Trifluoperazine 1Mg/5Ml Syrup Can Trifluoperazine 1Mg/5Ml Syrup Have Effects on Muscle Control

Total Page:16

File Type:pdf, Size:1020Kb

Trifluoperazine 1Mg/5Ml Syrup Can Trifluoperazine 1Mg/5Ml Syrup Have Effects on Muscle Control • Rarely patients may develop Neuroleptic Malignant Syndrome. This causes a high temperature, rigid muscles, drowsiness, occasional loss of consciousness, and requires emergency admission to hospital for treatment. PATIENT INFORMATION LEAFLET • If you have chest pain (angina) and your pain is getting worse. • Very occasionally, medicines such as Trifluoperazine 1mg/5ml Syrup can Trifluoperazine 1mg/5ml Syrup have effects on muscle control. If this happens, symptoms can include slurred speech, odd movements of the face, particularly of the tongue, eyes, head or neck (such as twisting of the neck which causes an Read all of this leaflet carefully before you start taking this medicine. unnatural positioning of the head, rigid muscles, tremors or restlessness Keep this leaflet. You may need to read it again. and difficulty in sitting still). Some patients (especially on high doses of If you have any further questions, ask your doctor or pharmacist. this medicine) experience problems with muscle control which may This medicine has been prescribed for you. Do not pass it on to others. It continue for years. Such patients may experience constant chewing or may harm them, even if their symptoms are the same as yours. tongue movements or other gentle movements of the neck, head or trunk. If any of the side effects become serious, or if you notice any side effects Uncontrollable movements of the arms and legs have also been reported not listed in this leaflet, please tell your doctor or pharmacist. in these patients. In this leaflet: • Occasionally, some patients have complained of feeling slowed down, 1. What Trifluoperazine 1mg/5ml Syrup is and what it is used for whilst • Rarely, jaundice (yellowing of skin and whites of eyes), eye problems, 2. Before you take Trifluoperazine 1mg/5ml Syrup skin colouring (pigmentation) and blood problems. 3. How to take Trifluoperazine 1mg/5ml Syrup • if you suffer from a sore throat, high fever, feel very tired, become pale, 4. Possible side effects develop bruises and nose bleeds. These may indicate blood problems 5. How to store Trifluoperazine 1mg/5ml Syrup developing as a result of using this medicine. 6. Further information • In elderly people with dementia, a small increase in the number of deaths 1. WHAT TRIFLUOPERAZINE 1mg/5ml SYRUP IS AND WHAT IT IS USED FOR has been reported for patients taking antipsychotics compared with those not receiving antipsychotics. Trifluoperazine 1mg/5ml Syrup contains the active ingredient trifluoperazine Some patients may also experience weakness, drowsiness, dizziness, hydrochloride, which belongs to a class of drugs called phenothiazine restlessness, difficulty in sleeping, dry mouth, blurred vision, muscle tranquilisers, also referred to as a neuroleptic drug. It influences the activity weakness, loss of appetite, faintness on standing up, skin rashes (including of certain brain cells by decreasing the effect of dopamine, a natural increased sensitivity to the sun), weight gain, water retention causing chemical in the brain. swelling or confusion. • At a low dose, Trifluoperazine 1mg/5ml Syrup is used to manage anxiety Your doctor should check your progress regularly if you are on and depression. It is used in this way for short periods of time. Trifluoperazine 1mg/5ml Syrup to make sure no unwanted effects are Trifluoperazine 1mg/5ml Syrup may also be used to treat nausea (feeling developing. sick) and vomiting (being sick). If any of the side effects become serious, or if you notice any side effects not • At high doses, Trifluoperazine 1mg/5ml Syrup is used to treat and prevent listed in this leaflet, please tell your doctor or pharmacist. relapses of schizophrenia (a serious mental illness). It can also be used 5. HOW TO STORE TRIFLUOPERAZINE 1mg/5ml SYRUP for short periods of time to treat bad agitation or dangerous behaviour. Keep this medicine out of the sight and reach of children. 2. BEFORE YOU TAKE TRIFLUOPERAZINE 1mg/5ml SYRUP Do not use Trifluoperazine 1mg/5ml Syrup after the expiry date which is DO NOT take Trifluoperazine 1mg/5ml Syrup if: stated on the box. The expiry date refers to the last day of that month. If your • You know that you are allergic to trifluoperazine hydrochloride or any of the Syrup is out of date, take it to your pharmacist who will get rid of it safely. other ingredients of Trifluoperazine 1mg/5ml Syrup (see section 6 of this Do not store above 25°C. Store in the original package. leaflet). 