Acute Medication Poisoning Causing Hospital Admissions in Childhood: a 3-Year Prospective Observational Single-Center Study

Total Page:16

File Type:pdf, Size:1020Kb

Acute Medication Poisoning Causing Hospital Admissions in Childhood: a 3-Year Prospective Observational Single-Center Study Physiol. Res. 68 (Suppl. 1): S31-S38, 2019 https://doi.org/10.33549/physiolres.934321 Acute Medication Poisoning Causing Hospital Admissions in Childhood: a 3-Year Prospective Observational Single-Center Study P. MATALOVÁ1, M. PORUBA1, M. WAWRUCH2, P. ONDRA3, K. URBÁNEK1 1Department of Pharmacology, Faculty of Medicine and Dentistry, Palacký University in Olomouc, Czech Republic, 2Institute of Pharmacology and Clinical Pharmacology, Faculty of Medicine, Comenius University, Bratislava, Slovakia, 3Department of Forensic Medicine and Medical Law, Faculty of Medicine and Dentistry, Palacký University in Olomouc, Czech Republic Received June 17, 2019 Accepted July 4, 2019 Summary Introduction Although the risks of medication poisoning in children are often reported, there is a lack of studies addressing this issue. The Medication poisoning is one of the serious majority of papers deal with a wide range of xenobiotics health-related risks in children. Prevention is of major poisoning and, in particular, alcohol intoxications. All hospital importance, where simple precautions can prevent many admissions during three years were prospectively recorded. serious but avoidable cases (Meyer et al. 2007). Patients younger than 19 years of age admitted for acute drug According to the data from the Toxicological Information intoxications were further evaluated. A total of 15,069 children Center (TIC) in Prague, Czech Republic, the largest were admitted. Of them, 55 were hospitalized for acute proportion of all poisonings is caused by medications. medication poisoning. The condition was more common in girls The age of one to three years old carries the highest risk (72.7 % vs. 27.3 %, p<0.01). Toddlers were the largest patient with a wide occurrence of noxae which can cause long- group (36.4 %). Non-steroidal anti-inflammatory drugs (NSAIDs) lasting damage. Motor skills are already well developed were the most frequently used agents, with ibuprofen being the in children of this age; however, they are still unable to leading drug (20 % of all cases). The route of intoxication was rationally recognize dangerous situations. Drug almost exclusively oral. Solid drug forms were involved in intoxications (both by OTC and prescription medications) 40 (72.7 %) cases. There was one fatal accidental poisoning. The at this age are purely accidental, and any serious highest occurrence of accidental drug intoxications was in the complications are rare (Rakovcová 2013, Pawłowicz age group from one to three years. Attempted suicides were et al. 2013, Sahin et al. 2011, Bates et al. 1997). In 2012, most frequent among adolescents. We are currently actively the TIC assessed 5,840 toddlers between the ages of one dealing with the issue. The cohort has been expanded to include to three years, i.e. 72 % of all queries in the age group up a period of ten years and is being analyzed. to 18 years. Certain number of sudden poisonings occurs even among younger children. In the first six months of Key words age, these are mainly caused by parents. Other causes are Medication poisoning • Drug intoxications • Children • accidental, for instance spillage of liquid drugs over the Adolescents face, nose or mouth (Rakovcová 2013, Mühlendahl et al. 2003). By contrast, in adolescents, in the cases of Corresponding author attempted suicides, poisonings can either be fatal or cause K. Urbánek, Department of Pharmacology, Faculty of Medicine long-lasting damage. In those cases, very toxic drugs are and Dentistry, Palacký University in Olomouc, Hněvotínská 3, frequently used found by those individuals in home Olomouc, 775 15, Czech Republic. Fax: 00420 585 632 552. medicine cabinets; these are often medications taken by E-mail: [email protected] grandparents (Bentur et al. 2010). PHYSIOLOGICAL RESEARCH • ISSN 0862-8408 (print) • ISSN 1802-9973 (online) 2019 Institute of Physiology of the Czech Academy of Sciences, Prague, Czech Republic Fax +420 241 062 164, e-mail: [email protected], www.biomed.cas.cz/physiolres S32 Matalová et al. Vol. 68 As for errors and accidents associated with Ethics approval misadministration of prescribed drugs, the victim The study was approved by the Local Institutional commonly is a very young child. Those cases can involve Research Ethics Committee [No. 1236/04 S-IV]. situations of accidental swap of medications or of their inappropriate use and dosage. Another cause can be Methods wrong understanding of the recommended dosage; also, it is not uncommon for different family members to All admissions to the Department of Pediatrics give separate doses independently from one another (DP) of the University Hospital Olomouc, Czech (Rakovcová 2013). Republic, including surgical cases and hospitalizations A whole range of medicines can cause serious for specialized diagnostic purposes were screened in the intoxications. A substantial risk is associated with electronic Hospital Information System. The study period cardiovascular medications, particularly calcium channel was from January 1, 2010 to December 31, 2012. All blockers, beta blockers, and digoxin. Other known patients aged 18 years and younger possibly admitted causing agents are tricyclic antidepressants and because of acute pharmaceutical drug intoxications, both carbamazepine, oral antidiabetics, antihistamines, and intentional and unintentional, were further evaluated. drugs containing iron ions. Cases in which parents Patients who were admitted because of adverse drug unintentionally combine several anti-inflammatory agents reactions caused by usual therapeutic doses or because of containing paracetamol are also common. Moreover, intoxication by alcohol, “street” drugs, chemical parents often underestimate the toxic properties of compounds, poisonous plants, food or other noxious paracetamol due to its presence in many easily available agents were excluded from the study. over-the-counter drugs (Mund et al. 2015, Peden 2008). The study was conducted following the Increasingly used slow release drug formulations which guidelines of the Declaration of Helsinki. All data were usually contain larger amounts of the active compound processed anonymously. can lead to unpredictable clinical course of intoxication Admissions were assessed in the hospital (Rakovcová 2013). information system on a daily basis. The study team Although the risks of medication poisoning in collected the following information from the case notes: children are often reported in the literature, there have not age, sex, the substance and its formulation, source of the been many studies addressing this issue. The majority of agent, causes of poisoning, presenting complaint and papers published in this field deal with a wide range of clinical symptoms on admission, the length of hospital xenobiotics poisoning and, in particular, alcohol stay, and information on patient’s condition at discharge. intoxication. Studies describing the occurrence of The results of toxicological analysis including medication poisonings leading to hospitalizations, detection of toxic agents in blood, urine and/or gastric however, are rather rare, limited to unintentional content, and measurements of plasma levels of the poisonings (Hoy et al. 1999) or specific type of medicinal substances were also evaluated. The following methods products like opioids (Gaither et al. 2016). Although were used at the Department of Forensic Medicine and some earlier studies have brought interesting results, the Medical Law for toxicology analysis: fluorescence spectrum of drugs used is changing quite rapidly. polarization immunoassay (FPIA), thin layer Therefore, we consider it useful to complement the study chromatography (TLC), gas chromatography-mass specifically addressing intoxications caused by medicinal spectrometry (GC-MS), gas chromatography with products, in particular because of the identification of the electron capture detector (GC-ECD), and high- risks of