteredforusein(allagecategoriesof)children?Yes
Thedoseofepinephrineshouldbe0.01mg/kg,uptoamaximumof0.30mg.This
presentsadilemmaforcliniciansinthattheprefilledautoinjectorkitsusedosesofonly
0.15and0.30mg/kg,makingtheprecisedosingofchildrenandadolescentsdifficultif
notimpossible.Whilethereislittledirectevidencecomparingonedosewithanother,the
authorssuggestthefollowingdosingalgorithmbasedonpatientweight:
o 10kgorless:Consideruseofampuleofepinephrinewithneedleandsyringeto
drawcorrectdose(0.01mg/kg)ofepinephrine.Themaindifficultieswiththis
approacharetimingandaccuracy.Onestudydemonstratedthatparentsrequired
142secondstodrawadoseof0.09mLofepinephrinevs52secondsforclinicians.
Moreover,theactualdoseofepinephrinedrawnbyparentsrangedbetween0.004
and0.151mL.
o 10to25kg:Autoinjectionwith0.15mgofepinephrine.
o 25kgormore:Autoinjectionwith0.30mgofepinephrine.
Aseconddoseofepinephrineisrequiredforanaphylaxisinupto35%ofcases.
Epinephrinemayberepeated5to20minutesaftertheinitialdose.
Brasil:(RENAME)somentesolinjetvel1mg/ml
http://www.medscape.com/viewarticle/554150acessoem22/05/2007
PediatricDosageHandbookAmericanPharmaceuticalAssociation,2001/2002P.386

Aretheyanyunanswered/unexpectedclinicalissueswithrespecttoeffectivenessor
safety?No.

Theriskiswellknown.Anecessidadedefazerumadiluiomuitograndeumrisco.

Aretherespecialrequirementsortrainingneededforsafe/effectiveuse?

Yes;carefuldilutionprocedure

Possibletransientadverseeventsassociatedwithepinephrineadministrationincludetremor,
anxiety,andpalpitations.
Epinephrineshouldbekeptawayfromextremetemperaturesanddirectsunlighttoprotect
againstdrugdegradation,andthesolutionwillnotnecessarilyappeardifferentafter
degradationhasoccurred.
http://www.medscape.com/viewarticle/554150acessoem22/05/2007
Martindale33ed.,P.829

TheinjectionwiththeEpiPen,everychilddevelopedtransientpallor,tremor,anxiety,and
palpitationsorothercardiovasculareffects;somealsodevelopedheadacheandnausea.
JAllergyClinImmunol;109(1):1715,2002Jan.EpiPenJrversusEpiPeninyoungchildren
weighing15to30kgatriskforanaphylaxis.
Martindale33ed.,P.829

Additionalcommentsifany:Inmanycountriesthereisonlyoneconcentrationmarketed
ActionproposedfortheCommitteetotake:toapprove;tosuggestotherdilutions;prefilled
siringues

Forgreens:Isthereanyreasonnottoendorsetheseasessentialmedicinesforchildren?
Hydrocortisone
Dothesemedicinesmeetapublichealth?Yes

Aretheyregisteredforusein(allagecategoriesof)children?Yes
Children:Initial:50mg/kgthenreapeatedin4hoursand/orevery24hoursifneeded
PediatricDosageHandbookAmericanPharmaceuticalAssociation,2001/2002P.508
Children up to 1 year of age may be given 25mg, those aged 1 to 5 years 50 mg, and those
aged6to12years100mg.
Martindale33ed.,P.1074
PediatricMin/MaxDose:0.16mg/kg/50.0mg/kg
http://www.medscape.com/druginfo/dosage?drugid=6829&drugname=Hydrocortisone+Sod
+Succinate+Inj&monotype=defaultacessoem22/05/2007

Aretheyanyunanswered/unexpectedclinicalissueswithrespecttoeffectivenessor
safety?No.

Aretherespecialrequirementsortrainingneededforsafe/effectiveuse?No

Additionalcommentsifany:

ActionproposedfortheCommitteetotake:
PERGUNTAMOSAOSPEDIATRAS:ESTEMEDICAMENTONECESSRIONESTA
CATEGORIA?

Forproposedyellows:Arethesemedicinesforchildren?

Prednisolone

Dothesemedicinesmeetapublichealth?
Yes.

Aretheyregisteredforusein(allagecategoriesof)children?Yes

PrednisoloneOral
Somecliniciansstatethatchildrenmaybegivenaprednisolonedosageof0.142mg/kgdaily
or460mg/m
2
daily,administeredin4divideddoses.
http://www.medscape.com/druginfo/dosage?drugid=6307&drugname=Prednisolone+Oral&
monotype=defaultacessoem28/05/2007

PrednisoloneSodiumPhosphateOral(bettertaste)
PediatricMin/MaxDose:0.1mg/kg/2.0mg/kg
http://www.medscape.com/druginfo/dosage?drugid=13557&drugname=Prednisolone+Sodiu
m+Phosphate+Oral&monotype=defaultacessoem28/05/2007

MethylprednisoloneAcetateInjectableSuspensionUSP
Intramuscular,0.14to0.84mgperkgofbodyweightor4.16to25mgpersquaremeterof
bodysurfaceareaeverytwelvetotwentyfourhours.
USPExpertCommitteesconsensusonreviewoftheballot,01/2002.

Arethereanyunanswered/unexpectedclinicalissueswithrespecttoeffectivesorsafety?
No.

Additionalcommentsifany:

METHYLPREDNISOLONEACETATEINJECTABLESUSPENSIONUSP

Useofpreparationscontainingbenzylalcoholisnotrecommendedinneonates.Afataltoxic
syndromeconsistingofmetabolicacidosis,centralnervoussystem(CNS)depression,
respiratoryproblems,renalfailure,hypotension,andpossiblyseizuresandintracranial
hemorrhageshasbeenassociatedwiththisuse.
USPExpertCommitteesconsensusonreviewoftheballot,01/2002.

PrelonesyroupcontainsbenzoicacidandOrapredoralsolutioncontainssodium
benzoate;usewithcautioninneonates,asthesepreservativesmaydisplacebilirubinfrom
proteinbindingsitesandatlargesdosescancausethegaspingsyndrome.