6. FURTHER INFORMATION • You are suffering from liver problems, blood disease, inability of the heart to maintain adequate circulation causing breathlessness and swelling of The active substance in Trifluoperazine 1mg/5ml Syrup is trifluoperazine the ankles. hydrochloride. Each 5ml spoonful of Syrup contains 1mg trifluoperazine present as hydrochloride. • If you have previously had to stop taking other medicines for psychiatric problems like trifluoperazine (known as phenothiazines) because they Trifluoperazine 1mg/5ml Syrup also contains sodium saccharin, sodium benzoate (E211), anhydrous citric acid (E330), sodium citrate, sorbitol have affected your blood cells or caused jaundice (yellowing of the skin (E420), quinoline yellow (E104), sunset yellow (E110), peach flavour and or eyes). Ask your doctor about this. purified water. Take special care with Trifluoperazine 1mg/5ml Syrup and tell your What Trifluoperazine 1mg/5ml Syrup looks like and contents of the doctor if you are: pack • suffering from any disease involving the heart and blood vessels Trifluoperazine 1mg/5ml Syrup is a clear pale yellow, peach flavoured syrup (cardiovascular disease) including chest pain (angina) and irregular heart beats and comes in amber glass bottles, containing 200ml syrup. • suffering from a brain disorder causing tremors, rigidity and slowing of Marketing Authorisation Holder movement (Parkinson’s disease) Mercury Pharmaceuticals Ltd., • suffering from fits (epilepsy) Capital House, 85 King William Street, London EC4N 7BL, UK • suffering from an eye disease called narrow angle glaucoma which Manufacturer causes increased pressure inside the eye, Laleham Health and Beauty Limited, • suffering from abnormal muscle weakness (Myasthenia gravis) Fairfield, Bradshaw Lane, Greenhalgh, Preston, Lancashire, PR4 3JA • suffering from an enlargement of prostate gland • exposed to extremes in temperature as this medicine can affect body This leaflet was last revised in December 2014. 101961/LF/139/05 temperature control 4 1 continued over • an elderly person Remember each 5ml spoonful of syrup contains 1mg of “Trifluoperazine” • if you suffer from loss of cognitive (memory, language, intelligence) ability - dementia. Patient Type Low dosage High dosage • if you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots. For the treatment of For the control of • If you have had a stroke or have any of the following that can increase your anxiety or nausea schizophrenia and risk of having a stroke (e.g. heart attack, uncontrolled high blood pressure, and vomiting related conditions diabetes, family history of strokes, you smoke or drink excess alcohol). Even though some of the above may appear obvious, it is important that your doctor is aware if any of them apply to you. Adults The usual dose is 2 mg to High dose in adults is 6mg a day 5-25mg a day in Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken divided doses any other medicines, including medicines obtained without a prescription. The effects of these medicines may change, especially if you are taking: Elderly The starting dose of The starting dose of • sleeping tablets, (over 65 years of age) syrup should be no syrup should be no • strong pain killers (e.g. codeine) more than half that of more than half that of • medicines which result in lowering of blood pressure (e.g. guanethidine) adult patients adult patients • anticholinergic medicines used to reduce saliva and lung secretions (e.g. atropine, procyclidine) Children For children aged 3-5 High dose in children • antidepressants (e.g. other phenothiazines, lithium) years, the dose is no (aged 6-12 years) is • medicines for fits (anticonvulsants) • medicines for Parkinson’s disease (e.g. levodopa) more than 1mg a day. 5mg in divided doses. • blood thinning medicines (anticoagulants such as warfarin) For children aged 6-12 • medicines used to treat iron poisoning (desferrioxamine) years the dose is no • antacids used to treat indigestion. more than 4mg a day. • medicines for psychiatric conditions (neuroleptics) • heart medicines which prolong the QT interval (e.g quinidine, disopyramide, procainamide, amiodarone, sotalol) During treatment your doctor should regularly check you for physical side • drugs causing electrolyte imbalances (e.g diuretics) effects, changes in your blood counts or liver function, and any heart You should tell your doctor or dentist that you are taking Trifluoperazine problem, especially if you taking this medicine for a long time or are also before being given an anaesthetic. taking other medicines. Taking Trifluoperazine 1mg/5ml Syrup with food and drink You should not drink alcohol whilst you are taking this medicine. If you stop taking Trifluoperazine 1mg/5ml Syrup Trifluoperazine 1mg/5ml Syrup can be taken with or without food. Continue to take Trifluoperazine 1mg/5ml Syrup even if you no longer feel ill. Pregnancy and breast feeding Do not stop taking this medicine without talking with your doctor first, Do not take Trifluoperazine 1mg/5ml Syrup if you are pregnant, think you may especially if you have taken large doses for a long time. When the time be pregnant or are planning to become pregnant, or while breast feeding, comes to stop your doctor will probably decrease your dose gradually as unless your doctor decides that treatment is essential. It is particularly important not to take Trifluoperazine 1mg/5ml Syrup during the first three stopping the Syrup suddenly may cause ill-effects such as nausea (feeling months of pregnancy.
