JRRD Volume 46, Number 6, 2009
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Australian Product Information Parlodel® (Bromocriptine Mesilate)
AUSTRALIAN PRODUCT INFORMATION PARLODEL® (BROMOCRIPTINE MESILATE) TABLET AND HARD CAPSULE 1 NAME OF THE MEDICINE Bromocriptine mesilate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION • Parlodel tablets and capsules contain bromocriptine mesilate • Oral tablets: ➢ 2.5 mg bromocriptine (present as 2.9 mg mesilate). • Oral capsules: ➢ 10 mg bromocriptine (present as 11.5 mg mesilate). ➢ 5 mg bromocriptine (present at 5.735 mg mesilate). • List of excipients with known effect: lactose and sugars. • For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Oral tablets: • White, coded XC with breakline on one side, SANDOZ on the other side. Oral capsules: • 5 mg: opaque white and opaque blue, marked PS • 10 mg: opaque white 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Prevention of onset of lactation in the puerperium for clearly defined medical reasons. Therapy should be continued for 14 days to prevent rebound lactation. Parlodel should not be used to suppress established lactation. • Treatment of hyperprolactinaemia where surgery and/or radiotherapy are not indicated or have already been used with incomplete resolution. Precautions should be taken to ensure that the hyperprolactinaemia is not due to severe primary hypothyroidism. Where the cause of hyperprolactinaemia is a prolactin-secreting microadenoma or macroadenoma, Parlodel is indicated for conservative treatment; prior to surgery in order to reduce tumour size and to facilitate removal; after surgery if prolactin level is still elevated. • Adjunctive therapy in the management of acromegaly when: (1) The patient refuses surgery and/or radiotherapy (2) Surgery and/or radiotherapy has been unsuccessful or full effects are not expected for some months (3) A manifestation of the acromegaly needs to be brought under control pending surgery and/or radiotherapy. -
Addictions and the Brain
9/18/2012 Addictions and the Brain TAAP Conference September 14, 2012 Acknowledgements • La Hacienda Treatment Center • American Society of Addiction Medicine • National Institute of Drug Abuse © 2012 La Hacienda Treatment Center. All rights reserved. 1 9/18/2012 Definition • A primary, progressive biochemical, psychosocial, genetically transmitted chronic disease of relapse who’s hallmarks are denial, loss of control and unmanageability. DSM IV Criteria for dependency: At least 3 of the 7 below 1. Withdrawal 2. Tolerance 3. The substance is taken in larger amounts or over a longer period than was intended. 4. There is a persistent desire or unsuccessful efforts to cut down or control substance use. 5. A great deal of time is spent in activities necessary to obtain the substance, use the substance, or recover from its effects. 6. Important social, occupational, or recreational activities are given up or reduced because of the substance use. 7. The substance use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance. © 2012 La Hacienda Treatment Center. All rights reserved. 2 9/18/2012 Dispute between behavior and disease Present understanding of the Hypothalamus location of the disease hypothesis. © 2012 La Hacienda Treatment Center. All rights reserved. 3 9/18/2012 © 2012 La Hacienda Treatment Center. All rights reserved. 4 9/18/2012 © 2012 La Hacienda Treatment Center. All rights reserved. 5 9/18/2012 Dispute regarding behavior versus disease © 2012 La Hacienda Treatment Center. All rights reserved. 6 9/18/2012 © 2012 La Hacienda Treatment Center. -
Anti-Inflammatory Effects of Amantadine and Memantine
