DOCSLIB.ORG

Les Perspectives Dans La Prise En Charge Thérapeutique De L'alcoolo

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Les Perspectives Dans La Prise En Charge Thérapeutique De L'alcoolo Les perspectives dans la prise en charge thérapeutique de l’alcoolo-dépendance Leslie Bellec To cite this version: Leslie Bellec. Les perspectives dans la prise en charge thérapeutique de l’alcoolo-dépendance. Sciences du Vivant [q-bio]. 2016. dumas-01758776 HAL Id: dumas-01758776 https://dumas.ccsd.cnrs.fr/dumas-01758776 Submitted on 5 Jun 2018 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. N° d'ordre : ANNÉE 2016 THÈSE D'EXERCICE / UNIVERSITÉ DE RENNES 1 sous le sceau de l’Université Bretagne Loire Thèse en vue du DIPLÔME D'ÉTAT DE DOCTEUR EN PHARMACIE présentée par Leslie Bellec Les perspectives dans la prise Thèse soutenue à Rennes en charge le 22 juin 2016 thérapeutique de devant le jury composé de : Isabelle MOREL l’alcoolo-dépendance Professeur à la faculté de Pharmacie de l’Université de Rennes 1 / président Damien PUISSANT Docteur en Pharmacie, titulaire de la Pharmacie du Pont de Chateaudun à Rennes / examinateur Nicolas MARIE Docteur en Pharmacie, Praticien au Centre Hospitalier Guillaume Régnier à Rennes / directeur de thèse 1 N° d'ordre : ANNÉE 2016 THÈSE D'EXERCICE / UNIVERSITÉ DE RENNES 1 sous le sceau de l’Université Bretagne Loire Thèse en vue du DIPLÔME D'ÉTAT DE DOCTEUR EN PHARMACIE présentée par Leslie Bellec Les perspectives dans la prise Thèse soutenue à Rennes en charge le 22 juin 2016 thérapeutique de devant le jury composé de : Isabelle MOREL l’alcoolo-dépendance Professeur à la faculté de Pharmacie de l’Université de Rennes 1 / président Damien PUISSANT Docteur en Pharmacie, titulaire de la Pharmacie du Pont de Chateaudun à Rennes / examinateur Nicolas MARIE Docteur en Pharmacie, Praticien au Centre Hospitalier Guillaume Régnier à Rennes / directeur de thèse 2 ANNEE 2015-2016 Listes des enseignants-chercheurs de la Faculté des Sciences Pharmaceutiques et Biologiques PROFESSEURS Pharmacien HDR Hospitalo-U 1 BOUSTIE Joël X HDR 2 BURGOT Gwenola X HDR X 3 DONNIO Pierre Yves X HDR X 4 FAILI Ahmad HDR 5 FARDEL Olivier X HDR X 6 FELDEN Brice X HDR 7 GAMBAROTA Giulio HDR 8 GOUGEON Anne X HDR 9 LAGENTE Vincent X HDR 10 LE CORRE Pascal X HDR X 11 LORANT (BOICHOT) Elisabeth HDR 12 MOREL Isabelle X HDR X 13 SERGENT Odile X HDR 14 SPARFEL-BERLIVET Lydie X HDR 15 TOMASI Sophie X HDR 16 URIAC Philippe X HDR 17 VAN DE WEGHE Pierre HDR 18 VERNHET Laurent X HDR PROFESSEURS ASSOCIES Pharmacien HDR Hospitalo-U 1 BUREAU Loïc X 2 DAVOUST Noëlle X HDR PROFESSEURS EMERITES Pharmacien HDR Hospitalo-U 1 CILLARD Josiane X HDR 2 GUILLOUZO André HDR 3 MAITRES DE CONFERENCES Pharmacien HDR Hospitalo-U 1 ABASQ-PAOFAI Marie-Laurence 2 ANINAT Caroline X HDR 3 AUGAGNEUR Yoann 4 BEGRICHE Karima 5 BOUSARGHIN Latifa HDR 6 BRANDHONNEUR Nolwenn 7 BRUYERE Arnaud X 8 BUNETEL Laurence X 9 CHOLLET-KRUGLER Marylène X 10 COLLIN Xavier X 11 CORBEL Jean-Charles X HDR 12 DAVID Michèle X HDR 13 DELALANDE Olivier 14 DELMAIL David 15 DION Sarah 16 DOLLO Gilles X HDR X 17 GILOT David HDR 18 GOUAULT Nicolas HDR 19 HITTI Eric 20 JEAN Mickaël 21 LECUREUR Valérie HDR 22 LE FERREC Eric X 23 LE PABIC Hélène 24 LEGOUIN-GARGADENNEC Béatrice 25 LOHEZIC-LE DEVEHAT Françoise X 26 MARTIN-CHOULY Corinne HDR 27 MINET Jacques X HDR 28 MOURET-PLEIBER Liza 29 NOURY Fanny 30 PINEL-MARIE Marie-Laure 31 PODECHARD Normand 32 POTIN Sophie XX 