individual types of medicines. performance liquid chromatography (HPLC). Continuous data were expressed as mean ± Aim of the study standard deviation, while categorical variables as The aim of this study was to evaluate the frequency and percentage. prevalence, causes, and outcomes of medication poisonings leading to hospital admission in children over Results a three-year period in the University Hospital in Olomouc, Czech Republic. Over the study period, a total of 15,069 children and adolescents were admitted to the DP. Of them, 55 were 2019 Medication Poisoning Causing Hospital Admissions in Children S33 hospitalized for (suspected) acute medication intoxication, than in boys (72.7 % vs. 27.3 %, p<0.01). Toddlers were which accounts for 0.36 % of all patient admissions to the the largest patient group (36.4 %), followed by DP. None of the intoxicated patients was admitted schoolchildren (27.3 %), and adolescents (14.5 %). In the repeatedly during the study period for the same reason. two oldest age groups (i.e. children ≥ 12 years), girls In general, poisoning was more common in girls prevailed significantly (Table 1). Table 1. Distribution of the patients hospitalized for acute drug intoxication according to the age and sex. Number of patients Female Male Age group Age (%) (%) (%) Newborns 0-28 d 0 (0) 0 (0) 0 (0) Infants 29-364 d 6 (10.9) 4 (7.3) 2 (3.6) Toddlers 1-3 y 20 (36.4) 11 (20) 9 (16.4) Preschoolers 3-6 y 4 (7.3) 4 (7.3) 0 (0) Early school age children 6-11 y 2 (3.6) 0 (0) 2 (3.6) Schoolchildren 11-15 y 15 (27.3) 13 (23.6) 2 (3.6) Adolescents 15-19 y 8 (14.5) 8 (14.5) 0 (0) Total 0-19
Recommended publications
  • (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
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2004/0224012 A1 Suvanprakorn Et Al
    US 2004O224012A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2004/0224012 A1 Suvanprakorn et al. (43) Pub. Date: Nov. 11, 2004 (54) TOPICAL APPLICATION AND METHODS Related U.S. Application Data FOR ADMINISTRATION OF ACTIVE AGENTS USING LIPOSOME MACRO-BEADS (63) Continuation-in-part of application No. 10/264,205, filed on Oct. 3, 2002. (76) Inventors: Pichit Suvanprakorn, Bangkok (TH); (60) Provisional application No. 60/327,643, filed on Oct. Tanusin Ploysangam, Bangkok (TH); 5, 2001. Lerson Tanasugarn, Bangkok (TH); Suwalee Chandrkrachang, Bangkok Publication Classification (TH); Nardo Zaias, Miami Beach, FL (US) (51) Int. CI.7. A61K 9/127; A61K 9/14 (52) U.S. Cl. ............................................ 424/450; 424/489 Correspondence Address: (57) ABSTRACT Eric G. Masamori 6520 Ridgewood Drive A topical application and methods for administration of Castro Valley, CA 94.552 (US) active agents encapsulated within non-permeable macro beads to enable a wider range of delivery vehicles, to provide longer product shelf-life, to allow multiple active (21) Appl. No.: 10/864,149 agents within the composition, to allow the controlled use of the active agents, to provide protected and designable release features and to provide visual inspection for damage (22) Filed: Jun. 9, 2004 and inconsistency. US 2004/0224012 A1 Nov. 11, 2004 TOPCAL APPLICATION AND METHODS FOR 0006 Various limitations on the shelf-life and use of ADMINISTRATION OF ACTIVE AGENTS USING liposome compounds exist due to the relatively fragile LPOSOME MACRO-BEADS nature of liposomes. Major problems encountered during liposome drug Storage in vesicular Suspension are the chemi CROSS REFERENCE TO OTHER cal alterations of the lipoSome compounds, Such as phos APPLICATIONS pholipids, cholesterols, ceramides, leading to potentially toxic degradation of the products, leakage of the drug from 0001) This application claims the benefit of U.S.
    [Show full text]
  • List of Union Reference Dates A
    Active substance name (INN) EU DLP BfArM / BAH DLP yearly PSUR 6-month-PSUR yearly PSUR bis DLP (List of Union PSUR Submission Reference Dates and Frequency (List of Union Frequency of Reference Dates and submission of Periodic Frequency of submission of Safety Update Reports, Periodic Safety Update 30 Nov. 2012) Reports, 30 Nov.
