New devices and guidance available for management of COPD and asthma

Transcription

1 New devices and guidance available for management of COPD and Item Type Article Authors Ging, Patricia;Conroy, Leah;Johnston, Grainne;Kehoe, Brona;Brown, Jennifer Publisher Nursing in General Practice Journal Nursing in General Practice Download date 23/08/ :35:44 Link to Item Find this and similar works at -

2 nursingingeneralpractice clinical review New devices and guidance available for management of COPD and a sthma PATRICIA GING, LEAH CONROy, GRAINNE JOHNSTON, BRONA kehoe, JENNIFER BROWN, PHArMACY DEPT., MATEr MISErICDIAE UNIVErSITY HOSPITAL, DUBLIN Nurses will have noticed a recent explosion in the number of new inhalers becoming available for the management of and even more so for COPD. There are new devices and new drugs to become familiar with (as well as expanded indications for some existing agents) and nurses may have already observed changes in prescribing patterns. This article will discuss the evolving place of these new agents in the context of limited health budgets, updated GOLD guideline s 1 and the Health Service Executive (HSE) Medicines Management Programme (MMP) 2, 3 as well as an overview of the newer inhalers available on the Irish market. The HSE spent in excess of 107 million 2 on inhaled therapies in 2013 so it is no surprise that the MMP has identified inhaled therapies as a priority with regard to cost containment and rationalisation. Medicines Management Programme COPD Inhaled drugs have been identified as a priority by the MMP and drawing on these guidelines, the MMP has collated information on the most appropriate treatment options for patients with COPD. Table 1 details a selection of currently licensed agents in each therapeutic category. (There are currently over 50 different inhalers reimbursable on the PCrS). The MMP do not specify preferred drugs in each category but recommend that: Prescribers should be mindful of variations in cost when prescribing inhaled therapies for the treatment of COPD and should endeavour to prescribe the least expensive inhaler device that is appropriate for a particular patient, in line with international best practice. Some device suggestions are given in each disease category on the basis of cost. GOLD Guidelines updated In 2014 the International GOLD 1 guidelines for COPD were updated. Patient classification and treatment recommendations now consider patient s symptom burden, the degree of airflow obstruction on spirometry (FEV1) and the annual number of exacerbations leading to hospitalisation. [Table 1] recent evidence has shown a link between use of inhaled corticosteroids and pneumonia in COPD and this information plus the guidance on the risk of fractures has informed these new GOLD guidelines. This information is likely to reduce the prescribing of Seretide and Symbicort inhalers in COPD and encourage the use of s or / combinations. Device choice There are numerous agents available in each therapeutic category (see Table 2) with subtle differences in terms of licensed indications, cautions and contraindications. Therefore, for an individual patient the choice is likely to be made on device and cost rather than drug. A patient s ability to use inhalers correctly is crucial when choosing an inhaler. The prescription should be individualised for each patient, taking into account ability to use the device (considering dexterity, cognition and inspiratory flow rate) and patient preferences, among other factors. Basic categories of devices available in Ireland include: dry inhalers (DPIs), pressurised metered dose inhalers (pmdis), breath-actuated MDI (BA MDI) and soft mist Inhalers (SMI). Within these broad categories there are numerous different devices. HSE device recommendations include: 2,3 1. Prescribe the same inhaler device for each drug. Avoid switching between devices unless required. This removes the need to train the patient on using multiple device types, 19

3 clinical review nursingingeneralpractice Table 1 COPD Patient Categories with first and second line treatment recommendations Patient Group A B C D Symptom Burden Low risk less symptoms * COPD Assessment Test<10 1 annual exacerbation Spirometry Gold stage 1-2 Low Risk more symptoms COPD Assessment Test 10 1 annual exacerbation Spirometry Gold stage 1-2 High Risk less symptoms COPD assessment test <10 2 annual exacerbations Spirometry Gold stage 3-4 High risk more symptoms COPD assessment test 10 2 annual exacerbations Spirometry Gold stage 3-4 Recommended Treatment SAMA PRN SABA PRN ICS plus ICS plus And/or MMP suggested inhaler 3 Ipratropium MDI Salbutamol MDI Glycopyrronium (Seebri DPI) Salmeterol Diskus (DPI) Indacaterol 150 micrograms (Onbrez Breezehaler DPI) Bufomix Easyhaler 320/9 Glycopyrronium (Seebri DPI) As above Second line treatment or Combination SAMA/SABA / combination / combination /PDE4 inhibitor /PDE4 