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  • 8/11/2019 3_rev1

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    ReviewerNo.1Section3

    ANTIALLERGICSANDMEDICINESUSEDINANAPHYLAXIS

    Forproposedyellows:Arethesemedicinesforchildren?

    Dothese

    medicines

    meet

    apublic

    health?

    Chlorphenamine: Yes.

    Dothesemedicinesmeetapublichealth?

    Yes.Chlorphenamine

    Aretheyregisteredforusein(allagecategoriesof)children?

    No.

    Chlorphenaminemaleateoral:Dosesforchildrenare:1to2years,1mgtwicedaily;2to5years,1mgevery4to6hours(maximum6mgdaily);6to12years,2mg every4to6hours(maximum12mgdaily).Martindale33ed.,P.412

    Chlorphenaminemaleateoral:Children

  • 8/11/2019 3_rev1

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    RegistroCochranedeEnsaiosControlados(CENTRAL/CCTR)Loratadineanddexchlorpheniramineinthetreatmentofperennialallergicrhinitisinpediatricpatients]Effectofallergymedicationonchildrensreadingcomprehension.Efficacyandsafetyofloratadinesuspensioninthetreatmentofchildrenwithallergicrhinitis.Comparativestudyoftheefficacy,toleranceandsideeffectsofdexchlorpheniraminemaleate6mgb.i.d.withterfenadine60mgb.i.d.ComparisonofCNSadverseeffectsbetweenastemizoleandchlorpheniramineinchildren:arandomized,doubleblindstudy.

    Anaphylaxis

    Patientswithsevereanaphylacticoranaphylactoidreactionsshouldbegivenimmediatetreatmentwithadrenaline(seeAnaphylaxisandAnaphylacticShock,AdrenalineHydrochloride).Additionofaparenteralantihistaminesuchaschlorphenaminemaleateordiphenhydraminehydrochlorideandacorticosteroidsuchashydrocortisoneaftertheacuteepisodemaydecreasethedurationandseverityofsymptomsandpreventrelapse.

    MARTINDALE TheCompleteDrugReferenceacessoem28/05/2007

    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

    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ow.php?db=central&mfn=48630&id=&lang=pt&dblang=&lib=COC
  • 8/11/2019 3_rev1

    3/7

    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;tabletsnotlicensedforuseinchildrenunder6years;injectionnotlicensedforuseinneonates

    Administration

    forintravenousinjection,giveover1minute;ifsmalldoserequired,dilutewithSodiumChloride0.9%

    Antihistaminesshouldbeusedwithcautioninhepaticimpairment,andthedosemayneedtobereducedinrenalimpairment;also,usewithcautioninchildrenwithepilepsy.Mostantihistaminesshouldbeavoidedinporphyria,butsome(e.g.chlorphenaminearethoughttobesafe.Sedatingantihistaminesshouldnotbegiventochildrenunder2years,exceptonspecialistadvice,becausethesafetyofsuchusehasnotbeenestablished.Sedatingantihistamineshavesignificantantimuscarinicactivitytheyshouldnotbeusedinneonatesandshouldbeusedwithcautioninchildrenwithurinaryretention,glaucoma,orpyloroduodenalobstruction.Hepaticimpairment

    Sedatingantihistaminesshouldbeavoidedinchildrenwithsevereliverdiseaseincreasedriskofcoma.

    Sideeffects

    Drowsinessisasignificantsideeffectwithmostoftheolderantihistaminesalthoughparadoxicalstimulationmayoccurrarelyinchildren,especiallywithhighdoses.Drowsiness

    maydiminishafterafewdaysoftreatmentandisconsiderablylessofaproblemwiththenewerantihistamines(seealsonotesabove).Sideeffectsthataremorecommonwiththeolderantihistaminesincludeheadache,psychomotorimpairment,andantimuscariniceffectssuchasurinaryretention,drymouth,blurredvision,andgastrointestinaldisturbances.Otherraresideeffectsofantihistaminesincludehypotension,extrapyramidaleffects,dizziness,confusion,depression,sleepdisturbances,tremor,convulsions,palpitation,arrhythmias,hypersensitivityreactions(includingbronchospasm,angioedema,anaphylaxis,rashes,andphotosensitivityreactions),blooddisorders,andliverdysfunction.

    Sideeffects

    Alsoexfoliativedermatitisandtinnitusreported;injectionsmaycausetransienthypotensionorCNSstimulationandmaybeirritant

    CDBNFC,2006.

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    Forgreens:Isthereanyreasonnottoendorsetheseasessential medicinesfor children?