33 RENAULT Jacques X HDR 34 ROUILLON Astrid ASSISTANT HOSPITALO-UNIVERSITAIRE (AHU) Pharmacien HDR Hospitalo-U 1 GICQUEL Thomas X X ATER 1 SMIDA Imen 2 PASCREAU Gaëtan 3 SAVARY Camille 4 ALHARETH Khairallah 4 REMERCIEMENTS Au Pr. Isabelle Morel, merci pour les cours que vous nous avez prodigués pendant notre cursus, pour votre disponibilité et vos compétences ; et surtout, pour avoir accepté de présider ma thèse. Au Dr. Nicolas Marie, merci d’avoir accepté de diriger ma thèse. J’ai été particulièrement sensible à votre encadrement, à votre aide sur tous les plans, à votre gentillesse et à vos qualités de pharmacien. Au Dr. Damien Puissant, merci d’avoir accepté de faire partie de mon jury. Plus important, merci pour tout ce que tu m’as appris au cours de l’année que j’ai passé dans ta pharmacie, pour ta bonne humeur, ton sérieux, ta compréhension … Tout ce qui fait que tu es un pharmacien sur qui on veut prendre exemple, et pour qui c’est un plaisir de travailler. Et merci aussi à Lucile, avec qui j’ai compris et appris plein de choses, et beaucoup ri ! À toute l’équipe de la Pharmacie de Port Haliguen, un grand merci ! Vous m’avez accueillie, appris, et surtout donné le goût de l’officine pour tout ce qu’elle contient de formidable ! J’ai grandi à vos côtés … Plus spécialement, merci à toi Nathalie. Te voir exercer ton métier avec tant d’envie est communicatif ; tu es capable de soulever des montagnes et tu me motives à faire de même … À toute l’équipe de la pharmacie de Bréquigny, merci pour ce stage au cours duquel vous m’avez accompagnée. Il m’a tant appris sur le plan professionnel, comme personnel. Merci à Mr et Mme Davoust pour leur humanité et leur professionnalisme. Mme Davoust, je tiens à vous dire spécialement merci. D’une part, pour vos interventions à la faculté qui sont un réel plaisir, et pour votre passion de l’officine qui nous incite à nous dépasser toujours plus en termes de connaissances et de compétences. D’autre part, merci pour la gentillesse, la compréhension, voire l’affection, dont vous avez fait preuve à mon égard … Et un clin d’œil à Isabelle et Virginie en souvenir de leur bonne humeur et de nos moments thés-gâteaux … 5 À mon noyau familial …. Merci n’est pas suffisant ! Sans votre soutien sans faille, vos éclats de rire, votre joie de vivre, vos petits mots doux, vos grandes marques d’affection, et tout le reste, je n’en serais pas là ! Papa, maman, frérot, Elise, les loulous, soeurette, Tiéfou, vous êtes ma cure de bien être ! À toute ma famille, vous êtes formidablement drôles, chaleureux, avenants, généreux, et j’en passe ! Merci pour tout ce que vous m’apportez ! Un merci spécial à JMi et Dom, aux frangins d’adoption, à Marionnette et Louisette pour ces derniers mois … Aux amis de la famille, merci d’être des tontons, des tatas, d’aimer la mer, les vagues sans trop de remous, les bananiers, les balades à vélo, la cuisine … Merci pour votre affection et tous ces moments partagés ! À tous les copains et toutes les copines, merci pour tout le « fun » que vous m’avez offert avant et pendant les études, et de continuer après ! Merci pour toutes ces soirées (tisanes, bien sur), les bonnes résolutions non tenues, les week- ends à droite à gauche, les périodes de révisions, les crises de rire pré-exam, les crises de nerfs, les déménagements, les bonnes bouffes, le ski, la plage, le farniente, les phases « speedy gonzales », nos amours, nos envie, nos passions … Merci d’être