    [Show full text]
  • Prohibited Substances List
    Prohibited Substances List This is the Equine Prohibited Substances List that was voted in at the FEI General Assembly in November 2009 alongside the new Equine Anti-Doping and Controlled Medication Regulations(EADCMR). Neither the List nor the EADCM Regulations are in current usage. Both come into effect on 1 January 2010. The current list of FEI prohibited substances remains in effect until 31 December 2009 and can be found at Annex II Vet Regs (11th edition) Changes in this List : Shaded row means that either removed or allowed at certain limits only SUBSTANCE ACTIVITY Banned Substances 1 Acebutolol Beta blocker 2 Acefylline Bronchodilator 3 Acemetacin NSAID 4 Acenocoumarol Anticoagulant 5 Acetanilid Analgesic/anti-pyretic 6 Acetohexamide Pancreatic stimulant 7 Acetominophen (Paracetamol) Analgesic/anti-pyretic 8 Acetophenazine Antipsychotic 9 Acetylmorphine Narcotic 10 Adinazolam Anxiolytic 11 Adiphenine Anti-spasmodic 12 Adrafinil Stimulant 13 Adrenaline Stimulant 14 Adrenochrome Haemostatic 15 Alclofenac NSAID 16 Alcuronium Muscle relaxant 17 Aldosterone Hormone 18 Alfentanil Narcotic 19 Allopurinol Xanthine oxidase inhibitor (anti-hyperuricaemia) 20 Almotriptan 5 HT agonist (anti-migraine) 21 Alphadolone acetate Neurosteriod 22 Alphaprodine Opiod analgesic 23 Alpidem Anxiolytic 24 Alprazolam Anxiolytic 25 Alprenolol Beta blocker 26 Althesin IV anaesthetic 27 Althiazide Diuretic 28 Altrenogest (in males and gelidngs) Oestrus suppression 29 Alverine Antispasmodic 30 Amantadine Dopaminergic 31 Ambenonium Cholinesterase inhibition 32 Ambucetamide Antispasmodic 33 Amethocaine Local anaesthetic 34 Amfepramone Stimulant 35 Amfetaminil Stimulant 36 Amidephrine Vasoconstrictor 37 Amiloride Diuretic 1 Prohibited Substances List This is the Equine Prohibited Substances List that was voted in at the FEI General Assembly in November 2009 alongside the new Equine Anti-Doping and Controlled Medication Regulations(EADCMR).
    [Show full text]
  • In February 2013, Glaxosmithkline (GSK) Announced a Commitment To
    In February 2013, GlaxoSmithKline (GSK) announced a commitment to further clinical transparency through the public disclosure of GSK Clinical Study Reports (CSRs) on the GSK Clinical Study Register. The following guiding principles have been applied to the disclosure: Information will be excluded in order to protect the privacy of patients and all named persons associated with the study Patient data listings will be completely removed* to protect patient privacy. Anonymized data from each patient may be made available subject to an approved research proposal. For further information please see the Patient Level Data section of the GSK Clincal Study Register. Aggregate data will be included; with any direct reference to individual patients excluded *Complete removal of patient data listings may mean that page numbers are no longer consecutively numbered CONFIDENTIAL GM2004/00056/00GM2004/00056/00 SAM40040SAM40040 The GlaxoSmithKline group of companies A twenty-four week, randomised, double-dummy, double-blind, parallel group study to compare the occurrence of exacerbations between SERETIDE DISKUS 50/250µg 1 inhalation bd and formoterol/budesonide Breath-Actuated Dry Powder Inhaler 4.5/160µg 2 inhalations bd in subjects with moderate to severe asthma. Clinical Study Report for Study SAM40040 (Development Phase IV) Document Number: GM2004/00056/00 Compound Number: CCI18781/ GR33343 Investigational Product: SERETIDE Generic Drug Name: salmeterol/fluticasone propionate combination Indication Studied: Asthma Initiation Date: 26 Nov 2001 Completion Date: 13 Jan 2003 Early Termination Date: N/A Date of Report: August 2004 Sponsor Signatory: (and Medical Officer) Vice President European Clinical Respiratory Medicines Development Centre This study was performed in compliance with Good Clinical Practices including the archiving of essential documents.
