British Medical Association Royal Pharmaceutical Society of Great Britain

Appendix 8: Wound management products

The BNF welcomes comments from healthcare pro-

883 fessionals. Comments and constructive criticism

and elastic hosiery

Appendix 9: Cautionary and advisory labels

should be sent to:

902 British National Formulary,

for dispensed medicines

Dental Practitioners’ Formulary 917 Royal Pharmaceutical Society of Great Britain,

Nurse Prescribers’ Formulary 919

1 Lambeth High Street, London SE1 7JN. Non- medical prescribing 923 Email: editor@bnf.org

Index of manufacturers 924

Index

BNF 57 T. Hamp, J. Humphries,

J.M. James, Acknowledgements L.K. Kearney,

E. Laughton, A. McLaughlin, A. Melen, H.M.N. Neill,

C. Norton, A. Ohene-Djan, O. Ojeleye, A. Parkin, R. Soor- The Joint Formulary Committee is grateful to indivi-

iakumaran, R.G. Taljaard, and E.J. Tong provided con- duals and organisations that have provided advice and

siderable assistance during the production of this edition information to the BNF.

of the BNF.

The principal contributors for this edition were: Xpage have provided technical assistance with the

I.H. Ahmed-Jushuf, K.W. Ah-See, S.P. Allison, M.N. Bad- editorial database and typesetting software. minton,

T.P. Baglin, P.R.J. Barnes,

D.N. Bateman,

S.L. Bloom, D. Bowsher, E.M. Brown, R.J. Buckley, Owen Lyndon Wade D.J. Burn, I.F. Burgess,

J.J. Coleman, R. Dinwiddie, The BNF would like to acknowledge the valued P.N. Durrington, D.A.C. Elliman, M.D. Feher, B.G. Gaz-

contribution of Professor Owen Lyndon Wade, the zard,

first Chair of the JFC and founding father of the P.J. Goadsby, J. Guillebaud, B.G. Higgins, S.H.D. Jackson,

A.M. Geretti,

N.J.L. Gittoes, A.H. Ghodse,

modern British National Formulary, who died on

December 10 2008. T.H. Lee, D.N.J. Lockwood, M.G. Lucas, L. Luzzatto,

A. Jones, J.R. Kirwan, P.G. Kopelman,

A.J. Krentz,

A. MacDonald, A.G. Marson, P.D. Mason, K.E.L. McColl, G.M. Mead, E. Miller, J.M. Neuberger, D.J. Nutt, L.P. Or- merod, W.J. Penny, P.A. Poole-Wilson,

A.B. Provan,

M.M. Ramsay, D.J. Rowbotham, P.C. Rubin, J.W. Sander, J.A.T. Sandoe,

G.J. Shortland,

S.C.E. Sporton,

J.P. Thompson, J.A. Vale,

D.G. Waller,

D.A. Warrell,

R.P. Walt, N.J.A. Webb, A.D. Weeks, A. Wilcock, C.E. Wil- loughby, M.M Yaqoob.

Expert advice on the management of oral and dental conditions

was kindly provided

by

M. Addy,

P. Coulthard, A. Crighton, M.A.O. Lewis, J.G. Meechan, N.D. Robb, R.A. Seymour, R. Welbury, and J.M. Zakr- zewska. S. Kaur provided valuable advice on dental prescribing policy.

Members of the British Association of Dermatologists Therapy Guidelines Subcommittee, H.K. Bell, L.C. Ful- ler, J. Hughes, S. Lawton, J. Lear, N.J. Levell, A.J. McDo- nagh, M.J. Tidman, P.D. Yesudian, and M.F.M. Mustapa (Secretariat) have provided valuable advice.

Members of the Advisory Committee on Malaria Pre- vention, B.A. Bannister, R.H. Behrens, P.L. Chiodini,

F. Genasi, L. Goodyer, D. Hill, R. Jecock, G. Kassianos,

D.G. Lalloo, G. Lea, G. Pasvol, M. Powell, D.V. Shingadia,

D.A. Warrell, C.J.M. Whitty, and C. Lucas (Secretariat) have also provided valuable advice.

The Joint British Societies’ Coronary Risk Prediction Charts have been reproduced with the kind permission of P.N. Durrington who has also provided the BNF with access to the computer program for assessing coronary and stroke risk.

R. Suvarna and colleagues at the MHRA have provided valuable assistance.

Correspondents in the pharmaceutical industry have provided information on new products and commented on products in the BNF. The Prescription Pricing Divi- sion has supplied the prices of products in the BNF.

Numerous doctors, pharmacists, nurses and others have sent comments and suggestions.

The BNF has valuable access to the Martindale data banks by courtesy of S. Sweetman and staff.

J.E. Macintyre and staff provided valuable technical assistance.

C. Adetola, K. Ayorinde, N. Bansal,

A. Breewood,

L.M. Britton, I.M. Chiwele, M. Davis,

C. Fischetti,

R. Fisher, S. Foad,

D.T.H. Griffiths, E.H. Glover,

Editorial Staff

Managing Editor: Knowledge Creation John Martin BPharm, PhD, MRPharmS

Assistant Editors Leigh Anne Claase BSc, PhD, MRPharmS Bryony Jordan BSc, DipPharmPract, MRPharmS Colin R. Macfarlane BPharm, MSc, MRPharmS Allison F. Patterson BPharm, MRPharmS Rachel S. M. Ryan BPharm, MRPharmS Shama M. S. Wagle BPharm, DipPharmPract, MRPharmS

Staff Editors Onatefe Akporobaro-Iwudibia MPharm, MRPharmS Sejal Amin BPharm, MSc, MRPharmS

Susan E. Clarke BPharm, DipClinPharm, MRPharmS Julia A. Dickin MPharm, MRPharmS Manjula Halai BScChem, MPharm, MRPharmS Emma E. Harris MPharm, DipPharmPract, MRPharmS Amy E. Harvey MPharm, PGDipCommPharm,

