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Drug Use Evaluation: Antipsychotic Utilization in Schizophrenia Patients
© Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 | Fax 503-947-1119 Drug Use Evaluation: Antipsychotic Utilization in Schizophrenia Patients Research Questions: 1. How many schizophrenia patients are prescribed recommended first-line second-generation treatments for schizophrenia? 2. How many schizophrenia patients switch to an injectable antipsychotic after stabilization on an oral antipsychotic? 3. How many schizophrenia patients are prescribed 2 or more concomitant antipsychotics? 4. Are claims for long-acting injectable antipsychotics primarily billed as pharmacy or physician administered claims? 5. Does adherence to antipsychotic therapy differ between patients with claims for different routes of administration (oral vs. long-acting injectable)? Conclusions: In total, 4663 schizophrenia patients met inclusion criteria, and approximately 14% of patients (n=685) were identified as treatment naïve without claims for antipsychotics in the year before their first antipsychotic prescription. Approximately 45% of patients identified as treatment naïve had a history of remote antipsychotic use, but it is unclear if antipsychotics were historically prescribed for schizophrenia. Oral second-generation antipsychotics which are recommended as first-line treatment in the MHCAG schizophrenia algorithm were prescribed as initial treatment in 37% of treatment naive patients and 28% of all schizophrenia patients. Recommended agents include risperidone, paliperidone, and aripiprazole. Utilization of parenteral antipsychotics was limited in patients with schizophrenia. Overall only 8% of patients switched from an oral to an injectable therapy within 6 months of their first claim. Approximately, 60% of all schizophrenia patients (n=2512) had claims for a single antipsychotic for at least 12 continuous weeks and may be eligible to transition to a long-acting injectable antipsychotic. -
Schizophrenia Care Guide
August 2015 CCHCS/DHCS Care Guide: Schizophrenia SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT GOALS ALERTS Minimize frequency and severity of psychotic episodes Suicidal ideation or gestures Encourage medication adherence Abnormal movements Manage medication side effects Delusions Monitor as clinically appropriate Neuroleptic Malignant Syndrome Danger to self or others DIAGNOSTIC CRITERIA/EVALUATION (PER DSM V) 1. Rule out delirium or other medical illnesses mimicking schizophrenia (see page 5), medications or drugs of abuse causing psychosis (see page 6), other mental illness causes of psychosis, e.g., Bipolar Mania or Depression, Major Depression, PTSD, borderline personality disorder (see page 4). Ideas in patients (even odd ideas) that we disagree with can be learned and are therefore not necessarily signs of schizophrenia. Schizophrenia is a world-wide phenomenon that can occur in cultures with widely differing ideas. 2. Diagnosis is made based on the following: (Criteria A and B must be met) A. Two of the following symptoms/signs must be present over much of at least one month (unless treated), with a significant impact on social or occupational functioning, over at least a 6-month period of time: Delusions, Hallucinations, Disorganized Speech, Negative symptoms (social withdrawal, poverty of thought, etc.), severely disorganized or catatonic behavior. B. At least one of the symptoms/signs should be Delusions, Hallucinations, or Disorganized Speech. TREATMENT OPTIONS MEDICATIONS Informed consent for psychotropic -
THIORIDAZINE HYDROCHLORIDE- Thioridazine Hydrochloride Tablet, Film Coated Mylan Institutional Inc
THIORIDAZINE HYDROCHLORIDE- thioridazine hydrochloride tablet, film coated Mylan Institutional Inc. ---------- WARNING Thioridazine has been shown to prolong the QTc interval in a dose related manner, and drugs with this potential, including thioridazine, have been associated with Torsades de pointes type arrhythmias and sudden death. Due to its potential for significant, possibly life threatening, proarrhythmic effects, thioridazine should be reserved for use in the treatment of schizophrenic patients who fail to show an acceptable response to adequate courses of treatment with other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see WARNINGS, CONTRAINDICATIONS, and INDICATIONS). Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug- treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. -
Determination of Thiazinamium, Promazine and Promethazine in Pharmaceutical Formulations Using a CZE Method Francisco J