    [Show full text]
  • Moderní Antihistaminika V Léčbě Alergie – Současné Trendy V Symptomatické Terapii Alergických Onemocnění
    100 Hlavní téma Moderní antihistaminika v léčbě alergie – současné trendy v symptomatické terapii alergických onemocnění Jaroslava Braunová, Mojmír Račanský Oddělení alergologie a klinické imunologie FNOL, Ústav imunologie UP Olomouc Alergická onemocnění jsou problémem současné medicíny. Nejde o pouhé projevy sezónní rýmy, s nimiž se do jisté míry setkal snad každý, ale také o závažné stavy, jako je anafylakticky šok a exacerbace bronchiálního astmatu. Nezanedbatelnou kapitolu tvoří problematika různých kožních projevů přecitlivělosti. Vždy však působí postiženému značné nepříjemnosti. Spolu s rostoucí incidencí těchto alergolo- gických diagnóz pochopitelně stoupá i poptávka po jejich účinné léčbě. Za kauzální léčbu považujeme alergenovou imunoterapii (AIT). Ta však není indikována pro všechny pacienty a všechny alergologické diagnózy. Vyžaduje vysokou compliance ze strany nemocného, přesné určení spouštěče alergické reakce u daného pacienta a existenci dostupného standardizovaného alergenu. Symptomatická terapie antihistaminiky představuje jednu ze zásadních možností ovlivnění rozvoje alergické reakce přímo na periferním histaminovém receptoru H1. Klíčová slova: alergie, symptomatická terapie, antihistaminika, alergický zánět. Modern antihistamines in treating allergies: current trends in symptomatic therapy of allergic conditions Allergic diseases are a serious problem in modern medicine. It is not only a question of pollinosis, but also of other allergic diseases such as bronchial asthma, atopic dermatitis, urticaria, angioedema or
    [Show full text]
  • Potential Drug Interactions and Potentially Inappropriate Medications in Daily Radiooncology Practice : a Risk Assessment
    From the Department of Radiotherapy and Radiation Oncology of Marienhospital Herne – University Hospital – of the Ruhr-Universität Bochum Director: Prof. Dr. med. I. A. Adamietz Potential drug interactions and potentially inappropriate medications in daily radiooncology practice – a risk assessment Inaugural-Dissertation for the Attainment of a Doctor´s Degree in Medicine at the high Medical Faculty of the Ruhr-Universität Bochum Presented by Nina Sibylle Lamberty from Düsseldorf 2013 Dean of Faculty: Prof. Dr. med Klaus Überla Referee: Prof. Dr. med. Irenäus A. Adamietz Co-Referee: PD Dr. med Oliver Lindner Date of oral exam: 03.02.2015 Abstract Lamberty Nina Potential drug interactions and potentially inappropriate medications in daily radiooncology practice – a risk assess- ment Background: Radiation treatment of malignant disease includes patients with various extents of tumor and different comorbidities. Due to bad general condition approximately 20 % of irradiated subjects are in-patients. Beyond elimi- nation of tumor and treatment of its side effects drug interactions and potentially inappropriate medications constitute a major challenge in these radiooncologic patients. The layering of polypharmacy with age and radiation related physiological and functional changes and comorbidities might increase the risk for potential drug drug interactions (pDDs). This study attempted to quantify the frequency of pDDIs and potential inappropriate medications (PIMs) not related to i.v. chemotherapy in patients undergoing radiation treatment aiming the assessment of risk by medication. Methods: Medication profiles were analyzed by reviewing discharge letters of 120 cancer patients who had been admitted to the Marienhospital, Herne between November 2010 and November 2011. An improvement of the Karnofsky index during hospital treatment had been registered.
