How to use the BNF - NHS Education for Scotland
Transcription
How to use the BNF - NHS Education for Scotland
How to use the BNF A CPPE interactive PDF learning programme E n t er November 2015 2 Welcome to How to use the BNF Contents This programme contains the following sections: 3 How to use this learning programme Thank you for downloading this CPPE interactive learning programme. We hope that you will find it a fun and informative way to help you learn about this topic. 4 About How to use the BNF Learning with CPPE 5 Learning objectives 6 Key changes to the BNF The Centre for Pharmacy Postgraduate Education (CPPE) offers a wide range of learning opportunities in a variety of formats for pharmacy professionals from all sectors of practice. We are funded by Health Education England to offer continuing professional development for all pharmacists and pharmacy technicians providing NHS services in England. For further information about our learning portfolio, visit: www.cppe.ac.uk This document uses interactive features that are supported on most mobile devices. If you are using this programme on a PC or laptop, please ensure you are using an up-to-date version of Adobe Reader. Programme guardians CPPE has a quality assurance process called programme guardians. A programme guardian is a recognised expert in an area relevant to the content of a learning programme who reviews the programme every six to eight months. Following the regular programme guardian review we update this programme with any necessary corrections, additions, deletions or further supporting materials. We recommend that you check you have the most up-to-date version of this programme if you are using it more than six months after its initial publication date. © Copyright Controller HMSO 2015 10 Case studies – introduction 11 Case studies 32 Next steps 33 Programme credits Click on a title to go directly to that section. Back Next 3 How to use this learning programme This programme uses an interactive PDF (iPDF) format. You can navigate your way through by using the arrows in the bottom right corner of each page. Where directed, you can also navigate to sections by clicking on text or images. The programme uses case studies and web links to help you explore this topic. You will need to be connected to the internet to access the web links. You will be able to type, save and view answers to the case studies. You can save your answers by saving this document to your computer. We would recommend that you keep notes as you go along as these could be ideal to generate CPD records. A note about web links Where we think it will be helpful we have provided web links to take you directly to an article or specific part of a website. However, we are aware that web links can change. If you have difficulty accessing any web links we provide, please go to the organisation’s home page or your preferred internet search engine and use appropriate key words to search for the relevant item. All web links were accessed on 27 October 2015. Back Contents Next 4 About How to use the BNF In 2015 the BNF underwent a fundamental change in structure in order to create purpose-designed digital products. These digital products build on longstanding existing products and sit alongside the familiar print BNF publications. The redesign of all formats makes the highly valued content in the BNF publications much more accessible. In this learning programme you will explore the main changes in structure to the BNF website (MedicinesComplete), the new BNF app and the latest edition of the book. In the following pages we have listed the main changes to the BNF structure. We have also included case studies to provide you with the opportunity to find information in the new BNF, and we have provided answers to show you how to navigate around the BNF. Please note that at the time of writing this programme the new BNF website was in development, so although the images in the programme should be very similar to the new website, particularly in terms of navigation, there might be some changes to the look and feel of the publication. You will need about 90 minutes to complete this programme. Before you start, make sure you have access to BNF 70, the new online version or the new BNF app. You can access the BNF online through MedicinesComplete. If you are not already registered, you will need to do so. Click here to register. UK-based individuals working for or on behalf of the NHS can register for free and access the BNF and BNF for Children. Back Contents Next 5 Learning objectives You can use our programmes to support you in building the evidence that you need for the different competency frameworks that apply across your career. These will include building evidence for your Foundation pharmacy framework (FPF), demonstrating development as your career progresses with the Knowledge and skills framework (KSF) and supporting your progression through the membership stages of the Royal Pharmaceutical Society (RPS) Faculty. As you work through the programme consider which competencies you are meeting and the level at which you meet these. What extra steps could you take to extend your learning in these key areas? After completing this interactive PDF, you should be able to use the BNF to: n s elect an appropriate choice of treatment for the management of a condition, taking into account contraindications and cautions n determine the appropriate dose for a specific indication and patient group n find information about the unlicensed use of a drug n find information about a specific preparation and any relevant patient and carer advice n f ind pre-treatment screening information before starting a medicine and the appropriate monitoring requirements of a medicine for different indications n f ind information to make an appropriate choice of treatment for the management of a condition, taking into account allergy information and interactions between drugs. Back Contents Next 6 Key changes to the BNF nW hen BNF Publications decided to change the structure of their resources, they started out with the aim of consistency and simplicity. So one of the main changes is that all the information you need about a medicine is now under one monograph. Information for the systemic use of any given drug has been collated in one place; separate monographs remain for topical and local uses of the drug. nT he number of sections in a drug monograph has been increased, allowing you to more swiftly identify the information needed. n Indication and dose has been moved into one section, at the top of the monograph, with the dose now immediately following the stated indication. n Age ranges have been changed so wherever possible there is no overlap. nD rug class monographs have been created, which follow the same structure as drug monographs and allow a consistency in presentation. n Information has been reorganised so it is presented systematically; in print the information is organised by disease state, with the drug classes and drugs used in the management of that condition following alphabetically. Click on the headings below to find out more about changes specific to the online version, the new app and the BNF book. BNF online BNF app BNF book Back Contents Next 7 Key changes to the online version of the BNF and BNF for Children nW hen you log into the online version of the BNF you will notice that the contents page is much more concise and no longer reflects a book chapter structure. n If you search a term, you will be presented with search results and tabs so you can filter your results; the default is to show full text, but you can filter the search by drugs, treatment summaries, medicines, interactions or all publications. n Indications and dose now appear at the top of a monograph. n Contraindications and cautions now appear as lists. n There are no changes to the presentation of interactions. nS ide-effects now have their own heading and are listed in terms of incidence, then alphabetically, rather than by body system. n Search using the search bar top right. n There are some new sections in monographs including: • Pre-treatment screening • Conception and contraception (for male and female patients) • Monitoring requirements • Patient and carer advice • National funding/access decisions General information on searching BNF publications on MedicinesComplete n Switch to BNF for Children using the tab left of the search bar. n Cautionary and advisory labels are now found in medicinal forms. nB rowse through the content and switch between different content types (drugs, treatment summaries, etc) using the menu on the BNF home page. Back Contents Next 8 Key changes to the new BNF app nT he new BNF app includes an A-Z list of drugs and a section-specific search function. nN avigation allows you to easily switch between drugs, the interactions checker, treatment summaries, wound care, medical devices and borderline substances. n You easily switch between the BNF and the BNF for Children within one app. n The app is available for use offline. nT he app prompts when updates are available and provides reminders when you need to update the app with the latest information. General information on searching BNF publications apps nA t first use, the screen defaults to adult (BNF) content. Switch to child content by using the menu (top left). earch using drug or brand names, or browse using the A-Z listing for drug nS names only. witch between content types (drugs, treatment summaries, etc) using the nS icons across the bottom of the screen. Back Contents Next 9 Key changes to print editions: BNF 70 and BNF for Children 2015-16 n Information within the BNF now has a green colour theme, with BNF for Children retaining its pink colour theme. n Indications and dose now appear in a green highlighted box in the BNF and a pink highlighted box in the BNF for Children, allowing for quick and efficient use. he chapters are organised by disease state, and drug information within each disease nT state is in alphabetical order by drug class then by drug. ithin the chapters there are information summaries on disease states. These do not nW include information about drugs; this has been moved to the monographs or drug class monographs. white flag in a green circle (BNF) and white flag in a pink circle (BNF for Children) nA indicates that the information provided is about a drug class. green flag (BNF) and pink flag (BNF for Children) indicates that a drug monograph nA has a corresponding drug class monograph. section (eg, monitoring) may appear in both the drug class monograph (eg, nA monitoring required by all members of the drug class) and the monograph (eg, monitoring required for the specific drug); the patient needs to be monitored for both. Back Contents Next 10 Case studies – introduction This programme contains ten case studies. In these, there will be space for you to type answers to the questions. You can save your answers by saving this document to your computer and view our suggested answers by clicking on the Suggested answer links. The suggested answers to each case include the answers to the questions and images of the online version, app or book to help you navigate around the BNF. Back Contents Next 11 Case studies The case studies look at the following areas (click on a title to go straight to that case). You will be able to return to this menu by clicking the link at the bottom of the page at the end of each question. Treatment choice and dose Dosing and licensing Patient and carer advice Medicinal forms Monograph sections Screening and monitoring Monograph structure Side-effects, cautions, allergy and cross-sensitivity Interactions Funding Back Contents Next 12 Treatment choice and dose Case study 1 will illustrate key changes relating to: n choice of treatment n choice of dose. Treatment summaries are of three main types: na n overview of delivering a drug to a particular body system (eg, skin conditions, management) na comparison between a group or groups of drugs (eg, beta-adrenoceptor blocking drugs) na n overview of the drug management or prophylaxis of common conditions intended to facilitate rapid appraisal of options (eg, hypertension). A treatment summary detailing an overview of the drug management of a condition can be used to aid the choice of an appropriate treatment and dose. In order to select safe and effective medicines for individual patients, information in the treatment summaries must be used in conjunction with other prescribing details about the drugs and knowledge of the patient’s medical and drug history. Back Contents Next 13 Mollie Davis is a 13-year-old child with a duodenal ulcer. She also has confirmed Helicobacter pylori and needs to be prescribed an eradication regimen; however, she is currently completing a course of clarithromycin that she was prescribed for otitis media. 1. Which eradication regimen should Mollie be prescribed? Suggested answers 2. What doses are suitable for a 13-year-old child? Back Don’t forget to save your answers Click to return to the case studies menu Contents Next 14 Dosing and licensing Case study 2 will illustrate key changes relating to searching for: n the dose for a given indication, route and patient group n information about the unlicensed use of a drug. In the new BNF and BNF for Children all of the information for the systemic use of a drug is contained within one monograph. This carries the advantage of providing all of the information in one place, so the user does not need to flick back and forth across several pages to find all of the relevant information for that drug. The dose of a drug may vary according to different indications, routes of administration, age, body weight, and body surface area. The right dose should be selected for the right age and body weight (or body surface area) of the child, as well as for the right indication, route of administration, and preparation. One of the most significant changes to the monograph structure is the increased granularity, with a move from around 9 sections to over 20 sections; sections are only included when relevant information has been identified. The Unlicensed use section provides pertinent information about the unlicensed use of a drug, which can be specific to a patient group, one or more routes of administration or the indication for which the drug is being used. Back Contents Next 15 David Jones is a 10-year-old boy with asthma who weighs 31 kg. David has had symptoms of a productive cough for several days and has been needing to use his salbutamol inhaler more frequently. The GP diagnoses a lower respiratory tract infection and prescribes clarithromycin treatment as David is allergic to penicillin. 