Heat Related Illness in Psychotropic Medication Users
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HIGHLIGHTS of PRESCRIBING INFORMATION These Highlights Do
HIGHLIGHTS OF PRESCRIBING INFORMATION • Metabolic Changes: Atypical antipsychotic drugs have been associated with These highlights do not include all the information needed to use metabolic changes that may increase cardiovascular/cerebrovascular risk. CLOZARIL safely and effectively. See full prescribing information for These metabolic changes include: CLOZARIL. o Hyperglycemia and Diabetes Mellitus: Monitor for symptoms of CLOZARIL® (clozapine) tablets, for oral use hyperglycemia including polydipsia, polyuria, polyphagia, and Initial U.S. Approval: 1989 weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes. (5.9) WARNING: SEVERE NEUTROPENIA; ORTHOSTATIC o Dyslipidemia: Undesirable alterations in lipids have occurred in HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; patients treated with atypical antipsychotics. (5.9) MYOCARDITIS AND CARDIOMYOPATHY; INCREASED o Weight Gain: Significant weight gain has occurred. Monitor weight MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA- gain. (5.9) RELATED PSYCHOSIS • Neuroleptic Malignant Syndrome (NMS): Immediately discontinue and See full prescribing information for complete boxed warning. monitor closely. Assess for co-morbid conditions. (5.10) • Fever: Evaluate for infection and for neutropenia, NMS. (5.11) • Pulmonary Embolism (PE): Consider PE if respiratory distress, chest pain, • Severe Neutropenia: CLOZARIL can cause severe neutropenia, which or deep-vein thrombosis occur. (5.12) can lead to serious and fatal infections. Patients initiating and • Anticholinergic Toxicity: Use cautiously in presence of specific conditions continuing treatment with CLOZARIL must have a baseline blood (e.g., narrow angle glaucoma, use of anticholinergic drugs). (5.13) absolute neutrophil count (ANC) measured before treatment initiation • Interference with Cognitive and Motor Performance: Advise caution when and regular ANC monitoring during treatment (2.1, 5.1). -
Management of Side Effects of Antipsychotics
Management of side effects of antipsychotics Oliver Freudenreich, MD, FACLP Co-Director, MGH Schizophrenia Program www.mghcme.org Disclosures I have the following relevant financial relationship with a commercial interest to disclose (recipient SELF; content SCHIZOPHRENIA): • Alkermes – Consultant honoraria (Advisory Board) • Avanir – Research grant (to institution) • Janssen – Research grant (to institution), consultant honoraria (Advisory Board) • Neurocrine – Consultant honoraria (Advisory Board) • Novartis – Consultant honoraria • Otsuka – Research grant (to institution) • Roche – Consultant honoraria • Saladax – Research grant (to institution) • Elsevier – Honoraria (medical editing) • Global Medical Education – Honoraria (CME speaker and content developer) • Medscape – Honoraria (CME speaker) • Wolters-Kluwer – Royalties (content developer) • UpToDate – Royalties, honoraria (content developer and editor) • American Psychiatric Association – Consultant honoraria (SMI Adviser) www.mghcme.org Outline • Antipsychotic side effect summary • Critical side effect management – NMS – Cardiac side effects – Gastrointestinal side effects – Clozapine black box warnings • Routine side effect management – Metabolic side effects – Motor side effects – Prolactin elevation • The man-in-the-arena algorithm www.mghcme.org Receptor profile and side effects • Alpha-1 – Hypotension: slow titration • Dopamine-2 – Dystonia: prophylactic anticholinergic – Akathisia, parkinsonism, tardive dyskinesia – Hyperprolactinemia • Histamine-1 – Sedation – Weight gain -
Appendix 13C: Clinical Evidence Study Characteristics Tables
