Peritoneal Dialysis Antimicrobial Dosing Recommendations
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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 ........................................................................................................................ -
Ceftazidime for Injection) PHARMACY BULK PACKAGE – NOT for DIRECT INFUSION
PRESCRIBING INFORMATION FORTAZ® (ceftazidime for injection) PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION To reduce the development of drug-resistant bacteria and maintain the effectiveness of FORTAZ and other antibacterial drugs, FORTAZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial drug for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4 thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1 azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6α,7β(Z)]]. It has the following structure: The molecular formula is C22H32N6O12S2, representing a molecular weight of 636.6. FORTAZ is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity. The Pharmacy Bulk Package vial contains 709 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3mEq) per gram of ceftazidime. FORTAZ in sterile crystalline form is supplied in Pharmacy Bulk Packages equivalent to 6g of anhydrous ceftazidime. The Pharmacy Bulk Package bottle is a container of sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous use. THE PHARMACY BULK PACKAGE IS NOT FOR DIRECT INFUSION, FURTHER DILUTION IS REQUIRED BEFORE USE. -
“Ceftriaxone– Sulbactam–EDTA” and Various Antibiotics Against Gram
ORIGINAL ARTICLE A Comparative In Vitro Sensitivity Study of “Ceftriaxone– Sulbactam–EDTA” and Various Antibiotics against Gram- negative Bacterial Isolates from Intensive Care Unit Sweta Singh1, Chinmoy Sahu2, Sangram Singh Patel3, Abhay Singh4, Nidhi Yaduvanshi5 ABSTRACT Introduction: A rapid increase in multidrug-resistant (MDR) strains is being seen across the globe especially in the Southeast Asian region, including India. Carbapenems and colistin form the mainstay of treatment against gram-negative pathogens, especially extended-spectrum beta-lactamase (ESBL)- and metallo-beta-lactamse (MBL)-producing isolates. However, due to increased resistance to carbapenems and toxicity of colistin, especially in intensive care units (ICUs), carbapenem-sparing antibiotics like ceftriaxone–sulbactam–EDTA (CSE) combination needs to be evaluated. Materials and methods: Bacterial isolates cultured from various clinical samples from all ICUs for a period of 9 months were evaluated. Bacterial identification was performed by matrix assisted laser desorption ionization time of flight mass spectrometry (MALDI-TOF MS) and antibiotic susceptibility testing were performed by disk diffusion and E test method. Antibiogram of various antibiotics was noted. Extended-spectrum beta-lactamase- and MBL-producing bacteria were identified by phenotypic methods. Antibiotic sensitivity results of CSE were compared with the comparator drugs like colistin, carbapenems, and tigecycline in Enterobacteriaceae, Acinetobacter spp., and Pseudomonas spp. along with ESBL and MBL producers. Results: A total of 2,760 samples of blood, cerebrospinal fluid (CSF), respiratory samples, tissue, and pus were collected from ICUs with maximum isolates from pus (37%) followed by respiratory samples (31%) and blood (27%). Escherichia coli and Klebsiella pneumoniae were the predominant gram-negative pathogens accounting for 56% of the isolates followed by Acinetobacter spp. -
Activity of Aztreonam in Combination with Ceftazidime-Avibactam Against
Diagnostic Microbiology and Infectious Disease 99 (2021) 115227 Contents lists available at ScienceDirect Diagnostic Microbiology and Infectious Disease journal homepage: www.elsevier.com/locate/diagmicrobio Activity of aztreonam in combination with ceftazidime–avibactam against serine- and metallo-β-lactamase–producing ☆ ☆☆ ★ Pseudomonas aeruginosa , , Michelle Lee a, Taylor Abbey a, Mark Biagi b, Eric Wenzler a,⁎ a College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA b College of Pharmacy, University of Illinois at Chicago, Rockford, IL, USA article info abstract Article history: Existing data support the combination of aztreonam and ceftazidime–avibactam against serine-β-lactamase Received 29 June 2020 (SBL)– and metallo-β-lactamase (MBL)–producing Enterobacterales, although there is a paucity of data against Received in revised form 15 