inhibitor ICS plus / combination ICS plus plus PDE4 inhibitor OR / combination or plus PDE4 inhibitor SAMA= Short acting anticholinergic, SABA = short acting beta agonist, = Long acting beta agonist, =Long acting anti-cholinergic, ICS= Inhaled corticosteroids. PDE4 inhibitor= phosphodiesterase inhibitor (e.g. roflumilast not reimbursed by GMS) *The COPD assessment test is a measure of symptom burden in COPD. (Adapted from the GOLD Guidelines and MMP3 for COPD) and avoids confusion. Switching between device types can result in incorrect dosing, adverse effects and drug wastage. A spacer device, e.g. Volumatic, may be useful when coordinating actuation and is a problem. (Note only Volumatic and Babyhaler spacer devices are reimbursable in Ireland). 2. pmdi are the least expensive inhaler devices and consequently, should be considered first line treatment for. 3. DPIs are often preferred in COPD due to improved drug deposition within the lungs. 4. Some COPD patients may have difficulty using a DPI, which often involves loading the dose, so a pmdi, BA MDI or SMI may be considered. A spacer device, e.g. Volumatic, may be useful where coordinating pmdi actuation and is problematic. 5. DPIs are useful for those who are unwilling or unable to use a pmdi. However, inspiratory flow rate must be sufficient. 6. More than one puff per dose of Seretide Diskus is NEVER indicated Medicines Management Programme Asthma For Asthma the MMP 2 has made some specific recommendations based around the stepwise GINA guidelines Beclometasone is the least expensive ICS and is preferred by the MMP on the basis of cost and should be considered first when prescribing an ICS. 8. A single inhaler device containing a combination of ICS and is preferred where this combination is indicated 9. Where a patient is accustomed to using a DPI for the maintenance treatment of (either as ICS monotherapy or combined ICS/), terbutaline DPI (i.e. Bricanyl Turbohaler) is preferred by the MMP for reliever therapy on the basis of cost. (This means the MMP are not recommending using the SMART (Symbicort) protocol). Conclusion This is an interesting time for nurses working with patients with respiratory disease. Practice nurses are uniquely placed to ensure that patients are prescribed the most suitable and cost effective device and are enabled to use it correctly. Endnotes 1. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) Available from: Accessed 07/12/ Health Service executive Medicines Management Programme. Inhalers for in and children 6 years and older. Prescribing and cost guidance. Available from natclinprog/medicinemanagementprogramme/yourmedicines/ prescribingtips/%20medicines.pdf Accessed 07/12/ Health Service Executive Medicines Management Programme. Inhaled Medicines for COPD. Prescribing and Cost Guidance. Available from medicines.pdf Accessed 07/12/ Global Strategy for Asthma Management and Prevention, Global Initiative forasthma (GINA) Available from: Accessed on 07/12/

4 THE FIRST ONCE-DAILY DUAL BRONCHODILATOR 1 ULTIBRO BREEZHALER START A NEW CHAPTER IN COPD mcg indacterol maleate/43mcg glycopyrronium bromide Once-daily ULTIBRO BREEZHALER is indicated as maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 1 Ultibro Breezhaler This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions. ABBREVIATED PRESCRIBING INFORMATION Please refer to Summary of Product Characteristics (SmPC) before prescribing. Presentation: Ultibro Breezhaler 85mcg / 43mcg hard capsules containing indacaterol maleate and glycopyronium bromide respectively and separate Ultibro Breezhaler inhaler. Indications: A maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Dosage and administration: Recommended dose is the of the content of one capsule once daily, administered at the same time of the day each day, using the Ultibro Breezhaler inhaler. Capsules must not be swallowed. No dose adjustment required in elderly patients, for patients with mild and moderate hepatic impairment or for patients with mild to moderate renal impairment. No data available for use in patients with severe hepatic impairment and should only be in patients with severe renal impairment or end-stage renal disease requiring dialysis if the expected benefit outweighs the potential risk. No relevant use in the paediatric population. Contraindications: Hypersensitivity to the. Warnings/Precautions: Not to be administered concomitantly with medicinal products containing other s or s. Asthma: ULTIBRO BREEZHALER SHOULD NOT BE USED FOR TREATMENT OF ASTHMA. Acute use: Not indicated for treatment of acute episodes of bronchospasm. Hypersensitivity related to indacaterol: Immediate hypersensitivity reactions have been reported after administration of indacaterol. If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, treatment should be discontinued immediately and alternative therapy instituted. Paradoxical bronchospasm: If paradoxical