DOCSLIB.ORG

Choosing Antipsychotics for Children with Schizophrenia: Evidence Plus Experience

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Choosing Antipsychotics for Children with Schizophrenia: Evidence Plus Experience Interview EXPERTS IN CHILD PSYCHIATRY Choosing antipsychotics for children with schizophrenia: Evidence plus experience Seeking effi cacy while managing adverse eff ects in early-onset psychosis ® Dowden“A patient Health I’ve seen Media for a number of years had been diag- nosed in the pervasive developmental disorder spectrum, but she was quite atypical. Her perseverative thinking CopyrightFor personalfocused use on aonly fantasy world, and she was so preoccupied that it was very diffi cult to pull her out of it. Now at age 12, she has a full-blown psychotic disorder, and the fantasy world is enveloping her. She hears people talking to her all day long.” Jean A. Frazier, MD, who treats this patient and other children with psychotic disorders, was 1 of 4 principal investigators in the Treatment of Early -Onset Schizo- phrenia Spectrum Disorders (TEOSS) study, a random- ized, double-blind, multisite trial funded by the National Institute of Mental Health. The study, published in © 2009 MARK KAUFFMAN November 2008,1 compared the effi cacy and tolerabil- ity of 3 antipsychotics—olanzapine, risperidone, and molindone—in pediatric patients with schizophrenia or schizoaffective disorder (Box 1, page 62). Dr. Frazier discusses the unexpected fi ndings of the TEOSS trial with Current Psychiatry Section Editor Robert A. Kowatch, MD, PhD. Based on the trial fi nd- ings and her experience, she tells how she makes deci- sions when prescribing antipsychotics for children and adolescents with schizophrenia and related disorders. DR. KOWATCH: The TEOSS trial found no signifi cant diff er- ences in effi cacy between molindone and the atypical antipsychotics (olanzapine and risperidone) included in the study. You’ve prescribed both typical and atypi- Current Psychiatry 60 July 2009 cal antipsychotics in research and in your clinical prac- For mass reproduction, content licensing and permissions contact Dowden Health Media. 60_CPSY0709 60 6/16/09 11:43:35 AM tice. Do you believe there’s any diff erence Jean A. Frazier, MD, is the between the 2 classes? Robert M. and Shirley S. Siff Chair DR. FRAZIER: There are some diff erences. and professor of psychiatry and pediatrics, and vice chair and For example, treatment-refractory patients, director, division of child and especially young children, sometimes adolescent psychiatry, University of Massachusetts Medical School, need more D2 blockade than some atypi- Worcester, MA. cal antipsychotics provide. I’ve seen more extra pyramidal side eff ects with the typical antipsychotics than the atypicals, although Robert A. Kowatch, MD, PhD, it’s not uncommon to see some akathisia a Section Editor for CURRENT PSYCHIATRY, is professor with ari piprazole or some dystonia and dys- of psychiatry and pediatrics, kinesia with risperidone. Cincinnati Children’s Hospital Medical Center, Cincinnati, OH. DR. KOWATCH: What are the benefi ts and risks of using antipsychotics in young children? DR. FRAZIER: The benefi t is that antipsychot- ics can decrease children’s suff ering and get them more centered in reality so they can Clinical Point enjoy their friends and progress in school. fi nding of this study to me was the side ef- The 3 antipsychotics And when that happens, it’s wonderful. What fect profi le of these agents. in TEOSS showed no are the risks? With the atypicals my greatest DR. KOWATCH: You mean weight gain with concern is weight gain, and with the typical olanzapine and extrapyramidal symptoms diff erence in effi cacy, agents it’s tardive dyskinesia. with molindone? but the meaningful DR. KOWATCH: Have you changed the way DR. FRAZIER: Yes. fi nding to me was you prescribe antipsychotics as a result of the side eff ect profi le the TEOSS study? DR. FRAZIER: Actually, I have. Clinicians have Managing side eff ects of these agents to be very