DOSULEPIN MYLAN 1. Product Name 2. Qualitative and Quantitative
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Dosulepin Prescribing
SAFETY BULLETIN: DOSULEPIN PRESCRIBING In December 2007, the Medicines and Healthcare Regulatory Agency (MHRA) issued safety advice around prescribing of dosulepin, related to the narrow margin between therapeutic doses and potentially fatal doses. Nevertheless, dosulepin continues to be prescribed widely. Over eight years after the safety advice was published, prescribing of dosulepin in the Dorset area remains high. In the South West area, Dorset CCG was the highest prescriber of dosulepin for the 2015/16 financial year (3.238% of all antidepressant items). Of the 209 CCGs in the UK, Dorset is the fourteenth highest prescriber of dosulepin, and well above the national average of 2.111%. The following points summarise the reasons that dosulepin is not recommended for prescribing nationally, and in Dorset: Dosulepin has a small margin of safety between the (maximum) therapeutic dose and potentially fatal doses. The NICE guideline on depression in adults recommends that dosulepin should not be prescribed for adults with depression because evidence supporting its tolerability relative to other antidepressants is outweighed by the increased cardiac risk and toxicity in overdose. Dosulepin has also been used ‘off label’ in other indications such as fibromyalgia and neuropathic pain. However the evidence for use in in this way is weak, and is not recommended. The lethal dose of dosulepin is relatively low and can be potentiated by alcohol and other CNS depressants. Dosulepin overdose is associated with high mortality and can occur rapidly, even before hospital treatment can be received. Onset of toxicity occurs within 4-6 hours. Every year, up to 200 people in England and Wales fatally overdose with dosulepin. -
Dose Equivalents of Antidepressants Evidence-Based Recommendations
Journal of Affective Disorders 180 (2015) 179–184 Contents lists available at ScienceDirect Journal of Affective Disorders journal homepage: www.elsevier.com/locate/jad Research report Dose equivalents of antidepressants: Evidence-based recommendations from randomized controlled trials Yu Hayasaka a,n, Marianna Purgato b, Laura R Magni c, Yusuke Ogawa a, Nozomi Takeshima a, Andrea Cipriani b,d, Corrado Barbui b, Stefan Leucht e, Toshi A Furukawa a a Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Yoshida Konoe-cho, Sakyo- ku, Kyoto 606-8501, Japan b Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Policlinico “G.B.Rossi”, Pzz.le L.A. Scuro, 10, Verona 37134, Italy c Psychiatric Unit, Istituto di Ricovero e Cura a Carattere Scientifico, Centro San Giovanni di Dio, Fatebenefratelli, Brescia, Italy d Department of Psychiatry, University of Oxford, Oxford, UK e Department of Psychiatry and Psychotherapy, Technische Universität München, Klinikum rechts der Isar, Ismaningerstr. 22, 81675 Munich, Germany article info abstract Article history: Background: Dose equivalence of antidepressants is critically important for clinical practice and for Received 4 February 2015 research. There are several methods to define and calculate dose equivalence but for antidepressants, Received in revised form only daily defined dose and consensus methods have been applied to date. The purpose of the present 10 March 2015 study is to examine dose equivalence of antidepressants by a less arbitrary and more systematic method. Accepted 12 March 2015 Methods: We used data from all randomized, double-blind, flexible-dose trials comparing fluoxetine or Available online 31 March 2015 paroxetine as standard drugs with any other active antidepressants as monotherapy in the acute phase Keywords: treatment of unipolar depression. -
Appendix A: Potentially Inappropriate Prescriptions (Pips) for Older People (Modified from ‘STOPP/START 2’ O’Mahony Et Al 2014)
