Appendix C Medication Tables
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Cefditoren Pivoxil) Tablets 200 and 400 Mg
SPECTRACEF® (cefditoren pivoxil) Tablets 200 and 400 mg. To reduce the development of drug-resistant bacteria and maintain the effectiveness of SPECTRACEF® and other antibacterial drugs, SPECTRACEF® should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION SPECTRACEF® tablets contain cefditoren pivoxil, a semi-synthetic cephalosporin antibiotic for oral administration. It is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active cefditoren. Chemically, cefditoren pivoxil is (-)-(6R,7R)-2,2-dimethylpropionyloxymethyl 7-[(Z)-2-(2-aminothiazol-4-yl)-2-methoxy iminoacetamido]-3-[(Z)-2-(4-methylthiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. The empirical formula is C25H28N6O7S3 and the molecular weight is 620.73. The structural formula of cefditoren pivoxil is shown below: cefditoren pivoxil The amorphous form of cefditoren pivoxil developed for clinical use is a light yellow powder. It is freely soluble in dilute hydrochloric acid and soluble at levels equal to 6.06 mg/mL in ethanol and <0.1 mg/mL in water. SPECTRACEF® (cefditoren pivoxil) tablets contain 200 mg or 400 mg of cefditoren as cefditoren pivoxil and the following inactive ingredients: croscarmellose sodium, D-mannitol, hydroxypropyl cellulose, hypromellose, magnesium stearate, sodium caseinate (a milk protein), and sodium tripolyphosphate. The tablet coating contains carnauba wax, hypromellose, polyethylene glycol, and titanium dioxide. Tablets are printed with ink containing D&C Red No. 27, FD&C Blue No. 1, propylene glycol, and shellac. CLINICAL PHARMACOLOGY Pharmacokinetics Absorption Oral Bioavailability Following oral administration, cefditoren pivoxil is absorbed from the gastrointestinal tract and hydrolyzed to cefditoren by esterases. -
Medical Review(S) Clinical Review
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 200327 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 200327 Priority or Standard Standard Submit Date(s) December 29, 2009 Received Date(s) December 30, 2009 PDUFA Goal Date October 30, 2010 Division / Office Division of Anti-Infective and Ophthalmology Products Office of Antimicrobial Products Reviewer Name(s) Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD Review Completion October 29, 2010 Date Established Name Ceftaroline fosamil for injection (Proposed) Trade Name Teflaro Therapeutic Class Cephalosporin; ß-lactams Applicant Cerexa, Inc. Forest Laboratories, Inc. Formulation(s) 400 mg/vial and 600 mg/vial Intravenous Dosing Regimen 600 mg every 12 hours by IV infusion Indication(s) Acute Bacterial Skin and Skin Structure Infection (ABSSSI); Community-acquired Bacterial Pneumonia (CABP) Intended Population(s) Adults ≥ 18 years of age Template Version: March 6, 2009 Reference ID: 2857265 Clinical Review Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD NDA 200327: Teflaro (ceftaroline fosamil) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ......................................... 9 1.1 Recommendation on Regulatory Action ........................................................... 10 1.2 Risk Benefit Assessment.................................................................................. 10 1.3 Recommendations for Postmarketing Risk Evaluation and Mitigation Strategies ........................................................................................................................ -
Antibiotic Resistance and Molecular Typing of Pseudomonas Aeruginosa: Focus on Imipenem
