DOCSLIB.ORG

Drugs of Choice 2019

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

Drugs of Choice Drugs of Choice 2019 Selected 2018 Articles from The Medical Letter on Drugs and Therapeutics ® Published by The Medical Letter, Inc. 145 Huguenot St. New Rochelle, New York 10801-7537 800-211-2769 914-235-0500 Fax 914-632-1733 www.medicalletter.org 20th Edition Contents Copyright 2019 (ISSN 1065-6596) Introduction ............................................................................................. vii (ISBN 978-0-9846522-0-4) Adult Immunization ................................................................................ 1 Rheumatoid Arthritis ............................................................................... 27 The Medical Letter Inc. 145 Huguenot St., Ste. 312 Contraceptives ......................................................................................... 43 New Rochelle, New York 10801-7537 GERD and Peptic Ulcer Disease ............................................................. 67 Infl ammatory Bowel Disease .................................................................. 89 Insomnia .................................................................................................. 115 Nonopioid Drugs for Pain ....................................................................... 129 No part of the material may be reproduced or transmitted by any process Opioid Withdrawal Symptoms ................................................................ 153 in whole or in part without prior permission in writing. The editors and Opioids for Pain ...................................................................................... 167 publisher do not warrant that all the material in this publication is accurate Sunscreens ............................................................................................... 191 and complete in every respect. The editors and publisher shall not be held responsible for any damage resulting from any error, inaccuracy or omission. Vaccines for Travelers ............................................................................. 201 Varicella-Zoster Virus and Herpes Simplex Virus Infections ................. 221 Permissions: To reproduce any portion of this handbook, please e-mail your request to [email protected] Venous Thromboembolism ..................................................................... 233 Weight Management ............................................................................... 253 Index ....................................................................................................... 273 ii iii Tables Adult Immunization Nonopioid Drugs for Pain Some Vaccines for Adults ............................................................ 4-9 Recommendations for Treatment of Pain .................................... 130 Adult Vaccines for Special Populations ....................................... 12-13 Some Nonopioid Analgesics for Pain .......................................... 132-139 Recommendations for Pneumococcal Vaccination ...................... 17 Some Adjuvant Pain Medications ................................................ 144-147 Rheumatoid Arthritis Opioid Withdrawal Symptoms Recommendations for Treatment of Rheumatoid Arthritis ......... 28 Recommendations........................................................................ 154 Some Conventional DMARDs for Rheumatoid Arthritis ............ 30-31 Some Drugs for Management of Opioid Withdrawal Symptoms 156-157 Some Biologic Agents and JAK Inhibitors for Rheumatoid Opioids for Pain Arthritis.................................................................................... 34-37 Recommendations for Treatment of Pain .................................... 168 Contraceptives Opioid Prescribing for Chronic Noncancer Pain ......................... 171 Recommendations........................................................................ 44 Some Oral/Topical Opioid Analgesics ......................................... 174-181 Effi cacy of Contraceptives for Pregnancy Prevention ................. 46-51 Sunscreens Some Oral Hormonal Contraceptives .......................................... 54-59 FDA-Approved Sunscreens ......................................................... 193 Some Emergency Contraceptives ................................................ 63 Some Sunscreen Products ............................................................ 194-197 GERD and Peptic Ulcer Disease Vaccines for Travelers Recommendations for Treatment of GERD, PUD, and Some Vaccines for Travelers........................................................ 204-207 Helicobacter pylori Infection .................................................. 68 Varicella-Zoster Virus and Herpes Simplex Virus Infections Some Drugs for GERD and Peptic Ulcer Disease ....................... 