DOCSLIB.ORG

References Used in Algorithms for the Treatment of Persons With

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
References Used in Algorithms for the Treatment of Persons With REFERENCES USED IN ALGORITHMS FOR THE TREATMENT OF PERSONS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE 1. Agusti A, Edwards LD, Celli B, Macnee W, Calverley PM, Mullerova H, Lomas DA, Wouters E, Bakke P, Rennard S et al: Characteristics, stability and outcomes of the 2011 GOLD COPD groups in the ECLIPSE cohort. The European respiratory journal 2013, 42(3):636-646. 2. Albert RK, Connett J, Bailey WC, Casaburi R, Cooper JA, Jr., Criner GJ, Curtis JL, Dransfield MT, Han MK, Lazarus SC et al: Azithromycin for prevention of exacerbations of COPD. The New England journal of medicine 2011, 365(8):689-698. 3. ANI Pharmaceuticals Inc: Terbutaline Sulfate. In: US Product Monograph. Baudette, MN; 2018. 4. Anthonisen NR, Manfreda J, Warren CP, Hershfield ES, Harding GK, Nelson NA: Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Annals of internal medicine 1987, 106(2):196-204. 5. Appleton S, Poole P, Smith B, Veale A, Lasserson TJ, Chan MM: Long-acting beta2-agonists for poorly reversible chronic obstructive pulmonary disease. The Cochrane database of systematic reviews 2006(3):CD001104. 6. AstraZeneca Canada Inc: Pulmicort Nebuamp (budesonide). In: CA Product Monograph. Mississauga, ON; 2013. 7. AstraZeneca Canada Inc: Symbicort Turbuhaler (budesonide / formoterol fumarate dihydrate). In: CA Product Monograph. Mississauga, ON; 2016. 8. AstraZeneca Canada Inc: Duaklir Genuair (aclidinium bromide/formoterol fumarate dihydrate). In: CA Product Monograph. Mississauga, ON; 2017. 9. Astrazeneca Canada Inc: Daxas (roflumilast). In: CA Product Monograph. Mississauga, ON; 2017. 10. AstraZeneca Canada Inc: Pulmicort Turbuhaler (budesonide). In: CA Product Monograph. Mississauga, ON; 2017. 11. AstraZeneca Canada Inc: Alvesco (ciclesonide). In: CA Product Monograph. Mississauga, ON; 2017. 12. AstraZeneca Canada Inc: Tudorza Genuair (aclidinium bromide). In: CA Product Monograph. Mississauga, ON; 2017. 13. Astrazeneca Canada Inc: Bevespi Aerosphere (glycopyrronium / formoterol fumarate dihydrate). In: CA Product Monograph. Mississauga, ON; 2018. 14. AstraZeneca Canada Inc: Oxeze Turbuhaler (formoterol fumarate dihydrate). In: CA Product Monograph. Mississauga, ON; 2018. GenXys Health Care Systems Inc. Commercial in Confidence February 2020 15. AstraZeneca Canada Inc: Bricanyl Turbuhaler (terbutaline sulfate). In: CA Product Monograph. Mississauga, ON; 2018. 16. AstraZeneca Pharmaceuticals LP: Symbicort (budesonide / formoterol fumarate dihydrate). In: US Product Monograph. Wilmington, DE; 2017. 17. AstraZeneca Pharmaceuticals LP: Tudorza Pressair (aclidinium bromide). In: US Product Monograph. Wilmington, DE; 2018. 18. AstraZeneca Pharmaceuticals LP: Daliresp (roflumilast). In: US Product Monograph. Wilmington, DE; 2018. 19. Aubier M: Pharmacotherapy of respiratory muscles. Clinics in chest medicine 1988, 9(2):311- 324. 20. Barnes PJ: New anti-inflammatory targets for chronic obstructive pulmonary disease. Nat Rev Drug Discov 2013, 12(7):543-559. 21. Barr RG, Bourbeau J, Camargo CA, Ram FS: Inhaled tiotropium for stable chronic obstructive pulmonary disease. The Cochrane database of systematic reviews 2005(2):CD002876. 22. Basu K, Palmer CN, Tavendale R, Lipworth BJ, Mukhopadhyay S: Adrenergic beta(2)-receptor genotype predisposes to exacerbations in steroid-treated asthmatic patients taking frequent albuterol or salmeterol. The Journal of allergy and clinical immunology 2009, 124(6):1188-1194.e1183. 23. BC Renal Agency: Common oral antimicrobial therapy dosage adjustments for renal function. In.; 2018. 