The Latest Medications A Pharmacological Update for RTs

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1 The Latest Medications A Pharmacological Update for RTs Douglas S. Gardenhire, EdD, RRT-NPS, FAARC Associate Professor and Chairman Department of Respiratory Therapy Georgia State University

2 Objectives Identify related drug groups in respiratory therapy. Determine changes to pulmonary medication in the US. Describe clinical application of aerosol agents.

3 Overview Pulmonary Drug Agents Beta Agonists Anticholinergics Inhaled Corticosteroids Non-steroidal Agents Inhaled steroid Agents Combination Therapy Surfactants Other Agents of Interest

4 b 2 Agonists

5 Myth vs. Fact Deletions of Beta Agonists Alupent (metaproterenol) Inhalation Aerosol Boehringer Ingelheim June 14, 2010 Still available as generic liquid and syrup Epinephrine (Primatenemist) Armstrong December 31, 2011 Maxair (pirbuterol) Graceway December 31, 2013 Metaproterenol (Alupent) Tablet and Syrup are available

6 Deletions of Beta Agonists (cont.) Bronkosol (isoetherine) Removed from market Isuprel (isoproterenol) Only available as Injectable Breathaire and Bricanyl (terbutaline) Available as Injectable or tablet Generic Only Foradil Certihaler & Aerolizer Formoterol

7 Asthmanefrin Over-the-counter 11.25mg Racemic Epinephrine Atomizer 1-3 inhalations, not more often than Q3h $50 Atomizer/10 doses $30 doses Nephron Pharmaceuticals

8 Prime Asthma Relief Over-the-counter 0.22 mg Epinephrine DPI $35 DPI/20 doses $35 40 dose refill Age 4+ Dr Natural Healing

9 Epi Mist Over-the-counter Racemic Epi )Equivalent 0.22 mg Epinephrine) Bulb Atomizer Squeeze bulb 3-5 time Equal to 1 inhalation Age 4+ To be released soon! Dr Natural Healing

10 Indacaterol (Arcapta) Selective Beta 2 receptor activation Ultra-long-acting bronchodilator Approved July 2011 Duration up to 24 hrs Dosage DPI 75mcg/puff

11 Olodaterol Striverdi Respimat COPD 2.5mcg 2 inhalations once daily

12 Pro Air RespiClick DPI Age 4 and Older Indications Bronchospasm EIB Dose Counter Expires 10 months after opening Loss of dose with repeated opening Approved April 2016

13 Anticholinergics

14 Combination Anticholinergics Combivent Inhalation Aerosol (albuterol and ipratropium in combination) Boehringer Ingelheim December 31, 2013 Duoneb and generic solutions available

15 From Gardenhire, DS Rau s Respiratory Care Pharmacology,, 2016 Mosby, St. Louis, MO

16 New Delivery Mechanism COMBIVENT RESPIMAT is a propellant-free inhaler with the 2-in-1 COPD efficacy of COMBIVENT Inhalation Aerosol 1 COMBIVENT RESPIMAT has a delivery mechanism that relies on a spring, rather than propellants, to generate a slow-moving mist from a solution of medication contained in the cartridge 2 1. COMBIVENT RESPIMAT [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; Data on file. Boehringer Ingelheim Pharmaceuticals, Inc. Please see Important Safety Information on slides and full Prescribing Information for both COMBIVENT RESPIMAT and COMBIVENT Inhalation Aerosol.

17 Dose Indicator and Last-Dose Locking Mechanism COMBIVENT RESPIMAT [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; Please see Important Safety Information on slides and full Prescribing Information for both COMBIVENT RESPIMAT and COMBIVENT Inhalation Aerosol. RESPIMAT has a dose indicator that shows approximately how much medicine is left. When it reaches the red zone, there is enough medicine for 7 days It also has a last-dose locking mechanism when all medicine has been used

18 Aclidinium bromide inhalation powder Tudorza Pressair Anticholinergic; M3 receptor Maintenance of COPD Approved July 2012 Multi-dose DPI 400mg per inhalation BID

19 Acladinium has a faster onset than tiotropium and longer lasting than ipratropium Parasympathetic Airway Smooth Muscle Preganglionic Postganglionic M 2 Ach M 1 Ach M 3 Aclidinium selectively blocks M 3 receptors

20 Umeclidinium Bromide Incruse Ellipta 62.5mcg COPD Approved May 2014

21 Glycopyrrolate Seebri Neohaler BID COPD Approved Oct /26; 60 LPM

22 Spiriva Respimat The long-term, once-daily, maintenance treatment of COPD Reducing COPD exacerbations The long-term, once-daily, maintenance treatment of asthma in patients12 years of age and older COPD; 2.5 mcg/inhalation (5mcg) Asthma; 1.25 mcg/inhalation (2.5mcg)