MRPharmS Bele´n Granell Villen BSc, PGDipClinPharm, MRPharmS Paul S. Maycock MPharm, DipPharmPract, MRPharmS Elizabeth Nix DipPharm(NZ), MRPharmS Claire L. Preston BPharm, MRPharmS Shaistah J. Qureshi MPharm, MRPharmS Vinaya K. Sharma BPharm, MSc, PGDipPIM, MRPharmS

Editorial Assistant Jennifer L. Palmer

Senior BNF Administrator Heidi Homar BA

Administrative Assistant Cristina Lopez-Bueno BA

Managing Editor: Digital Development and Delivery Cornelia Schnelle MPhil

Knowledge Systems Robert C. Buckingham BSc Digital Development Assistant Philip D. Lee BSc, PhD Digital Development Editor

Sarah Peck BSc Terminologist

Head of Publishing Services John Wilson

BNF Publishing Director Duncan S. T. Enright MA, PGCE, MInstP, FIDM

Managing Director, RPS Publishing Charles Fry

Joint Formulary Committee 2008–2009

Chairman Derek G. Waller BSc, MB, BS, DM, FRCP (from January 2009) Martin J. Kendall OBE, MD, FRCP, FFPM (until December 2008)

Deputy Chairman Alison Blenkinsopp PhD, BPharm, FRPharmS

Committee Members Jeffrey K. Aronson MA, MB ChB, DPhil, FRCP, FBPharmacolS, FFPM

Anthony J. Avery BMedSci, MB ChB, DM, FRCGP Tawfique K. Daneshmend MB ChB, MD, FRCP Beth Hird BPharm, MSc, MRPharmS, SP, IP W. Moira Kinnear BSc, MSc, MRPharmS Gul Root BSc(Pharm), MRPharmS, DMS

Rafe Suvarna MBBS, BSc, FFPM, DAvMed, DipIMC Carwen Wynne Howells BPharm, FRPharmS

Executive Secretary Heidi Homar

BA

BNF 57

Dental Advisory Group 2008–2009

Chairman David Wray MD, BDS, MB ChB, FDSRCPS, FDSRCS Ed, F MedSci

Committee Members Christine Arnold BDS, DDPHRCS, MCDH Simon J. Carruthers LDSRCS, BDS, MFGDP(UK) (until October 2008) Barry Cockcroft BDS, FDSRCS (Eng) Duncan S.T. Enright MA, PGCE, MInstP, FIDM

Amy E. Harvey MPharm, PGDipCommPharm, MRPharmS Martin J. Kendall OBE, MD, FRCP, FFPM

Lesley P. Longman BSc, BDS, FDSRCS Ed, PhD John Martin BPharm, PhD, MRPharmS Michelle Moffat BDS, MFDS RCS Ed, M Paed Dent RCPS, FDS (Paed Dent) RCS Ed Richard J. Oliver BDS, BSc, PhD, FDSRCPS, FDS (OS) RCPS Rachel S.M. Ryan BPharm, MRPharmS

Secretary Richard Clifford BA, MA

Executive Secretary Heidi Homar

BA Advice on dental practice

The British Dental Association has contributed to the advice on medicines for dental practice through its representatives on the Dental Advisory Group.

Nurses Prescribers’ Advisory Group 2008–2009

Chairman Nicky A. Cullum PhD, RGN Committee Members Una J. Adderley MSc, BA, RGN, DN Michele L. Cossey BPharm, MSc, MRPharmS Molly Courtenay PhD, MSc, Cert Ed, BSc, RGN Duncan S.T. Enright MA, PGCE, MInstP, FIDM

Margaret F. Helliwell MB, BS, BSc, MFPHM, FRCP (Edin) Bryony Jordan BSc, DipPharmPract, MRPharmS

Martin J. Kendall OBE, MD, FRCP, FFPM Fiona Lynch BSc, MSc, RGN, RSCN John Martin BPharm, PhD, MRPharmS Paul S. Maycock MPharm, DipPharmPract, MRPharmS Maureen P. Morgan RN, RHV, MBA

Elizabeth J. Plastow RMN, RGN, RSCPHN(HV), MSc, PGDipEd Paul G.H. Robinson

Gul Root BSc, MRPharmS, DMS Jill M. Shearer BSc, RGN, RM Rabina Tindale RGN, RSCN, BSc, DipAEN, PGCE Vicky Vidler MA, RGN, RSCN Executive Secretary Heidi Homar

BA

vi

BNF 57

BNF 57

vii

How the BNF is checking draft amendments for appropriate inter-

pretation of any new evidence;

constructed

providing expert opinion in areas of controversy or when reliable evidence is lacking;

The BNF is unique in bringing together authoritative,

advising on areas where the BNF diverges from independent guidance on best practice with clinically

summaries of product characteristics; validated drug information, enabling healthcare profes-

providing independent advice on drug interactions, sionals to select safe and effective medicines for indivi-

prescribing in hepatic impairment, renal impair- dual patients.

ment, pregnancy, breast-feeding, children, the Information in the BNF has been validated against

elderly, palliative care, and the emergency treat- ment of poisoning.

emerging evidence, best-practice guidelines, and advice from a network of clinical experts.

In addition to consulting with regular advisers, the BNF calls on other clinical specialists for specific develop-

Hundreds of changes are made between editions, and ments when particular expertise is required. the most clinically significant changes are listed at the

The BNF also works closely with a number of expert front of each edition (pp. xi–xii).

bodies that produce clinical guidelines. Drafts or pre- publication copies of guidelines are routinely received for comment and for assimilation into the BNF.