vous ! Les copines de fac, vous êtes toutes exceptionnelles ! On en aura passé de bons moments sur les bancs des amphis, ceux de la BU, et ceux des troquets, mais toujours en riant ! À toi bibi, pour ton esprit de chimiste qui me dépassera toujours ! Aux copains-copines qui ont fait que les « petits boulots étudiants » n’étaient pas tant que ça du travail, mais surtout des « petits moments de bonheur ». À ceux avec qui nous avons partagé la même maison, on se ferait bien une bonne raclette, non !? À tous ceux qui répondent présents, pour les bons et les mauvais moments, et auprès de qui la vie est toujours plus belle. Et aussi à ceux qui voulaient des noms … non ! À tous ceux qui gravitent dans des sphères diverses et variées, vous êtes tous autant de petites bulles d’air qui me sont nécessaires … D’ailleurs, merci à ceux qui m’ont oxygéné l’esprit ces derniers mois avec des idées de running, piscine, soleil, pluie … À vous tous, pour tous ces défis sportifs (au sens propre, comme au figuré) que nous nous sommes lancés, et surtout pour ceux qui ont aboutit, merci ! Nous passons une belle jeunesse ! 6 TABLE DES MATIÈRES INTRODUCTION p.19 I. La prise en charge actuelle de l’alcoolo-dépendance p.20 A. L’alcoolo-dépendance, une pathologie biopsychosociale complexe p.20 1) L’alcool p.20 1.1. Aspects historiques p.20 1.2. Aspects pharmacologiques p.23 1.2.1. Formule chimique p.23 1.2.2. Pharmacocinétique p.23 1.2.2.1. Absorption p.23 1.2.2.2. Distribution p.24 1.2.2.3. Métabolisme p.24 1.2.2.4. Élimination p.29 1.2.3. Mécanisme d’action p.29 1.2.3.1. Action sur le métabolisme p.29 1.2.3.2. Action sur le système nerveux central p.31 2) Aspects cliniques liés à la consommation d’alcool p.35 2.1. L’ivresse p.36 2.1.1. Définition p.36 2.1.2. Symptomatologie p.37 2.1.2.1.
Load more

Recommended publications
  • (12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 De Juan Et Al
    US 200601 10428A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 de Juan et al. (43) Pub. Date: May 25, 2006 (54) METHODS AND DEVICES FOR THE Publication Classification TREATMENT OF OCULAR CONDITIONS (51) Int. Cl. (76) Inventors: Eugene de Juan, LaCanada, CA (US); A6F 2/00 (2006.01) Signe E. Varner, Los Angeles, CA (52) U.S. Cl. .............................................................. 424/427 (US); Laurie R. Lawin, New Brighton, MN (US) (57) ABSTRACT Correspondence Address: Featured is a method for instilling one or more bioactive SCOTT PRIBNOW agents into ocular tissue within an eye of a patient for the Kagan Binder, PLLC treatment of an ocular condition, the method comprising Suite 200 concurrently using at least two of the following bioactive 221 Main Street North agent delivery methods (A)-(C): Stillwater, MN 55082 (US) (A) implanting a Sustained release delivery device com (21) Appl. No.: 11/175,850 prising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more (22) Filed: Jul. 5, 2005 bioactive agents into the vitreous humor of the eye; (B) instilling (e.g., injecting or implanting) one or more Related U.S. Application Data bioactive agents Subretinally; and (60) Provisional application No. 60/585,236, filed on Jul. (C) instilling (e.g., injecting or delivering by ocular ion 2, 2004. Provisional application No. 60/669,701, filed tophoresis) one or more bioactive agents into the Vit on Apr. 8, 2005. reous humor of the eye. Patent Application Publication May 25, 2006 Sheet 1 of 22 US 2006/0110428A1 R 2 2 C.6 Fig.
