Vyvanse (Lisdexamfetamine)
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(19) United States (12) Patent Application Publication (10) Pub
US 20130289061A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2013/0289061 A1 Bhide et al. (43) Pub. Date: Oct. 31, 2013 (54) METHODS AND COMPOSITIONS TO Publication Classi?cation PREVENT ADDICTION (51) Int. Cl. (71) Applicant: The General Hospital Corporation, A61K 31/485 (2006-01) Boston’ MA (Us) A61K 31/4458 (2006.01) (52) U.S. Cl. (72) Inventors: Pradeep G. Bhide; Peabody, MA (US); CPC """"" " A61K31/485 (201301); ‘4161223011? Jmm‘“ Zhu’ Ansm’ MA. (Us); USPC ......... .. 514/282; 514/317; 514/654; 514/618; Thomas J. Spencer; Carhsle; MA (US); 514/279 Joseph Biederman; Brookline; MA (Us) (57) ABSTRACT Disclosed herein is a method of reducing or preventing the development of aversion to a CNS stimulant in a subject (21) App1_ NO_; 13/924,815 comprising; administering a therapeutic amount of the neu rological stimulant and administering an antagonist of the kappa opioid receptor; to thereby reduce or prevent the devel - . opment of aversion to the CNS stimulant in the subject. Also (22) Flled' Jun‘ 24’ 2013 disclosed is a method of reducing or preventing the develop ment of addiction to a CNS stimulant in a subj ect; comprising; _ _ administering the CNS stimulant and administering a mu Related U‘s‘ Apphcatlon Data opioid receptor antagonist to thereby reduce or prevent the (63) Continuation of application NO 13/389,959, ?led on development of addiction to the CNS stimulant in the subject. Apt 27’ 2012’ ?led as application NO_ PCT/US2010/ Also disclosed are pharmaceutical compositions comprising 045486 on Aug' 13 2010' a central nervous system stimulant and an opioid receptor ’ antagonist. -
Enhanced Reporting
Drug Profile, Targeted with Interpretation by Tandem Mass Spectrometry and Enzyme Immunoassay, Urine Patient: PAIN HYB 2, 2009288 | Date of Birth: | Gender: M | Physician: DR T. TEST Patient Identifiers: | Visit Number (FIN): Drug Analyte Result Cutoff Notes Meperidine metabolite Not Detected 50 ng/mL normeperidine Tapentadol Not Detected 100 ng/mL --Tapentadol-o-sulfate Not Detected 200 ng/mL tapentadol metabolite AMPHETAMINE-LIKE, MASS SPEC Amphetamine Present 50 ng/mL eg, Vyvanse; also a metabolite of methamphetamine Methamphetamine Present 200 ng/mL d- and l- isomers are not distinguished by this test; may reflect Vicks inhaler, Desoxyn, Selegiline, or illicit source MDMA - Ecstasy Not Detected 200 ng/mL MDA Not Detected 200 ng/mL also a metabolite of MDMA and MDEA MDEA - Eve Not Detected 200 ng/mL Phentermine Not Detected 100 ng/mL Methylphenidate Not Detected 100 ng/mL eg, Ritalin, Dexmethylphenidate, Focalin, Concerta BENZODIAZEPINE-LIKE, MASS SPEC Alprazolam Not Detected 40 ng/mL eg, Xanax --Alpha-hydroxyalprazolam Not Detected 20 ng/mL alprazolam metabolite Clonazepam Not Detected 20 ng/mL eg, Klonopin --7-aminoclonazepam Not Detected 40 ng/mL clonazepam metabolite Diazepam Not Detected 50 ng/mL eg, Valium Nordiazepam Not Detected 50 ng/mL metabolite of chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam, halazepam (Alapryl), prazepam (Centrax) and others Oxazepam Not Detected 50 ng/mL eg, Serax; also metabolite of nordiazepam and temazepam Temazepam Not Detected 50 ng/mL eg, Restoril; also a metabolite of diazepam Lorazepam Not Detected 60 ng/mL eg, Ativan Midazolam Not Detected 20 ng/mL eg, Versed Zolpidem Present 20 ng/mL eg, Ambien Reference interval Creatinine value (mg/dL) 200.0 20.0 - 400.0 mg/dL Patient: PAIN HYB 2, 2009288 ARUP Accession: 21-048-107698 4848 Chart continues on following page(s) ARUP Enhanced Reporting | February 17, 2021 | page 4 of 5 Drug Profile, Targeted with Interpretation by Tandem Mass Spectrometry and Enzyme Immunoassay, Urine Patient: PAIN HYB 2, 2009288 | Date of Birth | Gender: M | Physician: DR T. -
Amphetamine/Dextroamphetamine IR Generic
