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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 ........................................................................................................................ -
Use of Ceftaroline Fosamil in Children: Review of Current Knowledge and Its Application
Infect Dis Ther (2017) 6:57–67 DOI 10.1007/s40121-016-0144-8 REVIEW Use of Ceftaroline Fosamil in Children: Review of Current Knowledge and its Application Juwon Yim . Leah M. Molloy . Jason G. Newland Received: November 10, 2016 / Published online: December 30, 2016 Ó The Author(s) 2016. This article is published with open access at Springerlink.com ABSTRACT infections, CABP caused by penicillin- and ceftriaxone-resistant S. pneumoniae and Ceftaroline is a novel cephalosporin recently resistant Gram-positive infections that fail approved in children for treatment of acute first-line antimicrobial agents. However, bacterial skin and soft tissue infections and limited data are available on tolerability in community-acquired bacterial pneumonia neonates and infants younger than 2 months (CABP) caused by methicillin-resistant of age, and on pharmacokinetic characteristics Staphylococcus aureus, Streptococcus pneumoniae in children with chronic medical conditions and other susceptible bacteria. With a favorable and those with invasive, complicated tolerability profile and efficacy proven in infections. In this review, the microbiological pediatric patients and excellent in vitro profile of ceftaroline, its mechanism of action, activity against resistant Gram-positive and and pharmacokinetic profile will be presented. Gram-negative bacteria, ceftaroline may serve Additionally, clinical evidence for use in as a therapeutic option for polymicrobial pediatric patients and proposed place in therapy is discussed. Enhanced content To view enhanced content for this article go to http://www.medengine.com/Redeem/ 1F47F0601BB3F2DD. Keywords: Antibiotic resistance; Ceftaroline J. Yim (&) fosamil; Children; Methicillin-resistant St. John Hospital and Medical Center, Detroit, MI, Staphylococcus aureus; Streptococcus pneumoniae USA e-mail: [email protected] L. -
Redalyc.Patterns of Antimicrobial Therapy in Acute Tonsillitis: a Cross
Anais da Academia Brasileira de Ciências ISSN: 0001-3765 [email protected] Academia Brasileira de Ciências Brasil JOHN, LISHA J.; CHERIAN, MEENU; SREEDHARAN, JAYADEVAN; CHERIAN, TAMBI Patterns of Antimicrobial therapy in acute tonsillitis: A cross-sectional Hospital-based study from UAE Anais da Academia Brasileira de Ciências, vol. 86, núm. 1, enero-marzo, 2014, pp. 451-457 Academia Brasileira de Ciências Rio de Janeiro, Brasil Available in: http://www.redalyc.org/articulo.oa?id=32730090032 How to cite Complete issue Scientific Information System More information about this article Network of Scientific Journals from Latin America, the Caribbean, Spain and Portugal Journal's homepage in redalyc.org Non-profit academic project, developed under the open access initiative Anais da Academia Brasileira de Ciências (2014) 86(1): 451-457 (Annals of the Brazilian Academy of Sciences) Printed version ISSN 0001-3765 / Online version ISSN 1678-2690 http://dx.doi.org/10.1590/0001-3765201420120036 www.scielo.br/aabc Patterns of Antimicrobial therapy in acute tonsillitis: A cross-sectional Hospital-based study from UAE LISHA J. JOHN1, MEENU CHERIAN2, JAYADEVAN SREEDHARAN3 and TAMBI CHERIAN2 1Department of Pharmacology, Gulf Medical University, 4184, Ajman, United Arab Emirates 2Department of ENT, Gulf Medical College Hospital, 4184, Ajman, United Arab Emirates 3Statistical Support Facility, Centre for Advanced Biomedical Research and Innovation, Gulf Medical University, 4184, Ajman, United Arab Emirates Manuscript received on December 20, 2012; accepted for publication on October 14, 2013 ABSTRACT Background: Diseases of the ear, nose and throat (ENT) are associated with significant impairment of the daily life and a major cause for absenteeism from work. -
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. -
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. -
United States Patent ( 10 ) Patent No.: US 10,561,6759 B2 Griffith Et Al