careful about selecting psycho- DR. KOWATCH: How do you manage antipsy- tropic agents that can worsen pediatric- chotic side eff ects? onset obesity. Olanzapine is an eff ective DR. FRAZIER: For any of the antipsychotics’ agent for targeting psychosis and mood side eff ects, you have to decide whether symptoms, but the weight gain associ- to continue the agent or switch to anoth- ated with it is a concern. I do not prescribe er anti psychotic. For example, I’ve had a olanzapine as much as I have in the past, number of children—many with signifi cant although I keep it in my armamentarium weight problems—whose psychotic symp- and tend to reserve it for third- or fourth- toms have responded only to risperidone. line therapy. So we put them back on risperidone, and I have found molindone to be quite ef- the decision then becomes what can we do fective in children with schizophrenia or to help with the weight gain while continu- schizoaff ective disorder, especially in those ing that agent. who have gained a lot of weight on atypi- For weight gain, I think the best inter- cal antipsychotics. They usually lose weight vention is diet, exercise, and drinking a lot on molindone. of water, but that can be eff ective only if DR. KOWATCH: Do you think the TEOSS you engage the patient’s entire family in study had adequate power to demonstrate the intervention as well. Short of that, a diff erences among molindone, olanzapine, number of pharmacologic interventions and risperidone? have been studied, although not specifi - DR. FRAZIER: We enrolled 119 patients— cally in children. which is large for a study such as this—but In an open-label trial our group con- we did not reach our target of 168 patients, ducted with 11 children age 10 to 18 years which might have increased our power to who had gained weight while taking atyp- detect diff erences. Among the children we ical antipsychotics, metformin decreased did enroll, the 3 antipsychotics showed no lipid levels and body mass index but not Current Psychiatry diff erence in effi cacy, but the meaningful signifi cantly. I’ve followed these children Vol. 8, No. 7 61 61_CPSY0709 61 6/16/09 11:43:40 AM Box 1 Antipsychotics in children with schizophrenia: TEOSS study adds to debate about effi cacy and tolerability he 5-year National Institute Tof Mental Health-funded Observed PANSS total score by week Treatment of Early-Onset of treatment Children and Schizophrenia Spectrum Disorders antipsychotics (TEOSS) trial began with an ambitious goal: to compare the Molindone Olanzapine Risperidone effi cacy and safety of 1 typical 110 and 2 atypical antipsychotics 100 in children age 8 to 19 with 90 schizophrenia. The primary 80 hypothesis was that atypical 70 agents would show greater 60 Clinical Point effi cacy and tolerability when given 50 for 8 weeks. Instead, the atypical total score PANSS 40 If a child has not agents showed no greater effi cacy, 30 and adverse effects occurred with 012345678 responded to 2 trials all 3 antipsychotics. Because the Weeks with atypicals, trial was designed for 168 subjects but enrolled 119, it may not have Mean Positive and Negative Symptom Scale (PANSS) total scores of I might start thinking observed cases during each week of the TEOSS trial. Minimum possible been adequately powered to PANSS score is 30; scores >60 typically are viewed as problematic. about a typical agent detect differences among the 3 or clozapine agents. Medications: Most of the 116 children who treatment discontinuation. Extrapyramidal received medications were severely ill with symptoms were monitored with involuntary psychotic symptoms when randomly assigned movement and akathisia scales. to 1 of the 3 antipsychotics for 8 weeks of Among the 70 patients who completed double-blind treatment. Administration began at treatment (25 of 40 with molindone, 17 of 35 the lowest dose in a set range and usually was olanzapine, and 28 of 41 with risperidone), increased to midrange within 10 to 14 days. more than one-half failed to achieve an Dosing remained fl exible