Daubert Psychotropics Revised
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(12) United States Patent (10) Patent No.: US 9,381,189 B2 Green Et Al
US009381189B2 (12) United States Patent (10) Patent No.: US 9,381,189 B2 Green et al. (45) Date of Patent: Jul. 5, 2016 (54) INGREDIENTS FOR INHALATION AND (56) References Cited METHODS FOR MAKING THE SAME U.S. PATENT DOCUMENTS (75) Inventors: Matthew Michael James Green, 4,582,265 A * 4/1986 Petronelli ....................... 241.95 Wiltshire (GB); Richard Michael Poole, 6,257,233 B1 7/2001 Burr et al. 2004/01 18007 A1* 6/2004 Chickering et al. ............ 34/360 Wiltshire (GB) 2006, O257491 A1* 11, 2006 Morton et al. ... 424/489 (73) Assignee: VECTURA LIMITED, Wiltshire (GB) 2008/0063719 A1 3/2008 Morton et al. ................ 424/489 (*) Notice: Subject to any disclaimer, the term of this FOREIGN PATENT DOCUMENTS patent is extended or adjusted under 35 EP O709086 A2 5, 1996 U.S.C. 154(b) by 641 days. EP 14981 16 A1 1, 2005 GB 2387781 A 10, 2003 JP 2005298.347 10/2005 (21) Appl. No.: 13/514,672 JP 200954.1393 11, 2009 JP 2012,542618 6, 2012 (22) PCT Fled: Dec. 8, 2010 WO 96.23485 A1 8, 1996 WO 9703649 A1 2, 1997 (86) PCT NO.: PCT/GB2O10/052053 WO O2OO197 A1 1, 2002 WO O243701 A2 6, 2002 S371 (c)(1), WO 2005105043 A2 11/2005 Aug. 20, 2012 WO 2007053904 A1 5/2007 (2), (4) Date: WO 2008.000482 1, 2008 (87) PCT Pub. No.: WO2O11AO70361 WO 2009095684 A1 8, 2009 OTHER PUBLICATIONS PCT Pub. Date: Jun. 16, 2011 Brunauer et al. "Adsorption of Gases in Multimolecular Layers'. J. (65) Prior Publication Data Am. -
Treatment of Psychosis: 30 Years of Progress
Journal of Clinical Pharmacy and Therapeutics (2006) 31, 523–534 REVIEW ARTICLE Treatment of psychosis: 30 years of progress I. R. De Oliveira* MD PhD andM.F.Juruena MD *Department of Neuropsychiatry, School of Medicine, Federal University of Bahia, Salvador, BA, Brazil and Department of Psychological Medicine, Institute of Psychiatry, King’s College, University of London, London, UK phrenia. Thirty years ago, psychiatrists had few SUMMARY neuroleptics available to them. These were all Background: Thirty years ago, psychiatrists had compounds, today known as conventional anti- only a few choices of old neuroleptics available to psychotics, and all were liable to cause severe extra them, currently defined as conventional or typical pyramidal side-effects (EPS). Nowadays, new antipsychotics, as a result schizophrenics had to treatments are more ambitious, aiming not only to suffer the severe extra pyramidal side effects. improve psychotic symptoms, but also quality of Nowadays, new treatments are more ambitious, life and social reinsertion. We briefly but critically aiming not only to improve psychotic symptoms, outline the advances in diagnosis and treatment but also quality of life and social reinsertion. Our of schizophrenia, from the mid 1970s up to the objective is to briefly but critically review the present. advances in the treatment of schizophrenia with antipsychotics in the past 30 years. We conclude DIAGNOSIS OF SCHIZOPHRENIA that conventional antipsychotics still have a place when just the cost of treatment, a key factor in Up until the early 1970s, schizophrenia diagnoses poor regions, is considered. The atypical anti- remained debatable. The lack of uniform diagnostic psychotic drugs are a class of agents that have criteria led to relative rates of schizophrenia being become the most widely used to treat a variety of very different, for example, in New York and psychoses because of their superiority with London, as demonstrated in an important study regard to extra pyramidal symptoms. -
Centre for Reviews and Dissemination
Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta- analysis Leucht S, Corves C, D Arbter, Engel R R, Li C, Davis J M CRD summary The authors concluded that amisulpride, clozapine, olanzapine and risperidone can be effective in treating schizophrenia patients. Second-generation antipsychotic drugs can also result in fewer extrapyramidal side effects, but can induce weight gain. The authors' conclusions reflected the evidence presented, but some potential methodological flaws in the review process meant that the extent to which those conclusions were reliable was unclear. Authors' objectives To compare the effects of first and second-generation antipsychotic drugs in schizophrenia patients. Searching The search for eligible studies was started in 2005, including MEDLINE to October 2006, Cochrane Schizophrenia Group's Specialised Register and the US Food and Drugs Administration website. Search terms were reported and there were no language restrictions. Previous reviews were searched for additional relevant studies. Study selection Randomised controlled trials (RCTs) of oral second-generation antipsychotic drugs (amisulpride, aripiprazole, clozapine, olanzapine, quetiapine, risperidone, sertindole, ziprasidone and zotepine) compared with first-generation drugs in patients with schizophrenia or related disorders (schizoaffective, schizophreniform or delusional disorders) irrespective of diagnostic criteria were eligible for inclusion in the review. The optimum doses of second-generation drugs were selected -
Quantitative Resting State Electroencephalography in Patients with Schizophrenia Spectrum Disorders Treated with Strict Monotherapy Using Atypical Antipsychotics
Original Article https://doi.org/10.9758/cpn.2021.19.2.313 pISSN 1738-1088 / eISSN 2093-4327 Clinical Psychopharmacology and Neuroscience 2021;19(2):313-322 Copyrightⓒ 2021, Korean College of Neuropsychopharmacology Quantitative Resting State Electroencephalography in Patients with Schizophrenia Spectrum Disorders Treated with Strict Monotherapy Using Atypical Antipsychotics Takashi Ozaki1,2, Atsuhito Toyomaki1, Naoki Hashimoto1, Ichiro Kusumi1 1Department of Psychiatry, Graduate School of Medicine, Hokkaido University, 2Department of Psychiatry, Hokkaido Prefectural Koyogaoka Hospital, Sapporo, Japan Objective: The effect of antipsychotic drugs on quantitative electroencephalography (EEG) has been mainly examined by the administration of a single test dose or among patients using combinations of other psychotropic drugs. We therefore investigated the effects of strict monotherapy with antipsychotic drugs on quantitative EEG among schizophrenia patients. Methods: Data from 2,364 medical reports with EEG results from psychiatric patients admitted to the Hokkaido University Hospital were used. We extracted EEG records of patients who were diagnosed with schizophrenia spectrum disorders and who were either undergoing strict antipsychotic monotherapy or were completely free of psychotropic drugs. The spectral power was compared between drug-free patients and patients using antipsychotic drugs. We also performed multiple regression analysis to evaluate the relationship between spectral power and the chlorpromazine equivalent daily dose of antipsychotics in all the patients. Results: We included 31 monotherapy and 20 drug-free patients. Compared with drug-free patients, patients receiving antipsychotic drugs demonstrated significant increases in theta, alpha and beta power. When patients taking different types of antipsychotics were compared with drug-free patients, we found no significant change in any spectrum power for the aripiprazole or blonanserin groups. -
)&F1y3x PHARMACEUTICAL APPENDIX to THE
)&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE -
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 .................................................................................................................... -
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 -
Maternal Use of Psychiatric Medications During Pregnancy And