BJID 2002; 6 (February) 1 Antibiotic Resistance and Molecular Typing of Pseudomonas aeruginosa: Focus on Imipenem Ana Lúcia Peixoto de Freitas and Afonso Luis Barth Federal University of Rio Grande do Sul, Pharmacy School, Clinical Hospital of Porto Alegre, Cardiology Institute, Porto Alegre, RS; Catholic University of Pelotas, Pharmacy School, Pelotas, RS, Brazil Susceptibility tests by disk diffusion and by E-test and molecular typing by macrorestriction analysis were performed to determine the relatedness of Pseudomonas aeruginosa isolates from three distinct hospitals. The resistance profile of 124 isolates to 8 antimicrobial agents was determined in three different hospitals, in Porto Alegre, Brazil. Frequencies of susceptibility ranged from 43.9% for carbenicillin to 87.7% for ceftazidime. Cross-resistance data of imipenem-resistant isolates indicated that most (70%) were also resistant to carbenicillin, although 30% remained susceptible to ceftazidime and cefepime. In general, susceptibility profiles were not able to determine relatedness among isolates of P. aeruginosa. On the other hand, molecular typing by macrorestriction analysis demonstrated high discriminatory power and identified 66 strains among 72 isolates of P. aeruginosa. Imipenem-susceptible isolates were all different. However, identical clones of imipenem-resistant isolates were found in two of the hospitals, despite variable response to other antibiotics. No clustering of infection among the different medical centers was observed. In conclusion, clones of P. aeruginosa did not spread among the different hospitals in our city even though related isolates of imipenem- resistant P. aeruginosa were found. Key Words: Pseudomonas aeruginosa, antibiotic resistance, imipenem. Despite improvements in antibiotic therapy, However, nosocomial isolates may easily develop Pseudomonas aeruginosa remains as one of the most resistance to carbapenens due to reduced uptake of prominent Gram-negative bacteria causing hospital- the drug, which leads to outbreaks of multiresistant/ associated infections. -
Allosteric Drug Transport Mechanism of Multidrug Transporter Acrb
ARTICLE https://doi.org/10.1038/s41467-021-24151-3 OPEN Allosteric drug transport mechanism of multidrug transporter AcrB ✉ Heng-Keat Tam 1,3,4 , Wuen Ee Foong 1,4, Christine Oswald1,2, Andrea Herrmann1, Hui Zeng1 & ✉ Klaas M. Pos 1 Gram-negative bacteria maintain an intrinsic resistance mechanism against entry of noxious compounds by utilizing highly efficient efflux pumps. The E. coli AcrAB-TolC drug efflux pump + 1234567890():,; contains the inner membrane H /drug antiporter AcrB comprising three functionally inter- dependent protomers, cycling consecutively through the loose (L), tight (T) and open (O) state during cooperative catalysis. Here, we present 13 X-ray structures of AcrB in inter- mediate states of the transport cycle. Structure-based mutational analysis combined with drug susceptibility assays indicate that drugs are guided through dedicated transport chan- nels toward the drug binding pockets. A co-structure obtained in the combined presence of erythromycin, linezolid, oxacillin and fusidic acid shows binding of fusidic acid deeply inside the T protomer transmembrane domain. Thiol cross-link substrate protection assays indicate that this transmembrane domain-binding site can also accommodate oxacillin or novobiocin but not erythromycin or linezolid. AcrB-mediated drug transport is suggested to be allos- terically modulated in presence of multiple drugs. 1 Institute of Biochemistry, Goethe-University Frankfurt, Frankfurt am Main, Germany. 2 Sosei Heptares, Steinmetz Building, Granta Park, Great Abington, Cambridge, UK. 3Present -