24. Bleecker ER, Yancey SW, Baitinger LA, Edwards LD, Klotsman M, Anderson WH, Dorinsky PM: Salmeterol response is not affected by beta2-adrenergic receptor genotype in subjects with persistent asthma. The Journal of allergy and clinical immunology 2006, 118(4):809-816. 25. Bleecker ER, Postma DS, Lawrance RM, Meyers DA, Ambrose HJ, Goldman M: Effect of ADRB2 polymorphisms on response to longacting beta2-agonist therapy: a pharmacogenetic analysis of two randomised studies. Lancet (London, England) 2007, 370(9605):2118-2125. 26. Bleecker ER, Meyers DA, Bailey WC, Sims AM, Bujac SR, Goldman M, Martin UJ: ADRB2 polymorphisms and budesonide/formoterol responses in COPD. Chest 2012, 142(2):320-328. 27. Blondel-Hill E, Fryters S: Bugs & Drugs. In. Calgary: Alberta Health Services; 2012. 28. Boardman C, Chachi L, Gavrila A, Keenan CR, Perry MM, Xia YC, Meurs H, Sharma P: Mechanisms of glucocorticoid action and insensitivity in airways disease. Pulmonary pharmacology & therapeutics 2014, 29(2):129-143. 29. Boehringer Ingelheim (Canada) Ltd: Combivent UDV (ipratropium / salbutamol). In: CA Product Monograph. Burlington, ON; 2015. GenXys Health Care Systems Inc. Commercial in Confidence February 2020 30. Boehringer Ingelheim (Canada) Ltd: Atrovent HFA (ipratropium). In: CA Product Monograph. Burlington, ON; 2016. 31. Boehringer Ingelheim (Canada) Ltd: Combivent Respimat (ipratropium and salbutamol). In: CA Product Monograph. Burlington, ON; 2016. 32. Boehringer Ingelheim (Canada) Ltd: Striverdi Respimat (olodaterol). In: CA Product Monograph. Burlington, ON; 2016. 33. Boehringer Ingelheim (Canada) Ltd: Spiriva Respimat (tiotropium). In: CA Product Monograph. Burlington, ON; 2016. 34. Boehringer Ingelheim (Canada) Ltd: Inspiolto Respimat (tiotropium / olodaterol). In: CA Product Monograph. Burlington, ON; 2017. 35. Boehringer Ingelheim (Canada) Ltd: Spiriva (tiotropium). In: CA Product Monograph. Burlington, ON; 2017. 36. Boehringer Ingelheim (Canada) Ltd: Spiriva Respimat (tiotropium). In: CA Product Monograph. Burlington, ON; 2019. 37. Boehringer Ingelheim Pharmaceuticals Inc: Spiriva Handihaler (tiotropium). In: US Product Monograph. Ridgefield, CT; 2018. 38. Boehringer Ingelheim Pharmaceuticals Inc: Stiolto Respimat (tiotropium / olodaterol). In: US Product Monograph. Ridgefield, CT; 2018. 39. Boehringer Ingelheim Pharmaceuticals Inc: Striverdi Respimat (olodaterol). In: US Product Monograph. Ridgefield, CT; 2018. 40. Boehringer Ingelheim Pharmaceuticals Inc: Spiriva Respimat (tiotropium). In: US Product Monograph. Ridgefield, CT; 2018. 41. Boehringer Ingelheim Pharmaceuticals Inc: Spiriva Respimat (tiotropium). In: US Product Monograph. Ridgefield, CT 2019. 42. Bonini M, Permaul P, Kulkarni T, Kazani S, Segal A, Sorkness CA, Wechsler ME, Israel E: Loss of salmeterol bronchoprotection against exercise in relation to ADRB2 Arg16Gly polymorphism and exhaled nitric oxide. American journal of respiratory and critical care medicine 2013, 188(12):1407-1412. 43. British Columbia Guidelines and Protocols Advisory Committee: Chronic Obstructive Pulmonary Disease (COPD): Diagnosis and management. In. Edited by Association BCM. Victoria, BC: Guidelines and Protocols Advisory Committee; 2017. 44. Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ: Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet (London, England) 2009, 374(9691):685-694. GenXys Health Care Systems Inc. Commercial in Confidence February 2020 45. Canadian Pharmacists Association: Corticosteroids: inhaled [CPhA monograph]. In: RxTx. Ottawa, ON; 2016. 46. Canadian Pharmacists Association: Erythromycin [CPhA monograph]. In: RxTx. Ottawa, ON; 2018. 47. Chong J, Leung B, Poole P: Phosphodiesterase 4 inhibitors for chronic obstructive pulmonary disease. The Cochrane database of systematic reviews 2013(11):CD002309. 