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Young Sup Woo, Hee-Ryung Wang, Bo-Hyun Yoon, Sang-Yeol Lee, Kwang Hun Lee, Jeong Seok Seo, Won-Myong Bahk
OBJECTIVE: Clozapine is the treatment of choice for refractory schizophrenia. The aim of this study was to compare the pharmacokinetics of the brand name (Clozaril) formulation and a generic formulation (Clzapine) of clozapine in Korean schizophrenic patients. METHODS: A prospective, randomized, crossover study was conducted to evaluate the steady-state pharmacokinetic profiles of Clozaril and Clzapine. Schizophrenic patients were randomized to receive either the brand name or generic formulation (100 mg twice daily) for 10 days, followed by the other formulation for 10 days...
July 2015: Psychiatry Investigation
Ichiro Kusumi
Clozapine is effective for treatment-refractory schizophrenia, but it shows several severe and potentially life-threatening side effects such as agranulocytosis, myocarditis, and cardiomyopathy. Therefore, it is necessary to minimize the risk of clozapine and maximize its effectiveness by monitoring of safety. White blood cell monitoring is mandatory in many countries, but the clozaril patient monitoring service (CPMS) in Japan additionally requires blood sugar monitoring for adverse metabolic events. Aside from the side effects described above, clozapine can cause various adverse events including constipation, paralytic ileus, seizure, orthostatic hypotension, syncope, hypersalivation, aspiration pneumonia, and oversedation...
2014: Seishin Shinkeigaku Zasshi, Psychiatria et Neurologia Japonica
Ken Inada, Jun Ishigooka
Clozapine is a drug used in the management of treatment-resistant schizophrenia. Numerous clinical trials, including randomized double-blind clinical trials and large cohort studies, have revealed that clozapine is more effective than any other antipsychotic drugs. However, the same studies have also shown that this drug has several adverse effects such as an agranulocytosis. Therefore, in Japan, clozapine is approved for administration to only patients with treatment-resistant schizophrenia in whom treatment with other antipsychotic drugs was ineffective...
April 2013: Nihon Rinsho. Japanese Journal of Clinical Medicine
Paul Glue, Christopher Gale, David B Menkes, Noelyn Hung
BACKGROUND AND OBJECTIVE: Clozapine is the most effective drug for schizophrenia. A suspension formulation of clozapine for patients who may have difficulty swallowing tablets was approved based on the 1996 US Food and Drug Administration (FDA) Guidance and has been launched in Australia, New Zealand and the UK. The objective of this study was to compare the bioequivalence of a new suspension formulation of clozapine with clozapine tablets (Clozaril(®)). METHODS: The steady-state bioequivalence of a 50-mg/mL clozapine suspension and Clozaril(®) tablets was compared under fasting and fed conditions in a randomized, multiple-dose, two-way crossover study, consistent with the 2005 FDA Bioequivalence Guidance...
November 2012: Clinical Drug Investigation
Amit Agarwal
Drug developers are grappling with the impact of personalized medicine on their portfolios. The combination of molecular diagnostics with targeted biologic therapies has been hailed as a recent innovation with few historical analogs to guide behavior. However, if the definition of companion diagnostics is broadened to include any drug whose FDA approved label requires diagnostic testing before prescription then over 50 drugs across multiple therapeutic areas arise. Most importantly for current drug developers, these drugs represent a wide variety of market situations and with sufficient historical data to evaluate different commercialization strategies for the combination...
September 15, 2012: New Biotechnology
Zahinoor Ismail, Alette M Wessels, Hiroyuki Uchida, Wenzie Ng, David C Mamo, Tarek K Rajji, Bruce G Pollock, Benoit H Mulsant, Robert R Bies
BACKGROUND: Although clozapine is primarily used in a younger to mid-life population of patients with psychosis, there are limited data on the clinical pharmacology of clozapine later in life. The objective of this study was to assess the magnitude and variability of plasma concentrations of clozapine and norclozapine across the lifespan in a real-world clinical setting. DESIGN: A population pharmacokinetic study using nonlinear mixed effect modeling (NONMEM). Age, sex, height, weight, and dosage formulation were covariates...