23 GINA 2015 changes to Steps 4 and 5 STEP 5 STEP 4 PREFERRED CONTROLLER CHOICE STEP 1 STEP 2 Low dose ICS STEP 3 Low dose ICS/LABA* Med/high ICS/LABA Refer for add-on treatment e.g. anti-ige Other controller options RELIEVER Consider low dose ICS Leukotriene receptor antagonists (LTRA) Low dose theophylline* As-needed short-acting beta 2 -agonist (SABA) Med/high dose ICS Low dose ICS+LTRA (or + theoph*) Add tiotropium# High dose ICS + LTRA (or + theoph*) As-needed SABA or low dose ICS/formoterol** Add tiotropium# Add low dose OCS *For children 6-11 years, theophylline is not recommended, and preferred Step 3 is medium dose ICS **For patients prescribed BDP/formoterol or BUD/formoterol maintenance and reliever therapy # Tiotropium by soft-mist inhaler is indicated as add-on treatment for patients with a history of exacerbations; it is not indicated in children <18 years. GINA 2015, Box 3-5, Steps 4 and 5 Global Initiative for Asthma

24 Non-steroidal Anti-asthma Agents

25 Deletions Tilade Inhaler (nedocromil) King June 14, 2010 Not to be reformulated Intal Inhaler (cromolyn) King June 14, 2010 Not to be reformulated

26 Inhaled Corticosteroids

27 Fluticasone furoate Arnuity Ellipta Fluticasone furoate once-daily treatment of asthma in patients aged 12 years and older.

28 ArmonAir Respiclick Fluticsone propionate DPI BID 55mcg, 113mcg, and 232mcg 12 and older 88 LPM (1.4 sec)

29 Mometasone Asmanex HFA 100 and 200mcg 2 puffs, BID Approved 12 and older DPI mometsone approved for those as young as 4.

30 Ciclesonide (Alvesco) A lung activated corticosteroid (Prodrug) Thought is to reduce inflammatory mediators before drug is at the cell site Limited oral candidiasis HFA QD dosing Approved January 2008 Chapman KR, Patel P, D Urzo AD, et al. Maintenance of asthma control by once-daily inhaled ciclesonide in adults with persistent asthma. Allergy. 2005;60:

31 Deletions Azmacort (triamcinolone) Abbott December 31, 2010 Multiple choices Aerobid (flunisolide) Forrest December 31, 2010 Aersopan HFA

32 Combination Therapy

33 Umeclidnium/Vilanterol Anoro Ellipta (umeclidinium and vilanterol inhalation powder) 62.5mcg/25mcg Once daily; COPD Approved 2013 Reduced Exacerbations Reduced Breathlessness Reduced Inhaler Use Feldman G.J. Ther Adv Resp Dis. 2013;7(6):

34 Umeclidinium Monotherapy?

35 Breo Ellipta Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) 100mcg/25mcg Once daily; COPD Once daily; Asthma

36 Ellipta Function

37 Stiolto Respimat Tiotropium bromide and olodaterol Long-term, once-daily maintenance treatment of airflow obstruction in COPD. Not indicated for COPD Exacerbations Not indicated for Asthma 2.5 mcg/actuation per drug 2 actuations daily

38

39 Utibron Neohaler Glycopyrronium bromide 15.6mcg Indacaterol 27.5 mcg BID Tx of COPD

40 Glycopyrrolate Monotherapy?

41 Bevespi Aerosphere Glycopyrronium bromide 9 mcg Formoterol 4.8 mcg HFA BID COPD Approved April 2016

42 AirDuo fluticasone propionate/salmeterol 55/14; 113/14; 232/14 BID 12 and older 85 LPM (1.4 sec)

43 Surfactants

44 New Synthetic Surfaxin (lucinactant) Approved March 2012 Synthetic surfactant Has functional SP-B KL4 peptide (sinapultide) Single use vial Can heat in dry heater to reach 37C Do not re-refrigerate SHAKE VIGROUSLY Deliver in 4 doses

45 Surfaxin Preformed as well as Beractant for RDS Better overall mortality rate than Beractant Reduced BPD rates Moya, FR. Pediatrics, 2005

46 Aerosurf Aerosurf (lucinactant) Phase II complete Aerosolized surfactant Capillary Aerosol Generator Used with Affectair

47 Agents of Interest

48 Treprostinil Tyvaso Treatment of Pulmonary HTN NYHA Class III symptoms 6mcg per breath 9 breath per session 4 times/day

49 Aztreonam Cayston Treatment of Pseudomonas in CF Approved February 2010 Must be reconstituted

50 Tobramyacin Bethkis 300mg/4ml TOBI; 300mg/5ml Tobi Podhaler Four, 28mg capsules, BID

51 ADASUVE (loxapine) Single use DPI 10mg Antipsychotic Indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults

52 Sumatriptan Serotonin receptor Agonist Acute Migraine Onzetra Xsail Single Dose Dry Powder Delivered by Exhalation Imitrex 0.1 ml liquid Generic 0.1 ml liqid

53 Inhaled Insulin Exubera (no longer on market) Afreeza Not a replacement for long acting insulin 4 and 8 unit inhaled doses Can alter PFT Not tested in lung disease and patients that smoke. Caution in lung disease

54 Naloxone Narcan Intranasal Approved for emergency treatment of known or suspected opioid overdose 2 and 4 mg dosing Plasma in 2.5 minutes Safe for general public to administer

55

56 Questions, Comments, Happy Thoughts?

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