Active Moiety Name FDA Established Pharmacologic Class (EPC) Text

Total Page：16

File Type：pdf, Size：1020Kb

Active Moiety Name FDA Established Pharmacologic Class (EPC) Text

FDA Established Pharmacologic Class (EPC) Text Phrase PLR regulations require that the following statement is included in the Highlights Indications and Usage heading if a drug is a member of an EPC [see 21 CFR 201.57(a)(6)]: “(Drug) is a (FDA EPC Text Phrase) indicated for [indication(s)].” For Active Moiety Name each listed active moiety, the associated FDA EPC text phrase is included in this document. For more information about how FDA determines the EPC Text Phrase, see the 2009 "Determining EPC for Use in the Highlights" guidance and 2013 "Determining EPC for Use in the Highlights" MAPP 7400.13. .alpha.

Copy Link

Recommended publications

List of Covered Drugs
List of Covered Drugs Effective July 1, 2016 INTRODUCTION We are pleased to provide the 2011 Gold Coast Health Plan List of Covered Drugs as a useful reference and informational tool. The GCHP List of Covered Drugs can assist practitioners in selecting clinically appropriate and cost effective products for their patients. The information contained in the GCHP List of Covered Drugs is provided solely for the convenience of medical providers. We do not warrant or assure accuracy of such information nor is it intended to be comprehensive in nature. This List of Covered Drugs is not intended to be a substitute for the knowledge, expertise, skill and judgment of the medical provider in his or her choice of prescription drugs. All the information in this List of Covered Drugs is provided as a reference for drug therapy selection. Specific drug selection for an individual patient rests solely with the prescriber. We assume no responsibility for the actions or omissions of any medical provider based upon reliance, in whole or in part, on the information contained herein. The medical provider should consult the drug manufacturer's product literature or standard references for more detailed information. National guidelines can be found on the National Guideline Clearinghouse site at http://www.guideline.gov PREFACE The GCHP List of Covered Drugs is organized by sections. Each section is divided by therapeutic drug class primarily defined by mechanism of action. Unless exceptions are noted, generally all applicable dosage forms and strengths of the drug cited are included in the GCHP List of Covered Drugs. Generics should be considered the first line of prescribing.
[Show full text]
Once-Daily Skeletal Muscle Relaxant in SA
NEWS Once-daily skeletal muscle relaxant in SA Myprocam (cyclobenzaprine with spine-related disorders and other 8. What are the classes of muscle a protective coating, and a polymer extended release [ER] sports injuries are excellent candidates relaxants? membrane that controls the rate of hydrochloride) is the most widely for Myprocam. Skeletal muscle relaxants (SMRs) are drug release. prescribed skeletal muscle a group of structurally unrelated drugs, The formulation of the drug relaxant in the US, is now available 4. What are the common as shown in Figure 1. These are divided ensures early systemic exposure in SA. Myprocam’s safety and efficacy indications for which Myprocam into two categories: to cyclobenzaprine, with a plasma has been shown in more than 20 clinical is used, and what are the common • Antispasticity agents: Used to concentration at four hours that trials. It was recently launched by causes of these ailments? treat muscle spasticity caused by is similar to that observed with Adcock Ingram nationally, making SA Low back pain, neck pain, sports traumatic neurologic injury, multiple cyclobenzaprine IR. the second country (only to the US) to injuries, muscle sprains and strains. sclerosis, and other conditions. However, in contrast to the bring the product to market. Common causes of these conditions • Antispasmodic agents: Used fluctuating peaks and troughs in Myprocam, indicated for the relief of include sports injuries, car accidents, to treat muscular pain or spasm plasma cyclobenzaprine concentration muscle spasm associated with acute work-related injuries, and everyday associated with acute, nonspecific after administration of the IR and painful musculoskeletal conditions, activities, which account for acute musculoskeletal conditions.