Recommended publications
  • 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
    [Show full text]
  • Opipramol and Trifluoperazine in the Treatment of Anxiety and Tension
    A COMPARATIVE STUDY OF TWO ANTIHISTAMINES 395 In table VI are given the results of a question directed at discovering how effective the preferred treatment was compared to any other antihistamine used. Fifteen patients only were able to give this information but the results are interesting. Discussion TABLE VI The design of this study was very simple as COMPARISON WITH PREVIOUSLY USED ANTIHISTAMINE such studies must be if they are to be completed under the conditions of a busy general practice. In a condition such as hay fever where anti- Worse As good Better Total histamines are known to be etfective and where fairly rapid symptomatic relief is needed by the 2 4 9 15* patient, we did not feel justified in including a placebo. The results of the study seem fairly *In the majority of patients the previously used clear-cut that if patients are offered the choice antihistamine was the chemically related chlor- of a plain form of this antihistamine or a long- pheniramine maleate B.P. acting form more will choose the latter. Ofthose that do so, however, only about a third find a single tablet at night completely effective, the remainder have to take one further tablet during the day. Both forms of antihistamine are effective and where a retrospective comparison can be made this effectiveness is considered greater or equal to that of previously administered anti-histamines. Summary A simple comparative study under general-practice conditions of two formulations of pheniramine is described. Sixty-one per cent of patients preferred the long-acting form of this antihistamine.
    [Show full text]
  • Clomipramine Suppresses ACE2-Mediated SARS-Cov-2 Entry
    bioRxiv preprint doi: https://doi.org/10.1101/2021.03.13.435221; this version posted March 14, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. Clomipramine suppresses ACE2-mediated SARS-CoV-2 entry Yuri Kato1, Shigeru Yamada2, Kazuhiro Nishiyama1, Ayano Satsuka2, Suyong Re3, Daiki Tomokiyo1, Jae Man Lee4, Tomohiro Tanaka5, Akiyuki Nishimura5, Kenzo Yonemitsu6, Hiroshi Asakura6, Yuko Ibuki7, Yumiko Imai8, Noriho Kamiya9,10, Kenji Mizuguchi3,11, Takahiro Kusakabe12, Yasunari Kanda2*, and Motohiro Nishida1,5*,# 1 Graduate School of Pharmaceutical Sciences, Kyushu University, Fukuoka 812-8582, Japan, 2 Division of Pharmacology, National Institute of Health Sciences (NIHS), Kanagawa, 210-9501, Japan 3 Artificial Intelligence Center for Health and Biomedical Research (ArCHER), National Institutes of Biomedical Innovation, Health and Nutrition, 7-6-8 Saito-Asagi, Ibaraki, Osaka, 567-0085, Japan 4 Laboratory of Creative Science for Insect Industries, Faculty of Agriculture, Kyushu University, Motooka 744, Nishi-ku, Fukuoka, 819-0395, Japan 5 National Institute for Physiological Sciences & Exploratory Research Center on Life and Living Systems, National Institutes of Natural Sciences, Okazaki, 444-8787, Japan 6 Division of Biomedical Food Research, National Institute of Health Sciences (NIHS), Kanagawa, 210-9501, Japan 7 Graduate Division of Nutritional and Environmental Sciences, University of Shizuoka, 52-1 Yada, Shizuoka 422-8526, Japan bioRxiv preprint doi: https://doi.org/10.1101/2021.03.13.435221; this version posted March 14, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved.
