Prescribing Information for SPIRIVA Handihaler
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Differentiating Between Anxiety, Syncope & Anaphylaxis
Differentiating between anxiety, syncope & anaphylaxis Dr. Réka Gustafson Medical Health Officer Vancouver Coastal Health Introduction Anaphylaxis is a rare but much feared side-effect of vaccination. Most vaccine providers will never see a case of true anaphylaxis due to vaccination, but need to be prepared to diagnose and respond to this medical emergency. Since anaphylaxis is so rare, most of us rely on guidelines to assist us in assessment and response. Due to the highly variable presentation, and absence of clinical trials, guidelines are by necessity often vague and very conservative. Guidelines are no substitute for good clinical judgment. Anaphylaxis Guidelines • “Anaphylaxis is a potentially life-threatening IgE mediated allergic reaction” – How many people die or have died from anaphylaxis after immunization? Can we predict who is likely to die from anaphylaxis? • “Anaphylaxis is one of the rarer events reported in the post-marketing surveillance” – How rare? Will I or my colleagues ever see a case? • “Changes develop over several minutes” – What is “several”? 1, 2, 10, 20 minutes? • “Even when there are mild symptoms initially, there is a potential for progression to a severe and even irreversible outcome” – Do I park my clinical judgment at the door? What do I look for in my clinical assessment? • “Fatalities during anaphylaxis usually result from delayed administration of epinephrine and from severe cardiac and respiratory complications. “ – What is delayed? How much time do I have? What is anaphylaxis? •an acute, potentially -
(Loxapine) REMS
Current as of 6/1/2013.® This document may not be part of the latest approved REMS. Alexza Pharmaceuticals, Inc. 2091 Stierlin Court, Mountain View, CA 94043 IMPORTANT DRUG WARNING Risk of bronchospasm with ADASUVE™ (loxapine) inhalation powder ADASUVE™ available only in enrolled healthcare facilities, under an FDA-required REMS Program Dear Healthcare Professional: This letter contains important safety information for ADASUVE™ (loxapine) Inhalation Powder. ADASUVE is a drug-device combination product that delivers the antipsychotic, loxapine, by oral inhalation. ADASUVE has been approved by the US Food and Drug Administration (FDA) for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of treatment outweigh the risk of bronchospasm in patients treated with ADASUVE. ADASUVE is not available in an outpatient setting. If you are an outpatient provider, you are receiving this letter because ADASUVE may be, or may have been, administered to one of your patients in an enrolled healthcare facility. Enrolled healthcare facilities, such as an acute care or inpatient setting, must have immediate on-site access to equipment and personnel trained to manage acute bronchospasm, including advanced airway management, eg, intubation and mechanical ventilation. (See below for more facility enrollment requirements.) It is important that anyone caring for patients treated with ADASUVE be aware of the risk of bronchospasm after administration. This letter does not contain a complete list of all the risks associated with ADASUVE. Reference ID:Please 3235446 see the enclosed full prescribing information for more information. -
Early Protective Effects of Tiotropium Bromide in Patients with Airways Hyperres P O N S I V E N E S S
European Review for Medical and Pharmacological Sciences 2004; 8: 259-264 Early protective effects of tiotropium bromide in patients with airways hyperres p o n s i v e n e s s C. TERZANO, A. PETROIANNI, A. RICCI, L. D’ANTONI, L. ALLEGRA* Department of Cardiovascular and Respiratory Sciences, Respiratory Diseases Unit, Fondazione E. Lorillard Spencer Cenci, “La Sapienza” University - Rome (Italy) *Institute of Respiratory Diseases, University of Milan, Ospedale Maggiore IRCCS – Milan (Italy) Abstract. – Tiotropium is an anticholiner- Introduction gic drug for Ch ronic Obstructive Pulmonary Di sease (COPD) patients, with a peak b ron- Ti o t rop ium is a qu atern a ry amm o niu m chodilator effect observed after 1.5 to 2 hours and a long duration of action. The aim of our co ngener of atropine. It has been developed study was to quantify the early protection of a as a lon g-acting an ticho linergic bro n c h o d i l a- single dose of inhaled tiotropium against metha- tor for inhalation by patients with chronic ob- choline-induced bronchoconstriction in asthmat- s t ructive pu lmon ary d isease (COPD). Dru g ic patients with airway hyperresponsiveness. p ro p e rties o f ant icho lin ergic agent s have Ten subjects (7M, 3F), with history of asthma been well-kno wn to man y cultures for many and a baseline FEV (Forced Expiratory Volume 1 1 1 c e n t u r i e s . In the 1920s the d iscovery o f the sec) >80% of pred icted, were enrolled in the s t u d y. -
Non-Steroidal Drug-Induced Glaucoma MR Razeghinejad Et Al 972