[Show full text]
First Xenon-Xenon Collisions in the Lhc
9th International Particle Accelerator Conference IPAC2018, Vancouver, BC, Canada JACoW Publishing ISBN: 978-3-95450-184-7 doi:10.18429/JACoW-IPAC2018-MOPMF039 FIRST XENON-XENON COLLISIONS IN THE LHC M. Schaumann∗, R. Alemany-Fernandez, P. Baudrenghien, T. Bohl, C. Bracco, R. Bruce, N. Fuster-Martinez, M. A. Jebramcik, J.M. Jowett, T. Mertens, D. Mirarchi, S. Redaelli, B. Salvachua, M. Solfaroli, H. Timko, J. Wenninger, CERN, Geneva, Switzerland Abstract EXECUTION OF THE RUN In 2017, the CERN accelerator complex once again demonstrated its flexibility by producing beams of a new A total of about 18 h of LHC time were taken for the Xe ion species, xenon, that were successfully injected into LHC. collision run. The schedule was designed to include set-up, On 12 October, collisions of fully stripped xenon nuclei first injection, validation and physics data taking. A further 12 h were devoted to experiments on crystal collimation, de- were recorded for the first time in the LHC√ at a centre-of- scribed elsewhere [3]. This tight schedule was only feasible mass energy per colliding nucleon pair of sNN = 5.44 TeV. Physics data taking started 9.5hafter the first injection of by drastically reducing the complexity of the set-up follow- xenon beams and lasted a total of 6h. The integrated lumi- ing the model of the p–Pb pilot run in September 2012 [4,5] nosity delivered to the four LHC experiments was sufficient when first injection, validation and physics data-taking were that new physics results can be expected soon. We provide achieved within a single fill.
[Show full text]
XENON X-1100 High-Intensity Pulsed Light System
XENON X-1100 High-Intensity Pulsed Light System The low cost R&D tool for investigating the applicability of Pulsed Light for new and emerging applications. The tool that researchers, scientists and engineers have been looking for is here. An easy-to-use photonic system developed by XENON that will open new doors and lead to new discoveries. The power of Pulsed Light In virtually all disciplines of science and technology there are applications where precise delivery of energy is demanded. One less studied energy delivery mechanism is the use of high-intensity pulsed light. At present the most prevalent example of this is in the use of lasers. However, the point source, coherent and single wavelength nature of lasers, are often not suited to the majority of challenges facing many industries. In these situations, it is crucial to have a broad spectra source so as not to be restricted in choosing materials with specific absorption characteristics. Because XENON sources generate light which extends from the deep UV to IR and often with peak pulse powers measured in megawatts, the ability of these sources to perform tasks such as breaking chemical bonds, sintering, ablating or sterilizing is highly realizable. The high peak powers generated by XENON’s production level systems are possible by tightly controlling the pulse durations measured from a few microseconds to milliseconds. Until now there was no practical method of generating this intense pulsed light in a low-cost R&D tool that was safe, compact and versatile. XENON has developed a system to address this challenge based on over 50 years of exper- tise in the Pulsed Light industry.
[Show full text]
Role of Thrombin and Thromboxane A2 in Reocclusion Following Coronary
Proc. Natl. Acad. Sci. USA Vol. 86, pp. 7585-7589, October 1989 Medical Sciences Role of thrombin and thromboxane A2 in reocclusion following coronary thrombolysis with tissue-type plasminogen activator (thrombolytic therapy/coronary thrombosis/platelet activation/reperfusion) DESMOND J. FITZGERALD*I* AND GARRET A. FITZGERALD* Divisions of *Clinical Pharmacology and tCardiology, Vanderbilt University, Nashville, TN 37232 Communicated by Philip Needleman, June 28, 1989 (receivedfor review April 12, 1989) ABSTRACT Reocclusion of the coronary artery occurs against the prothrombinase formed on the platelet surface after thrombolytic therapy of acute myocardlal infarction (13) and the neutralization ofheparin by platelet factor 4 (14) despite routine use of the anticoagulant heparin. However, and thrombospondin (15), proteins released by activated heparin is inhibited by platelet activation, which is greatly platelets. enhanced in this setting. Consequently, it is unclear whether To address the role of thrombin during coronary throm- thrombin induces acute reocclusion. To address this possibility, bolysis, we have examined the effect of a specific thrombin we examined the effect of argatroban {MCI9038, (2R,4R)- inhibitor, argatroban {MCI9038, (2R,4R)-4-methyl-1-[N-(3- 4-methyl-l-[Na-(3-methyl-1,2,3,4-tetrahydro-8-quinolinesulfo- methyl-1,2,3,4-tetrahydro-8-quinolinesulfonyl)-L-arginyl]-2- nyl)-L-arginyl]-2-piperidinecarboxylic acid}, a specific throm- piperidinecarboxylic acid} on the response to tissue plasmin- bin inhibitor, on the response to tissue-type plasminogen ogen activator (t-PA) in a closed-chest canine model of activator in a dosed-chest canine model of coronary thrombo- coronary thrombosis. MCI9038, an argimine derivative which sis. MCI9038 prolonged the thrombin time and shortened the binds to a hydrophobic pocket close to the active site of time to reperfusion (28 + 2 min vs.