    [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]
  • 211230Orig1s000 211230Orig2s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 211230Orig1s000 211230Orig2s000 RISK ASSESSMENT and RISK MITIGATION REVIEW(S) Division of Risk Management (DRISK) Office of Medication Error Prevention and Risk Management (OMEPRM) Office of Surveillance and Epidemiology (OSE) Center for Drug Evaluation and Research (CDER) Application Type NDA Application Number 211230 PDUFA Goal Date December 20, 2018 OSE RCM # 2018‐1313 Reviewer Name(s) Naomi Redd, Pharm.D. Team Leader Elizabeth Everhart, RN, MSN, ACNP Division Director Cynthia LaCivita, Pharm.D. Review Completion Date September 25, 2018 Subject Evaluation of the Need for a REMS Established Name Solriamfetol Trade Name Sunosi Name of Applicant Jazz Pharmaceuticals Therapeutic class Dopamine and Norepinephrine Reuptake Inhibitor (DNRI) Formulation 75 mg, 150 mg (b) (4) oral tablets Dosing Regimen Take one tablet once daily upon awakening 1 Reference ID: 4327439 Table of Contents EXECUTIVE SUMMARY ......................................................................................................................................................... 3 1 Introduction ..................................................................................................................................................................... 3 2 Background ...................................................................................................................................................................... 3 2.1 Product Information ..........................................................................................................................................
    [Show full text]
  • Misuse of Drugs Act 1975
    Reprint as at 1 July 2014 Misuse of Drugs Act 1975 Public Act 1975 No 116 Date of assent 10 October 1975 Commencement see section 1(2) Contents Page Title 4 1 Short Title and commencement 4 2 Interpretation 4 3 Act to bind the Crown 9 3A Classification of drugs 9 4 Amendment of schedules that identify controlled drugs 10 and precursor substances, and set amount, level, or quantity at and over which controlled drugs are presumed to be for supply 4A Procedure for bringing Order in Council made under 12 section 4(1) or (1B) into force 4B Matters to which Minister must have regard before 13 recommending Order in Council under section 4(1) or (1B) 4C Temporary class drug notice [Repealed] 14 4D Effect of temporary class drug notice [Repealed] 15 4E Duration of temporary class drug notice [Repealed] 15 Note Changes authorised by subpart 2 of Part 2 of the Legislation Act 2012 have been made in this official reprint. Note 4 at the end of this reprint provides a list of the amendments incorporated. This Act is administered by the Ministry of Health. 1 Reprinted as at Misuse of Drugs Act 1975 1 July 2014 5 Advisory and technical committees 15 5AA Expert Advisory Committee on Drugs 15 5A Approved laboratories 17 5B Functions of Minister 17 6 Dealing with controlled drugs 18 7 Possession and use of controlled drugs 20 8 Exemptions from sections 6 and 7 22 9 Cultivation of prohibited plants 26 10 Aiding offences against corresponding law of another 27 country 11 Theft, etc, of controlled drugs 28 12 Use of premises or vehicle, etc 29 12A Equipment,
    [Show full text]
  • Nonpeptide Orexin Type-2 Receptor Agonist Ameliorates Narcolepsy-Cataplexy Symptoms in Mouse Models
    Nonpeptide orexin type-2 receptor agonist ameliorates narcolepsy-cataplexy symptoms in mouse models Yoko Irukayama-Tomobea,1, Yasuhiro Ogawaa,1, Hiromu Tominagaa,1, Yukiko Ishikawaa, Naoto Hosokawaa, Shinobu Ambaia, Yuki Kawabea, Shuntaro Uchidaa, Ryo Nakajimaa, Tsuyoshi Saitoha, Takeshi Kandaa, Kaspar Vogta, Takeshi Sakuraia, Hiroshi Nagasea, and Masashi Yanagisawaa,2 aInternational Institute for Integrative Sleep Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan Contributed by Masashi Yanagisawa, March 22, 2017 (sent for review January 13, 2017; reviewed by Thomas S. Kilduff and Thomas E. Scammell) Narcolepsy-cataplexy is a debilitating disorder of sleep/wakefulness methylphenidate and modafinil), sedative (sodium oxybate), and caused by a loss of orexin-producing neurons in the lateroposterior tricyclic antidepressants. However, the use of these medications is hypothalamus. Genetic or pharmacologic orexin replacement ame- often limited by adverse side effects such as headache, nausea, liorates symptoms in mouse models of narcolepsy-cataplexy. We anxiety, irritability, and insomnia. have recently discovered a potent, nonpeptide OX2R-selective Murine models of narcolepsy-cataplexy include OXKO mice − − − − agonist, YNT-185. This study validates the pharmacological activity (2), orexin receptor-deficient (Hcrtr1 / ;Hcrtr2 / , abbreviated as of this compound in OX2R-transfected cells and in OX2R-expressing OXRDKO) mice, and the orexin/ataxin-3 transgenic mice (in neurons in brain slice preparations. Intraperitoneal, and intracere- which orexin neurons are genetically and postnatally ablated) broventricular, administration of YNT-185 suppressed cataplexy-like (12). Tabuchi et al. created another narcolepsy mouse model, episodes in orexin knockout and orexin neuron-ablated mice, but not which expressed diphtheria toxin A in orexin neurons under in orexin receptor-deficient mice.
