WHO Model List Essential Medicines for Children

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  • WHOModelListofEssentialMedicinesfor

    Children

    4thlist(April2013)

    Statusofthisdocument

    ThisisareprintofthetextontheWHOMedicineswebsite

    http://www.who.int/medicines/publications/essentialmedicines/en/index.html

  • Thepublishedmaterialisbeingdistributedwithoutwarrantyofanykind,eitherexpressedorimplied.Theresponsibilityfortheinterpretationanduseofthemateriallieswiththereader.InnoeventshalltheWorld

    HealthOrganizationbeliablefordamagesarisingfromitsuse.

  • 4th WHO Model List of Essential Medicines for Children's (April 2013) page 3

    WHOModelListofEssentialMedicinesforChildren

    ExplanatoryNotesThisModelListisintendedforuseforchildrenupto12yearsofage.Thecorelistpresentsalistofminimummedicineneedsforabasichealthcaresystem,listingthemostefficacious,safeandcosteffectivemedicinesforpriorityconditions.Priorityconditionsareselectedonthebasisofcurrentandestimatedfuturepublichealthrelevance,andpotentialforsafeandcosteffectivetreatment.Thecomplementarylistpresentsessentialmedicinesforprioritydiseases,forwhichspecializeddiagnosticormonitoringfacilities,and/orspecialistmedicalcare,and/orspecialisttrainingareneeded.Incaseofdoubtmedicinesmayalsobelistedascomplementaryonthebasisofconsistenthighercostsorlessattractivecosteffectivenessinavarietyofsettings.Thesquareboxsymbol()isprimarilyintendedtoindicatesimilarclinicalperformancewithinapharmacologicalclass.Thelistedmedicineshouldbetheexampleoftheclassforwhichthereisthebestevidenceforeffectivenessandsafety.Insomecases,thismaybethefirstmedicinethatislicensedformarketing;inotherinstances,subsequentlylicensedcompoundsmaybesaferormoreeffective.Wherethereisnodifferenceintermsofefficacyandsafetydata,thelistedmedicineshouldbetheonethatisgenerallyavailableatthelowestprice,basedoninternationaldrugpriceinformationsources.TherapeuticequivalenceisonlyindicatedonthebasisofreviewsofefficacyandsafetyandwhenconsistentwithWHOclinicalguidelines.Nationallistsshouldnotuseasimilarsymbolandshouldbespecificintheirfinalselection,whichwoulddependonlocalavailabilityandprice.Theformatandnumberingofthe18thWHOModelListofEssentialMedicineshavebeenretainedbut,asindicatedinthetext,somesectionshavebeendeletedbecausetheycontainmedicinesthatarenotrelevantforchildren.aindicatesthatthereisanageorweightrestrictiononuseofthemedicines;thedetailsforeachmedicineareinTable1.IntheListofEssentialMedicinesforChildren,anadditionalsymbolisused:RindicatesthattheCommitteehasendorsedthemedicineasessentialbuthasrequestedareviewoftheefficacyandsafetytoconfirmthisdecision,ortoexpandusetoadditionalagegroups.ThepresenceofanentryontheEssentialMedicinesListcarriesnoassuranceastopharmaceuticalquality.Itistheresponsibilityoftherelevantnationalorregionaldrugregulatoryauthoritytoensurethateachproductisofappropriatepharmaceuticalquality(includingstability)andthatwhenrelevant,differentproductsareinterchangeable.ForrecommendationsandadviceconcerningallaspectsofthequalityassuranceofmedicinesseetheWHOMedicineswebsitehttp://www.who.int/medicines/areas/quality_assurance/en/index.htmlMedicinesanddosageformsarelistedinalphabeticalorderwithineachsectionandthereisnoimplicationofpreferenceforoneformoveranother.Standardtreatmentguidelinesshouldbeconsultedforinformationonappropriatedosageforms.

  • 4th WHO Model List of Essential Medicines for Children's (April 2013) page 4

    ThemaintermsusedfordosageformsintheEssentialMedicinesListcanbefoundinAnnex1.DefinitionsofmanyofthesetermsandpharmaceuticalqualityrequirementsapplicabletothedifferentcategoriesarepublishedinthecurrenteditionofTheInternationalPharmacopoeiahttp://www.who.int/medicines/publications/pharmacopoeia/en/index.html.