bronchospasm occurs, Ultibro Breezhaler should be discontinued immediately and alternative therapy instituted. Anticholinergic effects related to glycopyrronium: To be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Patients with severe renal impairment: Should only be used in patients with severe renal impairment, including those with end-stage renal disease requiring dialysis, if the expected benefit outweighs the potential risk. These patients should be monitored closely for potential adverse reactions. Cardiovascular effects: To be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with known or suspected prolongation of the QT interval or patients treated with medicinal products affecting the QT interval and in patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged. s may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms, ECG changes. In case such effects occur, treatment may need to be discontinued. Hypokalaemia: s may produce significant hypokalaemia in some patients, which has the potential to produce cardiovascular effects. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment which may increase the susceptibility to cardiac arrhythmias. Hyperglycaemia: of high doses of s may produce increases in plasma glucose. Upon initiation of treatment with Ultibro Breezhaler plasma glucose should be monitored more closely in diabetic patients. Ultibro Breezhaler has not been investigated in patients for whom diabetes mellitus is not well controlled. General disorders: To be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to s. Excipients: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Pregnancy and Lactation: Ultibro Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus. Not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk. Use of Ultibro Breezhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant. Interactions: Concomitant use is not recommended with beta-adrenergic blockers, anticholinergics or sympathomimetic agents. Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution. Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-gp, does not raise any safety concerns given the safety experience of treatment with indacaterol. No clinically relevant drug interaction is expected when glycopyrronium is co-administered with cimetidine or other inhibitors of the organic cation transport. Adverse reactions: Very common: upper respiratory tract infection. Common: nasopharyngitis, urinary tract infection, sinusitis, rhinitis, dizziness, headache, cough, oropharyngeal pain including throat irritation, dyspepsia, dental caries, gastroenteritis, musculoskeletal pain, pyrexia, chest pain. Uncommon: hypersensitivity, diabetes mellitus and hyperglycaemia, insomnia, paraesthesia, glaucoma, ischaemic heart disease, atrial fibrillation, tachycardia, palpitations, paradoxical bronchospasm, epistaxis, dry mouth, pruritus / rash, muscle spasm, myalgia, pain in extremity, bladder obstruction and urinary retention, peripheral oedema and fatigue. Please refer to SmPC for a full list of adverse events for Ultibro Breezhaler. Legal Category: POM Pack sizes: Cartons containing 6 capsules (1x6 capsule blister strips) and one Ultibro Breezhaler inhaler or 30 capsules (5x6 capsule blister strips) and one Ultibro Breezhaler inhaler. Marketing Authorisation Holder: Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom. Marketing Authorisation Numbers: EU/1/13/862/001 & 003.Full prescribing information is available on request from Novartis Ireland Ltd, Beech Hill Office Campus, Clonskeagh, Dublin 4. Tel: or at Date of Creation of API Text: February 2014 Date of Preparation: October 2014 References: 1.Ultibro Breezhaler SmPC. accessed on Nov Vogelmeier CF, Bateman ED, Pallante J, et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone in patients with COPD (ILLUMINATE): a randomised, double-blind, prallel group study. Lancet Respir Med. 2013;1: Bateman ED, Ferguson GT, Barnes et al. Dual bronchodilation with QVA149 vs single bronchodilatot therapy: the SHINE study. EUR Respir J. Published online May 2013 as doi: / Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of chronic obstructive pulnmonary disease exacerbations with the dual bronchodilator therapy QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel group study. Lancet Respir Med. 2013;1: IE02/ULT14-CNF098b

