3_rev1
TRANSCRIPT
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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
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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 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8/11/2019 3_rev1
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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.