Combination SABA + SAMA Inhaled Corticosteroi
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Chronic Obstructive Lung Disease
Chronic Obstructive Lung Disease Amita Vasoya, DO FACOI FCCP FAASM Christiana Care Pulmonary Associates Clinical Assistant Professor of Medicine Sidney Kimmel Medical College of Thomas Jefferson University Rowan University School of Osteopathic Medicine ACOI Board Review 2019 Disclosures No Disclosures Obstructive Lung Diseases COPD Chronic ◦ Chronic Bronchitis Bronchitis Emphysema ◦ Emphysema Asthma Other ◦ Bronchiectasis Asthma ◦ Bronchiolitis ◦ Cystic Fibrosis ◦ Alpha 1 anti-trypsin deficiency Inter-relationship: Inflammation and Bronchial Hyperreactivity ATS GOLD CHEST 2002; 121: 121S-126S COPD THIRD leading cause of death worldwide It is the only leading cause of death whose prevalence is increasing! http://www.who.int/mediacentre/factsheets COPD Risk Factors Cigarette smoking Occupational exposures ◦ Silica, formaldehyde, toluene, nickel, cadmium, cotton, dust, etc Air pollution Biomass fuel Hyperresponsive airway Asthma Genetic factors Pathogenesis of COPD ATS Pulmonary Board Review 2015 Inflammatory Mediators: COPD ATS Pulmonary Board Review 2015 INFLAMMATION Small Airway Disease Parenchyma destruction Airway inflammation Loss of alveolar attachments Airway remodeling Decreased elastic recoil AIRFLOW LIMITATION ATS Pulmonary Board Review 2015 COPD Phenotypes Non-exacerbator Exacerbator with emphysema Exacerbator with chronic bronchitis Frequent exacerbator Alpha 1 Antitrypsin deficiency ACOS BCOS www.eclipse-copd.com, Lange P. Int J COPD 2016. 11: 3-12 Hurst JR. NEJM 2010. 363: 1128-38 Morphologic Types of -
Comparison of Intramuscular Betamethasone and Oral
Color profile: Disabled Composite Default screen 100 ORIGINAL ARTICLE 100 95 95 75 75 25 25 5 5 0 Comparison of intramuscular 0 betamethasone and oral prednisone in the prevention of relapse of acute asthma John S Chan MD1, Robert L Cowie MD1, Gerald C Lazarenko MD2, Cinde Little RRT1, Sandra Scott RRT1, Gordon T Ford MD FCCP1 1Division of Respiratory Medicine and 2Department of Emergency Medicine, University of Calgary, Calgary, Alberta JS Chan, RL Cowie, GC Lazarenko, C Little, S Scott, tively) and use of inhaled corticosteroids (46% versus 64.3% GT Ford. Comparison of intramuscular betamethasone respectively) (P<0.05). Using intention-to-treat analysis, the and oral prednisone in the prevention of relapse of acute relapse rates for betamethasone and prednisone at day 7 were asthma. Can Respir J 2001;8(3):147-152. 14.9% (13 of 87 patients) and 25% (21 of 84 patients), respectively (P=0.1), and at day 21, the rates were 36.8% (32 OBJECTIVE: To compare the relapse rate after a single intra- of 87 patients) and 31% (26 of 84 patients), respectively muscular injection of a long acting corticosteroid, betametha- (P=0.4). There were no differences in symptom score, peak sone, with oral prednisone in patients discharged from the flows and adverse effects between the two groups at days 7 emergency department (ED) for acute exacerbations of and 21. asthma. CONCLUSIONS: A single dose of intramuscular betametha- PATIENTS AND METHODS: Patients with acute exacer- sone 12 mg was safe and as efficacious as prednisone in pre- bations of asthma who were suitable for discharge from the venting the relapse of acute asthma. -
Long-Term Budesonide Or Nedocromil Mineral Accretion Over a Period of Years
term inhaled corticosteroid (ICS) treatment on bone Long-term Budesonide or Nedocromil mineral accretion over a period of years. Treatment, Once Discontinued, Does Not Alter the Course of Mild to Moderate Asthma in STUDY POPULATION. Cohort follow-up study for a median Children and Adolescents of 7 years with 877 children 5 to 12 years of age who Strunk RC, Sternberg AL, Szefler SJ, et al. J Pediatr. had mild-to-moderate asthma and initially were ran- 2009;154(5):682–687 domly assigned in the Childhood Asthma Management Program. PURPOSE OF THE STUDY. To determine whether long-term, METHODS. Serial dual-energy x-ray absorptiometry scans continuous use of inhaled antiinflammatory medications of the lumbar spine to assess bone mineral density were affects asthma outcomes in children with mild-to-mod- performed for all patients. Annual bone mineral accre- erate asthma after use is discontinued. tion was calculated for 531 boys and 346 girls. STUDY POPULATION. A total of 941 children, 5 to 12 years of RESULTS. Oral corticosteroid bursts produced dose- age, who had previously participated in the Childhood dependent reductions in bone mineral accretion (0.052, Asthma Management Program (CAMP). 0.049, and 0.046 g/cm2 per year with 0, 1–4, and Ն5 courses, respectively) and increases in the risk for osteo- METHODS. During the CAMP trial, subjects received treat- penia (10%, 14%, and 21%, respectively) in boys but ment with budesonide, nedocromil, or placebo for 4.3 not girls. Cumulative ICS use was associated with a small years. During the posttrial period, asthma manage- decrease in bone mineral accretion in boys but not girls ment was provided by primary care physicians ac- but no increased risk for osteopenia. -