5 Reference: 1. SPIRIVA Respimat 2.5μg Summary of Product Characteristics. ICS: inhaled corticosteroids; : long-acting beta 2 agonist SPIRIVA Respimat : New for Asthma Prescribing Information (Ireland) SPIRIVA RESPIMAT (tiotropium) Solution for containing 2.5 microgram tiotropium (as bromide monohydrate) per puff. Indication: COPD: Tiotropium is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD). Asthma: Spiriva Respimat is indicated as an add-on maintenance bronchodilator treatment in adult patients with who are currently treated with the maintenance combination of inhaled corticosteroids ( 800 μg budesonide/day or equivalent) and long-acting β 2 agonists and who experienced one or more severe exacerbations in the previous year. Dose and Administration: Adults only age 18 years or over: 5 microgram tiotropium given as two puffs from the Respimat inhaler once daily, at the same time of the day. Contraindications: Hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to ; benzalkonium chloride, disodium edetate, purified water, hydrochloric acid 3.6 % (for ph adjustment). Warnings and Precautions: Not for the initial treatment of acute episodes of bronchospasm or for the relief of acute symptoms. Spiriva Respimat should not be used as (first-line) monotherapy for. Asthma patients must be advised to continue taking anti-inflammatory therapy, i.e. inhaled corticosteroids, unchanged after the introduction of Spiriva Respimat, even when their symptoms improve. Immediate hypersensitivity reactions may occur after administration of tiotropium bromide solution for. Caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction. Inhaled medicines may cause -induced bronchospasm. Caution in patients with known cardiac rhythm disorders. In patients with moderate to severe renal impairment (creatinine clearance 50 ml/min) tiotropium bromide should be used only if the expected benefit outweighs the potential risk. Patients should be cautioned to avoid getting the spray into their eyes. They should be advised that this may result in precipitation or worsening of narrow-angle glaucoma, eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema. Should any combination of these eye symptoms develop, patients should stop using tiotropium bromide and consult a specialist immediately. Tiotropium bromide should not be used more frequently than once a day. Interactions: Although no formal drug interaction studies have been performed, tiotropium bromide has been used

6 Add-on maintenance bronchodilator treatment for adult patients treated with maintenance combination of ICS ( 800 μg budesonide/day or equivalent) and who experienced 1 severe exacerbations in the previous year 1 concomitantly with other drugs commonly used in the treatment of COPD and, including sympathomimetic bronchodilators, methylxanthines, oral and inhaled steroids, antihistamines, mucolytics, leukotriene modifiers, cromones, anti-ige treatment without clinical evidence of drug interactions. The co-administration of tiotropium bromide with other anticholinergiccontaining drugs has not been studied and is therefore not recommended. Fertility, Pregnancy and Lactation: Very limited amount of data in pregnant women. Avoid the use of Spiriva Respimat during pregnancy. It is unknown whether tiotropium bromide is excreted in human breast milk. Use of Spiriva Respimat during breast feeding is not recommended. A decision on whether to continue/discontinue breast feeding or therapy with Spiriva Respimat should be made taking into account the benefit of breast feeding to the child and the benefit of Spiriva Respimat therapy to the woman. Clinical data on fertility are not available for tiotropium. Effects on ability to drive and use machines: No studies have been performed. The occurrence of dizziness or blurred vision may influence the ability to drive and use machinery. Undesirable effects: COPD: Common ( 1/100 to < 1/10) Dry mouth. Uncommon ( 1/1000 to < 1/100) Dizziness, headache, atrial fibrillation, palpitations, supraventricular tachycardia, tachycardia, cough, epistaxis, pharyngitis, dysphonia, constipation, oropharyngeal candidiasis, dysphagia, rash, pruritus, urinary retention, dysuria. Asthma: Common ( 1/100 to < 1/10) Dry mouth. Uncommon ( 1/1000 to < 1/100) Dizziness, headache, insomnia, palpitations, cough, pharyngitis, dysphonia, bronchospasm, oropharyngeal candidiasis. Serious undesirable effects include anaphylactic reaction and consistent with anticholinergic effects: glaucoma, constipation, intestinal obstruction including ileus paralytic and urinary retention. An increase in anticholinergic effects may occur with increasing age. Prescribers should consult the Summary of Product Characteristics for further information on undesirable effects. Pack sizes: Single pack: 1 Respimat inhaler and 1 cartridge providing 60 puffs (30 medicinal doses). Legal category: POM. MA number: PA 775/2/2. Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, D Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information. Additional information is available on request from Boehringer Ingelheim Ireland Ltd, The Hyde Building, The Park, Carrickmines, Dublin 18. Prepared in September IRE/SPR d Date of preparation: September 2014

