Guidelines on Antihistamines, Intranasal Steroid Sprays and Drops (Nasules)
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(CD-P-PH/PHO) Report Classification/Justifica
COMMITTEE OF EXPERTS ON THE CLASSIFICATION OF MEDICINES AS REGARDS THEIR SUPPLY (CD-P-PH/PHO) Report classification/justification of medicines belonging to the ATC group R01 (Nasal preparations) Table of Contents Page INTRODUCTION 5 DISCLAIMER 7 GLOSSARY OF TERMS USED IN THIS DOCUMENT 8 ACTIVE SUBSTANCES Cyclopentamine (ATC: R01AA02) 10 Ephedrine (ATC: R01AA03) 11 Phenylephrine (ATC: R01AA04) 14 Oxymetazoline (ATC: R01AA05) 16 Tetryzoline (ATC: R01AA06) 19 Xylometazoline (ATC: R01AA07) 20 Naphazoline (ATC: R01AA08) 23 Tramazoline (ATC: R01AA09) 26 Metizoline (ATC: R01AA10) 29 Tuaminoheptane (ATC: R01AA11) 30 Fenoxazoline (ATC: R01AA12) 31 Tymazoline (ATC: R01AA13) 32 Epinephrine (ATC: R01AA14) 33 Indanazoline (ATC: R01AA15) 34 Phenylephrine (ATC: R01AB01) 35 Naphazoline (ATC: R01AB02) 37 Tetryzoline (ATC: R01AB03) 39 Ephedrine (ATC: R01AB05) 40 Xylometazoline (ATC: R01AB06) 41 Oxymetazoline (ATC: R01AB07) 45 Tuaminoheptane (ATC: R01AB08) 46 Cromoglicic Acid (ATC: R01AC01) 49 2 Levocabastine (ATC: R01AC02) 51 Azelastine (ATC: R01AC03) 53 Antazoline (ATC: R01AC04) 56 Spaglumic Acid (ATC: R01AC05) 57 Thonzylamine (ATC: R01AC06) 58 Nedocromil (ATC: R01AC07) 59 Olopatadine (ATC: R01AC08) 60 Cromoglicic Acid, Combinations (ATC: R01AC51) 61 Beclometasone (ATC: R01AD01) 62 Prednisolone (ATC: R01AD02) 66 Dexamethasone (ATC: R01AD03) 67 Flunisolide (ATC: R01AD04) 68 Budesonide (ATC: R01AD05) 69 Betamethasone (ATC: R01AD06) 72 Tixocortol (ATC: R01AD07) 73 Fluticasone (ATC: R01AD08) 74 Mometasone (ATC: R01AD09) 78 Triamcinolone (ATC: R01AD11) 82 -
Composition for Rectal Administration Combined with an Oral Alpha-Lipoic
(19) & (11) EP 2 162 125 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 31/136 (2006.01) A61K 31/01 (2006.01) 19.10.2011 Bulletin 2011/42 A61P 1/00 (2006.01) A61K 45/06 (2006.01) A61K 31/56 (2006.01) A61K 31/573 (2006.01) (2006.01) (21) Application number: 08768441.1 A61K 31/606 (22) Date of filing: 13.06.2008 (86) International application number: PCT/US2008/007401 (87) International publication number: WO 2008/156671 (24.12.2008 Gazette 2008/52) (54) Composition for rectal administration combined with an oral alpha-lipoic acid composition for the treatment of inflammatory bowel disease Zusammensetzung zur rektalen Verabreichung kombiniert mit einer oralen Zusammentzung enthaltend alpha Liponsäure zur Behandlung von entzündlicher Darmerkrankung Composition pour l’administration rectale en combinaison avec une composition orale de l’ acide alpha- lipoique pour le traitment des maladies intestinales inflammatoires (84) Designated Contracting States: (56) References cited: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR EP-B1- 0 671 168 WO-A2-02/089796 HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT US-A- 4 657 900 US-A- 5 082 651 RO SE SI SK TR US-A- 5 378 470 (30) Priority: 13.06.2007 US 934505 P • MULDER CJ. ET AL.: ’Beclomethasone 06.02.2008 US 63745 P dipropionate (3mg) versus 5- aminosalicylic acid (2g) versus the combination of both (3mg/2g)as (43) Date of publication of application: retention enemas in active ulcerative proctitis’ 17.03.2010 Bulletin 2010/11 EUR.J.GASTROENTEROL HEPATOL vol. -
Flonase Sensimist Allergy Relief (Fluticasone Furoate)
Flonase® Sensimist™ Allergy Relief (fluticasone furoate) – Rx-to-OTC Approval • On February 8, 2017, GlaxoSmithKline Consumer Healthcare announced the launch of Flonase Sensimist Allergy Relief (fluticasone furoate) nasal spray, as an over the counter (OTC) treatment to temporarily relieve symptoms of hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose; and itchy, watery eyes (in ages 12 years and older). — Flonase Sensimist Allergy Relief contains 27.5 mcg/spray of fluticasone furoate. — Flonase Sensimist Allergy Relief should not be used in children less than 2 years of age. • Previously, fluticasone furoate was only available by prescription as Veramyst®. Veramyst is