An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels
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- Jose de Leon
- Mental Health Research Center, Eastern State Hospital, Lexington, KY, USA
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- Georgios Schoretsanitis
- Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Zürich, Switzerland
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- Robert L. Smith
- Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, Norway
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- Espen Molden
- Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, Norway
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- Anssi Solismaa
- Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland
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- Niko Seppälä
- Department of Psychiatry, Satasairaala, Finland
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- Miloslav Kopeček
- National Institute of Mental Health, Klecany, Czech Republic
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- Patrik Švancer
- National Institute of Mental Health, Klecany, Czech Republic
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- Ismael Olmos
- Clinical Pharmacology Unit and Pharmacy Department, Vilardebó Hospital, Administración de Servicios de Salud, Montevideo, Uruguay
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- Carina Ricciardi
- Clinical Pharmacology Unit and Outpatient Clinic, Vilardebó Hospital, Administración de Servicios de Salud, Montevideo, Uruguay
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- Celso Iglesias-Garcia
- Universidad de Oviedo. CIBERSAM. INEUROPA. ISPA-FIMBA, Oviedo, Spain
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- Ana Iglesias-Alonso
- Hospital Universitario Central de Asturias, Oviedo, Spain
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- Edoardo Spina
- Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy
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- Can-Jun Ruan
- Laboratory of Clinical Psychopharmacology, Beijing Anding Hospital, Capital Medical University, Beijing, China
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- Chuan-Yue Wang
- The National Clinical Research Centre for Mental Disorders & Beijing Key Lab of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China
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- Gang Wang
- The National Clinical Research Centre for Mental Disorders & Beijing Key Lab of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China
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- Yi-Lang Tang
- Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, USA
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- Shih-Ku Lin
- Department of Psychiatry, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan
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- Hsien-Yuan Lane
- Graduate Institute of Biomedical Sciences, China Medical University, Taichung, Taiwan
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- Yong Sik Kim
- Department of Neuropsychiatry, Nowon Eulji Medical Center, Eulji University, School of Medicine, Seoul, Korea
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- Se Hyun Kim
- Department of Psychiatry, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea
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- Anto P. Rajkumar
- Department of Psychiatry, Christian Medical College, Vellore, India
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- Dinora F. González-Esquivel
- Instituto Nacional de Neurología y Neurocirugía, México City, México
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- Helgi Jung-Cook
- Instituto Nacional de Neurología y Neurocirugía, México City, México
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- Trino Baptista
- Department of Physiology, Los Andes University Medical School, Mérida, Venezuela
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- Christopher Rohde
- Department of Affective Disorders, Aarhus University Hospital - Psychiatry, Aarhus, Denmark
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- Jimmi Nielsen
- Mental Health Centre Glostrup, Copenhagen University Hospital, Copenhagen, Denmark
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- Hélène Verdoux
- Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219, F-33000 Bordeaux, France
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- Clelia Quiles
- Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219, F-33000 Bordeaux, France
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- Emilio J. Sanz
- Department of Physical Medicine and Pharmacology, School of Medicine, Universidad de La Laguna, Canary Islands, Spain
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- Carlos De Las Cuevas
- Department of Internal Medicine, Dermatology and Psychiatry, School of Medicine, and Instituto Universitario de Neurociencia (IUNE), University of La Laguna, Canary Islands, Spain
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- Dan Cohen
- Dutch Clozapine Collaboration Group, Castricum, The Netherlands
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- Peter F.J. Schulte
- Dutch Clozapine Collaboration Group, Castricum, The Netherlands
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- Aygün Ertuğrul
- Department of Psychiatry, Hacettepe University Faculty of Medicine, Ankara, Turkey
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- A. Elif Anıl Yağcıoğlu
- Department of Psychiatry, Hacettepe University Faculty of Medicine, Ankara, Turkey
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- Nitin Chopra
- Addictions Division, Centre for Addiction and Mental Health, Toronto, Canada
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- Betsy McCollum
- Eastern State Hospital, Lexington, Kentucky, USA
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- Charles Shelton
- Department of Psychiatry, University of Kentucky, Lexington, KY, USA
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- Robert O. Cotes
- Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, USA
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- Arun R. Kaithi
- Hazelwood Center, Louisville, Kentucky, USA
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- John M. Kane
- The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks, New York, USA
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- Saeed Farooq
- School of Medicine, Keele University, Staffordshire, and Midlands Partnership NHS Foundation Trust, Staffordshire, United Kingdom
