WHO Library Cataloguing!in!Publication Data WHO model formulary (cid:19)(cid:20)(cid:20)(cid:19)/ editors: Mary R+ Couper- Dinesh K+ Mehta+ 0+ Formularies – standards (cid:19)+ Essential drugs 2+ Biological products I+ Couper- Mary R+ II+ Mehta- Dinesh K+ ISBN 5(cid:19) 6 076775 2 (NLM classification: QV 7(cid:20)) The World Health Organization welcomes requests for permission to reproduce or translate its publications- in part or in full+ Applications and enquiries should be addressed to the Office of Publications- World Health Organization- Geneva- Switzerland- which will be glad to provide the latest information on any changes made to the text- plans for new editions- and reprints and translations already available+ ©©©©© WWWWWooooorrrrrlllllddddd HHHHHeeeeeaaaaalllllttttthhhhh OOOOOrrrrrgggggaaaaannnnniiiiizzzzzaaaaatttttiiiiiooooonnnnn (cid:19)(cid:19)(cid:19)(cid:19)(cid:19)(cid:20)(cid:20)(cid:20)(cid:20)(cid:20)(cid:20)(cid:20)(cid:20)(cid:20)(cid:20)(cid:19)(cid:19)(cid:19)(cid:19)(cid:19) Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol (cid:19) of the Universal Copyright Convention+ All rights reserved+ The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the World Health Organization concerning the legal status of any country- territory- city or area or of its authorities- or concerning the delimitation of its frontiers or boundaries+ The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned+ Errors and omissions excepted- the names of proprietary products are distinguished by initial capital letters+ Typeset and printed in the United Kingdom Cover design: Renata Kerr Design FormCovNew.pm 2 17/4/2002, 8:41 am SSSSSeeeeellllleeeeecccccttttteeeeeddddd WWWWWHHHHHOOOOO pppppuuuuubbbbbllllliiiiicccccaaaaatttttiiiiiooooonnnnnsssss aaaaannnnnddddd dddddooooocccccuuuuummmmmeeeeennnnntttttsssss ooooofffff rrrrreeeeelllllaaaaattttteeeeeddddd iiiiinnnnnttttteeeeerrrrreeeeesssssttttt TTTTThhhhheeeee uuuuussssseeeee ooooofffff eeeeesssssssssseeeeennnnntttttiiiiiaaaaalllll dddddrrrrruuuuugggggsssss+++++ Ninth report of the WHO Expert Committee (including the Revised Model List of Essential Drugs)+ Technical report series No+D57+ (cid:19)(cid:20)(cid:20)(cid:20) (E0 pages) WWWWWHHHHHOOOOO mmmmmooooodddddeeeeelllll ppppprrrrreeeeessssscccccrrrrriiiiibbbbbiiiiinnnnnggggg iiiiinnnnnfffffooooorrrrrmmmmmaaaaatttttiiiiiooooonnnnn::::: dddddrrrrruuuuugggggsssss uuuuussssseeeeeddddd iiiiinnnnn ssssskkkkkiiiiinnnnn dddddiiiiissssseeeeeaaaaassssseeeeesssss 055G (0(cid:19)E pages) WWWWWHHHHHOOOOO mmmmmooooodddddeeeeelllll ppppprrrrreeeeessssscccccrrrrriiiiibbbbbiiiiinnnnnggggg iiiiinnnnnfffffooooorrrrrmmmmmaaaaatttttiiiiiooooonnnnn::::: dddddrrrrruuuuugggggsssss uuuuussssseeeeeddddd iiiiinnnnn bbbbbaaaaacccccttttteeeeerrrrriiiiiaaaaalllll iiiiinnnnnfffffeeeeeccccctttttiiiiiooooonnnnnsssss (cid:19)(cid:20)(cid:20)0 (0(cid:19)E pages) GGGGGuuuuuiiiiidddddeeeee tttttooooo gggggooooooooooddddd ppppprrrrreeeeessssscccccrrrrriiiiibbbbbiiiiinnnnnggggg+++++ A practical manual 0557 (0(cid:20)D pages) (A Teachers Guide is also available direct from the WHO Department of Essential Drugs and Medicines Policy) HHHHHooooowwwww tttttooooo