within these ranges: adequate response. Response rates were • molindone, 10 to 140 mg/d (mean endpoint 50% with molindone, 34% with olanzapine, dose 59.9 mg/d) and 46% with risperidone. The atypical • olanzapine, 2.5 to 20 mg/d (mean endpoint antipsychotics did not show greater effi cacy dose 11.4 mg/d) than molindone, and mean reductions in psychotic symptoms were modest (20% to • risperidone, 0.5 to 6 mg/d (mean endpoint 34% on the PANSS). Mean medication doses dose 2.8 mg/d). were midrange and considered moderate. Benztropine, ≥1 mg/d, was given to all patients Tolerability: Sedation, irritability, and anxiety treated with molindone, 14% of those treated were frequent adverse events. Patients with olanzapine, and 34% of those treated with receiving molindone reported signifi cantly risperidone to prevent or manage akathisia. higher rates of akathisia (P < .0008). Those Effi cacy: Two criteria defi ned treatment receiving olanzapine reported signifi cantly response: a Clinical Global Impression higher rates of weight gain (P < .0001) and improvement score of 1 or 2 and a ≥20% were the only group with increased lipid and reduction in baseline Positive and Negative insulin serum levels and liver function tests. Syndrome Scale (PANSS) score. Tolerability Patients in the risperidone group reported outcomes included neurologic side effects, signifi cantly higher rates of constipation (P < weight changes, laboratory analyses, vital .021) and were the only group that experienced signs, ECG, serious adverse events, and elevated serum prolactin. Source: Sikich L, Frazier JA, McClellan J, et al. Double-blind comparison of fi rst- and second-generation antipsychotics in early-onset schizophrenia and schizoaffective disorder: fi ndings from the Treatment of Early-Onset Schizophrenia Spectrum disorders (TEOSS) Current Psychiatry study. Am J Psychiatry. 2008;165:1420-1431 62 July 2009 continued on page 66 62_CPSY0709 62 6/16/09 11:43:46 AM continued from page 62 Box 2 Prodromal symptoms of early-onset psychotic disorder became interested in the complicated clearly differentiate the prodromal signs of I overlap between pervasive developmental psychosis from normal childhood behaviors.
Load more

Recommended publications
  • Management of Side Effects of Antipsychotics
    Management of side effects of antipsychotics Oliver Freudenreich, MD, FACLP Co-Director, MGH Schizophrenia Program www.mghcme.org Disclosures I have the following relevant financial relationship with a commercial interest to disclose (recipient SELF; content SCHIZOPHRENIA): • Alkermes – Consultant honoraria (Advisory Board) • Avanir – Research grant (to institution) • Janssen – Research grant (to institution), consultant honoraria (Advisory Board) • Neurocrine – Consultant honoraria (Advisory Board) • Novartis – Consultant honoraria • Otsuka – Research grant (to institution) • Roche – Consultant honoraria • Saladax – Research grant (to institution) • Elsevier – Honoraria (medical editing) • Global Medical Education – Honoraria (CME speaker and content developer) • Medscape – Honoraria (CME speaker) • Wolters-Kluwer – Royalties (content developer) • UpToDate – Royalties, honoraria (content developer and editor) • American Psychiatric Association – Consultant honoraria (SMI Adviser) www.mghcme.org Outline • Antipsychotic side effect summary • Critical side effect management – NMS – Cardiac side effects – Gastrointestinal side effects – Clozapine black box warnings • Routine side effect management – Metabolic side effects – Motor side effects – Prolactin elevation • The man-in-the-arena algorithm www.mghcme.org Receptor profile and side effects • Alpha-1 – Hypotension: slow titration • Dopamine-2 – Dystonia: prophylactic anticholinergic – Akathisia, parkinsonism, tardive dyskinesia – Hyperprolactinemia • Histamine-1 – Sedation – Weight gain
    [Show full text]
  • 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 ....................................................................................................................