    [Show full text]
  • The Use of Stems in the Selection of International Nonproprietary Names (INN) for Pharmaceutical Substances
    WHO/PSM/QSM/2006.3 The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances 2006 Programme on International Nonproprietary Names (INN) Quality Assurance and Safety: Medicines Medicines Policy and Standards The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 © World Health Organization 2006 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
    [Show full text]
  • Obecná Alergologie, Alergie - Pojem
    12.02.2017 Obecná alergologie, Alergie - pojem (alergie, „nealergie“, alergeny, léčba neadekvátní reakce imunitního systému typu zánětu alergií a alergické stavy) na jinak neškodnou cizorodou látku (alergen), má s přihlédnutím k dětskému věku objektivní i subjektivní složku: - objektivně jsou známky poškození některých orgánů (sliznice nosu, spojivky, kůže, bronchy, ..) - subjektivně jsou nepříjemně vnímané poruchy funkce takto postižených orgánů Alergik = pacient s klinickými příznaky reakce přecitlivosti navozené imunolog.mechanismy. MUDr.Jiří NEVRLKA Poliklinika Zahradníkova 2/8 BRNO ambulance pro alergologii a klinickou imunologii Alergie pozitivita v testech na alergeny !! Alergie - pojem Alergie - pojem imunopatologické reakce „nepravé alergie a pseudoalergie“ časný typ Reakce I.typu - mediovaná protilátkami IgE, • IgE non dependentní alergie (pozdní typ) - vyjádřena u osob s atopickou reaktivitou Alergolog - reakce nezprostředkovaná IgE, ale Ag-specif.T-lymfocyty - nejčastější typ alergie (alergie v užším smyslu) navazující na IgE mechanismus .. např. potraviny, alergie na lepek - inhalační alergie, alergie hmyzí jed, anafylaxe, (atopická dermatitida).. dominantní mechanismus .. např. kontaktní alergeny, léky, celiakie Reakce II.typu - mediovaná non IgE protilátkami - cytotoxické protilátky, např. transfuzní reakce x blokující protilátky, např. • Zkřížená reaktivita: myastenia gravis x stimulační protilátky, např. Graves-Basedowova choroba - reakce na antigeny strukturálně podobné reálnému alergenu Reakce III.typu – mediovaná
    [Show full text]
  • Medicines Classification Committee
    Medicines Classification Committee Meeting date 1 May 2017 58th Meeting Title Reclassification of Sedating Antihistamines Medsafe Pharmacovigilance Submitted by Paper type For decision Team Proposal for The Medicines Adverse Reactions Committee (MARC) recommended that the reclassification to committee consider reclassifying sedating antihistamines to prescription prescription medicines when used in children under 6 years of age for the treatment of medicine for some nausea and vomiting and travel sickness [exact wording to be determined by indications the committee]. Reason for The purpose of this document is to provide the committee with an overview submission of the information provided to the MARC about safety concerns associated with sedating antihistamines and reasons for recommendations. Associated March 2013 Children and Sedating Antihistamines Prescriber Update articles February 2010 Cough and cold medicines clarification – antihistamines Medsafe website Safety information: Use of cough and cold medicines in children – new advice Medicines for Alimemazine Diphenhydramine consideration Brompheniramine Doxylamine Chlorpheniramine Meclozine Cyclizine Promethazine Dexchlorpheniramine New Zealand Some oral sedating antihistamines available without exposure to a prescription (pharmacist-only and pharmacy only), sedating therefore usage data is not easily available. antihistamines Table of Contents 1.0 PURPOSE ......................................................................................................................................