dddddeeeeevvvvveeeeellllloooooppppp aaaaannnnnddddd iiiiimmmmmpppppllllleeeeemmmmmeeeeennnnnttttt aaaaa nnnnnaaaaatttttiiiiiooooonnnnnaaaaalllll dddddrrrrruuuuuggggg pppppooooollllliiiiicccccyyyyy+++++ Second edition (cid:19)(cid:20)(cid:20)0 (D2 pages) Further information on these and other WHO publications and priced documents can be obtained from: Marketing and Dissemination- World Health Organization- 0(cid:19)00 Geneva (cid:19)G- Switzerland+ Tel: H60 (cid:19)(cid:19) G50 (cid:19)6 GE- fax: H60 (cid:19)(cid:19) G50 6D 7G- e!mail for orders: bookorders@who+int FormCovNew.pm 3 17/4/2002, 8:41 am WWWWW HHHHH OOOOO MMMMM OOOOO DDDDD EEEEE LLLLL FFFFF OOOOO RRRRR MMMMM UUUUU LLLLL AAAAA RRRRR YYYYY (cid:19) (cid:20) (cid:20) (cid:19) WWWWWOOOOORRRRRLLLLLDDDDD HHHHHEEEEEAAAAALLLLLTTTTTHHHHH OOOOORRRRRGGGGGAAAAANNNNNIIIIIZZZZZAAAAATTTTTIIIIIOOOOONNNNN FormTitle.pm 1 16/4/2002, 12:32 pm Black EEEEEdddddiiiiitttttooooorrrrrsssss Mary R(cid:29) Couper (#) Dinesh K(cid:29) Mehta ((cid:19)) (#) Department of Essential Drugs and Medicines Policy. World Health Organization. Geneva ((cid:19)) Royal Pharmaceutical Society of Great Britain. London AAAAAccccckkkkknnnnnooooowwwwwllllleeeeedddddgggggeeeeemmmmmeeeeennnnntttttsssss The WHO Model Formulary was developed over a period of several years and with the input of a large number of individuals and organizations(cid:29) The contributions and comments of the following persons are gratefully acknowledged: T(cid:29)I(cid:29)Bhutta (Pakistan). D(cid:29)Birkett (Australia). H(cid:29)Buschiazzo (Argentina). A(cid:29)Chidarikire (Zim7 babwe). I(cid:29)Darmansjah (Indonesia). P(cid:29)Folb (South Africa). H(cid:29)Fraser (Barbados). T(cid:29)Fukui (Japan). J(cid:29)P(cid:29)Giroud (France). A(cid:29)Haeri (Iran). M(cid:29)Hassar (Morocco). J(cid:29)Idänpään7Heikkilä (WHO). K(cid:29)Johnson (US Pharmacopeia). F(cid:29)Juma (Kenya). O(cid:29)Kasilo (Zimbabwe). G(cid:29) P(cid:29) Kilonzo (Tanzania). M(cid:29) E(cid:29) Kitler (WHO). M(cid:29)Koulu (Finland). A(cid:29)Kucers (Australia). V(cid:29)Lepakhin (Russian Federation). Jia7Tai Li (China). P(cid:29)Männistö (Finland). P(cid:29)Mordujovich de Buschiazzo (Argentina). P(cid:29)Neuvonen (Fin7 land). G(cid:29)O(cid:29)Obiago (Nigeria). P(cid:29)Paakari (Finland). J(cid:29)H(cid:29)Pater (Canada). L(cid:29)Rago (Estonia). M(cid:29)Reidenberg (USA). J(cid:29)Reinstein (World Self7Medication Industry). H(cid:29)Ruskoaho (Finland). B(cid:29)Santoso (Indonesia). S(cid:29)A(cid:29)Shah (World Self7Medication In7 dustry). M(cid:29)Thomas (India). O(cid:29)Tokola (Finland). H(cid:29)Vapaatalo (Finland). K(cid:29)Weerasuriya (Sri Lanka). H(cid:29)Yasuhara (Japan). P(cid:29)Ylitalo (Finland). Zhu Jun7ren (China)(cid:29) The draft text of the formulary was reviewed by a team of the Royal Pharmaceutical Society of Great Britain. consisting of Mildred Davis. Ann M(cid:29) Hargreaves. Sheenagh M(cid:29) Townsend7Smith and Louise J(cid:29) Whitley(cid:29) Without their dedicated support this formulary could not have been published(cid:29) Priscilla Appiah. Eric I(cid:29) Connor. Daphne Fresle. Charles Fry. Gerard P(cid:29) Gallagher. Prakash Gotecha. Kath