    [Show full text]
  • Clinical Guideline Drug/Drug Class: Antipsychotics Prepared By
    MassHealth Drug Utilization Review Program Commonwealth Medicine University of Massachusetts Medical School P.O. Box 2586 Worcester MA, 01613-2586 Clinical Guideline Drug/Drug Class: Antipsychotics Prepared by: Drug Utilization Review Program Prepared for: MassHealth Pharmacy Program Purpose: The purpose of this guideline is to clarify the procedures for approving and denying prior authorization (PA) requests for: Polypharmacy with two or more antipsychotics for members ≥ 18 years old (including first- generation [typical] and second-generation [atypical]) for greater than 60 days (excluding clozapine and injectable formulations) Orally disintegrating dosage forms and Versacloz® (clozapine) oral suspension Medication exceeding defined quantity limits Fanapt® (iloperidone), Invega® (paliperidone), Latuda® (lurasidone), Rexulti® (brexpiprazole), Saphris® (asenapine), and Vraylar® (cariprazine) for members of all ages and all quantities Abilify® (aripiprazole) and Seroquel XR® (quetiapine extended-release) for members 18 years of age and older and all quantities Background: Since 2003, MassHealth has determined that oral second-generation (atypical) antipsychotics (with the exception of clozapine and injectables) would require prior authorization for polypharmacy, defined as two or more second-generation (atypical) antipsychotics for greater than 60 days. Clozapine is excluded from the polypharmacy requirement because the guidelines for the treatment of schizophrenia recognize that combinations including clozapine have been reported. 1 In 2016, the adult antipsychotic polypharmacy criteria was updated and the PA restriction was expanded to include first-generation (typical), and second-generation (atypical) antipsychotics, excluding clozapine and injectable formulations. Orally disintegrating tablets (ODT) of aripiprazole, clozapine, olanzapine and risperidone, as well as Versacloz® (clozapine) oral suspension also require PA since there are more cost-effective alternatives available.
    [Show full text]
  • Heat Related Illness in Psychotropic Medication Users
    Common psychotropic medications which Prevention of Heat can impair your response to heat Related Illness Trade Name Generic Name Abilify aripiprazole During periods of high temperature (85º Asendin amoxapine and above) and humidity, there are things Artane trihexyphenidyl everyone, particularly people at high risk, Aventil, Pamelor nortriptyline should do to lessen the chances of heat Clozaril clozapine illness. Cogentin benztropine Compazine prochlorperazine ¾ Try to stay cool. Desyrel trazodone • Stay in air conditioned areas if Elavil, Limbitrol, possible. If you do not have air Triavil amitriptyline conditioning at home, go to a Eskalith, Lithobid, shopping mall or public library. Lithonate lithium • Keep windows shut and draperies, Geodon ziprasidone shades, or blinds drawn during the Haldol haloperidol heat of the day. Loxitane loxapine • Open windows in the evening or Ludiomil maprotiline night hours when the air outside is Mellaril thioridazine Heat Related Illness cooler. Moban molindone • Move to cooler rooms during the Navane thiothixene in heat of the day. Norpramin desipramine Psychotropic ¾ Avoid overexertion and outdoor Phenergan promethazine activity, particularly during warmer Prolixin fluphenazine Medication Users periods of the day. Risperdal risperidone ¾ Apply sunscreen and lotion as needed. Serentil mesoridazine Seroquel quetiapine ¾ Drink plenty of fluids (avoid coffee, tea, and alcohol). Sinequan doxepin ¾ Dress in loose fitting, light colored Stelazine trifluoperazine clothing. Wear a hat, sunglasses, and Thorazine chlorpromazine other protective clothing. Tofranil imipramine ¾ Take a cool shower or bath. Trilafon perphenazine ¾ Lose weight if you are overweight. Wellbutrin buproprion ¾ Eat regular meals to ensure that you Zyprexa olanzapine Ohio Department of Mental Health have adequate salt and fluids. *Note: This is not an all inclusive list.
