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https://www.readbyqxmd.com/read/29774778/an-overview-of-glycopyrrolate-eflow%C3%A2-cs-in-copd
#1
Edward Kerwin, Gary T Ferguson
COPD is highly prevalent in the US and globally, requiring new treatment strategies due to the high disease burden and increase in the aging population. Here, we profile the newly FDA-approved LONHALA MAGNAIR (glycopyrrolate [GLY]/eFlow® Closed System [CS]; 25 mcg twice daily), a nebulized long-acting muscarinic antagonist (LAMA) for the long-term maintenance treatment of COPD, including chronic bronchitis and/or emphysema. Areas covered: An overview of COPD and the treatment landscape, focusing on GLY/eFlow CS, is reported by reviewing the published literature pertinent to the drug/device combination...
May 18, 2018: Expert Review of Respiratory Medicine
https://www.readbyqxmd.com/read/29724397/randomized-study-of-the-effects-of-aerochamber-plus-%C3%A2-flow-vu-%C3%A2-on-the-efficacy-pharmacokinetics-and-safety-of-glycopyrronium-formoterol-fumarate-dihydrate-metered-dose-inhaler-in-patients-with-chronic-obstructive-pulmonary-disease
#2
Faisal Fakih, Selwyn Spangenthal, Barry Sigal, Patrick Darken, Andrea Maes, Shahid Siddiqui, Michael Gillen, Colin Reisner, Ubaldo J Martin
OBJECTIVES: This study compared the efficacy, pharmacokinetics (PK), and safety of GFF MDI (Bevespi Aerosphere® ), a fixed-dose combination of glycopyrronium and formoterol fumarate dihydrate (14.4/10 μg) delivered by a metered dose inhaler (MDI) formulated using innovative co-suspension delivery technology, in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) with and without the Aerochamber Plus® Flow-Vu® valved holding chamber (VHC). METHODS: In this multicenter, open-label, crossover, Phase III study (NCT02454959), patients were randomized to receive GFF MDI 14...
May 2018: Respiratory Medicine
https://www.readbyqxmd.com/read/29716836/cardiovascular-and-respiratory-effects-of-two-doses-of-fentanyl-in-the-presence-or-absence-of-bradycardia-in-isoflurane-anesthetized-dogs
#3
Allan J Williamson, Joao Hn Soares, Natalia Henao-Guerrero, Roberto McAlister Council-Troche, Noah D Pavlisko
OBJECTIVE: To compare the cardiopulmonary effects of low and high doses of fentanyl before and after the correction of bradycardia in isoflurane-anesthetized dogs. STUDY DESIGN: Prospective, randomized crossover trial. ANIMALS: Eight healthy male Beagle dogs weighing 11.1 ± 1.3 kg [mean ± standard deviation (SD)] and aged approximately 1 year. METHODS: The dogs were anesthetized with isoflurane [1.3 × minimum alveolar concentration (MAC)] on two occasions and fentanyl was administered intravenously; either low-dose fentanyl, loading dose (33 μg kg-1 ) and infusion (0...
March 19, 2018: Veterinary Anaesthesia and Analgesia
https://www.readbyqxmd.com/read/29667949/nebulized-glycopyrrolate-lonhala-magnair-for-copd
#4
(no author information available yet)
No abstract text is available yet for this article.
April 23, 2018: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/29643623/effect-of-dexmedetomidine-infusion-on-hemodynamic-responses-in-microsurgery-of-larynx
#5
Shakuntala Basantwani, Mayuresh Patil, Balasaheb Govardhane, Jyoti Magar, Bharati Tendolkar
Background and Aims: Microlaryngeal surgery is a frequently performed ear, nose, and throat procedure used to diagnose and treat laryngeal disorders. Suspension laryngoscopy causes prolonged stimulation of the deep pressure receptors of the larynx leading to adverse circulatory responses and consequently cardiac complications. In this study, dexmedetomidine infusion was used to assess its effectiveness for attenuation of this hemodynamic stress response. Material and Methods: Sixty patients undergoing elective microlaryngeal surgery randomly received either dexmedetomidine 1 μg/kg over 10 min followed by continuous infusion of 0...
