Bnf Chapter 3: Respiratory
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Dosing Time Matters
bioRxiv preprint doi: https://doi.org/10.1101/570119; this version posted March 21, 2019. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY-NC-ND 4.0 International license. Dosing Time Matters 1 2,3 4,5,6 1* Marc D. Ruben , David F. Smith , Garret A. FitzGerald , and John B. Hogenesch 1 Division of Human Genetics, Center for Chronobiology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, 240 Albert Sabin Way, Cincinnati, OH, 45229 2 Divisions of Pediatric Otolaryngology and Pulmonary and Sleep Medicine, Cincinnati Children’s Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH 45229 3 Department of Otolaryngology-Head and Neck Surgery, University of Cincinnati School of Medicine, 231 Albert Sabin Way, Cincinnati, OH, 45267 4 Department of Systems Pharmacology and Translational Therapeutics, at the University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104 USA 5 Department of Medicine, at the University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104 USA 6 Institute for Translational Medicine and Therapeutics (ITMAT), at the University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104 USA *Corresponding Author. Email: [email protected] Abstract Trainees in medicine are taught to diagnose and administer treatment as needed; time-of-day is rarely considered. Yet accumulating evidence shows that ~half of human genes and physiologic functions follow daily rhythms. Circadian medicine aims to incorporate knowledge of these rhythms to enhance diagnosis and treatment. -
Inhibitory Activity of Pranlukast and Montelukas Against Histamine
Showa Univ J Med Sci 21（2）, 77～84, June 2009 Original Inhibitory Activity of Pranlukast and Montelukas Against Histamine Release and LTC4 Production from Human Basophils 1, 2 1 1 Satoshi HIBINO ）, Ryoko ITO ）, Taeru KITABAYASHI ）, 1 2 Kazuo ITAHASHI ） and Toshio NAKADATE ） Abstract : Leukotriene receptor antagonists（LTRAs）are routinely used to treat bronchial asthma and are thought to act mostly by inhibiting leukotriene receptors. However, there is no preclinical or clinical evidence of the direct effect of LTRAs on histamine release from and leukotriene（LT）C4 produc- tion by basophils. We used anti-IgE antibody（Ab）, FMLP, and C5a to induce histamine release, and anti-IgE Ab and FMLP to stimulate LTC 4 production. Basophils were exposed to different concentrations of pranlukast and montelu- kast, and then to anti-IgE Ab, FMLP, and C5a. Culture supernatant histamine and LTC 4 levels were measured by using a histamine ELISA kit and a LTC 4 EIA kit, respectively. Histamine release was expressed as a percentage of the total histamine content（％HR）induced by anti-IgE Ab, FMLP, or C5a. To evaluate the effects of pranlukast and montelukast on histamine release and LTC 4 production, we calculated the percent inhibition of histamine release and LTC 4 production, expressed as percent inhibition, at different concentrations of pranlukast and montelukast. Pranlukast significantly inhibited histamine release stimulated by FMLP and C5a, but had no effect on histamine release stimulated by anti-IgE Ab. By comparison, montelukast signicantly inhibited histamine release stimulated by FMLP, C5a, and anti-IgE Ab, in a concentration-dependent manner. Both pranlukast and montelukast signicantly inhibited LTC 4 production stimulated by anti-IgE Ab and FMLP. -
Study Protocol and Statistical Analysis Plan
Propranolol and Gene Expression in HCT Protocol v3.0, January 15, 2016 RANDOMIZED CONTROLLED PILOT STUDY USING PROPRANOLOL TO DECREASE GENE EXPRESSION OF STRESS-MEDIATED BETA- ADRENERGIC PATHWAYS IN HEMATOPOIETIC STEM CELL TRANSPLANT RECIPIENTS Version 3.0 Principal Investigator: Jennifer M. Knight, MD Medical College of Wisconsin 8701 Watertown Plank Road Milwaukee, WI 53226 Telephone: 414-955-8908 Fax: 414-955-6285 Email: [email protected] Co-Investigator: J. Douglas Rizzo, MD, MS CIBMTR Froedtert and the Medical College of Wisconsin Clinical Cancer Center 9200 W. Wisconsin Avenue Suite C5500 Milwaukee, WI 53226 Telephone: 414-805-0700 Fax: 414-805-0714 Email: [email protected] Co-Investigator: Parameswaran Hari, MD, MS Froedtert and the Medical College of Wisconsin Clinical Cancer Center 9200 W. Wisconsin Avenue Suite C5500 Milwaukee, WI 53226 Telephone: 414-805-4600 Fax: 414-805-4606 Email: [email protected] Consultant Steve W. Cole, PhD and