Analytica Chimica Acta 535 (2005) 101–108 Determination of thiazinamium, promazine and promethazine in pharmaceutical formulations using a CZE method Francisco J. Lara, Ana M. Garc´ıa-Campana˜ ∗, Ferm´ın Ales-Barrero,´ Juan M. Bosque-Sendra Department of Analytical Chemistry, Faculty of Sciences, University of Granada, Avd. Fuente Nueva s/n, E-18071 Granada, Spain Received 26 July 2004; received in revised form 30 November 2004; accepted 30 November 2004 Available online 15 January 2005 Abstract We present the validation of a developed method using capillary zone electrophoresis (CZE) for quantitative analysis of three phenoth- iazines: thiazinamium methylsulphate (TMS), promazine hydrochloride (PMH) and promethazine hydrochloride (PTH) in pharmaceutical formulations. The influence of various parameters affecting the CZE separation (buffer pH and concentration, acetonitrile percentage, capil- lary temperature and applied voltage) was investigated by means of multivariate optimization using experimental designs so as to obtain the highest efficiency. The method allows the separation of the phenothiazines in 5.0 min at optimized conditions: 100 mM tris(hydroxymethyl)- aminomethane (Tris) buffer at a pH 8.0, 15% acetonitrile, capillary with 58.5 cm in length at 25 ◦C and a voltage of 30 kV.Detection occurred at 254 nm. Acceptable precision (relative standard deviation (R.S.D.) 5.3%) and linearity were achieved using the internal standard (IS) method. The limits of detection (LODs) were 2.8 gml−1 for TMS and 3.3 gml−1 for PMH and PTH. The method has been successfully applied in the analysis of pharmaceutical formulations. © 2004 Elsevier B.V. All rights reserved. Keywords: Capillary zone electrophoresis; Thiazinamium methylsulphate; Promazine; Promethazine; Pharmaceutical analysis 1. -
Promethazine-Chlorpromazine Combination in the Treatment of Unmanageable Psychotic Patients Armando R
Henry Ford Hospital Medical Journal Volume 17 | Number 4 Article 10 12-1969 Promethazine-Chlorpromazine Combination in the Treatment of Unmanageable Psychotic Patients Armando R. Favazza Follow this and additional works at: https://scholarlycommons.henryford.com/hfhmedjournal Part of the Chemicals and Drugs Commons, Life Sciences Commons, Medical Specialties Commons, Psychiatry and Psychology Commons, and the Public Health Commons Recommended Citation Favazza, Armando R. (1969) "Promethazine-Chlorpromazine Combination in the Treatment of Unmanageable Psychotic Patients," Henry Ford Hospital Medical Journal : Vol. 17 : No. 4 , 305-310. Available at: https://scholarlycommons.henryford.com/hfhmedjournal/vol17/iss4/10 This Article is brought to you for free and open access by Henry Ford Health System Scholarly Commons. It has been accepted for inclusion in Henry Ford Hospital Medical Journal by an authorized editor of Henry Ford Health System Scholarly Commons. Henry Ford Hosp. Med. Journal VoL 17, No. 4, 1969 Promethazine-chlorpromazine Combination in the Treatment of Unmanageable Psychotic Patients Armando R. Favazza, M.D.* Administering a combination of promethazine and chlorpromazine to patients with a "galloping psychosis" has an antipsychotic and tranquilizing effect which calms them down to a more manageable and less aggressive state. The drugs are chemically similar; promethazine's actions are strongly potentiated in the combina tion, so large doses must be given under careful supervision. Case histories demonstrate successful short term management of acutely psychotic, aggressive patients who were a danger to themselves and others. Acute, intense psychotic episodes common in the author's experience for can pose difficult problems for both some patients to receive massive doses the patient and those who care for him. -
Medications to Be Avoided Or Used with Caution in Parkinson's Disease
Medications To Be Avoided Or Used With Caution in Parkinson’s Disease This medication list is not intended to be complete and additional brand names may be found for each medication. Every patient is different and you may need to take one of these medications despite caution against it. Please discuss your particular situation with your physician and do not stop any medication that you are currently taking without first seeking advice from your physician. Most medications should be tapered off and not stopped suddenly. Although you may not be taking these medications at home, one of these medications may be introduced while hospitalized. If a hospitalization is planned, please have your neurologist contact your treating physician in the hospital to advise which medications should be avoided. Medications to be avoided or used with caution in combination with Selegiline HCL (Eldepryl®, Deprenyl®, Zelapar®), Rasagiline (Azilect®) and Safinamide (Xadago®) Medication Type Medication Name Brand Name Narcotics/Analgesics Meperidine Demerol® Tramadol Ultram® Methadone Dolophine® Propoxyphene Darvon® Antidepressants St. John’s Wort Several Brands Muscle Relaxants Cyclobenzaprine Flexeril® Cough Suppressants Dextromethorphan Robitussin® products, other brands — found as an ingredient in various cough and cold medications Decongestants/Stimulants Pseudoephedrine Sudafed® products, other Phenylephrine brands — found as an ingredient Ephedrine in various cold and allergy medications Other medications Linezolid (antibiotic) Zyvox® that inhibit Monoamine oxidase Phenelzine Nardil® Tranylcypromine Parnate® Isocarboxazid Marplan® Note: Additional medications are cautioned against in people taking Monoamine oxidase inhibitors (MAOI), including other opioids (beyond what is mentioned in the chart above), most classes of antidepressants and other stimulants (beyond what is mentioned in the chart above). -