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- Chee H. Ng
- Department of Psychiatry, The University of Melbourne, Melbourne, Victoria, Australia
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- John Bilbily
- Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri, USA
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- Christoph Hiemke
- Department of Psychiatry and Psychotherapy, University Medical Center of Mainz, Germany
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- Carlos López-Jaramillo
- Grupo de Investigación en Psiquiatría GIPSI, Departamento de Psiquiatría, Facultad de Medicina, Universidad de Antioquia, Medellin, Colombia
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- Ian McGrane
- Department of Pharmacy Practice, University of Montana, Missoula, USA
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- Fernando Lana
- Institute of Neuropsychiatry and Addictions (INAD), Parc de Salut Mar, Barcelona, Spain
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- Chin B. Eap
- Unit of Pharmacogenetics and Clinical Psychopharmacology, Center for Psychiatric Neurosciences, Lausanne University Hospital and University of Lausanne, Switzerland
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- Manuel Arrojo-Romero
- Department of Psychiatry, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain
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- Flavian Ş. Rădulescu
- Center for Drug Sciences, Faculty of Pharmacy, University of Medicine and Pharmacy Carol Davila, Bucharest, Romania
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- Erich Seifritz
- Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Zürich, Switzerland
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- Susanna Every-Palmer
- Te Korowai Whāriki Central Regional Forensic Service, Capital and Coast District Health Board, Wellington, New Zealand
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- Chad A. Bousman
- Departments of Medical Genetics, Psychiatry, Physiology & Pharmacology, and Community Health Sciences University of Calgary, Alberta, Canada
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- Emmanuel Bebawi
- Faculty of Medicine, University of Montreal, Montreal, Canada
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- Rahul Bhattacharya
- East London NHS Foundation Trust, London, United Kingdom
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- Deanna L. Kelly
- Department of Psychiatry, School of Medicine, Maryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, Maryland, USA
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- Yuji Otsuka
- Department of Psychiatry, Asahi General Hospital, Chiba, Japan
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- Judit Lazary
- National Institute of Mental Health, Neurology and Neurosurgery, Budapest, Hungary
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- Rafael Torres
- Department of Psychiatry, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile
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- Agustin Yecora
- Secretaría de Salud Mental y Adicciones, Ministerio de Salud de la Provincia de Jujuy, San Salvador de Jujuy, Argentina
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- Mariano Motuca
- Instituto Vilapriño, Center for Studies, Assistance and Research in Neurosciences, Mendoza, Argentina
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- Sherry K.W. Chan
- Department of Psychiatry, LSK Faculty of Medicine, The University of Hong Kong, Hong Kong SAR
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- Monica Zolezzi
- College of Pharmacy, QU Health, Qatar University, Doha, Qatar
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- Sami Ouanes
- Department of Psychiatry, Hamad Medical Corporation, Doha, Qatar
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- Domenico De Berardis
- NHS, Department of Mental Health, “G. Mazzini” Hospital, Teramo, Italy
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- Sandeep Grover
- Department of Psychiatry, Post Graduate Institute of Medical Education and Research, Chandigarh, India
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- Ric M. Procyshyn
- British Columbia Mental Health and Substance Use Research Institute, Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada
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- Richard A. Adebayo
- Federal Neuropsychiatric Hospital Yaba, Lagos, Nigeria
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- Oleg O. Kirilochev
- Department of Clinical Pharmacology, Astrakhan State Medical University, Astrakhan, Russian Federation
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- Andrey Soloviev
- Department of Psychiatry and Clinical Psychology, Northern State Medical University, Arkhangelsk, Russia
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- Konstantinos N. Fountoulakis
- 3rd Department of Psychiatry, Division of Neurosciences, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Greece
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- Alina Wilkowska
- Department of Psychiatry, Medical University of Gdańsk, Gdańsk, Poland
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- Wiesław J. Cubała
- Department of Psychiatry, Medical University of Gdańsk, Gdańsk, Poland
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- Muhammad Ayub
- Department of Psychiatry, Queens University, Kingston, Canada
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- Alzira Silva
- Psychiatry Department, Centro Hospitalar Universitário de S. João, Porto, Portugal
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- Raphael M. Bonelli
- Sigmund Freud University, Vienna, Austria
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- José M. Villagrán-Moreno
- Department of Neurosciences, Jerez University Hospital, Andalusian Health Service, University of Cadiz, Jerez, Spain
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- Benedicto Crespo-Facorro
- Department of Psychiatry, School of Medicine, University Hospital Virgen del Rocio-IBIS, Sevilla, Spain
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- Henk Temmingh
- Department of Psychiatry and Mental Health, University of Cape Town, Valkenberg Hospital, Western Cape, Cape Town, South Africa
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- Eric Decloedt
- Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa
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- Maria R. Pedro
