Medicines information servicesInformation on any aspect of drug therapy can beobtained from Regional and District Medicines Informa-tion Services. Details regarding the local services pro-vided within your Region can be obtained by telephon-ing the following numbers.

England

Birmingham (0121) 424 7298

Bristol (0117) 342 2867

Ipswich (01473) 704 431

Leeds (0113) 206 5377

Leicester (0116) 255 5779

Liverpool (0151) 794 8113/4/5/7

(0151) 794 8206

London

Guy’s Hospital (020) 7188 8750(020) 7188 3849(020) 7188 3855

Northwick Park Hospital (020) 8869 2761

(020) 8869 3973

Newcastle (0191) 282 4631

Southampton (023) 8079 6908/9

Wales

Cardiff (029) 2074 2979

(029) 2074 2251

Scotland

Aberdeen (01224) 552 316

Dundee (01382) 632 351

(01382) 660 111Extn 32351

Edinburgh (0131) 242 2920

Glasgow (0141) 211 4407

Northern Ireland

Belfast (028) 9063 2032

(028) 9063 3847

Republic of Ireland

Dublin Dublin 473 0589

Dublin 453 7941Extn 2348

United Kingdom Medicines Information Pharma-cists Group (UKMIPG) website

www.ukmi.nhs.uk

UK Teratology Information Service

Information on drug and chemicalexposures in pregnancy 0844 892 0909

Medicines for Children information leaflets

Medicines information for parents and carers.

www.medicinesforchildren.org.uk

Patient Information Lines

NHS Direct 0845 4647

Poisons Information Services

UK National Poisons InformationService 0844 892 0111

Travel Immunisation

Up-to-date information on travel immunisationrequirements may be obtained from:

National Travel Health Network and Centre (forhealthcare professionals only) 0845 602 6712(09.00–12.00 and 14.00–16.30 hours weekdays)

Travel Medicine Team, Health Protection Scotland(0141) 300 1130 (14.00–16.00 hours weekdays)

www.travax.nhs.uk (for registered users of the NHSwebsite Travax only)

Welsh Assembly Government (029) 2082 1318(09.00–17.30 hours weekdays)

Department of Health and Social Services (Belfast)(028) 9052 2118 (weekdays)

Information on drug therapy relating to dentaltreatment can be obtained by telephoning:

Liverpool (0151) 794 8206

Sport

Information on substances currently permitted orprohibited is provided in a card supplied by UK Anti-Doping.

Further information regarding medicines in sport isavailable from: www.ukad.org.uk

Tel: (020) 7766 7350

information@ukad.org.uk

Telephone numbers and email addresses of manu-facturers listed in BNF Publications are shown in theIndex of Manufacturers

2011–2012for childrenBNF

Published byBMJ GroupTavistock Square, London WC1H 9JP, UK

Pharmaceutical PressPharmaceutical Press is the publishing division of theRoyal Pharmaceutical Society1 Lambeth High Street, London, SE1 7JN, UK

RCPCH Publications Ltd5–11 Theobalds Road, London WC1X 8SH, UK

Copyright # BMJ Group, the Royal PharmaceuticalSociety of Great Britain, and RCPCH Publications Ltd2011

ISBN: 978 0 85369 959 0

ISSN: 1747–5503

Printed by CPI Clausen & Bosse, Leck, Germany

Typeset by Xpage

A catalogue record for this book is available from theBritish Library.

All rights reserved. No part of this publication may bereproduced, stored in a retrieval system, or transmittedin any form or by any means, without the prior writtenpermission of the copyright holder.

Material published in the BNF for Children may notbe used for any form of advertising, sales or publicitywithout prior written permission. Each of the classi-fication and the text are protected by copyright and/or database right

Paper copies may be obtained through any bookseller ordirect from:

Pharmaceutical Pressc/o Macmillan Distribution (MDL)Brunel RoadHoundmillsBasingstokeRG21 6XSUKTel: +44 (0) 1256 302 692Fax: +44 (0) 1256 812 521Email: direct@macmillan.co.ukwww.pharmpress.com

For all bulk orders of more than 20 copies:Email: pharmpress@rpharms.comTel: +44 (0) 207 572 2266

Pharmaceutical Press also supplies BNF for Children indigital formats suitable for standalone computers andintranets, and for use on mobile devices.

Distribution of BNFCsThe UK health departments distribute BNFCs to NHShospitals, doctors, and community pharmacies.In England, BNFCs are mailed individually to NHSdoctors, pharmacists, and non-medical prescriberswho have prescribing responsibility for children; forextra copies or changes relating to mailed BNFCs,contact the DH Publications Orderline:Tel: 0300 123 1002In Scotland email:nss.psd-bnf@nhs.netIn Wales, telephone the Business Services Centre:Tel: (01495) 332 000In Northern Ireland email:ni.bnf@hscni.net

The BNF for Children is for use by health profes-sionals engaged in prescribing, dispensing, andadministering medicines to children. It has beenprepared under the guidance of the PaediatricFormulary Committee.

BNF for Children has been constructed using robustprocedures for gathering, assessing and assimilatinginformation on paediatric drug treatment. It is, how-ever, expected that the reader will be relying onappropriate professional knowledge and expertiseto interpret the contents in the context of the cir-cumstances of the individual child. BNF for Childrenshould be used in conjunction with other appropriateand up-to-date literature and, where necessary, sup-plemented by expert advice. Information is alsoavailable from Medicines Information Services (seeinside front cover).

Special care is required in managing childhoodconditions with unlicensed medicines or withlicensed medicines for unlicensed uses. Responsibil-ity for the appropriate use of medicines lies solelywith the individual health professional.

ContentsPreface .................................................................................................................................. ivAcknowledgements ................................................................................................................ vBNF Staff ............................................................................................................................... viHow BNF for Children is constructed .................................................................................... ixHow to use BNF for Children................................................................................................. xiChanges for this edition .................................................................................................... xviiGeneral guidance...................................................................................................................1Prescription writing................................................................................................................4Supply of medicines ..............................................................................................................6Emergency supply of medicines ............................................................................................8Prescribing Controlled Drugs .................................................................................................9Adverse reactions to drugs................................................................................................. 12Prescribing in hepatic impairment...................................................................................... 14Prescribing in renal impairment ......................................................................................... 14Prescribing in pregnancy .................................................................................................... 16Prescribing in breast-feeding.............................................................................................. 16Prescribing in palliative care .............................................................................................. 17Prescribing in dental practice ............................................................................................. 22Drugs and sport .................................................................................................................. 23Emergency treatment of poisoning .................................................................................... 24

Notes on drugs and Preparations

1: Gastro-intestinal system........................................................................................ 352: Cardiovascular system ........................................................................................... 733: Respiratory system .............................................................................................. 1334: Central nervous system ....................................................................................... 1695: Infections ............................................................................................................. 2426: Endocrine system................................................................................................. 3487: Obstetrics, gynaecology, and urinary-tract disorders ......................................... 3938: Malignant disease and immunosuppression ....................................................... 4149: Nutrition and blood.............................................................................................. 442

10: Musculoskeletal and joint diseases .................................................................... 49911: Eye ....................................................................................................................... 51712: Ear, nose, and oropharynx ................................................................................... 53413: Skin ...................................................................................................................... 55014: Immunological products and vaccines ................................................................. 59915: Anaesthesia ......................................................................................................... 628

Appendices and indicesAppendix 1: Interactions.................................................................................................. 655Appendix 2: Borderline substances ................................................................................. 743Appendix 3: Cautionary and advisory labels for dispensed medicines........................... 788Appendix 4: Intravenous infusions for neonatal intensive care ...................................... 791Dental Practitioners’ Formulary ........................................................................................ 794Nurse Prescribers’ Formulary............................................................................................ 796Non-medical prescribing ................................................................................................... 799Index of manufacturers ..................................................................................................... 800Index ................................................................................................................................. 811Medical emergencies in the community .................................................... Inside back cover

BNFC 2011–2012 iii

PrefaceBNF for Children aims to provide prescribers, pharma-cists and other healthcare professionals with sound up-to-date information on the use of medicines for treatingchildren.

A joint publication of the British Medical Association,the Royal Pharmaceutical Society of Great Britain, theRoyal College of Paediatrics and Child Health, and theNeonatal and Paediatric Pharmacists Group, BNF forChildren (‘BNFC’) is published under the authority of aPaediatric Formulary Committee.

Many areas of paediatric practice have suffered frominadequate information on effective medicines. BNFCaddresses this significant knowledge gap by providingpractical information on the use of medicines in childrenof all ages from birth to adolescence. Medicines forChildren (RCPCH Publications Ltd) and the BritishNational Formulary itself form the basis for BNFC.Information in BNFC has been validated against emer-ging evidence, best-practice guidelines, and crucially,advice from a network of clinical experts.

Drawing information from manufacturers’ literaturewhere appropriate, BNFC also includes a great deal ofadvice that goes beyond marketing authorisations (pro-duct licences). This is necessary because licensed indi-cations frequently do not cover the clinical needs ofchildren; in some cases, products for use in childrenneed to be specially manufactured or imported. Carefulconsideration has been given to establishing the clinicalneed for unlicensed interventions with respect to theevidence and experience of their safety and efficacy;local paediatric formularies, clinical literature andnational information resources have been invaluable inthis process.

BNFC has been designed for rapid reference and theinformation presented has been carefully selected to aiddecisions on prescribing, dispensing and administrationof medicines. Less detail is given on areas such asmalignant disease and the very specialist use of medi-cines generally undertaken in tertiary centres. BNFCshould be interpreted in the light of professional knowl-edge and it should be supplemented as necessary byspecialised publications. Information is also availablefrom Medicines Information Services (see inside frontcover).

It is vital to use the most recent edition of BNFC formaking clinical decisions. The more important changesfor this edition are listed on p. xvii.