Eye (2011) 25, 971–980 & 2011 Macmillan Publishers Limited All rights reserved 0950-222X/11 www.nature.com/eye 1,2 1 1 Non-steroidal drug- MR Razeghinejad , MJ Pro and LJ Katz REVIEW induced glaucoma Abstract vision. The majority of drugs listed as contraindicated in glaucoma are concerned with Numerous systemically used drugs are CAG. These medications may incite an attack in involved in drug-induced glaucoma. Most those individuals with narrow iridocorneal reported cases of non-steroidal drug-induced angle.3 At least one-third of acute closed-angle glaucoma are closed-angle glaucoma (CAG). glaucoma (ACAG) cases are related to an Indeed, many routinely used drugs that have over-the-counter or prescription drug.1 Prevalence sympathomimetic or parasympatholytic of narrow angles in whites from the Framingham properties can cause pupillary block CAG in study was 3.8%. Narrow angles are more individuals with narrow iridocorneal angle. The resulting acute glaucoma occurs much common in the Asian population. A study of a more commonly unilaterally and only rarely Vietnamese population estimated a prevalence 4 bilaterally. CAG secondary to sulfa drugs is a of occludable angles at 8.5%. The reported bilateral non-pupillary block type and is due prevalence of elevated IOP months to years to forward movement of iris–lens diaphragm, after controlling ACAG with laser iridotomy 5,6 which occurs in individuals with narrow or ranges from 24 to 72%. Additionally, a open iridocorneal angle. A few agents, significant decrease in retinal nerve fiber layer including antineoplastics, may induce thickness and an increase in the cup/disc ratio open-angle glaucoma. -
COPD Agents Review – October 2020 Page 2 | Proprietary Information
COPD Agents Therapeutic Class Review (TCR) October 1, 2020 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. October 2020 -
Inhaled Loxapine Monograph
Inhaled Loxapine Monograph Inhaled Loxapine (ADASUVE) National Drug Monograph February 2015 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/Mechanism of Inhaled loxapine is a typical antipsychotic used in the treatment of acute Action agitation associated with schizophrenia and bipolar I disorder in adults. Loxapine’s mechanism of action for reducing agitation in schizophrenia and bipolar I disorder is unknown. Its effects are thought to be mediated through blocking postsynaptic dopamine D2 receptors as well as some activity at the serotonin 5-HT2A receptors. Indication(s) Under Review in Inhaled loxapine is a typical antipsychotic indicated for the acute treatment of this document (may include agitation associated with schizophrenia or bipolar I disorder in adults. off label) Off-label use Agitation related to any other cause not due to schizophrenia and bipolar I disorder. Dosage Form(s) Under 10mg oral inhalation using a new STACCATO inhaler device. Review REMS REMS No REMS Post-marketing Study Required See Other Considerations for additional REMS information Pregnancy Rating C Executive Summary Efficacy Inhaled loxapine was superior to placebo in reducing acute agitation at 2 hours post dose measured by the Positive and Negative Syndrome Scale-Excited Component (PEC) in patients with bipolar I disorder and schizophrenia. -
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 -
Beta Adrenergic Agents
Beta2 Adrenergic Agents –Long Acting Review 04/10/2008 Copyright © 2007 - 2008 by Provider Synergies, L.L.C. All rights reserved. Printed in the United States of America. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage and retrieval system without the express written consent of Provider Synergies, L.L.C. All requests for permission should be mailed to: Attention: Copyright Administrator Intellectual Property Department Provider Synergies, L.L.C. 5181 Natorp Blvd., Suite 205 Mason, Ohio 45040 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Comments and suggestions may be sent to [email protected]. -
SPIRIVA Handihaler Safely and Effectively
HIGHLIGHTS OF PRESCRIBING INFORMATION -------------------------------CONTRAINDICATIONS------------------------------ These highlights do not include all the information needed to use • Hypersensitivity to ipratropium or tiotropium (4) SPIRIVA HandiHaler safely and effectively. See full prescribing information for SPIRIVA HandiHaler. -----------------------WARNINGS AND PRECAUTIONS------------------------ • Not for acute use: Not for use as a rescue medication (5.1) SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) • Immediate hypersensitivity reactions: Discontinue SPIRIVA HandiHaler Capsules for Respiratory Inhalation at once and consider alternatives if immediate hypersensitivity reactions, including angioedema, occur. Use with caution in patients with severe DO NOT Swallow SPIRIVA Capsules hypersensitivity to milk proteins. (5.2) FOR ORAL INHALATION ONLY with the HandiHaler Device • Paradoxical bronchospasm: Discontinue SPIRIVA HandiHaler and consider other treatments if paradoxical bronchospasm occurs (5.3) Initial U.S. Approval: 2004 • Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to consult a ----------------------------RECENT MAJOR CHANGES-------------------------- physician immediately if this occurs (5.4) Indications and Usage (1) 12/2009 • Worsening of urinary retention may occur. Use with caution in patients Dosage and Administration (2) 12/2009 with prostatic hyperplasia or bladder-neck obstruction and instruct Contraindications (4) 12/2009 -