GEORGIA MEDICAID FEE-FOR-SERVICE STIMULANT AND RELATED AGENTS PA SUMMARY Preferred Non-Preferred Amphetamine/dextroamphetamine IR generic Adzenys ER (amphetamine ER oral suspension) Armodafinil generic Adzenys XR (amphetamine ER dispersible tab) Atomoxetine generic Amphetamine/dextroamphetamine ER (generic Concerta (methylphenidate ER/SA) Adderall XR) Dextroamphetamine IR tablets generic Aptensio XR (methylphenidate ER) Focalin (dexmethylphenidate) Clonidine ER generic Focalin XR (dexmethylphenidate ER) Cotempla XR (methylphenidate ER disintegrating Guanfacine ER generic tablet) Methylin oral solution (methylphenidate) Daytrana (methylphenidate TD patch) Methylphenidate CD/CR/ER generic by Lannett Desoxyn (methamphetamine) [NDCs 00527-####-##] and Kremers Urban [NDCs Dexmethylphenidate IR generic 62175-####-##] (generic Metadate CD) Dexmethylphenidate ER generic Methylphenidate IR generic Dextroamphetamine ER capsules generic Modafinil generic Dextroamphetamine oral solution generic Quillichew ER (methylphenidate ER chew tabs) Dyanavel XR (amphetamine ER oral suspension) Quillivant XR (methylphenidate ER oral suspension) Evekeo (amphetamine tablets) Vyvanse (lisdexamfetamine) Methamphetamine generic Zenzedi 5 mg, 10 mg IR tablets (dextroamphetamine) Methylphenidate IR chewable tablets generic Methylphenidate ER/SA (generic Concerta) Methylphenidate ER/LA/SR (generic Ritalin LA, Ritalin SR, Metadate ER) Methylphenidate ER/SA 72 mg generic Methylphenidate oral solution generic Mydayis (amphetamine/dextroamphetamine ER) Ritalin LA 10 mg -
Current Topics in Behavioral Neurosciences
Current Topics in Behavioral Neurosciences Series Editors Mark A. Geyer, La Jolla, CA, USA Bart A. Ellenbroek, Wellington, New Zealand Charles A. Marsden, Nottingham, UK For further volumes: http://www.springer.com/series/7854 About this Series Current Topics in Behavioral Neurosciences provides critical and comprehensive discussions of the most significant areas of behavioral neuroscience research, written by leading international authorities. Each volume offers an informative and contemporary account of its subject, making it an unrivalled reference source. Titles in this series are available in both print and electronic formats. With the development of new methodologies for brain imaging, genetic and genomic analyses, molecular engineering of mutant animals, novel routes for drug delivery, and sophisticated cross-species behavioral assessments, it is now possible to study behavior relevant to psychiatric and neurological diseases and disorders on the physiological level. The Behavioral Neurosciences series focuses on ‘‘translational medicine’’ and cutting-edge technologies. Preclinical and clinical trials for the development of new diagostics and therapeutics as well as prevention efforts are covered whenever possible. Cameron S. Carter • Jeffrey W. Dalley Editors Brain Imaging in Behavioral Neuroscience 123 Editors Cameron S. Carter Jeffrey W. Dalley Imaging Research Center Department of Experimental Psychology Center for Neuroscience University of Cambridge University of California at Davis Downing Site Sacramento, CA 95817 Cambridge CB2 3EB USA UK ISSN 1866-3370 ISSN 1866-3389 (electronic) ISBN 978-3-642-28710-7 ISBN 978-3-642-28711-4 (eBook) DOI 10.1007/978-3-642-28711-4 Springer Heidelberg New York Dordrecht London Library of Congress Control Number: 2012938202 Ó Springer-Verlag Berlin Heidelberg 2012 This work is subject to copyright. -
Stimulant and Related Medications: US Food and Drug
Stimulant and Related Medications: U.S. Food and Drug Administration-Approved Indications and Dosages for Use in Adults The therapeutic dosing recommendations for stimulant and related medications are based on U.S. Food and Drug Administration (FDA)-approved product labeling. Nevertheless, the dosing regimen is adjusted according to a patient’s individual response to pharmacotherapy. The FDA-approved dosages and indications for the use of stimulant and related medications in adults are provided in this table. All medication doses listed are for oral administration. Information on the generic availability of the stimulant and related medications can be found by searching the Electronic Orange Book at https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm on the FDA website. Generic Medication Indication Dosing Information Other Information Availability amphetamine/dextroamphetamine ADHD Initial dose: May increase daily dose by 5 mg at Yes mixed salts[1] 5 mg once or twice a day; weekly intervals