Long-Acting Injectable Antipsychotic Medications and Conversion Dosing
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HALDOL Brand of Haloperidol Injection (For Immediate Release) WARNING Increased Mortality in Elderly Patients with Dementia
HALDOL® brand of haloperidol injection (For Immediate Release) WARNING 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. HALDOL Injection is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). DESCRIPTION Haloperidol is the first of the butyrophenone series of major antipsychotics. The chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino] 4’-fluorobutyrophenone and it has the following structural formula: HALDOL (haloperidol) is available as a sterile parenteral form for intramuscular injection. The injection provides 5 mg haloperidol (as the lactate) and lactic acid for pH adjustment between 3.0 – 3.6. -
Medication Conversion Chart
Fluphenazine FREQUENCY CONVERSION RATIO ROUTE USUAL DOSE (Range) (Range) OTHER INFORMATION KINETICS Prolixin® PO to IM Oral PO 2.5-20 mg/dy QD - QID NA ↑ dose by 2.5mg/dy Q week. After symptoms controlled, slowly ↓ dose to 1-5mg/dy (dosed QD) Onset: ≤ 1hr 1mg (2-60 mg/dy) Caution for doses > 20mg/dy (↑ risk EPS) Cmax: 0.5hr 2.5mg Elderly: Initial dose = 1 - 2.5mg/dy t½: 14.7-15.3hr 5mg Oral Soln: Dilute in 2oz water, tomato or fruit juice, milk, or uncaffeinated carbonated drinks Duration of Action: 6-8hr 10mg Avoid caffeinated drinks (coffee, cola), tannics (tea), or pectinates (apple juice) 2° possible incompatibilityElimination: Hepatic to inactive metabolites 5mg/ml soln Hemodialysis: Not dialyzable HCl IM 2.5-10 mg/dy Q6-8 hr 1/3-1/2 po dose = IM dose Initial dose (usual): 1.25mg Onset: ≤ 1hr Immediate Caution for doses > 10mg/dy Cmax: 1.5-2hr Release t½: 14.7-15.3hr 2.5mg/ml Duration Action: 6-8hr Elimination: Hepatic to inactive metabolites Hemodialysis: Not dialyzable Decanoate IM 12.5-50mg Q2-3 wks 10mg po = 12.5mg IM CONVERTING FROM PO TO LONG-ACTING DECANOATE: Onset: 24-72hr (4-72hr) Long-Acting SC (12.5-100mg) (1-4 wks) Round to nearest 12.5mg Method 1: 1.25 X po daily dose = equiv decanoate dose; admin Q2-3wks. Cont ½ po daily dose X 1st few mths Cmax: 48-96hr 25mg/ml Method 2: ↑ decanoate dose over 4wks & ↓ po dose over 4-8wks as follows (accelerate taper for sx of EPS): t½: 6.8-9.6dy (single dose) ORAL DECANOATE (Administer Q 2 weeks) 15dy (14-100dy chronic administration) ORAL DOSE (mg/dy) ↓ DOSE OVER (wks) INITIAL DOSE (mg) TARGET DOSE (mg) DOSE OVER (wks) Steady State: 2mth (1.5-3mth) 5 4 6.25 6.25 0 Duration Action: 2wk (1-6wk) Elimination: Hepatic to inactive metabolites 10 4 6.25 12.5 4 Hemodialysis: Not dialyzable 20 8 6.25 12.5 4 30 8 6.25 25 4 40 8 6.25 25 4 Method 3: Admin equivalent decanoate dose Q2-3wks. -
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 -
Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment for Schizophrenia in Adult Patients? Kyle J
Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Physician Assistant Studies Student Student Dissertations, Theses and Papers Scholarship 2017 Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment For Schizophrenia In Adult Patients? Kyle J. Knowles Philadelphia College of Osteopathic Medicine Follow this and additional works at: https://digitalcommons.pcom.edu/pa_systematic_reviews Part of the Psychiatry Commons Recommended Citation Knowles, Kyle J., "Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment For Schizophrenia In Adult Patients?" (2017). PCOM Physician Assistant Studies Student Scholarship. 381. https://digitalcommons.pcom.edu/pa_systematic_reviews/381 This Selective Evidence-Based Medicine Review is brought to you for free and open access by the Student Dissertations, Theses and Papers at DigitalCommons@PCOM. It has been accepted for inclusion in PCOM Physician Assistant Studies Student Scholarship by an authorized administrator of DigitalCommons@PCOM. For more information, please contact [email protected]. Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment For Schizophrenia In Adult Patients? Kyle J. Knowles, PA-S A SELECTIVE EVIDENCE BASED MEDICINE REVIEW In Partial Fulfillment of the Requirements For The Degree of Master of Science In Health Sciences- Physician Assistant Department of Physician Assistant Studies Philadelphia College of Osteopathic Medicine Philadelphia, Pennsylvania December 16, 2016 ABSTRACT OBJECTIVE: The objective of this selective EBM review is to determine whether or not “Is Aristada (aripiprazole lauroxil) a safe and effective treatment for schizophrenia in adult patients?” STUDY DESIGN: Review of three randomized controlled studies. All three trials were conducted between 2014 and 2015. DATA SOURCES: One randomized, controlled trial and two randomized, controlled, double- blind trials found via Cochrane Library and PubMed. -
Appendix 18: References to Studies from the Previous Guideline
Appendix 18: References to studies from the previous guideline This appendix contains references to the studies from the previous guideline, as they appeared in that guideline. References to studies added to the guideline update are in Appendix 17a-d. Contents Service references…………………………………………………………………..1 Psychology references……………………………………………………………..15 Pharmacology references………………………………………………………….28 Service references Araya2003 {published data only} Araya R, Rojas G, Fritsch R, Gaete J, Rojas M, Simon G, Peters TJ. Treating depression in primary care in low-income women in Santiago, Chile: A randomised controlled trial. Lancet 2003;361(9362):995-1000. Arthur2002 {published data only} Arthur AJ, Jagger C, Lindesay J, Matthews RJ. Evaluating a mental health assessment for older people with depressive symptoms in general practice: a randomised controlled trial. British Journal of General Practice 2002;52(476):202-207. Austin-Los Angeles Austin NK, Liberman RP, King LW, DeRisi WJ. A comparative evaluation of two day hospitals. Goal attainment scaling of behaviour therapy vs. milieu therapy. Journal of Nervous and Mental Disease 1976;163:253-62. Azim-Alberta Azim HF, Weiden TD, Ratcliffe WD, Nutter RW, Dyck RJ, Howarth BG. Current utilization of day hospitalization. Canadian Psychiatric Association Journal 1978;23:557-66 Baker2001 {published data only} Baker R, Reddish S, Robertson N, Hearnshaw H, Jones B. Randomised controlled trial of tailored strategies to implement guidelines for the management of patients with depression in general practice. British Journal of General Practice 2001;51:737-741. Barkley-Ontario Barkley AL, Fagen K, Lawson JS. Day care: can it prevent readmission to a psychiatric hospital? Psychiatric Journal of the University of Ottawa 1989;14:536-41. -
Second-Generation Long-Acting Injectable Antipsychotics: a PRACTICAL GUIDE Understanding Each of These Medications’ Unique Properties Can Optimize Patient Care
Second-generation long-acting injectable antipsychotics: A PRACTICAL GUIDE Understanding each of these medications’ unique properties can optimize patient care Brittany L. Parmentier, PharmD, MPH, here are currently 7 FDA-approved second-generation long-acting BCPS, BCPP 1-7 Clinical Assistant Professor injectable antipsychotics (LAIAs). These LAIAs provide a Department of Pharmacy Practice Tunique dosage form that allows patients to receive an antipsy- The University of Texas at Tyler Fisch College of Pharmacy chotic without taking oral medications every day, or multiple times per Tyler, Texas day. This may be an appealing option for patients and clinicians, but Disclosure The author reports no financial relationships with any because there are several types of LAIAs available, it may be difficult to companies whose products are mentioned in this article, or with determine which LAIA characteristics are best for a given patient. manufacturers of competing products. Since the FDA approved the first second-generation LAIA, risperidone long-acting injectable (LAI),1 in 2003, 6 additional second-generation LAIAs have been approved: • aripiprazole LAI • aripiprazole lauroxil LAI • olanzapine pamoate LAI • paliperidone palmitate monthly injection • paliperidone palmitate 3-month LAI • risperidone LAI for subcutaneous (SQ) injection. When discussing medication options with patients, clinicians need to consider factors that are unique to each LAIA. In this article, I describe the similarities and differences among the second-generation LAIAs, and address common questions about these medications. A major potential benefit: Increased adherence One potential benefit of all LAIAs is increased medication adherence com- pared with oral antipsychotics. One meta-analysis of 21 randomized con- trolled trials (RCTs) that compared LAIAs with oral antipsychotics and Current Psychiatry GEORGE MATTEI/SCIENCE SOURCE GEORGE MATTEI/SCIENCE Vol. -