The website (bnfc.org) includes additional informationof relevance to healthcare professionals. Other digitalformats of BNFC—including intranet and versions formobile devices—are produced in parallel with theprinted version.

BNFC aims to provide information suited to theneeds of the clinician and recognises that, althoughthis edition represents a considerable advance in thecontent and presentation of information on thepaediatric use of medicines, further changes will benecessary. Comments from healthcare professionalsare therefore very welcome and should be sent to:

British National Formulary Publications, Royal Phar-maceutical Society of Great Britain, 1 Lambeth HighStreet, London SE1 7JN.

bnfc@bnf.org

The contact email for manufacturers or pharmaceut-ical companies wishing to contact BNF publicationsis manufacturerinfo@bnf.org

iv BNFC 2011–2012

AcknowledgementsThe Paediatric Formulary Committee is grateful toindividuals and organisations that have provided adviceand information to the BNF for Children.

The principal contributors for this edition were:

I.H. Ahmed-Jushuf, M.N. Badminton, S. Bailey, T.G.Barrett, D.N. Bateman, G.D.L. Bates, H. Bedford, M.W.Beresford, R.M. Bingham, I.W. Booth, L. Brook, K.G.Brownlee, R.J. Buckley, M. Burch, I.F. Burgess, A. Cant,L.J. Carr, R. Carr, E.A. Chalmers, T.D. Cheetham, A.J.Cotgrove, J.B.S. Coulter, B.G. Craig, S.M. Creighton, J.H.Cross, A. Dhawan, P.N. Durrington, A. Durward, A.B.Edgar, J.A. Edge, D.A.C. Elliman, N.D. Embleton, P.J.Goadsby, P.W. Golightly, J. Gray, J.W. Gregory, P. Grin-gras, J.P. Harcourt, P.J. Helms, C. Hendriksz, R.F.Howard, R.G. Hull, H.R. Jenkins, S. Jones, B.A. Judd,C.J.H. Kelnar, P.T. Khaw, J.M.W. Kirk, P.J. Lee, T.H. Lee,S. Lewis-Jones, E.G.H. Lyall, A. MacDonald, D.J.Macrae, P.S. Malone, A.Y. Manzur, S.D. Marks, D.F.Marsh, A.G. Marson, K.A. Matyka, P.J. McKiernan,L.M. Melvin, E. Miller, R.E. Morton, C. Moss, P. Mulhol-land, C. Nelson-Piercy, J.M. Neuberger, K.K. Nischal,C.Y. Ng, L.P. Omerod, J.Y. Paton, G.A. Pearson, M.M.Ramsay, I.A.G. Roberts, J. Rogers, K.E. Rogstad, P.C.Rubin, J.W. Sander, N.J. Scolding, M.R. Sharland, N.J.Shaw, G.J. Shortland, O.F.W. Stumper, M.R.J. Sury, A.G.Sutcliffe, A. Sutherland, A.M. Szarewski, E.A. Taylor,A.H. Thomson, M.A. Thomson, J.A. Vale, J.O. Warner,D.A. Warrell, N.J.A. Webb, A.D. Weeks, R. Welbury, W.P.Whitehouse, C.E. Willoughby, C. Wren, A. Wright, M.M.Yaqoob, Z. Zaiwalla, and S.M. Zuberi.

Members of the British Association of Dermatologists’Therapy & Guidelines Subcommittee, D.A. Buckley, L.C.Fuller, J. Hughes, S.E. Hulley, J. Lear, A.J. McDonagh, J.McLelland, N. Morar, I. Nasr, S. Punjabi, M.J. Tidman,S.E. Haveron (Secretariat), and M.F. Mohd Mustapa(Secretariat) have provided valuable advice.

Members of the Advisory Committee on Malaria Pre-vention, R.H. Behrens, P.L. Chiodini, F. Genasi, L. Good-yer, A. Green, D. Hill, G. Kassianos, D.G. Lalloo, G.Pasvol, S. Patel, M. Powell, D.V. Shingadia, C.J.M.Whitty, M. Blaze (Secretariat), and V. Smith (Secretariat)have provided valuable advice.

Members of the UK Ophthalmic Pharmacy Group havealso provided valuable advice.

R. Suvarna and colleagues at the MHRA have providedvaluable assistance.

Correspondents in the pharmaceutical industry haveprovided information on new products and commentedon products in the BNF for Children. NHS PrescriptionServices has supplied the prices of products in the BNFfor Children.

Numerous doctors, pharmacists, nurses and others havesent comments and suggestions.

The BNF for Children has valuable access to the Mar-tindale data banks by courtesy of S. Sweetman and staff.

J. E. Macintyre and staff provided valuable technicalassistance.

C. Adetola, N. Bansal, J.J. Coleman, S. Foad, E.H.Glover, T. Hamp, A. Holmes, J. Humphreys, J.M.James, E. Laughton, H.M.N. Brady, R.M. Patel, J. Rey-nolds, and E.J. Tong provided considerable assistanceduring the production of this edition of BNF for Chil-dren.

Xpage have provided assistance with typesetting devel-opment and related production processes.

BNFC 2011–2012 v

BNF Staff

Managing Editor: Knowledge Creation

John Martin BPharm, PhD, MRPharmS

Assistant Editors

Leigh-Anne Claase BSc, PhD

Bryony Jordan BSc, DipPharmPract, MRPharmS

Colin R. Macfarlane BPharm, MSc, MRPharmS

Paul S. Maycock MPharm, DipPharmPract,MRPharmS

Claire L. Preston BPharm, PGDipMedMan,MRPharmS

Rachel S. M. Ryan BPharm, MRPharmS

Shama M. S. Wagle BPharm, DipPharmPract,MRPharmS

Staff Editors

Sejal Amin BPharm, MSc

Angela K. Bennett MPharm, DipPharmPract

Shena S. Chauhan BPharm, MRPharmS

Susan E. Clarke BPharm, DipClinPharm, MRPharmS

Kristina Fowlie MPharm, PGCertPharmPract,MRPharmS

Belén Granell Villen BSc, PGDipClinPharm

Manjula Halai BScChem, MPharm

Emma E. Harris MPharm, DipPharmPract,MRPharmS

Amy E. Harvey MPharm, PGDipCommPharm

Amber F. Lauder BPharm, PGCertPharm

Angela M. G. McFarlane BSc, DipClinPharm,MRPharmS

Sarah Mohamad MPharm

Elizabeth Nix DipPharm(NZ), MRPharmS

Sanjay Patel BPharm

Vinaya K. Sharma BPharm, MSc, PGDipPIM,MRPharmS

Katie E. Walters MPharm, PGCertPharmPract,MRPharmS

Editorial Assistants

Rebecca S. Bastable BA, BTEC

Cristina Lopez-Bueno BA

Senior BNF Administrator

Heidi Homar BA

Managing Editor: Digital Development and Delivery

Cornelia Schnelle MPhil

Digital Development Editor

Philip D. Lee BSc, PhD

Digital Development Assistants

Robert C. Buckingham BSc

Michelle Cartwright

Jennifer L. Palmer FdSc

Terminologist

Sarah Peck BSc

Head of Production

John Wilson

Senior Production Editor

Linda Paulus

BNF Publishing Director

Duncan S.T. Enright MA, PGCE, MInstP, FIDM

Managing Director, Pharmaceutical Press

Robert Bolick BA, MA

Senior Medical Adviser

Martin J. Kendall OBE, MB, ChB, MD, FRCP, FFPM

vi BNFC 2011–2012

Paediatric FormularyCommittee2010–2011

Chair

Warren Lenney

MD, FRCP, FRCPCH, DCH

Committee Members

Jeffrey K. Aronson

MA, MBChB, DPhil, FRCP, FBPharmacolS, FFPM

Neil A. Caldwell

BSc, MSc, MRPharmS

Ian Costello

BPharm, MSc, MRPharmS

Martin G. Duerden BMedSci, MB BS, DRCOG,MRCGP, DipTher, DPH

Simon Keady

BSc, MRPharmS, SP

Martin J. Kendall

OBE, MB, ChB, MD, FRCP, FFPM (Chair, ContentStrategy Committee)

James H. Larcombe

MB, ChB, FRCGP, DipAdvGP

E. David G. McIntosh

MB BS, MPH, PhD, FAFPHM, FRACP, FRCPCH,FFPM, DRCOG, DCH, DipPharmMed

Neena Modi

MB, ChB, MD, FRCP, FRCPCH

Matthew J. Thatcher

MB BS, FRCS, DRCOG, DMRD

David Tuthill MB, BCh, FRCPCH

William G. van’t Hoff

BSc, MB, MD, FRCPCH, FRCP

Edward R. Wozniak

BSc, MB BS, FRCP, FRCPCH, DCH

Executive Secretary

Heidi Homar

BA

Dental AdvisoryGroup2010–2011

Chair

David Wray

MD, BDS, MB ChB, FDSRCPS, FDSRCS Ed,F MedSci

Committee Members

Christine Arnold

BDS, DDPHRCS, MCDH

Barry Cockcroft

BDS, FFDS (Eng)

Duncan S.T. Enright

MA, PGCE, MInstP, FIDM

Amy E. Harvey

MPharm, PGDipCommPharm

Martin J. Kendall

OBE, MB, ChB, MD, FRCP, FFPM

Lesley P. Longman

BSc, BDS, FDSRCS Ed, PhD

Sarah Manton

BDS, FDSRCS Ed, FHEA, PhD

John Martin

BPharm, PhD, MRPharmS

Michelle Moffat

BDS, MFDS RCS Ed, M Paed Dent RPCS, FDS (PaedDent) RSC Ed

Rachel S.M. Ryan

BPharm, MRPharmS

Secretary

Arianne J. Matlin

MA, MSc, PhD

Executive Secretary

Heidi Homar

BA

Advice on dental practice

The British Dental Association has contributed tothe advice on medicines for dental practice throughits representatives on the Dental Advisory Group.