    Dexamethasone

    Dothesemedicinesmeetapublichealth?Yes?TEMOSDVIDAS

    Aretheyregisteredforusein(allagecategoriesof)children?YesNeonates:I.V.Usual:0,25mg/kg/dosegiven~4hourspriortoscheduledextubationandthenevery8hoursfor3dosestotal;range:0,251mg/kg/dosefor13doses;maximumdose1mg/kg/day.Children:I.V.,I.M:0,5 2mg/kg/dose individeddosesevery6hours;begin24hourspriortoextubationandcontinuefor46dosesafterextubation.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.Thispresentsadilemmaforcliniciansinthattheprefilledautoinjectorkitsusedosesofonly

    0.15and

    0.30

    mg/

    kg,

    making

    the

    precise

    dosing

    of

    children

    and

    adolescents

    difficult

    if

    notimpossible.Whilethereislittledirectevidencecomparingonedosewithanother,theauthorssuggestthefollowingdosingalgorithmbasedonpatientweight:o 10kgorless:Consideruseofampuleofepinephrinewithneedleandsyringeto

    drawcorrectdose(0.01mg/kg)ofepinephrine.Themaindifficultieswiththisapproacharetimingandaccuracy.Onestudydemonstratedthatparentsrequired142secondstodrawadoseof0.09mLofepinephrinevs52secondsforclinicians.Moreover,theactualdoseofepinephrinedrawnbyparentsrangedbetween0.004and0.151mL.

    o 10to25kg:Autoinjectionwith0.15mgofepinephrine.

    o 25

    kg

    or

    more:

    Autoinjection

    with

    0.30

    mg

    of

    epinephrine.

    Aseconddoseofepinephrineisrequiredforanaphylaxisinupto35%ofcases.Epinephrinemayberepeated5to20minutesaftertheinitialdose.

    Brasil:(RENAME)somentesolinjetvel1mg/ml

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    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.Epinephrineshouldbekeptawayfromextremetemperaturesanddirectsunlighttoprotectagainstdrugdegradation,andthesolutionwillnotnecessarilyappeardifferentafterdegradationhasoccurred.http://www.medscape.com/viewarticle/554150acessoem22/05/2007

    Martindale33ed.,P.829

    TheinjectionwiththeEpiPen,everychilddevelopedtransientpallor,tremor,anxiety,andpalpitationsorothercardiovasculareffects;somealsodevelopedheadacheandnausea.JAllergyClinImmunol;109(1):1715,2002Jan.EpiPenJrversusEpiPeninyoungchildrenweighing15to30kgatriskforanaphylaxis.Martindale33ed.,P.829

    Additionalcomments

    if

    any:

    InmanycountriesthereisonlyoneconcentrationmarketedActionproposedfortheCommitteetotake:toapprove;tosuggestotherdilutions;prefilledsiringues

    Forgreens:Isthereanyreasonnottoendorsetheseasessential medicinesfor children?Hydrocortisone

    Dothesemedicinesmeetapublichealth?Yes

    Aretheyregisteredforusein(allagecategoriesof)children?YesChildren:Initial:50mg/kgthenreapeatedin4hoursand/orevery24hoursifneededPediatricDosageHandbookAmericanPharmaceuticalAssociation,2001/2002P.508Childrenupto1yearofagemaybegiven25mg,thoseaged1to5years50mg,andthoseaged6to12years100mg.Martindale33ed.,P.1074PediatricMin/MaxDose:0.16mg/kg/50.0mg/kghttp://www.medscape.com/druginfo/dosage?drugid=6829&drugname=Hydrocortisone+Sod+Succinate+Inj&monotype=defaultacessoem22/05/2007

    Aretheyanyunanswered/unexpectedclinicalissueswithrespecttoeffectivenessor

    safety?No.