September 2020 SBL- and MBL-producing Pseudomonas aeruginosa. In this study, 5 SBL- and MBL-producing P. aeruginosa (1 Accepted 19 September 2020 IMP, 4 VIM) were evaluated against aztreonam and ceftazidime–avibactam alone and in combination via broth Available online xxxx microdilution and time-kill analyses. All 5 isolates were nonsusceptible to aztreonam, aztreonam–avibactam, – – Keywords: and ceftazidime avibactam. Combining aztreonam with ceftazidime avibactam at subinhibitory concentrations Metallo-β-lactamase produced synergy and restored bactericidal activity in 4/5 (80%) isolates tested. These results suggest that the VIM combination of aztreonam and ceftazidime–avibactam may be a viable treatment option against SBL- and IMP MBL-producing P. aeruginosa. Aztreonam © 2020 Elsevier Inc. All rights reserved. Ceftazidime–avibactam Synergy 1. Introduction of SBLs and MBLs harbored by P. aeruginosa are fundamentally different than those in Enterobacterales (Alm et al., 2015; Kazmierczak et al., The rapid global dissemination of Ambler class B metallo-β- 2016; Periasamy et al., 2020; Poirel et al., 2000; Watanabe et al., lactamase (MBL) enzymes along with their increasing diversity across 1991). -
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. -
Global Assessment of the Antimicrobial Activity of Polymyxin B Against 54 731 Clinical Isolates of Gram-Negative Bacilli
View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Elsevier - Publisher Connector ORIGINAL ARTICLE 10.1111/j.1469-0691.2005.01351.x Global assessment of the antimicrobial activity of polymyxin B against 54 731 clinical isolates of Gram-negative bacilli: report from the SENTRY antimicrobial surveillance programme (2001–2004) A. C. Gales1, R. N. Jones2,3 and H. S. Sader1,2 1Division of Infectious Diseases, Universidade Federal de Sa˜o Paulo, Sa˜o Paulo, Brazil, 2JMI Laboratories, North Liberty, IA, USA, and 3Tufts University School of Medicine, Boston, MA, USA ABSTRACT In total, 54 731 Gram-negative bacilli isolated worldwide between 2001 and 2004 from diverse sites of infection were tested for susceptibility to polymyxin B by the broth reference microdilution method, with interpretation of results according to CLSI (formerly NCCLS) guidelines. Polymyxin B showed excellent potency and spectrum against 8705 Pseudomonas aeruginosa and 2621 Acinetobacter spp. isolates (MIC50, £ ⁄ ⁄ 1mg L and MIC90,2mg L for both pathogens). Polymyxin B resistance rates were slightly higher for carbapenem-resistant P. aeruginosa (2.7%) and Acinetobacter spp. (2.8%), or multidrug-resistant (MDR) P. aeruginosa (3.3%) and Acinetobacter spp. (3.2%), when compared with the entire group (1.3% for P. aeruginosa and 2.1% for Acinetobacter spp.). Among P. aeruginosa, polymyxin B resistance rates varied from 2.9% in the Asia-Pacific region to only 1.1% in Europe, Latin America and North America, while polymyxin B resistance rates ranged from 2.7% in Europe to 1.7% in North America and Latin America £ ⁄ % among Acinetobacter spp. -
Antimicrobial Susceptibility Among Colistin, Sulbactam, And
Hindawi Journal of Pathogens Volume 2018, Article ID 3893492, 5 pages https://doi.org/10.1155/2018/3893492 Research Article Antimicrobial Susceptibility among Colistin, Sulbactam, and Fosfomycin and a Synergism Study of Colistin in Combination with Sulbactam or Fosfomycin against Clinical Isolates of Carbapenem-Resistant Acinetobacter baumannii Sombat Leelasupasri,1 Wichai Santimaleeworagun ,2,3 and Tossawan Jitwasinkul3,4 1 Internal Medicine Unit, Phyathai II International Hospital, Bangkok, Tailand 2Department of Pharmacy, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom, Tailand 3Antibiotic Optimization and Patient Care Project by Pharmaceutical Initiative for Resistant Bacteria and Infectious Diseases Working Group (PIRBIG), Silpakorn University, Nakhon Pathom, Tailand 4Department of Biopharmacy, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom, Tailand Correspondence should be addressed to Wichai Santimaleeworagun; [email protected] Received 28 August 2017; Revised 9 December 2017; Accepted 25 December 2017; Published 18 January 2018 Academic Editor: Jose Yuste Copyright © 2018 Sombat Leelasupasri et al. Tis 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. Tis in vitro study aimed to determine the activity of colistin plus sulbactam and colistin plus fosfomycin against carbapenem- resistant A. baumannii (CRAB). Fifeen clinical isolates were obtained from patients admitted to Phyathai II International Hospital, Bangkok, Tailand, from August 2014 to April 2015. Te antimicrobial susceptibilities of colistin, sulbactam, and fosfomycin were evaluated using the E-test or broth microdilution and the synergistic activity of the antibacterial combinations (colistin plus sulbactam or fosfomycin) was determined using the chequerboard method. Clonal relationships were explored using repetitive element palindromic- (REP-) PCR. -