January 2012: American Journal of Geriatric Psychiatry
Lewis Couchman, Phillip Edgar Morgan, Edgar Pathrose Spencer, Atholl Johnston, Robert James Flanagan
To investigate the bioequivalence of the three clozapine brands licensed in the United Kingdom, we compared plasma clozapine and norclozapine in therapeutic drug monitoring samples from patients switched from Clozaril to either Denzapine or Zaponex tablets. For Clozaril/Denzapine, the median prescribed clozapine dose was 450 mg/day (range, 125-850 mg/day) (n = 66) and the median time between samples was 16 weeks. The Clozaril/Zaponex comparison (n = 57) was not dose-controlled; the median Clozaril dose was 450 mg/day (range, 150-900 mg/day) and the median Zaponex dose 400 mg/day (range, 100-850 mg/day)...
October 2010: Therapeutic Drug Monitoring
A Abu-Akel
The current study investigated the use of cohesive links analysis as a measure of Clozaril's efficacy in treating disorganized schizophrenia. Two adolescent patients with disorganized schizophrenia, and a comparison group of adolescents with no reported history of psychiatric disturbances, were engaged in the study. All participants were engaged by an examiner in 20-minute conversations that touched on various topics. The conversations were audiotaped, transcribed, and coded blindly for several types of cohesive links...
1999: Clinical Linguistics & Phonetics
Oloruntoba Oluboka, Sandra Stewart, Suzette Landry, Susan Adams
This study prospectively assessed outcomes in a group of patients who were randomly switched from Clozaril to generic clozapine (Gen-Clozapine). The authors examined data from rating scales administered before the switch and at points after the switch. There were no statistically significant differences between the groups on any baseline measures, including psychiatric status and dose of medication. In the group of patients who were switched to the generic formulation, there was a significant increase in Global Assessment Scale scores by the end of the 6-month monitoring period...
May 2010: Journal of Clinical Pharmacology
William V Bobo, Jeffrey A Stovall, Molly Knostman, Jim Koestner, Richard C Shelton
PURPOSE: The effectiveness and tolerability of switching patients' therapy from brand-name to generic clozapine are reviewed. SUMMARY: Clozapine is the most effective treatment for patients with refractory psychotic disorders and is also effective for reducing suicidal and violent behavior in this same population. Generic versions of clozapine are widely used. However, possible differences in pharmacokinetic profiles between branded and generic clozapine, and the potential risks of medication changes in severely ill but stable patients, may result in apprehension about converting from branded to generic clozapine...
January 1, 2010: American Journal of Health-system Pharmacy: AJHP
H Meltzer, H Hippius
Consensus was reached on the five following points: (1) "Treatment resistance" is a term which is widely used, but not adequately defined. In particular, definitions of "responders" and "non-responders" need to be more precise. (2) There is a need to extend the assessment of the results of treatment to include factors such as quality of life and the subjective evaluation by the patient and relatives. (3) Clozapine (Clozaril((R))/Leponex((R))) has become the standard for atypical antipsychotic drugs. The adjective "atypical" is not an exact descriptor...
1995: European Psychiatry: the Journal of the Association of European Psychiatrists
Elke Ericson, Marinella Gebbia, Lawrence E Heisler, Jan Wildenhain, Mike Tyers, Guri Giaever, Corey Nislow
To better understand off-target effects of widely prescribed psychoactive drugs, we performed a comprehensive series of chemogenomic screens using the budding yeast Saccharomyces cerevisiae as a model system. Because the known human targets of these drugs do not exist in yeast, we could employ the yeast gene deletion collections and parallel fitness profiling to explore potential off-target effects in a genome-wide manner. Among 214 tested, documented psychoactive drugs, we identified 81 compounds that inhibited wild-type yeast growth and were thus selected for genome-wide fitness profiling...
2008: PLoS Genetics
Gil Golden, Gilbert Honigfeld
BACKGROUND: This study compared the bioequivalence of FazaClo (clozapine orally disintegrating tablets) 100 mg to Clozaril (clozapine standard oral tablets) 100 mg after multiple doses in patients with schizophrenia. METHODS: This was a randomized, open-label, multiple-dose study in which patients with schizophrenia received FazaClo or Clozaril 100 mg twice daily for 5 days before crossing over to the alternate therapy. Blood samples were obtained at regular intervals during and after the completion of treatment, and standard pharmacokinetic parameters were calculated...