Journal of Personalized Medicine Communication Anti-Inflammatory Effects of Amantadine and Memantine: Possible Therapeutics for the Treatment of Covid-19? Félix Javier Jiménez-Jiménez 1,* , Hortensia Alonso-Navarro 1 , Elena García-Martín 2 and José A. G. Agúndez 2 1 Section of Neurology, Hospital Universitario del Sureste, Arganda del Rey, E-28500 Madrid, Spain; [email protected] 2 University Institute of Molecular Pathology Biomarkers, UNEx. ARADyAL Instituto de Salud Carlos III, E-10071 Cáceres, Spain; [email protected] (E.G.-M.); [email protected] (J.A.G.A.) * Correspondence: [email protected]; Tel.: +34-636968395 Received: 2 October 2020; Accepted: 6 November 2020; Published: 9 November 2020 Abstract: We have reviewed current data on the anti-inflammatory effects of amantadine and memantine in clinical and in vivo models of inflammation, and we propose that these effects have potential interest for the treatment of the SARS-CoV-2 infection (COVID-19 disease). To that end, we performed a literature search using the PubMed Database from 1966 up to October 31 2020, crossing the terms “amantadine” and “memantine” with “inflammation” and “anti-inflammatory”. Amantadine and/or memantine have shown anti-inflammatory effects in chronic hepatitis C, in neuroinflammation induced by sepsis and by lipopolysaccharides, experimental models of multiple sclerosis, spinal cord injury, and respiratory diseases. Since the inflammatory response is one of the main pathogenetic mechanisms in the progression of the SARS-CoV-2 infection, anti-inflammatory effects of amantadine and memantine could be hypothetically useful in the treatment of this condition. This potential utility deserves further research. Keywords: amantadine; memantine; anti-inflammatory effects; SARS-Cov-2; COVID-19; therapy 1. -
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 -
(12) United States Patent (10) Patent No.: US 8,603,526 B2 Tygesen Et Al
USOO8603526B2 (12) United States Patent (10) Patent No.: US 8,603,526 B2 Tygesen et al. (45) Date of Patent: Dec. 10, 2013 (54) PHARMACEUTICAL COMPOSITIONS 2008. O152595 A1 6/2008 Emigh et al. RESISTANT TO ABUSE 2008. O166407 A1 7/2008 Shalaby et al. 2008/0299.199 A1 12/2008 Bar-Shalom et al. 2008/0311205 A1 12/2008 Habib et al. (75) Inventors: Peter Holm Tygesen, Smoerum (DK); 2009/0022790 A1 1/2009 Flath et al. Jan Martin Oevergaard, Frederikssund 2010/0203129 A1 8/2010 Andersen et al. (DK); Karsten Lindhardt, Haslev (DK); 2010/0204259 A1 8/2010 Tygesen et al. Louise Inoka Lyhne-versen, Gentofte 2010/0239667 A1 9/2010 Hemmingsen et al. (DK); Martin Rex Olsen, Holbaek 2010, O291205 A1 11/2010 Downie et al. (DK); Anne-Mette Haahr, Birkeroed 2011 O159100 A1 6/2011 Andersen et al. (DK); Jacob Aas Hoellund-Jensen, FOREIGN PATENT DOCUMENTS Frederikssund (DK); Pemille Kristine Hoeyrup Hemmingsen, Bagsvaerd DE 20 2006 014131 1, 2007 (DK) EP O435,726 8, 1991 EP O493513 7, 1992 EP O406315 11, 1992 (73) Assignee: Egalet Ltd., London (GB) EP 1213014 6, 2002 WO WO 89,09066 10, 1989 (*) Notice: Subject to any disclaimer, the term of this WO WO91,040 15 4f1991 patent is extended or adjusted under 35 WO WO95/22962 8, 1995 U.S.C. 154(b) by 489 days. WO WO99,51208 10, 1999 WO WOOOf 41704 T 2000 WO WO 03/024426 3, 2003 (21) Appl. No.: 12/701,429 WO WOO3,O24429 3, 2003 WO WOO3,O24430 3, 2003 (22) Filed: Feb. -
Positron Emission Tomography Studies of Potential Mechanisms Underlying Phencyclidine-Induced Alterations in Striatal Dopamine