until optimal response Maximum dose: 40 mg per day is achieved. Only in rare cases will it be necessary to exceed a total of 40 mg per day. amphetamine/dextroamphetamine narcolepsy Initial dose: 10 mg per day; May increase daily dose by 10 mg at Yes mixed salts Usual dose: weekly intervals until optimal response 5 mg to 60 mg per day is achieved. Take first dose in divided doses upon awakening. amphetamine/dextroamphetamine ADHD Recommended dose: Patients switching from regular-release Yes mixed salts ER*[2] 20 mg once a day amphetamine/dextroamphetamine mixed salts may take the same total daily dose once a day. armodafinil[3] narcolepsy Recommended dose: Take as a single dose in the morning. -
A Brief Overview of Psychiatric Pharmacotherapy
A Brief Overview of Psychiatric Pharmacotherapy Joel V. Oberstar, M.D. Chief Executive Officer Disclosures • Some medications discussed are not approved by the FDA for use in the population discussed/described. • Some medications discussed are not approved by the FDA for use in the manner discussed/described. • Co-Owner: – PrairieCare and PrairieCare Medical Group – Catch LLC Disclaimer The contents of this handout are for informational purposes only and are not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical or psychiatric condition. Never disregard professional/medical advice or delay in seeking it because of something you have read in this handout. Material in this handout may be copyrighted by the author or by third parties; reasonable efforts have been made to give attribution where appropriate. Caveat Regarding the Role of Medication… Neuroscience Overview Mind Over Matter, National Institute on Drug Abuse, National Institutes of Health. Available at: http://teens.drugabuse.gov/mom/index.asp. http://medicineworld.org/images/news-blogs/brain-700997.jpg Neuroscience Overview Mind Over Matter, National Institute on Drug Abuse, National Institutes of Health. Available at: http://teens.drugabuse.gov/mom/index.asp. Neurotransmitter Receptor Source: National Institute on Drug Abuse Common Diagnoses and Associated Medications • Psychotic Disorders – Antipsychotics • Bipolar Disorders – Mood Stabilizers, Antipsychotics, & Antidepressants • Depressive Disorders – Antidepressants • Anxiety Disorders – Antidepressants & Anxiolytics • Attention Deficit Hyperactivity Disorder – Stimulants, Antidepressants, 2-Adrenergic Agents, & Strattera Classes of Medications • Anti-depressants • Stimulants and non-stimulant alternatives • Anti-psychotics (a.k.a. -
Established Aggregate Production Quotas for Schedule I and II
59980 Federal Register / Vol. 77, No. 190 / Monday, October 1, 2012 / Notices DEPARTMENT OF JUSTICE for Schedule I and II Controlled information, DEA has determined that Substances and Proposed Assessment of adjustments to the proposed aggregate Drug Enforcement Administration Annual Needs for the List I Chemicals production quotas and assessment of [Docket No. DEA–365] Ephedrine, Pseudoephedrine, and annual needs for 3,4-methylenedioxy-N- Phenylpropanolamine for 2013,’’ was methylcathinone (methylone), Established Aggregate Production published in the Federal Register (77 3,4,methylenedioxypyrovalerone Quotas for Schedule I and II Controlled FR 46519). That notice proposed the (MDPV), 4-methyl-N-methylcathinone Substances and Established 2013 aggregate production quotas for (mephedrone), N-benzylpiperazine, Assessment of Annual Needs for the each basic class of controlled substance amphetamine (for conversion), List I Chemicals Ephedrine, listed in schedules I and II and the 2013 amphetamine (for sale), hydrocodone Pseudoephedrine, and assessment of annual needs for the list (for sale), hydromorphone, Phenylpropanolamine for 2013 I chemicals ephedrine, lisdexamfetamine, methylphenidate, pseudoephedrine, and morphine (for sale), oxycodone (for AGENCY: Drug Enforcement phenylpropanolamine. All interested sale), oxymorphone (for conversion), Administration (DEA), Department of persons were invited to comment on or remifentanil, sufentanil, tapentadol, Justice. object to the proposed aggregate ephedrine (for conversion), ephedrine ACTION: -
A Dose-Escalating, Phase-2 Study of Oral Lisdexamfetamine