72-75 Drugs for Varicella-Zoster Virus Infection .................................. 222 Preferred Regimens for Helicobacter pylori Infection ................ 78-79 Drugs for Herpes Simplex Virus Infections ................................. 224-227 Some Alternative Regimens for Helicobacter pylori Infection ... 82-85 Venous Thromboembolism Infl ammatory Bowel Disease Recommendations........................................................................ 234 Recommendations for Treatment of IBD .................................... 90 Some Parenteral Anticoagulants for VTE .................................... 236-237 Drugs for Ulcerative Colitis......................................................... 92-93 Some Oral Anticoagulants for VTE ............................................. 238-239 Drugs for Crohn’s Disease ........................................................... 95 FDA-Approved Indications of Anticoagulants for VTE.............. 240-241 Some Drugs for Infl ammatory Bowel Disease ............................ 98-103 Duration of Anticoagulation for VTE .......................................... 243 Safety of Drugs for IBD in Pregnancy ........................................ 107 Non-Bleeding Adverse Effects and Drug Interactions ............... 246-247 Insomnia Recommendations for Treatment of Chronic Insomnia ............... 116 Some Oral Hypnotics for Chronic Insomnia ............................... 118-121 iv v PRESIDENT: Mark Abramowicz, M.D. VICE PRESIDENT AND EXECUTIVE EDITOR: Gianna Zuccotti, M.D., M.P.H., F.A.C.P., Harvard Medical School Weight Management EDITOR IN CHIEF: Jean-Marie Pfl omm, Pharm.D. Recommendations for Weight Management ................................ 254 ASSOCIATE EDITORS: Susan M. Daron, Pharm.D., Amy Faucard, MLS, Some FDA-Approved Drugs for Weight Management ............... 258-261 Corinne Z. Morrison, Pharm.D., Michael P. Viscusi, Pharm.D. CONSULTING EDITORS: Brinda M. Shah, Pharm.D., F. Peter Swanson, Gastric Balloons for Weight Loss ................................................ 265 M.D. CONTRIBUTING EDITORS: Carl W. Bazil, M.D., Ph.D., Columbia University College of Physicians and Surgeons Ericka L. Crouse, Pharm.D., B.C.P.P., C.G.P., F.A.S.H.P., F.A.S.C.P., Virginia Commonwealth University Health Vanessa K. Dalton, M.D., M.P.H., University of Michigan Medical School Eric J. Epstein, M.D., Albert Einstein College of Medicine David N. Juurlink, BPhm, M.D., Ph.D., Sunnybrook Health Sciences Centre Richard B. Kim, M.D., University of Western Ontario Franco M. Muggia, M.D., New York University Medical Center Sandip K. Mukherjee, M.D., F.A.C.C., Yale School of Medicine Dan M. Roden, M.D., Vanderbilt University School of Medicine Esperance A.K. Schaefer, M.D., M.P.H., Harvard Medical School F. Estelle R. Simons, M.D., F.R.C.P.C., F.R.S.C., University of Manitoba Neal H. Steigbigel, M.D., New York University School of Medicine Arthur M. F. Yee, M.D., Ph.D., F.A.C.R., Weill Medical College of Cornell University MANAGING EDITOR AND DIRECTOR OF CONTENT OPERATIONS: Susie Wong ASSISTANT MANAGING EDITOR: Liz Donohue FULFILLMENT AND SYSTEMS MANAGER: Cristine Romatowski SITE LICENSE SALES: Elaine Reaney-Tomaselli EXECUTIVE DIRECTOR OF MARKETING AND COMMUNICATIONS: Joanne F. Valentino VICE PRESIDENT AND PUBLISHER: Yosef Wissner-Levy vi vii Introduction The Medical Letter, Inc. is a nonprofi t organization that publishes critical NOTE: The drug costs listed in the tables are based on the pricing appraisals of new prescription drugs and comparative reviews of drugs information that was available in the month the article was originally for common diseases in its newsletter, The Medical Letter on Drugs published. When the cost of a drug has been updated or added since pub- and Therapeutics. It is committed to providing objective, practical, and lication, it is designated as such. timely information on drugs and treatments of common diseases to help readers make the best decisions for their patients—without the infl uence The Medical Letter, Inc. is based in New Rochelle, NY. For more infor- of the pharmaceutical industry. The Medical Letter is supported by its mation, go to www.medicalletter.org or call 800-211-2769. readers, and does not receive any commercial support or accept advertis- ing in any of its publications. Many of our readers know that pharmaceutical companies and their representatives often exaggerate the therapeutic effects and understate the adverse effects of their products, but busy practitioners have neither the time nor the resources to check the accuracy of the manufacturers’ claims. Our publication is intended specifi cally to meet the needs of busy healthcare professionals who want unbiased, reliable, and timely drug information. Our editorial process
Recommended publications
  • Suitability of Immobilized Systems for Microbiological Degradation of Endocrine Disrupting Compounds

