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The SULPYCO Method Using Sulpiride Integrated with an Atypical Adjuvant Therapy for Treating Depressive Syndrome: an Observational Study Amgad M
oepidem ac io m lo r g a y Rabie, Adv Pharmacoepidem Drug Safety 2013, 2:1 h & P Advances in Pharmacoepidemiology & D n i DOI: 10.4172/2167-1052.1000126 r u s g e c ISSN: 2167-1052 S n a a f v e t d y A Drug Safety Research Article Open Access The SULPYCO Method Using Sulpiride Integrated with an Atypical Adjuvant Therapy for Treating Depressive Syndrome: An Observational Study Amgad M. Rabie* Pharmaceutical Organic Chemistry Department, Faculty of Pharmacy, Mansoura University, Mansoura, Dakahlia Governorate, Egypt Abstract In this observational study, we studied the effects of a new drug combination on depression. Patients were analyzed before and after antidepressant treatment using the Hamilton rating scale for depression (HAMD). One group of patients was treated with the new integrated medicine consisting of two separate subcutaneous injections of a low dose (20 mg) of sulpiride and a 2.2 ml complex homeopathic solution based on the Krebs cycle elements; each injection was administered once daily. Another group of patients was treated with conventional therapy of 20 mg sulpiride only. The third group was treated with only the homeopathic solution. The differences in the HAMD scores were evaluated before and after 3 months of treatment in these three groups of patients. The HAMD score showed a statistically significant decrease in the group treated with combined sulpiride and homeopathy. This observation suggests that a low parenteral dose (20 mg) of sulpiride, when administered subcutaneously with a complex homeopathic remedy, may give better therapeutic results for mild and moderate depression than either sulpiride or complex homeopathy alone. -
Pharmaceuticals and Medical Devices Safety Information No
Pharmaceuticals and Medical Devices Safety Information No. 258 June 2009 Table of Contents 1. Selective serotonin reuptake inhibitors (SSRIs) and aggression ······································································································································ 3 2. Important Safety Information ······································································· 10 . .1. Isoflurane ························································································· 10 3. Revision of PRECAUTIONS (No. 206) Olmesartan medoxomil (and 3 others)··························································· 15 4. List of products subject to Early Post-marketing Phase Vigilance.....................................................17 Reference 1. Project for promoting safe use of drugs.............................................20 Reference 2. Manuals for Management of Individual Serious Adverse Drug Reactions..................................................................................21 Reference 3. Extension of cooperating hospitals in the project for “Japan Drug Information Institute in Pregnancy” ..............25 This Pharmaceuticals and Medical Devices Safety Information (PMDSI) is issued based on safety information collected by the Ministry of Health, Labour and Welfare. It is intended to facilitate safer use of pharmaceuticals and medical devices by healthcare providers. PMDSI is available on the Pharmaceuticals and Medical Devices Agency website (http://www.pmda.go.jp/english/index.html) and on the -
Use and Cardiovascular Safety of Transdermal and Other Granisetron Preparations in Cancer Management