    [Show full text]
  • Xyrem (Sodium Oxybate) Is a CNS Depressant
    HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Important Administration Information for All Patients XYREM safely and effectively. See full prescribing information for • Take each dose while in bed and lie down after dosing (2.3). XYREM. • Allow 2 hours after eating before dosing (2.3). • Prepare both doses prior to bedtime; dilute each dose with approximately ¼ XYREM® (sodium oxybate) oral solution, CIII cup of water in pharmacy-provided containers (2.3). Initial U.S. Approval: 2002 • Patients with Hepatic Impairment: starting dose is one-half of the original dosage per night, administered orally divided into two doses (2.4). • WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION Concomitant use with Divalproex Sodium: an initial reduction in Xyrem dose and ABUSE AND MISUSE. of at least 20% is recommended (2.5, 7.2). --------------------DOSAGE FORMS AND STRENGTHS------------------- See full prescribing information for complete boxed warning. Oral solution, 0.5 g per mL (3) Central Nervous System Depression ----------------------------CONTRAINDICATIONS------------------------------ • Xyrem is a CNS depressant, and respiratory depression can occur with • In combination with sedative hypnotics or alcohol (4) Xyrem use (5.1, 5.4) • Succinic semialdehyde dehydrogenase deficiency (4) Abuse and Misuse • Xyrem is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB is associated with CNS adverse reactions, ---------------------WARNINGS AND PRECAUTIONS----------------------
    [Show full text]
  • Sodium Oxybate (Xyrem®) Armodafinil (Nuvigil®) Solriamfetol (Sunosi®) Approval December 1998 July 2002 June 2007 March 2019 Cephalon, Inc
    Modafanil (Provigil®) Sodium Oxybate (Xyrem®) Armodafinil (Nuvigil®) Solriamfetol (Sunosi®) Approval December 1998 July 2002 June 2007 March 2019 Cephalon, Inc. Orpahn Medical Cephalon, Inc. Jazz Pharmaceuticals Schedule C‐IV C‐III C‐IV C‐IV Sodium salt of gamma hydroxybutyrate (GHB active ingredient, Schedule I) Indication To improve wakefulness in adults with Treatment of cataplexy or excessive daytime To improve wakefulness in adults with To improve wakefulness in adults with excessive sleepiness associated with sleepiness in patients with Narcolepsy excessive sleepiness associated with excessive daytime sleepiness associated with narcolepsy, OSA, or shift work disorder narcolepsy, OSA, or shift work disorder narcolepsy or OSA (underlying airway obstruction should be treated for at least 1 month prior to & during Solriamfetol therapy Non-FDA Uses ● ADHD ● MDD (antidepressant ●Alcoholism ● Alcohol withdrawal syndrome ● Bipolar disorder, depressed phase, in - augmentation) ● Depression Unipolar or ● Breathing-related sleep disorder ● combination with conventional medications bipolar (adjunct) Fibromyalgia ● General anesthesia ● Opioid ● Multiple sclerosis/Depression withdrawal ● Sedation (adjunct)/Cancer related fatigue ● Schizophrenia (adjunct) ● Sleep deprivation ● Spastic cerebral palsy ● Steinert myotonic dystrophy syndrome MOA ●Modafinil increases dopamine by blocking Sodium oxybate’s (a CNS depressant) effects Armodafinil, the R-enantiomer of modafinil, Selective dopamine and norepinephrine (unclear) dopamine transporters are thought
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2011/0159073 A1 De Juan Et Al