[Show full text]
Stroke Prevention in Chronic Kidney Disease Disclosures
5/18/2020 Controversies: Stroke Prevention in Chronic Kidney Disease Wei Ling Lau, MD FASN FAHA FACP Assistant Professor, Nephrology University of California, Irvine Visiting Fellow at OptumLabsCOPY Disclosures • Prior or current research funding from NIH, AHA, Sanofi, ZS Pharma, and Hub Therapeutics. • Associate Medical Director for home peritoneal dialysis at Fresenius University Dialysis Center of Orange. • Has beenNOT on Fresenius medical advisory board for Velphoro. • No conflicts of interest relevant to the current talk. Controversies: Stroke prevention in CKD Wei Ling Lau, MD DO 1 5/18/2020 Stroke Prevention in CKD • Blood pressure targets • Antiplatelet agents • Statins • Anticoagulation Controversies: Stroke prevention in CKD Wei Ling Lau, MD COPY BP TARGETS Data is limited, as patients with CKD were historically excluded from clinical trials NOT Whelton 2017 ACC/AHA hypertension guidelines [Hypertension 2018] Controversies: Stroke prevention in CKD Wei Ling Lau, MD DO 2 5/18/2020 Systolic Blood Pressure Intervention Trial SPRINT: BP lowering to <120 vs <140 mmHg significantly lowered rate of CVD composite primary outcome; no clear effect on stroke Controversies: Stroke prevention in CKD The SPRINT Research Group. N Engl J Med 2015 p2103 Wei Ling Lau, MD COPY SPRINT subgroup analysis: CKD • Patients with CKD stage 3‐4 (eGFR of 20 to <60) comprised 28% of the SPRINT study population • Intensive BP management seemed to provide the same benefits for reduction in the CVD composite primary outcomeNOT – but did not impact stroke Controversies: Stroke prevention in CKD Cheung 2017 J Am Soc Nephrol p2812 Wei Ling Lau, MD DO 3 5/18/2020 The hazard of incident stroke associated with systolic BP (SBP) and chronic kidney disease (CKD)BP using and an unadjusted stroke model risk: that contained J‐shaped dummy variables association for CKD and BP groups (A) and a fully adjusted model that contained dummy variables for CKD and BP grou..
[Show full text]
Bonviva, INN- Ibandronic Acid
European Medicines Agency London, 1 September 2005 Doc.Ref.: EMEA/278873/2005 Bonviva International Nonproprietary Name: Ibandronic acid Following the procedure EMEA/H/C/501/X/01 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: [email protected] http://www.emea.eu.int EMEA 2005 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged 1 SCIENTIFIC DISCUSSION 1.1 Introduction and rationale The MAH submitted an extension application under Annex II, point 2 iii to Commission Regulation (EC) No 1085/2003 to request the approval of a 150 mg tablet as a monthly dosing regimen of ibandronate only for the indication of “treatment of osteoporosis in postmenopausal women, in order to reduce the risk of vertebral fractures”. This claim is based on the results of a phase III study MOBILE (BM16549) comparing 100 and 150 mg once monthly to 2.5 mg once daily. Due to the inconveniences associated with intake of oral bisphosphonates (i.e. fasting conditions, frequent upper gastrointestinal intolerance) that may result in poor compliance, it was considered desirable to develop a more convenient drug formulation. Hence a 150 mg once monthly oral regimen is expected to offer greater convenience to postmenopausal women when compared to the currently approved 2.5mg once daily tablet. The development programme No new pre-clinical pharmacodynamic and pharmacokinetic studies have been performed in addition to those included in the previous submission for ibandronate 2.5 mg daily oral tablets.