January 2018: Journal of Anaesthesiology, Clinical Pharmacology
https://www.readbyqxmd.com/read/29609685/stability-of-regularly-prescribed-oral-liquids-formulated-with-syrspend-%C3%A2-sf
#6
M Uriel, C Gómez-Rincón, D Marro
The purpose of this research was to evaluate the stability of 12 oral liquid formulations frequently compounded in hospital and community settings formulated in a specific vehicle: SyrSpend® SF. The stability of melatonin, glycopyrrolate, ciclosporin, chloral hydrate, flecainide acetate, tiagabine HCl, labetalol HCl, ciprofloxacin HCl, spironolactone/hydrochlorothiazide, hydrocortisone, itraconazole and celecoxib in SyrSpend SF PH4 (liquid) was investigated at 0, 30, 60 and 90 days and stored at both controlled room temperature and refrigerated...
April 2, 2018: Die Pharmazie
https://www.readbyqxmd.com/read/29606861/pharmacokinetics-of-glycopyrronium-formoterol-fumarate-dihydrate-delivered-via-metered-dose-inhaler-using-co-suspension-delivery-technology-in-patients-with-moderate-to-very-severe-copd
#7
Gary T Ferguson, Roberto Rodriguez-Roisin, Colin Reisner, Andrea Maes, Shahid Siddiqui, Ubaldo J Martin
Purpose: The efficacy and tolerability of GFF MDI (Bevespi Aerosphere® ), a fixed-dose combination of glycopyrronium (GP)/formoterol fumarate dihydrate (FF) 14.4/10 μg (equivalent to glycopyrrolate/formoterol fumarate 18/9.6 μg) delivered by metered dose inhaler (MDI) using innovative co-suspension delivery technology, has been investigated in a Phase III clinical trial program (NCT01854645, NCT01854658, NCT01970878) in patients with COPD. Here, we present findings from a pharmacokinetic (PK) sub-study of NCT01854645 (PINNACLE-1)...
2018: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/29567116/cardiovascular-safety-profile-of-a-fixed-dose-combination-of-glycopyrrolate-and-formoterol-fumarate-delivered-via-metered-dose-inhaler-using-co-suspension-delivery-technology
#8
Gary T Ferguson, Colin Reisner, James Pearle, Paolo DePetrillo, Andrea Maes, Ubaldo J Martin
BACKGROUND: Glycopyrrolate/formoterol fumarate (GFF) metered dose inhaler (MDI) is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA), glycopyrrolate (GP), and the long-acting β2 -agonist (LABA), formoterol fumarate (FF), delivered via metered dose inhaler using innovative co-suspension delivery technology. Here we report the results of two studies that examined the cardiovascular safety of GFF MDI. METHODS: The thorough QT (TQT) study was a Phase I, randomized, double-blind, single-dose, crossover study to assess GFF MDI 18/9...
April 2018: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29544728/the-pharmacokinetics-of-three-doses-of-budesonide-glycopyrronium-formoterol-fumarate-dihydrate-metered-dose-inhaler-compared-with-active-controls-a-phase-i-randomized-single-dose-crossover-study-in-healthy-adults
#9
Patrick Darken, Paolo DePetrillo, Colin Reisner, Earl St Rose, Paul Dorinsky
The budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler (BGF MDI) is an inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2 -agonist fixed-dose combination formulated with innovative co-suspension delivery technology that is in clinical development for the treatment of chronic obstructive pulmonary disease (COPD). This randomized, Phase I, single-dose, six-treatment, four-period, crossover study (NCT01980615) examined the pharmacokinetic (PK) and safety profile of three doses of BGF MDI (320/14...
March 12, 2018: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29540093/hyperinflation-of-glycopyrrolate
#10
Elizabeth Greenhalgh
No abstract text is available yet for this article.
January 1, 2018: Journal of Pharmacy Practice
https://www.readbyqxmd.com/read/29497193/use-of-modified-bilateral-electroconvulsive-therapy-during-pregnancy-a-case-series
#11
Sandeep Grover, Pooja Sikka, Shiv Sajan Saini, Neeru Sahni, Subho Chakrabarti, Devakshi Dua, Anisha Aggarwal, Anita Thakur, Shallu Dhiman, Amal Jolly, Swapnajeet Sahoo, Aseem Mehra, Aditya Somani
There is limited literature on the use of electroconvulsive therapy (ECT) during pregnancy. ECT is considered as a treatment of last resort during pregnancy. In this case series, we present the data of five patients who were administered ECT during pregnancy. The use of ECT required multidisciplinary approach involving psychiatrist, gynecologist, anesthetist and neonatologist. Two patients received ECT during the second trimester and three patients received ECT during the third trimester. In all the patients, ECT was administered by placing the patients in the left lateral position, glycopyrrolate was used for premedication, thiopentone was used for induction, and succinylcholine was used for muscle relaxation...