1. What oral dose should be prescribed? Suggested answers 2. Are clarithromycin tablets and intravenous infusion licensed for use in children? Back Don’t forget to save your answers Click to return to the case studies menu Contents Next 16 Patient and carer advice Case study 3 will illustrate key changes relating to finding: n preparation-specific information n patient and carer advice. In previous editions, when a particular preparation had safety information, dose advice or other clinical information specific to that particular product, it was contained within the preparations section. This information has now been moved to the relevant section in the main body of the monograph (now called Medicinal forms) and placed under a heading of the name of the particular medicinal form concerned. The dose panel also contains additional information relevant to indication and dose, under headings such as Pharmacokinetics, Potency and Dose equivalence and conversion. This information may affect the choice of dose, especially when switching between drugs or preparations. Taking the time to explain to the patient (and carers) the rationale and the potential adverse effects of treatment may improve adherence. For some medicines there is a special need for counselling (eg, appropriate posture during administration of doxycycline); this is shown in a Patient and carer advice section of the drug monograph. Back Contents Next 17 FIVE Marsha Dujon is a child aged 13 years who is currently at step 2 in the management of chronic asthma. Her condition is well-controlled with Salamol Easi-Breathe® and Clenil Modulite® 200 mcg twice daily. However, Clenil Modulite® device is no longer suitable for Marsha so the GP has decided to trial Qvar Easi-Breathe®. 1. What dose of Qvar Easi-Breathe® is appropriate? Suggested answers 2. Qvar Easi-Breathe® has been dispensed; what patient and carer advice should be provided? Back Don’t forget to save your answers Click to return to the case studies menu Contents Next 18 Medicinal forms Case study 4 will illustrate key changes relating to information on: n excipients n electrolytes n cautionary and advisory labels. In the new BNF, the medicinal forms (formerly preparations) record provides information on the type of formulation (eg, tablet or oral suspension), the amount of active drug in a solid dosage form, and the concentration of active drug in a liquid dosage form. Any clinical information relating to a medicinal form (eg, dose) has been moved to the relevant section within the drug monograph. Previously, the BNF only included excipients and electrolyte information for proprietary medicines. This information is now covered at the level of the dose form (eg, tablet or oral suspension). As generic products available on the UK market are constantly changing the information is provided as a reminder to the healthcare professional that if the presence of a particular excipient is of concern they should check the product literature for the particular product being prescribed or dispensed. Cautionary and advisory labels that pharmacists are recommended to add when dispensing are now included in the medicinal forms record. In previous editions, details of these labels could be found in Appendix 3. As these labels have now been applied at the level of the dose form, a full list of medicinal products with their relevant labels would be extensive. This list has therefore been removed, but the information is retained within the monograph. In the case of compound preparations, the prescribing information for all constituents should be taken into account. Back Contents Next 19 Paul Osinski, a 65-year-old male with dysphagia, is prescribed Augmentin® suspension to treat a respiratory tract infection. The patient has known sensitivities, so you are required to check the preparation for further information. 1. What excipients are included in Augmentin® suspension? 2. What cautionary and advisory label(s) are applicable to Augmentin® suspension? Suggested answers The patient is subsequently admitted to hospital and is prescribed Augmentin® injection instead. 3. What electrolytes are contained in this formulation? Back Don’t forget to save your answers Click to return to the case studies menu Contents Next 20 The new monograph structure Case study 5 will illustrate key changes relating to: n monograph structure. In previous editions of the BNF, information relating to a class of drug sharing the same properties (eg, tetracyclines on page 496 of BNF 70), was contained within the prescribing notes. In this new edition, drug class monographs have been created to contain the common information; this ensures such information is easier to find, and has a more consistent structure. Class monographs are indicated by the presence of a white flag in a green circle for the BNF and in a pink circle for the BNF for Children (eg, systemic beta-blockers on page 140 of the BNF). If a drug monograph has a corresponding class monograph that needs to be considered in tandem in order to understand the full information about a drug, the monograph is indicated by a green flag for the BNF or a pink flag for the BNF for Children (eg, metoprolol on page 144 of the BNF). Where the drug monographs run on from a class monograph, no further crossreferencing is given. However, occasionally, due to differences in therapeutic use, the drug monograph may not directly follow the class monograph. In this situation the need to consider a class monograph is still indicated by the flag, but a cross reference is also provided to help you navigate to the class monograph (eg, sotalol on page 93 of the BNF). In digital formats, the drug class information will be pushed into each drug that it is relevant to, meaning that all of the relevant drug and drug class information is displayed within one monograph. Back Contents Next 21 Amy Jones is a 55-year-old with acute angle-closure glaucoma, hypertension and COPD. She has been newly prescribed ipratropium bromide to treat her COPD. 1. Ipratropium bromide is cautioned in patients with acute angle-closure glaucoma. Are all inhaled antimuscarinics cautioned in patients with acute angle-closure glaucoma? Amy has been using her inhaler for several weeks and informs you that she is experiencing very dry skin. 2. Is this a possible side-effect of ipratropium bromide when used via the intranasal route? Suggested answers 3. Is cystic fibrosis a caution for all antimuscarinics (inhaled) or for ipratropium bromide only? Back Don’t forget to save your answers Click to return to the case studies menu Contents Next 22 New monograph sections Case study 6 will illustrate key changes relating to information about: n conception and contraception n prescribing and dispensing. In the BNF, information is provided to enable the prescriber and the patient to agree on the health outcomes that the patient desires and on the strategy for achieving them. Conception and contraception advice is therefore an important aspect of a patient’s health and should always be considered where appropriate. The Conception and contraception section within the BNF monograph contains information relevant to both males and females, covering the potential for a drug to have harmful effects on an unborn child. In addition, some drugs can affect the integrity, therefore the efficacy, of latex condoms and diaphragms and this information is also included within the Conception and contraception section. Another new section within the BNF monograph is the Prescribing and dispensing section. This covers practical information about how a drug can be prescribed and dispensed. Useful information which may influence the choice of preparation prescribed or dispensed, such as flavourings, is included, but also more important information, such as the requirement to check patients are enrolled in surveillance schemes, may also be present. Back Contents Next 23 Susan Williams is a 32-year-old woman who has recently stopped taking thalidomide. She is no longer taking any medicines and would like to begin planning to have children. Use the BNF to answer the following questions. or how long after stopping thalidomide treatment should women of child-bearing age use 1. F effective contraception? Suggested answers 2. What must accompany every prescription when prescribing and dispensing thalidomide? Back Don’t forget to save your answers Click to return to the case studies menu Contents Next 24 Screening and monitoring Case study 7 will illustrate key changes relating to: n pre-treatment screening n monitoring for different indications. When selecting the most appropriate drug, it may be necessary to screen the patient for certain genetic markers or metabolic states. This information is included within a section called Pre-treatment screening. This section covers one-off tests required to assess the suitability of a patient for a particular drug. After selecting and administering the most appropriate drug by the most appropriate route, patients should be monitored to ensure they are achieving the expected benefits from drug treatment without any unwanted side-effects. The Monitoring section specifies any special monitoring requirements for that drug. Back Contents Next 25 Amelie Colburn is a 17-year-old girl who is suffering from severe psoriasis, which is unresponsive to conventional therapy. Under the advice of a specialist, she will be initiated on ciclosporin. 1. What pre-treatment screening, if any, should be undertaken before initiating ciclosporin in psoriasis? After her pre-treatment screening, Amelie is started on ciclosporin for psoriasis. 2. What monitoring is required for the use of ciclosporin in severe psoriasis? Suggested answers James Anson, a 14-year-old boy, attends a dermatology clinic with severe atopic dermatitis. He has been suffering from severe atopic dermatitis for a number of months, and conventional therapy has not been successful. The dermatology consultant would now like to try ciclosporin for short-term treatment. 3. What monitoring is required for the use of ciclosporin in severe atopic dermatitis? Back Don’t forget to save your answers Click to return to the case studies menu Contents Next 26 Side-effects, cautions, allergy and cross-sensitivity Case study 8 will illustrate key changes relating to: n side-effects n cautions n allergies and cross-sensitivity. One key area of change within the restructured BNF publications is side-effects. Although the section is present as before, it has been restructured so that sideeffects are no longer broadly presented by body system but are presented by the frequency with which they occur, ordered within each frequency section alphabetically. In addition, because different routes of administration may be associated with different frequencies at which side-effects occur, the information may be further sub-divided by route of administration. Side-effects are distinct from Allergy and cross-sensitivity, which is presented in its own section. As hypersensitivity reactions can occur with virtually all medicines, this effect is generally not listed, unless the drug carries an increased risk of such reactions. The Cautions section is also retained from previous editions of the BNF but much of the information has been removed, for example, monitoring now has its own dedicated section. This leaves the Cautions section to describe situations where the use of the drug is known to present a risk of harm that is greater than usual but where the benefits of the use of that drug are still expected to outweigh the risks. Back Contents Next 27 Emma Hunt is a 48-year-old woman who comes in to the pharmacy with her 17-year-old son George. Emma wants to buy some ibuprofen to take for her headache, but also to give to her son as he hurt his ankle from a fall. On taking a medical history, you find out that both Emma and her son George suffer from ulcerative colitis. 1. Which route is cautioned in the use of ibuprofen in ulcerative colitis? 2. In both adults and children, what allergy and cross-sensitivity contraindicates the use of ibuprofen? Suggested answers Emma has suffered from blood disorders in the past and would like to know if blood disorders are a side-effect of ibuprofen. 3. Are blood disorders a side-effect of ibuprofen? And if so, which route is this side-effect applicable to? Back Don’t forget to save your answers Click to return to the case studies menu Contents Next 28 Interactions Case study 9 will illustrate key changes relating to: n interactions. A dedicated section for information on interactions is now included in the restructured BNF monograph. This provides a consistent place for information that was held variously in Cautions or within notes sections. In particular, additive side-effects, which are not included within the drug interactions section of the BNF; however, additive side-effects that result in measurable clinical signs (eg, QT-interval prolongation are listed within this new Interactions section). The Interactions section does not replace Appendix 1 in the book, and the content of Appendix 1 continues to be displayed in online formats. A new development for the app is the inclusion of an interactions checker. Back Contents Next 29 FIVE Sophie Hills is a 26-year-old woman who suffers from epilepsy, which is currently managed on carbamazepine. She is travelling abroad to Cambodia and Laos, and has a prescription from her GP for doxycycline for malaria prophylaxis. 1. Is there any interaction between carbamazepine and doxycycline? Suggested answers Back Don’t forget to save your answers Click to return to the case studies menu Contents Next 30 Funding Case study 10 will illustrate key changes relating to: n national funding and access decisions. A further section new to the monograph structure is National funding/access decisions. This section covers information about whether or not a drug is funded for use within the NHS, based on NICE decisions (NICE TAs) or Scottish Medicines Consortium (SMC) decisions. In addition, information on drugs that cannot be prescribed on the NHS is included. Rarely, national funding/access decisions information is not specific to a drug or class of drugs, eg, NICE TA10: Inhaler devices for children under 5 years with chronic asthma. In these cases, this information can be found in the appropriate treatment summary. Back Contents Next 31 Jim Williams is a 65-year-old male with severe chronic spontaneous urticaria. Jim has had an inadequate response to previous treatment including cetirizine; therefore, his GP would like to trial treatment with Xolair®. 