Summary of Product Characteristics
Health Products Regulatory Authority Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Salbutamol CFC-Free Inhaler 100 micrograms per metered dose, pressurised inhalation, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One metered dose contains 100 micrograms of salbutamol (equivalent to 120 micrograms of salbutamol sulphate). This is equivalent to a delivered dose of 90 micrograms of salbutamol (equivalent to 108 micrograms of salbutamol sulphate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation suspension Pressurised inhalation suspension supplied in an aluminium canister with a metering valve and a plastic actuator and dust cap. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Salbutamol CFC-Free Inhaler is indicated in adults, adolescents and children. For babies and children under 4 years of age, see sections 4.2 and 5.1. Salbutamol CFC-Free Inhaler is indicated for the relief and prevention of bronchial asthma and conditions associated with reversible airways obstruction. Salbutamol CFC-Free Inhaler can be used as relief medication in the management of mild, moderate or severe asthma, provided that its use does not delay the introduction and use of regular inhaled corticosteroid therapy, where necessary. 4.2 Posology and method of administration Salbutamol CFC-Free Inhaler is for oral inhalation use only. Posology Adults (including the elderly) and adolescents (children 12 years and over): For the relief of acute bronchospasm, one inhalation (100 micrograms) increasing to two inhalations (200 micrograms), if necessary. To prevent allergen- or exercise-induced symptoms, two inhalations (200 micrograms) should be taken 10-15 minutes before challenge. Maximum daily dose: two inhalations (200 micrograms) up to four times a day. -
Prediction of Premature Termination Codon Suppressing Compounds for Treatment of Duchenne Muscular Dystrophy Using Machine Learning
Prediction of Premature Termination Codon Suppressing Compounds for Treatment of Duchenne Muscular Dystrophy using Machine Learning Kate Wang et al. Supplemental Table S1. Drugs selected by Pharmacophore-based, ML-based and DL- based search in the FDA-approved drugs database Pharmacophore WEKA TF 1-Palmitoyl-2-oleoyl-sn-glycero-3- 5-O-phosphono-alpha-D- (phospho-rac-(1-glycerol)) ribofuranosyl diphosphate Acarbose Amikacin Acetylcarnitine Acetarsol Arbutamine Acetylcholine Adenosine Aldehydo-N-Acetyl-D- Benserazide Acyclovir Glucosamine Bisoprolol Adefovir dipivoxil Alendronic acid Brivudine Alfentanil Alginic acid Cefamandole Alitretinoin alpha-Arbutin Cefdinir Azithromycin Amikacin Cefixime Balsalazide Amiloride Cefonicid Bethanechol Arbutin Ceforanide Bicalutamide Ascorbic acid calcium salt Cefotetan Calcium glubionate Auranofin Ceftibuten Cangrelor Azacitidine Ceftolozane Capecitabine Benserazide Cerivastatin Carbamoylcholine Besifloxacin Chlortetracycline Carisoprodol beta-L-fructofuranose Cilastatin Chlorobutanol Bictegravir Citicoline Cidofovir Bismuth subgallate Cladribine Clodronic acid Bleomycin Clarithromycin Colistimethate Bortezomib Clindamycin Cyclandelate Bromotheophylline Clofarabine Dexpanthenol Calcium threonate Cromoglicic acid Edoxudine Capecitabine Demeclocycline Elbasvir Capreomycin Diaminopropanol tetraacetic acid Erdosteine Carbidopa Diazolidinylurea Ethchlorvynol Carbocisteine Dibekacin Ethinamate Carboplatin Dinoprostone Famotidine Cefotetan Dipyridamole Fidaxomicin Chlormerodrin Doripenem Flavin adenine dinucleotide -
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. -
BREO • Do Not Use in Combination with an Additional Medicine Containing a ELLIPTA Safely and Effectively