Appendix A: Potentially Inappropriate Prescriptions (PIPs) for older people (modified from ‘STOPP/START 2’ O’Mahony et al 2014) Consider holding (or deprescribing - consult with patient): 1. Any drug prescribed without an evidence-based clinical indication 2. Any drug prescribed beyond the recommended duration, where well-defined 3. Any duplicate drug class (optimise monotherapy) Avoid hazardous combinations e.g.: 1. The Triple Whammy: NSAID + ACE/ARB + diuretic in all ≥ 65 year olds (NHS Scotland 2015) 2. Sick Day Rules drugs: Metformin or ACEi/ARB or a diuretic or NSAID in ≥ 65 year olds presenting with dehydration and/or acute kidney injury (AKI) (NHS Scotland 2015) 3. Anticholinergic Burden (ACB): Any additional medicine with anticholinergic properties when already on an Anticholinergic/antimuscarinic (listed overleaf) in > 65 year olds (risk of falls, increased anticholinergic toxicity: confusion, agitation, acute glaucoma, urinary retention, constipation). The following are known to contribute to the ACB: Amantadine Antidepressants, tricyclic: Amitriptyline, Clomipramine, Dosulepin, Doxepin, Imipramine, Nortriptyline, Trimipramine and SSRIs: Fluoxetine, Paroxetine Antihistamines, first generation (sedating): Clemastine, Chlorphenamine, Cyproheptadine, Diphenhydramine/-hydrinate, Hydroxyzine, Promethazine; also Cetirizine, Loratidine Antipsychotics: especially Clozapine, Fluphenazine, Haloperidol, Olanzepine, and phenothiazines e.g. Prochlorperazine, Trifluoperazine Baclofen Carbamazepine Disopyramide Loperamide Oxcarbazepine Pethidine -
Efficacy of Dosulepin in Tension Type Headache and Midfacial Pain a Randomised Controlled Study
IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) e-ISSN: 2279-0853, p-ISSN: 2279-0861.Volume 19, Issue 3 Ser.4 (March. 2020), PP 10-14 www.iosrjournals.org Efficacy of Dosulepin in Tension Type Headache and Midfacial Pain a Randomised Controlled Study Corresponding Author: XXXXX Abstract Introduction: Patients presenting with pain in the facial region are commonly reffered to Otorhinolaryngologist. Due to the various causative factors causing pain in the facial region, the proper diagnosis and more importantly the skill to rule out the sinogenic pain plays an important role in management. Tension type headache and midfacial pain are often misdiagnosed and treated wrongly and thus add to the morbidity of patients. Of all the medications that are used for the treatment, most provide minimal, short term relief with side effects on prolong use. Dosulepin a Tricyclic Antidepressant helps in relieving pain with minimal side effects as compared to other Tricyclic Antidepressants. Aims and Objective: To study the efficacy of dosulepin in patients attending outpatient Department of otorhinolaryngology of Silchar Medical College and Hospital Methods: 130 patients attending outpatient Department of ENT and Head and Neck Surgery of Silchar Medical College & Hospital, from September 2017 to August 2018 with complaints of headache diagnosed as tension type headache and midfacial pain were evaluated. Neurological and radiographic examinations were performed prior to therapy and local cause of pain in the facial region were ruled out. Together with this we also performed psychic evaluation for those patients who could not be withdrawn from current medication and then to start them on our current medication. -
Cambridgeshire and Peterborough Joint Prescribing Group MEDICINE REVIEW
Cambridgeshire and Peterborough Joint Prescribing Group MEDICINE REVIEW Name of Medicine / Trimipramine (Surmontil®) Class (generic and brand) Licensed indication(s) Treatment of depressive illness, especially where sleep disturbance, anxiety or agitation are presenting symptoms. Sleep disturbance is controlled within 24 hours and true antidepressant action follows within 7 to 10 days. Licensed dose(s) Adults: For depression 50-75 mg/day initially increasing to 150-300 mg/day in divided doses or one dose at night. The maintenance dose is 75-150 mg/day. Elderly: 10-25 mg three times a day initially. The initial dose should be increased with caution under close