    [Show full text]
  • S1 Table. List of Medications Analyzed in Present Study Drug
    S1 Table. List of medications analyzed in present study Drug class Drugs Propofol, ketamine, etomidate, Barbiturate (1) (thiopental) Benzodiazepines (28) (midazolam, lorazepam, clonazepam, diazepam, chlordiazepoxide, oxazepam, potassium Sedatives clorazepate, bromazepam, clobazam, alprazolam, pinazepam, (32 drugs) nordazepam, fludiazepam, ethyl loflazepate, etizolam, clotiazepam, tofisopam, flurazepam, flunitrazepam, estazolam, triazolam, lormetazepam, temazepam, brotizolam, quazepam, loprazolam, zopiclone, zolpidem) Fentanyl, alfentanil, sufentanil, remifentanil, morphine, Opioid analgesics hydromorphone, nicomorphine, oxycodone, tramadol, (10 drugs) pethidine Acetaminophen, Non-steroidal anti-inflammatory drugs (36) (celecoxib, polmacoxib, etoricoxib, nimesulide, aceclofenac, acemetacin, amfenac, cinnoxicam, dexibuprofen, diclofenac, emorfazone, Non-opioid analgesics etodolac, fenoprofen, flufenamic acid, flurbiprofen, ibuprofen, (44 drugs) ketoprofen, ketorolac, lornoxicam, loxoprofen, mefenamiate, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, pranoprofen, proglumetacin, sulindac, talniflumate, tenoxicam, tiaprofenic acid, zaltoprofen, morniflumate, pelubiprofen, indomethacin), Anticonvulsants (7) (gabapentin, pregabalin, lamotrigine, levetiracetam, carbamazepine, valproic acid, lacosamide) Vecuronium, rocuronium bromide, cisatracurium, atracurium, Neuromuscular hexafluronium, pipecuronium bromide, doxacurium chloride, blocking agents fazadinium bromide, mivacurium chloride, (12 drugs) pancuronium, gallamine, succinylcholine
    [Show full text]
  • Weight Gain Associated with Antipsychotic Drugs
    Rohan Ganguli Weight Gain Associated With Antipsychotic Drugs Rohan Ganguli, M.D. © CopyrightWeight gain has been 2000 reported Physicians with nearly every antipsychotic Postgraduate drug on the market Press, (molindone Inc.is an exception). Weight gain occurs no matter what the patient’s age, sex, or race and is seen with both oral and depot drug formulations. Numerous studies have found that patients gain weight when treated with a conventional antipsychotic, such as chlorpromazine, fluphenazine, and haloperidol. The newer, novel antipsychotics offer advantages over conventional antipsychotics, especially a relative lack of extrapyramidal symptoms, but some still have the disadvantage of causing weight gain. Clozapine and olanzapine in particular appear to cause substantial weight gain, much more so than do most conven- tional neuroleptics and novel agents such as risperidone. Given the risks to health and treatment com- pliance associated with weight gain and obesity, clinicians should monitor weight during the course of antipsychotic therapy and consider switching agents if excessive weight gain occurs. (J Clin Psychiatry 1999;60[suppl 21]:20–24) One personal copy may be printed e have known for some time that treatment with CONVENTIONAL NEUROLEPTICS Wantipsychotic drugs is associated with weight gain. A few years after the first neuroleptic medications One of the earliest studies to examine weight gain asso- were introduced, researchers were reporting clinically sig- ciated with antipsychotic drugs in a large number of pa- nificant
    [Show full text]
  • Dopamine Antagonist Prescribing Practices in Patients with Parkinson Disease
    Dopamine Antagonist Prescribing Practices in Patients With Parkinson Disease Amie L. Peterson, MD; Joseph Quinn, MD; Brenna Lobb, MS, MPH; Marsha N. Andrews, MSW; and John G. Nutt, MD This study examines clinician prescribing habits at 3 VAMCs to see whether a change in the electronic medical record at 1 VAMC leads to a change in prescribing patterns of dopamine antagonists in patients with Parkinson disease compared with the other 2 centers. sychosis and nausea are com- In the 1990s, 2 studies on antipsy- prescribing in patients with PD, the mon problems in patients chotic use in PD in the United States Portland VAMC implemented a med- with Parkinson disease (PD) found that 88% to 99% of prescribed ication comment in the electronic or- and are often treated with do- antipsychotics were contraindicated dering system beginning June 2004. P 5,6 pamine antagonists, medications that typical antipsychotics. A later study can worsen parkinsonism. In 2 sur- in Canada in patients with PD found MATERIAL AND METHODS veys of clinic patients with PD, 24.4% the rate of typical antipsychotic use Permission to search the Veterans complained of nausea at least once in had decreased from 56% in 1998 to Data Warehouse was granted by the the month before the clinic visit, and 9% in 2002.7 In the Canadian study, Portland VAMC Institutional Review 39.8% experienced hallucinations in olanzapine and risperidone (which Board. The data were examined in the 3 months before the visit.1,2 can cause extrapyramidal signs) were 12-month intervals for 4 years before Historically, atypical antipsychot- included as acceptable medications.