28912 Oxoid FDA Cartridge Tables:1
* Adapted in part from CLSI document M100-S23 (M02-A11) : “Disc diffusion supplemental tablesʼʼ Performance standards for antimicrobial susceptibility testing. The complete standard may be obtained from the Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19807. Test Cultures (zone diameters in mm) Antimicrobial Agent Disc Code Potency Resistant Intermediate Susceptible Amikacin AK 30 μg EnterobacteriaceaeK, P. aeruginosa, Acinetobacter spp., and Staphylococcus spp. ≤14 15-16 ≥17 Amoxycillin - Clavulanic Acid AMC 20/10 μg EnterobacteriaceaeE ≤13 14-17 ≥18 Staphylococcus spp.A,Q ≤19 — ≥20 Haemophilus spp.A,Y ≤19 — ≥20 AmpicillinC,n AMP 10 μg EnterobacteriaceaeE and Vibrio choleraef ≤13 14-16 ≥17 Staphylococcus spp.A,Q ≤28 — ≥29 Enterococcus spp.A,V,W,k,m ≤16 — ≥17 Haemophilus spp.Y ≤18 19-21 ≥22 Streptococcus spp. ß-Hemolytic GroupA,d — — ≥24 Ampicillin – Sulbactam SAM 10/10 μg EnterobacteriaceaeE, Acinetobacter spp., and Staphylococcus spp. ≤11 12-14 ≥15 Haemophilus spp.A,Y ≤19 — ≥20 Azithromycin AZM 15 μg Staphylococcus spp., Streptococcus spp Viridans Groupn, ß-Hemolytic Group, and S. pneumoniae) ≤13 14-17 ≥18 Neisseria meningitidisA,i — — ≥20 Haemophilus spp.A — — ≥12 Aztreonam ATM 30 μg EnterobacteriaceaeE ≤17 18-20 ≤21 P. aeruginosa ≤15 16-21 ≥22 Haemophilus spp.A — — ≥26 CAR 100 μg Carbenicillin Enterobacteriaceae ≤19 20-22 ≥23 Pseudomonas aeruginosaP ≤13 14-16 ≥17 CEC 30 μg Cefaclor Enterobacteriaceae and Staphylococcus spp. ≤14 15-17 ≥18 Haemophilus spp.Y ≤16 17-19 ≥20 MA 30 μg Cefamandole EnterobacteriaceaeD,E and Staphylococcus spp. ≤14 15-17 ≥18 CefazolinG KZ 30 μg Staphylococcus spp. -
This Table Summarizes Changes to the HF Qxq As of 10/11/2019 Question
Updated HFS Instructions (QxQs) This table summarizes changes to the HF QxQ as of 10/11/2019 Question in HF QxQ Description of Changes in HF QXQ General Instructions, pg. 3 Clarification added to rules for history Q29.d.10., pg. 40 Clarification made on how to record pulmonary hypertention Q29.d.14., pg. 41 Clarification made on how to record diastolic dysfunction Q42., pg. 42 Clarification made on how to record troponin I Section VII: Medication, pg. 54 Clarificaiton made on how to record medications Appendix A, pg. 61 Updated list of medications Edoxaban (ACOAG, Generic) Lixiana (ACOAG, Trade) Prexxartan (ARB, Trade) INSTRUCTIONS FOR COMPLETING HEART FAILURE HOSPITAL RECORD ABSTRACTION FORM HFS Version C, 10/1/2015 HFA Version D, 10/1/2015 HF QxQ, 10/11/2019 Table of Contents Page General Instructions……………………………………………………………….. 2 Specific Items………………………………………………………………………. 3 Section l: Screening for Decompensation………………………………….. 5 Section ll: History of Heart Failure…………………………………………... 10 Section lll: Medical History ………………………………………………….. 13 Section lV: Physical Exam - Vital Signs…………………………………….. 24 Section V: Physical Exam - Findings……………………………………….. 26 Section Vl: Diagnostic Tests…………………………………………………. 31 Section Vll: Biochemical Analyses………………………………………….. 48 Section Vlll: Interventions…………………………………………………….. 51 Section lX: Medications………………………………………………………. 54 Section X: Complications Following Events………………………………… 59 Section Xl: Administrative……………………………………………………. 60 Appendix A: ARIC Heart Failure/Cardiac Drugs: ………………………………. 61 Alphabetical Sort Appendix B: Potential Scenarios of the Onset of Heart………………………. 73 Failure Event or Decompensation HF QxQ 10/11/2019 Page 1 of 73 General Instructions The HFAA form was initially used for all discharges selected for HF surveillance. It was replaced by the HFAB and HFSA forms and then updated June 2012 with HFAC and HFSB. -