BNFC 2011–2012 vii

Nurse Prescribers’Advisory Group2010–2011

Chair

Nicky A. Cullum (until November 2010)

PhD, RGN

Molly Courtenay (from December 2010)

PhD, MSc, Cert Ed, BSc, RGN

Committee Members

Fiona Culley

LLM, RN, BSc, Cert Ed

Duncan S.T. Enright

MA, PGCE, MInstP, FIDM

Penny M. Franklin

RN, RCN, RSCPHN(HV), MA, PGCE

Belén Granell Villen

BSc, PGDipClinPharm

Margaret F. Helliwell

MB, BS, BSc, MFPHM

Bryony Jordan

BSc, DipPharmPract, MRPharmS

Martin J. Kendall

OBE, MB, ChB, MD, FRCP, FFPM

Fiona Lynch

BSc, MSc, RGN, RSCN

John Martin

BPharm, PhD, MRPharmS

Wendy J. Nicholson

BSc, MA, Cert Ed, RGN, RSCN

Jill M. Shearer

BSc, RGN, RM

Rabina Tindale

RN, RSCN, BSc, DipAEN, PGCE

Vicky Vidler

MA, RGN, RSCN

John Wright

Executive Secretary

Heidi Homar

BA

viii BNFC 2011–2012

How BNF for Childrenis constructedBNF for Children (BNFC) is unique in bringing togetherauthoritative, independent guidance on best practicewith clinically validated drug information, enablinghealthcare professionals to select safe and effectivemedicines for individual children.

Information in BNFC has been validated against emer-ging evidence, best-practice guidelines, and advice froma network of clinical experts. BNFC includes a great dealof advice that goes beyond marketing authorisations(product licences or summaries of product characteris-tics). This is necessary because licensed indicationsfrequently do not cover the clinical needs of children;in some cases, products for use in children need to bespecially manufactured or imported. Careful considera-tion has been given to establishing the clinical need forunlicensed interventions with respect to the evidenceand experience of their safety and efficacy.

Hundreds of changes are made between editions, andthe most clinically significant changes are listed at thefront of each edition.

Paediatric Formulary CommitteeThe Paediatric Formulary Committee (PFC) is respon-sible for the content of BNFC. The PFC includes aneonatologist and paediatricians appointed by theRoyal College of Paediatrics and Child Health, paed-iatric pharmacists appointed by the Royal Pharmaceut-ical Society of Great Britain and the Neonatal andPaediatric Pharmacists Group, doctors appointed bythe BMJ Publishing Group, a GP appointed by theRoyal College of General Practitioners, and representa-tives from the Medicines and Healthcare products Reg-ulatory Agency (MHRA) and the UK health depart-ments. The PFC decides on matters of policy andreviews amendments to BNFC in the light of newevidence and expert advice. The Committee meetsevery 6 months and each member also receives proofsof all BNFC chapters for review before publication.

Dental Advisory GroupThe Dental Advisory Group oversees the preparation ofadvice on the drug management of dental and oralconditions; the group includes representatives fromthe British Dental Association.

Editorial teamBNFC staff editors are pharmacists with a sound under-standing of how drugs are used in clinical practice,including paediatrics. Each staff editor is responsiblefor editing, maintaining, and updating specific chaptersof BNFC. During the publication cycle the staff editorsreview information in BNFC against a variety of sources(see below).

Amendments to the text are drafted when the editorsare satisfied that any new information is reliable andrelevant. The draft amendments are passed to expertadvisers for comment and then presented to the Paed-iatric Formulary Committee for consideration. Addition-ally, for each edition, sections are chosen from every

chapter for thorough review. These planned reviews aimto verify all the information in the selected sections andto draft any amendments to reflect current best prac-tice.

Staff editors prepare the text for publication and under-take a number of checks on the knowledge at variousstages of the production.

Expert advisersBNFC uses about 80 expert clinical advisers (includingdoctors, pharmacists, nurses, and dentists) throughoutthe UK to help with the production of each edition. Therole of these expert advisers is to review existing textand to comment on amendments drafted by the staffeditors. These clinical experts help to ensure that BNFCremains reliable by:

. commenting on the relevance of the text in thecontext of best clinical practice in the UK;

. checking draft amendments for appropriate inter-pretation of any new evidence;

. providing expert opinion in areas of controversy orwhen reliable evidence is lacking;

. advising on areas where BNFC diverges from sum-maries of product characteristics;

. advising on the use of unlicensed medicines or oflicensed medicines for unlicensed uses (‘off-label’use);

. providing independent advice on drug interactions,prescribing in hepatic impairment, renal impair-ment, pregnancy, breast-feeding, neonatal care, pal-liative care, and the emergency treatment of pois-oning.

In addition to consulting with regular advisers, BNFCcalls on other clinical specialists for specific develop-ments when particular expertise is required.

BNFC also works closely with a number of expert bodiesthat produce clinical guidelines. Drafts or pre-publica-tion copies of guidelines are routinely received forcomment and for assimilation into BNFC.

Sources of BNFC informationBNFC uses a variety of sources for its information; themain ones are shown below.

Summaries of product characteristics BNFCreceives summaries of product characteristics (SPCs)of all new products as well as revised SPCs for existingproducts. The SPCs are a key source of product infor-mation and are carefully processed, despite the ever-increasing volume of information being issued by thepharmaceutical industry. Such processing involves:

. verifying the approved names of all relevant ingre-dients including ‘non-active’ ingredients (BNFC iscommitted to using approved names and descrip-tions as laid down by the Medicines Act);

. comparing the indications, cautions, contra-indica-tions, and side-effects with similar existing drugs.Where these are different from the expected pat-tern, justification is sought for their inclusion orexclusion;

. seeking independent data on the use of drugs inpregnancy and breast-feeding;

BNFC 2011–2012 ix

. incorporating the information into BNFC usingestablished criteria for the presentation and inclu-sion of the data;

. checking interpretation of the information by twostaff editors before submitting to a senior editor;changes relating to doses receive an extra check;

. identifying potential clinical problems or omissionsand seeking further information from manufacturersor from expert advisers;

. careful validation of any areas of divergence ofBNFC from the SPC before discussion by the Com-mittee (in the light of supporting evidence);

. constructing, with the help of expert advisers, acomment on the role of the drug in the context ofsimilar drugs.

Much of this processing is applicable to the followingsources as well.

Expert advisers The role of expert clinical advisers inproviding the appropriate clinical context for all BNFCinformation is discussed above.

Literature Staff editors monitor core medical, paed-iatric, and pharmaceutical journals. Research papersand reviews relating to drug therapy are carefully pro-cessed. When a difference between the advice in BNFCand the paper is noted, the new information is assessedfor reliability and relevance to UK clinical practice. Ifnecessary, new text is drafted and discussed with expertadvisers and the Paediatric Formulary Committee.BNFC enjoys a close working relationship with a num-ber of national information providers.

Systematic reviews BNFC has access to variousdatabases of systematic reviews (including theCochrane Library and various web-based resources).These are used for answering specific queries, forreviewing existing text and for constructing new text.Staff editors receive training in critical appraisal, litera-ture evaluation, and search strategies. Reviews pub-lished in Clinical Evidence are used to validate BNFCadvice.

Consensus guidelines The advice in BNFC ischecked against consensus guidelines produced byexpert bodies. A number of bodies make drafts or pre-publication copies of the guidelines available to BNFC; itis therefore possible to ensure that a consistent messageis disseminated. BNFC routinely processes guidelinesfrom the National Institute for Health and ClinicalExcellence (NICE), the Scottish Medicines Consortium(SMC), and the Scottish Intercollegiate Guidelines Net-work (SIGN).

Reference sources Paediatric formularies and refer-ence sources are used to provide background informa-tion for the review of existing text or for the constructionof new text. The BNFC team works closely with theeditorial team that produces Martindale: The CompleteDrug Reference. BNFC has access to Martindale infor-mation resources and each team keeps the otherinformed of significant developments and shifts in thetrends of drug usage.

Statutory information BNFC routinely processesrelevant information from various Government bodiesincluding Statutory Instruments and regulations affect-

ing the Prescription only Medicines Order. Official com-pendia such as the British Pharmacopoeia and itsaddenda are processed routinely to ensure that BNFCcomplies with the relevant sections of the MedicinesAct.

BNFC maintains close links with the Home Office (inrelation to controlled drug regulations) and the Medi-cines and Healthcare products Regulatory Agency(including the British Pharmacopoeia Commission).Safety warnings issued by the Commission on HumanMedicines (CHM) and guidelines on drug use issued bythe UK health departments are processed as a matter ofroutine.

Relevant professional statements issued by the RoyalPharmaceutical Society of Great Britain are included inBNFC as are guidelines from bodies such as the RoyalCollege of Paediatrics and Child Health.

BNFC reflects information from the Drug Tariff, theScottish Drug Tariff, and the Northern Ireland DrugTariff.

Pricing information NHS Prescription Servicesprovide information on prices of medicinal productsand appliances in BNFC. BNFC also receives and pro-cesses price lists from product suppliers.

Comments from readers Readers of BNFC areinvited to send in comments. Numerous letters andemails are received during the preparation of eachedition. Such feedback helps to ensure that BNFCprovides practical and clinically relevant information.Many changes in the presentation and scope of BNFChave resulted from comments sent in by users.

Comments from industry Close scrutiny of BNFC bythe manufacturers provides an additional check andallows them an opportunity to raise issues about BNFC’spresentation of the role of various drugs; this is yetanother check on the balance of BNFC advice. Allcomments are looked at with care and, where necessary,additional information and expert advice are sought.

Virtual user groups BNFC has set up virtual usergroups across various healthcare professions (e.g. doc-tors, pharmacists, nurses). The aim of these groups willbe to provide feedback to the editors and publishers toensure that BNF publications continue to serve theneeds of its users.