Ezard et al. BMC Psychiatry (2016) 16:428 DOI 10.1186/s12888-016-1141-x STUDY PROTOCOL Open Access Study protocol: a dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence Nadine Ezard1,2, Adrian Dunlop3, Brendan Clifford1* , Raimondo Bruno4, Andrew Carr5, Alexandra Bissaker1 and Nicholas Lintzeris6,7 Abstract Background: The treatment of methamphetamine dependence is a continuing global health problem. Agonist type pharmacotherapies have been used successfully to treat opioid and nicotine dependence and are being studied for the treatment of methamphetamine dependence. One potential candidate is lisdexamfetamine, a pro-drug for dexamphetamine, which has a longer lasting therapeutic action with a lowered abuse potential. The purpose of this study is to determine the safety of lisdexamfetamine in this population at doses higher than those currently approved for attention deficit hyperactivity disorder or binge eating disorder. Methods/design: This is a phase 2 dose escalation study of lisdexamfetamine for the treatment of methamphetamine dependence. Twenty individuals seeking treatment for methamphetamine dependence will be recruited at two Australian drug and alcohol services. All participants will undergo a single-blinded ascending-descending dose regime of 100 to 250 mg lisdexamfetamine, dispensed daily on site, over an 8-week period. Participants will be offered counselling as standard care. For the primary objectives the outcome variables will be adverse events monitoring, drug tolerability and regimen completion. Secondary outcomes will be changes in methamphetamine use, craving, withdrawal, severity of dependence, risk behaviour and other substance use. Medication acceptability, potential for non-prescription use, adherence and changes in neurocognition will also be measured. -
Product Monograph
PRODUCT MONOGRAPH VYVANSE®* lisdexamfetamine dimesylate Capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg Chewable Tablets: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg Central Nervous System Stimulant Takeda Canada Inc. Date of Preparation: 22 Adelaide Street West, Suite 3800 19 February 2009 Toronto, Ontario M5H 4E3 Date of Revision: July 21, 2020 Submission Control No.: 240669 *VYVANSE® and the VYVANSE Logo are registered trademarks of Shire LLC, a Takeda company. Takeda and the Takeda Logo are trademarks of Takeda Pharmaceutical Company Limited, used under license. © 2020 Takeda Pharmaceutical Company Limited. All rights reserved. Pa ge 1 of 60 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3 SUMMARY PRODUCT INFORMATION ................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................ 3 CONTRAINDICATIONS ............................................................................................ 5 WARNINGS AND PRECAUTIONS ............................................................................ 6 ADVERSE REACTIONS........................................................................................... 12 DRUG INTERACTIONS ........................................................................................... 23 DOSAGE AND ADMINISTRATION ........................................................................ 25 OVERDOSAGE ....................................................................................................... -
Guide for Use and Monitoring of Psychotropic Medications in Children and Adolescents
Guide for Use and Monitoring of Psychotropic Medications In Children and Adolescents This document was developed by Community Care of North Carolina with the assistance of Fostering Health NC’s Medication Management Workgroup. The information contained in this guide is not intended to substitute or act as medical advice. If you have any questions about a medication prescribed to a child or adolescent in your care, contact the prescriber or a licensed medical professional. www.ncpeds.org/fosteringhealthnc 1 | P a g e Guide for Use and Monitoring of Psychotropic Medications In Children and Adolescents (Original 3.22.17 – revised 5.22.19) Definition of Psychotropic Medication: Medication used in the treatment of mental illnesses and capable of affecting the mind, emotions, and behavior. Use of this Information: The tables below offer information for child welfare workers, care managers and foster/resource parents to use when they want to learn more about a psychotropic medication. Specific information is outlined including therapeutic class, brand and generic names, FDA approved uses, common evidence-based uses, potential side effects, and medication-specific safety/effectiveness monitoring necessary when prescribed to a child or adolescent. Because few medications have been FDA approved for use in children 5 years of age and under, there is a column in the table that lists the FDA approved status and age ranges for the approved uses of each medication. This guide also provides a color-coded quick reference guide for each medication (Appendix A), questions that a foster/resource parent should ask a prescriber (Appendix B), and a glossary of terms (Appendix C). -
Amphetamine Use Among Workers with Severe Hyperthermia
Morbidity and Mortality Weekly Report Notes from the Field Amphetamine Use Among Workers with Severe National Weather Service observation stations, the maximum Hyperthermia — Eight States, 2010–2019 outdoor heat index (a metric that combines temperature and Andrew S. Karasick, MD1,2; Richard J. Thomas, MD1; relative humidity into a single number that represents how hot Dawn L. Cannon, MD1; Kathleen M. Fagan, MD1; Patricia A. Bray, MD1; the conditions feel to humans) ranged from 86°F to 107°F 1 1 Michael J. Hodgson, MD ; Aaron W. Tustin, MD (median = 97°F) on the days of the nine incidents. Seven of the nine workers died, and two survived life-threat- Workers can develop hyperthermia when core body tem- ening illnesses. Peak body temperature ranged from 103°F to perature rises because of heat stress (environmental heat plus 110.6°F (39.4°C to 43.7°C) in eight workers with confirmed metabolic heat from physical activity) (1). Amphetamines are severe hyperthermia. In one fatality with no premortem body central nervous system stimulants that can induce hyperthermia temperature measurement, the medical examiner suspected independently or in combination with other risk factors (2). that hyperthermia was a significant contributing condition, During 2010–2016, the Directorate of Technical Support and based upon the circumstances (i.e., death occurred in a hot Emergency Management’s Office of Occupational Medicine environment after strenuous activity on a hot day) and lack and Nursing (OOMN), at the Occupational Safety and Health of anatomic evidence of an alternative cause of death (e.g., Administration (OSHA), identified three workers with fatal myocardial infarction). -
Pharmacy Prior Authorization Guideline 1. Criteria
Harvard Pilgrim Health Care – Pharmacy Prior Authorization Guideline Guideline Name ADHD Medications: Adderall (amphetamine-dextroamphetamine mixed salts), Adderall XR (amphetamine-dextroamphetamine mixed salts extended-release), Adzenys ER (amphetamine), Adzenys XR-ODT (amphetamine), Aptensio XR (methylphenidate), amphetamine, amphetamine-dextroamphetamine mixed salts, amphetamine-dextroamphetamine mixed salts extended-release, Concerta (methylphenidate), Cotempla-XR ODT (methylphenidate), Daytrana (methylphenidate), Desoxyn (methamphetamine), Dexedrine (dextroamphetamine), dexmethylphenidate, dexmethylphenidate extended- release, dextroamphetamine, dextroamphetamine extended-release, dextroamphetamine oral solution, Dyanavel XR (amphetamine), Evekeo (amphetamine), Focalin (dexmethylphenidate), Focalin XR (dexmethylphenidate), Jornay PM (methylphenidate), Metadate ER (methylphenidate), methamphetamine, Methylin oral solution (methylphenidate), methylphenidate, methylphenidate chewable tablets, methylphenidate extended-release, methylphenidate extended-release (CD), methylphenidate extended-release (LA), methylphenidate extended- release OSM, methylphenidate oral solution, Mydayis (amphetamine- dextroamphetamine), Procentra (dextroamphetamine), Quillivant XR (methylphenidate), Quillichew ER (methylphenidate), Relexxii (methylphenidate), Ritalin (methylphenidate), Ritalin LA (methylphenidate), Vyvanse (lisdexamfetamine), and Zenzedi (dextroamphetamine) 1. Criteria Product Name: Brand Adderall, Generic amphetamine-dextroamphetamine mixed