Xuebalib.Com.32748.Pdf
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Report on the Investigation Results
Pharmaceuticals and Medical Devices Agency This English version is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. Report on the Investigation Results February 28, 2017 Pharmaceuticals and Medical Devices Agency I. Overview of Product [Non-proprietary name] See Attachment 1 [Brand name] See Attachment 1 [Approval holder] See Attachment 1 [Indications] See Attachment 1 [Dosage and administration] See Attachment 1 [Investigating office] Office of Safety II 1 Pharmaceuticals and Medical Devices Agency This English version is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. II. Background of the investigation 1. Status in Japan Hypnotics and anxiolytics are prescribed by various specialties and widely used in clinical practice. In particular, benzodiazepine (BZ) receptor agonists, which act on BZ receptors, bind to gamma-aminobutyric acid (GABA)A-BZ receptor complex and enhance the function of GABAA receptors. This promotes neurotransmission of inhibitory systems and demonstrates hypnotic/sedative effects, anxiolytic effects, muscle relaxant effects, and antispasmodic effects. Since the approval of chlordiazepoxide in March 1961, many BZ receptor agonists have been approved as hypnotics and anxiolytics. Currently, hypnotics and anxiolytics are causative agents of drug-related disorders such as drug dependence in Japanese clinical practice. Hypnotics and anxiolitics that rank high in causative agents are BZ receptor agonists for which high frequencies of high doses and multidrug prescriptions have been reported (Japanese Journal of Clinical Psychopharmacology 2013; 16(6): 803-812, Modern Physician 2014; 34(6): 653-656, etc.). -
A Review of the Evidence of Use and Harms of Novel Benzodiazepines
ACMD Advisory Council on the Misuse of Drugs Novel Benzodiazepines A review of the evidence of use and harms of Novel Benzodiazepines April 2020 1 Contents 1. Introduction ................................................................................................................................. 4 2. Legal control of benzodiazepines .......................................................................................... 4 3. Benzodiazepine chemistry and pharmacology .................................................................. 6 4. Benzodiazepine misuse............................................................................................................ 7 Benzodiazepine use with opioids ................................................................................................... 9 Social harms of benzodiazepine use .......................................................................................... 10 Suicide ............................................................................................................................................. 11 5. Prevalence and harm summaries of Novel Benzodiazepines ...................................... 11 1. Flualprazolam ......................................................................................................................... 11 2. Norfludiazepam ....................................................................................................................... 13 3. Flunitrazolam .......................................................................................................................... -
Harmonized Tariff Schedule of the United States (2020) Revision 6 Annotated for Statistical Reporting Purposes