48. Cosio BG, Shafiek H, Iglesias A, Yanez A, Cordova R, Palou A, Rodriguez-Roisin R, Peces-Barba G, Pascual S, Gea J et al: Oral Low-dose Theophylline on Top of Inhaled Fluticasone-Salmeterol Does Not Reduce Exacerbations in Patients With Severe COPD: A Pilot Clinical Trial. Chest 2016, 150(1):123-130. 49. Covis Pharma: Alvesco (ciclesonide). In: US Product Monograph. Zug, Switzerland; 2018. 50. Crim C, Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F et al: Pneumonia risk with inhaled fluticasone furoate and vilanterol compared with vilanterol alone in patients with COPD. Annals of the American Thoracic Society 2015, 12(1):27-34. 51. Criner GJ, Bourbeau J, Diekemper RL, Ouellette DR, Goodridge D, Hernandez P, Curren K, Balter MS, Bhutani M, Camp PG et al: Prevention of acute exacerbations of COPD: American College of Chest Physicians and Canadian Thoracic Society Guideline. Chest 2015, 147(4):894-942. 52. Daskalopoulou SS, Rabi DM, Zarnke KB, Dasgupta K, Nerenberg K, Cloutier L, Gelfer M, Lamarre-Cliche M, Milot A, Bolli P et al: The 2015 Canadian Hypertension Education Program recommendations for blood pressure measurement, diagnosis, assessment of risk, prevention, and treatment of hypertension. The Canadian journal of cardiology 2015, 31(5):549-568. 53. Decramer ML, Chapman KR, Dahl R, Frith P, Devouassoux G, Fritscher C, Cameron R, Shoaib M, Lawrence D, Young D et al: Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study. The Lancet Respiratory medicine 2013, 1(7):524-533. 54. Delco F, Tchambaz L, Schlienger R, Drewe J, Krahenbuhl S: Dose adjustment in patients with liver disease. Drug safety 2005, 28(6):529-545. 55. Dijkstra A, Koppelman GH, Vonk JM, Bruinenberg M, Schouten JP, Postma DS: Pharmacogenomics and outcome of asthma: no clinical application for long-term steroid effects by CRHR1 polymorphisms. The Journal of allergy and clinical immunology 2008, 121(6):1510-1513. 56. Fabbri LM, Calverley PM, Izquierdo-Alonso
Load more

Recommended publications
  • 2019 Year in Review: Aerosol Therapy
    2019 Year in Review: Aerosol Therapy Ariel Berlinski Introduction COPD Newly Approved Drugs Asthma New Devices As-Needed Inhaled Corticosteroid/Long-Acting Bronchodilator Therapy Asthma Medication Report in Adolescents and Caregivers Cystic Fibrosis Hypertonic Saline in Cystic Fibrosis Infectivity of Cough Aerosols in Cystic Fibrosis Liposomal Amikacin for MAC Lung Disease Electronic Nicotine Delivery Systems E-Cigarette or Vaping Associated Lung Injury Secondhand Exposure Summary Relevant publications related to medicinal and toxic aerosols are discussed in this review. Treatment of COPD includes a combination of long-acting bronchodilators and long-acting muscarinic antagonists. A combination of aclidinium bromide and formoterol fumarate was approved in the United States. The combination was superior to its components alone, as well as tiotropium and a salmeterol-fluticasone combination. Increased risk of an asthma exacerba- tion was reported in children exposed to electronic nicotine delivery systems. A smart inhaler capable of recording inspiratory flow was approved in the United States. The use of as-needed budesonide-formoterol was reported to be superior to scheduled budesonide and as-needed ter- butaline for the treatment of adults with mild-to-moderate asthma. A survey among teens with asthma and their caregivers revealed a disagreement in the number of inhaled controller medi- cations the teen was taking. Treatment with inhaled hypertonic saline resulted in a decreased lung clearance index in infants and preschool children with cystic fibrosis. Surgical masks were well tolerated and significantly decreased the burden of aerosolized bacteria generated by coughing in adults with cystic fibrosis. Inhaled liposomal amikacin in addition to guideline- based therapy was reported to be superior to guideline-based therapy alone in achieving nega- tive sputum cultures in adult subjects with Mycobacterium avium complex pulmonary disease.