MATERNAL USE OF PSYCHIATRIC MEDICATIONS DURING PREGNANCY AND ADVERSE BIRTH OUTCOMES AND NEURODEVELOPMENTAL PROBLEMS IN OFFSPRING Ayesha C. Sujan Submitted to the faculty of the University Graduate School in partial fulfillment of the requirements for the degree Doctor of Philosophy in the Department of Psychological and Brain Sciences, Indiana University July 2021 ii Accepted by the Graduate Faculty, Indiana University, in partial fulfillment of the requirements for the degree of Doctor of Philosophy. Doctoral Committee _______________________________________________ Brian M. D’Onofrio, PhD _______________________________________________ Richard Viken, PhD _______________________________________________ Patrick D. Quinn, PhD _______________________________________________ Christina Ludema, PhD _______________________________________________ A. Sara Oberg, PhD, MD April 22nd, 2020 iii © 2021 Ayesha C. Sujan iv Ayesha Sujan MATERNAL USE OF PSYCHIATRIC MEDICATIONS DURING PREGNANCY AND ADVERSE BIRTH OUTCOMES AND NEURODEVELOPMENTAL PROBLEMS IN OFFSPRING Understanding consequences of prenatal exposure to psychiatric and analgesic medications is important because use of these medications among pregnant women is relatively common and increasing. Rodent experiments have shown effects of perinatal exposure to specific medications; however, these findings might not apply to humans. Human observational studies have been used to study prenatal exposure to psychiatric and analgesic medications rather than randomiZed control trials due to ethical concerns -
Revision of Precautions Asenapine Maleate, Aripiprazole, Olanzapine
Published by Translated by Ministry of Health, Labour and Welfare 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. Revision of Precautions Asenapine maleate, aripiprazole, olanzapine, quetiapine fumarate, clocapramine hydrochloride hydrate, chlorpromazine hydrochloride, chlorpromazine hydrochloride/promethazine hydrochloride/phenobarbital, chlorpromazine phenolphthalinate, spiperone, zotepine, timiperone, haloperidol, paliperidone, pipamperone hydrochloride, fluphenazine decanoate, fluphenazine maleate, brexpiprazole, prochlorperazine maleate, prochlorperazine mesilate, Pharmaceuticals and Medical Devices Agency Office of Safety I 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan E-mail: [email protected] Published by Translated by Ministry of Health, Labour and Welfare 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. propericiazine, bromperidol, perphenazine, perphenazine hydrochloride, perphenazine fendizoate, perphenazine maleate, perospirone hydrochloride hydrate, mosapramine hydrochloride, risperidone (oral drug), levomepromazine hydrochloride, levomepromazine maleate March 27, 2018 Non-proprietary name Asenapine maleate, -
Partial Agreement in the Social and Public Health Field
COUNCIL OF EUROPE COMMITTEE OF MINISTERS (PARTIAL AGREEMENT IN THE SOCIAL AND PUBLIC HEALTH FIELD) RESOLUTION AP (88) 2 ON THE CLASSIFICATION OF MEDICINES WHICH ARE OBTAINABLE ONLY ON MEDICAL PRESCRIPTION (Adopted by the Committee of Ministers on 22 September 1988 at the 419th meeting of the Ministers' Deputies, and superseding Resolution AP (82) 2) AND APPENDIX I Alphabetical list of medicines adopted by the Public Health Committee (Partial Agreement) updated to 1 July 1988 APPENDIX II Pharmaco-therapeutic classification of medicines appearing in the alphabetical list in Appendix I updated to 1 July 1988 RESOLUTION AP (88) 2 ON THE CLASSIFICATION OF MEDICINES WHICH ARE OBTAINABLE ONLY ON MEDICAL PRESCRIPTION (superseding Resolution AP (82) 2) (Adopted by the Committee of Ministers on 22 September 1988 at the 419th meeting of the Ministers' Deputies) The Representatives on the Committee of Ministers of Belgium, France, the Federal Republic of Germany, Italy, Luxembourg, the Netherlands and the United Kingdom of Great Britain and Northern Ireland, these states being parties to the Partial Agreement in the social and public health field, and the Representatives of Austria, Denmark, Ireland, Spain and Switzerland, states which have participated in the public health activities carried out within the above-mentioned Partial Agreement since 1 October 1974, 2 April 1968, 23 September 1969, 21 April 1988 and 5 May 1964, respectively, Considering that the aim of the Council of Europe is to achieve greater unity between its members and that this -