Market research Market research is conducted atregular intervals to gather feedback on specific areas ofdevelopment, such as drug interactions or changes tothe way information is presented in digital formats.

BNFC is an independent professional publicationthat is kept up-to-date and addresses the day-to-day prescribing information needs of healthcareprofessionals treating children. Use of this resourcethroughout the health service helps to ensure thatmedicines are used safely, effectively, and appropri-ately in children.

x BNFC 2011–2012

How to use BNF for Children

BNF for Children (BNFC) provides information onthe use of medicines in children ranging from neo-nates (including preterm neonates) to adolescents.The terms infant, child, and adolescent are not usedconsistently in the literature; to avoid ambiguityactual ages are used in the dose statements inBNFC. The term neonate is used to describe a new-born infant aged 0–28 days. The terms child orchildren are used generically to describe the entirerange from infant to adolescent in BNFC.

In order to achieve the safe, effective, and appropriateuse of medicines in children, healthcare professionalsmust be able to use BNFC effectively, and keep up todate with significant changes in each new edition ofBNFC that are relevant to their clinical practice. How toUse BNF for Children is aimed as a quick refresher forall healthcare professionals involved with prescribing,monitoring, supplying, and administering medicines forchildren, and as a learning aid for students training tojoin these professions. While How to Use BNF forChildren is linked to the main elements of rationalprescribing, the generic structure of this section meansthat it can be adapted for teaching and learning indifferent clinical settings.

Structure of BNFCThe Contents list (on p. iii) shows that information inBNFC is divided into:

. How BNF for Children is Constructed (p. ix);

. Changes for this Edition (p. xvii);

. General Guidance (p. 1), which provides practicalinformation on many aspects of prescribing fromwriting a prescription to prescribing in palliativecare;

. Emergency Treatment of Poisoning (p. 24), whichprovides an overview on the management of acutepoisoning;

. Classified notes on clinical conditions, drugs, andpreparations, these notes are divided into 15 chap-ters, each of which is related to a particular systemof the body (e.g. chapter 3, Respiratory System) orto an aspect of paediatric care (e.g. chapter 5,Infections). Each chapter is further divided intoclassified sections. Each section usually beginswith prescribing notes followed by relevant drugmonographs and preparations (see fig. 1). Drugsare classified in a section according to their phar-macology and therapeutic use;

. Appendices and Indices, includes 4 Appendices(providing information on drug interactions, border-line substances, cautionary and advisory labels fordispensed medicines, and intravenous infusions forneonatal intensive care), the Dental Practitioners’Formulary, the Nurse Prescribers’ Formulary, Non-medical Prescribing, Index of Manufacturers, andthe main Index. The information in the Appendicesshould be used in conjunction with relevant infor-mation in the chapters.

Finding information in BNFCBNFC includes a number of aids to help access relevantinformation:

. Index (p. 811), where entries are included in alpha-betical order of non-proprietary drug names, pro-prietary drug names, clinical conditions, and pre-scribing topics. A specific entry for ‘DentalPrescribing’ brings together topics of relevance todental surgeons. The page reference to the drugmonograph is shown in bold type. References todrugs in Appendices 1 and 3 are not included in themain Index;

. Contents (p. iii), provides a hierarchy of how infor-mation in BNFC is organised;

. The beginning of each chapter includes a classifiedhierarchy of how information is organised in thatchapter;

. Running heads, located next to the page number onthe top of each page, show the section of BNFC thatis being used;

. Thumbnails, on the outer edge of each page, showthe chapter of BNFC that is being used;

. Cross-references, lead to additional relevant infor-mation in other parts of BNFC.

Finding dental information in BNFCExtra signposts have been added to help access dentalinformation in BNFC:

. Prescribing in Dental Practice (p. 22), includes acontents list dedicated to drugs and topics of rele-vance to dentists, together with cross-references tothe prescribing notes in the appropriate sections ofBNFC. For example, a review of this list shows thatinformation on the local treatment of oral infectionsis located in chapter 12 (Ear, Nose, and Oro-pharynx) while information on the systemic treat-ment of these infections is found in chapter 5 (Infec-tions). Further guidance for dental practice can befound in the BNF.

. Side-headings, in the prescribing notes, side-head-ings facilitate the identification of advice on oralconditions (e.g. Dental and Orofacial Pain, p. 199);

. Dental prescribing on NHS, in the body of BNFC,preparations that can be prescribed using NHS formFP10D (GP14 in Scotland, WP10D in Wales) can beidentified by means of a note headed ‘Dental pre-scribing on NHS’ (e.g. Aciclovir Oral Suspension,p. 323).

Identifying effective drug treatmentsThe prescribing notes in BNFC provide an overview ofthe drug management of common conditions and facil-itate rapid appraisal of treatment options (e.g. epilepsy,p. 215). For ease of use, information on the managementof certain conditions has been tabulated (e.g. acuteasthma, p. 136).

Advice issued by the National Institute for Health andClinical Excellence (NICE) is integrated within BNFC

BNFC 2011–2012 xi

prescribing notes if appropriate. Summaries of NICEtechnology appraisals, and relevant short guidelines,are included in pink panels. BNFC also includes adviceissued by the Scottish Medicines Consortium (SMC)when a medicine is restricted or not recommended foruse within NHS Scotland.

In order to select safe and effective medicines forindividual children, information in the prescribingnotes must be used in conjunction with other pre-scribing details about the drugs and knowledge of thechild’s medical and drug history.

Figure 1 Illustrates the typical layout of a drug monograph and preparationrecords in BNFC

BNFC How to use BNFC xii

DRUG NAME UCautions details of precautions required and also

any monitoring required

Counselling Verbal explanation to the patient of spe-cific details of the drug treatment (e.g. posture whentaking a medicine)

Contra-indications circumstances when a drugshould be avoided

Hepatic impairment advice on the use of a drugin hepatic impairment

Renal impairment advice on the use of a drug inrenal impairment

Pregnancy advice on the use of a drug duringpregnancy

Breast-feeding advice on the use of a drug dur-ing breast-feeding

Side-effects very common (greater than 1 in 10)and common (1 in 100 to 1 in 10); less commonly(1 in 1000 to 1 in 100); rarely (1 in 10 000 to 1 in1000); very rarely (less than 1 in 10 000); alsoreported, frequency not known

Licensed use shows if drug unlicensed in theUK, or ‘off-label’ use of drug licensed in the UK

Indication and doseDetails of uses and indications. By route

Child dose and frequency of administration(max. dose) for specific age group

. By alternative route

Child dose and frequency

Administration practical advice on the adminis-tration of a drug

1Approved Name (Non-proprietary) APharmaceutical form, sugar-free, active ingre-dient mg/mL, net price, pack size = basic NHSprice. Label: (as in Appendix 3)

1. Exceptions to the prescribing status are indicated by anote or footnote.

Proprietary Name (Manufacturer) A DPharmaceutical form, colour, coating, activeingredient and amount in dosage form, net price,pack size = basic NHS price. Label: (as inAppendix 3)Excipients include clinically important excipientsElectrolytes clinically significant quantities of electrolytes

Note Specific notes about the product e.g. handling

PreparationsPreparations are included under a non-proprietarytitle, if they are marketed under such a title, if theyare not otherwise prescribable under the NHS, or ifthey may be prepared extemporaneously.

In the case of compound preparations, the indica-tions, cautions, contra-indications, side-effects, andinteractions of all constituents should be taken intoaccount for prescribing.

When no suitable licensed preparation is available,details of preparations that may be imported orformulations available as manufactured specials orextemporaneous preparations are included.

DrugsDrugs appear under pharmacopoeial or other non-proprietary titles. When there is an appropriatecurrent monograph (Medicines Act 1968, Section65) preference is given to a name at the head of thatmonograph; otherwise a British Approved Name(BAN), if available, is used.

The symbol U is used to denote those prepara-tions considered to be less suitable for prescribing.Although such preparations may not be consideredas drugs of first choice, their use may be justifiablein certain circumstances.

Prescription-only medicines A

This symbol has been placed against preparationsthat are available only on a prescription from anappropriate practitioner. For more detailed infor-mation see Medicines, Ethics and Practice, Lon-don, Pharmaceutical Press (always consult latestedition).

The symbols 23KL indicate that thepreparations are subject to the prescription require-ments of the Misuse of Drugs Act. For advice onprescribing such preparations see Prescribing Con-trolled Drugs, p. 9.

Preparations not available for NHSprescription DThis symbol has been placed against preparationsthat are not prescribable under the NHS. Thoseprescribable only for specific disorders have afootnote specifying the condition(s) for which thepreparation remains available. Some preparationswhich are not prescribable by brand name underthe NHS may nevertheless be dispensed using thebrand name provided that the prescription showsan appropriate non-proprietary name.

Prices

Prices have been calculated from the basic costused in pricing NHS prescriptions, see also Pricesin BNFC, p. xvi for details.

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xii BNFC 2011–2012

A brief description of the clinical uses of a drug canusually be found in the Indication and Dose section of itsmonograph (e.g. ibuprofen, p. 503); a cross-reference isprovided to any indications for that drug that are cov-ered in other sections of BNFC.

The symbol U is used to denote preparations that areconsidered by the Joint Formulary Committee to be lesssuitable for prescribing. Although such preparationsmay not be considered as drugs of first choice, theiruse may be justifiable in certain circumstances.

Drug management of medicalemergenciesGuidance on the drug management of medical emer-gencies can be found in the relevant BNFC chapters (e.g.treatment of anaphylaxis is included in section 3.4.3). Asummary of drug doses used for Medical Emergenciesin the Community can be found in the glossy pages atthe back of BNFC. Algorithms for Newborn, PaediatricBasic, and Paediatric Advanced Life Support can also befound within these pages.