APPENDIX 13C: CLINICAL EVIDENCE STUDY CHARACTERISTICS TABLES: PHARMACOLOGICAL INTERVENTIONS Abbreviations ............................................................................................................ 3 APPENDIX 13C (I): INCLUDED STUDIES FOR INITIAL TREATMENT WITH ANTIPSYCHOTIC MEDICATION .................................. 4 ARANGO2009 .................................................................................................................................. 4 BERGER2008 .................................................................................................................................... 6 LIEBERMAN2003 ............................................................................................................................ 8 MCEVOY2007 ................................................................................................................................ 10 ROBINSON2006 ............................................................................................................................. 12 SCHOOLER2005 ............................................................................................................................ 14 SIKICH2008 .................................................................................................................................... 16 SWADI2010..................................................................................................................................... 19 VANBRUGGEN2003 .................................................................................................................... -
NORPRAMIN® (Desipramine Hydrochloride Tablets USP)
NORPRAMIN® (desipramine hydrochloride tablets USP) Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of NORPRAMIN or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. NORPRAMIN is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.) DESCRIPTION NORPRAMIN® (desipramine hydrochloride USP) is an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz[bƒ]azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. 1 Reference ID: 3536021 Inactive Ingredients The following inactive ingredients are contained in all dosage strengths: acacia, calcium carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and 150 mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide, light mineral oil, magnesium stearate, mannitol, polyethylene glycol 8000, pregelatinized corn starch, sodium benzoate (except 150 mg), sucrose, talc, titanium dioxide, and other ingredients. -
The Effects of Antipsychotic Treatment on Metabolic Function: a Systematic Review and Network Meta-Analysis
The effects of antipsychotic treatment on metabolic function: a systematic review and network meta-analysis Toby Pillinger, Robert McCutcheon, Luke Vano, Katherine Beck, Guy Hindley, Atheeshaan Arumuham, Yuya Mizuno, Sridhar Natesan, Orestis Efthimiou, Andrea Cipriani, Oliver Howes ****PROTOCOL**** Review questions 1. What is the magnitude of metabolic dysregulation (defined as alterations in fasting glucose, total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, and triglyceride levels) and alterations in body weight and body mass index associated with short-term (‘acute’) antipsychotic treatment in individuals with schizophrenia? 2. Does baseline physiology (e.g. body weight) and demographics (e.g. age) of patients predict magnitude of antipsychotic-associated metabolic dysregulation? 3. Are alterations in metabolic parameters over time associated with alterations in degree of psychopathology? 1 Searches We plan to search EMBASE, PsycINFO, and MEDLINE from inception using the following terms: 1 (Acepromazine or Acetophenazine or Amisulpride or Aripiprazole or Asenapine or Benperidol or Blonanserin or Bromperidol or Butaperazine or Carpipramine or Chlorproethazine or Chlorpromazine or Chlorprothixene or Clocapramine or Clopenthixol or Clopentixol or Clothiapine or Clotiapine or Clozapine or Cyamemazine or Cyamepromazine or Dixyrazine or Droperidol or Fluanisone or Flupehenazine or Flupenthixol or Flupentixol or Fluphenazine or Fluspirilen or Fluspirilene or Haloperidol or Iloperidone -
Drug Repurposing for the Management of Depression: Where Do We Stand Currently?