    US 20110159073A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0159073 A1 de Juan et al. (43) Pub. Date: Jun. 30, 2011 (54) METHODS AND DEVICES FOR THE Publication Classification TREATMENT OF OCULAR CONDITIONS (51) Int. Cl. (76) Inventors: Eugene de Juan, LaCanada, CA A6F 2/00 (2006.01) (US); Signe E. Varner, Los (52) U.S. Cl. ........................................................ 424/427 Angeles, CA (US); Laurie R. Lawin, New Brighton, MN (US) (57) ABSTRACT Featured is a method for instilling one or more bioactive (21) Appl. No.: 12/981,038 agents into ocular tissue within an eye of a patient for the treatment of an ocular condition, the method comprising con (22) Filed: Dec. 29, 2010 currently using at least two of the following bioactive agent delivery methods (A)-(C): (A) implanting a Sustained release Related U.S. Application Data delivery device comprising one or more bioactive agents in a (63) Continuation of application No. 1 1/175,850, filed on posterior region of the eye so that it delivers the one or more Jul. 5, 2005, now abandoned. bioactive agents into the vitreous humor of the eye; (B) instill ing (e.g., injecting or implanting) one or more bioactive (60) Provisional application No. 60/585,236, filed on Jul. 2, agents Subretinally; and (C) instilling (e.g., injecting or deliv 2004, provisional application No. 60/669,701, filed on ering by ocular iontophoresis) one or more bioactive agents Apr. 8, 2005. into the vitreous humor of the eye. Patent Application Publication Jun. 30, 2011 Sheet 1 of 22 US 2011/O159073 A1 Patent Application Publication Jun.
    [Show full text]
  • Sodium Oxybate) Policy Number: C3925-A
    Prior Authorization Criteria Xyrem (sodium oxybate) Policy Number: C3925-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE 10/1/2013 7/17/2019 7/17/2020 J CODE TYPE OF CRITERIA LAST P&T APPROVAL/VERSION J8499 (NOC) RxPA Q3 2019 20190828C3925-A PRODUCTS AFFECTED: Xyrem (sodium oxybate) DRUG CLASS: Anti-Cataplectic Agents ROUTE OF ADMINISTRATION: Oral PLACE OF SERVICE: Specialty Pharmacy The recommendation is that medications in this policy will be for pharmacy benefit coverage and patient self-administered AVAILABLE DOSAGE FORMS: Xyrem SOLN 0.5 g per mL (180 mL bottle), Xyrem is a Schedule III drug under the Controlled Substances Act FDA-APPROVED USES: indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy COMPENDIAL APPROVED OFF-LABELED USES: None COVERAGE CRITERIA: INITIAL AUTHORIZATION DIAGNOSIS: Excessive daytime sleepiness/cataplexy REQUIRED MEDICAL INFORMATION: A. CATAPLEXY AND EXCESSIVE DAYTIME SLEEEPINESS (EDS) IN NARCOLEPSY: 1. Documented diagnosis of narcolepsy confirmed by overnight polysomnography (PSG) followed by multiple sleep latency test (MSLT). Documentation of testing results and provider interpretation for the PSG and MSLT AND 2. Prescriber attests that patient is not taking CNS depressants concomitantly (e.g. ethanol, sedative hypnotics, anxiolytics, barbiturates, benzodiazepines AND 3. Documentation patient does NOT have a succinic semialdehyde dehydrogenase deficiency AND 4. Patient must experience episodes of cataplexy OR excessive daytime sleepiness (ESD); AND Molina Healthcare, Inc. confidential and proprietary © 2018 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed or printed without written permission from Molina Healthcare.