HIGHLIGHTS OF PRESCRIBING INFORMATION treat acute symptoms. (5.2) These highlights do not include all the information needed to use BREO • Do not use in combination with an additional medicine containing a ELLIPTA safely and effectively. See full prescribing information for LABA because of risk of overdose. (5.3) BREO ELLIPTA. • Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water BREO ELLIPTA 100/25 (fluticasone furoate 100 mcg and vilanterol without swallowing after inhalation to help reduce the risk. (5.4) 25 mcg inhalation powder), for oral inhalation • Increased risk of pneumonia in patients with COPD. Monitor patients for BREO ELLIPTA 200/25 (fluticasone furoate 200 mcg and vilanterol signs and symptoms of pneumonia. (5.5) 25 mcg inhalation powder), for oral inhalation • Potential worsening of infections (e.g., existing tuberculosis; fungal, Initial U.S. Approval: 2013 bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course WARNING: ASTHMA-RELATED DEATH of chickenpox or measles can occur in susceptible patients. (5.6) See full prescribing information for complete boxed warning. • Risk of impaired adrenal function when transferring from systemic • Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, corticosteroids. Taper patients slowly from systemic corticosteroids if increase the risk of asthma-related death. A placebo-controlled trial transferring to BREO ELLIPTA. (5.7) with another LABA (salmeterol) showed an increase in • Hypercorticism and adrenal suppression may occur with very high asthma-related deaths. This finding with salmeterol is considered a dosages or at the regular dosage in susceptible individuals. -
Supporting Information a Analysed Substances
Electronic Supplementary Material (ESI) for Analyst. This journal is © The Royal Society of Chemistry 2020 List of contents: Tab. A1 Detailed list and classification of analysed substances. Tab. A2 List of selected MS/MS parameters for the analytes. Tab. A1 Detailed list and classification of analysed substances. drug of therapeutic doping agent analytical standard substance abuse drug (WADA class)* supplier (+\-)-amphetamine ✓ ✓ S6 stimulants LGC (+\-)-methamphetamine ✓ S6 stimulants LGC (+\-)-3,4-methylenedioxymethamphetamine (MDMA) ✓ S6 stimulants LGC methylhexanamine (4-methylhexan-2-amine, DMAA) S6 stimulants Sigma cocaine ✓ ✓ S6 stimulants LGC methylphenidate ✓ ✓ S6 stimulants LGC nikethamide (N,N-diethylnicotinamide) ✓ S6 stimulants Aldrich strychnine S6 stimulants Sigma (-)-Δ9-tetrahydrocannabinol (THC) ✓ ✓ S8 cannabinoids LGC (-)-11-nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) S8 cannabinoids LGC morphine ✓ ✓ S7 narcotics LGC heroin (diacetylmorphine) ✓ ✓ S7 narcotics LGC hydrocodone ✓ ✓ Cerillant® oxycodone ✓ ✓ S7 narcotics LGC (+\-)-methadone ✓ ✓ S7 narcotics Cerillant® buprenorphine ✓ ✓ S7 narcotics Cerillant® fentanyl ✓ ✓ S7 narcotics LGC ketamine ✓ ✓ LGC phencyclidine (PCP) ✓ S0 non-approved substances LGC lysergic acid diethylamide (LSD) ✓ S0 non-approved substances LGC psilocybin ✓ S0 non-approved substances Cerillant® alprazolam ✓ ✓ LGC clonazepam ✓ ✓ Cerillant® flunitrazepam ✓ ✓ LGC zolpidem ✓ ✓ LGC VETRANAL™ boldenone (Δ1-testosterone / 1-dehydrotestosterone) ✓ S1 anabolic agents (Sigma-Aldrich) -
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. -
Fluticasone Furoate/Vilanterol 92/22 Μg Once-A-Day Vs Beclomethasone Dipropionate/Formoterol 100/6 Μg B.I.D
Open Access Journal of Pulmonology and Respiratory Research Research Article Fluticasone furoate/Vilanterol 92/22 μg once-a-day vs Beclomethasone dipropionate/Formoterol 100/6 μg b.i.d. in asthma patients: a 12-week pilot study Claudio Terzano* and Francesca Oriolo Respiratory Diseases Unit and School of Specialization in Respiratory Diseases Policlinico Umberto I, “Sapienza” University of Rome, Italy *Address for Correspondence: Dr Claudio Abstract Terzano, Respiratory Diseases Unit and School of Specialization in Respiratory Two of the most recent LABA/ICS combinations for treatment of persistent asthma are Fluticasone furoate/ Diseases Policlinico Umberto I, “Sapienza” Vilanterol 92/22 μg (Ellipta) and Beclomethasone dipropionate/Formoterol 100/6 μg (Nexthaler). University of Rome, Italy, Tel: 0649979051; Fax: 06499790675; Email: Objective: To compare once-daily Fluticasone/ Vilanterol combination with twice daily Beclomethasone/ [email protected] Formoterol association in moderate asthma, in terms of quality of life and lung function. Submitted: 08 September 2017 Methods: Fourty patients with moderate asthma treated with Beclomethasone/Formoterol 100/6 μg or Approved: 26 September 2017 Fluticasone/Vilanterol 92/22 