Deprescribing Guide for Benzodiazepines and Z Drugs
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MEDICATION GUIDE RESTORIL™ (Res-Tə-Ril) (Temazepam) Capsules
MEDICATION GUIDE RESTORIL™ (res-tə-ril) (temazepam) Capsules, C-IV What is the most important information I should know about RESTORIL? RESTORIL is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. After taking RESTORIL, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with RESTORIL. Reported activities include: o driving a car (“sleep-driving”) o making and eating food o talking on the phone o having sex o sleep-walking Call your healthcare provider right away if you find out that you have done any of the above activities after taking RESTORIL. Do not take RESTORIL unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again. Do not take more RESTORIL than prescribed. What is RESTORIL? RESTORIL is a prescription sleep medicine. RESTORIL is used in adults for the short-term (usually 7 to 10 days) treatment of a sleep problem called insomnia. Symptoms of insomnia include trouble falling asleep and waking up often during the night. RESTORIL is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep RESTORIL in a safe place to prevent misuse and abuse. -
Benzodiazepines: Uses and Risks Charlie Reznikoff, MD Hennepin Healthcare
Benzodiazepines: Uses and Risks Charlie Reznikoff, MD Hennepin healthcare 4/22/2020 Overview benzodiazepines • Examples of benzos and benzo like drugs • Indications for benzos • Pharmacology of benzos • Side effects and contraindications • Benzo withdrawal • Benzo tapers 12/06/2018 Sedative/Hypnotics • Benzodiazepines • Alcohol • Z-drugs (Benzo-like sleeping aids) • Barbiturates • GHB • Propofol • Some inhalants • Gabapentin? Pregabalin? 12/06/2018 Examples of benzodiazepines • Midazolam (Versed) • Triazolam (Halcion) • Alprazolam (Xanax) • Lorazepam (Ativan) • Temazepam (Restoril) • Oxazepam (Serax) • Clonazepam (Klonopin) • Diazepam (Valium) • Chlordiazepoxide (Librium) 4/22/2020 Sedatives: gaba stimulating drugs have incomplete “cross tolerance” 12/06/2018 Effects from sedative (Benzo) use • Euphoria/bliss • Suppresses seizures • Amnesia • Muscle relaxation • Clumsiness, visio-spatial impairment • Sleep inducing • Respiratory suppression • Anxiolysis/disinhibition 12/06/2018 Tolerance to benzo effects? • Effects quickly diminish with repeated use (weeks) • Euphoria/bliss • Suppresses seizures • Effects incompletely diminish with repeated use • Amnesia • Muscle relaxation • Clumsiness, visio-spatial impairment • Seep inducing • Durable effects with repeated use • Respiratory suppression • Anxiolysis/disinhibition 12/06/2018 If you understand this pharmacology you can figure out the rest... • Potency • 1 mg diazepam <<< 1 mg alprazolam • Duration of action • Half life differences • Onset of action • Euphoria, clinical utility in acute -
Comparison of Short-And Long-Acting Benzodiazepine-Receptor Agonists
J Pharmacol Sci 107, 277 – 284 (2008)3 Journal of Pharmacological Sciences ©2008 The Japanese Pharmacological Society Full Paper Comparison of Short- and Long-Acting Benzodiazepine-Receptor Agonists With Different Receptor Selectivity on Motor Coordination and Muscle Relaxation Following Thiopental-Induced Anesthesia in Mice Mamoru Tanaka1, Katsuya Suemaru1,2,*, Shinichi Watanabe1, Ranji Cui2, Bingjin Li2, and Hiroaki Araki1,2 1Division of Pharmacy, Ehime University Hospital, Shitsukawa, Toon, Ehime 791-0295, Japan 2Department of Clinical Pharmacology and Pharmacy, Neuroscience, Ehime University Graduate School of Medicine, Shitsukawa, Toon, Ehime 791-0295, Japan Received November 7, 2007; Accepted May 15, 2008 Abstract. In this study, we compared the effects of Type I benzodiazepine receptor–selective agonists (zolpidem, quazepam) and Type I/II non-selective agonists (zopiclone, triazolam, nitrazepam) with either an ultra-short action (zolpidem, zopiclone, triazolam) or long action (quazepam, nitrazepam) on motor coordination (rota-rod test) and muscle relaxation (traction test) following the recovery from thiopental-induced anesthesia (20 mg/kg) in ddY mice. Zolpidem (3 mg/kg), zopiclone (6 mg/kg), and triazolam (0.3 mg/kg) similarly caused an approximately 2-fold prolongation of the thiopental-induced anesthesia. Nitrazepam (1 mg/kg) and quazepam (3 mg/kg) showed a 6- or 10-fold prolongation of the anesthesia, respectively. Zolpidem and zopiclone had no effect on the rota-rod and traction test. Moreover, zolpidem did not affect motor coordination and caused no muscle relaxation following the recovery from the thiopental-induced anesthesia. However, zopiclone significantly impaired the motor coordination at the beginning of the recovery. Triazolam significantly impaired the motor coordination and muscle relaxant activity by itself, and these impairments were markedly exacerbated after the recovery from anesthesia. -