Harmonized Tariff Schedule of the United States (2020) Revision 6 Annotated for Statistical Reporting Purposes CHAPTER 29 ORGANIC CHEMICALS VI 29-1 Notes 1. Except where the context otherwise requires, the headings of this chapter apply only to: (a) Separate chemically defined organic compounds, whether or not containing impurities; (b) Mixtures of two or more isomers of the same organic compound (whether or not containing impurities), except mixtures of acyclic hydrocarbon isomers (other than stereoisomers), whether or not saturated (chapter 27); (c) The products of headings 2936 to 2939 or the sugar ethers, sugar acetals and sugar esters, and their salts, of heading 2940, or the products of heading 2941, whether or not chemically defined; (d) Products mentioned in (a), (b) or (c) above dissolved in water; (e) Products mentioned in (a), (b) or (c) above dissolved in other solvents provided that the solution constitutes a normal and necessary method of putting up these products adopted solely for reasons of safety or for transport and that the solvent does not render the product particularly suitable for specific use rather than for general use; (f) The products mentioned in (a), (b), (c), (d) or (e) above with an added stabilizer (including an anticaking agent) necessary for their preservation or transport; (g) The products mentioned in (a), (b), (c), (d), (e) or (f) above with an added antidusting agent or a coloring or odoriferous substance added to facilitate their identification or for safety reasons, provided that the additions do not render the product particularly suitable for specific use rather than for general use; (h) The following products, diluted to standard strengths, for the production of azo dyes: diazonium salts, couplers used for these salts and diazotizable amines and their salts. -
PMDA Alert for Proper Use of Drugs When Using Benzodiazepine
■ PMDA Alert for Proper Use of Drugs https://www.pmda.go.jp/english/safety/info-services/drugs/properly- No. 11 March 2017 use-alert/0001.html PMDA Alert for Proper Use of Drugs Pharmaceuticals and Medical Devices Agency No. 11 March 2017 Dependence associated with Benzodiazepine Receptor Agonists [To Patients] This document is for healthcare professionals. If taking the drug, please consult with your physicians or pharmacists. Please don’t reduce the dosage or stop taking the drug on self-judgment. Benzodiazepine receptor agonists have a characteristic of developing physical dependence with long-term use even within an approved dose range, leading to various withdrawal symptoms on dose reduction or discontinuation. <Major withdrawal symptoms> insomnia, anxiety, feeling irritated, headache, queasy/vomiting, delirium, tremor, seizure, etc. Please pay careful attention to the following when using benzodiazepine receptor agonists as hypnotics-sedatives and anxiolytics. Healthcare professionals should avoid long-term use with chronic administration. - Dependence may occur with long-term use even within an approved dose range. - Therapeutic necessity should be carefully considered when continuing administration of the drug. Healthcare professionals should adhere to the dosage and confirm that there is no multiple prescription of similar drugs. - Long-term administration, high-dose administration, or multiple medications increase the risk of developing dependence. - Healthcare professionals should confirm that similar drugs are not prescribed by other medical institutions. Healthcare professionals should reduce the dose or discontinue carefully such as by gradual dose reduction or alternate-days administration when discontinuing the administration. - Sudden discontinuation will develop serious withdrawal symptoms in addition to aggravate primary diseases. -
Association Between Benzodiazepine Use and Dementia: Data Mining of Different Medical Databases Mitsutaka Takada , Mai Fujimoto, Kouichi Hosomi
Int. J. Med. Sci. 2016, Vol. 13 825 Ivyspring International Publisher International Journal of Medical Sciences 2016; 13(11): 825-834. doi: 10.7150/ijms.16185 Research Paper Association between Benzodiazepine Use and Dementia: Data Mining of Different Medical Databases Mitsutaka Takada , Mai Fujimoto, Kouichi Hosomi Division of Clinical Drug Informatics, School of Pharmacy, Kinkai University, Higashi-osaka, Osaka, 577-8502, Japan. Corresponding author: Mitsutaka Takada, PhD. Division of Clinical Drug Informatics, School of Pharmacy, Kindai University, 577-8502, 3-4-1, Kowakae, Higashi-osaka, Osaka, 577-8502, Japan. Telephone number: +81-6-6721-2332 Fax number: +81-6-6730-1394. E-mail address: [email protected] © Ivyspring International Publisher. Reproduction is permitted for personal, noncommercial use, provided that the article is in