Statistician: UCLA-David Geffen School of Medicine 10833 LeConte Ave 11-934 Factor Bldg Los Angeles, CA 90095-1678 Telephone: 310-267-4243 Email: [email protected] 1 Propranolol and Gene Expression in HCT Protocol v3.0, January 15, 2016 Sponsor: Medical College of Wisconsin Funding Sponsor: This project has an offer of sponsorship from the National Cancer Institute, National Institutes of Health, under Contract No. HHSN261200800001E. 2 Propranolol and Gene Expression in HCT Protocol v3.0, January 15, 2016 PROTOCOL SYNOPSIS Randomized Controlled Pilot Study Using Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in Hematopoietic Stem Cell Transplant Recipients Principal Investigator: Jennifer M. Knight, MD Study Design: This is a randomized controlled pilot study designed to evaluate whether the beta-adrenergic antagonist propranolol is effective in decreasing gene expression of stress-mediated beta-adrenergic pathways among a cohort of individuals receiving an autologous hematopoietic stem cell transplant (HCT) for multiple myeloma. -
Therapeutic Class Overview Inhaled Anticholinergics
Therapeutic Class Overview Inhaled Anticholinergics Therapeutic Class Overview/Summary: The inhaled anticholinergics are a class of bronchodilators primarily used in the management of chronic obstructive pulmonary disease (COPD), a condition characterized by progressive airflow restrictions that are not fully reversible.1-3 Symptoms associated with COPD typically include dyspnea, cough, sputum production, wheezing and chest tightness. Specifically, inhaled anticholinergics work via the inhibition of acetylcholine at parasympathetic sites in bronchial smooth muscle causing bronchodilation. Meaningful increases in lung function can be achieved with the use of inhaled anticholinergics in patients with COPD.1-3 The available single-entity inhaled anticholinergics include aclidinium (Tudorza® Pressair), glycopyrrolate (Seebri Neohaler®), ipratropium (Atrovent®, Atrovent® HFA), tiotropium (Spiriva®, Spiriva Respimat®) and umeclidinium (Incruse Ellipta®) with the combination products including glycopyrrolate/indacaterol (Utibron Neohaler®), umeclidinium/vilanterol (Anoro Ellipta®), tiotropium/olodaterol (Stiolto Respimat®) and ipratropium/albuterol, formulated as either an inhaler (Combivent Respimat®) or nebulizer solution (DuoNeb).4-15 Ipratropium, a short-acting bronchodilator, has a duration of action of six to eight hours and requires administration four times daily. Aclidinium, glycopyrrolate, tiotropium and umeclidinium are considered long-acting bronchodilators. Aclidinium is dosed twice daily, while glycopyrrolate, tiotropium and umeclidinium -
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. -
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. -
COVID-19 Evidence Bulletin 8
COVID-19 Evidence Bulletin 8 Public Health England PHE International Epidemiology Daily Evidence Digest – 22nd April 2020 – 21st April 2020 – 20th April 2020 NICE COVID-19 rapid guideline: acute myocardial injury [NG171] Published 23rd April The purpose of this guideline is to help healthcare professionals who are not cardiology specialists identify and treat acute myocardial injury and its cardiac complications in adults with known or suspected COVID-19 but without known pre-existing cardiovascular disease. COVID-19 rapid guideline: gastrointestinal and liver conditions treated with drugs affecting the immune response [NG172] Published 23rd April The purpose of this guideline is to maximise the safety of children and adults who have gastrointestinal or liver conditions treated with drugs affecting the immune response during the COVID 19 pandemic. It also aims to protect staff from infection and enable services to make the best use of NHS resources. COVID-19 rapid guideline: managing symptoms (including at the end of life) in the community Published 3rd April, Last updated 22nd April NHS England Specialty Guides: Clinical guide for acute kidney injury in hospitalised patients with COVID-19 outside the intensive care unit during the coronavirus pandemic (22nd April - updated) Management of palliative care in hospital during the coronavirus pandemic (22nd April – updated) Department of Health and Social Care Medicines that cannot be parallel exported from the UK (22nd April) 33 medicines have been added to the parallel export list and the -
Olodaterol Monograph