Red with Nitrazepam and Placebo in Acute Emergency Driving Situations and in Monotonous Simulated Driving
109 A 1986 The Carry-over Effects of Triazolam Compa- red with Nitrazepam and Placebo in Acute Emergency Driving Situations and in Mono- tonous Simulated Driving Hans Laurell and Jan Törnroos Reprint from Acta Pharmacologica et toxicologica 1986 v Väg06/7 Efi/( Statens väg- och trafikinstitut (VTI) * 581 01 Linköping [St]tlltet Swedish Road and Traffic Research Institute * S-581 01 Linköping Sweden Acta pharmacol. et toxicol. 1986, 58, 182186. From the National Swedish Road and Traffic Research Institute, (V.T.I.), S-58 101 Linköping, Sweden The Carry-over Effects of Triazolam Compared with Nitrazepam and Placebo in Acute Emergency Driving Situations and in Monotonous Simulated Driving Hans Laurell and Jan Törnros (Received October 9, 1985; Accepted January 9, 1986) Abstract: Eighteen healthy volunteers of both sexes, aged 2034, were tested in the morning while undertaking real car driving avoidance manoeuvres and during monotonous simulated driving after 1 and 3 nights of medication with triazolam 0.25 mg, nitrazepam 5 mg or placebo. The study was a double-blind, randomized, cross-over study, where a minimum of 7 days wash-out separated the 3 treatment periods. Nitrazepam was found to impair performance in the simulated task after 1 but not after 3 nights of medication. Performance in the triazolam condition was not signicantly different from the other conditions on this task on either day. However, after one night of medication triazolam tended to score worse than placebo but better than nitrazepam. In real car driving a tendency was noted for nitrazepam to score worst, whereas the difference between placebo and triazolam was hardly noticeable. -
Calculating Equivalent Doses of Oral Benzodiazepines
Calculating equivalent doses of oral benzodiazepines Background Benzodiazepines are the most commonly used anxiolytics and hypnotics (1). There are major differences in potency between different benzodiazepines and this difference in potency is important when switching from one benzodiazepine to another (2). Benzodiazepines also differ markedly in the speed in which they are metabolised and eliminated. With repeated daily dosing accumulation occurs and high concentrations can build up in the body (mainly in fatty tissues) (2). The degree of sedation that they induce also varies, making it difficult to determine exact equivalents (3). Answer Advice on benzodiazepine conversion NB: Before using Table 1, read the notes below and the Limitations statement at the end of this document. Switching benzodiazepines may be advantageous for a variety of reasons, e.g. to a drug with a different half-life pre-discontinuation (4) or in the event of non-availability of a specific benzodiazepine. With relatively short-acting benzodiazepines such as alprazolam and lorazepam, it is not possible to achieve a smooth decline in blood and tissue concentrations during benzodiazepine withdrawal. These drugs are eliminated fairly rapidly with the result that concentrations fluctuate with peaks and troughs between each dose. It is necessary to take the tablets several times a day and many people experience a "mini-withdrawal", sometimes a craving, between each dose. For people withdrawing from these potent, short-acting drugs it has been advised that they switch to an equivalent dose of a benzodiazepine with a long half life such as diazepam (5). Diazepam is available as 2mg tablets which can be halved to give 1mg doses. -
Intermittent Treatment of Febrile Convulsions with Nitrazepam Michel Vanasse, Pierre Masson, Guy Geoffroy, Albert Larbrisseau and Pierre C
LE JOURNAL CANADIEN DES SCIENCES NEUROLOGIQUES Intermittent Treatment of Febrile Convulsions with Nitrazepam Michel Vanasse, Pierre Masson, Guy Geoffroy, Albert Larbrisseau and Pierre C. David ABSTRACT: Intermittent oral or rectal administration of diazepam for the prophylactic treatment of febriie convulsions has given results comparable to the continuous use of phenobarbital while limiting side effects and risks of toxicity. Since we believe that nitrazepam is a better anticonvulsant than diazepam, we performed a study to evaluate the effectiveness of this medication in the prophylactic treatment of febrile convulsions. Nitrazepam was given only when the children had fever and almost exclusively in children with a high risk of recurrence (less than 12 months of age at first convulsion; atypical convulsion; one or several previous convulsions). Thirty one children with a high risk of recurrence received nitrazepam. The rate of recurrence in this group was 19.3% after a follow-up of 16 months, compared to 45.8% in 24 children who also had a high risk of recurrence but in whom the parents refused the medication or gave it inadequately (p<0.05). Fifty one children with a low risk of recurrence also were evaluated and followed for at least 12 months (mean 15.4 months). Six were treated with nitrazepam, mostly because of parental anxiety, and none had a recurrence; of the 45 untreated children in this group, 6 (13.6%) had another convulsion. These results show the efficiency of nitrazepam in the prophylactic treatment of febrile convulsions. RESUME: L'utilisation intermittente du diazepam par voie orale ou rectale pour le traitement prophylactique des convulsions febriles a donne d'aussi bons resultats que l'utilisation continue du phenobarbital. -