October 2017: Indian Journal of Psychiatry
https://www.readbyqxmd.com/read/29491694/pharmaceutical-approval-update
#12
Michele B Kaufman
Zoster vaccine recombinant, adjuvanted (Shingrix) for the prevention of shingles in adults; angiotensin II injection (Giapreza) to increase blood pressure in adults with septic or other distributive shock; and glycopyrrolate inhalation solution (Lonhala Magnair) for the maintenance treatment of chronic obstructive pulmonary disease.
March 2018: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/29214645/recovery-characteristics-of-patients-receiving-either-sugammadex-or-neostigmine-and-glycopyrrolate-for-reversal-of-neuromuscular-block-a-randomised-controlled-trial
#13
M J Paech, R Kaye, C Baber, E A Nathan
Sugammadex more rapidly and reliably reverses rocuronium-induced neuromuscular block compared with neostigmine, but it is not known if subsequent patient outcomes, including nausea, vomiting and other aspects of recovery are modified. In this study, we compared the recovery characteristics of sugammadex and neostigmine/glycopyrrolate following reversal of neuromuscular block. This was a single-centre, randomised, blinded, parallel-group clinical trial in women undergoing elective day-surgical laparoscopic gynaecological surgery, with a standardised general anaesthesia regimen that included rocuronium...
March 2018: Anaesthesia
https://www.readbyqxmd.com/read/29202767/dose-selection-for-glycopyrrolate-eflow-%C3%A2-phase-iii-clinical-studies-results-from-golden-glycopyrrolate-for-obstructive-lung-disease-via-electronic-nebulizer-phase-ii-dose-finding-studies
#14
James F Donohue, Thomas Goodin, Robert Tosiello, Alistair Wheeler
BACKGROUND: Long-acting muscarinic antagonists (LAMAs) are recommended for the treatment of chronic obstructive pulmonary disease (COPD). Glycopyrrolate/eFlow® is an investigational drug-device combination of the LAMA glycopyrrolate administered by an eFlow® Closed System (eFlow® CS) nebulizer. The GOLDEN 2 (NCT01706536) and GOLDEN 6 (NCT02038829) Phase II, multicenter studies were conducted to inform dose selection for the GOLDEN Phase III clinical trials. Bronchodilator responses and safety assessments supported dose selection...
December 4, 2017: Respiratory Research
https://www.readbyqxmd.com/read/29180850/role-of-nebulized-glycopyrrolate-in-the-treatment-of-chronic-obstructive-pulmonary-disease
#15
REVIEW
Pierachille Santus, Dejan Radovanovic, Andrea Cristiano, Vincenzo Valenti, Maurizio Rizzi
In the upcoming years, the proportion of elderly patients with chronic obstructive pulmonary disease (COPD) will increase, according to the progressively aging population and the increased efficacy of the pharmacological treatments, especially considering the management of chronic comorbidities. The issue to prescribe an appropriate inhalation therapy to COPD patients with significant handling or coordination difficulties represents a common clinical experience; in the latter case, the choice of an inadequate inhalation device may jeopardize the adherence to the treatment and eventually lead to its ineffectiveness...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29125918/in-vitro-characterization-of-the-eflow-closed-system-nebulizer-with-glycopyrrolate-inhalation-solution
#16
Stephen Pham, Gary T Ferguson, Edward Kerwin, Thomas Goodin, Alistair Wheeler, Andrea Bauer
BACKGROUND: Glycopyrrolate administered by a novel, investigational eFlow(®) Closed System (CS) nebulizer (eFlow CS) is being evaluated for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The eFlow CS is a hand-held, vibrating membrane nebulizer optimized to deliver 1 mL of glycopyrrolate solution into the lung in <3 minutes. Clinical studies have shown improvements in lung function of subjects treated with nebulized glycopyrrolate. METHODS: The aerosol performance of the eFlow CS nebulizer was characterized by delivered dose, aerodynamic droplet size distribution and nebulization time...