  • 4th WHO Model List of Essential Medicines for Children's (April 2013) page 5

    1. ANAESTHETICS

    1.1 General anaesthetics and oxygen

    1.1.1 Inhalational medicines

    halothane Inhalation.

    isoflurane Inhalation.

    nitrousoxide Inhalation.

    oxygen Inhalation(medicinalgas).

    1.1.2 Injectable medicines

    ketamine Injection:50 mg(ashydrochloride)/mlin10mlvial.

    propofol*

    Injection:10 mg/ml; 20 mg/ml.

    *Thiopentalmaybeusedasanalternativedependingonlocalavailabilityandcost.

    1.2 Local anaesthetics

    bupivacaineInjection: 0.25%;0.5%(hydrochloride)invial.

    Injectionforspinalanaesthesia:0.5%(hydrochloride)in4mlampouletobemixedwith7.5%glucosesolution.

    lidocaine

    Injection: 1%;2%(hydrochloride)invial.

    Injectionforspinalanaesthesia:5%(hydrochloride)in2mlampouletobemixedwith7.5%glucosesolution.

    Topicalforms:2%to4%(hydrochloride).

    lidocaine+epinephrine(adrenaline)Dentalcartridge: 2%(hydrochloride)+epinephrine1:80000.

    Injection:1%;2%(hydrochlorideorsulfate)+epinephrine1:200000invial.

    1.3 Preoperative medication and sedation for short-term procedures

    atropine Injection:1mg(sulfate)in1mlampoule.

    midazolam

    Injection: 1 mg/ml.

    Oralliquid:2mg/ml.

    Tablet:7.5mg;15mg.

    morphine Injection:10mg(sulfateorhydrochloride)in1mlampoule.

    2. MEDICINES FOR PAIN AND PALLIATIVE CARE

    2.1 Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs)

    ibuprofena

    Oralliquid:200 mg/5 ml.

    Tablet:200mg;400mg;600mg.

    a Not in children less than 3 months.

  • 4th WHO Model List of Essential Medicines for Children's (April 2013) page 6

    paracetamol*

    Oralliquid: 125mg/5 ml.

    Suppository:100mg.

    Tablet:100mgto500mg.

    *Notrecommendedforantiinflammatoryuseduetolackofprovenbenefittothateffect.

    2.2 Opioid analgesics

    morphine*

    Granules(slow release;tomixwithwater):20mgto200 mg(morphinesulfate).

    Injection:10mg(morphinehydrochlorideormorphinesulfate)in1mlampoule.

    Oralliquid:10mg(morphinehydrochlorideormorphinesulfate)/5ml.

    Tablet(immediaterelease):10mg(morphinesulfate).

    Tablet(slowrelease):10mgto200mg(morphinehydrochlorideormorphinesulfate).

    *Alternativeslimitedtohydromorphoneandoxycodone.

    2.3 Medicines for other symptoms common in palliative care

    amitriptyline Tablet:10mg;25mg.

    cyclizineInjection:50mg/ml.

    Tablet:50mg.

    dexamethasone

    Injection:4mg/mlin1mlampoule(asdisodiumphosphatesalt).

    Oralliquid:2mg/5ml.

    Tablet:2mg.

    diazepam

    Injection:5mg/ml.

    Oralliquid:2mg/5ml.

    Rectalsolution:2.5mg;5mg;10mg.

    Tablet:5mg;10mg.

    docusatesodiumCapsule:100mg.

    Oralliquid:50mg/5ml.

    fluoxetinea Solidoraldosageform: 20mg(ashydrochloride).

    a >8 years.

    hyoscinehydrobromideInjection:400micrograms/ml;600micrograms/ml.

    Transdermalpatches:1mg/72hours.

    lactulose Oralliquid:3.13.7g/5ml.

    midazolam

    Injection:1 mg/ml;5 mg/ml.

    Oralliquid:2mg/ml.