Joint Formulary Committee

The Joint Formulary Committee (JFC) is responsible for the content of the BNF. The JFC includes doctors appointed by the BMJ Publishing Group, pharmacists

Sources of BNF information

appointed by the Royal Pharmaceutical Society of Great Britain, and representatives from the Medicines and

The BNF uses a variety of sources for its information; Healthcare products Regulatory Agency (MHRA) and

the main ones are shown below. the UK health departments. The JFC decides on matters

of policy and reviews amendments to the BNF in the Summaries of product characteristics The BNF light of new evidence and expert advice. The Commit-

receives summaries of product characteristics (SPCs) of tee meets quarterly and each member also receives

all new products as well as revised SPCs for existing proofs of all BNF chapters for review before publication.

products. The SPCs are the principal source of product information and are carefully processed, despite the ever-increasing volume of information being issued by the pharmaceutical industry. Such processing involves:

Editorial team

verifying the approved names of all relevant ingre- BNF staff editors are pharmacists with a sound under-

dients including ‘non-active’ ingredients (the BNF is standing of how drugs are used in clinical practice. Each

committed to using approved names and descrip- staff editor is responsible for editing, maintaining, and

tions as laid down by the Medicines Act); updating specific chapters of the BNF. During the pub-

comparing the indications, cautions, contra-indica- lication cycle the staff editors review information in the

tions, and side-effects with similar existing drugs. BNF against a variety of sources (see below).

Where these are different from the expected pat- Amendments to the text are drafted when the editors

tern, justification is sought for their inclusion or are satisfied that any new information is reliable and

exclusion;

relevant. The draft amendments are passed to expert

seeking independent data on the use of drugs in advisers for comment and then presented to the Joint

pregnancy and breast-feeding; Formulary Committee for consideration. Additionally, for each edition, sections are chosen from every chapter

incorporating the information into the BNF using for thorough review. These planned reviews aim to

established criteria for the presentation and inclu- verify all the information in the selected sections and

sion of the data; to draft any amendments to reflect the current best

checking interpretation of the information by two practice.

staff editors before submitting to a senior editor; changes relating to doses receive an extra check;

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

identifying potential clinical problems or omissions stages of the production.

and seeking further information from manufacturers or from expert advisers;

careful validation of any areas of divergence of the

Expert advisers BNF from the SPC before discussion by the Com-

mittee (in the light of supporting evidence); The BNF uses about 60 expert clinical advisers (includ-

constructing, with the help of expert advisers, a ing doctors, pharmacists, nurses, and dentists) through-

comment on the role of the drug in the context of out the UK to help with the production of each edition.

similar drugs.

The role of these expert advisers is to review existing Much of this processing is applicable to the following text and to comment on amendments drafted by the

sources as well.

staff editors. These clinical experts help to ensure that the BNF remains reliable by:

Expert advisers The role of expert clinical advisers in .

commenting on the relevance of the text in the providing the appropriate clinical context for all BNF context of best clinical practice in the UK;

information is discussed above.

viii

BNF 57 Literature Staff editors monitor core medical and Pricing information The Prescription Pricing Divi-

pharmaceutical journals. Research papers and reviews sion provides information on prices of medicinal pro- relating to drug therapy are carefully processed. When a

ducts and appliances in the BNF. The BNF also receives difference between the advice in the BNF and the paper

and processes price lists from product suppliers. is noted, the new information is assessed for reliability and relevance to UK clinical practice. If necessary, new

Comments from readers Readers of the BNF are text is drafted and discussed with expert advisers and

invited to send in comments. Numerous letters and the Joint Formulary Committee. The BNF enjoys a close

emails are received during the preparation of each working relationship with a number of national informa-

edition. Such feedback helps to ensure that the BNF tion providers.

provides practical and clinically relevant information. Many changes in the presentation and scope of the BNF

Systematic reviews The BNF has access to various have resulted from comments sent in by users. databases of systematic reviews (including the Cochrane Library and various web-based resources).

Comments from industry Each manufacturer is These are used for answering specific queries, for

provided with a complimentary copy of the BNF and reviewing existing text and for constructing new text.

invited to comment on it. Close scrutiny of the BNF by Staff editors receive training in critical appraisal, litera-

the manufacturers provides an additional check and ture evaluation, and search strategies. Reviews pub-

allows them an opportunity to raise issues about the lished in Clinical Evidence are used to validate BNF

BNF’s presentation of the role of various drugs; this is advice.

yet another check on the balance of the BNF’s advice. All comments are looked at with care and, where necessary, additional information and expert advice

Consensus guidelines The advice in the BNF is are sought. checked against consensus guidelines produced by expert bodies. A number of bodies make drafts or pre-

Virtual user groups The BNF has set up virtual user publication copies of the guidelines available to the

groups across various healthcare professions (e.g. doc- BNF; it is therefore possible to ensure that a consistent

tors, pharmacists, nurses, dentists). The aim of these message is disseminated. The BNF routinely processes

groups will be to provide feedback to the editors and guidelines from the National Institute for Health and

publishers to ensure that BNF publications continue to Clinical Excellence (NICE), the Scottish Medicines Con-

serve the needs of its users. sortium (SMC), and the Scottish Intercollegiate Guide- lines Network (SIGN).

Market research Market research is conducted at regular intervals to gather feedback on specific areas of

Reference sources development, such as drug interactions or changes to

Textbooks and reference sources the way information is presented in digital formats. are used to provide background information for the

review of existing text or for the construction of new The BNF is an independent professional publication text. The BNF team works closely with the editorial

that is kept up-to-date and addresses the day-to-day team that produces Martindale: The Complete Drug Refer-

prescribing information needs of healthcare profes- ence . The BNF has access to Martindale information

sionals. Use of this resource throughout the health resources and each team keeps the other informed of significant developments and shifts in the trends of drug

service helps to ensure that medicines are used usage.

safely, effectively, and appropriately.

Statutory information The BNF routinely processes relevant information from various Government bodies including Statutory Instruments and regulations affect- ing the Prescription only Medicines Order. Official com- pendia such as the British Pharmacopoeia and its addenda are processed routinely to ensure that the BNF complies with the relevant sections of the Medi- cines Act. The BNF itself is named as an official com- pendium in the Medicines Act.