Cancer Management and Research Dovepress open access to scientific and medical research Open Access Full Text Article REVIEW Use and cardiovascular safety of transdermal and other granisetron preparations in cancer management 1 Jay W Mason Abstract: 5-HT3 antagonists have been available as oral and intravenous preparations for Thomas E Moon2 decades. The availability more recently of transdermal granisetron and the anticipated availability of a subcutaneous granisetron preparation have provided helpful alternatives to patients, and 1School of Medicine, University of Utah, Salt Lake City, UT, these preparations have been shown to have less potential to prolong QT than other drugs in 2Tarizona eHealth Services, Inc, the class. Emeryville, CA, USA Keywords: chemotherapy-induced nausea, vomiting, granisetron, QT prolongation Introduction Problem of chemotherapy-induced nausea and vomiting For personal use only. Chemotherapy-induced nausea and vomiting (CINV) occurs in 10%–90% of patients, depending on the emetic risk of the chemotherapeutic agent.1,2 There is a consider- able cost involved, not only for the expense of hospitalization and the direct treatment of CINV, but also because of the loss of workdays and the consequences of delayed 3–7 chemotherapy administration. There is consistent evidence that 5-HT3 antagonist antiemetic therapy has improved this problem without increasing the cost.3–7 Unmet needs in CINV treatment Delayed nausea and vomiting occurring hours or days after chemotherapy, either as a result of reduced plasma concentrations -
In February 2013, Glaxosmithkline (GSK) Announced a Commitment To
In February 2013, GlaxoSmithKline (GSK) announced a commitment to further clinical transparency through the public disclosure of GSK Clinical Study Reports (CSRs) on the GSK Clinical Study Register. The following guiding principles have been applied to the disclosure: Information will be excluded in order to protect the privacy of patients and all named persons associated with the study Patient data listings will be completely removed* to protect patient privacy. Anonymized data from each patient may be made available subject to an approved research proposal. For further information please see the Patient Level Data section of the GSK Clinical Study Register. Aggregate data will be included; with any direct reference to individual patients excluded *Complete removal of patient data listings may mean that page numbers are no longer consecutively numbered CONFIDENTIAL HM2009/00361/00HM2009/00361/00 TheThe GlaxoSmithKline GlaxoSmithKline group group of companies of companies NKP106254 Division: Worldwide Development Retention Category: GRS019 Information Type: Clinical Pharmacology Study Report Title: Randomised, double-blind, placebo controlled, cross-over study comparing the effects of both single dose and repeated dosing treatment for 14 days of vestipitant or vestipitant + paroxetine combination in an enriched population of subjects with tinnitus & hearing loss. Phase: II Compound Number: GW597599 Effective Date: 10-DEC-2009 Description: Tinnitus associated with hearing loss is a high prevalent audiologic disorder with important unmet needs as far as therapy is concerned. The present study explored the possible beneficial effects on tinnitus loudness or annoyance of a combination drug treatment aimed to increase the local inhibitory activity of neural circuitries involved in sound perception and generation. -
Pharmacology and Toxicology of Amphetamine and Related Designer Drugs
Pharmacology and Toxicology of Amphetamine and Related Designer Drugs U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES • Public Health Service • Alcohol Drug Abuse and Mental Health Administration Pharmacology and Toxicology of Amphetamine and Related Designer Drugs Editors: Khursheed Asghar, Ph.D. Division of Preclinical Research National Institute on Drug Abuse Errol De Souza, Ph.D. Addiction Research Center National Institute on Drug Abuse NIDA Research Monograph 94 1989 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Alcohol, Drug Abuse, and Mental Health Administration National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 For sale by the Superintendent of Documents, U.S. Government Printing Office Washington, DC 20402 Pharmacology and Toxicology of Amphetamine and Related Designer Drugs ACKNOWLEDGMENT This monograph is based upon papers and discussion from a technical review on pharmacology and toxicology of amphetamine and related designer drugs that took