    [Show full text]
  • Terbutaline Sulfate Injection, USP
    Terbutaline Sulfate Injection, USP 1 mg per mL | NDC 70860-801-01 ATHENEX AccuraSEESM PACKAGING AND LABELING BIG, BOLD AND BRIGHT — TO HELP YOU SEE IT, SAY IT AND PICK IT RIGHT DIFFERENTIATION IN EVERY LABEL, DESIGNED TO HELP REDUCE MEDICATION ERRORS PLEASE SEE FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING, FOR TERBUTALINE SULFATE INJECTION, USP, ENCLOSED. THE NEXT GENERATION OF PHARMACY INNOVATION To order, call 1-855-273-0154 or visit www.Athenexpharma.com Terbutaline Sulfate Injection, USP 1 mg NDC 70860-801-01 1 mg per mL DESCRIPTION Glass Vial CONCENTRATION 1 mg per mL CLOSURE 13 mm UNIT OF SALE 10 vials BAR CODED Yes CHOOSE AccuraSEESM FOR YOUR PHARMACY Our proprietary, differentiated and highly-visible label designs can assist pharmacists in accurate medication selection. With a unique AccuraSEE label design for every Athenex product, we’re helping your pharmacy to reduce the risk of medication errors. The idea is simple: “So what you see is exactly what you get.” Athenex, AccuraSEE and all label designs are copyright of Athenex. ©2019 Athenex. APD-0022-02-4/19 To order, call 1-855-273-0154 or visit www.Athenexpharma.com TERBUTALINE SULFATE Injection, USP • The use of beta-adrenergic agonist bronchodilators • Terbutaline sulfate should be used during nursing alone may not be adequate to control asthma in only if the potential benefit justifies the possible risk INDICATIONS AND USAGE many patients. Early consideration should be given to to the newborn. • Terbutaline sulfate injection is indicated for the adding anti-inflammatory agents, e.g., corticosteroids. prevention and reversal of bronchospasm in patients ADVERSE REACTIONS 12 years of age and older with asthma and reversible • Terbutaline sulfate should be used with caution • Common adverse reactions reported with terbutaline bronchospasm associated with bronchitis and emphysema.
    [Show full text]
  • Tocolytic Therapy a Meta-Analysis and Decision Analysis
    Tocolytic Therapy A Meta-Analysis and Decision Analysis David M. Haas, MD, MS, Thomas F. Imperiale, MD, Page R. Kirkpatrick, Robert W. Klein, Terrell W. Zollinger, DrPH, and Alan M. Golichowski, MD, PhD OBJECTIVE: To determine the optimal first-line tocolytic ing prostaglandin inhibitors, only 80 would deliver within agent for treatment of premature labor. 48 hours, compared with 182 for the next-best treatment. METHODS: We performed a quantitative analysis of ran- CONCLUSION: Although all current tocolytic agents domized controlled trials of tocolysis, extracting data on were superior to no treatment at delaying delivery for maternal and neonatal outcomes, and pooling rates for both 48 hours and 7 days, prostaglandin inhibitors were each outcome across trials by treatment. Outcomes were superior to the other agents and may be considered the delay of delivery for 48 hours, 7 days, and until 37 weeks; optimal first-line agent before 32 weeks of gestation to adverse effects causing discontinuation of therapy; absence delay delivery. of respiratory distress syndrome; and neonatal survival. We (Obstet Gynecol 2009;113:585–94) used weighted proportions from a random-effects meta- analysis in a decision model to determine the optimal first-line tocolytic therapy. Sensitivity analysis was per- reterm birth, defined as any birth before the gesta- formed using the standard errors of the weighted propor- Ptional age of 37 weeks, is responsible for most of the 1–3 tions. neonatal morbidity and mortality in the United States and consumes 35% of all U.S. healthcare spending on RESULTS: Fifty-eight studies satisfied the inclusion crite- 4 ria.