    [Show full text]
  • Label for SODIUM OXYBATE Oral Solution
    HIGHLIGHTS OF PRESCRIBING INFORMATION 9 g per night 4.5 g 4.5 g These highlights do not include all the information needed to use • Take each dose while in bed and lie down after dosing (2.2). SODIUM OXYBATE ORAL SOLUTION safely and effectively. See full • Allow 2 hours after eating before dosing (2.2). prescribing information for SODIUM OXYBATE ORAL SOLUTION. • Prepare both doses prior to bedtime; dilute each dose with SODIUM OXYBATE oral solution, CIII approximately 1/4 cup of water in the provided dosing cups (2.2). Initial U.S. Approval: 2002 • Patients with Hepatic Impairment: Starting dose is 2.25 g per night administered orally in two equal, divided doses of approximately 1.13 g at bedtime and approximately 1.13 g taken 2.5 to 4 hours later (2.3). WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION • Concomitant use with divalproex sodium: an initial reduction in and MISUSE AND ABUSE sodium oxybate dose of at least 20% is recommended (2.4, 7.2). See full prescribing information for complete boxed warning. --------------------- DOSAGE FORMS AND STRENGTHS -------------------­ • Respiratory depression can occur with sodium oxybate use Oral solution, 0.5 g per mL (3) (5.4). • Sodium Oxybate Oral Solution is a Schedule III controlled ------------------------------ CONTRAINDICATIONS ----------------------------­ substance and is the sodium salt of gamma hydroxybutyrate • Succinic semialdehyde dehydrogenase deficiency (4). (GHB), a Schedule I controlled substance. Abuse or misuse of • In combination with sedative hypnotics or alcohol (4). illicit GHB is associated with CNS adverse reactions, including seizure, respiratory depression, decreased ----------------------- WARNINGS AND PRECAUTIONS ---------------------­ consciousness, coma and death (5.2, 9.2).
    [Show full text]
  • Misuse of Drugs Act 1975
    Reprint as at 1 October 2012 Misuse of Drugs Act 1975 Public Act 1975 No 116 Date of assent 10 October 1975 Commencement see section 1(2) Contents Page Title 4 1 Short Title and commencement 4 2 Interpretation 4 3 Act to bind the Crown 8 3A Classification of drugs 9 4 Amendment of schedules that identify controlled drugs 9 and precursor substances, and set amount, level, or quantity at and over which controlled drugs are presumed to be for supply 4A Procedure for bringing Order in Council made under 11 section 4(1) or (1B) into force 4B Matters to which Minister must have regard before 12 recommending Order in Council under section 4(1) or (1B) 4C Temporary class drug notice 14 4D Effect of temporary class drug notice 14 4E Duration of temporary class drug notice 16 Note Changes authorised by section 17C of the Acts and Regulations Publication Act 1989 have been made in this reprint. A general outline of these changes is set out in the notes at the end of this reprint, together with other explanatory material about this reprint. This Act is administered by the Ministry of Health. 1 Reprinted as at Misuse of Drugs Act 1975 1 October 2012 5 Advisory and technical committees 16 5AA Expert Advisory Committee on Drugs 17 5A Approved laboratories 18 5B Functions of Minister 19 6 Dealing with controlled drugs 19 7 Possession and use of controlled drugs 21 8 Exemptions from sections 6 and 7 23 9 Cultivation of prohibited plants 28 10 Aiding offences against corresponding law of another 28 country 11 Theft, etc, of controlled drugs 29 12 Use of
    [Show full text]
  • Do You Know... GHB
    Do You Know... GHB Street names: G, liquid ecstasy, liquid x, grievous bodily harm, fantasy Generic and trade names: sodium oxybate (Xyrem) What is it? GHB (gamma-hydroxybutyrate) is produced naturally in the human body in very small amounts. When taken as a recreational drug, and especially when taken in combination with alcohol or other drugs, GHB can be extremely dangerous. GHB is a central nervous system depressant. That means it makes you sleepy, and slows down your breathing and heart rate. The only current medical use of GHB in Canada is as a treatment for narcolepsy, a rare sleep disorder. It is illegal to possess, traffic, import or produce GHB in Canada. 1/4 © 2001, 2013 CAMH | www.camh.ca Where does GHB come from? How does GHB make you feel? Access to pharmaceutical GHB is tightly regulated. GHB How GHB affects you depends on various factors: that is sold as a street drug is produced illegally using · your age and body weight chemicals and processes that vary from lab to lab. The · how much you take and how often you take it strength and purity of the final product also vary. · how long you’ve been taking it · the method you use to take the drug GHB “precursors” gamma-butyrolactone (GBL) and · the environment you’re in 1,4-butanediol (BD) are commercially available · whether you have certain pre-existing medical or industrial substances that are not intended for human psychiatric conditions consumption. When ingested, these substances are · whether you’ve taken any alcohol or other drugs converted by the body into GHB.
    [Show full text]