whole, unmodified, and properly cited. See http://ivyspring.com/terms for terms and conditions. Received: 2016.05.16; Accepted: 2016.09.27; Published: 2016.10.18 Abstract Purpose: Some studies have suggested that the use of benzodiazepines in the elderly is associated with an increased risk of dementia. However, this association might be due to confounding by indication and reverse causation. To examine the association between benzodiazepine anxiolytic drug use and the risk of dementia, we conducted data mining of a spontaneous reporting database and a large organized database of prescriptions. Methods: Data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2004 through the end of 2013 and data from the Canada Vigilance Adverse Reaction Online Database from the first quarter of 1965 through the end of 2013 were used for the analyses. -
Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of the Meeting on 24-27 October 2016
01 December 2016 EMA/PRAC/127425/2017 Inspections, Human Medicines Pharmacovigilance and Committees Division Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of the meeting on 24-27 October 2016 Chair: June Raine – Vice-Chair: Almath Spooner Health and safety information In accordance with the Agency’s health and safety policy, delegates were briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in the minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scope listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also change during the course of the review. Additional details on some of these procedures will be published in the PRAC meeting highlights once the procedures are finalised. Of note, the minutes are a working document primarily designed for PRAC members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2017. -
(12) Patent Application Publication (10) Pub. No.: US 2010/0184806 A1 Barlow Et Al
US 20100184806A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0184806 A1 Barlow et al. (43) Pub. Date: Jul. 22, 2010 (54) MODULATION OF NEUROGENESIS BY PPAR (60) Provisional application No. 60/826,206, filed on Sep. AGENTS 19, 2006. (75) Inventors: Carrolee Barlow, Del Mar, CA (US); Todd Carter, San Diego, CA Publication Classification (US); Andrew Morse, San Diego, (51) Int. Cl. CA (US); Kai Treuner, San Diego, A6II 3/4433 (2006.01) CA (US); Kym Lorrain, San A6II 3/4439 (2006.01) Diego, CA (US) A6IP 25/00 (2006.01) A6IP 25/28 (2006.01) Correspondence Address: A6IP 25/18 (2006.01) SUGHRUE MION, PLLC A6IP 25/22 (2006.01) 2100 PENNSYLVANIA AVENUE, N.W., SUITE 8OO (52) U.S. Cl. ......................................... 514/337; 514/342 WASHINGTON, DC 20037 (US) (57) ABSTRACT (73) Assignee: BrainCells, Inc., San Diego, CA (US) The instant disclosure describes methods for treating diseases and conditions of the central and peripheral nervous system (21) Appl. No.: 12/690,915 including by stimulating or increasing neurogenesis, neuro proliferation, and/or neurodifferentiation. The disclosure (22) Filed: Jan. 20, 2010 includes compositions and methods based on use of a peroxi some proliferator-activated receptor (PPAR) agent, option Related U.S. Application Data ally in combination with one or more neurogenic agents, to (63) Continuation-in-part of application No. 1 1/857,221, stimulate or increase a neurogenic response and/or to treat a filed on Sep. 18, 2007. nervous system disease or disorder. Patent Application Publication Jul. 22, 2010 Sheet 1 of 9 US 2010/O184806 A1 Figure 1: Human Neurogenesis Assay Ciprofibrate Neuronal Differentiation (TUJ1) 100 8090 Ciprofibrates 10-8.5 10-8.0 10-7.5 10-7.0 10-6.5 10-6.0 10-5.5 10-5.0 10-4.5 Conc(M) Patent Application Publication Jul. -
Appendix 1 Cross-Reference of Research, Generic and Trade Names of Benzodiazepines