A Phase I, 3-Part Placebo-Controlled Randomised Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Aztreonam-Av
EV0643 Contactinformation: A phase I, 3-part placebo-controlled randomised trial to evaluate the safety, SeamusO’Brien AstraZenecaResearch&Development Macclesfield,Cheshire,UK tolerability and pharmacokinetics of aztreonam-avibactam in healthy subjects [email protected] Timi Edeki1, Diansong Zhou2, Frans van den Berg3, Helen Broadhurst4, William C. Holmes5, Gary Peters3, Maria Sunzel6, Seamus O’Brien4 1AstraZeneca, Wilmington, DE, USA; 2AstraZeneca, Waltham, MA, USA; 3Hammersmith Medicines Research, London, UK; 4AstraZeneca, Macclesfield, UK; 5AstraZeneca, Gaithersburg, MD, USA; 6Contractor at AstraZeneca, Wilmington, DE, USA Background Table 1.Subjects’baselinecharacteristics Figure 1. Geometricmean(A)aztreonamand(B)avibactamconcentration-timeprofilesinPartAfollowingindividualandcombinedadministrationofaztreonam2000mgandavibactam600mgby1-hIVinfusion Part A Part B Part C • Theemergenceandglobaldisseminationofmetallo-β-lactamase(MBL)-producing (A) (B) Enterobacteriaceae,includingNDM-typeandVIM-type,whichareresistanttocarbapenems, Active Placebo Active Placebo Active Placebo 100 Aztreonam 2000 mg alone (n=7) 100 Avibactam 600 mg alone (n=8) representsanurgentthreattohumanhealthforwhichfewtreatmentoptionscurrentlyexist.1, 2 (n=8) (n=4) (n=40) (n=16) (n=18) (n=6) Aztreonam-avibactam 2000-600 mg (n=7) Aztreonam-avibactam 2000-600 mg (n=7) • Aztreonam,amonobactamβ-lactam,isstabletoAmblerclassBMBLsincludingNDM-typeand Mean(SD)age,years 31(7) 34(7) 30(7) 27(5) 49(19) 51(19) VIM-type.However,bacteriathatexpressMBLsfrequentlyco-expressotherclassesofβ-lactamase -
Clinical Review (Cubicin)
Clinical Review Amol Purandare, MD NDA 021572 Cubicin (Daptomycin for injection) CLINICAL REVIEW Application Type NDA supplement Application Number(s) 21572 Priority or Standard Priority Submit Date(s) June 30, 2016 Received Date(s) June 30, 2016 PDUFA Goal Date March 30, 2017 (Major amendment) Division / Office DAIP/OAP Reviewer Name(s) Amol Purandare, MD Review Completion Date March 23, 2017 Established Name Daptomycin (Proposed) Trade Name Cubicin Therapeutic Class Cyclic Lipopeptide Applicant Cubist Pharmaceuticals Formulation(s) Injection Dosing Regimen 5 mg/kg (12-<18 years), 7 mg/kg (7-11 years), 9 mg/kg (2-6 years), and 10 mg/kg (1-< 2 years) Indication(s) Complicated Skin and Skin Structure Infections 1 Reference ID: 4075320 Clinical Review Amol Purandare, MD NDA 021572 Cubicin (Daptomycin for injection) Intended Population(s) Ages 1 year to <18 years Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT..........................................6 1.1 Recommendation on Regulatory Action ..............................................................6 1.2 Risk Benefit Assessment .....................................................................................6 1.3 Recommendations for Postmarket Risk Evaluation and Mitigation Strategies ....6 1.4 Recommendations for Postmarket Requirements and Commitments.................7 2 INTRODUCTION AND REGULATORY BACKGROUND .........................................7 2.1 Product Information .............................................................................................7 -
Activity of Imipenem, Meropenem, Cefepime, and Sulbactam in Combination with the Β-Lactamase Inhibitor LN-1-255 Against Acinetobacter Spp