place on August 2 through 4, 1988, in Bethesda, MD. The review meeting was sponsored by the Biomedical Branch, Division of Preclinical Research, and the Addiction Research Center, National Institute on Drug Abuse. COPYRIGHT STATUS The National Institute on Drug Abuse has obtained permission from the copyright holders to reproduce certain previously published material as noted in the text. Further reproduction of this copyrighted material is permitted only as part of a reprinting of the entire publication or chapter. For any other use, the copyright holder’s permission is required. All other matieral in this volume except quoted passages from copyrighted sources is in the public domain and may be used or reproduced without permission from the Institute or the authors. -
( 12 ) United States Patent
US009974742B2 (12 ) United States Patent (10 ) Patent No. : US 9 , 974 , 742 B2 Ottoboni et al. (45 ) Date of Patent: * May 22, 2018 ( 54 ) EMULSION FORMULATIONS OF AN NK - 1 2013 /0236501 A1 * 9 /2013 Booth . .. .. .. A61K 9 /0019 424 / 400 RECEPTOR ANTAGONIST AND USES 2013 /0317016 AL 11 /2013 Hingorani et al. THEREOF 2016 / 0024092 Al 1 / 2016 Wan et al. 2016 / 0082013 Al 3 / 2016 Ottoboni et al . @(71 ) Applicant : Heron Therapeutics , Inc. , Redwood 2016 /0206622 A1 3 / 2016 Ottoboni et al . City , CA (US ) 2017 / 0112847 AL 4 /2017 Ottoboni et al. @(72 ) Inventors : Thomas B . Ottoboni, Belmont, CA (US ) ; Han Han , Mountain View , CA FOREIGN PATENT DOCUMENTS (US ) CN 102379 * 3 / 2012 CN 102379845 A 3 / 2012 @(73 ) Assignee : Heron Therapeutics, Inc. , San Diego , WO WO 2005 /016308 AL 2 / 2005 WO WO 2009 / 124756 AL 10 / 2009 CA (US ) WO WO 2011 / 158053 AL 12 / 2011 WO WO 2013 / 177501 A2 11 / 2013 @( * ) Notice : Subject to any disclaimer , the term of this WO WO 2014 /0209962 AL 12 /2014 patent is extended or adjusted under 35 WO WO 2014 /005606 AL 3 / 2016 U . S . C . 154 ( b ) by 0 days . days . WO WO 2016 /044784 Al 3 / 2016 This patent is subject to a terminal dis claimer . OTHER PUBLICATIONS (21 ) Appl. No. : 15 /012 , 532 Cassileth et al. in Arch . Intern Med . 1983 ; 143 ( 7 ) : 1347 - 1349 ( Abstract ) . * Dexamethasone Hydrogen Phosphate at web .archive . org/ web / ( 22 ) Filed : Feb . 1 , 2016 20141224130045 /http :/ /www . drugs . com / pro / dexamethasone -so dium -phosphate .html ( retrieved on the internet Mar. -
Effect of Chronic Administration of Antidepressants on Duration of Immobility in Rats Forced to Swim
Effect of Chronic Administration of Antidepressants on Duration of Immobility in Rats Forced to Swim Kazuaki KAWASHIMA, Hiroaki ARAKI and Hironaka AIHARA Department of Pharmacology, Research Center, Taisho Pharamceutical Co., Ltd., Yoshino-cho 1-403, Ohmiya, Saitama 330, Japan Accepted October 14, 1985 Abstract-Chronic administration of imipramine and desipramine significantly reduced the duration of immobility in rats forced to swim in comparison with acute administration. However, amitriptyline did not potentiate the reductive effect of chronic administration. Chlorimipramine, a selective serotonin uptake inhibitor, did not affect the duration of immobility in both the acute and chronic adminis tration. On the other hand, the chronic administration of chlorpromazine, haloperidol and diazepam enhanced the duration of immobility, whereas their acute administration had no effect on it. Sulpiride reduced and enhanced the duration of immobility by the acute and chronic administration, respectively. The present results suggest that the chronic administration of drugs to rats in a forced swimming test can clarify the characteristics of the psychotropic drugs. The forced swimming test in rats and mice illnesses. So, we were very interested in is a useful model for the screening of anti investigating the effects of sulpiride in rats depressants. Porsolt et al. described that forced to swim, particularly, with regard to animals forced to swim in a restricted space the difference between its acute and chronic ceased to make attempts to escape and be administration. The present study was came immobile. This immobility was reduced performed to investigate the effects of the and extended by the acute administration of chronic administration of antidepressants, typical and atypical antidepressants and neuroleptics including sulpiride, and anxioly neuroleptics and anxiolytics, respectively (1 tics on the duration of immobility in rats 3). -