    [Show full text]
  • 210428Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210428Orig1s000 OTHER REVIEW(S) DIVISION OF CARDIOVASCULAR AND RENAL PRODUCTS Regulatory Project Manager Overview I. GENERAL INFORMATION NDA: 210428 Drug: Metoprolol Succinate Extended-Release Capsules, 25 mg, 50 mg, 100 mg and 200 mg Class: Beta- Blocker Applicant: Sun Pharmaceutical Industries Limited Proposed Indications: Hypertension, Angina Pectoris & Heart Failure Date of submission: March 30, 2017 PDUFA date: January 30, 2018 II. REVIEW TEAM Office of New Drugs, Office of Drug Evaluation I: Division of Cardiovascular & Renal Product Norman Stockbridge, MD, PhD, Director Mary Ross Southworth, PharmD, Deputy Director for Safety Michael Monteleone, MS, RAC, Assistant Director for Labeling Martina Sahre, PhD, Cross Discipline Team Leader Fortunato Senatore, MD, Clinical Reviewer Albert DeFelice, PhD, Non-Clinical Supervisor Muriel Saulnier, PhD, Non-Clinical Reviewer Edward Fromm, RPh, RAC, Chief, Project Management Staff Maryam Changi, PharmD, Regulatory Project Manager Office of Pharmaceutical Quality: Wendy Wilson-Lee, PhD, Application Technical Lead Grafton Adams, Regulatory Business Process Manager Milton Sloan, PhD, Drug Product Reviewer Rohit Tiwari, PhD, Drug Substance Reviewer Ben Stevens, PhD, Drug Substance Team Leader Kaushal Dave, PhD, Biopharmaceutical Reviewer Wu, Ta-Chin, PhD, Biopharmaceutical Team Leader Viviana Matta, PhD, Facility Reviewer Ruth Moore, PhD, Facility Team Leader Chunsheng Cai, PhD, Process Reviewer NDA 210428 RPM review Page 1 Reference ID: 42132034213643 Labeling/PMC-PMR to Sponsor: November 30, 2017 PDUFA Date: January 30, 2018 (Standard, 10-Month) PDUFA Goal Date: January 30, 2018 Approval letter: January 26, 2018 7. Reviews a) Divisional Memorandum: (January 26, 2018) Dr. Stockbridge indicated his concurrence on Dr. Sahre’s CDTL memo.
    [Show full text]
  • Chronic Obstructiv Chronic Obstructive Pulmonary Disease
    pat hways Chronic obstructive pulmonary disease: beclometasone, formoterol and glycopyrronium (Trimbow) Evidence summary Published: 3 May 2018 nice.org.uk/guidance/es17 Key points The content of this evidence summary was up-to-date in May 2018. See summaries of product characteristics (SPCs), British national formulary (BNF) or the Medicines and Healthcare products Regulatory Agency (MHRA) or NICE websites for up-to-date information. Regulatory status: Beclometasone/formoterol/glycopyrronium (Trimbow, Chiesi Limited) received a European marketing authorisation in July 2017. This triple-therapy inhaler contains an inhaled corticosteroid (ICS), long-acting beta-2 agonist (LABA) and long-acting muscarinic antagonist (LAMA). It is licensed for maintenance treatment of adults with moderate-to-severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an ICS and a LABA. Overview This evidence summary discusses 3 randomised controlled trials (TRILOGY, TRINITY and TRIBUTE) looking at the safety and efficacy of beclometasone/formoterol/glycopyrronium in people with COPD with severe or very severe airflow limitation, symptoms despite treatment and a history of exacerbations. © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- Page 1 of conditions#notice-of-rights). 78 Chronic obstructive pulmonary disease: beclometasone, formoterol and glycopyrronium (Trimbow) (ES17) Overall, the studies found small, statistically significant improvements in lung function, rates of moderate-to-severe exacerbations of COPD and health-related quality-of-life scores with beclometasone/formoterol/glycopyrronium compared with beclometasone/formoterol or indacaterol/glycopyrronium dual therapy, or tiotropium alone. The improvements may be of limited clinical importance. In TRILOGY and TRINITY, improvements in primary outcomes relating to lung function and exacerbation rates just reached the level considered to be clinically important.