no longer commercially available. • Fluticasone is also available OTC as brand (Flonase® Allergy Relief, Children’s Flonase® Allergy Relief) and generic products containing 50 mcg/spray of fluticasone propionate. — These products share the same indications as Flonase Sensimist Allergy Relief, but are not intended for children under 4 years of age. • Prescription fluticasone propionate nasal spray (50 mcg/spray) is available generically and indicated for the management of the nasal symptoms of perennial non-allergic rhinitis in adult and pediatric patients aged 4 years and older. • Warnings for Flonase Sensimist Allergy Relief state the following: — Do not use: in children under 2 years of age, to treat asthma, if there is an injury or surgery to the nose that is not fully healed, or if an allergic reaction to Flonase Sensimist Allergy Relief or any of its ingredients has occurred. — Ask a doctor prior to use if the patient has or had glaucoma or cataracts. -
Inhaled Corticosteroid (ICS) Only – Metered Dose Inhalers (MDI)
Categorisation and Formulary Choices of Inhaled Corticosteroids for Adults Inhaled Corticosteroid (ICS) only – Metered Dose Inhalers (MDI) MDI Beclometasone dipropionate Use with a compatible Fluticasone Propionate spacer device Prescribe by BRAND Clenil Modulite® Qvar®(extrafine) Qvar®(extrafine) Flixotide® Evohaler MDI Easi-Breathe Low Dose 100mcg, two puffs twice a 50 mcg, two puffs twice a day 50 mcg, two puffs twice a day 50 mcg, two puffs twice a day (BDP equivalent day (200 dose) (200 dose) (200 dose) (120 dose) ≤400mcg BDP) £4.45/month £4.72/month £4.64/month £5.44/month Medium Dose 200mcg, two puffs twice a 100 mcg, two puffs twice a day 100 mcg, two puffs twice a day 125mcg, two puffs twice a day (BDP equivalent day (200 dose) (200 dose) (200 dose) (120 dose) 400-1000mcg BDP) £9.70/month £10.33/month £10.17/month £12.50/month High Dose 250mcg, two puffs twice a 100 mcg, four puffs twice a day 100 mcg, four puffs twice a day 250mcg, two puffs twice a day (BDP equivalent day (200 dose) (200 dose) (200 dose) (120 dose) >1000mcg BDP) £9.77/month £20.66/month £20.34/month £20.00/month Simultaneous specialist OR referral recommended 250mcg four puffs, twice a day (200 dose) £19.55/month Prices correct as per Drug Tariff and DM&D December2018 1st line choices (dark green, solid border) 2nd line choices (light green, dashed border) Approved by Hertfordshire Medicines Management Committee – October 2018 Inhaled Corticosteroid (ICS) only – Dry Powder Inhalers (DPI) Beclometasone DPI dipropionate Budesonide Fluticasone Propionate Prescribe -
New Zealand Data Sheet
NEW ZEALAND DATA SHEET 1. PRODUCT NAME TRELEGY ELLIPTA 100/62.5/25 fluticasone furoate (100 micrograms)/umeclidinium (as bromide) (62.5 micrograms)/vilanterol (as trifenatate) (25 micrograms), powder for inhalation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose leaving the mouthpiece of the inhaler) contains 92 micrograms fluticasone furoate, 55 micrograms umeclidinium (equivalent to 65 micrograms umeclidinium [as bromide]) and 22 micrograms vilanterol (as trifenatate). This corresponds to a pre-dispensed dose of 100 micrograms fluticasone furoate, 62.5 micrograms umeclidinium (equivalent to 74.2 micrograms umeclidinium bromide) and 25 micrograms vilanterol (as trifenatate). Excipient with known effect: Each delivered dose contains approximately 25 milligrams of lactose (as monohydrate). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Powder for inhalation. White powder in a light grey inhaler (Ellipta) with a beige mouthpiece cover and a dose counter. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications TRELEGY ELLIPTA is indicated for the maintenance treatment of adults with moderate to severe chronic obstructive pulmonary disease (COPD) who require treatment with a long- acting muscarinic receptor antagonist (LAMA) + long-acting beta2-receptor agonist (LABA) + inhaled corticosteroid (ICS). TRELEGY ELLIPTA should not be used for the initiation of COPD treatment. 4.2. Dose and method of administration Patients can be changed from their existing inhalers to TRELEGY ELLIPTA at the next dose. However it is important that patients do not take other LABA or LAMA or ICS while taking TRELEGY ELLIPTA. A stepwise approach to the management of COPD is recommended, including the cessation of smoking and a pulmonary rehabilitation program. -