    Suitability of Immobilized Systems for Microbiological Degradation of Endocrine Disrupting Compounds

    molecules Review Suitability of Immobilized Systems for Microbiological Degradation of Endocrine Disrupting Compounds Danuta Wojcieszy ´nska , Ariel Marchlewicz and Urszula Guzik * Institute of Biology, Biotechnology and Environmental Protection, Faculty of Natural Science, University of Silesia in Katowice, Jagiello´nska28, 40-032 Katowice, Poland; [email protected] (D.W.); [email protected] (A.M.) * Correspondence: [email protected]; Tel.: +48-3220-095-67 Academic Editors: Urszula Guzik and Danuta Wojcieszy´nska Received: 10 September 2020; Accepted: 25 September 2020; Published: 29 September 2020 Abstract: The rising pollution of the environment with endocrine disrupting compounds has increased interest in searching for new, effective bioremediation methods. Particular attention is paid to the search for microorganisms with high degradation potential and the possibility of their use in the degradation of endocrine disrupting compounds. Increasingly, immobilized microorganisms or enzymes are used in biodegradation systems. This review presents the main sources of endocrine disrupting compounds and identifies the risks associated with their presence in the environment. The main pathways of degradation of these compounds by microorganisms are also presented. The last part is devoted to an overview of the immobilization methods used for the purposes of enabling the use of biocatalysts in environmental bioremediation. Keywords: EDCs; hormones; degradation; immobilization; microorganisms 1. Introduction The development of modern tools for the separation and identification of chemical substances has drawn attention to the so-called micropollution of the environment. Many of these contaminants belong to the emergent pollutants class. According to the Stockholm Convention they are characterized by high persistence, are transported over long distances in the environment through water, accumulate in the tissue of living organisms and can adversely affect them [1].
  • Gastrointestinal (GI) Motility, Chronic Therapeutic Class Review

    Gastrointestinal (GI) Motility, Chronic Therapeutic Class Review

    Gastrointestinal (GI) Motility, Chronic Therapeutic Class Review (TCR) March 7, 2019 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. March 2019 Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2019 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Drug Manufacturer Indication(s) alosetron (Lotronex®)1 generic, .
  • SPIRONOLACTONE Spironolactone – Oral (Common Brand Name

    SPIRONOLACTONE Spironolactone – Oral (Common Brand Name

    SPIRONOLACTONE Spironolactone – oral (common brand name: Aldactone) Uses: Spironolactone is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It is also used to treat swelling (edema) caused by certain conditions (e.g., congestive heart failure) by removing excess fluid and improving symptoms such as breathing problems. This medication is also used to treat low potassium levels and conditions in which the body is making too much of a natural chemical (aldosterone). Spironolactone is known as a “water pill” (potassium-sparing diuretic). Other uses: This medication has also been used to treat acne in women, female pattern hair loss, and excessive hair growth (hirsutism), especially in women with polycystic ovary disease. Side effects: Drowsiness, lightheadedness, stomach upset, diarrhea, nausea, vomiting, or headache may occur. To minimize lightheadedness, get up slowly when rising from a seated or lying position. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur; dizziness, increased thirst, change in the amount of urine, mental/mood chances, unusual fatigue/weakness, muscle spasms, menstrual period changes, sexual function problems. This medication may lead to high levels of potassium, especially in patients with kidney problems. If not treated, very high potassium levels can be fatal. Tell your doctor immediately if you notice any of the following unlikely but serious side effects: slow/irregular heartbeat, muscle weakness. Precautions: Before taking spironolactone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
  • Inflammatory Bowel Disease Irritable Bowel Syndrome