Appendix 1 Cross-Reference of Research, Generic and Trade Names of Benzodiazepines Table 1. Benzodiazepine research designations with corresponding generic names Research Designation Generic Name lactam demoxepam methyloxazepam temazepam A 101 nordazepam AB 35616 clorazepate AB 39083 clorazepate AH 3232 clorazepate CB 4261 tetrazepam CB 4306 clorazepate CB 4311 clorazepate CGS 8216 (antagonist) CI683 ripazepam CS 370 cloxazolam CS 430 haloxazolam D40TA estazolam EGYT 341 tofisopam ER 115 temazepam HR 158 loprazolam HR376 clobazam HR 4723 clobazam HR930 fosazepam K3917 temazepam 287 THE BENZODIAZEPINES Research Designation Generic Name LA 111 diazepam LM 2717 clobazam ORF 8063 triflubazam Ro 4-5360 nitrazepam Ro 5-0690 chlordiazepoxide Ro 5-0883 desmethy1chlordiazepoxide Ro 5-2092 demoxepam Ro 5-2180 desmethyldiazepam Ro 5-2807 diazepam Ro 5-2925 desmethylmedazepam Ro 5-3059 nitrazepam Ro 5-3350 bromazepam Ro 5-3438 fludiazepam Ro 5-4023 clonazepam Ro 5-4200 flunitrazepam Ro 5-4556 medazepam Ro 5-5345 temazepam Ro 5-6789 oxazepam Ro 5-6901 flurazepam Ro 15-1788 (antagonist) Ro 21-3981 midazolam RU 31158 loprazolam S 1530 nimetazepam SAH 1123 isoquinazepam SAH 47603 temazepam SB 5833 camazepam SCH 12041 halazepam SCH 16134 quazepam U 28774 ketazolam U 31889 alprazolam U 33030 triazolam W4020 prazepam We 352 triflubazam 288 RESEARCH, GENERIC AND TRADE NAMES Research Designation Generic Name We 941 brotizolam Wy 2917 temazepam Wy 3467 diazepam Wy 3498 oxazepam Wy 3917 temazepam Wy 4036 lorazepam Wy 4082 lormetazepam Wy 4426 oxazepam Y 6047 -
Table III. Defined Daily Doses for Statistical Purposes (S-DDD) for Psychotropic Substances
Table III. Defined daily doses for statistical purposes (S-DDD) for psychotropic substances The term “defined daily doses for statistical purposes (S-DDD)”, indicated defined daily doses for statistical purposes should be which has replaced the term “defined daily doses (DDD)”, is used considered approximate and subject to modifications if more by INCB as a technical unit of measurement for the purpose of precise information becomes available. The basis for the grouping statistical analysis and is not a recommended prescription dose. Its of the substances was, as far as possible, the anatomical definition is not free of a certain degree of arbitrariness. Certain therapeutic chemical (ATC) classification system used in the Nordic psychotropic substances may be used in certain countries for differ- Statistics on Medicines and recommended by the World Health ent treatments or in accordance with different medical practices, Organization (WHO) for drug utilization studies. In addition, the and therefore a different daily dose could be more appropriate. The grouping reflects the Schedules of the 1971 Convention. 25 Table III.1. Defined daily doses for statistical purposes (S-DDD) for psychotropic substances, by schedule Tableau III.1. Doses quotidiennes déterminées à des fins statistiques (S-DDD) pour les substances psychotropes, par tableau Cuadro III.1. Dosis diarias definidas con fines estadísticos (S-DDD) para las sustancias sicotrópicas, por lista S-DDD S-DDD (mg) (mg) Substances listed in Schedule II Amfepramone — Amfépramone — Anfepramona ......... 75.00 Substances inscrites au Tableau II Aminorex ......................................... — Sustancias incluidas en la Lista II Barbital .......................................... 500.00 Benzfetamine — Benzfétamine — Benzfetamina ......... 75.00 Amfetamine — Amfétamine — Anfetamina ............. 15.00 Bromazepam — Bromazépam ....................... -
Drug/Substance Trade Name(S)
A B C D E F G H I J K 1 Drug/Substance Trade Name(s) Drug Class Existing Penalty Class Special Notation T1:Doping/Endangerment Level T2: Mismanagement Level Comments Methylenedioxypyrovalerone is a stimulant of the cathinone class which acts as a 3,4-methylenedioxypyprovaleroneMDPV, “bath salts” norepinephrine-dopamine reuptake inhibitor. It was first developed in the 1960s by a team at 1 A Yes A A 2 Boehringer Ingelheim. No 3 Alfentanil Alfenta Narcotic used to control pain and keep patients asleep during surgery. 1 A Yes A No A Aminoxafen, Aminorex is a weight loss stimulant drug. It was withdrawn from the market after it was found Aminorex Aminoxaphen, Apiquel, to cause pulmonary hypertension. 1 A Yes A A 4 McN-742, Menocil No Amphetamine is a potent central nervous system stimulant that is used in the treatment of Amphetamine Speed, Upper 1 A Yes A A 5 attention deficit hyperactivity disorder, narcolepsy, and obesity. No Anileridine is a synthetic analgesic drug and is a member of the piperidine class of analgesic Anileridine Leritine 1 A Yes A A 6 agents developed by Merck & Co. in the 1950s. No Dopamine promoter used to treat loss of muscle movement control caused by Parkinson's Apomorphine Apokyn, Ixense 1 A Yes A A 7 disease. No Recreational drug with euphoriant and stimulant properties. The effects produced by BZP are comparable to those produced by amphetamine. It is often claimed that BZP was originally Benzylpiperazine BZP 1 A Yes A A synthesized as a potential antihelminthic (anti-parasitic) agent for use in farm animals. -