    [Show full text]
  • 3,2,4 Tricyclic Antidepressants and the Risk of Congenital Malformation
    Tricyclic antidepressants and the risk of congenital malformations CONFIDENTIAL Medicines Adverse Reactions Committee Meeting date 3/12/2020 Agenda item 3.2.4 Title Tricyclic antidepressants and the risk of congenital malformations Submitted by Medsafe Pharmacovigilance Paper type For advice Team Active ingredient Product name Sponsor Amitriptyline Arrow-Amitriptyline Film coated tablet, 10 mg, 25 Teva Pharm (NZ) Ltd mg & 50 mg Amirol Film coated tablet, 10 mg & 25 mg AFT Pharmaceuticals Ltd Clomipramine Apo-Clomipramine Film coated tablet, 10 mg & Apotex NZ Ltd 25 mg Anafranil Tablet, 10 mg Section 29 Dosulepin Dosulepin Mylan Film coated tablet, 75 mg Mylan New Zealand Ltd Dosulepin Mylan Capsule, 25 mg Section 29 Doxepin Anten 50 Capsule, 50 mg Mylan New Zealand Ltd Imipramine Tofranil Coated tablet, 10 mg & 25 mg AFT Pharmaceuticals Ltd Nortriptyline Norpress Tablet, 10 mg & 25 mg Mylan New Zealand Ltd PHARMAC funding Product highlighted in bold above are funded on the Community Schedule. Two products (shown in italics) are funded but only available under Section 29 of the Medicines Act (ie, the products have not been approved by Medsafe). Previous MARC In utero exposure to serotonin reuptake inhibitors and risk of congenital meetings abnormalities 141st meeting March 2010 International action None Prescriber Update The use of antidepressants in pregnancy September 2010 Classification Prescription medicine Usage data The following pregnancy usage data for 2019 was obtained from the National Collections using the Pharmaceutical Dispensing in Pregnancy application in Qlik. The table shows the total number of dispensings, repeat dispensings and number of pregnancies exposed during first trimester (defined as 30 days prior to the estimated pregnancy start date to week 13) for pregnancies that ended in 2019.
    [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]
  • 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.
    [Show full text]
  • 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).
    [Show full text]
  • Perphenazine Shortage
    Perphenazine Shortage Perphenazine is currently only marketed by one company, AA Pharma Inc.1 DIN Company Brand Name Active ingredient Strength 00335096 AA PHARMA INC PERPHENAZINE PERPHENAZINE 16 MG 00335118 AA PHARMA INC PERPHENAZINE PERPHENAZINE 8 MG 00335126 AA PHARMA INC PERPHENAZINE PERPHENAZINE 4 MG 00335134 AA PHARMA INC PERPHENAZINE PERPHENAZINE 2 MG Perphenazine is a piperazine phenothiazine.2 Indications3: Psychotic disorders Nausea and vomiting Shortage management strategies: 1. Ensure medication is indicated. For example, first general antipsychotics should be avoided if possible in elderly patients.4 If no clear indication, consider tapering patient off the medication. 2. Therapeutic alternatives2,4: a) Phenothiazines are the most similar pharmacologic alternatives: CPE* Drug Psychotic Disorder: Nausea and Vomiting: (perphenazine Suggested Dose Suggested Dose = 10 mg) Initial dose: 25–75 mg daily in 2–4 divided doses. Daily dose may be ↑twice weekly by 25– 50 mg until symptoms are controlled. During an acute 12.5–25 mg Q 4–6H Chlorpromazine 100 mg episode of schizophrenia: 300– Increase dose as needed and 1000 mg/day tolerated Maintenance dose: 300–600 mg/day given in 1 or 2 divided doses with larger dose at bedtime 2.5–10 mg daily in divided doses Q6–8H Fluphenazine 2 mg Usual dose: 1–5 mg daily as a single dose Initial dose: 25–75 mg/day; use caution if starting with >100 Methotrimeprazine 70 mg mg/day Usual dose: 50–200 mg/day Divided in 1–3 doses Prochlorperazine ? 5–10 mg 3–4 times daily 2–5 mg BID or TID Trifluoperazine 5 mg Usual dose: 15–20 mg/day * Chlorpromazine 100 mg equivalent b) Other first generation antipsychotics e.g.