Neuropsychopharmacology (2003) 28, 2192–2198 & 2003 Nature Publishing Group All rights reserved 0893-133X/03 $25.00 www.neuropsychopharmacology.org Positron Emission Tomography Studies of Potential Mechanisms Underlying Phencyclidine-Induced Alterations in Striatal Dopamine ,1,2 2 1,2 Wynne K Schiffer* , Jean Logan and Stephen L Dewey 1SUNY Stony Brook, Department of Neurobiology and Behavior, Stony Brook, NY, USA; 2Brookhaven National Laboratory, Chemistry Department, Upton, NY, USA 11 Positron emission tomography (PET), in combination with C-raclopride, was used to examine the effects of phencyclidine (PCP) on dopamine (DA) in the primate striatum. In addition, we explored the hypotheses that GABAergic pathways as well as molecular targets beyond the N-methyl-D-aspartate (NMDA) receptor complex (ie dopamine transporter proteins, DAT) contribute to PCP’s effects. In 11 the first series of experiments, C-raclopride was administered at baseline and 30 min following intravenous PCP administration. In the second series of studies, g-vinyl GABA (GVG) was used to assess whether enhanced GABAergic tone altered NMDA antagonist- induced changes in DA. Animals received an initial PET scan followed by pretreatment with GVG (300 mg/kg), then PCP 30 min prior to 11 a second scan. Finally, we explored the possible contributions of DAT blockade to PCP-induced increases in DA. By examining C- cocaine binding a paradigm in which PCP was coadministered with the radiotracer, we assessed the direct competition between these 11 two compounds for the DAT. At 0.1, 0.5, and 1.0 mg/kg, PCP decreased C-raclopride binding by 2.1, 14.9 7 2.2 and 8.18 7 1.1%, 11 respectively. -
(12) United States Patent (10) Patent No.: US 9,469,601 B2 Vacher Et Al
USOO94.69601 B2 (12) United States Patent (10) Patent No.: US 9,469,601 B2 Vacher et al. (45) Date of Patent: Oct. 18, 2016 (54) AMINOCYCLOBUTANE DERIVATIVES, FOREIGN PATENT DOCUMENTS METHOD FOR PREPARING SAME AND THE EP 0 747 348 A1 12/1996 USE THEREOF AS DRUGS EP O747348 A1 * 12, 1996 ............. CO7B 57/OO WO WO 98.07447 A1 2, 1998 (71) Applicant: PIERRE FABRE MEDICAMENT, WO WO 99.12537 A1 3, 1999 Boulogne-Billancourt (FR) WO WO 99.52848 A1 10, 1999 WO WOOOO3716 A1 1, 2000 WO WOOO, 51607 A1 9, 2000 (72) Inventors: Bernard Vacher, Castres (FR); Elodie WO WO 03/06165.6 A1 T 2003 Blanc, Semalens (FR); Ronan WO WO O3,063797 A2 8, 2003 Depoortere, Castres (FR) WO WO 2006/081179 A1 8, 2006 WO WO 2008/092.955 A1 8, 2008 WO WO 2009/O29618 A1 3, 2009 (73) Assignee: PIERRE FABRE MEDICAMENT, WO WO 2009/06961.0 A1 6, 2009 Boulogne-Billancourt (FR) WO WO 2009/092324 A1 T 2009 WO WO 2010/036937 A1 4/2010 (*) Notice: Subject to any disclaimer, the term of this WO WO 2010/037533 A1 4, 2010 patent is extended or adjusted under 35 (Continued) U.S.C. 154(b) by 0 days. OTHER PUBLICATIONS (21) Appl. No.: 14/649,448 Aarts et al., “Novel Treatment of Excitotoxicity: Targeted Disrup (22) PCT Filed: Dec. 4, 2013 tion of Intracellular Signalling from Glutamate Receptors,” Bio chemical Pharmacology, vol. 66, 2003, pp. 877-886. (86). PCT No.: PCT/EP2013/075481 (Continued) S 371 (c)(1), (2) Date: Jun. -
Phencyclidine: an Update
Phencyclidine: An Update U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES • Public Health Service • Alcohol, Drug Abuse and Mental Health Administration Phencyclidine: An Update Editor: Doris H. Clouet, Ph.D. Division of Preclinical Research National Institute on Drug Abuse and New York State Division of Substance Abuse Services NIDA Research Monograph 64 1986 DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Alcohol, Drug Abuse, and Mental Health Administratlon National Institute on Drug Abuse 5600 Fishers Lane Rockville, Maryland 20657 For sale by the Superintendent of Documents, U.S. Government Printing Office Washington, DC 20402 NIDA Research Monographs are prepared by the research divisions of the National lnstitute on Drug Abuse and published by its Office of Science The primary objective of the