[Show full text]
CCA Senior Care Options Formulary
Commonwealth Care Alliance Senior Care Option HMO SNP 2021 List of Covered Drugs Formulary 30 Winter Street • Boston, MA 02108 PLEASE READ: THIS DOCUMENT CONTAINS INFORMATION ABOUT THE DRUGS WE COVER IN THIS PLAN This formulary was updated on 08/01/2021. For more recent information or other questions, please contact Senior Care Options Program (HMO SNP) Member Services, at 1-866-610-2273 or, for TTY users, 711, 8 a.m. – 8 p.m., 7 days a week, or visit www.commonwealthcaresco.org. HPMS Approved Formulary File Submission ID 00021589, Version Number 13 Senior Care Options Program (HMO SNP) 2021 Formulary (List of Covered Drugs) PLEASE READ: THIS DO CUMENT CONTAINS INFORMATION ABOUT THE DRUGS WE COVER IN THIS PLAN HPMS Approved Formulary File Submission ID 00021589, Version Number 13 Note to existing members: This formulary has changed since last year. Please review this document to make sure that it still contains the drugs you take. When this drug list (formulary) refers to “we,” “us”, or “our,” it means Commonwealth Care Alliance. When it refers to “plan” or “our plan,” it means 2021 Senior Care Options Program. This document includes list of the drugs (formulary) for our plan which is current as of 08/01/2021. This formulary document applies to all SCO members. For an updated formulary, please contact us. Our contact information, along with the date we last updated the formulary, appears on the front and back cover pages. You must generally use network pharmacies to use your prescription drug benefit. Benefits, formulary, pharmacy n etwork, and/or copayments/coinsurance may change on January 1, 2022, and from time to time during the year.
[Show full text]
Supplementary Information
Supplementary Information Network-based Drug Repurposing for Novel Coronavirus 2019-nCoV Yadi Zhou1,#, Yuan Hou1,#, Jiayu Shen1, Yin Huang1, William Martin1, Feixiong Cheng1-3,* 1Genomic Medicine Institute, Lerner Research Institute, Cleveland Clinic, Cleveland, OH 44195, USA 2Department of Molecular Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH 44195, USA 3Case Comprehensive Cancer Center, Case Western Reserve University School of Medicine, Cleveland, OH 44106, USA #Equal contribution *Correspondence to: Feixiong Cheng, PhD Lerner Research Institute Cleveland Clinic Tel: +1-216-444-7654; Fax: +1-216-636-0009 Email: [email protected] Supplementary Table S1. Genome information of 15 coronaviruses used for phylogenetic analyses. Supplementary Table S2. Protein sequence identities across 5 protein regions in 15 coronaviruses. Supplementary Table S3. HCoV-associated host proteins with references. Supplementary Table S4. Repurposable drugs predicted by network-based approaches. Supplementary Table S5. Network proximity results for 2,938 drugs against pan-human coronavirus (CoV) and individual CoVs. Supplementary Table S6. Network-predicted drug combinations for all the drug pairs from the top 16 high-confidence repurposable drugs. 1 Supplementary Table S1. Genome information of 15 coronaviruses used for phylogenetic analyses. GenBank ID Coronavirus Identity % Host Location discovered MN908947 2019-nCoV[Wuhan-Hu-1] 100 Human China MN938384 2019-nCoV[HKU-SZ-002a] 99.99 Human China MN975262
[Show full text]
GTH 2021 State of the Art—Cardiac Surgery: the Perioperative Management of Heparin-Induced Thrombocytopenia in Cardiac Surgery
Review Article 59 GTH 2021 State of the Art—Cardiac Surgery: The Perioperative Management of Heparin-Induced Thrombocytopenia in Cardiac Surgery Laura Ranta1 Emmanuelle Scala1 1 Department of Anesthesiology, Cardiothoracic and Vascular Address for correspondence Emmanuelle Scala, MD, Centre Anesthesia, Lausanne University Hospital (CHUV), Lausanne, Hospitalier Universitaire Vaudois, Rue du Bugnon 46, BH 05/300, 1011 Switzerland Lausanne, Suisse, Switzerland (e-mail: [email protected]). Hämostaseologie 2021;41:59–62. Abstract Heparin-induced thrombocytopenia (HIT) is a severe, immune-mediated, adverse drug Keywords reaction that paradoxically induces a prothrombotic state. Particularly in the setting of ► Heparin-induced cardiac surgery, where full anticoagulation is required during cardiopulmonary bypass, thrombocytopenia the management of HIT can be highly challenging, and requires a multidisciplinary ► cardiac surgery approach. In this short review, the different perioperative strategies to run cardiopul- ► state of the art monary bypass will be summarized. Introduction genicity of the antibodies and is diagnostic for HIT. The administration of heparin to a patient with circulating Heparin-induced thrombocytopenia (HIT) is a severe, im- pathogenic HITabs puts the patient at immediate risk of mune-mediated, adverse drug reaction that paradoxically severe thrombotic complications. induces a prothrombotic state.1,2 Particularly in the setting The time course of HIT can be divided into four distinct of cardiac surgery, where full anticoagulation is required phases.6 Acute HIT is characterized by thrombocytopenia during cardiopulmonary bypass (CPB), the management of and/or thrombosis, the presence of HITabs, and conﬁrma- HIT can be highly challenging, and requires a multidisciplin- tion of their platelet activating capacity by a functional ary approach.