1. Is it appropriate for a GP to be solely responsible for the management of Jim’s treatment with Xolair®? Suggested answers 2. What is the maximum number of doses of Xolair® a patient may receive if the condition is failing to respond? Back Don’t forget to save your answers Click to return to the case studies menu Contents Next 32 Next steps Now that you have completed the case studies, what’s next? You might like to: n return to the start of the case studies n r evisit the learning objectives. Are you confident that you have achieved these? n tackle the reflective essay that you can download from your CPPE record n complete a CPD record n email CPPE with any feedback you may have on your learning experience. We hope that you have enjoyed your learning. Back Contents Next 33 Credits CPPE programme manager Caroline Barraclough, regional manager, East Midlands Authors Karen Baxter, director, BNF Publications Katie Page, clinical writer, BNF Publications Heenaben Patel, content manager, BNF Publications Reviewers Anne Cole, regional manager, South West, CPPE Editors Terri Lucas, editor, CPPE Paddy McLaughlin, assistant editor, CPPE External websites CPPE is not responsible for the content of any non-CPPE websites mentioned in this programme or for the accuracy of any information to be found there. Production Gemini West, 25 Hockeys Lane, Fishponds, Bristol BS16 3HH T: 0117 965 5252. www.gemini-west.co.uk Published in October 2015 by the Centre for Pharmacy Postgraduate Education, Manchester Pharmacy School, The University of Manchester, Oxford Road, Manchester M13 9PT. www.cppe.ac.uk Disclaimer We have developed this learning programme to support your practice in this topic area. We recommend that you use it in combination with other established reference sources. If you are using it significantly after the date of initial publication, then you should refer to current published evidence. CPPE does not accept responsibility for any errors or omissions. Brand names and trademarks CPPE acknowledges the following brand names and registered trademarks mentioned throughout this programme: Augmentin®, Clenil Modulite®, Easi-Breathe®, Qvar®, Salamol®, Xolair®. Back Contents Next Contacting CPPE For information on your orders or bookings, or any general enquiries, please contact us by email, telephone or post. A member of our customer services team will be happy to help you with your enquiry. Email [email protected] Telephone 0161 778 4000 By post entre for Pharmacy Postgraduate Education (CPPE) C Manchester Pharmacy School 1st Floor, Stopford Building The University of Manchester Oxford Road Manchester M13 9PT Share your learning experience with us: email us at [email protected] Funded by: For information on all our programmes and events: visit our website www.cppe.ac.uk Developed by: Suggested answers Contents Treatment choice and dose How to find this information in the printed BNF Step 1: Search the BNF for Children index for Helicobacter pylori infection. Step 2: Locate the relevant section of the treatment summary. Step 3: Read the ‘Recommended regimens for Helicobacter pylori eradication’ table and find: • the row for children aged 12-17 years (highlighted in green) • the recommended antibacterial options available that do not include clarithromycin (highlighted in yellow) • the recommended acid suppressant and dose (highlighted in orange). 713 Hepatitis B, chronic, 363 Hepatitis B immunoglobulin, 694 Hepatitis B vaccine, 713 Hepatitis C, chronic, 363 Hepatyrix, 713 Heroin hydrochloride, see Diamorphine hydrochloride Herpes labialis, 644 Herpes simplex and varicella–zoster infection, 366 Herpes simplex infections, 366 Herpesvirus infections, 366 Hexetidine, 628 Hibi, 685 Hibiscrub, 685 HiBiTane Plus, 685 Hidrasec, 43 High-dose inhaled corticosteroids, 133 High lower-limb amputation, 271 Hirudoid, 688 HIV infection, 371 Hizentra, 696 Homatropine hydrobromide, 599 Hormone treatment for acne, 676 How BNF publications are constructed, ix How to use BNF publications, xi H2-receptor antagonists, 48 Humalog, 411 Humalog KwikPen, 411 Humalog Mix25, 408 Humalog Mix50, 408 Humalog Mix25 KwikPen, 408 Humalog Mix50 KwikPen, 408 Human Albumin Solution, see Albumin solution Human Chorionic Gonadotrophin, see Chorionic gonadotrophin Human Coagulation Factor VIII, Dried, see Factor VIII fraction, dried Hydrotalcite with simeticone, see Co-simalcite Hydroxocobalamin, 516 Anaemias, 503 Emergency treatment of poisoning, 752 Hydroxycarbamide, 495 Sickle-cell disease, 503 Hydroxychloroquine sulfate, 572 1a-Hydroxycholecalciferol, see Alfacalcidol Hydroxyethylcellulose, 600 Hydroxypropyl guar with polyethylene glycol and propylene glycol, 600 Hydroxyurea, see Hydroxycarbamide Hydroxyzine hydrochloride, 162 Hylo-Comod, 602 Hy-Opti, 602 Hyoscine butylbromide, 54 Hyoscine hydrobromide, 206 Hyperprolactinaemia, 188 Hypersal, 601 Hypertension, 85 In diabetes, 85 In pregnancy, 85 In renal disease, 85 Hypertensive emergencies, 85 Hypnomidate, 725 Hypnovel, 265 Hypodermic insulin injection pens, 1 l Oral suspension ▶ I Ibucalm, 585 Ibuprofen, 584 Drugs affecting the ductus arteriosus, 129 Ichthammol, 656 Return to case study MAGNESIUM CARBONATE WITH MAGNESIUM TRISILICATE AND SODIUM BICARBONATE (Non-proprietary) Magnesium carbonate light 50 mg per 1 ml, Magnesium trisilicate 50 mg per 1 ml, Sodium bicarbonate 50 mg per 1 ml Magnesium trisilicate oral suspension | 200 ml G £1.28 DT price = £1.28 DEFOAMING DRUGS Simeticone (Activated dimeticone) l DRUG ACTION Simeticone (activated dimeticone) is an antifoaming agent. INDICATIONS AND DOSE INFACOL ® Colic | Wind pains BY MOUTH ▶ Neonate: 0.5–1 mL, to be taken before feeds Child 1 month–1 year: 0.5–1 mL, to be taken before feeds DENTINOX ® Colic | Wind pains Recommended regimens for Helicobacter pylori eradication BY MOUTH Acid suppressant ▶ ▶ ▶ l l BY MOUTH ▶ ▶ l l l Neonate: 2.5 mL, to be taken with or after each feed; may be added to bottle feed; maximum 6 doses per day. Child 1 month–1 year: 2.5 mL, to be taken with or after each feed; may be added to bottle feed; maximum 6 doses per day PATIENT AND CARER ADVICE INFACOL ® Patients or carers should be given advice on use of the Infacol ® dropper. LESS SUITABLE FOR PRESCRIBING INFACOL ® Infacol ® is less suitable for prescribing (evidence of benefit in infantile colic uncertain). DENTINOX ® Dentinox ® colic drops are less suitable for prescribing (evidence of benefit in infantile colic uncertain). MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Oral suspension ▶ Infacol (Forest Laboratories UK Ltd) Simeticone 40 mg per 1 ml Infacol 40mg/ml oral suspension (sugar-free) | 50 ml G £2.71 DT price = £2.71 Oral drops ▶ Dentinox Infant (Dendron Ltd) Simeticone 8.4 mg per 1 ml Dentinox Infant colic drops | 100 ml G £1.73 Aluminium hydroxide with magnesium hydroxide and simeticone The properties listed below are those particular to the combination only. For the properties of the components please consider, aluminium hydroxide p. 536, simeticone above. Gastric and duodenal ulceration 47 BNFC 2015–2016 INDICATIONS AND DOSE Dyspepsia Child 2–4 years: 5 mL 3 times a day Child 5–11 years: 5–10 mL 3–4 times a day Child 12–17 years: 5–10 mL 4 times a day, to be taken after meals and at bedtime, or when required PRESCRIBING AND DISPENSING INFORMATION Maalox Plus ® is low Na+. MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Oral suspension ▶ Maalox Plus (Sanofi) Aluminium hydroxide gel dried 44 mg per 1 ml, Magnesium hydroxide 39 mg per 1 ml, Simeticone 5 mg per 1 ml Maalox Plus oral suspension (sugar-free) | 500 ml G £3.90 4.2 Gastric and duodenal ulceration ▶ 416 Hypoglycaemia, 417 Hypotension and interference with temperature regulation, 188 Hypovase, 94 Hypromellose, 600 Dry eye, 599 Hypromellose with dexamethasone, neomycin and polymyxin B sulfate, see Dexamethasone with hypromellose, neomycin and polymyxin B sulphate Hypromellose with dextran 70, see Dextran 70 with hypromellose Hypromol, 600 Hypurin Bovine Isophane, 411 Hypurin Bovine Lente, 411 Hypurin Bovine Neutral, 409 Hypurin Bovine Protamine Zinc, 412 Hypurin Porcine Isophane, 412 Hypurin Porcine 30/70 Mix, 408 Hypurin Porcine Neutral, 409 BNFC 2015–2016 MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Peptic ulceration Peptic ulceration commonly involves the stomach, duodenum, and lower oesophagus; after gastric surgery it involves the gastro-enterostomy stoma. Healing can be promoted by general measures, stopping smoking and taking antacids and by antisecretory drug treatment, but relapse is common when treatment ceases. Nearly all duodenal ulcers and most gastric ulcers not associated with NSAIDs are caused by Helicobacter pylori. Helicobacter pylori infection Eradication of Helicobacter pylori reduces the recurrence of gastric and duodenal ulcers and the risk of rebleeding. The presence of H. pylori should be confirmed before starting eradication treatment. If possible, the antibacterial sensitivity of the organism should be established at the time of endoscopy and biopsy. Acid inhibition combined with antibacterial treatment is highly effective in the eradication of H. pylori; reinfection is rare. Antibiotic-associated colitis is an uncommon risk. Treatment to eradicate H. pylori infection in children should be initiated under specialist supervision. One week triple-therapy regimens that comprise omeprazole p. 51, amoxicillin p. 310, and either clarithromycin p. 299 or metronidazole p. 646 are recommended. Resistance to clarithromycin or to metronidazole is much more common than to amoxicillin and can develop during treatment. A regimen containing amoxicillin and clarithromycin is therefore recommended for initial therapy and one containing amoxicillin and metronidazole is recommended for eradication failure or for a child who has been treated with a macrolide for other infections. There is usually no need to continue antisecretory treatment (with a proton pump inhibitor or H2-receptor antagonist); however, if the ulcer is large, or complicated by haemorrhage or perforation then antisecretory treatment is continued for a further 3 weeks. Lansoprazole may be considered if omeprazole is unsuitable. Treatment failure usually indicates antibacterial resistance or poor compliance. Two-week triple-therapy regimens offer the possibility of higher eradication rates compared to one-week regimens, but adverse effects are common and poor compliance is likely to offset any possible gain. Age range Child 1–5 years 250 mg twice daily 125 mg 3 times a day Omeprazole 1–2 mg/kg (max. 40 mg) once daily Child 6–11 years 500 mg twice daily 250 mg 3 times a day — — Omeprazole 40 mg once daily Child 12–17 years 1 Antibacterial Amoxicillin Omeprazole 1–2 mg/kg (max. 40 mg) once daily 1 g twice daily 500 mg 3 times a day — Two-week dual-therapy regimens using a proton pump inhibitor and a single antibacterial produce low rates of H. pylori eradication and are not recommended. See under NSAID-associated ulcers for the role of H. pylori eradication therapy in children starting or taking NSAIDs. Test for Helicobacter pylori 13 C-Urea breath test kits are available for confirming the presence of gastro-duodenal infection with Helicobacter pylori. The test involves collection of breath samples before and after ingestion of an oral solution of 13C-urea; the samples are sent for analysis by an appropriate laboratory. The test should not be performed within 4 weeks of treatment with an antibacterial or within 2 weeks of treatment with an antisecretory drug. A specific 13C-Urea breath test kit for children is available (Helicobacter Test INFAI for children of the age 3–11 ®). However the appropriateness of testing for H. pylori infection in children has not been established. Breath, saliva, faecal, and urine tests for H. pylori are frequently unreliable in children; the most accurate method of diagnosis is endoscopy with biopsy. Metronidazole — 100 mg 3 times a day 100 mg twice daily — 7.5 mg/kg twice daily 7.5 mg/kg (max. 500 mg) twice daily — 7.5 mg/kg (max. 500 mg) twice daily 500 mg twice daily — 500 mg twice daily — 200 mg 3 times a day 200 mg twice daily — 400 mg 3 times a day 400 mg twice daily GASTROPROTECTIVE COMPLEXES AND CHELATORS Chelates and complexes Sucralfate below is a complex of aluminium hydroxide and sulfated sucrose that appears to act by protecting the mucosa from acid-pepsin attack; it has minimal antacid properties. Sucralfate INDICATIONS AND DOSE Benign gastric ulceration | Benign duodenal ulceration BY MOUTH Child 1 month–1 year: 250 mg 4–6 times a day Child 2–11 years: 500 mg 4–6 times a day Child 12–14 years: 1 g 4–6 times a day Child 15–17 years: 2 g twice daily, dose to be taken on rising and at bedtime, alternatively 1 g 4 times a day for 4–6 weeks, or in resistant cases up to 12 weeks, dose to be taken 1 hour before meals and at bedtime; maximum 8 g per day Prophylaxis of stress ulceration in child under intensive care ▶ ▶ ▶ ▶ NSAID-associated ulcers Gastro-intestinal bleeding and ulceration can occur with NSAID use. Whenever possible, NSAIDs should be withdrawn if an ulcer occurs. Children at high risk of developing gastro-intestinal complications with a NSAID include those with a history of peptic ulcer disease or serious upper gastro-intestinal complication, those taking other medicines that increase the risk of upper gastro-intestinal side-effects, or those with serious co-morbidity. In children at risk of ulceration, a proton pump inhibitor can be considered for protection against gastric and duodenal ulcers associated with nonselective NSAIDs; high dose ranitidine p. 48 is an alternative. NSAID use and H. pylori infection are independent risk factors for gastro-intestinal bleeding and ulceration. In children already taking a NSAID, eradication of H. pylori is unlikely to reduce the risk of NSAID-induced bleeding or ulceration. However, in children about to start long-term NSAID treatment who are H. pylori positive and have dyspepsia or a history of gastric or duodenal ulcer, eradication of H. pylori may reduce the overall