Hurst. Genevieve Meier. Balaji Ramachandran. Rachel S(cid:29)M(cid:29) Ryan. Li M(cid:29) Wan. Ann Wilberforce and John Wilson all made valuable contributions to the production process(cid:29) The project was managed by Mary R(cid:29) Couper and Hans V(cid:29) Hogerzeil of the WHO Department of Essential Drugs and Medicines Policy with the secretarial assistance of Pam Jude(cid:29) The development of the WHO Model Formulary was partly funded through a grant received from the Finnish International Development Agency(cid:29) FormTitle.pm 2 9/7/2002, 12:35 pm Black iii Contents Abbreviations iv Introduction v Generaladvidetoprescribers 1 Section1:DrugsusedinAnaesthesia 15 Section2:Analgesics,antipyretics,nonsteroidalanti-inflammatory drugs,drugsusedtotreatgout,anddisease-modifying antirheumaticdrugs 33 Section3:Antiallergicsanddrugsusedinanaphylaxis 49 Section4:Antidotesandothersubstancesusedinpoisonings 55 Section5:Anticonvulsants/antiepileptics 65 Section6:Anti-infectivedrugs 76 Section7:Antimigrainedrugs 177 Section8:Antineoplasticandimmunosuppressivedrugsanddrugs usedinpalliativecare 183 Section9:Antiparkinsondrugs 201 Section10:Drugsaffectingtheblood 205 Section11:Bloodproductsandplasmasubstitutes 214 Section12:Cardiovasculardrugs 218 Section13:DermatologicalDrugs(topical) 247 Section14:Diagnostics 262 Section15:DisinfectantsandAntiseptics 269 Section16:Diuretics 274 Section17:Gastrointestinaldrugs 282 Section18:Hormonesandotherendocrinedrugsandcontra- ceptives 297 Section19:Immunologicals 326 Section20:Musclerelaxants(peripherallyacting)andcholinesterase inhibitors 350 Section21:Ophthalmologicalpreparations 353 Section22:DrugsusedinObstetrics 363 Section23:Peritonealdialysissolution 368 Section24:Psychotherapeuticdrugs 370 Section25:Drugsactingontherespiratorytract 384 Section26:Solutionscorrectingwater,electrolyteandacid-base disturbances 396 Section27:Vitaminsandminerals 404 Appendix1:Interactions 413 Appendix2:Pregnancy 477 Appendix3:Breastfeeding 488 Appendix4:Renalimpairment 495 Appendix5:Hepaticimpairment 502 Index 506 WHOModelFormulary2002 iv Abbreviations ACE angiotensin-convertingenzyme ADR adversedrugreaction AIDS acquiredimmunodeficiencysyndrome AV atrioventricular BP BritishPharmacopoeia CNS centralnervoussystem CSF cerebrospinalfluid DMARD disease-modifyingantirheumaticdrug ECG electrocardiogram EEG electro-encephalogram G6PD glucose6-phosphatedehydrogenase GFR glomerularfiltrationrate HIV humanimmunodeficiencyvirus HRT hormonereplacementtherapy INR internationalnormalizedratio MDI metereddoseinhaler NSAID nonsteroidalanti-inflammatorydrug spp. species SSRI selectiveserotoninreuptakeinhibitor USP UnitesStatesPharmacopeia WHO WorldHealthOrganization WHOModelFormulary2002 v Introduction In1995theWHOExpertCommitteeontheUseofEssential DrugsrecommendeddevelopmentofaWHOModelFormulary which wouldcomplement theWHO ModelListofEssential Drugs(the‘ModelList’)andthatwouldbeupdatedeverytwo years.ItwasconsideredthatsuchaModelFormularywouldbe ausefulresourceforcountrieswishingto developtheirown nationalformulary. AfterafirstconsultationinApril1996workwasstartedto draftsectionsofthetextaccordingtothetherapeuticcategories