    Inflammatory Bowel Disease Irritable Bowel Syndrome

    Inflammatory Bowel Disease and Irritable Bowel Syndrome Similarities and Differences 2 www.ccfa.org IBD Help Center: 888.MY.GUT.PAIN 888.694.8872 Important Differences Between IBD and IBS Many diseases and conditions can affect the gastrointestinal (GI) tract, which is part of the digestive system and includes the esophagus, stomach, small intestine and large intestine. These diseases and conditions include inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). IBD Help Center: 888.MY.GUT.PAIN 888.694.8872 www.ccfa.org 3 Inflammatory bowel diseases are a group of inflammatory conditions in which the body’s own immune system attacks parts of the digestive system. Inflammatory Bowel Disease Inflammatory bowel diseases are a group of inflamma- Causes tory conditions in which the body’s own immune system attacks parts of the digestive system. The two most com- The exact cause of IBD remains unknown. Researchers mon inflammatory bowel diseases are Crohn’s disease believe that a combination of four factors lead to IBD: a (CD) and ulcerative colitis (UC). IBD affects as many as 1.4 genetic component, an environmental trigger, an imbal- million Americans, most of whom are diagnosed before ance of intestinal bacteria and an inappropriate reaction age 35. There is no cure for IBD but there are treatments to from the immune system. Immune cells normally protect reduce and control the symptoms of the disease. the body from infection, but in people with IBD, the immune system mistakes harmless substances in the CD and UC cause chronic inflammation of the GI tract. CD intestine for foreign substances and launches an attack, can affect any part of the GI tract, but frequently affects the resulting in inflammation.
  • The Role of Organic Small Molecules in Pain Management

    The Role of Organic Small Molecules in Pain Management

    molecules Review The Role of Organic Small Molecules in Pain Management Sebastián A. Cuesta and Lorena Meneses * Laboratorio de Química Computacional, Facultad de Ciencias Exactas y Naturales, Escuela de Ciencias Químicas, Pontificia Universidad Católica del Ecuador, Av. 12 de Octubre 1076 Apartado, Quito 17-01-2184, Ecuador; [email protected] * Correspondence: [email protected]; Tel.: +593-2-2991700 (ext. 1854) Abstract: In this review, a timeline starting at the willow bark and ending in the latest discoveries of analgesic and anti-inflammatory drugs will be discussed. Furthermore, the chemical features of the different small organic molecules that have been used in pain management will be studied. Then, the mechanism of different types of pain will be assessed, including neuropathic pain, inflammatory pain, and the relationship found between oxidative stress and pain. This will include obtaining insights into the cyclooxygenase action mechanism of nonsteroidal anti-inflammatory drugs (NSAID) such as ibuprofen and etoricoxib and the structural difference between the two cyclooxygenase isoforms leading to a selective inhibition, the action mechanism of pregabalin and its use in chronic neuropathic pain, new theories and studies on the analgesic action mechanism of paracetamol and how changes in its structure can lead to better characteristics of this drug, and cannabinoid action mechanism in managing pain through a cannabinoid receptor mechanism. Finally, an overview of the different approaches science is taking to develop more efficient molecules for pain treatment will be presented. Keywords: anti-inflammatory drugs; QSAR; pain management; cyclooxygenase; multitarget drug; Citation: Cuesta, S.A.; Meneses, L. cannabinoid; neuropathic pain The Role of Organic Small Molecules in Pain Management.
  • Therapeutic Class Overview Irritable Bowel Syndrome Agents