BSG Plan for IBD Patients During COVID19 Pandemic V1.5 349.88 KB
British Society of Gastroenterology (BSG) advice for management of inflammatory bowel diseases during the COVID-19 pandemic Date of publication: 22nd March 2020 Introduction Inflammatory bowel disease (IBD), comprising Crohn’s disease (CD) and ulcerative colitis (UC), is a condition in which the gastrointestinal immune system responds inappropriately. It is therefore often treated with immune suppression medications to control inflammation and to prevent ‘flares’, a worsening in symptoms, which may be unpredictable. It is known that 0.8% of people in the UK (approx. 524,000 patients) currently have IBD, but only 44% have been to a clinic in the last 3 years1,2. There will be many patients who will be worried about the effect of the Coronavirus pandemic (SARS-CoV-2 or COVID-19 disease) on their IBD and vice versa. During the COVID-19 outbreak we will do everything we can to keep our IBD patients safe. The biggest risks are related not only to the infection itself, but also the emergency reorganisation of hospital and general practice services to deal with the pandemic, meaning routine IBD services will be significantly affected. A combined approach covering both primary and secondary care is therefore required to keep vulnerable IBD patients out of hospital as much as possible. Insights from Hubei, China and from Italy suggest hospital admission for non-COVID-19 illness will provide a reservoir for further spread of infection. However, alterations to the way we deliver IBD care in the UK must be balanced against the risks of undertreated, active IBD. Importantly, patients with active IBD are likely to have a higher risk of infection both in the community and during inpatient care, even in the absence of immunosupressant treatment3. -
FF/UMEC/VI) Triple Therapy Versus Tiotropium Monotherapy in Patients with COPD
www.nature.com/npjpcrm ARTICLE OPEN Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD Sandeep Bansal1, Martin Anderson2, Antonio Anzueto3,4, Nicola Brown5, Chris Compton6, Thomas C. Corbridge7,8, David Erb9, Catherine Harvey5, Morrys C. Kaisermann10, Mitchell Kaye11, David A. Lipson 10,12, Neil Martin6,13, Chang-Qing Zhu5 and ✉ Alberto Papi 14 Chronic obstructive pulmonary disease (COPD) treatment guidelines do not currently include recommendations for escalation directly from monotherapy to triple therapy. This 12-week, double-blind, double-dummy study randomized 800 symptomatic moderate-to-very-severe COPD patients receiving tiotropium (TIO) for ≥3 months to once-daily fluticasone furoate/umeclidinium/ vilanterol (FF/UMEC/VI) 100/62.5/25 mcg via ELLIPTA (n = 400) or TIO 18 mcg via HandiHaler (n = 400) plus matched placebo. Study endpoints included change from baseline in trough forced expiratory volume in 1 s (FEV1) at Days 85 (primary), 28 and 84 (secondary), health status (St George’s Respiratory Questionnaire [SGRQ] and COPD Assessment Test [CAT]) and safety. FF/UMEC/VI significantly improved trough FEV1 at all timepoints (Day 85 treatment difference [95% CI] 95 mL [62–128]; P < 0.001), and significantly improved SGRQ and CAT versus TIO. Treatment safety profiles were similar. Once-daily single-inhaler FF/UMEC/VI significantly improved lung function and health status versus once-daily TIO in symptomatic moderate-to-very-severe COPD 1234567890():,; patients, with a similar safety profile. npj Primary Care Respiratory Medicine (2021) 31:29 ; https://doi.org/10.1038/s41533-021-00241-z INTRODUCTION performed to date and a lack of updated recommendations Chronic obstructive pulmonary disease (COPD) is a major cause of based on the current body of evidence. -
A Practical Approach To, Diagnosis, Assessment and Management Of