    Aretherespecialrequirementsortrainingneededforsafe/effectiveuse? No

    http://www.medscape.com/viewarticle/554150http://www.medscape.com/viewarticle/554150%20acesso%20em%2022/05/2007http://www.medscape.com/viewarticle/554150%20acesso%20em%2022/05/2007http://www.medscape.com/viewarticle/554150%20acesso%20em%2022/05/2007http://www.medscape.com/viewarticle/554150%20acesso%20em%2022/05/2007http://www.medscape.com/viewarticle/554150%20acesso%20em%2022/05/2007http://www.medscape.com/viewarticle/554150%20acesso%20em%2022/05/2007http://www.medscape.com/viewarticle/554150%20acesso%20em%2022/05/2007http://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis|database_name=TITLES|list_type=title|cat_name=ALL|from=1|count=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=J%20Allergy%20Clin%20Immunolhttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis|database_name=TITLES|list_type=title|cat_name=ALL|from=1|count=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=J%20Allergy%20Clin%20Immunolhttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis|database_name=TITLES|list_type=title|cat_name=ALL|from=1|count=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=J%20Allergy%20Clin%20Immunolhttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis|database_name=TITLES|list_type=title|cat_name=ALL|from=1|count=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=J%20Allergy%20Clin%20Immunolhttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis|database_name=TITLES|list_type=title|cat_name=ALL|from=1|count=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=J%20Allergy%20Clin%20Immunolhttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis|database_name=TITLES|list_type=title|cat_name=ALL|from=1|count=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=J%20Allergy%20Clin%20Immunolhttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis|database_name=TITLES|list_type=title|cat_name=ALL|from=1|count=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=J%20Allergy%20Clin%20Immunolhttp://www.medscape.com/druginfo/dosage?drugid=6829&drugname=Hydrocortisone+Sod+Succinate+Inj&monotype=defaulthttp://www.medscape.com/druginfo/dosage?drugid=6829&drugname=Hydrocortisone+Sod+Succinate+Inj&monotype=defaulthttp://www.medscape.com/druginfo/dosage?drugid=6829&drugname=Hydrocortisone+Sod+Succinate+Inj&monotype=defaulthttp://www.medscape.com/druginfo/dosage?drugid=6829&drugname=Hydrocortisone+Sod+Succinate+Inj&monotype=defaulthttp://portal.revistas.bvs.br/transf.php?xsl=xsl/titles.xsl&xml=http://catserver.bireme.br/cgi-bin/wxis1660.exe/?IsisScript=../cgi-bin/catrevistas/catrevistas.xis|database_name=TITLES|list_type=title|cat_name=ALL|from=1|count=50&lang=pt&comefrom=home&home=false&task=show_magazines&request_made_adv_search=false&lang=pt&show_adv_search=false&help_file=/help_pt.htm&connector=ET&search_exp=J%20Allergy%20Clin%20Immunolhttp://www.medscape.com/viewarticle/554150%20acesso%20em%2022/05/2007http://www.medscape.com/viewarticle/554150
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    Additionalcommentsifany:

    ActionproposedfortheCommitteetotake:

    PERGUNTAMOSAOSPEDIATRAS:ESTEMEDICAMENTONECESSRIONESTACATEGORIA?

    Forproposedyellows:Arethesemedicinesforchildren?

    Prednisolone

    Dothesemedicinesmeetapublichealth?

    Yes.

    Aretheyregisteredforusein(allagecategoriesof)children?Yes

    Prednisolone Oral

    Somecliniciansstatethatchildrenmaybegivenaprednisolonedosageof0.142mg/kgdailyor460mg/m2daily,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/kghttp://www.medscape.com/druginfo/dosage?drugid=13557&drugname=Prednisolone+Sodiu

    m+Phosphate+Oral&monotype=defaultacessoem28/05/2007

    MethylprednisoloneAcetateInjectableSuspensionUSP

    Intramuscular,0.14to0.84mgperkgofbodyweightor4.16to25mgpersquaremeterofbodysurfaceareaeverytwelvetotwentyfourhours.USPExpertCommitteesconsensusonreviewoftheballot,01/2002.

    Arethereanyunanswered/unexpectedclinicalissueswithrespecttoeffectivesorsafety?

    No.

    Additionalcommentsifany:

    http://www.medscape.com/druginfo/dosage?drugid=6307&drugname=Prednisolone+Oral&monotype=defaulthttp://www.medscape.com/druginfo/dosage?drugid=6307&drugname=Prednisolone+Oral&monotype=defaulthttp://www.medscape.com/druginfo/dosage?drugid=13557&drugname=Prednisolone+Sodium+Phosphate+Oral&monotype=defaulthttp://www.medscape.com/druginfo/dosage?drugid=13557&drugname=Prednisolone+Sodium+Phosphate+Oral&monotype=defaulthttp://www.medscape.com/druginfo/dosage?drugid=13557&drugname=Prednisolone+Sodium+Phosphate+Oral&monotype=defaulthttp://www.medscape.com/druginfo/dosage?drugid=13557&drugname=Prednisolone+Sodium+Phosphate+Oral&monotype=defaulthttp://www.medscape.com/druginfo/dosage?drugid=6307&drugname=Prednisolone+Oral&monotype=defaulthttp://www.medscape.com/druginfo/dosage?drugid=6307&drugname=Prednisolone+Oral&monotype=default
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    METHYLPREDNISOLONEACETATEINJECTABLESUSPENSIONUSP

    Useofpreparationscontainingbenzylalcoholisnotrecommendedinneonates.Afataltoxicsyndromeconsistingofmetabolicacidosis,centralnervoussystem(CNS)depression,respiratoryproblems,renalfailure,hypotension,andpossiblyseizuresandintracranial

    hemorrhages

    has

    been

    associated

    with

    this

    use.

    USPExpertCommitteesconsensusonreviewoftheballot,01/2002.

    PrelonesyroupcontainsbenzoicacidandOrapredoralsolutioncontainssodiumbenzoate;usewithcautioninneonates,asthesepreservativesmaydisplacebilirubinfromproteinbindingsitesandatlargesdosescancausethegaspingsyndrome.