life Review Drug Repurposing for the Management of Depression: Where Do We Stand Currently? Hosna Mohammad Sadeghi 1,†, Ida Adeli 1,† , Taraneh Mousavi 1,2, Marzieh Daniali 1,2, Shekoufeh Nikfar 3,4,5 and Mohammad Abdollahi 1,2,* 1 Toxicology and Diseases Group (TDG), Pharmaceutical Sciences Research Center (PSRC), The Institute of Pharmaceutical Sciences (TIPS), Tehran University of Medical Sciences, Tehran 1417614411, Iran; [email protected] (H.M.S.); [email protected] (I.A.); [email protected] (T.M.); [email protected] (M.D.) 2 Department of Toxicology and Pharmacology, School of Pharmacy, Tehran University of Medical Sciences, Tehran 1417614411, Iran 3 Personalized Medicine Research Center, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran 1417614411, Iran; [email protected] 4 Pharmaceutical Sciences Research Center (PSRC) and the Pharmaceutical Management and Economics Research Center (PMERC), Evidence-Based Evaluation of Cost-Effectiveness and Clinical Outcomes Group, The Institute of Pharmaceutical Sciences (TIPS), Tehran University of Medical Sciences, Tehran 1417614411, Iran 5 Department of Pharmacoeconomics and Pharmaceutical Administration, School of Pharmacy, Tehran University of Medical Sciences, Tehran 1417614411, Iran * Correspondence: [email protected] † Equally contributed as first authors. Citation: Mohammad Sadeghi, H.; Abstract: A slow rate of new drug discovery and higher costs of new drug development attracted Adeli, I.; Mousavi, T.; Daniali, M.; the attention of scientists and physicians for the repurposing and repositioning of old medications. Nikfar, S.; Abdollahi, M. Drug Experimental studies and off-label use of drugs have helped drive data for further studies of ap- Repurposing for the Management of proving these medications. -
Clinical Guideline Drug/Drug Class: Antipsychotics Prepared By
MassHealth Drug Utilization Review Program Commonwealth Medicine University of Massachusetts Medical School P.O. Box 2586 Worcester MA, 01613-2586 Clinical Guideline Drug/Drug Class: Antipsychotics Prepared by: Drug Utilization Review Program Prepared for: MassHealth Pharmacy Program Purpose: The purpose of this guideline is to clarify the procedures for approving and denying prior authorization (PA) requests for: Polypharmacy with two or more antipsychotics for members ≥ 18 years old (including first- generation [typical] and second-generation [atypical]) for greater than 60 days (excluding clozapine and injectable formulations) Orally disintegrating dosage forms and Versacloz® (clozapine) oral suspension Medication exceeding defined quantity limits Fanapt® (iloperidone), Invega® (paliperidone), Latuda® (lurasidone), Rexulti® (brexpiprazole), Saphris® (asenapine), and Vraylar® (cariprazine) for members of all ages and all quantities Abilify® (aripiprazole) and Seroquel XR® (quetiapine extended-release) for members 18 years of age and older and all quantities Background: Since 2003, MassHealth has determined that oral second-generation (atypical) antipsychotics (with the exception of clozapine and injectables) would require prior authorization for polypharmacy, defined as two or more second-generation (atypical) antipsychotics for greater than 60 days. Clozapine is excluded from the polypharmacy requirement because the guidelines for the treatment of schizophrenia recognize that combinations including clozapine have been reported. 1 In 2016, the adult antipsychotic polypharmacy criteria was updated and the PA restriction was expanded to include first-generation (typical), and second-generation (atypical) antipsychotics, excluding clozapine and injectable formulations. Orally disintegrating tablets (ODT) of aripiprazole, clozapine, olanzapine and risperidone, as well as Versacloz® (clozapine) oral suspension also require PA since there are more cost-effective alternatives available. -
Psychotropic Medications Judicial Reference Guide