7 clinical review nursingingeneralpractice Table 2. Selection of newly and recently licensed inhalers for and COPD (Pharmacy Department Mater Misericordiae University Hospital) Brand 1 Device Generic Drug Name 5 Class 5 Dose 5 Licensed Indication 5 Contraindications 5 Cautions 5 Picture Price (MIMS) 6 Type 5 Eklira Genuair Aclidinium (322 micrograms) per dose One twice daily Maintenance bronchodilator for COPD in Deterioration of disease Patients with a myocardial infarction in the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for NYHA heart failure classes III and IV No dose adjustment in renal impairment ( Seebri Breezhaler hard capsules Glycopyrronium (44 micrograms) One capsule once daily Maintenance bronchodilator for COPD in Patients with narrow-angle glaucoma or urinary retention Patients with severe renal impairment Patients with a history of cardiovascular disease Spiriva Handihaler hard capsules Tiotropium 18 micrograms per One capsule once daily Bronchodilator treatment to relieve symptoms of COPD. Hypersensitivity to the active substances, to atropine or to any of the excipients which include milk protein Patients with narrow-angle glaucoma or bladder neck obstruction Patients with severe renal impairment Dry mouth may lead to dental caries Spiriva respimat Solution for delivered as a soft mist Tiotropium 2.5 micrograms per dose Two s once daily Maintenance bronchodilator in COPD Add-on maintenance bronchodilator treatment in Hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients Patients with narrow-angle glaucoma or urinary retention Dry mouth may be associated with dental caries Patients with severe renal impairment CF Not to be used as monotherapy for Cardiac rhythm disorders (60 puffs=30 doses) Incruse 55 Micrograms Ellipta predispensed Umeclidium (55 micrograms) One once daily Maintenance bronchodilator for COPD in Patients with narrow-angle glaucoma or urinary retention Patients with severe renal impairment Patients with a history of cardiovascular disease Expected launch 2015 Anoro Ellipta predispensed Umeclidium (55 micrograms) and Vilanterol (22 micrograms) per One once daily Maintenance bronchodilator for COPD in Patients with severe cardiovascular disease Patients with narrow-angle glaucoma or urinary retention Patients with convulsive disorders or thyrotoxicosis 247 / 24

8 nursingingeneralpractice clinical review / Brand 1 Device Generic Drug Name 5 Class 5 Dose 5 Licensed Indication 5 Contraindications 5 Cautions 5 Picture Price (MIMS) 6 Type 5 Ultibro Breezhaler hard capsules Onbrez Breezhaler hard capsules Indacaterol (85 micrograms) and Glycopyrronium (43 micrograms) Indacterol (150 micrograms) One capsule once daily Maintenance bronchodilator for COPD in One capsule once daily Maximum dose of 300 micrograms once daily Maintenance bronchodilator for COPD in Should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists Not indicated for the treatment of acute episodes of bronchospasm Patients with known or suspected prolongation of the QT interval or treated with medicines affecting the QT interval Hypokalaemia (150 micrograms, 30 doses) Striverdi respimat Solution for delivered as a soft mist Indacterol (300 micrograms) Olodaterol (2.5 micrograms ) Two s once daily Maintenance bronchodilator for COPD in Hypersensitivity to olodaterol or to any of the excipients Cardiovascular disorders, especially ischaemic heart disease, severe cardiac decompensation, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, hypertension, and aneurysm. Myocardial infarction during the previous year. Convulsive disorders Thyrotoxicosis Hospitalized for heart failure during the previous year. Paroxysmal tachycardia (300 micrograms, 30 doses) ( 6 0p u ff s) Oxis Turbohaler Seretide Evohaler Pressurised, suspension Formoterolfumaratedihydrate (6 micrograms) per Formoterol fumarate dihydrate (12 micrograms) Salmeterol (25 micrograms) and Fluticasone propionate (50 micrograms, 125 micrograms, or 250 micrograms) One or two s once or twice daily Max. 12 (8 in COPD) s within 24 hours No more than 6 (4 in COPD) s on any occasion One once or twice daily Max. 6 (4 in COPD) s within 24 hours No more than 3 (2 COPD) s on any occasion The dose should be titrated to the lowest dose at which effective control of symptoms is maintained Two s twice daily Children 4-12 years old; two s of the 25/50 strength twice daily Add-on therapy to maintenance treatment with inhaled corticosteroids in when corticosteroids are not sufficient Can be used relief medication to relieve acute broncho-obstructive symptoms in Relief of broncho-obstructive symptoms in COPD regular treatment of where use of a combination product ( and inhaled steroid) is appropriate i.e. patients not adequately controlled with inhaled corticosteroids and as needed inhaled SABA, or, patients already adequately controlled on both inhaled corticosteroid and Note: not licensed for COPD Hypersensitivity to the Should not be used (and is not sufficient) as first line treatment for Patients not to be initiated during an exacerbation, worsening or deteriorating Patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic sub-valvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders QTc-interval prolongation possible Should not be used to treat acute symptoms for which a fast and short acting bronchodilator is required. Not to be initiated during an exacerbation, or if significantly worsening or acutely deteriorating. Patients with severe cardiovascular disorders, heart rhythm abnormalities, diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium. Patients with pulmonary tuberculosis. Treatment should not be stopped abruptly. may occur. Patients on CYP3A inhibitors (6 micrograms, (12 micrograms, (50 micrograms Evohaler, (125 micrograms Evohaler, (250 micrograms Evohaler, / Corticosteroid 25