    [Show full text]
  • Bnf Chapter 3: Respiratory
    BNF CHAPTER 3: RESPIRATORY Information resources: ● If an inhaler device is changed then patients must be assessed to ensure inhaler technique is adequate Respiratory Futures Consider issuing a Steroid warning card to patients prescribed high dose inhaled steroids Asthma guidelines NICE guideline [NG80] Asthma: diagnosis, monitoring and chronic asthma management NICE guidance TA 138 Asthma - inhaled corticosteroids for the treatment of chronic asthma in adults and children aged 12 years and over. https://www.sign.ac.uk/assets/sign153.pdf SIGN 153: British guideline on the management of asthma Global Initiative for Asthma 2018. GINA Report, Global Strategy for Asthma Management and Prevention. West Cheshire local guidelines COPD guidelines: NICE [NG115] COPD in over 16s diagnosis and management. NICE guideline Dec 18 [NG115] GOLD : Global strategy for the diagnosis, management, and prevention of Chronic Obstructive Pulmonary Disease 2018 Report West Cheshire local guidelines Abbreviations used: MDI: metered dose inhaler DPI: dry powder inhaler SABA: short acting beta agonist LABA: long acting beta agonist SAMA: short acting muscarinic antagonist LAMA: long acting muscarinic antagonist ICS: inhaled corticosteroid LTRA: leukotriene receptor antagonist PDE4: phosphodiesterase-4 enzyme inhibitor Joint Formulary – Respiratory Approved by Area Prescribing Committee: n/a Review by: July 2021 3.1 BRONCHODILATORS 3.1.1.1 SELECTIVE BETA2-AGONISTS Short acting Beta2 Agonist (SABA) Salbutamol 100 micrograms/metered inhalation MDI 100/200
    [Show full text]
  • Project Review
    PROJECT REVIEW ”Development of analytical methods for the quantitative determination of beta-agonists and determination of detection times after therapeutic use” Beta-agonists are substances frequently used for the treatment of asthma. These drugs are most frequently administered by inhalation of aerosol, powder or nebulised solution. Besides the main pharmacological effect, at higher doses, side effects of the use of these products result in anabolic action. Hence, beta-2- agonists might be misused for their stimulating effect on respiration and growth promoting action when administered in higher doses. As a result, WADA has prohibited the use of these drugs in sports. Exceptions are formoterol, salbutamol, fenoterol, salmeterol and terbutaline which can be used by athletes if a proper medical justification (TUE) is issued. Although this group of medication is frequently declared by athletes on the doping control forms these substances are not always detected. In addition, no minimum required performance levels (MRPL) for laboratories have been presently issued by WADA. Information about the excretion of beta-2-agonists in urine after the use by different administration routes could result in the establishment of MRPL levels based upon scientific evidence. Therefore this project will focus on the administration of different beta-2-agonists by different administration routes. In this project 5 beta-2-agonists will be administered (i.e. salbutamol, formoterol, fenoterol, salmeterol and terbutaline) of which 2 of them will be administered both by inhalation and orally. All these studies will be conducted following a strict research protocol as approved by an ethical committee. As the supposed outcome of this research is a MRPL level, the first step of this project is to develop and validate quantitative analytical methods for all administered beta-2-agonists (except salbutamol for which these methods already exist).