risk of ulceration. If the NSAID can be discontinued in a child who has developed an ulcer, a proton pump inhibitor usually produces the most rapid healing; alternatively the ulcer can be treated with an H2-receptor antagonist. If NSAID treatment needs to continue, the ulcer is treated with a proton pump inhibitor. Clarithromycin 7.5 mg/kg twice daily Gastro-intestinal system 46 Disorders of gastric acid and ulceration BNFC 2015–2016 Human Fibrinogen, see Fibrinogen, dried Human Fibrin-stabilising Factor, Dried, see Factor XIII fraction, dried Human hemin, see Haem arginate Human papillomavirus vaccines, 715 Human Prothrombin Complex, see Dried prothrombin complex Humatrope, 428 Humira, 575 Humulin I, 411 Humulin I KwikPen, 411 Humulin M3, 408 Humulin M3 KwikPen, 408 Humulin S, 409 Hyabak, 602 Hyaluronidase, 592 Soft-tissue disorders, 592 Hycosan, 602 Hydatid disease, 346 Hydralazine hydrochloride, 102 HydraMed, 602 Hydrea, 496 Hydrex, 685 Hydrocortisone, 397, 631, 666 Airways disease, use of corticosteroids, 143 Oral ulceration and inflammation, 630 Soft-tissue disorders, 592 Hydrocortisone and clotrimazole, see Clotrimazole with hydrocortisone Hydrocortisone butyrate, 666 Hydrocortisone with benzalkonium chloride, dimeticone, and nystatin, see Benzalkonium chloride with dimeticone, hydrocortisone and nystatin Hydrocortisone with chlorhexidine hydrochloride and nystatin, see Chlorhexidine hydrochloride with hydrocortisone and nystatin Hydrocortisone with cinchocaine, see Cinchocaine with hydrocortisone Hydrocortisone with Fusidic acid, 668 Gentamicin, 618 Lidocaine, 62 Miconazole, 668 Oxytetracycline, 668 Ppramocaine, 62 Urea, 668 Hydrocortistab, 398 Hydrogen peroxide, 628, 685 Hydromol Intensive, 644 Hydromoor, 600 Hydromorphone hydrochloride, 224 Gastro-intestinal system Index 958 Index HCU express, 922 HCU Lophlex LQ, 922 Head lice, 644 Heavy metals, 752 Hedrin, 652 Helicobacter pylori infection, 46 Helixate NexGen, 75 Helminth infections, 346 Heparinoid, 688 Heparins, 81 Heparin (unfractionated), 83 Venous thromboembolism, 77 Heparon Junior, 908 Hepatect CP, 694 Hepatitis, 363 Hepatitis A and B vaccine, 712 Hepatitis A vaccine, 712 Hepatitis A with typhoid vaccine, BY MOUTH ▶ ▶ ▶ ▶ l l l l ▶ ▶ Child 1 month–1 year: 250 mg 4–6 times a day Child 2–11 years: 500 mg 4–6 times a day Child 12–14 years: 1 g 4–6 times a day Child 15–17 years: 1 g 6 times a day; maximum 8 g per day UNLICENSED USE Not licensed for use in children under 15 years. Tablets not licensed for prophylaxis of stress ulceration. CAUTIONS Patients under intensive care (Important: reports of bezoar formation) CAUTIONS, FURTHER INFORMATION Bezoar formation Following reports of bezoar formation associated with sucralfate, caution is advised in seriously ill patients, especially those receiving concomitant enteral feeds or those with predisposing conditions such as delayed gastric emptying. INTERACTIONS → Appendix 1 (sucralfate). SIDE-EFFECTS Common or very common Constipation Uncommon Back pain . bezoar formation . diarrhoea . dizziness . drowsiness . dry mouth . eadache . flatulence . gastric discomfort . indigestion . nausea . rash continue to answers part 2 Treatment choice and dose Answers 1. Omeprazole, amoxicillin or metronidazole. 2. Omeprazole 40 mg once daily. Amoxicillin 500 mg three times daily. Metronidazole 400 mg three times daily. How to find this information in the app • Ensure you have selected child content in the app. • Switch to treatment summaries using the icons. • Search the name of the relevant disease state or browse through treatment summaries, by body system (similar to book chapters), then alphabetically. • Select relevant sections of the treatment summary and review the Helicobacter pylori table, as with book content. How to find this information online (MedicinesComplete) •S earch the name of the relevant disease state or browse through treatment summaries, by body system (similar to book chapters), then alphabetically. • Select relevant sections of the treatment summary and review the Helicobacter pylori table, as with book content. Return to case study return to answers part 1 Dosing and licensing How to find this information in the app Step 1: Ensure you have selected child content in the app. Return to case study Step 2: Switch to drugs using the icons. Step 3: Search ‘clarithromycin’. continue to answers part 2 Dosing and licensing Answers 1. 250 mg twice daily. 2. Clarithromycin tablets and intravenous infusion are not licensed for use in children under 12 years. How to find this information in print •Search the BNF for Children index for the page number of the clarithromycin monograph. • Use the Indications and dose section of the clarithromycin monograph to find the correct dose. • Pass down the monograph to find the Unlicensed use section in order to find information about the unlicensed use of clarithromycin in children. How to find this information online (MedicinesComplete) • Search ‘clarithromycin’. • Scroll down the monograph or jump through the section headings using the navigation pane on the left to find the relevant monograph sections. Return to case study return to answers part 1 Patient and carer advice How to find this information online (MedicinesComplete) Step 1: Ensure you are in BNF for Children, or search and select BNF for Children from the available options. Step 4: Scroll through the monograph (or use the navigation tab) to locate the relevant monograph sections (Dose equivalence and conversion and Potency, and Patient and carer advice). Step 2: Search ‘Qvar’. Step 3: Too many results? Select the drugs tab. Step 5: Move down the monograph to find Patient and carer advice. continue to answers part 2 Return to case study Patient and carer advice Answers 1. 100 mcg twice daily. 2. Patients on long-term corticosteroid treatment should carry a Steroid Treatment Card which gives guidance on minimising the risks of treatment and provides details of prescriber, drug, dosage and duration of treatment. A Medicines for children information leaflet is available at the web address provided in the monograph. This can be used to provide further advice about the use of beclomethasone inhalers for the control of asthma in children. How to find this information in print •Search the BNF for Children index for ‘Qvar Easi-Breath’. • Locate information relating to Dose equivalence and conversion and Potency. • Move down the monograph to find Patient and carer advice. How to find the information on the app • Ensure you have selected child content in the app. • Search ‘Qvar’ within the drugs section – results will indicate Qvar® appears as a medicine in the beclomethasone monograph. • Select the beclomethasone monograph and choose the relevant sections (Dose equivalence and conversion and Potency; and Patient and carer advice) from the menu. Return to case study return to answers part 1 Medicinal forms How to find this information in print Bacterial infection 485 BNF 70 Return to case study ▶ l ▶ ▶ l l l l With intravenous use in children Co-amoxiclav injection: use normal initial dose and then use half normal dose every 12 hours if estimated glomerular filtration rate 10–30 mL/minute/1.73 m2; use normal initial dose and then use half normal dose every 24 hours if estimated glomerular filtration rate less than 10 mL/minute/1.73 m2. Accumulation of electrolytes contained in parenteral preparations can occur in patients with renal failure. DIRECTIONS FOR ADMINISTRATION With intravenous use in adults For intravenous infusion (Augmentin ®), give intermittently in Sodium chloride 0.9%. Reconstitute 600 mg initially with 10 mL water for injections, then dilute with 50 mL infusion fluid; reconstitute 1.2 g initially with 20 mL water for injections, then dilute with 100 mL infusion fluid; give over 30–40 minutes via drip tubing in Sodium chloride 0.9%. With intravenous use in children For intravenous infusion, dilute reconstituted solution to a concentration of 10 mg/mL with Sodium Chloride 0.9%; give intermittently over 30–40 minutes. PRESCRIBING AND DISPENSING INFORMATION Doses are expressed as co-amoxiclav: a mixture of amoxicillin (as the trihydrate or as the sodium salt) and clavulanic acid (as potassium clavulanate); the proportions are expressed in the form x/y where x and y are the strengths in milligrams of amoxicillin and clavulanic acid respectively. Flavours of oral liquid formulations may include raspberry and orange. PATIENT AND CARER ADVICE Medicines for Children leaflet: Co-amoxiclav for bacterial infections www.medicinesforchildren.org.uk/ co-amoxiclav-bacterial-infections-0 PROFESSION SPECIFIC INFORMATION Dental practitioners’ formulary Co-amoxiclav 250/125 Tablets may be prescribed. Co-amoxiclav 125/31 Suspension may be prescribed. Co-amoxiclav 250/62 Suspension may be prescribed. MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: infusion Tablet CAUTIONARY AND ADVISORY LABELS 9 CO-AMOXICLAV (Non-proprietary) Amoxicillin (as Amoxicillin trihydrate) 250 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Co-amoxiclav 250mg/125mg tablets | 21 tablet P £7.00 DT price = £4.87 | 100 tablet P £35.00 Amoxicillin (as Amoxicillin trihydrate) 500 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Co-amoxiclav 500mg/125mg tablets | 21 tablet P £15.00 DT price = £4.23 Amoxicillin (as Amoxicillin trihydrate) 875 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Co-amoxiclav 875mg/125mg tablets | 14 tablet P £10.97 DT price = £8.60 ▶ Augmentin (GlaxoSmithKline UK Ltd) Amoxicillin (as Amoxicillin trihydrate) 250 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Augmentin 375mg tablets | 21 tablet P £5.03 DT price = £4.87 Amoxicillin (as Amoxicillin trihydrate) 500 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Augmentin 625mg tablets | 21 tablet P £9.60 DT price = £4.23 ▶ Oral suspension CAUTIONARY AND ADVISORY LABELS 9 EXCIPIENTS: May contain Aspartame ▶ CO-AMOXICLAV (Non-proprietary) Amoxicillin (as Amoxicillin trihydrate) 25 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 6.2 mg per 1 ml Co-amoxiclav 125mg/31mg/5ml oral suspension | 100 ml P £4.20 Co-amoxiclav 125mg/31mg/5ml oral suspension sugar free (sugarfree) | 100 ml P £25.00 DT price = £1.81 Amoxicillin (as Amoxicillin trihydrate) 50 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 12.5 mg per 1 ml Co-amoxiclav 250mg/62mg/5ml oral suspension | 100 ml P £6.29 Co-amoxiclav 250mg/62mg/5ml oral suspension sugar free (sugarfree) | 100 ml P £35.00 DT price = £1.89 Amoxicillin (as Amoxicillin trihydrate) 80 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 11.4 mg per 1 ml Coamoxiclav 400mg/57mg/5ml oral suspension sugar free (sugarfree) | 35 ml P £4.13 DT price = £4.13 (sugar-free) | 70 ml P £5.79 DT price = £5.79 ▶ Augmentin (GlaxoSmithKline UK Ltd) Amoxicillin (as Amoxicillin trihydrate) 25 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 6.2 mg per 1 ml Augmentin 125/31 SF oral suspension (sugar-free) | 100 ml P £3.54 DT price = £1.81 Amoxicillin (as Amoxicillin trihydrate) 50 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 12.5 mg per 1 ml Augmentin 250/62 SF oral suspension (sugar-free) | 100 ml P £3.60 DT price = £1.89 ▶ Augmentin-Duo (GlaxoSmithKline UK Ltd) Amoxicillin (as Amoxicillin trihydrate) 80 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 11.4 mg per 1 ml Augmentin-Duo 400/57 oral suspension (sugar-free) | 35 ml P £4.13 DT price = £4.13 (sugar-free) | 70 ml P £5.79 DT price = £5.79 Powder for solution for injection 5 l ▶ ▶ l ELECTROLYTES: May contain Potassium, sodium CO-AMOXICLAV (Non-proprietary) Amoxicillin (as Amoxicillin sodium) 500 mg, Clavulanic acid (as Potassium clavulanate) 100 mg Co-amoxiclav 500mg/100mg powder for solution for injection vials | 10 vial P £14.90 Amoxicillin (as Amoxicillin sodium) 1000 mg, Clavulanic acid (as Potassium clavulanate) 200 mg Co-amoxiclav 1000mg/200mg powder for solution for injection vials | 10 vial P £29.70 ▶ Augmentin Intravenous (GlaxoSmithKline UK Ltd) Amoxicillin (as Amoxicillin sodium) 500 mg, Clavulanic acid (as Potassium clavulanate) 100 mg Augmentin Intravenous 600mg powder for solution for injection vials | 10 vial P £10.60 Amoxicillin (as Amoxicillin sodium) 1000 mg, Clavulanic acid (as Potassium clavulanate) 200 mg Augmentin Intravenous 1.2g powder for solution for injection vials | 10 vial P £10.60 ▶ Co-fluampicil BY MOUTH ▶ ▶ ▶ Child 1 month–9 years: 125/125 mg every 6 hours Child 10–17 years: 250/250 mg every 6 hours Adult: 250/250 mg every 6 hours BY INTRAMUSCULAR INJECTION OR BY SLOW INTRAVENOUS INJECTION OR BY INTRAVENOUS INFUSION Adult: 250/250 mg every 6 hours Severe mixed infections involving beta-lactamase-producing staphylococci ▶ BY MOUTH ▶ ▶ ▶ Child 1 month–9 years: 250/250 mg every 6 hours Child 10–17 years: 500/500 mg every 6 hours Adult: 500/500 mg every 6 hours BY INTRAMUSCULAR INJECTION OR BY SLOW INTRAVENOUS INJECTION OR BY INTRAVENOUS INFUSION ▶ Adult: 500/500 mg every 6 hours Important safety information HEPATIC DISORDERS Cholestatic jaundice and hepatitis may occur very rarely, up to two months after treatment with flucloxacillin has been stopped. Administration for more than 2 weeks and increasing age are risk factors. Healthcare professionals are reminded that: . flucloxacillin should not be used in patients with a history of hepatic dysfunction associated with flucloxacillin; . flucloxacillin should be used with caution in patients with hepatic impairment; l l F INDICATIONS AND DOSE Mixed infections involving beta-lactamase-producing staphylococci Bacterial infection 485 BNF 70 ▶ l With intravenous use in children Co-amoxiclav injection: use normal initial dose and then use half normal dose every 12 hours if estimated glomerular filtration rate 10–30 mL/minute/1.73 m2; use normal initial dose and then use half normal dose every 24 hours if estimated glomerular filtration rate less than 10 mL/minute/1.73 m2. Accumulation of electrolytes contained in parenteral preparations can occur in patients with renal failure. DIRECTIONS FOR ADMINISTRATION With intravenous use in adults For intravenous infusion (Augmentin ®), give intermittently in Sodium chloride 0.9%. Reconstitute 600 mg initially with 10 mL water for injections, then dilute with 50 mL infusion fluid; reconstitute 1.2 g initially with 20 mL water for injections, then dilute with 100 mL infusion fluid; give over 30–40 minutes via drip tubing in Sodium chloride 0.9%. With intravenous use in children For intravenous