Severe Extrapyramidal Symptoms Due to Sulpiride and Fluoxetine Combination in a Case of OCD*
B. Kaya, M. Güzelipek, M. E. Özcan Severe Extrapyramidal Symptoms Due to Sulpiride and Fluoxetine Combination in a Case of OCD* Burhanettin Kaya M.D.1, Mehmet Güzelipek M.D.2, M. Erkan Özcan M.D.1 ABSTRACT: ÖZET: SEVERE EXTRAPYRAMIDAL SYMPTOMS DUE TO SULPIRIDE SÜLP‹R‹D VE FLUOKSET‹N’‹N B‹RL‹KTE KULLANIMINA BA⁄LI AND FLUOXETINE COMBINATION IN A CASE OF OCD OLARAK fi‹DDETL‹ EKSTRAP‹RAM‹DAL YAN ETK‹ ORTAYA ÇIKAN B‹R OKB OLGUSU Sulpiride is an antipsychotic agent which has an antidepressant effect in low doses. The combination of antipsychotics in lower Düflük dozlarda kullan›lan sülpiridin antidepresan etkinlik gös- dosages with antidepressants in obsessive-compulsive disorder terdi¤i bilinmektedir. Obsesif kompulsif bozuklu¤un (OKB) (OCD) patients has also been reported to be useful. The case tedavisinde düflük dozlarda antidepresan ilaçlarla birlikte kul- reported was a 53 years old female patient with OCD and major lan›labilmektedir. DSM-V’e göre OKB ve major depresyon tan›s› depression according to the DSM-IV diagnostic criteria. OCD konan 53 yafl›nda bayan hasta. 6 y›ld›r süren OKB’u, 6 ayd›r diagnosis was present for six years and she had been süren depresyonu var. Dirençli OKB olarak kabul edilen ve has- depressied for the last six months. She was accepted as having taneye yat›r›lan hastaya 20 mg/gün fluoksetin baflland›. 1 hafta resistant OCD according to the patient’s history. After she was sonra doz 40 mg’a yükseltildi ve 200 mg sülpirid eklendi. hospitalized, the treatment began with fluoksetin 20 mg/day. -
LEVOSULPIRIDE ARISTO 25 Mg, 50 Mg, 100 Mg Tablets
CMDh/223/2005 February 2014 Public Assessment Report Scientific discussion LEVOSULPIRIDE ARISTO 25 mg, 50 mg, 100 mg tablets Aristo Pharma GmbH Wallenroder Straβe 8-10 13435 Berlino Germania IT/H/534/001-003/DC Date: 15/06/2020 This module reflects the scientific discussion for the approval of Levosulpiride Aristo. The procedure was finalised at 5 June 2019. For information on changes after this date please refer to the module ‘Update’. I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Levosulpiride Aristo, 25 mg, 50 mg and 100 mg tablet, from Aristo Pharma GmbH. Levosulpiride Aristo 25 mg is indicated for: • Short-term treatment of dyspeptic syndrome (anorexia, bloating, a feeling of epigastric tenderness, postprandial headache, heartburn, belching, diarrhoea, constipation) from delayed gastric emptying related to organic factors (diabetic gastroparesis, cancer, etc.) and / or functional factors (visceral somatisation in anxious subjects -depressants) in patients who failed to respond to other therapy. • Symptomatic short-term treatment of nausea and vomiting (induced by anticancer drugs) after failure of first-line therapy. • Symptomatic short-term treatment of dizziness, tinnitus, hearing loss and nausea associated with Meniere’s syndrome. Levosulpiride Aristo 50 mg and 100 mg is indicated for: • Somatic symptom disorders. • Treatment of chronic schizophrenia with negative symptoms. A comprehensive description of the indications and posology is given in the SmPC. The active substance levosulpiride belongs to the pharmacotherapeutic group of psycholeptics, antipsychotics, ATC code: N05AL07. Levosulpride blocks the presynaptic dopaminergic D2 receptors. Like its parent compound (sulpiride), levosulpiride shows antagonism at D3 and D2 receptors present presynaptically as well as postsynaptically. -
(12) United States Patent (10) Patent No.: US 6,255,329 B1 Maj (45) Date of Patent: *Jul