supervision. Half the normal maintenance dose may be sufficient to produce a satisfactory clinical response. Children: Not recommended. Purpose of Document To review information currently available on this class of medicines, give guidance on potential use and assign a prescribing classification http://www.cambsphn.nhs.uk/CJPG/CurrentDrugClassificationTable.aspx Annual cost (FP10) 10mg three times daily: £6,991 25mg three times daily: £7,819 150mg daily: £7,410 300mg daily: £14,820 Alternative Treatment Options within Class Tricyclic Annual Cost CPCCG Formulary Classification Antidepressant (FP10) Amitriptyline (75mg) Formulary £36 Lofepramine (140mg) Formulary £146 Imipramine (75mg) Non-formulary £37 Clomipramine (75mg) Non-formulary £63 Trimipramine (75mg). TBC £7,819 Nortriptyline (75mg) Not Recommended (pain) £276 Doxepin (150mg) TBC £6,006 Dosulepin (75mg) Not Recommended (NICE DO NOT DO) £19 Dosages are based on possible maintenance dose and are not equivalent between medications Recommendation It is recommended to Cambridgeshire and Peterborough CCG JPG members and through them to local NHS organisations that the arrangements for use of trimipramine are in line with restrictions agreed locally for drugs designated as NOT RECOMMENDED:. -
Properties and Units in Clinical Pharmacology and Toxicology
Pure Appl. Chem., Vol. 72, No. 3, pp. 479–552, 2000. © 2000 IUPAC INTERNATIONAL FEDERATION OF CLINICAL CHEMISTRY AND LABORATORY MEDICINE SCIENTIFIC DIVISION COMMITTEE ON NOMENCLATURE, PROPERTIES, AND UNITS (C-NPU)# and INTERNATIONAL UNION OF PURE AND APPLIED CHEMISTRY CHEMISTRY AND HUMAN HEALTH DIVISION CLINICAL CHEMISTRY SECTION COMMISSION ON NOMENCLATURE, PROPERTIES, AND UNITS (C-NPU)§ PROPERTIES AND UNITS IN THE CLINICAL LABORATORY SCIENCES PART XII. PROPERTIES AND UNITS IN CLINICAL PHARMACOLOGY AND TOXICOLOGY (Technical Report) (IFCC–IUPAC 1999) Prepared for publication by HENRIK OLESEN1, DAVID COWAN2, RAFAEL DE LA TORRE3 , IVAN BRUUNSHUUS1, MORTEN ROHDE1, and DESMOND KENNY4 1Office of Laboratory Informatics, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark; 2Drug Control Centre, London University, King’s College, London, UK; 3IMIM, Dr. Aiguader 80, Barcelona, Spain; 4Dept. of Clinical Biochemistry, Our Lady’s Hospital for Sick Children, Crumlin, Dublin 12, Ireland #§The combined Memberships of the Committee and the Commission (C-NPU) during the preparation of this report (1994–1996) were as follows: Chairman: H. Olesen (Denmark, 1989–1995); D. Kenny (Ireland, 1996); Members: X. Fuentes-Arderiu (Spain, 1991–1997); J. G. Hill (Canada, 1987–1997); D. Kenny (Ireland, 1994–1997); H. Olesen (Denmark, 1985–1995); P. L. Storring (UK, 1989–1995); P. Soares de Araujo (Brazil, 1994–1997); R. Dybkær (Denmark, 1996–1997); C. McDonald (USA, 1996–1997). Please forward comments to: H. Olesen, Office of Laboratory Informatics 76-6-1, Copenhagen University Hospital (Rigshospitalet), 9 Blegdamsvej, DK-2100 Copenhagen, Denmark. E-mail: [email protected] Republication or reproduction of this report or its storage and/or dissemination by electronic means is permitted without the need for formal IUPAC permission on condition that an acknowledgment, with full reference to the source, along with use of the copyright symbol ©, the name IUPAC, and the year of publication, are prominently visible. -
NORPRAMIN® (Desipramine Hydrochloride Tablets USP)
NORPRAMIN® (desipramine hydrochloride tablets USP) Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of NORPRAMIN or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. NORPRAMIN is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.) DESCRIPTION NORPRAMIN® (desipramine hydrochloride USP) is an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz[bƒ]azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. 1 Reference ID: 3536021 Inactive Ingredients The following inactive ingredients are contained in all dosage strengths: acacia, calcium carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except 10 mg and 150 mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated soy oil, iron oxide, light mineral oil, magnesium stearate, mannitol, polyethylene glycol 8000, pregelatinized corn starch, sodium benzoate (except 150 mg), sucrose, talc, titanium dioxide, and other ingredients. -