New Zealand Data Sheet 1. Product Name
NEW ZEALAND DATA SHEET 1. PRODUCT NAME Norvir 100 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg ritonavir. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White film-coated oval tablets debossed with the corporate Abbott "A" logo and the Abbott-Code “NK”. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications NORVIR is indicated for use in combination with appropriate antiretroviral agents or as monotherapy if combination therapy is inappropriate, for the treatment of HIV-1 infection in adults and children aged 12 years and older. For persons with advanced HIV disease, the indication for ritonavir is based on the results for one study that showed a reduction in both mortality and AIDS defining clinical events for patients who received ritonavir. Median duration of follow-up in this study was 6 months. The clinical benefit from ritonavir for longer periods of treatment is unknown. For persons with less advanced disease, the indication is based on changes in surrogate markers in controlled trials of up to 16 weeks duration (see section 5.1 Pharmacodynamic properties). 4.2 Dose and method of administration General Dosing Guidelines Prescribers should consult the full product information and clinical study information of protease inhibitors if they are co-administered with a reduced dose of ritonavir. The recommended dose of NORVIR is 600 mg (six tablets) twice daily by mouth, and should be given with food. NORVIR tablets should be swallowed whole and not chewed, broken or crushed. NORVIR DS 29 April 2020 Page 1 of 37 Version 35 Paediatric population Ritonavir has not been studied in patients below the age of 12 years; hence the safety and efficacy of ritonavir in children below the age of 12 have not been established. -
Prohibited Substances List
Prohibited Substances List This is the Equine Prohibited Substances List that was voted in at the FEI General Assembly in November 2009 alongside the new Equine Anti-Doping and Controlled Medication Regulations(EADCMR). Neither the List nor the EADCM Regulations are in current usage. Both come into effect on 1 January 2010. The current list of FEI prohibited substances remains in effect until 31 December 2009 and can be found at Annex II Vet Regs (11th edition) Changes in this List : Shaded row means that either removed or allowed at certain limits only SUBSTANCE ACTIVITY Banned Substances 1 Acebutolol Beta blocker 2 Acefylline Bronchodilator 3 Acemetacin NSAID 4 Acenocoumarol Anticoagulant 5 Acetanilid Analgesic/anti-pyretic 6 Acetohexamide Pancreatic stimulant 7 Acetominophen (Paracetamol) Analgesic/anti-pyretic 8 Acetophenazine Antipsychotic 9 Acetylmorphine Narcotic 10 Adinazolam Anxiolytic 11 Adiphenine Anti-spasmodic 12 Adrafinil Stimulant 13 Adrenaline Stimulant 14 Adrenochrome Haemostatic 15 Alclofenac NSAID 16 Alcuronium Muscle relaxant 17 Aldosterone Hormone 18 Alfentanil Narcotic 19 Allopurinol Xanthine oxidase inhibitor (anti-hyperuricaemia) 20 Almotriptan 5 HT agonist (anti-migraine) 21 Alphadolone acetate Neurosteriod 22 Alphaprodine Opiod analgesic 23 Alpidem Anxiolytic 24 Alprazolam Anxiolytic 25 Alprenolol Beta blocker 26 Althesin IV anaesthetic 27 Althiazide Diuretic 28 Altrenogest (in males and gelidngs) Oestrus suppression 29 Alverine Antispasmodic 30 Amantadine Dopaminergic 31 Ambenonium Cholinesterase inhibition 32 Ambucetamide Antispasmodic 33 Amethocaine Local anaesthetic 34 Amfepramone Stimulant 35 Amfetaminil Stimulant 36 Amidephrine Vasoconstrictor 37 Amiloride Diuretic 1 Prohibited Substances List This is the Equine Prohibited Substances List that was voted in at the FEI General Assembly in November 2009 alongside the new Equine Anti-Doping and Controlled Medication Regulations(EADCMR).