207533Orig1s000
( CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207533Orig1s000 RISK ASSESSMENT and RISK MITIGATION REVIEW(S) Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Office of Medication Error Prevention and Risk Management Risk Evaluation and Mitigation Strategy (REMS) Review Date: October 2, 2015 Reviewer(s): Cathy A. Miller, MPH, B.SN Risk Management Analyst Division of Risk Management Team Leader Kimberly Lehrfeld, Pharm.D. Division of Risk Management Acting Deputy Division Reema Mehta, Pharm.D., MPH Director Division of Risk Management Drug Name(s): Aristada (aripiprazole lauroxil) extended-release injection Therapeutic Class: Atypical Antipsychotic Dosage and Route: 441 mg/1.6 mL; 662 mg/2.4 mL; 882 mg/3.2mL intramuscular injection Application Type/Number: NDA 207533 Submission Number: ORIG-1 Submission Seq. No. 0000 dated August 22, 2014 Applicant/Sponsor: Alkermes OSE RCM #: 2014-1849 ***This document contains proprietary and confidential information that should not be released to the public*** Reference ID: 3828483 CONTENTS 1 INTRODUCTION ....................................................................................................... 1 1.1 Product Background............................................................................................ 1 1.2 Disease Background............................................................................................ 2 1.3 Regulatory History ............................................................................................. -
207533Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207533Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 207553 Priority or Standard Standard Submit Date(s) 8/22/2014 Received Date(s) 8/22/2014 PDUFA Goal Date 8/22/2015 Division / Office DPP/ODE1 Reviewer Name(s) Lucas Kempf, MD Review Completion Date October 2, 2015 Established Name Aripiprazole lauroxil (Proposed) Trade Name Aristada Therapeutic Class Antipsychotic Applicant Alkermes Inc. Formulation(s) Extended release injection Dosing Regimen Suspension/ IM up to 6 weeks Indication(s) Schizophrenia Intended Population(s) Schizophrenia Template Version: March 6, 2009 Reference ID: 3806701 Clinical Review Lucas Kempf, MD NDA 207533 Aristada, Aripiprazole lauroxil Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ......................................... 7 1.1 Recommendation on Regulatory Action ............................................................. 7 1.2 Risk Benefit Assessment .................................................................................... 7 1.3 Recommendations for Postmarket Risk Evaluation and Mitigation Strategies ... 8 1.4 Recommendations for Postmarket Requirements and Commitments ................ 8 2 INTRODUCTION AND REGULATORY BACKGROUND ........................................ 8 2.1 Product Information ............................................................................................ 8 2.2 Currently Available Treatments for Proposed Indications .................................. -
Pharmacological Modification of Blood-Brain Barrier Permeability Following a Cold Lesion Jennifer J
LE JOURNAL CANADIEN DES SCIENCES NEUROLOGIQUES Pharmacological Modification of Blood-Brain Barrier Permeability Following a Cold Lesion Jennifer J. Raymond, David M. Robertson, Henry B. Dinsdale, and Sukriti Nag ABSTRACT: The effect of desipramine, imidazole, thioridazine and trifluoperazine on blood-brain barrier(BBB) permeability after a 24 hour cold lesion was studied in rats. Changes in BBB permeability were determined using a quantitative horseradish peroxidase (HRP) assay. The four drugs tested did not alter the quantity of HRP in the cortex of control animals, or in the contralateral cortex of test animals. However, imidazole, desipramine and trifluoperazine significantly reduced the HRP extravasation in and around the cold lesion. Several mechanisms for this effect are suggested; one possible mechanism common to all these drugs is the reduction of increased vesicular transport in cortical vessels adjacent to the cold lesions. RESUME: L'effet de la desipramine, de I'imidazole, de la thioridazine, et de la trifluoperazine sur la permeability de la barriere h6mato-enc6phalique (BHE) apres une exposition au froid de 24 heures a 6te 6tudi6 chez le rat. Des changements dans la perm6abilit6 de la BHE ont 6t6 calcules en employant un titrage quantitatif de la peroxidase de raifort (PR). Les quatre drogues essaydes n'ont pas modifid la quantite du PR dans le cortex des animaux controles, hi dans le cortex contra-lateral des animaux exp6rimentaux. Cependant, I'imidazole, la desipramine, et le trifluoperazine ont rdduit significativement l'extravasation du PR dans et autour de la lesion par le froid. Plusieurs mecanismes pour expliquer cet effet sont sugger£s; un mecanisme possible qui est commun a toutes ces droques est la reduction du transport vesiculaire augmente dans les vaisseau corticaux adjacent aux atteintes induites par le froid. -