    Therapeutic Class Overview Irritable Bowel Syndrome Agents

    Therapeutic Class Overview Irritable Bowel Syndrome Agents Therapeutic Class Overview/Summary: This review will focus on agents used for the treatment of Irritable Bowel Syndrome (IBS).1-5 IBS is a gastrointestinal syndrome characterized primarily by non-specific chronic abdominal pain, usually described as a cramp-like sensation, and abnormal bowel habits, either constipation or diarrhea, in which there is no organic cause. Other common gastrointestinal symptoms may include gastroesophageal reflux, dysphagia, early satiety, intermittent dyspepsia and nausea. Patients may also experience a wide range of non-gastrointestinal symptoms. Some notable examples include sexual dysfunction, dysmenorrhea, dyspareunia, increased urinary frequency/urgency and fibromyalgia-like symptoms.6 IBS is defined by one of four subtypes. IBS with constipation (IBS-C) is the presence of hard or lumpy stools with ≥25% of bowel movements and loose or watery stools with <25% of bowel movements. When IBS is associated with diarrhea (IBS-D) loose or watery stools are present with ≥25% of bowel movements and hard or lumpy stools are present with <25% of bowel movements. Mixed IBS (IBS-M) is defined as the presence of hard or lumpy stools with ≥25% and loose or water stools with ≥25% of bowel movements. Final subtype, or unsubtyped, is all other cases of IBS that do not fall into the other classes. Pharmacological therapy for IBS depends on subtype.7 While several over-the-counter or off-label prescription agents are used for the treatment of IBS, there are currently only two agents approved by the Food and Drug Administration (FDA) for the treatment of IBS-C and three agents approved by the FDA for IBS-D.
  • United States Patent (10) Patent No.: US 8,969,514 B2 Shailubhai (45) Date of Patent: Mar

    United States Patent (10) Patent No.: US 8,969,514 B2 Shailubhai (45) Date of Patent: Mar

    USOO896.9514B2 (12) United States Patent (10) Patent No.: US 8,969,514 B2 Shailubhai (45) Date of Patent: Mar. 3, 2015 (54) AGONISTS OF GUANYLATECYCLASE 5,879.656 A 3, 1999 Waldman USEFUL FOR THE TREATMENT OF 36; A 6. 3: Watts tal HYPERCHOLESTEROLEMIA, 6,060,037- W - A 5, 2000 Waldmlegand et al. ATHEROSCLEROSIS, CORONARY HEART 6,235,782 B1 5/2001 NEW et al. DISEASE, GALLSTONE, OBESITY AND 7,041,786 B2 * 5/2006 Shailubhai et al. ........... 530.317 OTHER CARDOVASCULAR DISEASES 2002fOO78683 A1 6/2002 Katayama et al. 2002/O12817.6 A1 9/2002 Forssmann et al. (75) Inventor: Kunwar Shailubhai, Audubon, PA (US) 2003,2002/0143015 OO73628 A1 10/20024, 2003 ShaubhaiFryburg et al. 2005, OO16244 A1 1/2005 H 11 (73) Assignee: Synergy Pharmaceuticals, Inc., New 2005, OO32684 A1 2/2005 Syer York, NY (US) 2005/0267.197 A1 12/2005 Berlin 2006, OO86653 A1 4, 2006 St. Germain (*) Notice: Subject to any disclaimer, the term of this 299;s: A. 299; NS et al. patent is extended or adjusted under 35 2008/0137318 A1 6/2008 Rangarajetal.O U.S.C. 154(b) by 742 days. 2008. O151257 A1 6/2008 Yasuda et al. 2012/O196797 A1 8, 2012 Currie et al. (21) Appl. No.: 12/630,654 FOREIGN PATENT DOCUMENTS (22) Filed: Dec. 3, 2009 DE 19744O27 4f1999 (65) Prior Publication Data WO WO-8805306 T 1988 WO WO99,26567 A1 6, 1999 US 2010/O152118A1 Jun. 17, 2010 WO WO-0 125266 A1 4, 2001 WO WO-02062369 A2 8, 2002 Related U.S.
  • Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals

    Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals

    Journal of Clinical Medicine Review Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals Carlotta Cocchetti 1, Jiska Ristori 1, Alessia Romani 1, Mario Maggi 2 and Alessandra Daphne Fisher 1,* 1 Andrology, Women’s Endocrinology and Gender Incongruence Unit, Florence University Hospital, 50139 Florence, Italy; [email protected] (C.C); jiska.ristori@unifi.it (J.R.); [email protected] (A.R.) 2 Department of Experimental, Clinical and Biomedical Sciences, Careggi University Hospital, 50139 Florence, Italy; [email protected]fi.it * Correspondence: fi[email protected] Received: 16 April 2020; Accepted: 18 May 2020; Published: 26 May 2020 Abstract: Introduction: To date no standardized hormonal treatment protocols for non-binary transgender individuals have been described in the literature and there is a lack of data regarding their efficacy and safety. Objectives: To suggest possible treatment strategies for non-binary transgender individuals with non-standardized requests and to emphasize the importance of a personalized clinical approach. Methods: A narrative review of pertinent literature on gender-affirming hormonal treatment in transgender persons was performed using PubMed. Results: New hormonal treatment regimens outside those reported in current guidelines should be considered for non-binary transgender individuals, in order to improve psychological well-being and quality of life. In the present review we suggested the use of hormonal and non-hormonal compounds, which—based on their mechanism of action—could be used in these cases depending on clients’ requests. Conclusion: Requests for an individualized hormonal treatment in non-binary transgender individuals represent a future challenge for professionals managing transgender health care. For each case, clinicians should balance the benefits and risks of a personalized non-standardized treatment, actively involving the person in decisions regarding hormonal treatment.
  • Contraception and Misconceptions

    Contraception and Misconceptions

    CONTRACEPTION AND MISCONCEPTIONS CONTRACEPTION IN WOMEN WITH MENTAL ILLNESS OVERVIEW Hormones and mood How mental illness impacts on contraceptive choice Ideal contraception Pro and cons of contraceptive methods in women with mental illness Hormonal contraception and mood ESTROGENS anti-inflammatory neuroprotective effects of estradiol modulation of the limbic processing memory of emotionally-relevant information. estradiol “beneficially” modulates pathways implicated in the pathophysiology of depression, including serotonin and norepinephrine pathways PROGESTROGENS Previously thought to be anxiogenic, depressogenic Breakdown products Depression – alpha hydroxy progestrogen breakdown products pro – inflammatory, anxiogenic HORMONES AND MOODS – COMPLEX INTERPLAY MENTAL ILLNESS AND CONTRACEPTIVE CHOICE Effect of mental illness on contraceptive choice Effect of contraceptive choice on mental illness Drug interactions EFFECT MENTAL ILLNESS ON CONTRACEPTIVE CHOICE Impulsive Poor planning Cognitive and problem judgement Poor adherence IMPULSIVITY COGNITION POOR JUDGEMENT LETS NOT FORGET SUBSTANCES…… TYPES OF CONTRACEPTION No method Non hormonal Condom/Femidom Diaphragm Non hormone containing IUCD (Copper T) Hormonal COC POP Mirena Evra Patch Nuva Ring Implant ORAL CONTRACEPTIVES POP – avoid Same time every day COC Pros Effective Reduction PMS – monophasic estrogen dominant pill eg Femodene, Yaz, Nordette Cons Drug interactions Pill burden Daily dose EVRA PATCH Weekly patch Transdermal system: 150 mcg/day
  • Estrogen Actions Throughout the Brain