μg. We revalued patients in terms of lung function and Asthma Control Test, at 4, 8 Published: 27 September 2017 and 12 weeks to assess any differences between the two groups. After 4 weeks, thirty-one of the fourty patients were evaluated in terms of respiratory function at predetermined time intervals. Copyright: 2017 Terzano C, et al. This is an open access article distributed under the Result: In patients treated with beclomethasone/formoterol FEV1 presented a mean value of 78% at the Creative Commons Attribution License, which third visit and of 79.1% during the fi nal check, compared with 74.5% and to 75.8% in patients in treatment permits unrestricted use, distribution, and with fl uticasone/vilanterol (p 0.01). -
Prodrugs Design Based on Inter- and Intramolecular Chemical Processes
Chem Biol Drug Des 2013; 82: 643–668 Review Prodrugs Design Based on Inter- and Intramolecular Chemical Processes Rafik Karaman1,2,* compound satisfies a number of preset criteria to start clinical development. The number of years it takes to intro- 1Bioorganic Chemistry Department, Faculty of Pharmacy, duce a drug to the pharmaceutical market is over 10 years Al-Quds University, P.O. Box 20002, Jerusalem, Palestine with a cost of more than $1 billion dollars (1,2). 2Department of Science, University of Basilicata, Via dell’Ateneo Lucano 10, 85100, Potenza, Italy Modifying the absorption, distribution, metabolism, and *Corresponding author: Rafik Karaman, elimination (ADME) properties of an active drug requires a [email protected] complete understanding of the physicochemical and bio- logical behavior of the drug candidate (3 6). This includes This review provides the reader a concise overview of – the majority of prodrug approaches with the emphasis comprehensive evaluation of drug-likeness involving on the modern approaches to prodrug design. The prediction of ADME properties. These predictions can be chemical approach catalyzed by metabolic enzymes attempted at several levels: in vitro–in vivo using data which is considered as widely used among all other obtained from tissue or recombinant material from human approaches to minimize the undesirable drug physico- and preclinical species, and in silico or computational pre- chemical properties is discussed. Part of this review dictions projecting in vitro or in vivo data, involving the will shed light on the use of molecular orbital methods evaluation of various ADME properties, using computa- such as DFT, semiempirical and ab initio for the design tional approaches such as quantitative structure activity of novel prodrugs. -
The 2013 "Research on Drug Evidence"
The 2013 “Research on Drug Evidence” Report [From the 17th ICPO / INTERPOL Forensic Science Symposium] Robert F. X. Klein U.S. Department of Justice Drug Enforcement Administration Special Testing and Research Laboratory 22624 Dulles Summit Court Dulles, VA 20166 [[email protected]] ABSTRACT: A reprint of the 2013 “Research on Drug Evidence” Report (a review) is provided. KEYWORDS: INTERPOL, Illicit Drugs, Controlled Substances, Forensic Chemistry. Important Information: Distributed at the 17th ICPO / INTERPOL Forensic Science Symposium, Lyon, France, October 8 - 10, 2013.* Authorized Reprint. Copyright INTERPOL. All rights reserved. May not be reprinted without express permission from INTERPOL. For pertinent background, see: Klein RFX. ICPO / INTERPOL Forensic Science Symposia, 1995 - 2016. “Research on Drug Evidence”. Prefacing Remarks (and a Request for Information). Microgram Journal 2016;13(1-4):1-3. Citations in this report from the Journal of the Clandestine Laboratory Investigating Chemists Association were (and remain) Law Enforcement Restricted. The "General Overview" (Talking Paper) was removed from this reprint (Editor's discretion). This reprint is derived from the original electronic document, and is not an image of the best available hard copy (as was utilized for the 1995 and 1998 reports). For this reason, the pagination in the Proceedings is not retained in this reprint, some minor reformatting was done to eliminate deadspace, and all widow and orphan lines were left as is. [* Due to travel restrictions in effect in late 2013, this report and the associated "General Overview" (Talking Paper) was not actually presented, but rather the report was only distributed to the attendees.] Microgram Journal 2016, Volume 13; Numbers 1-4 511 Research on Drug Evidence January 1, 2010 - June 30, 2013 Presented by: Jeffrey H.