MEDGUIDE MEDICATION GUIDE Temazepam (Tem Az′ E Pam) Capsules, USP CIV
MEDGUIDE MEDICATION GUIDE Temazepam (tem az′ e pam) Capsules, USP CIV What is the most important information I should know about temazepam capsules? • Temazepam capsules are a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. • After taking temazepam capsules, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with temazepam capsules. Reported activities include: ◦ driving a car (“sleep-driving”) ◦ making and eating food ◦ talking on the phone ◦ having sex ◦ sleep-walking Call your healthcare provider right away if you find out that you have done any of the above activities after taking temazepam capsules. • Do not take temazepam capsules unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again. • Do not take more temazepam capsules than prescribed. What are temazepam capsules? • Temazepam capsules are a prescription sleep medicine. Temazepam capsules are used in adults for the short-term (usually 7 to 10 days) treatment of a sleep problem called insomnia. Symptoms of insomnia include trouble falling asleep and waking up often during the night. • Temazepam capsules are a federal controlled substance (CIV) because it can be abused or lead to dependence. -
Benzodiazepines
Benzodiazepines CRIT program May 2011 Alex Walley, MD, MSc Assistant Professor of Medicine Boston University School of Medicine Medical Director, Opioid Treatment Program Boston Public Health Commission Medical Director, Overdose Prevention Pilot Program Massachusetts Department of Public Health CRIT 2011 Learning objectives At the end of this session, you should: 1. Understand why people use benzodiazepines 2. Know the characteristics of benzodiazepine intoxication and withdrawal syndromes 3. Understand the consequences of these drugs 4. Know the current options for treatment of benzodiazepine dependence CRIT 2011 Roadmap 1. Case and controversies 2. History and Epidemiology 3. Benzo effects 4. Treatment CRIT 2011 Case • 29 yo man presents for follow-up at methadone clinic after inpatient admission for femur fracture from falling onto subway track from platform. • Treated with clonazepam since age 16 for panic disorder. Takes 6mg in divided doses daily. Missed his afternoon dose, the day of the accident • Started using heroin at age 23 • On methadone maintenance for 1 year, doing well, about to get his first take home CRIT 2011 Thoughts • Did BZDs cause his fall? – or did not taking BZDs cause his fall? • Is he addicted to benzos? • Should he come off of BZDs? How? • If not, how do we keep him safe? • Should he get take homes? • Did teenage BZD treatment cause his heroin addiction? CRIT 2011 History and Epidemiology CRIT 2011 History • First discovered in 1954 by a Austrian scientist, Leo Sternbach Æ Librium • 1963 Æ Valium • Used for -
Chloral Hydrate: Summary Report
Chloral Hydrate: Summary Report Item Type Report Authors Yuen, Melissa V.; Gianturco, Stephanie L.; Pavlech, Laura L.; Storm, Kathena D.; Yoon, SeJeong; Mattingly, Ashlee N. Publication Date 2020-02 Keywords Compounding; Food, Drug, and Cosmetic Act, Section 503B; Food and Drug Administration; Outsourcing facility; Drug compounding; Legislation, Drug; United States Food and Drug Administration; Chloral Hydrate Rights Attribution-NoDerivatives 4.0 International Download date 26/09/2021 09:06:16 Item License http://creativecommons.org/licenses/by-nd/4.0/ Link to Item http://hdl.handle.net/10713/12087 Summary Report Chloral Hydrate Prepared for: Food and Drug Administration Clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: 2U01FD005946 Prepared by: University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) University of Maryland School of Pharmacy February 2020 This report was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award (U01FD005946) totaling $2,342,364, with 100 percent funded by the FDA/HHS. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement by, the FDA/HHS or the U.S. Government. 1 Table of Contents REVIEW OF NOMINATION ..................................................................................................... 4 METHODOLOGY ................................................................................................................... -