REVIEW A practical approach to, diagnosis, Pract Neurol: first published as 10.1136/practneurol-2014-000821 on 8 May 2014. Downloaded from assessment and management of idiopathic intracranial hypertension Susan P Mollan,1 Keira A Markey,2 James D Benzimra,1 Andrew Jacks,1 Tim D Matthews,1 Michael A Burdon,1 Alex J Sinclair2,3 1Birmingham Neuro- ABSTRACT term to encompass primary raised intra- Ophthalmology Unit, Adult patients who present with papilloedema cranial pressure where there is no identi- Ophthalmology Department, — — University Hospitals Birmingham and symptoms of raised intracranial pressure fiable cause which we term IIH and 3 NHS Trust, Queen Elizabeth need urgent multidisciplinary assessment secondary causes of raised pressure. Hospital Birmingham, including neuroimaging, to exclude life- The diagnostic criteria of IIH are well Birmingham, UK 2 threatening causes. Where there is no apparent known and have evolved since Dandy’s Neurotrauma and 4 Neurodegeneration, School of underlying cause for the raised intracranial initial description in 1937 ; they include Clinical and Experimental pressure, patients are considered to have a CSF opening pressure of ≥25 cm H2O Medicine, College of Medical idiopathic intracranial hypertension (IIH). The (box 1).3 However, these criteria recom- and Dental Sciences, The incidence of IIH is increasing in line with the mend imaging only to exclude a venous Medical School, The University of Birmingham, Birmingham, UK global epidemic of obesity. There are sinus thrombosis in patients without the 3Department of Neurology, controversial issues in its diagnosis and typical IIH phenotype (obesity and University Hospital Birmingham management. This paper gives a practical female sex). We feel, however, that it is NHS Trust, Queen Elizabeth Hospital Birmingham, approach to assessing patients with essential to exclude venous sinus throm- Birmingham, UK papilloedema, its investigation and the bosis (using MRI or CT with venography) subsequent management of patients with IIH. -
Asthma Medications
Relievers / Rescue / Bronchodilators Asthma Short-acting Beta Agonists 2 Medications Ipratropium Bromide ProAir ProAir RespiClick Proventil Ventolin Xopenex albuterol sulfate albuterol sulfate dry powder albuterol sulfate albuterol sulfate levalbuterol tartrate 90mcg 90mcg 90mcg 90mcg 45mcg Teva Teva Merck GlaxoSmithKline Sunovion Atrovent* Combivent Respimat* ipratropium bromide ipratropium bromide 20mcg, 17mcg albuterol sulfate 100mcg Boehringer Ingelheim Boehringer Ingelheim Nebulized Albuterol Xopenex Inhalation Solution Xopenex Inhalation Solution Xopenex Inhalation Solution * Ipratropium bromide is not a recommended rescue inhaler albuterol sulfate levalbuterol HCl levalbuterol HCl levalbuterol HCl outside of use in the emergency room or urgent care but may, 2.5mg/3mL 0.31mg/3mL 0.63mg/3mL 1.25mg/3mL on occasion, be prescribed to supplement short-acting Beta 2 generic Sunovion Sunovion Sunovion agonists. Controllers Inhaled Corticosteroids (ICS): Metered-Dose Inhalers (MDI) Aerospan Alvesco Alvesco Asmanex Asmanex Flovent Flovent Flovent flunisolide ciclesonide ciclesonide mometasone furoate mometasone furoate fluticasone propionate fluticasone fluticasone propionate 80mcg 80mcg 160mcg 100mcg 200mcg 44mcg propionate 220mcg Meda Pharmaceuticals Sunovion Sunovion Merck Merck GlaxoSmithKline 110mcg GlaxoSmithKline GlaxoSmithKline Inhaled Corticosteroids (ICS): Dry Powder Inhalers(continued on back) QVAR QVAR beclomethasone beclomethasone dipropionate dipropionate 40mcg 80mcg ArmonAir RespiClick ArmonAir RespiClick ArmonAir RespiClick -
Utah Medicaid Pharmacy and Therapeutics Committee Drug