Minimising harm in children with co-morbiditiesThe drug chosen to treat a particular condition shouldhave minimal detrimental effects on the child’s otherdiseases and minimise the child’s susceptibility toadverse effects. To achieve this, the Cautions, Contra-indications, and Side-effects of the relevant drug shouldbe reviewed, and can usually be found in the drugmonograph. However, if a class of drugs (e.g. tetracy-clines, p. 274) share the same cautions, contra-indica-tions, and side-effects, these are amalgamated in theprescribing notes while those unique to a particular drugin that class are included in its individual drug mono-graph. Occasionally, the cautions, contra-indications,and side-effects may be included within a preparationrecord if they are specific to that preparation or if thepreparation is not accompanied by a monograph.

The information under Cautions can be used to assessthe risks of using a drug in a child who has co-morbid-ities that are also included in the Cautions for thatdrug—if a safer alternative cannot be found, the drugmay be prescribed while monitoring the child foradverse-effects or deterioration in the co-morbidity.Contra-indications are far more restrictive than Cau-tions and mean that the drug should be avoided in achild with a condition that is contra-indicated.

The impact that potential side-effects may have on achild’s quality of life should also be assessed. Forinstance, in a child who has constipation, it may bepreferable to avoid a drug that frequently causes con-stipation. The prescribing notes in BNFC may highlightimportant safety concerns and differences betweendrugs in their ability to cause certain side-effects.

Prescribing for children with hepatic orrenal impairmentDrug selection should aim to minimise the potential fordrug accumulation, adverse drug reactions, and exacer-bation of pre-existing hepatic or renal disease. If it isnecessary to prescribe drugs whose effect is altered byhepatic or renal disease, appropriate drug dose adjust-

ments should be made, and the child should be mon-itored adequately. The general principles for prescribingare outlined under Prescribing in Hepatic Impairment(p. 14) and Prescribing in Renal Impairment (p. 14).Information about drugs that should be avoided orused with caution in hepatic disease or renal impair-ment can be found in drug monographs under HepaticImpairment and Renal Impairment (e.g. fluconazole,p. 301). However, if a class of drugs (e.g. tetracyclines,p. 274) share the same recommendations for use inhepatic disease or renal impairment, this advice ispresented in the prescribing notes under HepaticImpairment and Renal Impairment and any advicethat is unique to a particular drug in that class isincluded in its individual drug monograph.

Prescribing for patients who arepregnant or breast-feedingDrug selection should aim to minimise harm to thefetus, nursing infant, and mother. The infant should bemonitored for potential side-effects of drugs used by themother during pregnancy or breast-feeding. The generalprinciples for prescribing are outlined under Prescribingin Pregnancy (p. 16) and Prescribing in Breast-feeding(p. 16). The prescribing notes in BNFC chapters provideguidance on the drug treatment of common conditionsthat can occur during pregnancy and breast-feeding (e.g.asthma, p. 133). Information about the use of specificdrugs during pregnancy and breast-feeding can befound in their drug monographs under Pregnancy andBreast-feeding (e.g. fluconazole, p. 301). However, if aclass of drugs (e.g. tetracyclines, p. 274) share the samerecommendations for use during pregnancy or breast-feeding, this advice is amalgamated in the prescribingnotes under Pregnancy and Breast-feeding while anyadvice that is unique to a particular drug in that class isincluded in its individual drug monograph.

Minimising drug interactionsDrug selection should aim to minimise drug interac-tions. If it is necessary to prescribe a potentially seriouscombination of drugs, children should be monitoredappropriately. The mechanisms underlying drug inter-actions are explained in Appendix 1 (p. 655).

Details of drug interactions can be found in Appendix 1of BNFC (p. 656). Drugs and their interactions are listedin alphabetical order of the non-proprietary drug name,and cross-references to drug classes are provided whereappropriate. Each drug or drug class is listed twice: inthe alphabetical list and also against the drug or classwith which it interacts. The symbol . is placed againstinteractions that are potentially serious and where com-bined administration of drugs should be avoided (oronly undertaken with caution and appropriate monitor-ing). Interactions that have no symbol do not usuallyhave serious consequences.

If a drug or drug class has interactions, a cross referenceto where these can be found in Appendix 1 is providedunder the Cautions of the drug monograph or pre-scribing notes.

BNFC 2011–2012 xiii

Selecting the doseThe drug dose is usually located in pink panels withinthe Indication and Dose section of the drug monographor within the Dose section of the preparation record.Doses are linked to specific indications and routes ofadministration. The dose of a drug may vary accordingto different indications, routes of administration, age,body-weight, and body-surface area. When the dose of adrug varies according to different indications, eachindication and its accompanying dose is included in aseparate pink panel (e.g. aciclovir, p. 322). The dose islocated within the preparation record when the dosevaries according to different formulations of that drug(e.g. amphotericin, p. 305) or when a preparation has adose different to that in its monograph. Occasionally,drug doses may be included in the prescribing notes forpractical reasons (e.g. doses of drugs in Helicobacterpylori eradication regimens, p. 42). The right doseshould be selected for the right age and body-weight(or body surface area) of the child, as well as for the rightindication, route of administration, and preparation.

Doses in BNFC are usually assigned to specific ageranges; neonatal doses are preceded by the wordNeonate, all other doses are preceded by the wordChild. Age ranges in BNFC are described as shownin the following example:

Child 1 month–4 years refers to a child from 1month old up to their 4th birthday;

Child 4–10 years refers to a child from the day oftheir 4th birthday up to their 10th birthday.

However, a pragmatic approach should be applied tothese cut-off points depending on the child’s physio-logical development, condition, and if weight isappropriate for the child’s age.

For some drugs (e.g. gentamicin, p. 278) the neonataldose varies according to the postmenstrual age of theneonate. Postmenstrual age is the neonate’s total ageexpressed in weeks from the start of the mother’s lastmenstrual period. For example, a 3 week old baby bornat 27 weeks gestation is treated as having a postmenstr-ual age of 30 weeks. A term baby has a postmenstrualage of 37–42 weeks when born. For most other drugs,the dose can be based on the child’s actual date of birthirrespective of postmenstrual age. However, the degreeof prematurity, the maturity of renal and hepatic func-tion, and the clinical properties of the drug need to beconsidered on an individual basis.

Many children’s doses in BNFC are standardised bybody-weight. To calculate the dose for a given childthe weight-standardised dose is multiplied by the child’sweight (or occasionally by the child’s ideal weight forheight). The calculated dose should not normallyexceed the maximum recommended dose for an adult.For example, if the dose is 8 mg/kg (max. 300 mg), achild of 10 kg body-weight should receive 80 mg, but achild of 40 kg body-weight should receive 300 mg(rather than 320 mg). Calculation by body-weight inthe overweight child may result in much higher dosesbeing administered than necessary; in such cases, thedose should be calculated from an ideal weight forheight.

Occasionally, some doses in BNFC are standardised bybody surface area because many physiological phe-nomena correlate better with body surface area. Inthese cases, to calculate the dose for a given child, the

body surface area-standardised dose is multiplied by thechild’s body surface area. The child’s body surface areacan be estimated from his or her weight using the tablesfor Body Surface Area in Children located in the glossypages at the back of the print version of BNFC.

The doses of some drugs may need to be adjusted iftheir effects are altered by concomitant use with otherdrugs, or in patients with hepatic or renal impairment(see Minimising Drug Interactions, and Prescribing forChildren with Hepatic or Renal Impairment).

Wherever possible, doses are expressed in terms of adefinite frequency (e.g. if the dose is 1 mg/kg twicedaily, a child of body-weight 9 kg would receive 9 mgtwice daily). Occasionally, it is necessary to includedoses in the total daily dose format (e.g. 10 mg/kgdaily in 3 divided doses); in these cases the total dailydose should be divided into individual doses (in thisexample a child of body-weight 9 kg would receive30 mg 3 times daily).

Most drugs can be administered at slightly irregularintervals during the day. Some drugs, e.g. antimicrobials,are best given at regular intervals. Some flexibilityshould be allowed in children to avoid waking themduring the night. For example, the night-time dose maybe given at the child’s bedtime.

Special care should be taken when converting dosesfrom one metric unit to another, and when calculatinginfusion rates or the volume of a preparation to admin-ister. Conversions for imperial to metric measures canbe found in the glossy pages at the back of BNFC.Where possible, doses should be rounded to facilitateadministration of suitable volumes of liquid prepara-tions, or an appropriate strength of tablet or capsule.

Selecting a suitable preparationChildren should be prescribed a preparation that com-plements their daily routine, and that provides the rightdose of drug for the right indication and route ofadministration.

In BNFC, preparations usually follow immediately afterthe monograph for the drug which is their main ingre-dient. The preparation record (see fig. 1) provides infor-mation on the type of formulation (e.g. tablet), theamount of active drug in a solid dosage form, and theconcentration of active drug in a liquid dosage form.The legal status is shown for prescription only medi-cines and controlled drugs; any exception to the legalstatus is shown by a Note immediately after the pre-paration record or a footnote. If a proprietary prepara-tion has a distinct colour, coating, scoring, or flavour,this is shown in the preparation record. If a proprietarypreparation includes excipients usually specified inBNFC (see p. 2), these are shown in the Excipientsstatement, and if it contains clinically significant quan-tities of electrolytes, these are usually shown in theElectrolytes statement.

Branded oral liquid preparations that do not containfructose, glucose, or sucrose are described as ‘sugar-free’ in BNFC. Preparations containing hydrogenatedglucose syrup, mannitol, maltitol, sorbitol, or xylitol arealso marked ‘sugar-free’ since there is evidence that theydo not cause dental caries. Children receiving medicinescontaining cariogenic sugars, or their carers, should beadvised of appropriate dental hygiene measures to pre-

xiv BNFC 2011–2012

vent caries. Sugar-free preparations should be usedwhenever possible.