    [Show full text]
  • 203975Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 203975Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) CLINICAL PHARMACOLOGY REVIEW NDA 203975 Submission Date 12/18/2012 Proposed Brand Name ANORO ELLIPTA Generic Name Umeclidinium Bromide/Vilanterol Inhalation Powder Clinical Pharmacology Reviewer Jianmeng Chen, M.D., Ph.D. and Ping Ji Ph.D. Clinical Pharmacology Team Satjit Brar, Pharm. D., Ph.D. Leader Pharmacometrics Reviewer Hongshan Li Ph.D. Pharmacometrics Team Leader Atul Bhattaram, Ph.D. Pharmacogenomics Reviewer Sarah Dorff, Ph.D. Pharmacogenomics Team Leader Michael Pacanowski, Pharm. D., MPH OCP Division Clinical Pharmacology II OND Division Division of Pulmonary, Allergy, and Rheumatology Products Sponsor/Authorized Applicant GSK Submission Type; Code 505(b)(1); standard review Formulation; Strength(s) Inhalation powder administered from NDPI Indication COPD Dosage Regimen UMEC/VI (62.5/25) QD 1. Executive Summary............................................................................................. 4 1.1 Recommendations............................................................................................... 4 1.2 Phase IV Commitments ....................................................................................... 4 1.3 Summary of Clinical Pharmacology and Biopharmaceutics Findings ................ 4 2. Question Based Review ............................................................................................... 11 2.1 List the in vitro and in vivo Clinical Pharmacology and
    [Show full text]
  • Respiratory Inhalers
    Table LARGE 4_Layout 1 18/12/2015 09:06 Page 1 RESPIRATORY INHALERS The correct administration of inhaled therapy is essential for successful, cost-effective and safe therapy. Everyone, including the patient needs to understand the importance of ensuring correct inhaler technique. Patients should be instructed on how to use their inhaler and supervised when they are first prescribed a new inhaler and their inhalation technique should be checked by observation at every opportunity. INHALED MEDICINE DEVICE OPTIONS COST USUAL DOSE PHARMACOLOGICAL RECOMMENDED THINGS TO NOTE ACTION PLACE IN UK Generic Name RED = www.medicines.org.uk or BNF for more details Common adverse effects, precautions for use etc. 30 day treatment / PRACTICE DRY powder device per dose and key pharmacokinetic profiles Brand Name BLUE = For children please confirm licensed GUIDELINES AEROSOL device based on BNF indication and dose before prescribing September 2014 SHORT ACTING BRONCHODILATORS Short Acting Beta-2 agonist (SABA) Salbutamol Pulvinal ® £4.85 $ 100 –200 micrograms when required Mechanism of action: Relief of breathlessness and SABA inhalers should ideally be prescribed “ PRN - when required ” as this helps to monitor control. Easyhaler ® £3.31 $ • Bronchodilation through activation of chest tightness in people with Reliance on frequent use, or a sudden increase in dose, indicates poorly controlled or deteriorating □ □ □ Airomir ®o, Salamol ® , Ventolin ® MDI ,o £1.50 –£1.97 $ beta-2 receptors on the airway smooth muscle asthma and COPD (according disease. Salamol ® Easi-Breathe ® £6.30 $ • Reduction of lung hyperinflation, resulting in to the British Asthma Ventolin ® Accuhaler ® £3.00 $ increased inspiratory capacity guideline 1 and NICE COPD People with asthma using their SABA inhaler three times a week or more is a marker of uncontrolled Airomir ® Autohaler £6.02 $ guideline).