    Estrogen Actions Throughout the Brain

    Estrogen Actions Throughout the Brain BRUCE MCEWEN Harold and Margaret Milliken Hatch Laboratory of Neuroendocrinology, The Rockefeller University, New York, New York 10021 ABSTRACT Besides affecting the hypothalamus and other brain areas related to reproduction, ovarian steroids have widespread effects throughout the brain, on serotonin pathways, catecholaminergic neurons, and the basal forebrain cholinergic system as well as the hippocampal formation, a brain region involved in spatial and declarative memory. Thus, ovarian steroids have measurable effects on affective state as well as cognition, with implications for dementia. Two actions are discussed in this review; both appear to involve a combination of genomic and nongenomic actions of ovarian hormones. First, regulation of the serotonergic system appears to be linked to the presence of estrogen- and progestin-sensitive neurons in the midbrain raphe as well as possibly nongenomic actions in brain areas to which serotonin neurons project their axons. Second, ovarian hormones regulate synapse turnover in the CA1 region of the hippocampus during the 4- to 5-day estrous cycle of the female rat. Formation of new excitatory synapses is induced by estradiol and involves N-methyl-D-aspartate (NMDA) receptors, whereas downregulation of these synapses involves intracellular progestin receptors. A new, rapid method of radioimmunocytochemistry has made possible the demonstration of synapse formation by labeling and quantifying the specific synaptic and dendritic molecules involved. Although NMDA receptor activation is required for synapse formation, inhibitory interneurons may play a pivotal role as they express nuclear estrogen receptor-alpha (ER␣). It is also likely that estrogens may locally regulate events at the sites of synaptic contact in the excitatory pyramidal neurons where the synapses form.
  • 209627Orig1s000

    209627Orig1s000

    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209627Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review Reviewers of Multi-Disciplinary Review and Evaluation SECTIONS OFFICE/ AUTHORED/ ACKNOWLEDGED/ DISCIPLINE REVIEWER DIVISION APPROVED Mark Seggel, Ph.D. OPQ/ONDP/DNDP2 Authored: Section 4.2 Digitally signed by Mark R. Seggel -S CMC Lead DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Mark R. Signature: Mark R. Seggel -S Seggel -S, 0.9.2342.19200300.100.1.1=1300071539 Date: 2018.08.08 16:29:15 -04'00' Frederic Moulin, DVM, PhD OND/ODE3/DBRUP Authored: Section 5 Pharmacology/ Digitally signed by Frederic Moulin -S Toxicology DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Reviewer Signature: Frederic Moulin -S 0.9.2342.19200300.100.1.1=2001708658, cn=Frederic Moulin -S Date: 2018.08.08 15:26:57 -04'00' Kimberly Hatfield, PhD OND/ODE3/DBRUP Approved: Section 5 Pharmacology/ Toxicology Digitally signed by Kimberly P. Hatfield -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Team Leader Signature: Kimberly P. Hatfield -S 0.9.2342.19200300.100.1.1=1300387215, cn=Kimberly P. Hatfield -S Date: 2018.08.08 14:56:10 -04'00' Li Li, Ph.D. OCP/DCP3 Authored: Sections 6 and 17.3 Clinical Pharmacology Dig ta ly signed by Li Li S DN c=US o=U S Government ou=HHS ou=FDA ou=People Reviewer cn=Li Li S Signature: Li Li -S 0 9 2342 19200300 100 1 1=20005 08577 Date 2018 08 08 15 39 23 04'00' Doanh Tran, Ph.D.
  • Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017

    Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017

    Q UO N T FA R U T A F E BERMUDA PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 BR 111 / 2017 The Minister responsible for health, in exercise of the power conferred by section 48A(1) of the Pharmacy and Poisons Act 1979, makes the following Order: Citation 1 This Order may be cited as the Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017. Repeals and replaces the Third and Fourth Schedule of the Pharmacy and Poisons Act 1979 2 The Third and Fourth Schedules to the Pharmacy and Poisons Act 1979 are repealed and replaced with— “THIRD SCHEDULE (Sections 25(6); 27(1))) DRUGS OBTAINABLE ONLY ON PRESCRIPTION EXCEPT WHERE SPECIFIED IN THE FOURTH SCHEDULE (PART I AND PART II) Note: The following annotations used in this Schedule have the following meanings: md (maximum dose) i.e. the maximum quantity of the substance contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. 1 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 mdd (maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours. mg milligram ms (maximum strength) i.e. either or, if so specified, both of the following: (a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or (b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w, or v/v, as appropriate.