Where a drug has several preparations, those of asimilar type may be grouped together under a heading(e.g. ‘Modified-release’ for theophylline preparations,p. 143). Where there is good evidence to show thatthe preparations for a particular drug are not inter-changeable, this is stated in a Note either in the Dosesection of the monograph or by the group of prepara-tions affected. When the dose of a drug varies accordingto different formulations of that drug, the right doseshould be prescribed for the preparation selected.

In the case of compound preparations, the prescribinginformation of all constituents should be taken intoaccount for prescribing.

Unlicensed preparations that are available from ‘Specialorder’ manufacturers and specialist importing compa-nies are included (e.g. midazolam buccal liquid, p. 639).The availability of an extemporaneous formulation of adrug is shown after its other preparations (e.g. captopril,p. 102).

Writing prescriptionsGuidance is provided on writing prescriptions that willhelp to reduce medication errors, see p. 4. Prescriptionrequirements for controlled drugs are also specified onp. 9.

Administering drugsBasic information on the route of administration isprovided in the Indication and Dose section of a drugmonograph or the Dose section of a preparation record.Further details, such as masking the bitter taste of somemedicines, may be provided in the Administration sec-tion of a drug monograph (e.g. proguanil, p. 336). Prac-tical information is also provided on the preparation ofintravenous drug infusions, including compatibility ofdrugs with standard intravenous infusion fluids, methodof dilution or reconstitution, and administration rates(e.g. co-amoxiclav, p. 263). The Administration sectionis located within preparation records when this informa-tion varies according to different preparations of thatdrug (e.g. amphotericin, p. 305). If a class of drugs (e.g.topical corticosteroids, p. 559) share the same adminis-tration advice, this may be presented in the prescribingnotes.

Information on intravenous infusions for neonatal inten-sive care can also be found in Appendix 4, p. 791.

Advising children (and carers)The prescriber, the child’s carer, and the child (if appro-priate) should agree on the health outcomes desired andon the strategy for achieving them (see Taking Medi-cines to Best Effect, p. 1). Taking the time to explain tothe child (and carers) the rationale and the potentialadverse effects of treatment may improve adherence.For some medicines there is a special need for counsel-ling (e.g. recognising signs of blood, liver, or skin dis-orders with carbamazepine); this is shown in Counsel-ling statements, usually in the Cautions or Indicationand Dose section of a monograph, or within a prepara-tion record if it is specific to that preparation.

Children and their carers should be advised if treatmentis likely to affect their ability to perform skilled tasks(e.g. driving).

Cautionary and advisory labels that pharmacists arerecommended to add when dispensing are included inthe preparation record (see fig. 1). Details of these labelscan be found in Appendix 3 (p. 788).

Monitoring drug treatmentChildren should be monitored to ensure they are achiev-ing the expected benefits from drug treatment withoutany unwanted side-effects. The prescribing notes or theCautions in the drug monograph specify any specialmonitoring requirements. Further information on mon-itoring the plasma concentration of drugs with a narrowtherapeutic index can be found in the Pharmacokineticssection or as a Note under the Dose section of the drugmonograph.

Identifying and reporting adverse drugreactionsClinically relevant Side-effects for most drugs areincluded in the monographs. However, if a class ofdrugs (e.g. tetracyclines, p. 274) share the same side-effects, these are presented in the prescribing noteswhile those unique to a particular drug in that classare included in its individual drug monograph. Occa-sionally, side-effects may be included within a prepara-tion record if they are specific to that preparation or ifthe preparation is not accompanied by a monograph.

Side-effects are generally listed in order of frequencyand arranged broadly by body systems. Occasionally arare side-effect might be listed first if it is considered tobe particularly important because of its seriousness. Thefrequency of side-effects is described in fig. 1.

An exhaustive list of side-effects is not included fordrugs that are used by specialists (e.g. cytotoxic drugsand drugs used in anaesthesia). Recognising that hyper-sensitivity reactions can occur with virtually all medi-cines, this effect is generally not listed, unless the drugcarries an increased risk of such reactions. BNFC alsoomits effects that are likely to have little clinical con-sequence (e.g. transient increase in liver enzymes).

The prescribing notes in BNFC may highlight importantsafety concerns and differences between drugs in theirability to cause certain side-effects. Safety warningsissued by the Commission on Human Medicines(CHM) or Medicines and Healthcare products Regula-tory Agency (MHRA) can also be found here or in thedrug monographs.

Adverse Reactions to Drugs (p. 12) provides advice onpreventing adverse drug reactions, and guidance onreporting adverse drug reactions to the MHRA. Theblack triangle symbol T identifies those preparations inBNFC that are monitored intensively by the MHRA.

BNFC 2011–2012 xv

Finding significant changes in a neweditionBNFC is published in July each year and includes lists ofchanges in a new edition that are relevant to clinicalpractice:

. The print version includes an Insert that sum-marises the background to several key changes. Acopy of the Insert can also be found at bnfc.org inthe section on Updates under ‘What’s new inBNFC?’;

. Changes for this edition (p. xvii), provides a list ofsignificant changes, dose changes, classificationchanges, new names, and new preparations thathave been incorporated into a new edition, as wellas a list of preparations that have been discontinuedsince the last edition. For ease of identification, themargins of these pages are marked in pink;

. E-newsletter, the BNF & BNFC e-newsletter serviceis available free of charge. It alerts healthcare pro-fessionals to details of significant changes in theclinical content of these publications and to the waythat this information is delivered. Newsletters alsoreview clinical case studies and provide tips onusing these publications effectively. To sign up fore-newsletters go to bnf.org/newsletter. To visitthe e-newsletter archive, go to bnfc.org/bnfc/bnfcextra/current/450066.htm.

So many changes are made to each new edition ofBNFC, that not all of them can be accommodated inthe Insert and the Changes section. We encouragehealthcare professionals to review regularly the pre-scribing information on drugs that they encounter fre-quently.

NutritionAppendix 2 (p. 743) includes tables of ACBS-approvedenteral feeds and nutritional supplements based on theirenergy and protein content. There are separate tablesfor specialised formulae for specific clinical conditions.Classified sections on foods for special diets and nutri-tional supplements for metabolic diseases are alsoincluded.

Licensed status of medicinesBNFC includes advice on the use of unlicensed medi-cines or of licensed medicines for unlicensed applica-tions (‘off-label’ use). Such advice reflects careful con-sideration of the options available to manage a givencondition and the weight of evidence and experience ofthe unlicensed intervention. Limitations of the market-ing authorisation should not preclude unlicensed usewhere clinically appropriate.

The Licensed Use statement in a drug monograph isused to indicate that:

. a drug is not licensed in the UK (e.g. pyrazinamide,p. 293);

. a drug is licensed in the UK, but not for use inchildren (e.g. lansoprazole, p. 45);

. BNFC advice for certain indications, age groups ofchildren, routes of administration, or preparations

falls outside a drug’s marketing authorisation (e.g.naproxen, p. 505).

The absence of the Licensed Use statement from a drugmonograph indicates that the drug is licensed for allindications given in the monograph (e.g. zanamivir,p. 327).

Prescribing unlicensed medicines or medicines outsidetheir marketing authorisation alters (and probablyincreases) the prescriber’s professional responsibilityand potential liability. The prescriber should be able tojustify and feel competent in using such medicines.Further information can be found in BNF for Childrenand Marketing Authorisation, p. 2.

Prices in BNFCBasic net prices are given in BNFC to provide anindication of relative cost. Where there is a choice ofsuitable preparations for a particular disease or condi-tion the relative cost may be used in making a selection.Cost-effective prescribing must, however, take intoaccount other factors (such as dose frequency andduration of treatment) that affect the total cost. Theuse of more expensive drugs is justified if it will result inbetter treatment of the patient, or a reduction of thelength of an illness, or the time spent in hospital. Priceshave generally been calculated from the net cost used inpricing NHS prescriptions in October 2010. Prices gen-erally reflect whole dispensing packs; prices for injec-tions are stated per ampoule, vial, or syringe. The pricefor an extemporaneously prepared preparation has beenomitted where the net cost of the ingredients used tomake it would give a misleadingly low impression of thefinal price.

BNFC prices are not suitable for quoting to patientsseeking private prescriptions or contemplating over-the-counter purchases because they do not take intoaccount VAT, professional fees, and other overheads.

A fuller explanation of costs to the NHS may beobtained from the Drug Tariff. Separate drug tariffsare applicable to England and Wales, Scotland, andNorthern Ireland; prices in the different tariffs may vary.