PSYCHOTROPIC MEDICATIONS JUDICIAL REFERENCE GUIDE (Revised Edition 7/15/10) PSYCHOTROPIC MEDICATIONS JUDICIAL REFERENCE GUIDE FIRST EDITION THE STEERING COMMITTEE ON FAMILIES AND CHILDREN IN THE COURT Distributed by Florida Supreme Court 500 South Duval Street Tallahassee, FL 32399-1900 (850) 488-0125 INTRODUCTION One of the toughest challenges facing our dependency courts is the mental health of our children. “In July 2003, the Florida Statewide Advocacy Council published a Red Item Report finding 55% of foster children…in the state of Florida had been put on powerful mind altering psychotropic drugs.”1 In order to assist in this regard, the Psychotherapeutic Medication Subcommittee of the Steering Committee on Families and Children in the Court of the Supreme Court of Florida compiled this resource guide to help judges have a better understanding of psychotropic medications and their interaction with other drugs and with mental health disorders. Recently, the tragic case of Gabriel Myers in 2009 highlighted the fact that a number of child deaths were linked to the off label use of anti-psychotic medications. This is of special concern to Dependency Judges who are ultimately responsible for children in Florida’s Foster Care system. The researchers used publically available data from the internet, FDA manufactures’ published guidelines, publically available non-copyrighted articles and Dr. Brenda Thompson graciously prepared the Psychotropic Medication Chart. Special thanks to Dr. Brenda Thompson, the Honorable Herbert J. Baumann, the Honorable Ralph C. Stoddard, General Magistrate Tracy Ellis, Avron Bernstein, Selena Schoonover, Daniel Ringhoff, Jovasha Lang and to the Members of the Psychotherapeutic Medication Subcommittee. -
S1 Table. List of Medications Analyzed in Present Study Drug
S1 Table. List of medications analyzed in present study Drug class Drugs Propofol, ketamine, etomidate, Barbiturate (1) (thiopental) Benzodiazepines (28) (midazolam, lorazepam, clonazepam, diazepam, chlordiazepoxide, oxazepam, potassium Sedatives clorazepate, bromazepam, clobazam, alprazolam, pinazepam, (32 drugs) nordazepam, fludiazepam, ethyl loflazepate, etizolam, clotiazepam, tofisopam, flurazepam, flunitrazepam, estazolam, triazolam, lormetazepam, temazepam, brotizolam, quazepam, loprazolam, zopiclone, zolpidem) Fentanyl, alfentanil, sufentanil, remifentanil, morphine, Opioid analgesics hydromorphone, nicomorphine, oxycodone, tramadol, (10 drugs) pethidine Acetaminophen, Non-steroidal anti-inflammatory drugs (36) (celecoxib, polmacoxib, etoricoxib, nimesulide, aceclofenac, acemetacin, amfenac, cinnoxicam, dexibuprofen, diclofenac, emorfazone, Non-opioid analgesics etodolac, fenoprofen, flufenamic acid, flurbiprofen, ibuprofen, (44 drugs) ketoprofen, ketorolac, lornoxicam, loxoprofen, mefenamiate, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, pranoprofen, proglumetacin, sulindac, talniflumate, tenoxicam, tiaprofenic acid, zaltoprofen, morniflumate, pelubiprofen, indomethacin), Anticonvulsants (7) (gabapentin, pregabalin, lamotrigine, levetiracetam, carbamazepine, valproic acid, lacosamide) Vecuronium, rocuronium bromide, cisatracurium, atracurium, Neuromuscular hexafluronium, pipecuronium bromide, doxacurium chloride, blocking agents fazadinium bromide, mivacurium chloride, (12 drugs) pancuronium, gallamine, succinylcholine -
Association of Selective Serotonin Reuptake Inhibitors with the Risk for Spontaneous Intracranial Hemorrhage
Supplementary Online Content Renoux C, Vahey S, Dell’Aniello S, Boivin J-F. Association of selective serotonin reuptake inhibitors with the risk for spontaneous intracranial hemorrhage. JAMA Neurol. Published online December 5, 2016. doi:10.1001/jamaneurol.2016.4529 eMethods 1. List of Antidepressants for Cohort Entry eMethods 2. List of Antidepressants According to the Degree of Serotonin Reuptake Inhibition eMethods 3. Potential Confounding Variables Included in Multivariate Models eMethods 4. Sensitivity Analyses eFigure. Flowchart of Incident Antidepressant (AD) Cohort Definition and Case- Control Selection eTable 1. Crude and Adjusted Rate Ratios of Intracerebral Hemorrhage Associated With Current Use of SSRIs Relative to TCAs eTable 2. Crude and Adjusted Rate Ratios of Subarachnoid Hemorrhage Associated With Current Use of SSRIs Relative to TCAs eTable 3. Crude and Adjusted Rate Ratios of Intracranial Extracerebral Hemorrhage Associated With Current Use of SSRIs Relative to TCAs. eTable 4. Crude and Adjusted Rate Ratios of Intracerebral Hemorrhage