The BNF maintains close links with the Home Office (in relation 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 Human Medicines (CHM) and guidelines on drug use issued by the UK health departments are processed as a matter of routine.

Relevant professional statements issued by the Royal Pharmaceutical Society of Great Britain are included in the BNF as are guidelines from bodies such as the Royal College of General Practitioners.

The BNF reflects information from the Drug Tariff, the Scottish Drug Tariff, and the Northern Ireland Drug Tariff.

BNF 57

ix

How to use the BNF

Notes on conditions, drugs and

preparations. Preparations which can be prescribed by

preparations

dental surgeons using NHS form FP10D (GP14 in Scot- The main text consists of classified notes on clinical

land, WP10D in Wales) are identified within the BNF by conditions, drugs and preparations. These notes are

means of a note headed Dental Prescribing on NHS. divided into 15 chapters, each of which is related to a

particular system of the body or to an aspect of medical For information available since publication of this care. Each chapter is then divided into sections which

edition see bnf.org begin with appropriate notes for prescribers. These notes

are intended to provide information to doctors, dental surgeons, pharmacists, nurses, and other healthcare professionals to facilitate the selection of suitable treat-

Guidance on prescribing

ment. Guidance on dental and oral conditions is identi- This part includes information on prescription writing, fied by means of a relevant heading (e.g. Dental and

controlled drugs and dependence, prescribing for chil- Orofacial pain) in the appropriate sections of the BNF.

dren and the elderly, and prescribing in palliative care. The notes are followed by details of relevant drugs and

Advice is given on the reporting of adverse reactions. The BNF also includes advice on medical emergencies

DRUG NAME U

Drugs

Indications details of uses and indications Drugs appear under pharmacopoeial or other non- Cautions details of precautions required (with

proprietary titles. When there is an appropriate cur- cross-references to appropriate Appendixes) and

rent monograph (Medicines Act 1968, Section 65) also any monitoring required

preference is given to a name at the head of that Counselling Verbal explanation to the patient of specific

monograph; otherwise a British Approved Name details of the drug treatment (e.g. posture when taking a

(BAN), if available, is used (see also Name changes). medicine)

Contra-indications details of any contra-indica- U is used to denote those preparations

The symbol

that are considered by the Joint Formulary Commit- tions to use of drug

tee to be less suitable for prescribing. Although such Side-effects details of common and more serious

preparations may not be considered as drugs of first side-effects

choice, their use may be justifiable in certain circum- Dose

stances.

. Dose and frequency of administration (max. dose); CHILD and ELDERLY details of dose for specific age group

Prescription-only medicines A . By alternative route , dose and frequency

This symbol has been placed against those prepara- *Approved Name (Non-proprietary)

A tions that are available only on a prescription issued Pharmaceutical form , colour, coating, active

by an appropriate practitioner. For more detailed ingredient and amount in dosage form, net price,

information see Medicines, Ethics and Practice, No. pack size = basic NHS price. Label: (as in Appendix

32, London, Pharmaceutical Press, 2008 (and sub- 9)

sequent editions as available).

Proprietary Name The symbol

C indicates that the preparation is AD subject to the prescription requirements of the Mis- Pharmaceutical form , sugar-free, active ingredient mg/mL, net price, pack size = basic NHS price.

(Manufacturer)

use of Drugs Act. For regulations governing prescrip- Label: (as in Appendix 9)

tions for such preparations see p. 7.

Excipients include clinically important excipients or electrolytes *exceptions to the prescribing status are indicated by a note or

footnote.

Preparations not available for NHS

Note Specific notes about the product e.g. handling

prescription D This symbol has been placed against those prepara-

Preparations

tions included in the BNF that are not prescribable Preparations usually follow immediately after the

under the NHS. Those prescribable only for specific drug which is their main ingredient.

disorders have a footnote specifying the condition(s) Preparations are included under a non-proprietary

for which the preparation remains available. Some title, if they are marketed under such a title, if they

preparations which are not prescribable by brand are not otherwise prescribable under the NHS, or if

name under the NHS may nevertheless be dispensed they may be prepared extemporaneously.

using the brand name providing that the prescription shows an appropriate non-proprietary name.

If proprietary preparations are of a distinctive colour this is stated.

In the case of compound preparations the indica-

Prices

tions, cautions, contra-indications, side-effects, and Prices have been calculated from the basic cost used interactions of all constituents should be taken into

in pricing NHS prescriptions dispensed in November account for prescribing.

2008, see also Prices in the BNF p. x for details.

and other medical problems in dental practice, together with a review of the oral side-effects of drugs.

An index of conditions relevant to dental surgeons is included.

Emergency treatment of poisoning

This chapter provides information on the management of acute poisoning when first seen in the home, although aspects of hospital-based treatment are mentioned.

Appendixes and indexes

The appendixes include information on interactions, liver disease, renal impairment, pregnancy, breast-feed- ing, intravenous additives, borderline substances, wound management products, and cautionary and advi- sory labels for dispensed medicines. They are designed for use in association with the main body of the text.

The Dental Practitioners’ List and the Nurse Prescribers’ List are also included in this section. The indexes consist of the Index of Manufacturers and the Main Index.

Patient packs

Directive 92/27/EEC specifies the requirements for the labelling of medicines and outlines the format and content of patient information leaflets to be supplied with every medicine; the directive also requires the use of Recommended International Non-proprietary Names for drugs (see p. xiii).

All medicines have approved labelling and patient infor- mation leaflets; anyone who supplies a medicine is responsible for providing the relevant information to the patient (see also Appendix 9).

Many medicines are available in manufacturers’ original packs complete with patient information leaflets. Where patient packs are available, the BNF shows the number of dose units in the packs. In particular clinical circum- stances, where patient packs need to be split or medi- cines are provided in bulk dispensing packs, manufac- turers will provide additional supplies of patient information leaflets on request.