A Drug Repositioning Approach Identifies Tricyclic Antidepressants As Inhibitors of Small Cell Lung Cancer and Other Neuroendocrine Tumors
Published OnlineFirst September 26, 2013; DOI: 10.1158/2159-8290.CD-13-0183 RESEARCH ARTICLE A Drug Repositioning Approach Identifi es Tricyclic Antidepressants as Inhibitors of Small Cell Lung Cancer and Other Neuroendocrine Tumors Nadine S. Jahchan 1 , 2 , Joel T. Dudley 1 , Pawel K. Mazur 1 , 2 , Natasha Flores 1 , 2 , Dian Yang 1 , 2 , Alec Palmerton 1 , 2 , Anne-Flore Zmoos 1 , 2 , Dedeepya Vaka 1 , 2 , Kim Q.T. Tran 1 , 2 , Margaret Zhou 1 , 2 , Karolina Krasinska 3 , Jonathan W. Riess 4 , Joel W. Neal 5 , Purvesh Khatri 1 , 2 , Kwon S. Park 1 , 2 , Atul J. Butte 1 , 2 , and Julien Sage 1 , 2 Downloaded from cancerdiscovery.aacrjournals.org on September 29, 2021. © 2013 American Association for Cancer Research. Published OnlineFirst September 26, 2013; DOI: 10.1158/2159-8290.CD-13-0183 ABSTRACT Small cell lung cancer (SCLC) is an aggressive neuroendocrine subtype of lung cancer with high mortality. We used a systematic drug repositioning bioinformat- ics approach querying a large compendium of gene expression profi les to identify candidate U.S. Food and Drug Administration (FDA)–approved drugs to treat SCLC. We found that tricyclic antidepressants and related molecules potently induce apoptosis in both chemonaïve and chemoresistant SCLC cells in culture, in mouse and human SCLC tumors transplanted into immunocompromised mice, and in endog- enous tumors from a mouse model for human SCLC. The candidate drugs activate stress pathways and induce cell death in SCLC cells, at least in part by disrupting autocrine survival signals involving neurotransmitters and their G protein–coupled receptors. The candidate drugs inhibit the growth of other neuroendocrine tumors, including pancreatic neuroendocrine tumors and Merkel cell carcinoma. -
PERPHENAZINE and AMITRIPTYLINE HYDROCHLORIDE- Perphenazine and Amitriptyline Hydrochloride Tablet, Film Coated Mylan Pharmaceuticals Inc
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE- perphenazine and amitriptyline hydrochloride tablet, film coated Mylan Pharmaceuticals Inc. ---------- 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. Perphenazine and amitriptyline hydrochloride is not approved for the treatment of patients with dementia- related psychosis (see WARNINGS). Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of perphenazine and amitriptyline or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. -
Detecting Depression and Anxiety in Older Adults
Detecting Depression and Anxiety in Older Adults Dr Nick Woodthorpe Depression in Older Adults Introduction to Depression • 1 in 5 older people living in the community • 2 in 5 living in care homes Causes of Depression • Painful events • Past depression or family history • Personality • Physical illness • Medicines • Drugs and Alcohol • Loneliness Particular Issues in Depression • Physical symptoms, for example, thyroid problems, heart disease or arthritis. • Long-term illness • Confusion and memory problems • A new sense of loneliness/lack of purpose Depression - Symptoms • 2 weeks • No hypomania or mania • No psychoactive drugs • No organic mental disorder Depression - Symptoms • Feeling low or sad (they may not report this) • Loss of interest in life • Low energy and tired for no reason Depression - Symptoms • Change in appetite and weight • Restlessness or psychomotor retardation • Anxious • Avoidance • Irritable • Sleep disturbance • Loss of confidence and self-esteem Depression - Symptoms • Hopelessness and worthlessness • Poor concentration • Panicky • Loss of libido • Sense of guilt • Suicidal thoughts • Delusions or hallucinations Depression - Diagnostic Categories • Mild • Moderate • Severe with or without psychosis • Recurrent Anxiety in Later Life Everyone gets anxious sometimes Everyone gets anxious sometimes Fight or Flight Response Fight or Flight Response Causes of anxiety in later life • Painful events • Stress • Past experiences- upbringing/Childhood • Personality • Physical illness • Medicines • Diet - caffeine, excess -