Should Inverse Agonists Be Defined by Pharmacological Mechanism Or
CNS Spectrums,(2019), 24 419 – 425. © Cambridge University Press 2018. This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited. doi:10.1017/S1092852918000986 ORIGINAL RESEARCH Switching stable patients with schizophrenia from their oral antipsychotics to aripiprazole lauroxil: a post hoc safety analysis of the initial 12-week crossover period Peter J. Weiden,1* Yangchun Du,2 Chih-Chin Liu,2 and Arielle D. Stanford3 1 Medical Affairs, Alkermes, Inc., Waltham, Massachusetts, USA 2 Clinical Development, Alkermes, Inc., Waltham, Massachusetts, USA 3 Clinical Science, Alkermes, Inc., Waltham, Massachusetts, USA Objective. Switching antipsychotic medications is common in patients with schizophrenia who are experiencing persistent symptoms or tolerability issues associated with their current drug regimen. This analysis assessed the safety of switching from an oral antipsychotic to the long-acting injectable antipsychotic aripiprazole lauroxil (AL). Methods. This was a post hoc analysis of outpatients with schizophrenia who were prescribed an oral antipsychotic and who enrolled in an international, open-label, long-term (52-week) safety study of AL. The analysis focused on the first 3 injections of AL 882 mg over 12 weeks, divided into the immediate 4-week crossover period between the first and second AL injections (initiation phase) and the subsequent 8 weeks (stabilization phase). Patients were grouped by preswitch oral antipsychotic medication, and safety and clinical symptoms were assessed. Results. In total, 190 patients had switched from one of the following oral antipsychotic medications: aripiprazole, conventional antipsychotics, risperidone/paliperidone, olanzapine, or quetiapine. -
HALDOL Decanoate 50 (Haloperidol)
HALDOL® Decanoate 50 (haloperidol) HALDOL® Decanoate 100 (haloperidol) For IM Injection Only WARNING 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. HALDOL Decanoate is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). DESCRIPTION Haloperidol decanoate is the decanoate ester of the butyrophenone, HALDOL (haloperidol). It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is: Haloperidol decanoate is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. -
Schizophrenia Paper
The new england journal of medicine review article drug therapy Alastair J.J. Wood, M.D., Editor Schizophrenia Robert Freedman, M.D. From the Institute for Children’s Mental chizophrenia is a chronic, debilitating psychotic mental dis- Disorders, University of Colorado and the order that affects about 1 percent of people. A new generation of medications Veterans Affairs Medical Center, Denver. s Address reprint requests to Dr. Freedman and recent developments in neuropathology, brain imaging, and molecular ge- at the Department of Psychiatry, C-268-71, netics have led to a greater understanding of the pathophysiology of schizophrenia and University of Colorado Health Sciences to improved treatment. Nonetheless, it remains an enigmatic illness that places a sub- Center, Denver CO 80262, or at robert. [email protected]. stantial burden on patients, their families, and society. N Engl J Med 2003;349:1738-49. clinical characteristics Copyright © 2003 Massachusetts Medical Society. Schizophrenia has varied and ominous symptoms that generally begin in late adoles- cence or early adulthood and usually continue throughout life.1 Most patients have a history of behavioral dysfunction — primarily social and learning difficulties.2 Diagnos- tic features of schizophrenia include