    [Show full text]
  • Multi-Discipline Review
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210595Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review NDA/BLA Multi‐disciplinary Review and Evaluation {NDA 210595} {Duaklir Pressair, Aclidinium Bromide/Formoterol Fumarate inhalation powder} NDA/BLA Multi‐Disciplinary Review and Evaluation Application Type NDA Application Number(s) 210595 Priority or Standard Standard Submit Date(s) May 31, 2018 Received Date(s) May 31, 2018 PDUFA Goal Date March 31, 2019 Division/Office Division of Pulmonary, Allergy, and Rheumatology Products Review Completion Date March 29, 2019 Established/Proper Name Aclidinium bromide/formoterol fumarate inhalation powder (Proposed) Trade Name Duaklir Pressair Pharmacologic Class Long‐acting muscarinic/Long‐acting B2‐agonist Code name Applicant AstraZenecaPharmaceuticals LP Doseage form Inhalation powder Applicant proposed Dosing One inhalation (400 µg aclidinium bromide/ 12 µg formoterol Regimen fumarate) twice daily Applicant Proposed ‐ (b) (4) maintenance treatment of (b) (4) Indication(s)/Population(s) patients with chronic obstructive pulmonary disease (COPD), (b) (4) Recommendation on Approval Regulatory Action Recommended (b) (4) maintenance treatment of patients with COPD Indication(s)/Population(s) (if applicable) Recommended Dosing One inhalation (400 µg aclidinium bromide/ 12 µg formoterol Regimen fumarate) twice daily 1 Version date: September 12, 2018 Reference
    [Show full text]
  • List Item Short-Acting Beta-Agonists Article-31 Referral
    Annex II Scientific conclusions and grounds for revocation or variation as applicable to the terms of the marketing authorisations and detailed explanation for the differences from the PRAC recommendation 19 Scientific conclusions and grounds for revocation or variation as applicable to the terms of the marketing authorisations and detailed explanation for the differences from the PRAC recommendation The CMDh considered the below PRAC recommendation dated 5 September 2013 with regards to the terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol and isoxsuprine containing medicinal products: 1. Overall summary of the scientific evaluation of terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol and isoxsuprine containing medicinal products by PRAC (see Annex I) On 27 November 2012, further to evaluation of data resulting from pharmacovigilance activities, Hungary informed the European Medicines Agency, pursuant to Article 31 of Directive 2001/83/EC, of their consideration that the risk-benefit balance of short-acting beta-agonists (SABAs) containing medicinal products authorised in obstetric indications has become unfavourable, taking into account the cardiovascular events reported. Hungary considered it was in the interest of the Union to refer the matter to the PRAC and expressed concerns with regards to the posology and warnings reflected in the product information. The short-acting beta-agonists (SABAs) (also known as beta-mimetics), salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine are all nationally authorised and have been on the market within the EU since the 1960s. Authorised obstetric indications for SABAs differ across Member States. The authorised obstetric indications include partus prematurus, tocolysis (for some products use is restricted to particular weeks of gestation but for others no specific gestation period is specified), external cephalic version (ECV), and hyper-uterine contractility.
    [Show full text]
  • Glycopyrronium Bromide (Seebri® Breezhaler) for Maintenance Treatment of Adults with Stable COPD
    New Medicines Committee Briefing Updated July 2017 Glycopyrronium bromide (Seebri® Breezhaler) for maintenance treatment of adults with stable COPD Primary Care Seebri® Breezhaler is to be reviewed for use within: Secondary Care Summary: Glycopyrronium (Seebri® Breezhaler) dry-powder inhaler is a once-daily, long-acting muscarinic antagonist (LAMA). Seebri® was launched in the UK in November 2012, as a maintenance bronchodilator for treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). Seebri® was previously reviewed in July 2013 and the Area Prescribing Committee (APC) concluded that Seebri® should not be included within the North Staffordshire Joint Formulary as at that time there were no direct comparator trials with other active bronchodilators, lack of long term safety data and little local experience of its use. There is no updated guidance available from NICE, SMC, RDTC, MTRAC or Cochrane since July 2013 but there are now two new clinical trials (GLOW5 and GEM3 study)1,2 that has compared Seebri with active bronchodilators The GLOW5 study – a randomised double blinded evaluation of the efficacy and safety of glycopyrronium versus tiotropium demonstrated similar efficacy and safety over 12 weeks, with glycopyrronium having a faster onset of action on day 1 in comparison to tiotropium in patients with moderate-to-severe COPD. The GEM3 study – a randomised double blinded parallel study of the long term safety of glycopyrronium in comparison to indacaterol demonstrated a similar safety profile over 52 weeks in patients with moderate-to-severe COPD. Seebri® is a black triangle drug ( ) and is monitored intensively by the MHRA.
    [Show full text]