- Hospital Central de Maputo, Maputo, Mozambique
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- Hiroyoshi Takeuchi
- Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan
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- Masaru Tsukahara
- Department of Psychiatry, Okayama Psychiatric Medical Center, Okayama, Japan
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- Gerhard Gründer
- Central Institute of Mental Health, Department of Molecular Neuroimaging, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany
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- Marina Sagud
- Department of Psychiatry, School of Medicine, University of Zagreb, Zagreb, Croatia
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- Andreja Celofiga
- Department of Psychiatry, University Medical Centre Maribor, Maribor, Slovenia
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- Dragana Ignjatovic Ristic
- University of Kragujevac, Faculty of Medical Sciences, Department of Psychiatry, Kragujevac, Serbia
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- Bruno B. Ortiz
- Group of Resistant Schizophrenia (GER), Schizophrenia Program (Proesq), Federal University of Sao Paulo, SP, Brazil
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- Helio Elkis
- Department and Institute of Psychiatry, University of São Paulo Medical School (FMUSP), Sao Paulo, Brazil
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- António J. Pacheco Palha
- Department and Institute of Psychiatry and Mental Health, Oporto Faculty of Medicine, Oporto, Portugal
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- Adrián LLerena
- INUBE Biosanitary Research Institute of Extremadura. Extremadura University Hospital and Medical School, Badajoz, Spain
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- Emilio Fernandez-Egea
- Cambridge Psychosis Centre, Cambrigeshire and Peterborough NHS Foundation Trust & Department of Psychiatry, University of Cambridge, Cambridge, United Kingdom
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- Dan Siskind
- Metro South Addiction and Mental Health Service, Brisbane, Australia
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- Abraham Weizman
- Research Unit, Geha Mental Health Center and Molecular Psychiatry Laboratory, Felsenstein Medical Research Center, Tel Aviv, Israel
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- Rim Masmoudi
- Psychiatry “A” Department, Hedi Chaker University Hospital, Sfax, Tunisia
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- Shamin Mohd Saffian
- Centre for Quality Management of Medicines, Faculty of Pharmacy, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
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- Jonathan G. Leung
- Department of Pharmacy, Mayo Clinic, Rochester, MN, USA
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- Peter F. Buckley
- School of Medicine, Virginia Commonwealth University, Richmond, VA, USA
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- Stephen R. Marder
- Semel Institute for Neuroscience at UCLA, Los Angeles, CA, USA
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- Leslie Citrome
- New York Medical College, Department of Psychiatry and Behavioral Sciences, Valhalla, NY, USA
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- Oliver Freudenreich
- Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
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- Christoph U. Correll
- The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks, New York, USA
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- Daniel J. Müller
- Addictions Division, Centre for Addiction and Mental Health, Toronto, Canada
Description
<jats:title>Abstract</jats:title><jats:p>This international guideline proposes improving clozapine package inserts worldwide by using ancestry-based dosing and titration. Adverse drug reaction (ADR) databases suggest that clozapine is the third most toxic drug in the United States (US), and it produces four times higher worldwide pneumonia mortality than that by agranulocytosis or myocarditis. For trough steady-state clozapine serum concentrations, the therapeutic reference range is narrow, from 350 to 600 ng/mL with the potential for toxicity and ADRs as concentrations increase. Clozapine is mainly metabolized by CYP1A2 (female non-smokers, the lowest dose; male smokers, the highest dose). Poor metabolizer status through phenotypic conversion is associated with co-prescription of inhibitors (including oral contraceptives and valproate), obesity, or inflammation with C-reactive protein (CRP) elevations. The Asian population (Pakistan to Japan) or the Americas’ original inhabitants have lower CYP1A2 activity and require lower clozapine doses to reach concentrations of 350 ng/mL. In the US, daily doses of 300–600 mg/day are recommended. Slow personalized titration may prevent early ADRs (including syncope, myocarditis, and pneumonia). This guideline defines six personalized titration schedules for inpatients: 1) ancestry from Asia or the original people from the Americas with lower metabolism (obesity or valproate) needing minimum therapeutic dosages of 75–150 mg/day, 2) ancestry from Asia or the original people from the Americas with average metabolism needing 175–300 mg/day, 3) European/Western Asian ancestry with lower metabolism (obesity or valproate) needing 100–200 mg/day, 4) European/Western Asian ancestry with average metabolism needing 250–400 mg/day, 5) in the US with ancestries other than from Asia or the original people from the Americas with lower clozapine metabolism (obesity or valproate) needing 150–300 mg/day, and 6) in the US with ancestries other than from Asia or the original people from the Americas with average clozapine metabolism needing 300–600 mg/day. Baseline and weekly CRP monitoring for at least four weeks is required to identify any inflammation, including inflammation secondary to clozapine rapid titration.</jats:p>
Journal
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- Pharmacopsychiatry
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Pharmacopsychiatry 55 (02), 73-86, 2021-12-15
Georg Thieme Verlag KG
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Details 詳細情報について
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- CRID
- 1360580235934144384
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- ISSN
- 14390795
- 01763679
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- Data Source
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- Crossref