During the revision of each edition of the BNF careful note is taken of the information that appears on the patient information leaflets. Where it is considered appropriate to alert a prescriber to some specific limita- tion appearing on the patient information leaflet (for example, in relation to pregnancy) this advice now appears in the BNF.

The patient information leaflet also includes details of all inactive ingredients in the medicine. A list of com- mon E numbers and the inactive ingredients to which they correspond is now therefore included in the BNF (see inside back cover).

PACT and SPA

PACT (Prescribing Analyses and Cost) and SPA (Scottish Prescribing Analysis) provide prescribers with informa- tion about their prescribing.

The PACT Standard Report, or in Scotland SPA Level 1 Report , is sent to all general practitioners on a quarterly basis. The PACT Standard Report contains an analysis of the practitioner’s prescribing and the practice pre-

scribing over the last 3 months, and gives comparisons with the local Primary Care Trust equivalent practice and with a national equivalent. The report also contains details of the practice prescribing for a specific topic; a different topic is chosen each quarter.

The PACT Catalogue, or in Scotland SPA Level 2 Report, provides a full inventory of the prescriptions issued by a prescriber. The PACT catalogue is available on request for periods between 1 and 24 months. To allow the prescriber to target specific areas of prescribing, a Catalogue may be requested to cover individual pre- parations, BNF sections, or combinations of BNF chap- ters.

PACT is also available electronically ( ePACT.net ). This system gives users on-line access through NHSnet to the 3 years’ prescribing data held on the Prescription Pricing Division’s database; tools for analysing the data are also provided.

Prices in the BNF

Basic net prices are given in the BNF to provide an indication of relative cost. Where there is a choice of suitable preparations for a particular disease or condi- tion the relative cost may be used in making a selection. Cost-effective prescribing must, however, take into account other factors (such as dose frequency and duration of treatment) that affect the total cost. The use of more expensive drugs is justified if it will result in better treatment of the patient or a reduction of the length of an illness or the time spent in hospital.

Prices have generally been calculated from the net cost used in pricing NHS prescriptions dispensed in Novem- ber 2008. Unless an original pack is available these prices are based on the largest pack size of the prepara- tion in use in community pharmacies. The price for an extemporaneously prepared preparation has been omitted where the net cost of the ingredients used to make it would give a misleadingly low impression of the final price. In Appendix 8 prices stated are per dressing or bandage.

The unit of 20 is still sometimes used as a basis for comparison, but where suitable original packs or patient packs are available these are priced instead.

Gross prices vary as follows:

1. Costs to the NHS are greater than the net prices quoted and include professional fees and overhead allowances;

2. Private prescription charges are calculated on a separate basis;

3. Over-the-counter sales are at retail price, as opposed to basic net price, and include VAT.

BNF prices are NOT, therefore, suitable for quot- ing to patients seeking private prescriptions or contemplating over-the-counter purchases.

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

BNF 57

Changes for this edition

Significant changes

The BNF is revised twice yearly and numerous changes are made between issues. All copies of BNF No. 56 (September 2008) should therefore be withdrawn and replaced by BNF No. 57 (March 200 ). Significant changes have been made in the following sections for BNF No. 57:

Salicylate poisoning [updated advice], Emergency treat- ment of poisoning

Heavy metal poisoning [updated advice], Emergency treatment of poisoning

Fistulating Crohn’s disease, section 1.5 Irritable bowel syndrome, section 1.5 Aminosalicylates [monitoring of renal function], section

1.5 Cardiovascular risk charts [change to estimated risk for

nondiabetic men aged 50–59 years who are non-smo- kers], inside back cover

Chronic obstructive pulmonary disease [oxygen alert card], section 3.1 Oxygen [new text], section 3.6

Antipsychotic drugs [prescribing for elderly], section

4.2.1 Clostridium difficile infection, section 5.1, Table 1 Throat infections, sinusitis, otitis media, section 5.1,

Table 1 Tendon damage with quinolones [updated advice], sec- tion 5.1.12 HIV infection [updated advice], section 5.3.1 Entecavir and telbivudine for chronic hepatitis B [NICE guidance], section 5.3.3 Prophylaxis of influenza [NICE guidance], section 5.3.4 Continuous subcutaneous insulin infusion [NICE gui- dance], section 6.1.1 Use of oral hypoglycaemic drugs for type 2 diabetes during pregnancy and breast-feeding, section 6.1.2 Use of metformin in renal impairment and risk of lactic acidosis, section 6.1.2.2 Primary prevention of osteoporotic fractures in post- menopausal women [NICE guidance], section 6.6 Secondary prevention of osteoporotic fractures in post- menopausal women [NICE guidance updated], section

6.6 Reasons to stop combined hormonal contraceptives

immediately [amendment to blood pressure bullet point], section 7.3.1 Risk factors for venous thromboembolism [addition of age and smoking as risk factors], section 7.3.1

Risk factors for arterial disease [amendment to blood pressure bullet point], section 7.3.1

Tacrolimus [MHRA/CHM advice], section 8.2.2 Management of hyperkalaemia [updated advice], sec-

tion 9.2.1.1 Management of severe acute hypocalcaemia [updated advice], section 9.5.1 Management of osteoarthritis, section 10.1 Adalimumab, etanercept, and infliximab for the treat- ment of ankylosing spondylitis [NICE guidance], section

10.1.3

Abatacept for the treatment of rheumatoid arthritis [NICE guidance], section 10.1.3

Glucosamine [less suitable for prescribing], section

10.1.5 Ranibizumab and pegaptanib for the treatment of wet

age-related macular degeneration [NICE guidance], sec- tion 11.8.2 Acitretin [duration of contraception after stopping treat- ment], section 13.5.2