    [Show full text]
  • Marrakesh Agreement Establishing the World Trade Organization
    No. 31874 Multilateral Marrakesh Agreement establishing the World Trade Organ ization (with final act, annexes and protocol). Concluded at Marrakesh on 15 April 1994 Authentic texts: English, French and Spanish. Registered by the Director-General of the World Trade Organization, acting on behalf of the Parties, on 1 June 1995. Multilat ral Accord de Marrakech instituant l©Organisation mondiale du commerce (avec acte final, annexes et protocole). Conclu Marrakech le 15 avril 1994 Textes authentiques : anglais, français et espagnol. Enregistré par le Directeur général de l'Organisation mondiale du com merce, agissant au nom des Parties, le 1er juin 1995. Vol. 1867, 1-31874 4_________United Nations — Treaty Series • Nations Unies — Recueil des Traités 1995 Table of contents Table des matières Indice [Volume 1867] FINAL ACT EMBODYING THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS ACTE FINAL REPRENANT LES RESULTATS DES NEGOCIATIONS COMMERCIALES MULTILATERALES DU CYCLE D©URUGUAY ACTA FINAL EN QUE SE INCORPOR N LOS RESULTADOS DE LA RONDA URUGUAY DE NEGOCIACIONES COMERCIALES MULTILATERALES SIGNATURES - SIGNATURES - FIRMAS MINISTERIAL DECISIONS, DECLARATIONS AND UNDERSTANDING DECISIONS, DECLARATIONS ET MEMORANDUM D©ACCORD MINISTERIELS DECISIONES, DECLARACIONES Y ENTEND MIENTO MINISTERIALES MARRAKESH AGREEMENT ESTABLISHING THE WORLD TRADE ORGANIZATION ACCORD DE MARRAKECH INSTITUANT L©ORGANISATION MONDIALE DU COMMERCE ACUERDO DE MARRAKECH POR EL QUE SE ESTABLECE LA ORGANIZACI N MUND1AL DEL COMERCIO ANNEX 1 ANNEXE 1 ANEXO 1 ANNEX
    [Show full text]
  • Azelastine Hydrochloride
    568 Antihistamines been withdrawn from the market in most countries because of the Preparations treatment of non-allergic rhinitis in adults and children risk of adverse effects. USP 31: Azatadine Maleate Tablets. aged 12 years and over. The dose is 2 sprays into each Astemizole has been given in an oral dose of 10 mg once daily, Proprietary Preparations (details are given in Part 3) nostril twice daily. In the treatment of conjunctivitis, or 5 mg daily in children aged 6 to 12 years. These doses must Austral.: Zadine; Canad.: Optimine; Hong Kong: Zadine†; Malaysia: azelastine is licensed in the UK for the treatment of not be exceeded because of the risk of cardiac arrhythmias with Zadine†; Mex.: Idulamine†; NZ: Zadine†; Singapore: Zadine†; Spain: seasonal allergic conjunctivitis in adults and children higher doses. Lergocil. aged 4 years and over and for the treatment of perenni- The active metabolite of astemizole, tecastemizole (norastemi- Multi-ingredient: Braz.: Cedrin; Canad.: Trinalin; Mex.: Trinalin†; al allergic conjunctivitis in adults and children aged 12 zole) has been investigated for the treatment of allergic rhinitis. Spain: Atiramin; Idulanex; USA: Rynatan†; Trinalin†. years and over. In the USA, it is licensed for the treat- Preparations ment of allergic conjunctivitis in adults and children USP 31: Astemizole Tablets. aged 3 years and over. Regardless of the age and indi- Azelastine Hydrochloride cation, a 0.05% solution is instilled into each eye twice Proprietary Preparations (details are given in Part 3) (BANM, USAN, rINNM) daily; this may be increased to four times daily in se- Arg.: Alermizol†; Astezol†; Cezane†; Mudantil†; Cz.: Hismanal†; Gr.: Mibiron†; Tulipe-R†; Tyrenol†; Waruzol†; India: Astizole; Stemiz†; Mex.: A-5610 (azelastine or azelastine hydrochloride); Atselastiinihy- vere conditions.
    [Show full text]