    [Show full text]
  • What Caregivers Need to Know About the Use of Antipsychotic Drugs in Nursing Homes
    What Caregivers Need to Know About the Use of Antipsychotic Drugs in Nursing Homes As someone who cares for a friend or family member in a nursing home you need to know about the potential risks of antipsychotic drugs. Antipsychotic drugs are frequently used to address the behavioral issues caused by dementia, including aggression, agitation and delirium. Because antipsychotic drugs can pose major health risks to older adults, the Centers for Medicare and Medicaid Services (CMS) has a national initiative to reduce the use of antipsychotic medications in nursing facilities. The Food and Drug Administration (FDA) requires many of these drugs to have a “black box” warning on their labels after finding that antipsychotic drugs are increasing death rates in older nursing home residents with dementia. What is a black box warning? A black box warning means that the drug carries a major risk of serious or even life-threatening effects. The FDA requires the warning on packaging for certain prescription drugs. It is the strongest warning a drug can carry before it is pulled from the shelves. Black-box warnings take their name from the black border around the drug label or patient information. What antipsychotic drugs have black box warnings? Here are the antipsychotic drugs that must have them: Risperdal (Risperidone) Zyprexa (Olanzapine) Seroquel (Quetiapine Fumarate) Geodon (Ziprasidone Hydrochloride, Ziprasidone Mesylate) Abilify (Aripiprazole) Invega (Paliperidone, Paliperidone Palmitate) Haldol (Haloperidol Decanoate, Haloperidol Lactate, Haloperidol) Moban (Molindone Hydrochloride) Navane (Thithixene) Symbyax (Fluoxetine Hydrochloride, Olanzapine) Clozaril (Clozapine) Fazaclo (Clozapine) What to do if you are concerned your loved one is being overmedicated The side effects of antipsychotic drugs can be harmful, robbing individuals of their quality of life.
    [Show full text]
  • Louisiana Fee-For-Service Medicaid Antipsychotics
    Louisiana Fee-for-Service Medicaid Antipsychotics The Louisiana Uniform Prescription Drug Prior Authorization Form should be utilized to request: Authorization for non-preferred agents for recipients 6 years of age and older; AND Authorization for all preferred and non-preferred agents for recipients younger than 6 years of age; AND Authorization to exceed maximum daily dose/quantity limit for all ages. See full prescribing information for individual agents for details on the information below: *These agents have Black Box Warnings †These agents are subject to Risk Evaluation and Mitigation Strategy (REMS) under FDA safety regulations ‡ For long-acting injectable agents, it is required that the previous 60-day period of pharmacy claims show one of the following: Established tolerance to the oral formulation (as evidenced by a paid pharmacy claim for the oral formulation); OR Established therapy with the requested injectable agent (as evidenced by a paid pharmacy claim for the requested injectable agent) NOTE: Diagnosis code requirements apply to both preferred and non-preferred agents (see Table 1). Maximum daily dose edits (see Table 2), quantity limits (see Table 3), and other requirements at Point-of-Sale for select agents in this category may apply to both preferred and non-preferred agents. For additional information, see http://www.lamedicaid.com/provweb1/Pharmacy/pharmacyindex.htm. Oral Antipsychotics – Generic Name (Brand Example) * Amitriptyline/Perphenazine * Aripiprazole ODT; Oral Solution (Abilify®); Tablet (Abilify®)
    [Show full text]
  • At-A-Glance: Psychotropic Drug Information for Children and Adolescents