Active immunity [reorganised and updated], section

14.1 Immunisation schedule [table], section 14.1 Vaccines and antisera [reformatted and updated], sec-

tion 14.4 Anti-D (Rh ) immunoglobulin [NICE guidance], section

14.5 Risk of neurological and haematological toxic effects

with nitrous oxide, section 15.1.2 Advice on reducing the risk of overdose with mid-

azolam, section 15.1.4.1 Adjustment of drug dosages in renal impairment

[updated advice], appendix 3

Dose changes

Changes in dose statements introduced into BNF No. 57:

Aciclovir [herpes simplex, prevention of recurrence], p. 344 Adenosine, p. 81

Betaine, p. 549 Bromocriptine, p. 265 Buprenorphine [opioid dependence], p. 279 Cabergoline, p. 265 Chloroquine [treatment of benign malaria], p. 354 and

[prophylaxis of malaria], p. 357 Doxycycline [syphilis], p. 304

EMLA c , p. 704 Etanercept [plaque psoriasis], p. 637 Fentanyl injection, p. 696

Flixotide c Accuhaler , p. 166 Flixotide c Diskhaler , p. 166 Flixotide c Evohaler , p. 166

Lisinopril [renal complications of diabetes mellitus], p. 103

Memantine, p. 282 Methotrexate [psoriasis], p. 636 Midazolam [premedication by intravenous injection and

dose for induction of anaesthesia], p. 694 Naloxone hydrochloride [overdosage with opioids],

p. 31 Omeprazole [severe peptic ulcer bleeding], p. 49 Pergolide, p. 265 Phosphate infusion, p. 535 Prednisolone [inflammatory bowel disease], p. 57 Propofol [maintenance of anaesthesia], p. 689 Rufinamide, p. 256 Trimethoprim, p. 316

BNF 57

xi

xii

BNF 57

Classification changes New preparations included in this

Classification changes have been made in the following

edition

sections for BNF No. 57: Preparations included in the relevant sections of BNF Section 1.5.1 Aminosalicylates [new sub-section]

No. 57:

Section 1.5.2 Corticosteroids [new sub-section] Bolamyn c SR , p. 378 Section 1.5.3 Drugs affecting the immune response

Bridion c , p. 701

[new sub-section] Bumetanide oral solution, p. 76 Section 1.5.4 Food allergy [new sub-section]

Clasteon c , p. 420

Section 1.6.6 Peripheral opioid-receptor antagonist

Clinitas c , p. 596

[new sub-section]

Doribax c , p. 301

Section 3.4.3 Allergic emergencies [section re-orga- Ethibide XL c , p. 75 nised]

Ferinject c , p. 507

Section 5.1.2 Cephalosporins, carbapenems, and other Ferriprox c oral solution, p. 514 beta-lactams [title change]

Firazyr c , p. 176

Section 5.1.2.1 Cephalosporins [new sub-section] Flexbumin c , p. 524 Section 5.1.2.2 Carbapenems [new sub-section]

Hycamtin c capsules, p. 484 Section 5.1.2.3 Other beta-lactam antibiotics [new sub-

Intal c aerosol inhalation, p. 168 section]

Intelence c , p. 342

Section 6.1.6 Oral glucose tolerance test [sub-section title change]

Isoplex c , p. 525

MucoClear c , p. 179

Mycamine c Discontinued preparations , p. 332

Nutriflex c basal, p. 528 Preparations discontinued during the compilation of

Nutriflex BNF No. 57: c peri, p. 528 Aerobec c preparations

Nutriflex c plus, p. 528 Agenerase c Nutriflex c Ocusan special, p. 528 c , p. 596 Amprenavir

Optichamber c , p. 160 Benzatropine

Optive c , p. 595 Oxyal c , p. 596

Clinoril c

Daclizumab

c Personal Best c Dynepo , p. 159

c Ratiograstim c Efcortelan , p. 517 Relistor c , p. 66 Epoetin delta

Retacrit c , p. 512

Fletchers’ c enemas

Rosiced c , p. 649

Graneodin c Seroquel c XL , p. 201 Gyno-Daktarin c pessaries

Tetraspan c , p. 526

Idrolax c Thalidomide Pharmion c , p. 495 Intal c spincaps

Thymoglobuline c , p. 488

Kloref c Toctino c , p. 630 Locoid C c Torisel c , p. 483 Tyverb Navoban c c , p. 482

Nifopress c Retard

Vimpat c , p. 253

Nisoldipine

Vismed c , p. 596

c Nystan c cream and ointment Vismed Multi , p. 596 Procainamide

Volibris c , p. 94 Xamiol c , p. 632

c Xarelto c Senokot , p. 131 granules

Pulmicort c LS aerosol inhaler

Yaz c , p. 442

Syscor MR c

Tri-Adcortyl c cream and ointment Tropisetron

Volmax c Late additions

Zenapax c Siklos c (Nordic) TA Tablets , f/c, hydroxycarbamide 1 g, net price 30-tab pack = £500.00 BNF section 9.1.3. For prophylaxis of recurrent painful vaso- occlusive crises including acute chest syndrome in patients with sickle-cell disease

BNF 57

xiii

Name changes

New BAN national Non-proprietary Name (rINN) for medicinal

European Law requires use of the Recommended Inter-

Former BAN

etamsylate substances. In most cases the British Approved Name

ethamsylate

ethinylestradiol (BAN) and rINN were identical. Where the two differed,

ethinyloestradiol

etynodiol the BAN was modified to accord with the rINN.

ethynodiol

flumetasone The following list shows those substances for which the

flumethasone

flupentixol former BAN has been modified to accord with the rINN.

flupenthixol

fludroxycortide Former BANs have been retained as synonyms in the

flurandrenolone

furosemide BNF.

hexachlorophene Adrenaline and noradrenaline Adrenaline and hexamine hippurate

hexachlorophane

methenamine hippurate noradrenaline are the terms used in the titles of mono-

hydroxycarbamide graphs in the European Pharmacopoeia and are thus the

hydroxyurea

indometacin official names in the member states. For these sub-

indomethacin

lidocaine stances, BP 2008 shows the European Pharmacopoeia

lignocaine

methotrimeprazine levomepromazine names and the rINNs at the head of the monographs; the

mecysteine BNF has adopted a similar style.