Restoril™ (Temazepam) Capsules USP Rx Only WARNING
Restoril™ (temazepam) Capsules USP Rx only WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS and Drug Interactions). • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation. DESCRIPTION Restoril™ (temazepam) is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is: C16H13ClN2O2 MW = 300.74 Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Restoril™ (temazepam) Capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg, and 30 mg Capsules Active Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide. May also include: n-butyl alcohol, iron oxide red, shellac, shellac glaze, SD-35A alcohol. Page 1 of 14 Reference ID: 4386617 15 mg Capsules Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide. May also include: n-butyl alcohol, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol. 22.5 mg Capsules Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide. -
Pharmacology
STATE ESTABLISHMENT «DNIPROPETROVSK MEDICAL ACADEMY OF HEALTH MINISTRY OF UKRAINE» V.I. MAMCHUR, V.I. OPRYSHKO, А.А. NEFEDOV, A.E. LIEVYKH, E.V.KHOMIAK PHARMACOLOGY WORKBOOK FOR PRACTICAL CLASSES FOR FOREIGN STUDENTS STOMATOLOGY DEPARTMENT DNEPROPETROVSK - 2016 2 UDC: 378.180.6:61:615(075.5) Pharmacology. Workbook for practical classes for foreign stomatology students / V.Y. Mamchur, V.I. Opryshko, A.A. Nefedov. - Dnepropetrovsk, 2016. – 186 p. Reviewed by: N.I. Voloshchuk - MD, Professor of Pharmacology "Vinnitsa N.I. Pirogov National Medical University.‖ L.V. Savchenkova – Doctor of Medicine, Professor, Head of the Department of Clinical Pharmacology, State Establishment ―Lugansk state medical university‖ E.A. Podpletnyaya – Doctor of Pharmacy, Professor, Head of the Department of General and Clinical Pharmacy, State Establishment ―Dnipropetrovsk medical academy of Health Ministry of Ukraine‖ Approved and recommended for publication by the CMC of State Establishment ―Dnipropetrovsk medical academy of Health Ministry of Ukraine‖ (protocol №3 from 25.12.2012). The educational tutorial contains materials for practical classes and final module control on Pharmacology. The tutorial was prepared to improve self-learning of Pharmacology and optimization of practical classes. It contains questions for self-study for practical classes and final module control, prescription tasks, pharmacological terms that students must know in a particular topic, medical forms of main drugs, multiple choice questions (tests) for self- control, basic and additional references. This tutorial is also a student workbook that provides the entire scope of student’s work during Pharmacology course according to the credit-modular system. The tutorial was drawn up in accordance with the working program on Pharmacology approved by CMC of SE ―Dnipropetrovsk medical academy of Health Ministry of Ukraine‖ on the basis of the standard program on Pharmacology for stomatology students of III - IV levels of accreditation in the specialties Stomatology – 7.110105, Kiev 2011. -
Drug Interactions and Lethal Drug Combinations
J Clin Pathol: first published as 10.1136/jcp.s3-9.1.94 on 1 January 1975. Downloaded from J. clin. Path., 28, Suppl. (Roy. Coll. Path.), 9, 94-98 The drug dilemma-benefits and hazards Drug interactions and lethal drug combinations ALAN RICHENS From the Department of Clinical Pharmacology, St Bartholomew's Hospital, London Although the development of drugs of greater example, aspirin can displace oral anticoagulants potency and efficacy confers on the physician from their plasma-protein-binding sites, and in- increasing power to treat serious diseases, it also directly acting sympathomimetics contained in cough increases the number and seriousness of potential mixtures can cause a hypertensive crisis in patients adverse effects and drug interactions which can on monoamine oxidase inhibitors. Self-medication is occur. Most hospital patients receive more than one common, and often involves drugs obtained on drug at a time, the average number often being prescription for a previous illness. greater than five (Smith, Seidl, and Cluff, 1966). The 4 When several clinics or doctors are involved in incidence of drug reactions rises with the number of the care of a patient, one doctor may not be aware of drugs prescribed simultaneously. In patients pre- what another has prescribed. scribed one to five drugs the incidence of reactions is 5 When preparations which contain more than 18-6%, while in patients prescribed six or more one ingredient are prescribed by their trade names. it rises to 814 % (Hurwitz and Wade, 1969). There are a number of ways in which drugs may The Boston Collaborative Drug Surveillance interact.