infusion, dilute reconstituted solution to a concentration of 10 mg/mL with Sodium Chloride 0.9%; give intermittently over 30–40 minutes. PRESCRIBING AND DISPENSING INFORMATION Doses are expressed as co-amoxiclav: a mixture of amoxicillin (as the trihydrate or as the sodium salt) and clavulanic acid (as potassium clavulanate); the proportions are expressed in the form x/y where x and y are the strengths in milligrams of amoxicillin and clavulanic acid respectively. Flavours of oral liquid formulations may include raspberry and orange. PATIENT AND CARER ADVICE Medicines for Children leaflet: Co-amoxiclav for bacterial infections www.medicinesforchildren.org.uk/ co-amoxiclav-bacterial-infections-0 PROFESSION SPECIFIC INFORMATION Dental practitioners’ formulary Co-amoxiclav 250/125 Tablets may be prescribed. Co-amoxiclav 125/31 Suspension may be prescribed. Co-amoxiclav 250/62 Suspension may be prescribed. MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: infusion Tablet CAUTIONARY AND ADVISORY LABELS 9 CO-AMOXICLAV (Non-proprietary) Amoxicillin (as Amoxicillin trihydrate) 250 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Co-amoxiclav 250mg/125mg tablets | 21 tablet P £7.00 DT price = £4.87 | 100 tablet P £35.00 Amoxicillin (as Amoxicillin trihydrate) 500 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Co-amoxiclav 500mg/125mg tablets | 21 tablet P £15.00 DT price = £4.23 Amoxicillin (as Amoxicillin trihydrate) 875 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Co-amoxiclav 875mg/125mg tablets | 14 tablet P £10.97 DT price = £8.60 ▶ Augmentin (GlaxoSmithKline UK Ltd) Amoxicillin (as Amoxicillin trihydrate) 250 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Augmentin 375mg tablets | 21 tablet P £5.03 DT price = £4.87 Amoxicillin (as Amoxicillin trihydrate) 500 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Augmentin 625mg tablets | 21 tablet P £9.60 DT price = £4.23 ▶ Oral suspension CAUTIONARY AND ADVISORY LABELS 9 EXCIPIENTS: May contain Aspartame ▶ CO-AMOXICLAV (Non-proprietary) Amoxicillin (as Amoxicillin trihydrate) 25 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 6.2 mg per 1 ml Co-amoxiclav 125mg/31mg/5ml oral suspension | 100 ml P £4.20 Co-amoxiclav 125mg/31mg/5ml oral suspension sugar free (sugarfree) | 100 ml P £25.00 DT price = £1.81 Amoxicillin (as Amoxicillin trihydrate) 50 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 12.5 mg per 1 ml Co-amoxiclav 250mg/62mg/5ml oral suspension | 100 ml P £6.29 Step 4: Locate Powder for solution for injection. Co-amoxiclav 250mg/62mg/5ml oral suspension sugar free (sugarfree) | 100 ml P £35.00 DT price = £1.89 Amoxicillin (as Amoxicillin trihydrate) 80 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 11.4 mg per 1 ml Coamoxiclav 400mg/57mg/5ml oral suspension sugar free (sugarfree) | 35 ml P £4.13 DT price = £4.13 (sugar-free) | 70 ml P £5.79 DT price = £5.79 ▶ Augmentin (GlaxoSmithKline UK Ltd) Amoxicillin (as Amoxicillin trihydrate) 25 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 6.2 mg per 1 ml Augmentin 125/31 SF oral suspension (sugar-free) | 100 ml P £3.54 DT price = £1.81 Amoxicillin (as Amoxicillin trihydrate) 50 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 12.5 mg per 1 ml Augmentin 250/62 SF oral suspension (sugar-free) | 100 ml P £3.60 DT price = £1.89 ▶ Augmentin-Duo (GlaxoSmithKline UK Ltd) Amoxicillin (as Amoxicillin trihydrate) 80 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 11.4 mg per 1 ml Augmentin-Duo 400/57 oral suspension (sugar-free) | 35 ml P £4.13 DT price = £4.13 (sugar-free) | 70 ml P £5.79 DT price = £5.79 Powder for solution for injection 5 l ▶ ▶ l ELECTROLYTES: May contain Potassium, sodium CO-AMOXICLAV (Non-proprietary) Amoxicillin (as Amoxicillin sodium) 500 mg, Clavulanic acid (as Potassium clavulanate) 100 mg Co-amoxiclav 500mg/100mg powder for solution for injection vials | 10 vial P £14.90 Amoxicillin (as Amoxicillin sodium) 1000 mg, Clavulanic acid (as Potassium clavulanate) 200 mg Co-amoxiclav 1000mg/200mg powder for solution for injection vials | 10 vial P £29.70 ▶ Augmentin Intravenous (GlaxoSmithKline UK Ltd) Amoxicillin (as Amoxicillin sodium) 500 mg, Clavulanic acid (as Potassium clavulanate) 100 mg Augmentin Intravenous 600mg powder for solution for injection vials | 10 vial P £10.60 Amoxicillin (as Amoxicillin sodium) 1000 mg, Clavulanic acid (as Potassium clavulanate) 200 mg Augmentin Intravenous 1.2g powder for solution for injection vials | 10 vial P £10.60 ▶ Co-fluampicil BY MOUTH ▶ ▶ ▶ Child 1 month–9 years: 125/125 mg every 6 hours Child 10–17 years: 250/250 mg every 6 hours Adult: 250/250 mg every 6 hours BY INTRAMUSCULAR INJECTION OR BY SLOW INTRAVENOUS INJECTION OR BY INTRAVENOUS INFUSION Adult: 250/250 mg every 6 hours Severe mixed infections involving beta-lactamase-producing staphylococci ▶ BY MOUTH ▶ ▶ ▶ Child 1 month–9 years: 250/250 mg every 6 hours Child 10–17 years: 500/500 mg every 6 hours Adult: 500/500 mg every 6 hours BY INTRAMUSCULAR INJECTION OR BY SLOW INTRAVENOUS INJECTION OR BY INTRAVENOUS INFUSION ▶ Adult: 500/500 mg every 6 hours Important safety information HEPATIC DISORDERS Cholestatic jaundice and hepatitis may occur very rarely, up to two months after treatment with flucloxacillin has been stopped. Administration for more than 2 weeks and increasing age are risk factors. Healthcare professionals are reminded that: . flucloxacillin should not be used in patients with a history of hepatic dysfunction associated with flucloxacillin; . flucloxacillin should be used with caution in patients with hepatic impairment; l l F INDICATIONS AND DOSE Mixed infections involving beta-lactamase-producing staphylococci Bacterial infection 485 BNF 70 ▶ l With intravenous use in children Co-amoxiclav injection: use normal initial dose and then use half normal dose every 12 hours if estimated glomerular filtration rate 10–30 mL/minute/1.73 m2; use normal initial dose and then use half normal dose every 24 hours if estimated glomerular filtration rate less than 10 mL/minute/1.73 m2. Accumulation of electrolytes contained in parenteral preparations can occur in patients with renal failure. DIRECTIONS FOR ADMINISTRATION With intravenous use in adults For intravenous infusion (Augmentin ®), give intermittently in Sodium chloride 0.9%. Reconstitute 600 mg initially with 10 mL water for injections, then dilute with 50 mL infusion fluid; reconstitute 1.2 g initially with 20 mL water for injections, then dilute with 100 mL infusion fluid; give over 30–40 minutes via drip tubing in Sodium chloride 0.9%. With intravenous use in children For intravenous infusion, dilute reconstituted solution to a concentration of 10 mg/mL with Sodium Chloride 0.9%; give intermittently over 30–40 minutes. PRESCRIBING AND DISPENSING INFORMATION Doses are expressed as co-amoxiclav: a mixture of amoxicillin (as the trihydrate or as the sodium salt) and clavulanic acid (as potassium clavulanate); the proportions are expressed in the form x/y where x and y are the strengths in milligrams of amoxicillin and clavulanic acid respectively. Flavours of oral liquid formulations may include raspberry and orange. PATIENT AND CARER ADVICE Medicines for Children leaflet: Co-amoxiclav for bacterial infections www.medicinesforchildren.org.uk/ co-amoxiclav-bacterial-infections-0 PROFESSION SPECIFIC INFORMATION Dental practitioners’ formulary Co-amoxiclav 250/125 Tablets may be prescribed. Co-amoxiclav 125/31 Suspension may be prescribed. Co-amoxiclav 250/62 Suspension may be prescribed. MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: infusion Tablet CAUTIONARY AND ADVISORY LABELS 9 CO-AMOXICLAV (Non-proprietary) Amoxicillin (as Amoxicillin trihydrate) 250 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Co-amoxiclav 250mg/125mg tablets | 21 tablet P £7.00 DT price = £4.87 | 100 tablet P £35.00 Amoxicillin (as Amoxicillin trihydrate) 500 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Co-amoxiclav 500mg/125mg tablets | 21 tablet P £15.00 DT price = £4.23 Amoxicillin (as Amoxicillin trihydrate) 875 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Co-amoxiclav 875mg/125mg tablets | 14 tablet P £10.97 DT price = £8.60 ▶ Augmentin (GlaxoSmithKline UK Ltd) Amoxicillin (as Amoxicillin trihydrate) 250 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Augmentin 375mg tablets | 21 tablet P £5.03 DT price = £4.87 Amoxicillin (as Amoxicillin trihydrate) 500 mg, Clavulanic acid (as Potassium clavulanate) 125 mg Augmentin 625mg tablets | 21 tablet P £9.60 DT price = £4.23 ▶ Oral suspension CAUTIONARY AND ADVISORY LABELS 9 EXCIPIENTS: May contain Aspartame ▶ CO-AMOXICLAV (Non-proprietary) Amoxicillin (as Amoxicillin trihydrate) 25 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 6.2 mg per 1 ml Co-amoxiclav 125mg/31mg/5ml oral suspension | 100 ml P £4.20 Co-amoxiclav 125mg/31mg/5ml oral suspension sugar free (sugarfree) | 100 ml P £25.00 DT price = £1.81 Amoxicillin (as Amoxicillin trihydrate) 50 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 12.5 mg per 1 ml Co-amoxiclav 250mg/62mg/5ml oral suspension | 100 ml P £6.29 Co-amoxiclav 250mg/62mg/5ml oral suspension sugar free (sugarfree) | 100 ml P £35.00 DT price = £1.89 Amoxicillin (as Amoxicillin trihydrate) 80 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 11.4 mg per 1 ml Coamoxiclav 400mg/57mg/5ml oral suspension sugar free (sugarfree) | 35 ml P £4.13 DT price = £4.13 (sugar-free) | 70 ml P £5.79 DT price = £5.79 ▶ Augmentin (GlaxoSmithKline UK Ltd) Amoxicillin (as Amoxicillin trihydrate) 25 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 6.2 mg per 1 ml Augmentin 125/31 SF oral suspension (sugar-free) | 100 ml P £3.54 DT price = £1.81 Amoxicillin (as Amoxicillin trihydrate) 50 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 12.5 mg per 1 ml Augmentin 250/62 SF oral suspension (sugar-free) | 100 ml P £3.60 DT price = £1.89 ▶ Augmentin-Duo (GlaxoSmithKline UK Ltd) Amoxicillin (as Amoxicillin trihydrate) 80 mg per 1 ml, Clavulanic acid (as Potassium clavulanate) 11.4 mg per 1 ml Augmentin-Duo 400/57 oral suspension (sugar-free) | 35 ml P £4.13 DT price = £4.13 (sugar-free) | 70 ml P £5.79 DT price = £5.79 Powder for solution for injection ELECTROLYTES: May contain Potassium, sodium CO-AMOXICLAV (Non-proprietary) Amoxicillin (as Amoxicillin sodium) 500 mg, Clavulanic acid (as Potassium clavulanate) 100 mg Co-amoxiclav 500mg/100mg powder for solution for injection vials | 10 vial P £14.90 Amoxicillin (as Amoxicillin sodium) 1000 mg, Clavulanic acid (as Potassium clavulanate) 200 mg Co-amoxiclav 1000mg/200mg powder for solution for injection vials | 10 vial P £29.70 ▶ Augmentin Intravenous (GlaxoSmithKline UK Ltd) Amoxicillin (as Amoxicillin sodium) 500 mg, Clavulanic acid (as Potassium clavulanate) 100 mg Augmentin Intravenous 600mg powder for solution for injection vials | 10 vial P £10.60 Amoxicillin (as Amoxicillin sodium) 1000 mg, Clavulanic acid (as Potassium clavulanate) 200 mg Augmentin Intravenous 1.2g powder for solution for injection vials | 10 vial P £10.60 ▶ Co-fluampicil F INDICATIONS AND DOSE Mixed infections involving beta-lactamase-producing staphylococci BY MOUTH ▶ ▶ ▶ Child 1 month–9 years: 125/125 mg every 6 hours Child 10–17 years: 250/250 mg every 6 hours Adult: 250/250 mg every 6 hours BY INTRAMUSCULAR INJECTION OR BY SLOW INTRAVENOUS INJECTION OR BY INTRAVENOUS INFUSION Adult: 250/250 mg every 6 hours Severe mixed infections involving beta-lactamase-producing staphylococci ▶ BY MOUTH ▶ ▶ ▶ Child 1 month–9 years: 250/250 mg every 6 hours Child 10–17 years: 500/500 mg every 6 hours Adult: 500/500 mg every 6 hours BY INTRAMUSCULAR INJECTION OR BY SLOW INTRAVENOUS INJECTION OR BY INTRAVENOUS INFUSION ▶ Adult: 500/500 mg every 6 hours Important safety information HEPATIC DISORDERS Cholestatic jaundice and hepatitis may occur very rarely, up to two months after treatment with flucloxacillin has been stopped. Administration for more than 2 weeks and increasing age are risk factors. Healthcare professionals are reminded that: . flucloxacillin should not be used in patients with a history of hepatic dysfunction associated with flucloxacillin; . flucloxacillin should be used with caution in patients with hepatic impairment; continue to answers part 2 5 Infection Atarax, 248 Atazanavir, 567 Atenolol, 141 Atenolol with chlortalidone, see Cotenidone Atenolol with nifedipine, 141 Atimos Modulite, 221 Ativan, 414 Atomoxetine, 272 Atonic and tonic seizures, 383 Atorvastatin, 179 Atosiban, 708 Atovaquone, 523 Pneumocystis pneumonia, 522 Atovaquone with proguanil hydrochloride, 536 Atracurium besilate, 1103 Atracurium besylate, see Atracurium besilate Atrial fibrillation, 84 Atrial flutter, 84 Atriance, 764 Atripla, 565 Atrolak XL, 319 Atropine sulfate, 950, 1099 Cardiopulmonary resuscitation, 195 Emergency treatment of poisoning, 1123 Atropine sulfate with diphenoxylate hydrochloride, see Co-phenotrope Atrovent, 218 Atrovent UDV, 218 Attention deficit hyperactivity disorder, 270 Attia, 107 Aubagio, 734 Audavate, 1023 Audmonal, 75 Augmentin, 485 Augmentin-Duo, 485 Augmentin Intravenous, 485 Aureocort, 1032 Avamys, 985 Avanafil, 698 Avastin, 737 Avaxim, 1082 Avelox, 493 Aviticol, 886 Avloclor, 537 Avoca, 1057 Avodart, 676 Avomine, 252 Avonex, 730 Axitinib, 802 Axorid, 932 Axsain, 383 Aymes Shake, 1266 Azacitidine, 757 Azactam, 474 Azapress, 717 Azarga, 966 Azathioprine, 716 Inflammatory bowel disease, 32 Azelaic acid, 1043 Rosacea and Acne, 1041 Azelastine hydrochloride, 945 Azelastine with fluticasone, 985 Azidothymidine, see Zidovudine Azilect, 340 Azilsartan medoxomil, 132 Azithromycin, 469, 955 Genital system infections, bacterial, 445 Azopt, 966 Aztreonam, 474 AZT, see Zidovudine Index Arava, 895 Arcoxia, 925 Aredia, 624 Argatroban monohydrate, 116 Aricept, 263 Aricept Evess, 263 Arimidex, 792 Aripiprazole, 312 Psychoses and related disorders, 300 Arixtra, 109 Arjun, 1041 Arkolamyl, 316 Arlevert, 343 Aromasin, 792 Aromatic inhalations, cough preparations and systemic nasal decongestants, 258 Arpicolin, 326 Arrangements for supplying oxygen, 214 Arrhythmias, 84 Arrhythmias after myocardial infarction, 84 Arsenic trioxide, 776 Artelac, 952 Artelac Nighttime, 951 Artelac Rebalance, 953 Artelac Splash, 953 Artemether with lumefantrine, 534 Artenimol with piperaquine phosphate, 535 Arthritis, 891 Arthrotec, 924 Articaine hydrochloride with adrenaline, see Adrenaline with articaine hydrochloride Artificial saliva products, 987 