Olodaterol Monograph Olodaterol (Striverdi Respimat) National Drug Monograph VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives The purpose of VA PBM Services drug monographs is to provide a comprehensive drug review for making formulary decisions. Updates will be made when new clinical data warrant additional formulary discussion. Documents will be placed in the Archive section when the information is deemed to be no longer current. FDA Approval Information Description/Mechan Olodaterol is a long-acting beta2-adrenergic agonist (LABA). Binding to and activating ism of Action beta2-adrenoceptors in the airways results in stimulation of intracellular adenyl cyclase, an enzyme that mediates the synthesis of cyclic-3’, 5’ adenosine monophosphate (cAMP). Elevated levels of cAMP induce bronchodilation by relaxation of airway smooth muscle cells. Indication(s) Under Long-term once daily maintenance bronchodilator treatment of airflow obstruction in Review patients with COPD including chronic bronchitis and/or emphysema Dosage Form(s) Inhalation spray for oral inhalation via Respimat (a soft-mist inhaler) Under Review The soft-mist inhalers (SMI) provide multi-dose medication using liquid formulations similar to that used in nebulizers and are propellant-free. Presently, Respimat is the only SMI commercially available for clinical use. The soft mist is released at a slower velocity and has more prolonged spray duration than the mist produced from pressurized metered dose inhalers (pMDIs). Pressurized MDIs require coordination of actuation with inhalation which may be difficult for some patients partly due to the rapid speed at which the drug is delivered and the short duration of the mist. -
Montelukast Sodium) Tablets, Chewable Tablets, and Oral
Merck Sharp & Dohme Corp., a subsidiary of o MERCK & CO., INC. Whitehouse Station, NJ 08889/ USA HIGHLIGHTS OF PRESCRIBING INFORMATION .....................DOSAGE FORMS AND STRENGTHS..................... These highlights do not include all the information needed to use . SINGULAIR 10-mg Film-Coated Tablets SINGULAIR safely and effectively. See full prescribing information . SINGULAIR 5-mg and 4-mg Chewable Tablets for SINGULAIR. SINGULAIR 4.mg Oral Granules SINGULAIRiI .............................. CONTRAINDICATIONS .............................. (montelukast sodium) tablets, chewable tablets, and oral . Hypersensitivity to any component of this product (4). granules ....................... WARNINGS AND PRECAUTIONS ....................... Initial U.S. Approval: 1998 . Do not prescribe SINGULAIR to treat an acute asthma attack. .......................... RECENT MAJOR CHANGES........................... Advise patients to have appropriate rescue medication available Warnings and Precautions, Neuropsychiatric Events (5.4) 04/2010 (5.1). Inhaled corticosteroid may be reduced gradually. Do not abruptly ...........................INDICATIONS AND USAGE ........................... substitute SINGULAIR for inhaled or oral corticosteroids (5.2). SINGULAIRiI is a leukotriene receptor antagonist indicated for: . Patients with known aspirin sensitivity should continue to avoid . Prophylaxis and chronic treatment of asthma in patients aspirin or non-steroidal anti-inflammatory agents while taking 12 months of age and older (1.1). SINGULAIR (5.3). Acute prevention of exercise-induced bronchoconstriction (EIS) in Neuropsychiatric events have been reported with SINGULAIR. patients 15 years of age and older (1.2). Instruct patients to be alert for neuropsychiatric events. Evaluate Relief of symptoms of allergic rhinitis (AR): seasonal allergic the risks and benefits of continuing treatment with SINGULAIR if rhinitis (SAR) in patients 2 years of age and older, and perennial such events occur (5.4 and 6.2). -
FDA Briefing Document Pulmonary-Allergy Drugs Advisory Committee Meeting
FDA Briefing Document Pulmonary-Allergy Drugs Advisory Committee Meeting August 31, 2020 sNDA 209482: fluticasone furoate/umeclidinium/vilanterol fixed dose combination to reduce all-cause mortality in patients with chronic obstructive pulmonary disease NDA209482/S-0008 PADAC Clinical and Statistical Briefing Document Fluticasone furoate/umeclidinium/vilanterol fixed dose combination for all-cause mortality DISCLAIMER STATEMENT The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee. The FDA background package often contains assessments and/or conclusions and recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the Review Division or Office. We have brought the supplemental New Drug Application (sNDA) 209482, for fluticasone furoate/umeclidinium/vilanterol, as an inhaled fixed dose combination, for the reduction in all-cause mortality in patients with COPD, to this Advisory Committee in order to gain the Committee’s insights and opinions, and the background package may not include all issues relevant to the final regulatory recommendation and instead is intended to focus on issues identified by the Agency for discussion by the advisory committee. The FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered -
Diagnosis and Management of Asthma in Older Adults Sanjay Haresh Chotirmall, MD, Michael Watts, MD, Peter Branagan, MD, Ciaran F
PROGRESS IN GERIATRICS Diagnosis and Management of Asthma in Older Adults Sanjay Haresh Chotirmall, MD, Michael Watts, MD, Peter Branagan, MD, Ciaran F. Donegan, MD, Allan Moore, MD, and Noel Gerard McElvaney, MD Despite comprehensive guidelines established by the Euro- from 6.5% to 17.0%.5 Death rates associated with asthma pean Global Initiative for Asthma and the U.S. National depend on patient age; in a group of patients aged 55 to 59, Asthma Education and Prevention Program on the diagno- the death rate was 2.8 per 100,000 people, whereas in sis and management of asthma, its mortality in older adults people aged 60 to 64, it was 4.2 per 100, 000.6 Diagnostic continues to rise. Diagnostic and therapeutic problems and therapeutic problems contribute to many patients being contribute to older patients being inadequately treated. The inadequately treated. Despite its importance in older pa- diagnosis of asthma rests on the history and characteristic tients, asthma is particularly difficult to diagnose in this age pulmonary function testing (PFT) with the demonstration group. Symptoms typical of asthma such as intermittent of reversible airway obstruction, but there are unique prob- wheezing, breathlessness, and cough can also indicate other lems in performing this test in older patients and in its in- respiratory problems in older patients, particularly chronic terpretation. This review aims to address the difficulties in obstructive pulmonary disease (COPD). Similarly, other performing and interpreting PFT in older patients because symptoms of asthma such as chest pain or tightness may of the effects of age-related changes in lung function on be due to nonpulmonary disease such as ischemic heart respiratory physiology. -
Long-Acting Beta-Agonists in the Management of Chronic Obstructive Pulmonary Disease: Current and Future Agents
UCLA UCLA Previously Published Works Title Long-acting beta-agonists in the management of chronic obstructive pulmonary disease: current and future agents Permalink https://escholarship.org/uc/item/7s74p6sc Journal Respiratory Research, 11(1) ISSN 1465-9921 Authors Tashkin, Donald P Fabbri, Leonardo M Publication Date 2010-10-29 DOI http://dx.doi.org/10.1186/1465-9921-11-149 Peer reviewed eScholarship.org Powered by the California Digital Library University of California Tashkin and Fabbri Respiratory Research 2010, 11:149 http://respiratory-research.com/content/11/1/149 REVIEW Open Access Long-acting beta-agonists in the management of chronic obstructive pulmonary disease: current and future agents Donald P Tashkin1*, Leonardo M Fabbri2 Abstract Chronic obstructive pulmonary disease (COPD) is characterized by progressive airflow limitation and debilitating symptoms. For patients with moderate-to-severe COPD, long-acting bronchodilators are the mainstay of therapy; as symptoms progress, guidelines recommend combining bronchodilators from different classes to improve efficacy. Inhaled long-acting b2-agonists (LABAs) have been licensed for the treatment of COPD since the late 1990s and include formoterol and salmeterol. They improve lung function, symptoms of breathlessness and exercise limita- tion, health-related quality of life, and may reduce the rate of exacerbations, although not all patients achieve clini- cally meaningful improvements in symptoms or health related quality of life. In addition, LABAs have an acceptable safety profile, and are not associated with an increased risk of respiratory mortality, although adverse effects such as palpitations and tremor may limit the dose that can be tolerated. Formoterol and salmeterol have 12-hour durations of action; however, sustained bronchodilation is desirable in COPD.