Utah Medicaid Pharmacy and Therapeutics Committee Drug Class Review Single Ingredient Nasal Corticosteroids Beclomethasone dipropionate (Qnasl) Beclomethasone dipropionate monohydrate (Beconase AQ) Budesonide (Rhinocort) Ciclesonide (Omnaris, Zetonna) Flunisolide (Generic) Fluticasone Furoate (Flonase Sensimist) Fluticasone Propionate (Flonase, Xhance) Mometasone Furoate (Nasonex) Triamcinolone Acetonide (Nasacort) AHFS Classification: 52.08.08 Corticosteroids (EENT) Final Report February 2018 Review prepared by: Valerie Gonzales, Pharm.D., Clinical Pharmacist Elena Martinez Alonso, B.Pharm., MSc MTSI, Medical Writer Vicki Frydrych, Pharm.D., Clinical Pharmacist Joanita Lake, B.Pharm., MSc EBHC (Oxon), Research Assistant Professor Joanne LaFleur, Pharm.D., MSPH, Associate Professor University of Utah College of Pharmacy University of Utah College of Pharmacy, Drug Regimen Review Center Copyright © 2018 by University of Utah College of Pharmacy Salt Lake City, Utah. All rights reserved Contents Abbreviations ................................................................................................................................................ 2 Executive Summary ....................................................................................................................................... 3 Introduction .................................................................................................................................................. 5 Table 1. Nasal corticosteroid products ............................................................................................. -
Drug Class Review Nasal Corticosteroids
Drug Class Review Nasal Corticosteroids Final Report Update 1 June 2008 The Agency for Healthcare Research and Quality has not yet seen or approved this report The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports. Dana Selover, MD Tracy Dana, MLS Colleen Smith, PharmD Kim Peterson, MS Oregon Evidence-based Practice Center Oregon Health & Science University Mark Helfand, MD, MPH, Director Marian McDonagh, PharmD, Principal Investigator, Drug Effectiveness Review Project Copyright © 2008 by Oregon Health & Science University Portland, Oregon 97239. All rights reserved. Final Report Update 1 Drug Effectiveness Review Project TABLE OF CONTENTS INTRODUCTION ..........................................................................................................................5 Scope and Key Questions .......................................................................................................................7 METHODS ....................................................................................................................................9 Literature Search .....................................................................................................................................9 -
Pharmacology/Therapeutics II Block III Lectures 2013-14
Pharmacology/Therapeutics II Block III Lectures 2013‐14 66. Hypothalamic/pituitary Hormones ‐ Rana 67. Estrogens and Progesterone I ‐ Rana 68. Estrogens and Progesterone II ‐ Rana 69. Androgens ‐ Rana 70. Thyroid/Anti‐Thyroid Drugs – Patel 71. Calcium Metabolism – Patel 72. Adrenocorticosterioids and Antagonists – Clipstone 73. Diabetes Drugs I – Clipstone 74. Diabetes Drugs II ‐ Clipstone Pharmacology & Therapeutics Neuroendocrine Pharmacology: Hypothalamic and Pituitary Hormones, March 20, 2014 Lecture Ajay Rana, Ph.D. Neuroendocrine Pharmacology: Hypothalamic and Pituitary Hormones Date: Thursday, March 20, 2014-8:30 AM Reading Assignment: Katzung, Chapter 37 Key Concepts and Learning Objectives To review the physiology of neuroendocrine regulation To discuss the use neuroendocrine agents for the treatment of representative neuroendocrine disorders: growth hormone deficiency/excess, infertility, hyperprolactinemia Drugs discussed Growth Hormone Deficiency: . Recombinant hGH . Synthetic GHRH, Recombinant IGF-1 Growth Hormone Excess: . Somatostatin analogue . GH receptor antagonist . Dopamine receptor agonist Infertility and other endocrine related disorders: . Human menopausal and recombinant gonadotropins . GnRH agonists as activators . GnRH agonists as inhibitors . GnRH receptor antagonists Hyperprolactinemia: . Dopamine receptor agonists 1 Pharmacology & Therapeutics Neuroendocrine Pharmacology: Hypothalamic and Pituitary Hormones, March 20, 2014 Lecture Ajay Rana, Ph.D. 1. Overview of Neuroendocrine Systems The neuroendocrine