methyl cysteine

methylene blue

methylthioninium chlor- ide

Former BAN New BAN

meticillin adrenaline

methicillin

mitoxantrone amethocaine

acenocoumarol aminacrine

see above

mitozantrone

see above amoxycillin

tetracaine

nicoumalone

estradiol amphetamine

estriol amylobarbitone sodium

amoxicillin

oestriol

estrone beclomethasone

amfetamine

pentoxifylline bendrofluazide

amobarbital sodium

oestrone

phenobarbital benzhexol

pipotiazine benzphetamine

trihexyphenidyl

pipothiazine

polihexanide busulphan

pramocaine butobarbitone

butobarbital procaine penicillin procaine benzylpenicil- carticaine

articaine lin cephalexin

protionamide cephradine

secobarbital chloral betaine

cefalexin

prothionamide

riboflavin chlorbutol

cefradine

quinalbarbitone

cloral betaine

riboflavine

calcitonin (salmon) chlormethiazole

chlorobutanol

salcatonin

clomethiazole sodium calciumedetate sodium calcium edetate chlorpheniramine

chlorphenamine sodium cromoglycate sodium cromoglicate chlorthalidone

chlortalidone sodium ironedetate sodium feredetate cholecalciferol

colecalciferol sodium picosulphate sodium picosulfate cholestyramine

colestyramine sorbitan monostearate sorbitan stearate clomiphene

sodium stibocaptate colistin sulphomethate

stibocaptate

diethylstilbestrol sodium

clomifene

colistimethate sodium

stilboestrol

sulfacetamide corticotrophin

sulphacetamide

sulfadiazine cyclosporin

ciclosporin sulphamethoxazole sulfamethoxazole cysteamine

corticotropin

sulphadiazine

sulfapyridine danthron

mercaptamine

sulphapyridine

sulfasalazine dexamphetamine

sulfathiazole dibromopropamidine

dantron

sulphasalazine

sulfinpyrazone dicyclomine

tetracosactide dienoestrol

tiabendazole dimethicone(s)

tioguanine dimethyl sulphoxide

dienestrol

thiabendazole

thiopental dothiepin

dimeticone

thioguanine

moxisylyte doxycycline hydrochlor-

dimethyl sulfoxide

levothyroxine sodium ide (hemihydrate hemi-

ribavirin ethanolate)

doxycycline hyclate

thyroxine sodium

tribavirin

alimemazine eformoterol

trimeprazine

formoterol

urofollitrophin

urofollitropin

BNF 57

Guidance on prescribing

General guidance

Medicines should be prescribed only when they are tically there should be no important differences between necessary, and in all cases the benefit of administering

the biosimilar and the biological reference medicine in the medicine should be considered in relation to the risk

terms of safety or efficacy, when prescribing biological involved. This is particularly important during

products, it is good practice to use the brand name. This pregnancy, when the risk to both mother and fetus

will ensure that substitution of a biosimilar medicine must be considered (for further details see Prescribing

does not occur when the medicine is dispensed. in Pregnancy, Appendix 4).

Biosimilar medicines have black triangle status ( T) at It is important to discuss treatment options carefully

the time of initial marketing. It is important to report with the patient to ensure that the patient is content to

suspected adverse reactions to biosimilar medicines take the medicine as prescribed (see also Taking Medi-

using the Yellow Card Scheme (p. 11). For biosimilar cines to Best Effect, below). In particular, the patient

medicines, adverse reaction reports should clearly state should be helped to distinguish the adverse effects of

the brand name of the suspected medicine. prescribed drugs from the effects of the medical disorder.

When the beneficial effects of the medicine are likely to Complementary and alternative medicine An

be delayed, the patient should be advised of this. increasing amount of information on complementary and alternative medicine is becoming available. The

Taking medicines to best effect Difficulties in scope of the BNF is restricted to the discussion of compliance with drug treatment occur regardless of

conventional medicines but reference is made to com- age. Factors contributing to poor compliance with pre-

plementary treatments if they affect conventional ther- apy (e.g. interactions with St John’s wort—see Appendix

General

scribed medicines include: .

prescription not collected or not dispensed; 1). Further information on herbal medicines is available .

purpose of medicine not clear;

at www.mhra.gov.uk .

guidanc

. perceived lack of efficacy;

Abbreviation of titles . In general, titles of drugs and

real or perceived side-effects; preparations should be written in full. Unofficial abbre- .

patients’ perception of the risk and severity of side-effects viations should not be used as they may be misinter- may differ from that of the prescriber;

preted.

. instructions for administration not clear; .

physical difficulty in taking medicines (e.g. with swallow- ing the medicine, with handling small tablets, or with

Non-proprietary titles Where non-proprietary (‘gen-

opening medicine containers); eric’) titles are given, they should be used in prescribing. .

unattractive formulation (e.g. unpleasant taste); This will enable any suitable product to be dispensed, .

complicated regimen. thereby saving delay to the patient and sometimes expense to the health service. The only exception is

The prescriber and the patient should agree on the where bioavailability problems are so important that the health outcomes that the patient desires and on the

patient should always receive the same brand; in such strategy for achieving them (‘concordance’). The pre-

cases, the brand name or the manufacturer should be scriber should be sensitive to religious, cultural, and

stated. Non-proprietary titles should not be invented for personal beliefs that can affect patients’ acceptance of

the purposes of prescribing generically since this can medicines.

lead to confusion, particularly in the case of compound Taking the time to explain to the patient (and relatives)

and modified-release preparations. the rationale and the potential adverse effects of treat-

Titles used as headings for monographs may be used ment may improve compliance. Reinforcement and

freely in the United Kingdom but in other countries may elaboration of the physician’s instructions by the phar-

be subject to restriction. macist also helps. Advising the patient of the possibility

of alternative treatments may encourage the patient to Many of the non-proprietary titles used in this book are seek advice rather than merely abandon unacceptable

titles of monographs in the European Pharmacopoeia, treatment.