List of Benzodiazepines - Wikipedia, the Free Encyclopedia
List of benzodiazepines - Wikipedia, the free encyclopedia Log in / create account Article Talk Read Edit Our updated Terms of Use will become effective on May 25, 2012. Find out more. List of benzodiazepines From Wikipedia, the free encyclopedia Main page The below tables contain a list of benzodiazepines that Benzodiazepines Contents are commonly prescribed, with their basic pharmacological Featured content characteristics such as half-life and equivalent doses to other Current events benzodiazepines also listed, along with their trade names and Random article primary uses. The elimination half-life is how long it takes for Donate to Wikipedia half of the drug to be eliminated by the body. "Time to peak" Interaction refers to when maximum levels of the drug in the blood occur Help after a given dose. Benzodiazepines generally share the About Wikipedia same pharmacological properties, such as anxiolytic, Community portal sedative, hypnotic, skeletal muscle relaxant, amnesic and Recent changes anticonvulsant (hypertension in combination with other anti The core structure of benzodiazepines. Contact Wikipedia hypertension medications). Variation in potency of certain "R" labels denote common locations of effects may exist among individual benzodiazepines. Some side chains, which give different Toolbox benzodiazepines produce active metabolites. Active benzodiazepines their unique properties. Print/export metabolites are produced when a person's body metabolizes Benzodiazepine the drug into compounds that share a similar pharmacological -
1. Background 2. Objective 4. Results 3. Method
CP-003 ‘Deprescribing psychoactive medication for geriatric patients in a multidisciplinary way’ S. Desmet, D. Kindt, A. Verhaeghe, K. Verhelle, Clinical pharmacy department AZ Groeninge, Kortrijk, Belgium 1. BACKGROUND 3. METHOD A lot of studies emphasize the incidence of serious harms caused by Period: during 5 weeks patients were screened. polymedication in elderly patients. Especially the use of INCLUSION criteria: patient over 75 years with at least one other benzodiazepines and/or combination with other psychoactive criterium: medication increase the risk for confusion, falls, cognitive - a contra-indication for benzodiazepines impairment, and other adverse drug events. - use of a diazepam equivalent of at least 20mg (calculated via 2. OBJECTIVE http://benzoschema.knmp.nl/benzos_enduser_pt), Guarding the safety and quality of life for geriatric patients with - pharmacodynamic synergistic interaction (antidepressants, polymedication by reducing the use of psychoactive medication in a antipsychotics, anticholinergics, sedative antihistaminics and multidisciplinary way with the clinical pharmacist, geriatrician, opioids) general practitioner and home pharmacist. EXCLUSION criteria: palliative patients, exclusion by the geriatrician. 4. RESULTS A) WORKFLOW AND TOOLS 1. Workflow of the clinical 2. Contra-indications 4. Reduction schedules pharmacist Reduction schedules for anti-depressants Other long acting benzodiazepines can be COPD and antipsychotics can be found on: swtiched to diazepam in order to reduce in Identify patients at risk (inclusion Asthma http://wiki.psychiatrienet.nl/index.php/ small steps. criteria) by checking their home Sleep apnea medication Short and intermediate acting Long acting benzodiazepine (e.g. Clobazam, Myasthenia gravis benzodiazepines can be reduced in steps Clorazepaat, Flurazepam, Nitrazepam, corresponding to half of the lowest Nordazepam) 3.