    [Show full text]
  • Schizoaffective Disorder?
    WHAT IS SCHIZOAFFECTIVE DISORDER? BASIC FACTS • SYMPTOMS • FAMILIES • TREATMENTS RT P SE A Mental Illness Research, Education and Clinical Center E C I D F I A C VA Desert Pacific Healthcare Network V M R E E Long Beach VA Healthcare System N T T N A E L C IL L LN A E IC S IN Education and Dissemination Unit 06/116A S R CL ESE N & ARCH, EDUCATIO 5901 E. 7th street | Long Beach, CA 90822 basic facts Schizoaffective disorder is a chronic and treatable psychiatric Causes illness. It is characterized by a combination of 1) psychotic symp- There is no simple answer to what causes schizoaffective dis- toms, such as those seen in schizophrenia and 2) mood symptoms, order because several factors play a part in the onset of the dis- such as those seen in depression or bipolar disorder. It is a psychi- order. These include a genetic or family history of schizoaffective atric disorder that can affect a person’s thinking, emotions, and be- disorder, schizophrenia, or bipolar disorder, biological factors, en- haviors and can impact all aspects of daily living, including work, vironmental stressors, and stressful life events. school, social relationships, and self-care. Research shows that the risk of schizoaffective disorder re- Schizoaffective disorder is considered a psychotic disorder sults from the influence of genes acting together with biological because of its prominent features of hallucinations and delusions. and environmental factors. A family history of schizoaffective dis- Therefore, people with this illness have periods when they have order does not necessarily mean children or other relatives will difficulty understanding the reality around them.
    [Show full text]
  • 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 ..................................
    [Show full text]
  • 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.
    [Show full text]
  • The Effects of Stimulants and Depressants on Cocaine Self-Administration Behavior in the Rhesus Monkey
    Psychopharmacologia (Bed.) 31, 291--304 (1973) by Springer-Verlag 1973 The Effects of Stimulants and Depressants on Cocaine Self-Administration Behavior in the Rhesus Monkey M. C. Wilson* and C. R. Schuster** Pharmacology Department, University of Michigan Medical School Ann Arbor, Michigan Received June 22, 1972 Abstract. The effects of acute intramuscular pretreatment with several dosages of a variety of centrally acting compounds on intravenous cocaine self-administra- tion behavior were ascertained. Pretreatment with morphine and pentobarbital produced no change in this behavior until dosages (2.0 mg/kg and 15.0 mg/kg respectively) were administered which grossly depressed grooming, exploratory, and locomotor activity behaviors, d-amphetamine (0.5--4.0 mg/kg) and phenmetra- zine (2.0--12.0 mg/kg) pretreatment produced a dose-related decrease in cocaine self-administration. Trifluoperazine in dosages of 0.01--0.1 mg/kg increased the frequency of this behavior; whereas, higher dosages (0,2, 0.4mg/kg) grossly depressed behavior. Imipramine (10--50 mg/kg) produced a dose-related decrease in cocaine self-administration. Potential mechanisms of these drug--behavior and drug--drug interactions are discussed. Key words: Self-Administration -- Cocaine -- Morphine -- Pentobarbital -- Trifluoperazine. Previous investigations have demonstrated an inverse relationship between reinforcing unit dosages (dosage per injection) and the fre- quency of psychomotor stimulant (including cocaine) intravenous self- administration behavior in Rhesus monkeys (Wilson, Hitomi, and Schuster, 1971; Woods and Schuster, 1968; Goldberg, Hoffmeister, Sehlichting, and Wuttke, 1971). Furthermore, when allowed limited daily access to these agents, a subject's total daily drug intake was very stable. Similar results have also been reported by several authors using rats as experimental subjects with intravenously self-administered eoeaine (Piekens and Thomson, 1968), methamphetamine (Piekens, Meisch, and McGuire, 1967) and d-amphetamine (Piekens and Harris, 1968).
    [Show full text]