[Show full text]
Sulfur Hexafluoride Hazard Summary Identification
Common Name: SULFUR HEXAFLUORIDE CAS Number: 2551-62-4 RTK Substance number: 1760 DOT Number: UN 1080 Date: April 2002 ------------------------------------------------------------------------- ------------------------------------------------------------------------- HAZARD SUMMARY * Sulfur Hexafluoride can affect you when breathed in. * If you think you are experiencing any work-related health * Sulfur Hexafluoride can irritate the skin causing a rash or problems, see a doctor trained to recognize occupational burning feeling on contact. Direct skin contact can cause diseases. Take this Fact Sheet with you. frostbite. * Exposure to hazardous substances should be routinely * Sulfur Hexafluoride may cause severe eye burns leading evaluated. This may include collecting personal and area to permanent damage. air samples. You can obtain copies of sampling results * Breathing Sulfur Hexafluoride can irritate the nose and from your employer. You have a legal right to this throat. information under OSHA 1910.1020. * Breathing Sulfur Hexafluoride may irritate the lungs causing coughing and/or shortness of breath. Higher WORKPLACE EXPOSURE LIMITS exposures can cause a build-up of fluid in the lungs OSHA: The legal airborne permissible exposure limit (pulmonary edema), a medical emergency, with severe (PEL) is 1,000 ppm averaged over an 8-hour shortness of breath. workshift. * High exposure can cause headache, confusion, dizziness, suffocation, fainting, seizures and coma. NIOSH: The recommended airborne exposure limit is * Sulfur Hexafluoride may damage the liver and kidneys. 1,000 ppm averaged over a 10-hour workshift. * Repeated high exposure can cause deposits of Fluorides in the bones and teeth, a condition called “Fluorosis.” This ACGIH: The recommended airborne exposure limit is may cause pain, disability and mottling of the teeth.
[Show full text]
Doxapram Shortens Recovery Following Sevoflurane Anesthesia [Le Doxapram Hâte La Récupération Après Une Anesthésie Au Sévoflurane]
456 CANADIAN JOURNALGENERAL OF ANESTHESIA ANESTHESIA Doxapram shortens recovery following sevoflurane anesthesia [Le doxapram hâte la récupération après une anesthésie au sévoflurane] Chi-Chen Wu MD,* Martin S. Mok MD,* Jui-Yuan Chen MD,† Gong-Jhe Wu MD,† Yeong-Ray Wen MD,† Chao-Shun Lin MD* Purpose: A randomized, double blind controlled trial was possibilité de serrer la main sur demande, le temps d’extubation et undertaken to investigate the effect of doxapram on recovery le score de récupération d’Aldrete. Les valeurs de l’index bispectral, times and bispectral index following sevoflurane anesthesia. la tension artérielle systolique et la fréquence cardiaque ont été Methods: Upon completion of surgery under sevoflurane anes- enregistrées avant l’anesthésie, pendant l’opération et à chaque thesia, 60 adult patients were randomly allocated to receive minute pendant 15 min après l’administration du médicament. either doxapram hydrochloride 1 mg·kg–1 iv or saline placebo. Résultats : Le temps écoulé avant l’ouverture des yeux a été plus Clinical recovery from anesthesia was assessed by time to eye court avec le doxapram qu’avec le placebo (6,9 ± 2,2 min vs 9,9 opening on verbal command, hand squeezing on command, ± 3,1 min, P < 0,05). Les scores moyens de l’index bispectral ont time to extubation, and the Aldrete recovery score. Bispectral été aussi plus élevés avec le doxapram sept à huit minutes après index values, systolic blood pressure, and heart rate were l’administration du médicament expérimental (P < 0,05). Un recorded at baseline (before anesthesia), during surgery, and retour à la conscience plus rapide a été associé à une plus grande every minute for 15 min after administration of the study drug.
[Show full text]