USOO6255329B1 (12) United States Patent (10) Patent No.: US 6,255,329 B1 Maj (45) Date of Patent: *Jul. 3, 2001 (54) COMBINED USE OF PRAMIPEXOLE AND Carter et al Eur. J. Pharmacol. 200(1):65–72 Pra & SERTRALINE FOR THE TREATMENT OF Sulpiride, 1991.* DEPRESSION Borsini et al Psychopharmacology (Berlin) 97(2):183-188 Forced Swimming Test Discovers Antidepressant Activity, (75) Inventor: Jerzy Maj, Kracau (PL) 1989.* Piercey et all Clinical Neuropharmacology 18 Suppl. 1 (73) Assignee: Boehringer Ingelheim Pharma KG, 534–542 Pra & Quinpirole, 1995.* Ingelheim (DE) Willner Psycyhopharmacology 83(1):1-16 Learned Help lessness Test for Antidepress, 1984.* (*) Notice: This patent issued on a continued pros Borsini et al Psychopharmacology 94(2): 147-160 FST in ecution application filed under 37 CFR Rats, not Mice Detects Antidepressants, 1988.* 1.53(d), and is subject to the twenty year Skrebuhhova et al Methods & Findings Exp. Clin. Pharma patent term provisions of 35 U.S.C. col. 21(3):173–178 FST 4, 1999.* 154(a)(2). Harkin et al Eur. J. Pharmacol. 364 2–3 123–132 Sertraline FST, Jan. 1999.* Subject to any disclaimer, the term of this J. Maj, Z. Rogoz, G. Skuza & K. Kolodziejczyk; “Antide patent is extended or adjusted under 35 pressant Effects Of Pramipexole, A Novel Dopamine Recep U.S.C. 154(b) by 0 days. tor Agonist'; Journal of Neural Transmission; Aug. 6, 1997; pp. 525-533; vol. 104; Pub. Springer-Verlag, Austria. (21) Appl. No.: 09/348,591 J. Maj, Z. Rogoz, G. Skuza & K. Kolodziejczyk; “Prami pexole Given Repeatedly Increases Responsiveness Of (22) Filed: Jul. -
CDR Clinical Review Report for Akynzeo
CADTH COMMON DRUG REVIEW Clinical Review Report Netupitant/Palonosetron 300 mg/0.5 mg (Akynzeo) (Purdue Pharma) Indication: In combination with dexamethasone, once- per-cycle treatment for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy, or with moderately emetogenic cancer chemotherapy that is uncontrolled by a 5-hydroxytryptamine-3 receptor antagonist alone. Service Line: CADTH Common Drug Review Version: Final Publication Date: June 2018 Report Length: 96 Pages Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. -
Use of Prescribed Psychotropics During Pregnancy: a Systematic Review of Pregnancy, Neonatal, and Childhood Outcomes
brain sciences Review Use of Prescribed Psychotropics during Pregnancy: A Systematic Review of Pregnancy, Neonatal, and Childhood Outcomes Catherine E. Creeley * and Lisa K. Denton Department of Psychology, State University of New York at Fredonia, Fredonia, NY 14063 USA; [email protected] * Correspondence: [email protected]; Tel.: +1-716-673-3890 Received: 19 July 2019; Accepted: 9 September 2019; Published: 14 September 2019 Abstract: This paper reviews the findings from preclinical animal and human clinical research investigating maternal/fetal, neonatal, and child neurodevelopmental outcomes following prenatal exposure to psychotropic drugs. Evidence for the risks associated with prenatal exposure was examined, including teratogenicity, neurodevelopmental effects, neonatal toxicity, and long-term neurobehavioral consequences (i.e., behavioral teratogenicity). We conducted a comprehensive review of the recent results and conclusions of original research and reviews, respectively, which have investigated the short- and long-term impact of drugs commonly prescribed to pregnant women for psychological disorders, including mood, anxiety, and sleep disorders. Because mental illness in the mother is not a benign event, and may itself pose significant risks to both mother and child, simply discontinuing or avoiding medication use during pregnancy may not be possible. Therefore, prenatal exposure to psychotropic drugs is a major public health concern. Decisions regarding drug choice, dose, and duration should be made carefully, by balancing severity, chronicity, and co-morbidity of the mental illness, disorder, or condition against the potential risk for adverse outcomes due to drug exposure. Globally, maternal mental health problems are considered as a major public health challenge, which requires a stronger focus on mental health services that will benefit both mother and child.