(Lamas) a New Frontier for COPD and Asthma Treatment
White Paper Long-Acting Muscarinic Agents (LAMAs) A New Frontier for COPD and Asthma Treatment LAMAs in Asthma and COPD Table of Contents 1. Introduction ............................................................................................. 3 2. Tiotropium Bromide ................................................................................. 4 3. Tiotropium + Olodaterol .......................................................................... 7 4. Aclidinium Bromide ................................................................................. 8 5. Aclidinium + Formoterol (ACLIFORM) ....................................................... 9 6. Glycopyrronium Bromide ....................................................................... 10 © 7. Glycopyrronium Bromide + Indacaterol (ULTIBRO )............................... 11 8. Glycopyrronium Bromide + Formoterol .................................................. 13 9. Umeclidinium ........................................................................................ 13 10. Umeclidinium + Vilanterol ..................................................................... 14 11. Triple Therapy ........................................................................................ 16 12. Conclusions ............................................................................................ 16 13. About the Author ................................................................................... 17 14. About CROMSOURCE ............................................................................ -
BREATHLESSNESS ABSTRACT INTRODUCTION Dyspnoea, Also
EMERGENCY MEDICINE – WHAT THE FAMILY PHYSICIAN CAN TREAT UNIT NO. 4 BREATHLESSNESS In one study of 85 patients presenting to a pulmonary unit Psychiatric conditions appropriate context of the history, physical examination, and ischaemia. Serial measurements of cardiac biomarkers are inhaler (MDI). In severe asthma, patients should be transferred breathlessness. In such cases, it is prudent to start therapies for with a complaint of chronic dyspnoea, the initial impression Psychogenic causes for acute dyspnoea is a diagnosis of the consideration of dierential diagnosis. Random testing necessary as initial results can often be normal. to ED for further treatment with nebulised ipratropium multiple conditions in the initial resuscitative phase. For Dr Pothiawala Sohil of the aetiology of dyspnoea based upon the patient history exclusion, and organic causes must be ruled out rst before without a clear dierential diagnosis will delay appropriate bromide, intravenous magnesium, ketamine, IM adrenaline, example, for a patient with a past medical history of COPD and alone was correct in only 66 percent of cases.4 us, a considering this diagnosis (e.g., panic attack).5 management. e use of dyspnoea biomarker panels does not Brain natriuretic peptide (BNP) intubation, and inhalational anaesthesia as needed. congestive cardiac failure, the initial management of sudden systematic approach, comprising of adequate history and appear to improve accuracy beyond clinical assessment and is is used to diagnose heart failure, but it can also be elevated onset of dyspnoea may include therapies directed at both these ABSTRACT diagnostic studies, and provide recommendations for initial physical examination, followed by appropriate investigations focused testing.6, 7 in uid overload secondary to renal failure. -
Inhaled Bronchodilator – Muscarinic Antagonist Medication
Inhaled Bronchodilator – Muscarinic Antagonist Medication Inhaled Bronchodilator ~ Muscarinic Antagonist Medication ~ Other names for this medication: Short-Acting: Atrovent – ipratropium bromide Long-Acting: Incruse – umeclidinium Incruse – umeclidinium bromide Seebri – glycopyrronium bromide Spiriva – tiotropium bromide Tudorza – aclidinium bromide How does this medication work? This medication helps the muscles around the bronchial tubes in the lungs to relax. This widens or bronchodilates the tubes and improves breathing. This medication also makes the muscle less likely to contract and narrow the tubes in response to exercise, cold air and irritants such as dust and cigarette smoke. How fast and long does this medication work? Atrovent: This depends on how you are advised to use it. It takes about 5 to 15 minutes to begin working. The effects can last for 4 to 6 hours. Incruse: Begins to work within 30 to 60 minutes. Seebri: Begins to work within 5 to 15 minutes. Spiriva: Begins to work within 30 to 60 minutes. Tudorza: Begins to work within 30 to 60 minutes. Please turn over 1 Inhaled Bronchodilator – Muscarinic Antagonist Medication How much medication do I take and how often? Take this medication on a regular basis as directed by your doctor. While taking this medication you may notice: headache dry mouth bad taste in mouth constipation Dry mouth often goes away. If not, talk to your health care provider about what you can do to help. Consult your doctor if: this medication is less effective than usual you have trouble passing urine If any of these occur, you may need other treatment. PD 6229 (Rev 03-2016) 2 .