    At-A-Glance: Psychotropic Drug Information for Children and Adolescents Pediatric Dosage/ Drug Generic FDA Approval Serum Level Name Age/Indication when applicable Warnings and Precautions/Black Box Warnings Combination Antipsychotic/Antidepressant fluoxetine & 18 and older N/A: Pediatric Black Box Warning for fluoxetine/olanzapine olanzapine dosing is currently combination formula (marketed as Symbyax): Usage unavailable or not increased the risk of suicidal thinking and behaviors in applicable for this children and adolescents with major depressive disorder drug. and other psychiatric disorders. Other precautions for fluoxetine/olanzapine combination: Possibly unsafe during lactation. Avoid abrupt withdrawal. Antipsychotic Medications *Precautions which apply to all atypical or second generation antipsychotics (SGA): Neuroleptic Malignant Syndrome/Tardive Dyskinesia/ Hyperglycemia/ Diabetes Mellitus/ Weight Gain/ Akathisia/Dyslipidemia †Precautions which apply to all typical or first generation antipsychotics (FGA): Extrapyramidal symptoms/Tardive Dyskinesia aripiprazole * (SGA) 10 and older for 2-10 mg/kg/day Black Box Warning for aripiprazole: Not approved for bipolar disorder, depression in under age 18. Increased risk of suicidal manic, or mixed thinking and behavior in short-term studies in children episodes; 13 to 17 and adolescents with major depressive disorder and for schizophrenia other psychiatric conditions. and bipolar; 6 to 17 for irritability associated with autistic disorder asenapine* 18 and older N/A Black Box Warning for asenapine: Not approved for dementia-related psychosis. Increased mortality risk for elderly dementia patients due to cardiovascular or infectious events. chlorpromazine† 18 and older 0.25 mg/kg tid Other precautions for chlorpromazine: May alter cardiac (FGA) conduction; sedation; Neuroleptic Malignant Syndrome; weight gain. Use caution with renal disease, seizure disorders, and respiratory disease and in acute illness.
    [Show full text]
  • FDA Listing of Established Pharmacologic Class Text Phrases January 2021
    FDA Listing of Established Pharmacologic Class Text Phrases January 2021 FDA EPC Text Phrase PLR regulations require that the following statement is included in the Highlights Indications and Usage heading if a drug is a member of an EPC [see 21 CFR 201.57(a)(6)]: “(Drug) is a (FDA EPC Text Phrase) indicated for Active Moiety Name [indication(s)].” For each listed active moiety, the associated FDA EPC text phrase is included in this document. For more information about how FDA determines the EPC Text Phrase, see the 2009 "Determining EPC for Use in the Highlights" guidance and 2013 "Determining EPC for Use in the Highlights" MAPP 7400.13.
    [Show full text]
  • Therapeutic Class Overview Atypical Antipsychotics
    Therapeutic Class Overview Atypical Antipsychotics INTRODUCTION Antipsychotic medications have been used for over 50 years to treat schizophrenia and a variety of other psychiatric disorders (Miyamato et al 2005). Antipsychotic medications generally exert their effect in part by blocking dopamine (D)-2 receptors (Jibson et al 2017). Antipsychotics are divided into 2 distinct classes based on their affinity for D2 and other neuroreceptors: typical antipsychotics, also called first-generation antipsychotics (FGAs), and atypical antipsychotics, also called second- generation antipsychotics (SGAs) (Miyamato et al 2005). Atypical antipsychotics do not have a uniform pharmacology or mechanism of action; these differences likely account for the different safety and tolerability profiles of these agents (Clinical Pharmacology 2019, Jibson et al 2017). The atypical antipsychotics differ from the early antipsychotics in that they have affinity for the serotonin 5-HT2 receptor in addition to D2. ○ Clozapine is an antagonist at all dopamine receptors (D1-5), with lower affinity for D1 and D2 receptors and high affinity for D4 receptors. Aripiprazole and brexpiprazole act as partial agonists at the D2 receptor, functioning as an agonist when synaptic dopamine levels are low and as an antagonist when they are high. Cariprazine is a partial agonist at D2 and D3. Pimavanserin does not have dopamine blocking activity and is primarily an inverse agonist at 5-HT2A receptors. The remaining atypical antipsychotics share the similarity of D2 and 5-HT2A
    [Show full text]