Light Scattering Studies of Amphiphilic Drugs Promethazine Hydrochloride and Imipramine Hydrochloride in Aqueous Electrolyte Solutions
12962 J. Phys. Chem. B 2008, 112, 12962–12967 Light Scattering Studies of Amphiphilic Drugs Promethazine Hydrochloride and Imipramine Hydrochloride in Aqueous Electrolyte Solutions Md. Sayem Alam,† Goutam Ghosh,‡ and Kabir-ud-Din*,† Department of Chemistry, Aligarh Muslim UniVersity, Aligarh-202 002, India, and UGC-DAE Consortium for Scientific Research, Trombay, Mumbai- 400 085, India ReceiVed: May 13, 2008; ReVised Manuscript ReceiVed: August 1, 2008 Two amphiphilic drugs, promethazine hydrochloride (PMT) and imipramine hydrochloride (IMP), have been studied using both static and dynamic light scattering techniques. Due to having rigid tricyclic hydrophobic moieties in their molecules, these drugs show interesting association behavior. The static light scattering (SLS) measurements show that the self-association commenced above a well-defined critical micellar concentration (cmc), which decreases with increasing NaBr concentration. The Gibbs energy of micellization, 0 ∆GM, in all cases, is negative. The colloidal stability of the system in terms of the interparticle interaction at different NaBr concentrations was studied using the dynamic light scattering (DLS) technique. The experimentally evaluated interparticle interaction parameter (kD) was compared with the Derjaguin-Landau- Verwey-Overbeek (DLVO) model. Interestingly, these two drugs with similar molecular structure show difference in their interparticle interactions, e.g., PMT showed complete agreement with the DLVO model whereas IMP showed clear deviation from this model at lower concentrations and agreement at higher concentrations of NaBr. 1. Introduction SCHEME 1: Molecular Structure of Promethazine Hydrochloride, PMT (a), and Imipramine Hydrochloride, Many drug molecules are amphiphilic and self-associate in IMP (b) a surfactant-like manner in aqueous environment to form small aggregates. -
Male Anorgasmia: from “No” to “Go!”
Male Anorgasmia: From “No” to “Go!” Alexander W. Pastuszak, MD, PhD Assistant Professor Center for Reproductive Medicine Division of Male Reproductive Medicine and Surgery Scott Department of Urology Baylor College of Medicine Disclosures • Endo – speaker, consultant, advisor • Boston Scientific / AMS – consultant • Woven Health – founder, CMO Objectives • Understand what delayed ejaculation (DE) and anorgasmia are • Review the anatomy and physiology relevant to these conditions • Review what is known about the causes of DE and anorgasmia • Discuss management of DE and anorgasmia Definitions Delayed Ejaculation (DE) / Anorgasmia • The persistent or recurrent delay, difficulty, or absence of orgasm after sufficient sexual stimulation that causes personal distress Intravaginal Ejaculatory Latency Time (IELT) • Normal (median) à 5.4 minutes (0.55-44.1 minutes) • DE à mean IELT + 2 SD = 25 minutes • Incidence à 2-11% • Depends in part on definition used J Sex Med. 2005; 2: 492. Int J Impot Res. 2012; 24: 131. Ejaculation • Separate event from erection! • Thus, can occur in the ABSENCE of erection! Periurethral muscle Sensory input - glans (S2-4) contraction Emission Vas deferens contraction Sympathetic input (T12-L1) SV, prostate contraction Bladder neck contraction Expulsion Bulbocavernosus / Somatic input (S1-3) spongiosus contraction Projectile ejaculation J Sex Med. 2011; 8 (Suppl 4): 310. Neurochemistry Sexual Response Areas of the Brain • Pons • Nucleus paragigantocellularis Neurochemicals • Norepinephrine, serotonin: • Inhibit libido,