series is to provide critical reviews of research problem areas and techniques, the content of state-of-the-art conferences, and integrative research reviews. its dual publication emphasis is rapid and targeted dissemination to the scientific and professional community. Editorial Advisors MARTIN W. ADLER, Ph.D. SIDNEY COHEN, M.D. Temple University School of Medicine Los Angeles, California Philadelphia, Pennsylvania SYDNEY ARCHER, Ph.D. MARY L. JACOBSON Rensselaer Polytechnic lnstitute National Federation of Parents for Troy, New York Drug Free Youth RICHARD E. BELLEVILLE, Ph.D. Omaha, Nebraska NB Associates, Health Sciences Rockville, Maryland REESE T. JONES, M.D. KARST J. BESTEMAN Langley Porter Neuropsychiatric lnstitute Alcohol and Drug Problems Association San Francisco, California of North America Washington, D.C. DENISE KANDEL, Ph.D GILBERT J. BOTV N, Ph.D. College of Physicians and Surgeons of Cornell University Medical College Columbia University New York, New York New York, New York JOSEPH V. -
Dexmethylphenidate
MICROMEDEX® Healthcare Series : Document Page 1 of 31 Case 3:09-cv-00080-TMB Document 78-23 Filed 03/24/2010 Page 1 of 105 DRUGDEX® Evaluations DEXMETHYLPHENIDATE 0.0 Overview 1) Class a) This drug is a member of the following class(es): Amphetamine Related CNS Stimulant 2) Dosing Information a) Dexmethylphenidate Hydrochloride 1) Adult a) Attention deficit hyperactivity disorder 1) extended-release: methylphenidate-naive patients, initial 10 mg ORALLY daily in the morning; adjust dose weekly in 10 mg increments; MAX 20 mg/day 2) extended-release: patients currently using methylphenidate, one-half the total daily dose of racemic methylphenidate; patients currently using dexmethylphenidate immediate-release may be switched to the same daily dose of dexmethylphenidate extended-release; MAX 20 mg/day 2) Pediatric a) safety and efficacy not established in patients under 6 years of age 1) Attention deficit hyperactivity disorder a) immediate-release (ages 6 years and older): methylphenidate-naive patients, initial 2.5 mg ORALLY twice daily; adjust dose weekly in 2.5 to 5 mg increments; MAX 20 mg/day (10 mg twice a day) b) immediate-release (ages 6 years and older): patients currently using methylphenidate, one-half the dose of racemic methylphenidate; MAX 20 mg/day (10 mg twice a day) c) extended-release (ages 6 years and older): methylphenidate-naive patients, initial 5 mg ORALLY in the morning; adjust dose weekly in 5 mg increments; MAX 20 mg/day(Prod Info FOCALIN XR(R) extended-release oral capsules, 2008) d) extended-release (ages 6 years -
Treatment of Patients with Substance Use Disorders Second Edition
PRACTICE GUIDELINE FOR THE Treatment of Patients With Substance Use Disorders Second Edition WORK GROUP ON SUBSTANCE USE DISORDERS Herbert D. Kleber, M.D., Chair Roger D. Weiss, M.D., Vice-Chair Raymond F. Anton Jr., M.D. To n y P. G e o r ge , M .D . Shelly F. Greenfield, M.D., M.P.H. Thomas R. Kosten, M.D. Charles P. O’Brien, M.D., Ph.D. Bruce J. Rounsaville, M.D. Eric C. Strain, M.D. Douglas M. Ziedonis, M.D. Grace Hennessy, M.D. (Consultant) Hilary Smith Connery, M.D., Ph.D. (Consultant) This practice guideline was approved in December 2005 and published in August 2006. A guideline watch, summarizing significant developments in the scientific literature since publication of this guideline, may be available in the Psychiatric Practice section of the APA web site at www.psych.org. 1 Copyright 2010, American Psychiatric Association. APA makes this practice guideline freely available to promote its dissemination and use; however, copyright protections are enforced in full. No part of this guideline may be reproduced except as permitted under Sections 107 and 108 of U.S. Copyright Act. For permission for reuse, visit APPI Permissions & Licensing Center at http://www.appi.org/CustomerService/Pages/Permissions.aspx. AMERICAN PSYCHIATRIC ASSOCIATION STEERING COMMITTEE ON PRACTICE GUIDELINES John S. McIntyre, M.D., Chair Sara C. Charles, M.D., Vice-Chair Daniel J. Anzia, M.D. Ian A. Cook, M.D. Molly T. Finnerty, M.D. Bradley R. Johnson, M.D. James E. Nininger, M.D. Paul Summergrad, M.D. Sherwyn M. -