Drug-Induced Parkinsonism
InformationInformation Sheet Sheet Drug-induced Parkinsonism Terms highlighted in bold italic are defined in increases with age, hypertension, diabetes, the glossary at the end of this information sheet. atrial fibrillation, smoking and high cholesterol), because of an increased risk of stroke and What is drug-induced parkinsonism? other cerebrovascular problems. It is unclear About 7% of people with parkinsonism whether there is an increased risk of stroke with have developed their symptoms following quetiapine and clozapine. See the Parkinson’s treatment with particular medications. This UK information sheet Hallucinations and form of parkinsonism is called ‘drug-induced Parkinson’s. parkinsonism’. While these drugs are used primarily as People with idiopathic Parkinson’s disease antipsychotic agents, it is important to note and other causes of parkinsonism may also that they can be used for other non-psychiatric develop worsening symptoms if treated with uses, such as control of nausea and vomiting. such medication inadvertently. For people with Parkinson’s, other anti-sickness drugs such as domperidone (Motilium) or What drugs cause drug-induced ondansetron (Zofran) would be preferable. parkinsonism? Any drug that blocks the action of dopamine As well as neuroleptics, some other drugs (referred to as a dopamine antagonist) is likely can cause drug-induced parkinsonism. to cause parkinsonism. Drugs used to treat These include some older drugs used to treat schizophrenia and other psychotic disorders high blood pressure such as methyldopa such as behaviour disturbances in people (Aldomet); medications for dizziness and with dementia (known as neuroleptic drugs) nausea such as prochlorperazine (Stemetil); are possibly the major cause of drug-induced and metoclopromide (Maxolon), which is parkinsonism worldwide. -
Antipsychotic Drugs Handout
Robert M. Millay RN MSN Ed Professor, Napa Valley College Psychiatric Technician Programs Copyright © 2015, 2011, 2007, 2003, 1999, 1995, 1991 by Mosby, an imprint of Elsevier Inc. Treat Schizophrenia Schizoaffective disorder Bipolar disorder Psychotic depression Off-label uses Insomnia Tics Delirium Stuttering Discovered accidentally around 1950 Chlorpromazine (Thorazine) Historically have been referred to as… 1 Traditional antipsychotics or first generation Atypical antipsychotics or second generation High-potency drugs Fluphenazine (Prolixin) Haloperidol (Haldol) Thiothixene (Navane) Trifluoperazine (Stelazine) Moderate-potency drugs Loxapine (Loxitane) Perphenazine (Trilafon) Low-potency drugs Chlorpromazine (Thorazine) Thioridazine Low-potency drugs cause more intense anticholinergic effects High-potency drugs cause more EPSE From 1990 to the present, the new drugs are called atypical antipsychotics owing to Reduced risk of EPSE Increased effectiveness in treating negative symptoms Minimal risk of Tardive Dyskinesia (TD) Reduced risk for elevated prolactin 2 Atypical antipsychotics (second-generation drugs) Aripiprazole Quetiapine Clozapine Risperidone Olanzapine Ziprasidone Paliperidone Novel antipsychotics (third-generation drug) Aripiprazole Positive symptoms Excessive dopamine in the mesolimbic tract Negative symptoms Too little dopamine in the mesocortical tract Increased levels of dopamine Antipsychotic drugs block dopamine. Liberation of dopamine in the mesocortical area treats -
Anafranil (Clomipramine Hydrochloride) Tablets 1 Name of the Medicine 2 Qualitative and Quant
AUSTRALIAN PRODUCT INFORMATION – ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Clomipramine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg clomipramine hydrochloride. Lactose and sucrose Anafranil tablets contain lactose and sucrose. Patients with rare hereditary problems of galactose intolerance, fructose intolerance, severe lactase deficiency, sucrase-isomaltase insufficiency or glucose-galactose malabsorption should not take Anafranil tablets. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Major depression. • Obsessive-compulsive disorders and phobias in adults. • Cataplexy associated with narcolepsy. 4.2 DOSE AND METHOD OF ADMINISTRATION General The dosage should be determined individually and adapted to the patient's condition. Doses should be kept as low as possible and increased cautiously. Note that the plasma concentrations of the drug and active metabolite do not stabilise for 7 to 14 days after commencing treatment and after a dosage change. During treatment, the efficacy and tolerability of Anafranil must be judged by keeping the patients under close surveillance. Depression, obsessive-compulsive disorders and phobias: Start treatment with one tablet of 25 mg 2 or 3 times daily. Raise the daily dosage stepwise, e.g. 25 mg every few days, (depending on how the medication is tolerated) to 4 to 6 tablets of 25 mg. Once a distinct improvement has set in, adjust the daily dosage to a maintenance level averaging 2 to 4 tablets of 25 mg. 1 Cataplexy accompanying narcolepsy: Anafranil should be given orally in a daily dose of 25 to 75 mg.