    Solidoraldosageform:7.5mg;15mg.

  • 4th WHO Model List of Essential Medicines for Children's (April 2013) page 7

    ondansetrona

    Injection:2mgbase/mlin2mlampoule(ashydrochloride).

    Oralliquid:4mgbase/5ml.

    Solidoraldosageform:Eq4mgbase;Eq8mgbase.

    a >1 month.

    senna Oralliquid:7.5mg/5ml.

    3. ANTIALLERGICS AND MEDICINES USED IN ANAPHYLAXIS

    dexamethasone Injection: 4mg/mlin1mlampoule(asdisodiumphosphatesalt).

    epinephrine(adrenaline) Injection: 1mg(ashydrochloride orhydrogentartrate)in1mlampoule.

    hydrocortisone Powderforinjection:100mg(assodiumsuccinate)invial.

    loratadine*

    Oralliquid:1mg/ml.

    Tablet:10mg.

    *Theremaybearoleforsedatingantihistaminesforlimitedindications.

    prednisoloneOralliquid: 5 mg/ml.

    Tablet:5mg;25mg.

    4. ANTIDOTES AND OTHER SUBSTANCES USED IN POISONINGS

    4.1 Non-specific

    charcoal,activated Powder.

    4.2 Specific

    acetylcysteineInjection: 200mg/mlin10mlampoule.

    Oralliquid:10%;20%.

    atropine Injection:1mg(sulfate)in1mlampoule.

    calciumgluconate Injection:100mg/mlin10mlampoule.

    naloxone Injection:400micrograms(hydrochloride)in1mlampoule.

    ComplementaryList

    deferoxamine Powderforinjection:500mg(mesilate)invial.

    dimercaprol Injectioninoil:50mg/mlin2mlampoule.

    fomepizole Injection:5mg/ml(sulfate)in20mlampouleor1g/ml(base)in1.5mlampoule.

    sodiumcalciumedetate Injection:200mg/mlin5mlampoule.

    succimer Solidoraldosageform:100mg.

    5. ANTICONVULSANTS/ANTIEPILEPTICS

    carbamazepine

    Oralliquid: 100mg/5ml.

    Tablet(chewable):100mg;200mg.

    Tablet(scored):100mg;200mg.

  • 4th WHO Model List of Essential Medicines for Children's (April 2013) page 8

    diazepam Gelorrectalsolution:5mg/mlin0.5ml;2ml;4mltubes.

    lorazepamParenteralformulation: 2mg/mlin1mlampoule;4mg/mlin1mlampoule.

    phenobarbital

    Injection:200mg/ml(sodium).

    Oralliquid:15mg/5ml.

    Tablet:15mgto100mg.

    phenytoin

    Injection: 50mg/mlin5mlvial(sodiumsalt).

    Oralliquid:25mgto30mg/5ml.*

    Solidoraldosageform:25mg;50mg;100mg(sodiumsalt).

    Tablet(chewable):50mg.

    *Thepresenceofboth25mg/5mland30mg/5mlstrengthsonthesamemarketwouldcauseconfusioninprescribinganddispensingandshouldbeavoided.

    valproicacid(sodiumvalproate)

    Oralliquid: 200mg/5ml.

    Tablet(crushable):100mg.

    Tablet(entericcoated):200mg;500mg(sodiumvalproate).

    ComplementaryList

    ethosuximideCapsule:250mg.

    Oralliquid:250mg/5ml.

    6. ANTI-INFECTIVE MEDICINES

    6.1 Anthelminthics

    6.1.1 Intestinal anthelminthics

    albendazole Tablet(chewable):400mg.

    levamisole Tablet:50mg;150mg(ashydrochloride).

    mebendazole Tablet(chewable):100mg;500mg.

    niclosamide Tablet(chewable):500mg.

    praziquantel Tablet:150mg;600mg.

    pyrantelOralliquid: 50mg(asembonate orpamoate)/ml.

    Tablet(chewable):250mg(asembonateorpamoate).

    6.1.2 Antifilarials

    albendazole Tablet(chewable):400mg.

    diethylcarbamazine Tablet:50mg;100mg(dihydrog