Investigating the Inhibition Mechanism of L,D-Transpeptidase 5 from Mycobacterium Tuberculosis Using Computational Methods
INVESTIGATING THE INHIBITION MECHANISM OF L,D-TRANSPEPTIDASE 5 FROM MYCOBACTERIUM TUBERCULOSIS USING COMPUTATIONAL METHODS BY: GIDEON FEMI TOLUFASHE 216076453 Submitted in fulfilment of the requirements for the degree of Doctor of Philosophy in Pharmaceutical Chemistry School of Health Sciences, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa. 2018 PREFACE The work described in this thesis was conducted at the Catalysis and Peptide Research Unit, Westville Campus, University of KwaZulu-Natal, Durban, South Africa, under the supervision of Dr Bahareh Honarparvar, Prof. H.G. Kruger and Dr G.E.M. Maguire. This work has not been submitted in any form for any degree or diploma to any institution, where use has been made of the work of others, it is duly acknowledged in the text. Supervisors: Dr B. Honarparvar Date 30/10/2018 Prof. H. G. Kruger________________ Date ___________ Dr. G.E.M Maguire_______________ Date ___________ As candidate’s supervisor I agree to the submission of this thesis. i DECLARATION DECLARATION I- PLAGIARISM I, Gideon Femi Tolufashe declare that (i). The research reports in this thesis, except where otherwise indicated, is my original work. (ii). This thesis has not been submitted for any degree or examination at any other university. (iii). This thesis does not contain other person’s data, pictures, graphs or other information, unless specifically acknowledged as being sourced from other persons. (iv). This thesis does not contain other person’s writing, unless specifically acknowledged as being sourced from other researchers. Where other written sources have been quoted, then: a. Their words have been re-written, but the general information attributed to them has been referenced. -
Tufts Health Unify 202 0 List of Covered Drugs (Formulary)
Tufts Health Unify 202 0 List of Covered Drugs (Formulary) Effective: 12/01/2020 Tufts Health Plan P.O. Box 9194 Watertown, MA 02471-9194 Phone: 855.393.3154 Seven days a week, from 8 a.m. to 8 p.m. TuftsHealthUnify.org Formulary ID: 20533 Version: 20 H7419_6507B Approved DISCRIMINATION IS AGAINST THE LAW Tufts Health Plan complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. Tufts Health Plan does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. Tufts Health Plan: . Provides free aids and services to people with disabilities to communicate effectively with us, such as: — Written information in other formats (large print, audio, accessible electronic formats, other formats) . Provides free language services to people whose primary language is not English, such as: — Qualified interpreters — Information written in other languages If you need these services, contact Tufts Health Plan Member Services at 855.393.3154. If you believe that Tufts Health Plan has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Tufts Health Plan Attention: Civil Rights Coordinator, Legal Dept. 705 Mount Auburn St. Watertown, MA 02472 Phone: 888.880.8699 ext. 48000, [TTY number— 711 or 800.439.2370] Fax: 617.972.9048 Email: [email protected] You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Tufts Health Plan Civil Rights Coordinator is available to help you. -
Antibacterial Drug Usage Analysis
Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Drug Use Review Date: April 5, 2012 To: Edward Cox, M.D. Director Office of Antimicrobial Products Through: Gerald Dal Pan, M.D., MHS Director Office of Surveillance and Epidemiology Laura Governale, Pharm.D., MBA Deputy Director for Drug Use Division of Epidemiology II Office of Surveillance and Epidemiology Hina Mehta, Pharm.D. Drug Use Data Analysis Team Leader Division of Epidemiology II Office of Surveillance and Epidemiology From: Tracy Pham, Pharm.D. Drug Use Data Analyst Division of Epidemiology II Office of Surveillance and Epidemiology Drug Name(s): Systemic Antibacterial Drug Products Application Type/Number: Multiple Applicant/sponsor: Multiple OSE RCM #: 2012-544 **This document contains proprietary drug use data obtained by FDA under contract. The drug use data/information in this document has been cleared for public release.** 1 EXECUTIVE SUMMARY The Division of Epidemiology II is providing an update of the drug utilization data in terms of number of kilograms or international units of selected systemic antibacterial drug products sold from manufacturers to various retail and non-retail channels of distribution for years 2010-2011 as a surrogate for nationwide antibacterial drug use in humans. Propriety drug use databases licensed by the FDA were used to conduct this analysis. Data findings are as follows: During years 2010 and 2011, the majority of kilograms of selected systemic antibacterial drug products sold were to outpatient retail pharmacy settings. Approximately 3.28 million kilograms of selected systemic antibacterial drug products were sold during year 2010, and around 3.29 million kilograms were sold during year 2011. -
Confidential: for Review Only
BMJ Confidential: For Review Only The risk of fall and fracture with the initiation of a prostate - selective alpha antagonist Journal: BMJ Manuscript ID: BMJ.2015.028205 Article Type: Research BMJ Journal: BMJ Date Submitted by the Author: 17-Jul-2015 Complete List of Authors: Welk, Blayne; Western University, McArthur, Eric; Institute for Clinical Evaluative Sciences,, Fraser, Lisa-Ann; Western University, Medicine Hayward, Jade; Institute for Clinical Evaluative Sciences,, Dixon, Stephanie; Institute for Clinical Evaluative Sciences,, Hwang, Joseph; Case Western Reserve University School of Medicine, Ordon, Michael; University of Toronto, Surgery (Urology) Keywords: BPH, Fall, Fracture, Alpha antgonist https://mc.manuscriptcentral.com/bmj Page 1 of 45 BMJ 1 2 The risk of fall and fracture with the initiation of a prostate-selective alpha antagonist 3 4 1,2,3 2 4 2 5 Blayne Welk MD MSc , Eric McArthur MSc , Lisa-Ann Fraser MD MSc , Jade Hayward , 6 Stephanie Dixon MSc PhD 2,3 , Y. Joseph Hwang MSc 5, Michael Ordon MD MSc 6 7 8 1 DepartmentConfidential: of Surgery, Western University, For London Review, Ontario, Canada Only 9 2 Institute for Clinical Evaluative Sciences, London, Ontario, Canada 10 11 3 Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada 12 4 Department of Medicine, Western University, London, Ontario 13 5 MD Candidate, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA 14 6 Division of Urology, Department of Surgery, University of Toronto, Toronto, Ontario, Canada 15 16 17 Correspondence: 18 Blayne Welk, MD MSc 19 Assistant Professor, Division of Urology and Epidemiology and Biostatistics 20 Western University 21 Room B4-667 22 23 St Joseph's Health Care 24 268 Grosvenor Street London ON N6A 4V2 25 Telephone: 519 646-6367 | Fax: 519 646-6037 26 [email protected] 27 28 29 Addresses: 30 Mr McArthur: [email protected] 31 LHSC – Victoria Hospital 32 ELL-101, 800 Commissioners Rd. -
New Brunswick Prescription Drug Program Formulary