2008: Clinical Drug Investigation
Diane M White, Anne C Van Cott
The antipsychotic agent clozapine (ClozarilE) is reserved for the treatment of refractory psychosis. Clozapine has allowed many schizophrenic patients to lead more independent and productive lives, but its use is restricted by side effects. Clozapine has been shown to lower seizure threshold and produce significant EEG changes. Although not a commonly used drug, both clinical neurophysiology technologists and interpreting electroencephalographers need to be aware of the effects of clozapine on the EEG. We review the findings of two patients who developed neurological symptoms and EEG abnormalities that resolved following reduction of clozapine therapy...
September 2007: American Journal of Electroneurodiagnostic Technology
James M Atkinson, Petrina Douglas-Hall, Catrin Fischetti, Anna Sparshatt, David M Taylor
BACKGROUND: Clozapine is uniquely effective in refractory schizophrenia, but treatment attrition is high. There has been minimal formal study of the outcomes of stopping clozapine, beyond published observations of the time period immediately after cessation. Our aim was to establish medium-term outcome in patients stopping clozapine in normal clinical practice. METHOD: This study was a retrospective analysis of all subjects registered with Clozaril Patient Monitoring Service and treated in South London and Maudsley National Health Service (NHS) Trust who stopped clozapine between March 2002 and March 2005 after at least 1 year's treatment...
July 2007: Journal of Clinical Psychiatry
Byung-Jo Kang, Man-Je Cho, Jung-Tae Oh, Yanghyun Lee, Beang-Jin Chae, Jaewook Ko
OBJECTIVES: This study documents the incidences of agranulocytosis and neutropenia, and the patterns of incidence of the side effects of long-term clozapine treatment in order to determine an appropriate time to stop the Clozaril Patient Monitoring System (CPMS). METHODS: Hematological, demographic, and other data from the CPMS for 6782 patients who took clozapine for the past 11 years in the Republic of Korea has been analyzed. RESULTS: Twenty-nine (53...
August 2006: Human Psychopharmacology
Carol Paton
Two generic preparations of clozapine have been licensed in the UK. The bioequivalence of these products compared with Clozaril has not been unequivocally demonstrated. Clinical equivalence has also been questioned. The objective of this study was to determine clinical outcomes for all patients switched from Clozaril to a generic formulation in one mental health service. We examined dosage data and Clinical Global Impression (CGI) of Severity of Illness scores for 337 patients before and after the switch and CGI change scores after the switch...
August 2006: British Journal of Psychiatry: the Journal of Mental Science
Daniel J Healy, Stephan Taylor, Mona Goldman, Kris Barry, Frederic Blow, Karen K Milner
OBJECTIVE: To determine if mental health service utilization increases when patients are converted to generic clozapine. METHOD: About 125 patients taking clozapine in a community mental health clinic were switched from Novartis Clozaril to generic clozapine (Mylan Pharmaceuticals). Serum clozapine levels were obtained 2 weeks before, and 2 weeks after, the switch to generic clozapine. The number of outpatient visits, emergency room visits, and hospitalizations in the year prior to the switch were compared to those in the year following the switch, to determine service utilization...
August 2005: Community Mental Health Journal
R J Flanagan, E P Spencer, P E Morgan, T R E Barnes, L Dunk
OBJECTIVE: Toxicological analyses are often performed to investigate suspected poisoning, but the interpretation of results may not be straightforward. We studied suspected poisoning cases 1992-2003 where blood clozapine and N-desmethylclozapine (norclozapine) were measured in order to assess the relationship of these parameters to outcome. METHODS: Samples were referred from clinicians, pathologists/coroners, or via the Clozaril Patient Monitoring Service (CPMS, Novartis)...
December 20, 2005: Forensic Science International
Wongwiwat Tassaneeyakul, Khanogwan Kittiwattanagul, Suda Vannaprasaht, Jureeporn Kampan, Arporn Tawalee, Prapawadee Puapairoj, Siriporn Tiamkao, Srisaard Juthagridsada, Veerapol Kukongviriyapan, Wichittra Tassaneeyakul
PURPOSE: To compare the bioavailability of two clozapine formulations (100 mg Clozaril tablet from Novartis Pharmaceuticals UK Ltd., UK, as a Reference formulation and 100 mg Cloril tablet from Atlantic Laboratories Corp., Ltd., Thailand, as a Test formulation). The present study was conducted under real-life conditions in schizophrenic patients using a steady-state, multiple-dose, randomized crossover design to avoid the risk of adverse effects in healthy volunteers and pharmacokinetic difference between single and multiple-dose of the drug...
2005: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
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