intheModelList.AsecondconsultationwasheldinHelsinkiin September1997,atwhichseveraldraftsectionsofthetextwere discussed.AtathirdconsultationinOctober1999thefulltext wasreviewed. In November 1999 the Expert Committee on the Use of Essential Drugs reviewed progress in the project. It recom- mendedthatWHOacceptanofferbytheRoyalPharmaceutical Society of Great Britain (which, together with the British MedicalAssociation,publishestheBritishNationalFormulary) totakeresponsibilityforfinaldatavalidation,editingandlay- out.Agreementtothiseffectwasreachedinearly2000. Duringthevalidationprocessallstatementsinthedrafttext were compared with the original references and checked for consistencywithotherWHOdocumentsandrecommendations andreputabledruginformationsources.Afullrecordofthis validationandallensuingtechnicalandeditorialchangestothe draft text, with the underlying reasons and the relevant references,isavailable.Asthiswasthefirsteditionofanew reference text this work took almost two years and was completed by the end of 2001. During this process when necessary the text was updated to take into account new informationthathadbecomeavailablesincethetimeofwriting. Monographswereincludedforthesmallnumberofessential drugsthathadbeenaddedtotheModelListinNovember1999. Although the initial plan was to maintain in the Model Formularythesectionheadingsandnumberingsystemofthe ModelList,thisproveddifficultinpractice.Themainreason wasthatthesectionsoftheModelListarenotalwaysusefulas therapeutic categories, and do not easily lend themselves to introductoryevaluativestatements.Smallchangeswerethere- foreintroduced.TheModelFormularyhasalsobeenrelatively generousinrepeatingtheformularytextofessentialdrugsunder otherrelevanttherapeuticcategories. Thelackoffullconcurrencewiththenumberingsystemofthe ModelListshouldnotbeamajorproblemforusers.Theywill beabletoaccessinformationreadilyeitherthroughthecontent listorthroughthemainindexwhichincludesbothdrugnames and disease terms. Dissemination of the Model List and the WHOModelFormulary2002 vi ModelFormularywillfocusonelectronicaccessthroughCD- ROMsandtheWHOMedicineswebsite;theModelFormulary willbelinkedtotheModelList. TheelectronicversionoftheModelFormularyisalsointended as a starting point for developing national or institutional formularies. Rather than having to start completely from the beginning,nationalorinstitutionalformularycommitteescan adaptthetextoftheModelFormularytotheirownneedsby changingthetextoraligningtheformularytotheirownlistof essentialdrugsbyaddingordeletingentries. Despitealleffortsitisunavoidablethatthisfirsteditionofthe WHOModelFormularymaycontainsomeomissionsorerrors. Everyefforthasbeenmadetoensurethattheinformationinthe ModelFormularyhasinternationalapplicability,butinevitably there will be instances where the local management of conditions will be different to that advised here. All readers are encouraged to send their comments, corrections and suggestions to the Editor of the WHO Model Formulary, DepartmentofEssentialDrugsandMedicinesPolicy,World Health Organization, 1211 Geneva, Switzerland, fax 41-22- 7914167. WHOModelFormulary2002
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