NEW BRUNSWICK PRESCRIPTION DRUG PROGRAM FORMULARY Copyright - 2003 The Queen In the right of The Province of New Brunswick as represented by The Honourable Elvy Robichaud Minister of Health and Wellness ADMINISTERED BY ATLANTIC BLUE CROSS CARE ON BEHALF OF THE GOVERNMENT OF NEW BRUNSWICK TABLE OF CONTENTS Page Introduction to the New Brunswick Prescription Drug Program Formulary I The New Brunswick Prescription Drug Program I New Brunswick Prescription Drug Program Plans II - III Exclusions IV - V Extemporaneous Preparations and Placebos VI Benefit Review Process VII Product Deletion VII Submission Requirements VIII Legend IX Comment Sheet X Pharmacologic - Therapeutic Classification of Drugs 4:00 Antihistamines 1 8:00 Anti-Infective Agents 3 10:00 Antineoplastic Agents 28 12:00 Autonomic Drugs 33 20:00 Blood Formation and Coagulation 43 24:00 Cardiovascular Agents 49 28:00 Central Nervous System Agent 76 40:00 Electrolytic, Caloric and Water Balance 128 48:00 Antitussives, Expectorants & Mucolytic Agents 133 52:00 Eye, Ear, Nose and Throat (EENT) Preparations 135 56:00 Gastrointestinal Drugs 149 60:00 Gold Compounds 159 64:00 Heavy Metal Antagonists 160 68:00 Hormones and Synthetic Substitutes 161 80:00 Serums, Toxoids, and Vaccines 179 84:00 Skin and Mucous Membrane Agents 180 86:00 Smooth Muscle Relaxants 198 88:00 Vitamins 201 92:00 Unclassified Therapeutic Agents 205 TABLE OF CONTENTS Page Appendices I-A Abbreviations of Dosage Forms A-1 - A-3 I-B Abbreviations of Routes A-4 - A-5 I-C Abbreviations of Units A-6 - A-7 II Abbreviations of Manufacturers' Names A-8 - A-9 III Extemporaneous Preparations A-10 IV Special Authorization A-11 IV Special Authorization Drug Criteria A-12 NEW BRUNSWICK PRESCRIPTION DRUG PROGRAM FORMULARY Introduction The New Brunswick Prescription Drug Program Formulary is a listing of all drugs and drug products which have been determined by the Minister of Health and Wellness to be entitled services. -
Biomarkers in Glioblastoma HIVE
Development of Integrated Imaging Techniques for Investigating Biomarkers in Glioblastoma HIVE HEISOOG KIM B.S., Nuclear Engineering (2004) Seoul National University M.D. Certificate, Graduate Education in Medical Sciences (2011) Harvard-MIT Division of Health Sciences and Technology SUBMITTED TO THE DEPARTMENT OF NUCLEAR SCIENCE AND ENGINEERING IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY IN NUCLEAR SCIENCE AND ENGINEERING AT THE MASSACHUSETTS INSTITUTE OF TECHNOLOGY SEPTEMBER 2011 @ 2011 Massachusetts Institute of Technology All rights reserved Signature of Author: Heisoog Kim Department of Nuclear Science and Engineering A.. ust 8"', 2011 Certified by Bruce R. n, Professor of Health Science and Technology/Nuclear Engineering All/7 Thesis Supervisor Certified by A. Gregory Sorensen, Professor at Harvard Medical School, Thesis Supervisor Reviewed by Elfar Adalsteinsson, Associate professor of Health Science and Technology, Thesis Reader Accepted by Mujid S. Kazimi, TEPCO P fess f Nuclear Engineering Chair, Department Committee on Graduate Students Table of Contents Abstract 5 Acknowledgements 7 List of Figures 9 List of Tables 11 1. Introduction 15 1.1. Significance of Developing Biomarkers 15 2. Cancer Physiology 19 2.1. Glioblastoma 19 2.2. Vascular Structure and Function in Brain Tumors 20 2.3. Angiogenesis in Tumor 22 2.4. Oxidative Metabolism in Tumors 23 2.5. Hypoxia in Tumors 26 3. Treatment Philosophies 33 3.1. Surgery 33 3.2. Radiotherapy 33 3.3. Chemotherapy 35 3.4. Antiangiogenic Therapy 37 4. Basics of Advanced Imaging Techniques 41 4.1. Magnetic Resonance Imaging Techniques 41 Simultaneous Blood Oxygenation Level Dependent (BOLD) and Arterial Spin Labeling (ASL) Imaging 42 Proton Magnetic Resonance Spectroscopy ('H MRS) Imaging 44 4.2.