auditory hallucinations (generally voices that con- verse with or about the patient) and delusions (often the paranoid belief that external forces are conspiring against the patient). Patients may have some insight that the voices are internal thoughts and that the delusions cannot possibly be true, but these phenom- ena remain persistent and troubling. In addition to these overt psychotic, or “positive,” symptoms, various deficits, or “negative” symptoms, occur, including an inability to pay attention, the loss of a sense of pleasure, the loss of will or drive, disorganization or im- poverishment of thoughts and speech, flattening of affect, and social withdrawal (Ta- ble 1). -
Aristada Initio (Aripiprazole Lauroxil), in Combination with Oral Aripiprazole for the Initiation of Aristada When Used for the Treatment of Schizophrenia in Adults
Aristada Initio™ (aripiprazole lauroxil) – New drug approval • On July 2, 2018, Alkermes announced the FDA approval of Aristada Initio (aripiprazole lauroxil), in combination with oral aripiprazole for the initiation of Aristada when used for the treatment of schizophrenia in adults. — The approval of Aristada Initio provides physicians with an alternative regimen to initiate patients onto any dose of Aristada injection on day 1. — Previously, the first Aristada injection was recommended in conjunction with oral aripiprazole for 21 consecutive days. • Oral aripiprazole is generically available as tablets, disintegrating tablets, and solution. Aripiprazole is also available as Abilify Maintena®, a brand extended-release injectable suspension. — The oral formulations are approved for the treatment of schizophrenia and other indications as outlined in the individual drug labels. — Abilify Maintena is indicated for the treatment of schizophrenia in adults and as maintenance monotherapy treatment of bipolar I disorder in adults. • Aristada Initio leverages Alkermes’ proprietary NanoCrystal® technology, which provides an extended-release formulation using a smaller particle size compared to Aristada, thereby enabling faster dissolution and more rapid achievement of relevant drug levels. • The effectiveness of Aristada Initio, in combination with oral aripiprazole and for the initiation of Aristada injection, was established by adequate and well-controlled studies of oral aripiprazole and Aristada injection in adult patients with schizophrenia. -
CENTRAL NERVOUS SYSTEM DEPRESSANTS Opioid Pain Relievers Anxiolytics (Also Belong to Psychiatric Medication Category) • Codeine (In 222® Tablets, Tylenol® No
CENTRAL NERVOUS SYSTEM DEPRESSANTS Opioid Pain Relievers Anxiolytics (also belong to psychiatric medication category) • codeine (in 222® Tablets, Tylenol® No. 1/2/3/4, Fiorinal® C, Benzodiazepines Codeine Contin, etc.) • heroin • alprazolam (Xanax®) • hydrocodone (Hycodan®, etc.) • chlordiazepoxide (Librium®) • hydromorphone (Dilaudid®) • clonazepam (Rivotril®) • methadone • diazepam (Valium®) • morphine (MS Contin®, M-Eslon®, Kadian®, Statex®, etc.) • flurazepam (Dalmane®) • oxycodone (in Oxycocet®, Percocet®, Percodan®, OxyContin®, etc.) • lorazepam (Ativan®) • pentazocine (Talwin®) • nitrazepam (Mogadon®) • oxazepam ( Serax®) Alcohol • temazepam (Restoril®) Inhalants Barbiturates • gases (e.g. nitrous oxide, “laughing gas”, chloroform, halothane, • butalbital (in Fiorinal®) ether) • secobarbital (Seconal®) • volatile solvents (benzene, toluene, xylene, acetone, naptha and hexane) Buspirone (Buspar®) • nitrites (amyl nitrite, butyl nitrite and cyclohexyl nitrite – also known as “poppers”) Non-Benzodiazepine Hypnotics (also belong to psychiatric medication category) • chloral hydrate • zopiclone (Imovane®) Other • GHB (gamma-hydroxybutyrate) • Rohypnol (flunitrazepam) CENTRAL NERVOUS SYSTEM STIMULANTS Amphetamines Caffeine • dextroamphetamine (Dexadrine®) Methelynedioxyamphetamine (MDA) • methamphetamine (“Crystal meth”) (also has hallucinogenic actions) • methylphenidate (Biphentin®, Concerta®, Ritalin®) • mixed amphetamine salts (Adderall XR®) 3,4-Methelynedioxymethamphetamine (MDMA, Ecstasy) (also has hallucinogenic actions) Cocaine/Crack