Arythmol, 93 Arzerra, 740 Asacol, 36 Asacol MR, 36 Asasantin Retard, 107 Ascaricides (common roundworm infections), 524 Ascorbic acid, 884 Anaemias, 822 Ascorbic acid with ferrous sulfate, 835 Ascorbic acid with vitamin B substances, see Vitamin b substances with ascorbic acid Ascur, 884 Asenapine, 276 Psychoses and related disorders, 300 Asmabec Clickhaler, 228 Asmanex Twisthaler, 232 Asmasal Clickhaler, 224 Asmavent, 224 Aspirin Drug monograph, 104 Acute coronary syndromes, 186 Antiplatelet drugs, 103 Arrhythmias, 84 Emergency treatment of poisoning, 1123 Gout, 908 Hypertension, 121 Management of stroke, 101 Aspirin with codeine, 354 Aspirin with dipyridamole, 107 Aspirin with metoclopramide, 381 Asplenia, 528 Asthma Airways disease, use of corticosteroids, 226 Treatment summary, 210 Asymptomatic contacts of patients with infectious syphilis, 445 AT10, 887 Step 3: Locate Oral suspension. Infection Index 1339 BNF 70 Sinusitis, 446 Throat infections, 995 Typhoid fever, 445 Uncomplicated genital chlamydial infection, non-gonococcal urethritis, and non-specific genital infection, 445 Upper urinary-tract infections, 510 Anticholinesterases, 912 Anticoagulants, 102, 104, 529 Antidepressants, 1127 Antidiarrhoeals, 83 Anti-d (rh0) immunoglobulin, 1061 Antiepileptic drugs, 383 Antiepileptic hypersensitivity syndrome, 384 Anti-lymphocyte monoclonal antibodies, 731 Antimalarials, 1123 Antimicrobial dressings, 1305 Antimotility drugs, 54 Antimuscarinic drugs used in parkinsonism, 324 Antimuscarinics (eye), 949 Antimuscarinics (inhaled), 217 Antimuscarinics (systemic), 668 Antiplatelet drugs, 103 Antiplatelet drugs and coronary stents, 103 Antipsychotic depot injections, 300 Antipsychotic drugs, 300 Class monograph, 303 Psychoses and related disorders, 300 Antiseptic mouthwashes, 992 Antispasmodics, 54 Antithymocyte immunoglobulin (rabbit), 723 Antituberculosis drugs Table, 501 Tuberculosis, 501 Antivaricella-zoster Immunoglobulin, see Varicella-zoster immunoglobulin Apercap, 40 Apidra, 606 Apidra SoloStar, 606 Apixaban, 108 Apodespan PR, 331 APO-go, 333 APO-go Pen, 333 APO-go PFS, 333 Apomorphine hydrochloride, 332 Parkinson’s disease and related disorders, 324 Approximate Conversions and Units, inside back cover Apraclonidine, 963 Glaucoma, 962 Aprepitant, 351 Apresoline, 158 Aprinox, 159 Aprokam, 955 Aprovel, 134 Aptivus, 571 Aqua-cool, 1041 Aquadrate, 1005 Aquamol, 1004 AquaSoothe, 1041 Arachis oil, 51 Arachis oil extract of coal tar with cade oil, coal tar, light liquid paraffin and tar, 1035 Arachis oil with chlorobutanol, 980 Arachis oil with extract of coal tar, 1036 Aragam, 1064 Aranesp, 826 Aranesp SureClick, 826 Step 2: Locate Medicinal forms in the monograph. Infection Step 1: Search index for Augmentin®. Medicinal forms Answers 1. May contain aspartame. 2. Cautionary and advisory labels 9: Space the doses evenly throughout the day. Keep taking this medicine until the course is finished, unless you are told to stop. 3. May contain potassium, sodium. How to find the information in the app or online avigate to the relevant drug (co-amoxiclav) by searching •N ‘Augmentin’ or ‘co-amoxiclav’. • Follow the same steps as for print. Return to case study return to answers part 1 The new monograph structure How to find this information in print Isovorin, 782 Ispaghula husk, 45 Ispaghula husk with mebeverine, 75 Ispaghula husk with senna, 54 Isradipine, 152 Isteranda, 694 Istin, 149 Itching, 1007 Itraconazole, 519 Oropharyx infections, fungal, 996 Ivabradine, 185 Stable angina, 182 Ivacaftor, 257 Ivemend, 351 Ivermectin, 525, 1015 Helminth infections, 524 Skin infections, 1006 Ixiaro, 1087 ANTIMUSCARINICS Antimuscarinics (inhaled) l l l ▶ ▶ J Jakavi, 816 Janumet, 598 Januvia, 598 Japanese encephalitis vaccine, 1086 Jardiance, 611 Javlor, 775 Jaydess, 694 Jentadueto, 597 Jet nebulisers, 209 Jetrea, 975 Jevity, 1262, 1264, 1265 Jevtana, 770 Jext, 198 Joint Formulary Committee 2015–2016, vii Joint prostheses and dental treatment, 442 Joint replacement including hip and knee, 441 Joy-Rides, 345 K Kadcyla, 744 Kalcipos-D, 886 Kaletra, 570 Kalspare, 204 Kalydeco, 257 Kaolin, 57 Kaolin with morphine, 55 Kapake, 359 Katya, 687 Kay-Cee-L, 864 Keflex, 457 Keftid, 456 Kelo-cote, 1309, 1310 Kemadrin, 326 Kemicetine, 453 Kenalog, 587 Kentera, 670 Kentipine MR, 154 Kenzem SR, 151 Kepivance, 783 Keppra, 397 Keral, 920 Kerstipon, 264 Ketalar, 1111 Ketamine, 1110 General anaesthesia, 1093 KetoCal, 1271 Ketoconazole, 587, 713, 1011 Scalp and hair conditions, 1048 Ketoprofen, 930 Ketoprofen with omeprazole, 932 Ketorolac trometamol, 961 Ketotifen, 249, 945 Return to case study ▶ l f CAUTIONS Bladder outflow obstruction . prostatic hyperplasia . susceptability to angle-closure glaucoma INTERACTIONS See Appendix 1 (antimuscarinics). However, note that interactions do not generally apply to antimuscarinics used by inhalation. SIDE-EFFECTS Common or very common Constipation . cough . diarrhoea . dry mouth . gastro-intestinal motility disorder . headache Uncommon Angle-closure glaucoma . atrial fibrillation . blurred vision . bronchospasm . dysphagia . dysphonia . gastro-oesophageal reflux disease . mydriasis . nasopharyngitis . nausea . palpitation . paradoxical bronchospasm . pharyngitis . tachycardia . throat irritation . urinary retention Rare Dental caries . dry skin Aclidinium bromide F l l l l l l ▶ ▶ F l BY INHALATION OF NEBULISED SOLUTION Adult: 250–500 micrograms 3–4 times a day Acute bronchospasm ▶ BY INHALATION OF NEBULISED SOLUTION Child 1 month–4 years: 125–250 micrograms as required; maximum 1 mg per day Child 6–11 years: 250 micrograms as required; maximum 1 mg per day Child 12–17 years: 500 micrograms as required Adult: 500 micrograms as required Severe or life-threatening acute asthma ▶ ▶ ▶ ▶ BY INHALATION OF NEBULISED SOLUTION ▶ Eklira (AstraZeneca UK Ltd) A Aclidinium bromide 375 microgram per 1 dose Eklira 322micrograms/dose Genuair | 60 dose P £28.60 ▶ Child 1 month–11 years: 250 micrograms every 20–30 minutes for the first 2 hours, then 250 micrograms every 4–6 hours as required Child 12–17 years: 500 micrograms every 4–6 hours as required Adult: 500 micrograms every 4–6 hours as required PHARMACOKINETICS The maximal effect of inhaled ipratropium occurs 30–60 minutes after use; its duration of action is 3 to 6 hours and bronchodilation can usually be maintained with treatment 3 times a day. l ▶ F INDICATIONS AND DOSE Maintenance treatment of chronic obstructive pulmonary disease BY INHALATION OF POWDER ▶ Adult: 50 micrograms once daily Dose equivalence and conversion For inhalation of powder, each 50 microgram capsule of glycopyrronium delivers 44 micrograms of glycopyrronium. CAUTIONS Arrhythmia (excluding chronic stable atrial fibrillation) . history of myocardial infarction . history of Child 6–11 years: 1–2 drops 1–2 times a day as required for maximum duration of 5 days, 0.05% solution to be administered into each nostril Child 12–17 years: 2–3 drops 2–3 times a day as required for maximum duration of 7 days, 0.1% solution to be administered into each nostril Adult: 2–3 drops 2–3 times a day as required for maximum duration of 7 days, 0.1% solution to be administered into each nostril CAUTIONS Cystic fibrosis CAUTIONS, FURTHER INFORMATION Glaucoma Acute angle-closure glaucoma has been reported with nebulised ipratropium, particularly when given with nebulised salbutamol (and possibly other beta2 agonists); care needed to protect the patient’s eyes from nebulised drug or from drug powder. l SIDE-EFFECTS ▶ Common or very common Dizziness . nausea (in children) ▶ Uncommon Laryngospasm . pharyngeal oedema (in children) . pruritus . stomatitis . vomiting ▶ Rare Atrial fibrillation (in children) . ocular accommodation disorder (in children) Child 12–17 years: 1 spray 1–3 times a day as required for maximum duration of 7 days, to be administered into each nostril Adult: 1 spray 1–3 times a day as required for maximum duration of 7 days, to be administered into each nostril Important safety information The CHM/MHRA has stated that non-prescription cough and cold medicines containing ephedrine, oxymetazoline, or xylometazoline can be considered for up to 5 days’ treatment in children aged 6–12 years after basic principles of best care have been tried; these medicines should not be used in children under 6 years of age. BY INHALATION OF AEROSOL (Glycopyrrolate) l ▶ Child 1 month–5 years: 20 micrograms 3 times a day ▶ Child 6–11 years: 20–40 micrograms 3 times a day ▶ Child 12–17 years: 20–40 micrograms 3–4 times a day Reversible airways obstruction, particularly in chronic obstructive pulmonary disease Inhalation powder ▶ BY INTRANASAL ADMINISTRATION USING NASAL DROPS BY INTRANASAL ADMINISTRATION USING NASAL SPRAY Adult: 20–40 micrograms 3–4 times a day Otrivine Adult Metered Dose 0.1% nasal spray | 10 ml G £3.31 DT price = £2.10 Sudafed Mucus Relief (McNeil Products Ltd) Xylometazoline hydrochloride 1 mg per 1 ml Sudafed Mucus Relief 0.1% nasal spray | 15 ml G £2.37 ▶ Sudafed Non-Drowsy Decongestant (xylometazoline) (McNeil Products Ltd) Xylometazoline hydrochloride 1 mg per 1 ml Sudafed Blocked Nose 0.1% spray | 15 ml G £2.38 DRUG ACTION Xylometazoline is a sympathomimetic. ▶ ▶ ▶ Nasal inflammation, nasal polyps and rhinitis 983 INDICATIONS AND DOSE Nasal congestion BY INHALATION OF AEROSOL MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Glycopyrronium bromide l INDICATIONS AND DOSE Reversible airways obstruction CAUTIONS Hospitalisation with moderate or severe heart failure within last 12 months . myocardial infarction within last 6 months . newly diagnosed arrhythmia within last 3 months . unstable angina SIDE-EFFECTS Sinusitis PREGNANCY Manufacturer advises use only if potential benefit outweighs risk. BREAST FEEDING Manufacturer advises avoid. PATIENT AND CARER ADVICE Patients or carers should be given advice on how to administer aclidinium bromide powder inhalation. ▶ 3 Seebri Breezhaler (Novartis Pharmaceuticals UK Ltd) A Glycopyrronium bromide 55 microgram Seebri Breezhaler 44microgram inhalation powder capsules with device | 6 capsule P £5.50 | 30 capsule P £27.50 Ipratropium bromide Adult: 375 micrograms twice daily Dose equivalence and conversion Each 375 microgram inhalation of aclidinium bromide delivers 322 micrograms of aclidinium. l BNF 70 Xylometazoline hydrochloride ▶ ▶ l MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. ▶ BY INHALATION OF POWDER l QT-interval prolongation . left ventricular failure . unstable ischaemic heart disease PREGNANCY Manufacturer advises use only if potential benefit outweighs risk. BREAST FEEDING Manufacturer advises use only if potential benefit outweighs risk. RENAL IMPAIRMENT Use with caution if eGFR less than 30 mL/minute/1.73 m2. PATIENT AND CARER ADVICE Patients or carers should be given advice on how to administer glycopyrronium for inhalation. Inhalation powder INDICATIONS AND DOSE Maintenance treatment of chronic obstructive pulmonary disease l Step 4: Locate Ipratropium monograph (intranasal). Airways disease, obstructive 217 BNF 70 Index Invodol SR, 374 Invokana, 609 Iodide with iodine, 665 Iodine, 1306 Iodine with iodide, see Iodide with iodine Iopidine, 963 Ipilimumab, 739 Ipocol, 36 Ipramol, 218 Ipratropium bromide, 217, 983 Ipratropium with salbutamol, 218 Irbesaran with hydrochlorothiazide, see Hydrochlorothiazide with irbesartan Irbesartan, 133 Iressa, 809 Irinotecan hydrochloride, 772 Iron-deficiency anaemias, 830 Iron dextran, 832 Iron (injectable), 831 Iron isomaltoside 1000, 832 Iron (oral), 833 Iron overload, 838 Iron preparations, 83 Iron salts, 1123 Iron sucrose, 832 Irriclens, 1053 Irrigation fluids, 1309 Irrigation solutions, 1053 Irritable bowel syndrome, 40 Ischaemic stroke, 101 Isentress, 558 Isib XL, 192 Ismo, 192 Ismo Retard, 192 Isocarboxazid, 282 Iso D3, 886 Isodur XL, 193 Isoflurane, 1098 General anaesthesia, 1093 Isoket, 192 Isoket Retard, 191 Isolated systolic hypertension, 121 Isoniazid Drug monograph, 506 Antibacterials, use for prophylaxis, 439 Tuberculosis, 501 Isoniazid with ethambutol with pyrazinamide and rifampicin, see Ethambutol with isoniazid, pyrazinamide and rifampicin Isoniazid with pyrazinamide and rifampicin, 510 Isoniazid with rifampicin, 510 Isophane insulin, 607 Isophane Insulin Injection, see Isophane insulin Isophane Insulin (NPH)—intermediate acting, see Isophane insulin Isophane Protamine Insulin Injection, see Isophane insulin Isoplex, 854 Isopropyl alcohol with chlorhexidine gluconate, see Chlorhexidine gluconate with isopropyl alcohol Isopto Alkaline, 952 Isopto Plain, 952 Isosorbide dinitrate, 191 Isosorbide mononitrate, 192 Isotard XL, 193 Isotretinoin, 1045 Rosacea and Acne, 1041 Isotretinoin with erythromycin, see Erythromycin with isotretinoin Isotrex, 1046 Isotrexin, 1047 Step 3: Locate Ipratropium monograph (inhaled). l l l l CAUTIONS Angle-closure glaucoma . avoid excessive or prolonged use . cardiovascular disease (in children) . diabetes mellitus . elderly . hypertension . hyperthyroidism . ischaemic heart disease (in adults) . prostatic hypertrophy (risk of acute retention) (in adults) . rebound congestion CAUTIONS, FURTHER INFORMATION Rebound congestion Sympathomimetic drugs are of limited value in the treatment of nasal congestion because they can, following prolonged use (more than 7 days), give rise to a rebound congestion (rhinitis medicamentosa) on withdrawal, due to a secondary vasodilatation with a subsequent temporary increase in nasal congestion. This in turn tempts the further use of the decongestant, leading to a vicious cycle of events. SIDE-EFFECTS Cardiovascular effects . hallucinations in small children . headache . local irritation . nausea . rebound congestion . restlessness in small children . sleep disturbances in small children . tolerance with diminished effect (after excessive use) . transient visual disturbances SIDE-EFFECTS, FURTHER INFORMATION Hallucinations (in small children) Discontinue treatment if the hallucinations occur. PREGNANCY Manufacturer advises avoid. BREAST FEEDING Manufacturer advises caution—no information available. MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Spray ▶ Otrivine (Novartis Consumer Health UK Ltd) Xylometazoline hydrochloride 1 mg per 1 ml Otrivine Congestion Relief 0.1% nasal spray | 10 ml G £2.93 DT price = £2.10 Otrivine Adult Measured Dose Sinusitis spray | 10 ml G £2.55 DT price = £2.10 Otrivine Allergy Relief 0.1% nasal spray | 10 ml G £2.55 DT price = £2.10 Otrivine Adult nasal