Bromocriptine-A Changing Scene
LONDON, SATURDAY 20 DECEMBER 1975 Br Med J: first published as 10.1136/bmj.4.5998.667 on 20 December 1975. Downloaded from MEDICAL JOURNAL Bromocriptine -a changing scene Ergot, known to man since ancient times, is a product of the Levodopa has been used to lower prolactin levels, but its fungus Claviceps purpurea that grows on rye and grain. A action does not last long enough; bromocriptine has a much symposium' at the Royal College of Physicians last May longer action and is therefore more effective. reviewed the pharmacology and clinical uses of the older as Since bromocriptine has been shown not to be teratogenic it well as the more recently introduced ergot compounds. All the has been used recently in restoring fertility. Its place has still ergot alkaloids are derivatives of lysergic acid: the best known finally to be defined, but it appears to be effective not only in are the oxytocic ergometrine and the mixed ao-adrenergic patients with hyperprolactinaemia but also in some with agonist and antagonist ergometrine compounds. Nevertheless, normal prolactin levels, as described by M 0 Thorner et al,14 the first group of ergot compounds isolated by Barger, Carr, at p 694 of this issue. There is, however, some danger in and Dale in 1906, and called ergotoxine,2 is a mixture of ergot restoring fertility in women with small pituitary tumours, alkaloids: ergocornine, ergocristine, and ergokryptine. since such lesions may rapidly enlarge, with visual impairment, The inhibition oflactation by ergot was described by Dodart3 during pregnancy. Arguably the tumour should be irradiated in 1676. -
Medicines Regulations 1984 (SR 1984/143)
Reprint as at 1 April 2020 Medicines Regulations 1984 (SR 1984/143) David Beattie, Governor-General Order in Council At the Government House at Wellington this 5th day of June 1984 Present: His Excellency the Governor-General in Council Pursuant to section 105 of the Medicines Act 1981, and, in the case of Part 3 of the regulations, to section 62 of that Act, His Excellency the Governor-General, acting on the advice of the Minister of Health tendered after consultation with the organisations and bodies that appeared to the Minister to be representatives of persons likely to be substantially affected, and by and with the advice and consent of the Executive Coun- cil, hereby makes the following regulations. Contents Page 1 Title and commencement 5 2 Interpretation 5 Part 1 Classification of medicines 3 Classification of medicines 9 Note Changes authorised by subpart 2 of Part 2 of the Legislation Act 2012 have been made in this official reprint. Note 4 at the end of this reprint provides a list of the amendments incorporated. These regulations are administered by the Ministry of Health. 1 Reprinted as at Medicines Regulations 1984 1 April 2020 Part 2 Standards 4 Standards for medicines, related products, medical devices, 10 cosmetics, and surgical dressings 4A Standard for CBD products 10 5 Pharmacist may dilute medicine in particular case 11 6 Colouring substances [Revoked] 11 Part 3 Advertisements 7 Advertisements not to claim official approval 11 8 Advertisements for medicines 11 9 Advertisements for related products 13 10 Advertisements