Associated With Current Use of Antidepressants With Strong Degree of Inhibition of Serotonin Reuptake Relative to Weak eTable 5. Crude and Adjusted Rate Ratios of Subarachnoid Hemorrhage Associated With Current Use of Antidepressants With Strong Degree of Inhibition of Serotonin Reuptake Relative to Weak eTable 6. Crude and Adjusted Rate Ratios of Intracranial Extracerebral Hemorrhage Associated With Current Use of Antidepressants With Strong Degree of Inhibition of Serotonin Reuptake Relative to Weak This supplementary material has been provided by the authors to give readers additional information about their work. © 2016 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 10/02/2021 eMethods 1. -
A Brief Overview of Psychotropic Medication Use for Persons with Intellectual Disabilities
A BRIEF OVERVIEW OF PSYCHOTROPIC MEDICATION USE FOR PERSONS WITH INTELLECTUAL DISABILITIES INTRODUCTION Individuals with intellectual disabilities are not uncommonly prescribed psychotropic medications. Too often, historically, such agents have been used to try to improve behavioral control without adequate understanding of the antecedents, purpose, and reinforcement of the problematic behavior. While an individual with an intellectual disability may experience a depressive, anxiety, or psychotic disorder in the more typical sense some individuals experience a pattern of anxiety/alarm/arousal leading to affective dysregulation and impulsive behavior. The anxiety can be stimulated by environmental change, physical discomfort, cues related to past trauma, overstimulation, boredom, confusion, or other unpleasant states. Addressing what is causing the distress or reinforcing the behavioral response is the most important thing (though not always easy). Psychotropic medications may be useful for treating more typically presenting psychiatric illnesses as well as being part of more comprehensive plans to attenuate risk behaviors. An individual with intellectual disabilities who seems sad, is withdrawn, shows low energy and lack of interest, is eating or sleeping more or less, or may be more irritable could be suffering from a depression that needs medication treatment. On the other hand an individual with intellectual disabilities who demonstrates aggression, property destruction, self-injury, or other forms of “dyscontrol” may be helped by medication aimed at blunting the anxiety/alarm and/or blocking its escalation into aggression or other dangerous behaviors. In such instances the medications are just part of an overall strategy or plan to help the individual avoid the “need” to engage in such behavior. -
Weight Gain Associated with Antipsychotic Drugs
Rohan Ganguli Weight Gain Associated With Antipsychotic Drugs Rohan Ganguli, M.D. © CopyrightWeight gain has been 2000 reported Physicians with nearly every antipsychotic Postgraduate drug on the market Press, (molindone Inc.is an exception). Weight gain occurs no matter what the patient’s age, sex, or race and is seen with both oral and depot drug formulations. Numerous studies have found that patients gain weight when treated with a conventional antipsychotic, such as chlorpromazine, fluphenazine, and haloperidol. The newer, novel antipsychotics offer advantages over conventional antipsychotics, especially a relative lack of extrapyramidal symptoms, but some still have the disadvantage of causing weight gain. Clozapine and olanzapine in particular appear to cause substantial weight gain, much more so than do most conven- tional neuroleptics and novel agents such as risperidone. Given the risks to health and treatment com- pliance associated with weight gain and obesity, clinicians should monitor weight during the course of antipsychotic therapy and consider switching agents if excessive weight gain occurs. (J Clin Psychiatry 1999;60[suppl 21]:20–24) One personal copy may be printed e have known for some time that treatment with CONVENTIONAL NEUROLEPTICS Wantipsychotic drugs is associated with weight gain. A few years after the first neuroleptic medications One of the earliest studies to examine weight gain asso- were introduced, researchers were reporting clinically sig- ciated with antipsychotic drugs in a large number of pa- nificant