antibiotics Article Activity of Imipenem, Meropenem, Cefepime, and Sulbactam in Combination with the β-Lactamase Inhibitor LN-1-255 against Acinetobacter spp. Cristina Lasarte-Monterrubio 1,† , Juan C. Vázquez-Ucha 1,† , Maria Maneiro 2, Jorge Arca-Suárez 1,*, Isaac Alonso 3, Paula Guijarro-Sánchez 1 , John D. Buynak 4, Germán Bou 1, Concepción González-Bello 2 and Alejandro Beceiro 1,* 1 Servicio de Microbiología, Instituto de Investigación Biomédica de A Coruña (INIBIC-CICA), Complejo Hospitalario Universitario A Coruña (CHUAC), As Xubias 84, 15006 A Coruña, Spain; [email protected] (C.L.-M.); [email protected] (J.C.V.-U.); [email protected] (P.G.-S.); [email protected] (G.B.) 2 Centro Singular de Investigación en Química Biolóxica e Materiais Moleculares (CIQUS), Departamento de Química Orgánica, Universidade de Santiago de Compostela, Jenaro de la Fuente s/n, 15782 Santiago de Compostela, Spain; [email protected] (M.M.); [email protected] (C.G.-B.) 3 Servicio de Microbiología, Hospital Provincial Pontevedra, Loureiro Crespo 2, 36002 Pontevedra, Spain; Citation: Lasarte-Monterrubio, C.; [email protected] 4 Vázquez-Ucha, J.C.; Maneiro, M.; Department of Chemistry, Southern Methodist University, Dallas, TX 75275, USA; [email protected] Arca-Suárez, J.; Alonso, I.; * Correspondence: [email protected] (J.A.-S.); [email protected] (A.B.); Tel.: +34-981-176-087 (J.A.-S.); +34-981-176-087 (A.B.) Guijarro-Sánchez, P.; Buynak, J.D.; † Cristina Lasarte-Monterrubio and Juan C. Vázquez-Ucha contributed equally to the study. Bou, G.; González-Bello, C.; Beceiro, A. -
Antimicrobial Surgical Prophylaxis
Antimicrobial Surgical Prophylaxis The antimicrobial surgical prophylaxis protocol establishes evidence-based standards for surgical prophylaxis at The Nebraska Medical Center. The protocol was adapted from the recently published consensus guidelines from the American Society of Health-System Pharmacists (ASHP), Society for Healthcare Epidemiology of America (SHEA), Infectious Disease Society of America (IDSA), and the Surgical Infection Society (SIS) and customized to Nebraska Medicine with the input of the Antimicrobial Stewardship Program in concert with the various surgical groups at the institution. The protocol established here-in will be implemented via standard order sets utilized within One Chart. Routine surgical prophylaxis and current and future surgical order sets are expected to conform to this guidance. Antimicrobial Surgical Prophylaxis Initiation Optimal timing: Within 60 minutes before surgical incision o Exceptions: Fluoroquinolones and vancomycin (within 120 minutes before surgical incision) Successful prophylaxis necessitates that the antimicrobial agent achieve serum and tissue concentrations above the MIC for probable organisms associated with the specific procedure type at the time of incision as well as for the duration of the procedure. Renal Dose Adjustment Guidance The following table can be utilized to determine if adjustments are needed to antimicrobial surgical prophylaxis for both pre-op and post-op dosing. Table 1 Renal Dosage Adjustment Dosing Regimen with Dosing Regimen with CrCl Dosing Regimen with -
In Vitro Susceptibilities of Escherichia Coli and Klebsiella Spp. To
Jpn. J. Infect. Dis., 60, 227-229, 2007 Short Communication In Vitro Susceptibilities of Escherichia coli and Klebsiella Spp. to Ampicillin-Sulbactam and Amoxicillin-Clavulanic Acid Birgul Kacmaz* and Nedim Sultan1 Department of Central Microbiology and 1Department of Microbiology, Faculty of Medicine, Gazi University, Ankara, Turkey (Received January 30, 2007. Accepted April 13, 2007) SUMMARY: Ampicillin-sulbactam (A/S) and amoxicillin-clavulanic acid (AUG) are thought to be equally efficacious clinically against the Enterobacteriaceae family. In this study, the in vitro activities of the A/S and AUG were evaluated and compared against Escherichia coli and Klebsiella spp. Antimicrobial susceptibility tests were performed by standard agar dilution and disc diffusion techniques according to the Clinical and Laboratory Standards Institute (CLSI). During the study period, 973 strains were isolated. Of the 973 bacteria isolated, 823 were E. coli and 150 Klebsiella spp. More organisms were found to be susceptible to AUG than A/S, regardless of the susceptibility testing methodology. The agar dilution results of the isolates that were found to be sensitive or resistant were also compatible with the disc diffusion results. However, some differences were seen in the agar dilution results of some isolates that were found to be intermediately resistant with disc diffusion. In E. coli isolates, 17 of the 76 AUG intermediately resistant isolates (by disc diffusion), and 17 of the 63 A/S intermediately resistant isolates (by disc diffusion) showed different resistant patterns by agar dilution. When the CLSI breakpoint criteria are applied it should be considered that AUG and A/S sensitivity in E. coli and Klebsiella spp.