spray | 10 ml G £2.10 DT price = £2.10 Nasal drops ▶ Otrivine (Novartis Consumer Health UK Ltd) Xylometazoline hydrochloride 500 microgram per 1 ml Otrivine Child nasal drops | 10 ml p £1.91 DT price = £1.91 Xylometazoline hydrochloride 1 mg per 1 ml Otrivine Adult 0.1% nasal drops | 10 ml G £2.10 DT price = £2.10 12 2.2 Nasal inflammation, nasal polyps and rhinitis Ear, nose and oropharynx Index 1351 BNF 70 Inflammatory bowel disease, 32 Inflectra, 908 Infliximab, 906 Inflammatory bowel disease, 32 Influenza, 571 Influenza vaccine, 1085 Influvac Sub-unit, 1086 Ingenol mebutate, 1039 Inhalational anaesthetics, 1093 Inhaled corticosteroids Airways disease, use of corticosteroids, 226 Inhaler devices, 209 Inlyta, 803 Innohep, 115 Innovace, 127 Innozide, 127 Inosine acedoben dimepranol, see Inosine pranobex Inosine pranobex, 550 Herpesvirus infections, 549 Inositol nicotinate, 206 Peripheral vascular disease, 205 Inovelon, 403 Insect stings, 1130 Inspra, 168 Instant Carobel, 1279 Instanyl, 366 Instillagel, 679 Insulatard, 607 Insulatard InnoLet, 607 Insulatard Penfill, 607 Insulin aspart, 604 Insulin degludec, 604 Insulin degludec with liraglutide, 605 Insulin delivery systems, needle free, see Needle free insulin delivery systems Insulin detemir, 605 Insulin glargine, 605 Insulin glulisine, 605 Insulin injection pens, hypodermic, see Hypodermic insulin injection pens Insulin Injection, see Insulin Insulin lispro, 606 Insulins, 602 Insulin zinc suspension, 607 Insulin Zinc Suspension (Mixed)—long acting, see Insulin zinc suspension Insuman Basal, 607 Insuman Comb, 603 Insuman Rapid, 604 Intal, 235 Intanza, 1086 Integrilin, 183 Intelence, 560 Interferon alfa, 794 Interferon beta, 729 Interferon gamma-1b, 795 Intermediate-acting insulin, see Biphasic insulin aspart Intermediate-acting insulin, see Biphasic insulin lispro Intracerebral haemorrhage, 101 Intralipid, 874 Intratect, 1064 Intra-uterine contraceptive devices (copper), 689 Intravenous anaesthetics, 1093 Intravenous glucose, 845 Intravenous potassium, 845 Intravenous sodium, 845 IntronA, 795 Invanz, 453 Invega, 318 Invirase, 571 InVita D3, 886 Step 2: Locate the class monograph. Respiratory system Step 1: Search index for ipratropium bromide. Drugs used for Nasal inflammation, nasal polyps and rhinitis not listed below; Desloratadine, p. 247 . Fexofenadine hydrochloride, p. 247 . Ketotifen, p. 249 ANTIMUSCARINICS Ipratropium bromide INDICATIONS AND DOSE Rhinorrhoea associated with allergic and non-allergic rhinitis BY INTRANASAL ADMINISTRATION Child 12–17 years: 2 sprays 2–3 times a day, dose to be sprayed into each nostril Adult: 2 sprays 2–3 times a day, dose to be sprayed into each nostril Dose equivalence and conversion 1 metered spray of nasal spray = 21 micrograms. ▶ ▶ l l ▶ ▶ ▶ l CAUTIONS Avoid spraying near eyes . bladder outflow obstruction . cystic fibrosis . prostatic hyperplasia (in adults) . risk of glaucoma (in children) . susceptability to angle-closure glaucoma (in adults) SIDE-EFFECTS Common or very common epistaxis . nasal dryness . nasal irritation Uncommon headache . nausea . pharyngitis (in children) Very rare gastro-intestinal motility disturbances . palpitations . urinary retention MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Spray EXCIPIENTS: May contain Benzalkonium chloride, disodium edetate ▶ Rinatec (Boehringer Ingelheim Ltd) Ipratropium bromide 21 microgram per 1 dose Rinatec 21micrograms/dose nasal spray | 180 dose P £6.54 DT price = £6.54 CORTICOSTEROIDS Corticosteroids (intranasal) l f CAUTIONS Avoid after nasal surgery (until healing has occurred) . avoid in pulmonary tuberculosis . avoid in the presence of untreated nasal infections . patients transferred from systemic corticosteroids may experience exacerbation of some symptoms continue to answers part 2 The new monograph structure Answers 1. All inhaled antimuscarinics (check both drug (inhaled) and class monograph). 2. No. It is listed as a rare side-effect in the antimuscarinic (inhaled) class monograph for inhaled route only. Intranasal ipratropium (Chapter 12) does not inherit the class monograph information. Note that there is no flag. Check both drug and class monographs, if applicable, to obtain the full information about a drug. 3. Ipratropium bromide only. Not listed in antimuscarinic (inhaled) class monograph which means that this caution does not apply to all inhaled antimuscarinics. Finding the information in the app or online (MedicinesComplete) • Navigate to the relevant drug by searching ‘ipratropium’. • Note that the information, including the class information, will be contained within the drug monograph – class information is automatically included within drug monograph in the app and online. Return to case study return to answers part 1 New monograph sections How to find the information on the app Step 1: Ensure the app is displaying adult content. Step 2: Search thalidomide in the drugs section. Step 3: Select Conception and contraception from the menu options. Step 4: Go back to the menu, (tap on drug name, top left). Step 5: Select Prescribing and dispensing information. Return to case study continue to answers part 2 New monograph sections Answers 1. W omen of child-bearing age must practise effective contraception at least one month before, during, and for at least one month after treatment, including during dose interruptions (oral combined hormonal contraceptives and copper-releasing intrauterine devices are not recommended). 2. Every prescription must be accompanied by a complete prescription authorisation form. How to find this information in print Question 1 • Search index for thalidomide. • Locate monograph and locate Conception and contraception heading within monograph. Question 2 • Locate monograph (as in Question 1) and locate Prescribing and dispensing heading within monograph. How to find the information online (MedicinesComplete) • Search ‘thalidomide’. • Scroll through the monograph (or use the navigation tab) to locate the relevant monograph sections. Return to case study return to answers part 1 Screening and monitoring How to find this information in print 628 Chlorhexidine with neomycin, 625 Chlorhexidine with nystatin, 651 Chlorobutanol and arachis oil, see Arachis oil with chlorobutanol Chlorobutanol with chlorhexidine, see Chlorhexidine with chlorobutanol Chloromycetin, 604 Chloroquine, 358 Malaria, prophylaxis, 350 Malaria, treatment, 351 Chloroquine with proguanil, 359 Chlorothiazide, 104 Hypoglycaemia, 417 Chlorphenamine maleate, 160 Chlorpheniramine maleate, see Chlorphenamine maleate Chlorpromazine hydrochloride, 191 Chlortalidone, 129 Chlortetracycline with triamcinolone, 669 Chlorthalidone, see Chlortalidone Cholecalciferol, see Colecalciferol Cholera vaccine, 710 Cholesterol, 58 Cholestyramine, see Colestyramine Choline salicylate, 632 Oral ulceration and inflammation, 630 Choragon, 427 Chorionic gonadotrophin, 427 Chronic bowel disorders, 23 Chronic constipation, 33 Step 3: Locate monograph and Monitoring requirements. It is important to note that the index will take you to the main monograph for ciclosporin. Although not listed in the Skin chapter, there is an indication listed for severe psoriasis. This is the main monograph for ciclosporin; therefore, all information about the drug will be located here. There will be general monitoring requirements and monitoring requirements specific to certain diseases, and the monitoring specific to psoriasis/ dermatitis will need to be chosen. 443 Citrulline, 550 Clairette, 678 Clamelle, 299 Clarelux, 662 Clarie XL, 300 Clarithromycin, 299 Antibacterials, use for prophylaxis, 271 Gastro-intestinal system infections, bacterial, 276 Clarityn, 164 Clasteon, 422 Clavulanic acid with amoxicillin, see Co-amoxiclav Clavulanic acid with ticarcillin, see Ticarcillin with clavulanic acid Clenil Modulite, 145 Cleosensa, 451 Clexane, 83 Clindamycin 297, 463 MRSA, 325 Oral bacterial infections, 278 Vaginal and vulval conditions, BNFC 2015–2016 Index Chronic facial pain, 233 Chronic hypoglycaemia, 417 Chronic otitis media, 616 Ciclesonide, 147 Ciclosporin, 468 Inflammatory bowel disease, 23 Cidomycin, 282 Cilastatin with imipenem, see Imipenem with cilastatin Cilest, 453 Ciloxan, 604 Cimizt, 450 Cinchocaine hydrochloride with fluocortolone caproate and fluocortolone pivalate, 61 Cinchocaine with hydrocortisone, 61 Cinchocaine with prednisolone, 62 Cinnarizine, 204 Cinryze, 168 Cipramil, 183 Ciprofloxacin, 320, 604 Anthrax, 325 Antibacterials, use for prophylaxis, 271 Ear, 616 Gastro-intestinal system infections, bacterial, 276 Inflammatory bowel disease, 23 Ciproxin, 320 Circadin, 266 Cisatracurium, 735 Cisplatin, 494 Citalopram, 183 Citanest, 750 Citanest with Octapressin, 750 Citramag, 31 Citric acid, 170 Citric acid with magnesium carbonate, 31 Citric acid with potassium citrate, 462 Clindamycin with benzoyl peroxide, see Benzoyl peroxide with clindamycin Clindamycin with tretinoin, 682 Clinitas, 602 Clinitas Carbomer, 599 Clioquinol with betamethasone, see Betamethasone with clioquinol Clioquinol with flumetasone pivalate, 617 Clioquinol with fluocinolone acetonide, 665 ClobaDerm, 663 Clobavate, 663 Clobazam, 258 Epilepsy, 234 Clobetasol propionate, 662 Clobetasol propionate with neomycin sulfate and nystatin, 663 Clobetasone butyrate, 663 Clobetasone butyrate with nystatin and oxytetracycline, 663 Clofarabine, 487 Clonazepam, 259 Epilepsy, 234 Clonidine hydrochloride, 94 Clostridium difficile infection, 23 Closure of the ductus arteriosus, 129 Clotrimazole, 464, 618, 648 Ear, 616 Clotrimazole with betamethasone, see Betamethasone with clotrimazole Clotrimazole with hydrocortisone, l l l ▶ ▶ ▶ ▶ l 667 Clozapine, 196 Psychoses and related disorders, 188 Clozaril, 197 Coal tar, 670 Psoriasis, 654 Coal tar with arachis oil extract of coal tar, cade oil, light liquid paraffin and tar, see Arachis oil extract of coal tar with cade oil, coal tar, light liquid paraffin and tar Coal tar with coconut oil and salicylic acid, 671 Coal tar with dithranol and salicylic acid, 671 Coal tar with lecithin, 671 Coal tar with salicylic acid and precipitated sulfur, 671 Coal tar with zinc oxide, 672 l l l l l ▶ ▶ ▶ Return to case study Immune system disorders and transplantation 469 indications) . uncontrolled hypertension (in nontransplant indications) . uncontrolled infections (in nontransplant indications) . use with tacrolimus specifically contraindicated CAUTIONS Hyperuricaemia . in atopic dermatitis Staphylococcus aureus skin infections—not absolute contra-indication providing controlled (but avoid erythromycin unless no other alternative) . in atopic dermatitis allow herpes simplex infections to clear before starting (if they occur during treatment withdraw if severe) . in atopic dermatitis and psoriasis discontinue if lymphoproliferative disorder develops . in psoriasis treat patients with malignant or pre-malignant conditions of skin only after appropriate treatment (and if no other option) INTERACTIONS → Appendix 1 (ciclosporin). For patients other than transplant recipients, preferably avoid other immunosuppressants (increased risk of infection and malignancies, including lymphoma and skin cancer). SIDE-EFFECTS Common or very common Abdominal pain . anorexia . diarrhoea . fatigue . gingival hyperplasia . headache . hepatic dysfunction . hypercholesterolaemia . hyperkalaemia . hyperlipidaemia . hypertension . hypertrichosis . hyperuricaemia . hypomagnesaemia . muscle cramps . myalgia . nausea . paraesthesia . renal dysfunction (renal structural changes on long-term administration) . tremor . vomiting Uncommon Anaemia . oedema . signs of encephalopathy . thrombocytopenia . weight gain Rare Gynaecomastia . haemolytic uraemic syndrome . hyperglycaemia . menstrual disturbances . microangiopathic haemolytic anaemia . motor polyneuropathy . muscle weakness . myopathy . pancreatitis . visual disturbances secondary to benign intracranial hypertension Frequency not known ▶ With intravenous use Anaphylaxis SIDE-EFFECTS, FURTHER INFORMATION Visual disturbances Discontinue if visual disturbances secondary to benign intracranial hypertension occur. PREGNANCY Crosses placenta. There is less experience of ciclosporin in pregnancy but it does not appear to be any more harmful than azathioprine. The use of ciclosporin during pregnancy needs to be supervised in specialist units. BREAST FEEDING Present in milk—manufacturer advises avoid. HEPATIC IMPAIRMENT Dosage adjustment based on bilirubin and liver enzymes may be needed. RENAL IMPAIRMENT In patients with nephrotic syndrome and renal impairment initially 2.5 mg/kg daily. Reduce dose by 25–50% if serum creatinine more than 30% above baseline on more than one measurement. In psoriasis and atopic dermatitis, reduce dose by 25–50% if serum creatinine increases more than 30% above baseline (even if within normal range) and discontinue if reduction not successful within 1 month. PRE-TREATMENT SCREENING In psoriasis, exclude malignancies (including those of skin and cervix) before starting (biopsy any lesions not typical of psoriasis). MONITORING REQUIREMENTS Monitor whole blood ciclosporin concentration (trough level dependent on indication—consult local treatment protocol for details). Dermatological and physical examination, including blood pressure and renal function measurements required at least twice before starting treatment for psoriasis or atopic dermatitis. Monitor liver function. ▶ ▶ ▶ ▶ ▶ ▶ ▶ ▶ l ▶ ▶ l l l l Monitor serum potassium especially in renal dysfunction (risk of hyperkalaemia). Monitor serum magnesium. Measure blood lipids before treatment and after the first month of treatment. In psoriasis and atopic dermatitis monitor serum creatinine every 2 weeks for first 3 months then every month. Investigate lymphadenopathy that persists despite improvement in atopic dermatitis. Monitor kidney function—dose dependent increase in serum creatinine and urea during first few weeks may necessitate discontinuation (exclude rejection of kidney transplant). Monitor blood pressure—discontinue if hypertension develops that cannot be controlled by antihypertensives. In long-term management of nephrotic syndrome, perform renal biopsies every 1–2 years. DIRECTIONS FOR ADMINISTRATION With oral use Mix solution with orange juice (or squash) or apple juice (to improve taste) or with water immediately before taking (and rinse with more to ensure total dose). Do not mix with grapefruit juice. With capsules and oral