British Pharmacopoeia, or British Pharmaceutical Codex 1973. In such cases the preparations must com-

Simplifying the drug regimen may help; the need for ply with the standard (if any) in the appropriate pub- frequent administration may reduce compliance,

lication, as required by the Medicines Act (Section 65). although there appears to be little difference in compli- ance between once-daily and twice-daily administra-

Proprietary titles Names followed by the symbol c tion. Combination products reduce the number of

are or have been used as proprietary names in the drugs taken but this may be at the expense of the ability

United Kingdom. These names may in general be to titrate individual doses.

applied only to products supplied by the owners of the trade marks.

Biosimilar medicines

A biosimilar medicine is a new biological product that is similar to a medicine that has

Marketing authorisation and BNF advice In gen- already been authorised to be marketed (the biological

eral the doses, indications, cautions, contra-indications, and reference medicine) in the European Union. The active

side-effects in the BNF reflect those in the manufacturers’ substance of a biosimilar medicine is similar, but not

data sheets or Summaries of Product Characteristics identical, to the biological reference medicine. Biologi-

(SPCs) which, in turn, reflect those in the corresponding cal products are different from standard chemical pro-

marketing authorisations (formerly known as Product ducts in terms of their complexity and although theore-

Licences). The BNF does not generally include proprie- Licences). The BNF does not generally include proprie-

Where an unlicensed drug is included in the BNF, this is indicated in square brackets after the entry. Where the BNF suggests a use (or route) that is outside the licensed indication of a product (‘off-label’ use), this too is indicated. Unlicensed use of medicines becomes neces- sary if the clinical need cannot be met by licensed medicines; such use should be supported by appropriate evidence and experience.

The doses stated in the BNF are intended for general guidance and represent, unless otherwise stated, the usual range of doses that are generally regarded as being suitable for adults.

Prescribing medicines outside the recommendations of their marketing authorisation alters (and probably increases) the prescriber’s professional responsibility and potential liability. The prescriber should be able to justify and feel competent in using such medi- cines.

Oral syringes An oral syringe is supplied when oral liquid medicines are prescribed in doses other than multiples of 5 mL. The oral syringe is marked in 0.5- mL divisions from 1 to 5 mL to measure doses of less than 5 mL (other sizes of oral syringe may also be available). It is provided with an adaptor and an instruc- tion leaflet. The 5-mL spoon is used for doses of 5 mL (or multiples thereof).

To avoid inadvertent intravenous administration of oral liquid medicines, only an appropriate oral or enteral syringe should be used to measure an oral liquid medicine (if a medicine spoon or graduated measure cannot be used); these syringes should not

be compatible with intravenous or other parenteral devices. Oral or enteral syringes should be clearly labelled ‘Oral’ or ‘Enteral’ in a large font size; it is the healthcare practitioner’s responsibility to label the syringe with this information if the manufacturer has not done so.

Strengths and quantities The strength or quantity to be contained in capsules, lozenges, tablets, etc. should be stated by the prescriber.

If a pharmacist receives an incomplete prescription for a systemically administered preparation and considers it would not be appropriate for the patient to return to the

doctor, the following procedures will apply 1 :

(a) an attempt must always be made to contact the prescriber to ascertain the intention; (b) if the attempt is successful the pharmacist must, where practicable, subsequently arrange for details of quantity, strength where applicable, and dosage to be inserted by the prescriber on the incomplete form;

(c) where, although the prescriber has been contacted, it has not proved possible to obtain the written intention regard- ing an incomplete prescription, the pharmacist may endorse the form ‘p.c.’ (prescriber contacted) and add details of the quantity and strength where applicable of the preparation supplied, and of the dose indicated. The endorsement should be initialled and dated by the phar- macist;

(d) where the prescriber cannot be contacted and the phar- macist has sufficient information to make a professional judgement the preparation may be dispensed. If the quan- tity is missing the pharmacist may supply sufficient to complete up to 5 days’ treatment; except that where a combination pack (i.e. a proprietary pack containing more than one medicinal product) or oral contraceptive is pre- scribed by name only, the smallest pack shall be dis- pensed. In all cases the prescription must be endorsed ‘p.n.c.’ (prescriber not contacted), the quantity, the dose, and the strength (where applicable) of the preparation supplied must be indicated, and the endorsement must

be initialled and dated; (e) if the pharmacist has any doubt about exercising discre-

tion, an incomplete prescription must be referred back to the prescriber.

Excipients Branded oral liquid preparations that do not contain fructose, glucose, or sucrose are described as ‘sugar-free’ in the BNF. Preparations containing hydro- genated glucose syrup, mannitol, maltitol, sorbitol, or xylitol are also marked ‘sugar-free’ since there is evi- dence that they do not cause dental caries. Patients receiving medicines containing cariogenic sugars should be advised of appropriate dental hygiene mea- sures to prevent caries. Sugar-free preparations should

be used whenever possible. Where information on the presence of aspartame, gluten,

sulphites , tartrazine, arachis (peanut) oil or sesame oil is available, this is indicated in the BNF against the rele- vant preparation.

Information is provided on selected excipients in skin preparations (section 13.1.3), in vaccines (section 14.1), and on selected preservatives and excipients in eye drops and injections. Pressurised metered aerosols con- taining chlorofluorocarbons (CFCs) have also been iden- tified throughout the BNF (see section 3.1.1.1).

The presence of benzyl alcohol and polyoxyl castor oil (polyethoxylated castor oil) in injections is indicated in the BNF. Benzyl alcohol has been associated with a fatal toxic syndrome in preterm neonates, and therefore, parenteral preparations containing the preservative should not be used in neonates. Polyoxyl castor oils, used as vehicles in intravenous injections, have been associated with severe anaphylactoid reactions.