Extra resources on the BNFC websiteWhile the BNFC website (bnfc.org) hosts the digitalcontent of BNFC proper, it also provides additionalresources such as Frequently Asked Questions andonline calculators.

xvi BNFC 2011–2012

Changes for thisedition

Significant changesThe BNF for Children is revised yearly and numerouschanges are made between issues. All copies of BNF forChildren 2010–2011 should therefore be withdrawn andreplaced by BNF for Children 2011–2012. Significantchanges have been made in the following sections for

BNF for Children 2011–2012:

How to use BNFC, p. xi

New symbols introduced throughout BNF for Childrento identify Controlled Drug preparations in Schedules 2,3, and 4, Prescribing Controlled Drugs

Ibuprofen poisoning, Emergency treatment of poisoning

Paracetamol poisoning [calculating the potentially toxicdose ingested by obese children], Emergency treatmentof poisoning

Infliximab for Crohn’s Disease [NICE guidance], section1.5

Formoterol [MHRA/CHM advice], section 3.1.1.1

Omalizumab [NICE guidance], section 3.4.2

Fentanyl [counselling for the use of patches], section4.7.2

Epilepsy in pregnancy, section 4.8.1

Neonatal seizures, section 4.8.1

Febrile convulsions, section 4.8.3

Nicotine dependence, section 4.10.2

Summary of antibacterial therapy [advice reformatted],section 5.1, Table 1

Cystic Fibrosis, section 5.1, Table 1

Meningitis, section 5.1, Table 1

Erysipelas and cellulitis, section 5.1, Table 1

Prevention of pertussis, section 5.1, Table 2

Prevention of pneumococcal infection in asplenia or inpatients with sickle-cell disease, section 5.1, Table 2

Prevention of infection in open fractures, section 5.1,Table 2

Urinary-tract infections [culture and sensitivity testing],section 5.1.13

Treatment of fungal infections: aspergillosis, section 5.2

HIV infection [initiation of treatment], section 5.3.1

Antiretroviral drugs [doses included in their mono-graphs], section 5.3.1

Palivizumab [respiratory syncytial virus], section 5.3.5

Prophylaxis against malaria [recommendations for Mor-occo and Turkmenistan removed], section 5.4.1

Dexamethasone [parenteral doses expressed as dexa-methasone base], section 6.3.2

Somatropin for the treatment of growth failure in chil-dren [NICE guidance], section 6.5.1

Recurrent vulvovaginal candidiasis [updated treatmentregimens], section 7.2.2

Combined hormonal contraceptive interactions, section7.3.1

Combined oral contraceptives [preparations tabulated],section 7.3.1

Progestogen-only contraceptive interactions, section7.3.2.1 and section 7.3.2.2

Nocturnal enuresis, section 7.4.2

Rapamunec tablets [0.5 mg tablet not bioequivalent toother strengths], section 8.2.2

G6PD deficiency [rasburicase and risk of haemolysis],section 9.1.5

Calcium gluconate injection [MHRA advice], section9.5.1.1

Drugs unsafe for use in acute porphyrias, section 9.8.2

Aqueous cream [skin reactions when used as a leave-onemollient], section 13.2.1

Nappy rash, section 13.2.2

Sunscreens [International Nomenclature for CosmeticIngredients, table added], section 13.8.1

Immunisation Schedule, section 14.1

Haemophilus type B conjugate vaccine and meningo-coccal vaccines [in asplenia, splenic dysfunction, orcomplement deficiency], section 14.4

Influenza vaccines, section 14.4

Meningococcal vaccines, section 14.4

Pertussis vaccine [management of contacts], section14.4

Sedative and analgesic peri-operative drugs, section15.1.4

Local anaesthesia [section updated and reorganised],section 15.2

Dose changesChanges in dose statements introduced into BNF forChildren 2011–2012:

Aciclovir [herpes simplex suppression], p. 322

Actiqc , p. 206

ACWY Vaxc , p. 615

AmBisomec , p. 306

Amitriptyline [neuropathic pain], p. 185

Ampicillin, p. 262

Atorvastatin, p. 126

Atropine [premedication by intravenous injection inneonates and intra-operative bradycardia in neonates],p. 635

Azathioprine [severe ulcerative colitis and Crohn’s dis-ease], p. 54

Bendroflumethiazide, p. 77

Cervarixc [alternative schedule], p. 611

Cetirizine [dose and dose in renal impairment], p. 154

Ciprofloxacin, p. 254

Co-amoxiclav [intravenous dose], p. 263

Colistimethate sodium (Colistin), p. 288

Dexamethasone, p. 374

Dexamfetamine, p. 189

Diazepam [intravenous dose for status epilepticus],p. 232

BNFC 2011–2012 xvii

Epilim Chronospherec , p. 228

Fersamalc , p. 444

Flucloxacillin [staphylococcal lung infection in cysticfibrosis], p. 259

Fludrocortisone acetate [mineralocorticoid replacementin adrenocortical insufficiency in neonates], p. 369

Flumazenil [intravenous injection dose for reversal ofsedative effects of benzodiazepines], p. 647

Foradilc [dose for children under 12 years], p. 138

Fresh frozen plasma, p. 125

Fungizonec [neonatal dose], p. 306

Glycopyrronium [premedication at induction in children12–18 years and control of muscarinic side-effects ofneostigmine in children 12–18 years], p. 636

Hydralazine [intravenous infusion in neonates], p. 93

Hydrocortisone [congenital adrenal hyperplasia andadrenal hypoplasia, Addison’s disease, chronic mainte-nance or replacement therapy], p. 375

Hydrocortisone [paediatric severe or life-threateningacute asthma], p. 134 and p. 136

Indometacin [symptomatic ductus arteriosus], p. 130

Ipratropium [dose frequency for severe or life-threaten-ing acute asthma in children 12–18 years], p. 134 andp. 136

Itraconazole [tinea capitis], p. 303

Isoniazid, p. 255

Lansoprazole [dose in hepatic impairment], p. 45

Levetiracetam [no dose adjustment when switchingbetween intravenous and oral therapy], p. 222

Macrogol Oral Powder, Compound [faecal impaction],p. 62

Menveoc , p. 615

Mercaptamine, p. 492

Meropenem, p. 273

Metronidazole, p. 296

Midazolam [neonatal dose for sedation in intensivecare], p. 638

Modigrafc , p. 437

Morphine [intravenous injection and oral dose in chil-dren 12–18 years], p. 207

Movicolc [faecal impaction], p. 62

Movicolc-Half [faecal impaction], p. 62

Naloxone [intravenous infusion dose for overdosagewith opioids], p. 29

Nifedipine [hypertensive crisis, acute angina in Kawa-saki disease or progeria], p. 107

Nitrous oxide [maintenance of anaesthesia], p. 635

Paracetamol [severe postoperative pain by mouth andby rectum], p. 200

Phenytoin sodium, p. 235

Prednisolone [corticosteroid replacement therapy],p. 376

Prografc , p. 437

Propranolol [migraine prophylaxis], p. 88

Retapamulin, p. 586

Salofalkc tablets, granules, and rectal foam, p. 51

Selenium sulphide [pityriasis versicolor], p. 584

Sodium valproate, p. 227

Sumatriptan [cluster headache], p. 213

Symbicortc 100/6 [dose for children 6–12 years], p. 149

Temazepam, p. 639

Tiagabine [adjunctive treatment for focal seizures anddose in hepatic impairment], p. 226

Topiramate [focal seizures and Lennox-Gastautsyndrome, migraine prophylaxis, and dose in renalimpairment], p. 226

Tranexamic acid [prevention of excessive bleeding afterdental procedures by intravenous injection and menorr-hagia], p. 123

Trimethoprim, p. 255

Valaciclovir, p. 323

Xylometazoline nasal spray, p. 542

Zydol SRc , p. 211

Classification changesClassification changes have been made in the followingsections of BNF for Children 2011–2012:

Section 2.1.2 Phosphodiesterase type-3 inhibitors [titlechange]

Section 4.7.1 Non-opioid analgesics and compoundanalgesic preparations [title change]

Section 4.10.2 Nicotine dependence [new section]

Section 5.2.1 Triazole antifungals [new sub-section]

Section 5.2.2 Imidazole antifungals [new sub-section]

Section 5.2.3 Polyene antifungals [new sub-section]

Section 5.2.4 Echinocandin antifungals [new sub-sec-tion]

Section 5.2.5 Other antifungals [new sub-section]

Section 6.1.2 Antidiabetic drugs [title change]

Section 10.3 Drugs for the relief of soft-tissue inflam-mation and topical pain relief [title change]

Section 10.3.2 Rubefacients, topical NSAIDs, capsaicin,and poultices [title change]

Section 13.2.1.1 Emollient bath additives and showerpreparations [title change]

Section 15.1.4.1 Anxiolytics [title change]

New NamesColistimethate sodium [formerly Colistin], p. 288

Dulcolaxc Pico Liquid and Pico Perles [formerlyDulcolaxc Liquid and Perles], p. 61

Hydrocortisone mucoadhesive buccal tablets [formerlyCorlanc], p. 544

Laxidoc Orange [formerly Laxidoc], p. 62

Oilatumc Junior bath additive [formerly Oilatumc

Junior emollient bath additive], p. 555

xviii BNFC 2011–2012

Deleted preparationsPreparations listed below have been discontinued dur-ing the compilation of BNF for Children 2011–2012, orare still available but are not considered suitable forinclusion by the Paediatric Formulary Committee (seefootnote):

Andropatchc

Atropine eye ointment

Atrovent Aerocapsc

Baxanc

Beclometasone Cyclocapsc

Betnesol-Nc eye ointment

Budesonide Cyclocapsc

Chlorohexc

Citanestc 4%

Crixivanc1

Dexedrinec

Dimercaprol1

Ditropanc elixir

Dopramc1

Dovonexc scalp solution

Doxapram1

Exeldermc

Flixotidec Diskhaler

Hewlettsc

Indinavir1

Ledermycinc

Linolac Gamma

Locerylc cream

Metrotopc

Mixtardc 30

Neosporinc

Norvirc capsules

Octagamc

Pharmorubicinc rapid dissolution injection

Polytar AFc

Posalfilinc

Protirelin

Pulmicortc aerosol inhalation

Salbutamol Cyclocapsc

Salinumc

Select-A-Jetc Dopamine

SpectraBanc

Sulconazole

Triclofos

Zantacc effervescent tablets

Zeffixc oral solution

New preparations included in thiseditionPreparations included in the relevant sections of BNFfor Children 2011–2012:

Adoportc [tacrolimus], p. 436

Antheliosc , p. 582

Aquamolc , p. 552

Calcichew-D3c 500 mg/400 unit caplets [calcium carb-

onate with colecalciferol], p. 484

Capimunec [ciclosporin], p. 435

Carmizec [carmellose sodium], p. 530

Catacromc [sodium cromoglicate], p. 523

Crestorc [rosuvastatin], p. 127

Cyanokitc [hydroxocobalamin], p. 32

Dermatonics Heel Balmc , p. 553

Diovanc [valsartan], p. 104

Dovobetc [betamethasone with calcipotriol], p. 568

Dovonexc ointment [calcipotriol], p. 568

Eczmolc, p. 554

Epiduoc [adapalene with benzoyl peroxide], p. 577

FlebogammaDIFc [normal immunoglobulin], p. 624

Fulsovinc [griseofulvin], p. 309

Gammanormc [normal immunoglobulin], p. 623

Gammaplexc [normal immunoglobulin], p. 624

Gynoxinc intravaginal cream [fenticonazole], p. 395

Humulin I KwikPenc [isophane insulin], p. 355

Humulin M3 KwikPenc [biphasic isophane insulin],p. 356

Hyabakc [sodium hyaluronate], p. 531

Hydromol HC Intensivec, p. 560

Hylo-Carec [sodium hyaluronate], p. 531

Insumanc Comb 25 Solostar [biphasic isophane insu-lin], p. 356

Jextc [adrenaline], p. 161

Kalcipos-Dc [calcium carbonate with colecalciferol],p. 484

LescolcXL [fluvastatin], p. 127

Lopresor SRc [metoprolol], p. 91

Lumecarec Long Lasting Tear Gel [carbomers], p. 530

Lumecarec Preservative Free Tear Drops [hypro-mellose], p. 531

Lumecarec Sodium Hyaluronate [sodium hyaluronate],p. 531

Marolc [tramadol], p. 211

Miphtelc [acetylcholine chloride], p. 532

Moxivigc [moxifloxacin], p. 520

Nebusalc [hypertonic sodium chloride], p. 166

Neokayc [phytomenadione], p. 487

Nexplanonc [etonogestrel], p. 405

Nicorette Quickmistc [nicotine], p. 240

Nivestimc [filgrastim], p. 456

Norvirc tablets [ritonavir], p. 3181. Not considered suitable for inclusion by the PaediatricFormulary Committee

BNFC 2011–2012 xix

Tears Naturalec Single Dose [hypromellose], p. 531

Tevagrastimc [filgrastim], p. 456

Tobraviscc [tobramycin], p. 520

Vismedc Gel [sodium hyaluronate], p. 531

Vivadexc [tacrolimus], p. 438

VPRIVc [velaglucerase alfa], p. 491

Wellvonec [atovaquone], p. 343

Xenicalc [orlistat], p. 191

Zerocreamc , p. 553

Zeroguentc , p. 553

Zerolatumc , p. 555

ZerolatumcPlus, p. 556

Zeroneumc , p. 555

Zerozolec , p. 556

xx BNFC 2011–2012

General guidance

Medicines should be given to children only when theyare necessary, and in all cases the potential benefit ofadministering the medicine should be considered inrelation to the risk involved. This is particularly impor-tant during pregnancy, when the risk to both mother andfetus must be considered (for further details see Pre-scribing in Pregnancy, p. 16).

It is important to discuss treatment options carefullywith the child and the child’s carer (see also TakingMedicines to Best Effect, below). In particular, the childand the child’s carer should be helped to distinguish theadverse effects of prescribed drugs from the effects ofthe medical disorder. When the beneficial effects of themedicine are likely to be delayed, this should be high-lighted.

Taking medicines to best effect Difficulties inadherence to drug treatment occur regardless of age.Factors that contribute to poor compliance with pre-scribed medicines include:

. difficulty in taking the medicine (e.g. inability toswallow the medicine);

. unattractive formulation (e.g. unpleasant taste);

. prescription not collected or not dispensed;

. purpose of medicine not clear;

. perceived lack of efficacy;

. real or perceived adverse effects;

. carers’ or child’s perception of the risk and severityof side-effects may differ from that of the prescriber;

. instructions for administration not clear.

The prescriber, the child’s carer, and the child (if appro-priate) should agree on the health outcomes desired andon the strategy for achieving them (‘concordance’). Theprescriber should be sensitive to religious, cultural, andpersonal beliefs of the child’s family that can affectacceptance of medicines.

Taking the time to explain to the child (and carers) therationale and the potential adverse effects of treatmentmay improve adherence. Reinforcement and elabora-tion of the physician’s instructions by the pharmacistand other members of the healthcare team can beimportant. Giving advice on the management of adverseeffects and the possibility of alternative treatments mayencourage carers and children to seek advice ratherthan merely abandon unacceptable treatment.

Simplifying the drug regimen may help; the need forfrequent administration may reduce adherence,although there appears to be little difference in adher-ence between once-daily and twice-daily administra-tion. Combination products reduce the number ofdrugs taken but at the expense of the ability to titrateindividual doses.

Drug treatment in children Children, and particu-larly neonates, differ from adults in their response todrugs. Special care is needed in the neonatal period (first28 days of life) and doses should always be calculated

with care; the risk of toxicity is increased by a reducedrate of drug clearance and differing target organ sensi-tivity.

For guidance on selecting doses of drugs in children seeHow to Use BNF for Children, p. xiv.

Administration of medicines to children Childrenshould be involved in decisions about taking medicinesand encouraged to take responsibility for using themcorrectly. The degree of such involvement will dependon the child’s age, understanding, and personal circum-stances.

Occasionally a medicine or its taste has to be disguisedor masked with small quantities of food. However,unless specifically permitted (e.g. some formulationsof pancreatin), a medicine should not be mixed withlarge quantities of food because the full dose might notbe taken and the child might develop an aversion tofood if the medicine imparts an unpleasant taste. Med-icines should not be mixed or administered in a baby’sfeeding bottle.

Children under 5 years (and some older children) find aliquid formulation more acceptable than tablets or cap-sules. However, for long-term treatment it may bepossible for a child to be taught to take tablets orcapsules.

An oral syringe (see below) should be used for accuratemeasurement and controlled administration of an oralliquid medicine. The unpleasant taste of an oral liquidcan be disguised by flavouring it or by giving a favouritefood or drink immediately afterwards, but the potentialfor food-drug interactions should be considered.

Advice should be given on dental hygiene to thosereceiving medicines containing cariogenic sugars forlong-term treatment; sugar-free medicines should beprovided whenever possible.

Children with nasal feeding tubes in place for prolongedperiods should be encouraged to take medicines bymouth if possible; enteric feeding should generally beinterrupted before the medicine is given (particularly ifenteral feeds reduce the absorption of a particular drug).Oral liquids can be given through the tube provided thatprecautions are taken to guard against blockage; thedose should be washed down with warm water. When amedicine is given through a nasogastric tube to aneonate, sterile water must be used to accompanythe medicine or to wash it down.

The intravenous route is generally chosen when amedicine cannot be given by mouth; reliable access,often a central vein, should be used for children whosetreatment involves irritant or inotropic drugs or whoneed to receive the medicine over a long period or forhome therapy. The subcutaneous route is used mostcommonly for insulin administration. Intramuscularinjections should preferably be avoided in children,particularly neonates, infants, and young children. How-ever, the intramuscular route may be advantageous foradministration of single doses of medicines when intra-venous cannulation would be more problematic or

BNFC 2011–2012 1G

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painful to the child. Certain drugs, e.g. some vaccines,are only administered intramuscularly.

The intrathecal, epidural and intraosseous routes shouldbe used only by staff specially trained to administermedicines by these routes. Local protocols for themanagement of intrathecal injections must be in place(section 8.1).

Managing medicines in school Administration of amedicine during schooltime should be avoided if possi-ble; medicines should be prescribed for once or twice-daily administration whenever practicable. If the med-icine needs to be taken in school, this should be dis-cussed with parents or carers and the necessaryarrangements made in advance; where appropriate,involvement of a school nurse should be sought. Mana-ging Medicines in Schools and Early Years Settingsproduced by the Department of Health provides gui-dance on using medicines in schools (www.dh.gov.uk).

Patient information leaflets Manufacturers’ patientinformation leaflets that accompany a medicine, coveronly the licensed use of the medicine (see BNF forChildren and Marketing Authorisation, below). There-fore, when a medicine is used outside its licence, it maybe appropriate to advise the child and the child’s parentor carer that some of the information in the leaflet mightnot apply to the child’s treatment. Where necessary,inappropriate advice in the patient information leafletshould be identified and reassurance provided about thecorrect use in the context of the child’s condition.

Biosimilar medicines A biosimilar medicine is a newbiological product that is similar to a medicine that hasalready been authorised to be marketed (the biologicalreference medicine) in the European Union. The activesubstance of a biosimilar medicine is similar, but notidentical, to the biological reference medicine. Biologi-cal products are different from standard chemical pro-ducts in terms of their complexity and although theore-tically there should be no important differences betweenthe biosimilar and biological reference medicine interms of safety or efficacy, when prescribing biologicalproducts, it is good practice to use the brand name. Thiswill ensure that substitution of a biosimilar medicinedoes not occur when the medicine is dispensed.

Biosimilar medicines have black triangle status (T, seep. 12) at the time of initial marketing. It is important toreport suspected adverse reactions to biosimilar medi-cines using the Yellow Card Scheme (p. 12). For biosi-milar medicines, adverse reaction reports should clearlystate the brand name of the suspected medicine.

Complementary and alternative medicine Anincreasing amount of information on complementaryand alternative medicine is becoming available. Whereappropriate, the child and the child’s carers should beasked about the use of their medicines, including dietarysupplements and topical products. The scope of BNFfor Children is restricted to the discussion of conven-tional medicines but reference is made to complemen-tary treatments if they affect conventional therapy (e.g.interactions with St John’s wort—see Appendix 1).Further information on herbal medicines is available atwww.mhra.gov.uk.

BNF for Children and marketing authorisationWhere appropriate the doses, indications, cautions,

contra-indications, and side-effects in BNF for Childrenreflect those in the manufacturers’ Summaries of Pro-duct Characteristics (SPCs) which, in turn, reflect thosein the corresponding marketing authorisations (formerl