solution, total daily dose should be taken in 2 divided doses. With intravenous use For intermittent intravenous infusion, dilute to a concentration of 0.5–2.5 mg/mL with Glucose 5% or Sodium Chloride 0.9%; give over 2–6 hours; not to be used with PVC equipment. Observe patient for signs of anaphylaxis for at least 30 minutes after starting infusion and at frequent intervals thereafter. PRESCRIBING AND DISPENSING INFORMATION Brand name prescribing Prescribing and dispensing of ciclosporin should be by brand name to avoid inadvertent switching. If it is necessary to switch a patient to a different brand of ciclosporin, the patient should be monitored closely for changes in blood-ciclosporin concentration, serum creatinine, blood pressure, and transplant function. Sandimmun ® capsules and oral solution are available direct from Novartis for patients who cannot be transferred to a different oral preparation. HANDLING AND STORAGE Keep medicine measure away from other liquids (including water). PATIENT AND CARER ADVICE Patients and carers should be counselled on the administration of ciclosporin capsules and oral solution. Avoid excessive exposure to UV light, including sunlight. In psoriasis and atopic dermatitis, avoid use of UVB or PUVA. Medicines for Children leaflet: Ciclosporin for nephrotic syndrome www.medicinesforchildren.org.uk/ciclosporinnephrotic-syndrome-0 BNFC 2015–2016 l 8 l l ▶ ▶ ▶ ▶ l l l l MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Capsule EXCIPIENTS: May contain Ethanol, ethyl lactate, propylene glycol CICLOSPORIN (Non-proprietary) Ciclosporin 25 mg Ciclosporin 25mg capsules | 30 capsule P no price available Ciclosporin 50 mg Ciclosporin 50mg capsules | 30 capsule P no price available Ciclosporin 100 mg Ciclosporin 100mg capsules | 30 capsule P no price available ▶ Capimune (Mylan Ltd) Ciclosporin 25 mg Capimune 25mg capsules | 30 capsule P £13.05 Ciclosporin 50 mg Capimune 50mg capsules | 30 capsule P £25.50 Ciclosporin 100 mg Capimune 100mg capsules | 30 capsule P £48.50 ▶ l l ▶ ▶ ▶ Immune system disorders and transplantation 469 indications) . uncontrolled hypertension (in nontransplant indications) . uncontrolled infections (in nontransplant indications) . use with tacrolimus specifically contraindicated CAUTIONS Hyperuricaemia . in atopic dermatitis Staphylococcus aureus skin infections—not absolute contra-indication providing controlled (but avoid erythromycin unless no other alternative) . in atopic dermatitis allow herpes simplex infections to clear before starting (if they occur during treatment withdraw if severe) . in atopic dermatitis and psoriasis discontinue if lymphoproliferative disorder develops . in psoriasis treat patients with malignant or pre-malignant conditions of skin only after appropriate treatment (and if no other option) INTERACTIONS → Appendix 1 (ciclosporin). For patients other than transplant recipients, preferably avoid other immunosuppressants (increased risk of infection and malignancies, including lymphoma and skin cancer). SIDE-EFFECTS Common or very common Abdominal pain . anorexia . diarrhoea . fatigue . gingival hyperplasia . headache . hepatic dysfunction . hypercholesterolaemia . hyperkalaemia . hyperlipidaemia . hypertension . hypertrichosis . hyperuricaemia . hypomagnesaemia . muscle cramps . myalgia . nausea . paraesthesia . renal dysfunction (renal structural changes on long-term administration) . tremor . vomiting Uncommon Anaemia . oedema . signs of encephalopathy . thrombocytopenia . weight gain Rare Gynaecomastia . haemolytic uraemic syndrome . hyperglycaemia . menstrual disturbances . microangiopathic haemolytic anaemia . motor polyneuropathy . muscle weakness . myopathy . pancreatitis . visual disturbances secondary to benign intracranial hypertension Frequency not known ▶ With intravenous use Anaphylaxis SIDE-EFFECTS, FURTHER INFORMATION Visual disturbances Discontinue if visual disturbances secondary to benign intracranial hypertension occur. PREGNANCY Crosses placenta. There is less experience of ciclosporin in pregnancy but it does not appear to be any more harmful than azathioprine. The use of ciclosporin during pregnancy needs to be supervised in specialist units. BREAST FEEDING Present in milk—manufacturer advises avoid. HEPATIC IMPAIRMENT Dosage adjustment based on bilirubin and liver enzymes may be needed. RENAL IMPAIRMENT In patients with nephrotic syndrome and renal impairment initially 2.5 mg/kg daily. Reduce dose by 25–50% if serum creatinine more than 30% above baseline on more than one measurement. In psoriasis and atopic dermatitis, reduce dose by 25–50% if serum creatinine increases more than 30% above baseline (even if within normal range) and discontinue if reduction not successful within 1 month. PRE-TREATMENT SCREENING In psoriasis, exclude malignancies (including those of skin and cervix) before starting (biopsy any lesions not typical of psoriasis). MONITORING REQUIREMENTS Monitor whole blood ciclosporin concentration (trough level dependent on indication—consult local treatment protocol for details). Dermatological and physical examination, including blood pressure and renal function measurements required at least twice before starting treatment for psoriasis or atopic dermatitis. Monitor liver function. ▶ ▶ ▶ ▶ ▶ ▶ ▶ ▶ l ▶ ▶ l l l l Monitor serum potassium especially in renal dysfunction (risk of hyperkalaemia). Monitor serum magnesium. Measure blood lipids before treatment and after the first month of treatment. In psoriasis and atopic dermatitis monitor serum creatinine every 2 weeks for first 3 months then every month. Investigate lymphadenopathy that persists despite improvement in atopic dermatitis. Monitor kidney function—dose dependent increase in serum creatinine and urea during first few weeks may necessitate discontinuation (exclude rejection of kidney transplant). Monitor blood pressure—discontinue if hypertension develops that cannot be controlled by antihypertensives. In long-term management of nephrotic syndrome, perform renal biopsies every 1–2 years. DIRECTIONS FOR ADMINISTRATION With oral use Mix solution with orange juice (or squash) or apple juice (to improve taste) or with water immediately before taking (and rinse with more to ensure total dose). Do not mix with grapefruit juice. With capsules and oral solution, total daily dose should be taken in 2 divided doses. With intravenous use For intermittent intravenous infusion, dilute to a concentration of 0.5–2.5 mg/mL with Glucose 5% or Sodium Chloride 0.9%; give over 2–6 hours; not to be used with PVC equipment. Observe patient for signs of anaphylaxis for at least 30 minutes after starting infusion and at frequent intervals thereafter. PRESCRIBING AND DISPENSING INFORMATION Brand name prescribing Prescribing and dispensing of ciclosporin should be by brand name to avoid inadvertent switching. If it is necessary to switch a patient to a different brand of ciclosporin, the patient should be monitored closely for changes in blood-ciclosporin concentration, serum creatinine, blood pressure, and transplant function. Sandimmun ® capsules and oral solution are available direct from Novartis for patients who cannot be transferred to a different oral preparation. HANDLING AND STORAGE Keep medicine measure away from other liquids (including water). PATIENT AND CARER ADVICE Patients and carers should be counselled on the administration of ciclosporin capsules and oral solution. Avoid excessive exposure to UV light, including sunlight. In psoriasis and atopic dermatitis, avoid use of UVB or PUVA. Medicines for Children leaflet: Ciclosporin for nephrotic syndrome www.medicinesforchildren.org.uk/ciclosporinnephrotic-syndrome-0 8 Malignant disease Index 951 BNFC 2015–2016 Cetrimide with chlorhexidine, 687 Cetrimide with undecenoic acid, 683 Changes, xvi Charcoal, activated, 759 Emergency treatment of poisoning, 752 Charcodote, 759 Chenodeoxycholic acid, 57 Biliary disorders, 56 Chirocaine, 745 Chloral hydrate, 265 Chlorambucil, 481 Chloramphenicol, 284, 604, 617 Ear, 616 ChloraPrep, 685 Chlorhexidine, 628, 684 Mouthwashes and other preparations for oropharyngeal use, 627 Chlorhexidine gauze dressing, 1094 Chlorhexidine gluconate with isopropyl alcohol, 685 Chlorhexidine hydrochloride with hydrocortisone and nystatin, 667 Chlorhexidine with cetrimide, see Cetrimide with chlorhexidine Chlorhexidine with chlorobutanol, Step 2: Locate monograph and Pretreatment screening. Malignant disease Step 1: Search the BNF for Children index for ciclosporin. MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Capsule EXCIPIENTS: May contain Ethanol, ethyl lactate, propylene glycol CICLOSPORIN (Non-proprietary) Ciclosporin 25 mg Ciclosporin 25mg capsules | 30 capsule P no price available Ciclosporin 50 mg Ciclosporin 50mg capsules | 30 capsule P no price available Ciclosporin 100 mg Ciclosporin 100mg capsules | 30 capsule P no price available ▶ Capimune (Mylan Ltd) Ciclosporin 25 mg Capimune 25mg capsules | 30 capsule P £13.05 Ciclosporin 50 mg Capimune 50mg capsules | 30 capsule P £25.50 Ciclosporin 100 mg Capimune 100mg capsules | 30 capsule P £48.50 ▶ continue to answers part 2 Screening and monitoring Answers 1. In psoriasis, exclude malignancies (including skin and cervix malignancies) before starting. 2. General monitoring requirements and monitoring requirements specific to dermatitis/psoriasis: • Monitor whole blood ciclosporin concentration (through level dependent on indication – consult local treatment protocol for details). •Dermatological and physical examination, including blood pressure and renal function measurements, required at least twice before starting treatment for psoriasis or atopic dermatitis. • Monitor liver function. • Monitor serum potassium especially in renal dysfunction (risk of hyperkalaemia). • Monitor serum magnesium. • Measure blood lipids before treatment and after the first month of treatment. • In psoriasis and atopic dermatitis monitor serum creatinine every two weeks for first three months then every month. • Investigate lymphadenopathy that persists despite improvement in atopic dermatitis. • Monitor kidney function – dose dependent increase in serum creatinine and urea during first few weeks may necessitate discontinuation (exclude rejection of kidney transplant). • Monitor blood pressure – discontinue if hypertension develops that cannot be controlled by antihypertensives. Finding the information in the app or online • Ensure the correct content set (adult or child) is selected in the app. • Navigate to the relevant drug by searching ‘ciclosporin’. • Navigate to the relevant monograph sections Pre-treatment screening and Monitoring requirements. Return to case study return to answers part 1 Side-effects, cautions, allergy and cross-sensitivity How to find the information online Step 1: Search ‘ibuprofen’. Return to case study Step 2: Use the navigation pane to jump between section titles or scroll down to the relevant sections (Cautions, Allergy and cross-sensitivity, Side-effects). continue to answers part 2 Side-effects, cautions, allergy and cross-sensitivity Answers 1. Oral use is cautioned in ulcerative colitis. 2. Ibuprofen is contraindicated in adults and children with a history of hypersensitivity to aspirin or any other non-steroidal anti-inflammatory drug (NSAID). 3. Blood disorders are a side-effect of ibuprofen. Blood disorders can be a side-effect of oral use but the frequency is not known. How to find the information in print • • • • Search the BNF index for ibuprofen. Locate Cautions in the monograph. In the monograph, locate Allergy and cross-sensitivity information. Locate Side-effects in the monograph. How to find the information on the app • Ensure the correct content set (adult or child) is selected in the app. • Search ‘ibuprofen’ from within the drugs section. • Select the ibuprofen monograph and choose the relevant sections (Cautions and Potency, Allergy and cross-sensitivity, and Side-effects) from the menu. Return to case study return to answers part 1 Interactions How to find the information on the app The app has an interactions checker, which allows you to add multiple drugs and check for pairwise interactions. Step 1: Select the interactions icon to enter the checker. Step 2: Add the relevant drugs. Return to case study Step 3: Click to see interactions information. Step 4: The interactions information is also listed in the Interactions section of the monograph, which allows you to browse all of the interactions for one drug. Step 5: When in a drug monograph, drugs may be added to the interactions checker using the symbol top right. continue to answers part 2 Interactions Answers 1. C arbamazepine reduces the effect of doxycycline, as it accelerates metabolism. It is not a ‘black dot’ interaction. How to find the information in print • Search for Appendix 1 Interactions in the BNF. • Drugs in Appendix 1 are listed alphabetically. Searching under antiepileptics directs you to go to single monographs. • Search for carbamazepine, check interaction with antibacterials and find doxycycline. How to find this information online • Search either drug. • Use the navigation pane to jump to the Interactions section. • Click on the hyperlinked drug name. Return to case study return to answers part 1 Funding How to find this information online Step 1: Navigate to the relevant drug by searching ‘omalizumab’. Return to case study Step 2: Navigate to the relevant monograph section National funding/ access decisions. continue to answers part 2 Funding Answers 1. It is not appropriate for a GP to solely manage treatment with Xolair®. NICE technology appraisal Omalizumab for previously treated chronic spontaneous urticarial (TA339) recommends that treatment with omalizumab (Xolair®) should be administered under the management of a secondary care specialist in dermatology, immunology or allergy for the treatment of previously treated chronic spontaneous urticaria. 2. Omalizumab is stopped at or before the fourth dose if the condition has not responded. How to find the information in print • Search index for omalizumab. • Locate monograph and National funding/access decisions. How to find the information in the app • Ensure the correct content set (adult or child) is selected in the app. • Navigate to the relevant drug by searching ‘omalizumab’. • Navigate to the relevant monograph section National funding/access decisions. Return to case study return to answers part 1