9 clinical review nursingingeneralpractice Brand 1 Device Generic Drug Name 5 Class 5 Dose 5 Licensed Indication 5 Contraindications 5 Cautions 5 Picture Price (MIMS) 6 Type 5 Seretide Diskus predispensed Salmeterol (50 micrograms) and Fluticasone propionate (100 micrograms, 250 micrograms, or 500 micrograms) The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Asthma; one twice daily COPD; one of the 50/500 strength twice daily As above Also indicated for the symptomatic treatment of patients with COPD, with a FEV1<60% predicted normal (prebronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. Should not be used to treat acute symptoms Should not be initiated during an exacerbation, or if significantly worsening or acutely deteriorating. Treatment should not be stopped abruptly. Patients with pulmonary tuberculosis. may occur. Very rare reports of increases in blood glucose Patients on CYP3A inhibitors (100 micrograms Diskus, (250 micrograms Diskus, (500 micrograms Diskus, / Corticosteroid Symbicort Turbohaler Corticosteroid/ SMART (Symbicort maintenance and reliever therapy) Budesonide (100 micrograms) (6 micrograms) Budesonide (200 micrograms) (6 micrograms) Budesonide (400 micrograms) (12 micrograms) One to two s twice daily. Max of 4 s twice daily. Children less than 6 years; 2 s twice daily One to two s twice daily. Max of 4 s twice daily. A lower strength is available for children 6-11 years. One to two s twice daily. Max of 4 s twice daily. A lower strength is available for children 6-11 years. Regular treatment of where use of a combination product ( and inhaled steroid) is appropriate Symptomatic treatment of patients with severe COPD (FEV1< 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators Bufomix Easyhaler Budesonide (160 micrograms) (4.5 micrograms) One to two s twice daily Maximum of four s twice daily Regular treatment of where use of a combination treatment is indicated Symptomatic treatment of patients with severe COPD (FEV1< 50% predicted) and a history of repeated exacerbations, who have significant symptoms Dose should be tapered when the treatment is discontinued. may occur Systemic effects of inhaled corticosteroids. Should not be initiated during an exacerbation, or if significantly worsening or acutely deteriorating. opharyngeal candida infection. Caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic sub-valvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure. Taper dose upon discontinuation Patients not to be initiated during an exacerbation, worsening or deteriorating Patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic sub-valvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders QTc-interval prolongation possible (100 micrograms, (200 micrograms, (400 micrograms, 60 doses) Corticosteroid/ Budesonide (320 micrograms) (9 micrograms) One twice daily Maximum of two s twice daily relvar Ellipta predispensed Fluticasone furoate (92 micrograms) and Vilanterol (22 micrograms) per One once daily Regular treatment of Symptomatic treatment of with COPD where FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history. Deterioration of disease Patients with severe cardiovascular disease Patients with moderate to severe hepatic impairment Signs of systemic corticosteroid effects Diabetic patients due to increased blood glucose levels. Patients on CYP3A inhibitors Corticosteroid/ Novolizer (Budelin) Fluticasone furoate (184 micrograms) and Vilanterol (22 micrograms) per Budesonide (200 micrograms) Budesonide (400 micrograms) The dose depends on the type, severity of the disorder. Maximum 800 micrograms twice daily in 24hrs for an adult and 400 micrograms twice daily in 24hrs for a child (6-12 years) Regular treatment of regular treatment of persistent Avoid concomitant use of ketoconazole, HIV Protease Inhibitors or other CYP3A4 inhibitors Not indicated for treatment of acute dyspnoea or status ticus Close observation of patients with both active and quiescent pulmonary tuberculosis and fungal/viral infections Reduced elimination rate in severe hepatic dysfunction (100 doses) Corticosteroid Endnotes 5. Summary of Product Characteristics. Available at last accessed 07/12/15 6. MIMS Monthly Index of Medical Specials September 2014 Publisher MPI Media 26