US010561675B2 United States Patent ( 10 ) Patent No.: US 10,561,6759 B2 Griffith et al. (45 ) Date of Patent : * Feb . 18 , 2020 (54 ) CYCLIC BORONIC ACID ESTER ( 58 ) Field of Classification Search DERIVATIVES AND THERAPEUTIC USES CPC A61K 31/69 ; A61K 31/396 ; A61K 31/40 ; THEREOF A61K 31/419677 (71 ) Applicant: Rempex Pharmaceuticals , Inc. , (Continued ) Lincolnshire , IL (US ) (56 ) References Cited (72 ) Inventors : David C. Griffith , San Marcos, CA (US ) ; Michael N. Dudley , San Diego , U.S. PATENT DOCUMENTS CA (US ) ; Olga Rodny , Mill Valley , CA 4,194,047 A 3/1980 Christensen et al . ( US ) 4,260,543 A 4/1981 Miller ( 73 ) Assignee : REMPEX PHARMACEUTICALS , ( Continued ) INC . , Lincolnshire , IL (US ) FOREIGN PATENT DOCUMENTS ( * ) Notice : Subject to any disclaimer, the term of this EP 1550657 A1 7/2005 patent is extended or adjusted under 35 JP 2003-229277 A 8/2003 U.S.C. 154 ( b ) by 1129 days. (Continued ) This patent is subject to a terminal dis claimer . OTHER PUBLICATIONS Abdel -Magid et al. , “ Reductive Amination ofAldehydes and Ketones ( 21) Appl. No .: 13 /843,579 with Sodium Triacetoxyborohydride: Studies on Direct and Indirect Reductive Amination Procedures ” , J Org Chem . ( 1996 )61 ( 11 ): 3849 ( 22 ) Filed : Mar. 15 , 2013 3862 . (65 ) Prior Publication Data (Continued ) US 2013/0331355 A1 Dec. 12 , 2013 Primary Examiner — Shengjun Wang Related U.S. Application Data (74 ) Attorney, Agent, or Firm — Wilmer Cutler Pickering (60 ) Provisional application No.61 / 656,452 , filed on Jun . Hale and Dorr LLP 6 , 2012 (57 ) ABSTRACT (51 ) Int. Ci. A61K 31/69 ( 2006.01) Method of treating or ameliorating a bacterial infection A61K 31/00 ( 2006.01 ) comprising administering a composition comprising a cyclic (Continued ) boronic acid ester compound in combination with a car ( 52 ) U.S. -
AMR Surveillance in Pharma: a Case-Study for Data Sharingauthor by Professor Barry Cookson
AMR Open Data Initiative AMR Surveillance in Pharma: a case-study for data sharingauthor by Professor Barry Cookson External Consultant to Project eLibrary • Division of Infection and Immunity, Univ. College London ESCMID• Dept. of Microbiology, © St Thomas’ Hospital Background of “90 day Project” Addressed some recommendations of the first Wellcome funded multi-disciplinary workshop (included Pharma Academia & Public Health invitees: 27thauthor July 2017 (post the Davos Declaration): by 1) Review the landscape of existing Pharma AMR programmes, their protocols,eLibrary data standards and sets 2) Develop a "portal" (register/platform) to access currently available AMR Surveillance data ESCMID Important ©to emphasise that this is a COLLABORATION between Pharma and others Overview of Questionnaire Content • General information - including name,author years active, countries, antimicrobials, microorganisms.by • Methodology - including accreditation, methodology for; surveillance, isolate collection, organism identification, breakpointseLibrary used, • Dataset - including data storage methodology, management and how accessed. ESCMID © 13 Company Responses author 7 by 3 3 eLibrary ESCMID © Structure of register Companies can have different ways of referring to their activities: We had to choose a consistent framework. author Companies Companyby 1 Programmes Programme A Programme B eLibrary Antimicrobials 1 2 3 4 5 company’s product comparator company’s product antimicrobials Programmes canESCMID contain multiple studies (e.g. Pfizer has© single -
Mechanisms of Resistance to P-Lactam Antibiotics Amongst 1993
J. Med. Microbiol. - Vol. 43 (1999, 30G309 0 1995 The Pathological Society of Great Britain and Ireland ANTI MICROBIAL AGENTS Mechanisms of resistance to p-lactam antibiotics amongst Pseudomonas aeruginosa isolates collected in the UK in 1993 H. Y. CHEN, ME1 YUAN and D. M. LIVERMORE Department of Medical Microbiology, The London Hospital Medical College, Turner Street, London El 2AD Summary. Antimicrobial resistance among 199 1 Pseudomonas aeruginosa isolates collected at 24 UK hospitals during late 1993 was surveyed. Three-hundred and seventy-two of the isolates were resistant, or had reduced susceptibility, to some or all of azlocillin, carbenicillin, ceftazidime, imipenem and meropenem, and the mechanisms underlying their behaviour were examined. Only 13 isolates produced secondary p-lactamases : six possessed PSE- 1 or PSE-4 enzymes and seven had novel OXA enzyme types. Those with PSE types were highly resistant to azlocillin and carbenicillin whereas those with OXA enzymes were less resistant to these penicillins. Chromosomal p-lactamase derepression was demonstrated in 54 isolates, most of which were resistant to ceftazidime and azlocillin although susceptible to carbenicillin and