November 10, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/29116244/delivery-of-neostigmine-and-glycopyrrolate-by-iontophoresis-a-nonrandomized-study-in-individuals-with-spinal-cord-injury
#17
Mark A Korsten, Brian L Lyons, Miroslav Radulovic, Tradd M Cummings, Gautam Sikka, Kamaldeep Singh, Joshua C Hobson, Anton Sabiev, Ann M Spungen, William A Bauman
STUDY DESIGN: Phase I Clinical Trial. OBJECTIVES: In this proof-of-principle study, the effectiveness and safety of transdermal administration of neostigmine/glycopyrrolate to elicit a bowel movement was compared to intravenous administration in patients with spinal cord injury. SETTING: James J. Peters Veterans Affairs Medical Center (Bronx, NY). METHODS: Individuals were screened for responsiveness (Physical Response) to intravenous neostigmine (0...
March 2018: Spinal Cord
https://www.readbyqxmd.com/read/29080329/dispersive-micro-solid-phase-extraction-combined-with-online-preconcentration-by-capillary-electrophoresis-for-the-determination-of-glycopyrrolate-stereoisomers-in-rat-plasma
#18
Yongjing Liu, Lishuang Yu, Hua Zhang, Dawei Chen
A simple and sensitive analytical method for four isomers of glycopyrrolate in rat plasma was developed using cation-selective exhaustive injection-sweeping cyclodextrin-modified electrokinetic chromatography (CSEI-Sweeping-CDEKC) for online enrichment combined with dispersive micro-solid-phase extraction pretreatment. The CSEI-Sweeping-CDEKC was conducted on an uncoated fused silica capillary (40.2 cm × 75 μm) with an applied voltage of -20 kV. The electrophoretic analysis was carried out in 30 mM phosphate solution at pH 2...
October 28, 2017: Journal of Separation Science
https://www.readbyqxmd.com/read/29076369/cardiovascular-effects-of-premedication-with-medetomidine-alone-and-in-combination-with-mk-467-or-glycopyrrolate-in-dogs-subsequently-anesthetized-with-isoflurane
#19
RANDOMIZED CONTROLLED TRIAL
Kati M Salla, Cosmin I Tuns, Rachel C Bennett, Marja R Raekallio, Mika Scheinin, Erja Kuusela, Outi M Vainio
OBJECTIVE To compare cardiovascular effects of premedication with medetomidine alone and with each of 3 doses of MK-467 or after glycopyrrolate in dogs subsequently anesthetized with isoflurane. ANIMALS 8 healthy purpose-bred 5-year-old Beagles. PROCEDURES In a randomized crossover study, each dog received 5 premedication protocols (medetomidine [10 μg/kg, IV] alone [MED] and in combination with MK-467 at doses of 50 [MMK50], 100 [MMK100], and 150 [MMK150] μg/kg and 15 minutes after glycopyrrolate [10 μg/kg, SC; MGP]), with at least 14 days between treatments...
November 2017: American Journal of Veterinary Research
https://www.readbyqxmd.com/read/29055732/gamma-scintigraphic-pulmonary-deposition-study-of-glycopyrronium-formoterol-metered-dose-inhaler-formulated-using-co-suspension-delivery-technology
#20
Glyn Taylor, Simon Warren, Sarvajna Dwivedi, Mark Sommerville, Lauren Mello, Chad Orevillo, Andrea Maes, Ubaldo J Martin, Omar S Usmani
This gamma scintigraphy imaging study was the first to assess pulmonary and extrathoracic deposition and regional lung deposition patterns of a radiolabelled long-acting muscarinic antagonist/long-acting β2-agonist fixed-dose combination glycopyrronium/formoterol fumarate dihydrate (GFF) 14.4/10μg (equivalent to glycopyrrolate/formoterol fumarate 18/9.6μg), delivered by pressurized metered dose inhaler (pMDI) using novel co-suspension delivery technology. In this Phase I, randomized, single-centre, single-blind, single-dose, two-treatment, crossover, placebo-controlled study (PT003020), 10 healthy male adults received two actuations of GFF pMDI (7...
October 18, 2017: European Journal of Pharmaceutical Sciences
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