carbapenems. p-Lactamase-independent “ intrinsic” resistance occurred in 277 isolates and is believed to reflect some combination of impermeability and efflux. Two forms were seen : the classical type, present in 195 isolates, gave carbenicillin resistance (MIC > 128 mg/L) and reduced susceptibility to ciprofloxacin and to all p-lactam agents except imipenem; a novel variant, seen in 82 isolates, affected only azlocillin, ceftazidime and, to a small extent, meropenem. Resistance to imipenem was largely dissociated from that to other p-lactam agents, and probably reflected loss of D2 porin, whereas resistance to meropenem was mostly associated with intrinsic resistance to penicillins and cephalosporins. -
)&F1y3x PHARMACEUTICAL APPENDIX to THE
)&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE -
The Efficacy of Cefmetazole Against Pyelonephritis Caused by Extended
International Journal of Infectious Diseases 17 (2013) e159–e163 Contents lists available at SciVerse ScienceDirect International Journal of Infectious Diseases jou rnal homepage: www.elsevier.com/locate/ijid The efficacy of cefmetazole against pyelonephritis caused by extended-spectrum beta-lactamase-producing Enterobacteriaceae a, b c d a,e Asako Doi *, Toshihiko Shimada , Sohei Harada , Kentaro Iwata , Toru Kamiya a Department of Infectious Diseases, Rakuwakai Otowa Hospital, Otowachinji-cho 2, Yamashina-ku, Kyoto, Japan b Department of General Internal Medicine, Nara City Hospital, Nara, Japan c Department of Microbiology and Infectious Diseases, Toho University School of Medicine, Ota-ku, Tokyo, Japan d Division of Infectious Diseases, Kobe University Hospital, Chuo-ku, Kobe, Hyogo, Japan e Department of General Internal Medicine, Rakuwakai Otowa Hospital, Otowachinji-cho 2, Yamashina-ku, Kyoto, Japan A R T I C L E I N F O S U M M A R Y Article history: Objectives: Urinary tract infections (UTIs) caused by extended-spectrum beta-lactamase (ESBL)- Received 3 April 2012 producing Enterobacteriaceae are on the increase. Although cefmetazole is stable in vitro against the Accepted 26 September 2012 hydrolyzing activity of ESBLs, no clinical study has ever evaluated its role in infections caused by these Corresponding Editor: William Cameron, organisms. We therefore evaluated the efficacy of cefmetazole compared to carbapenems against Ottawa, Canada pyelonephritis caused by ESBL-producing Enterobacteriaceae. Methods: A retrospective chart review was conducted at a tertiary care hospital from August 2008 to July Keywords: 2010. Chart reviews were done for patients with ESBL-producing organisms in urine identified in the Extended-spectrum beta-lactamase (ESBL) microbiology database. -
Comparative Study of 5-Day and 10-Day Cefditoren Pivoxil Treatments for Recurrent Group a Β-Hemolytic Streptococcus Pharyngitis in Children
Hindawi Publishing Corporation International Journal of Pediatrics Volume 2009, Article ID 863608, 5 pages doi:10.1155/2009/863608 Clinical Study Comparative Study of 5-Day and 10-Day Cefditoren Pivoxil Treatments for Recurrent Group A β-Hemolytic Streptococcus pharyngitis in Children Hideaki Kikuta, Mutsuo Shibata, Shuji Nakata, Tatsuru Yamanaka, Hiroshi Sakata, Kouji Akizawa, and Kunihiko Kobayashi Pediatric Clinic, Touei Hospital, N-41, E-16, Higashi-ku, Sapporo 007-0841, Japan Correspondence should be addressed to Hideaki Kikuta, [email protected] Received 20 November 2008; Accepted 23 January 2009 Recommended by Samuel Menahem Efficacy of short-course therapy with cephalosporins for treatment of group A β-hemolytic streptococcus (GABHS) pharyngitis is still controversial. Subjects were 226 children with a history of at least one episode of GABHS pharyngitis. Recurrence within the follow-up period (3 weeks after initiation of therapy) occurred in 7 of the 77 children in the 5-day treatment group and in 1 of the 149 children in the 10-day treatment group; the incidence of recurrence being significantly higher in the 5-day treatment group. Bacteriologic treatment failure (GABHS isolation without overt pharyngitis) at follow-up culture was observed in 7 of the 77 children in the 5-day treatment group and 17 of the 149 children in the 10-day treatment group. There was no statistical difference between the two groups. A 5-day course of oral cephalosporins is not always recommended for treatment of GABHS pharyngitis in children who have repeated episodes of pharyngitis. Copyright © 2009 Hideaki Kikuta et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.