Isolation and Antimicrobial Susceptibility Profile Of
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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 ........................................................................................................................ -
Severe Sepsis and Septic Shock Antibiotic Guide
Stanford Health Issue Date: 05/2017 Stanford Antimicrobial Safety and Sustainability Program Severe Sepsis and Septic Shock Antibiotic Guide Table 1: Antibiotic selection options for healthcare associated and/or immunocompromised patients • Healthcare associated: intravenous therapy, wound care, or intravenous chemotherapy within the prior 30 days, residence in a nursing home or other long-term care facility, hospitalization in an acute care hospital for two or more days within the prior 90 days, attendance at a hospital or hemodialysis clinic within the prior 30 days • Immunocompromised: Receiving chemotherapy, known systemic cancer not in remission, ANC <500, severe cell-mediated immune deficiency Table 2: Antibiotic selection options for community acquired, immunocompetent patients Table 3: Antibiotic selection options for patients with simple sepsis, community acquired, immunocompetent patients requiring hospitalization. Risk Factors for Select Organisms P. aeruginosa MRSA Invasive Candidiasis VRE (and other resistant GNR) Community acquired: • Known colonization with MDROs • Central venous catheter • Liver transplant • Prior IV antibiotics within 90 day • Recent MRSA infection • Broad-spectrum antibiotics • Known colonization • Known colonization with MDROs • Known MRSA colonization • + 1 of the following risk factors: • Prolonged broad antibacterial • Skin & Skin Structure and/or IV access site: ♦ Parenteral nutrition therapy Hospital acquired: ♦ Purulence ♦ Dialysis • Prolonged profound • Prior IV antibiotics within 90 days ♦ Abscess -
Severe Sepsis Tipsheet
Severe Sepsis Tipsheet SEVERE SEPSIS A, B, and C of the following must be met within 6 hours of each other. A. Documentation of a suspected infection. There may be reference to “possible infection,” “suspect infection,” “rule out infection,” or similar documentation. B. TWO or more manifestations of systemic infection according to the Systemic Inflammatory Response Syndrome (SIRS) criteria, which are: • Temperature > 38.3 C or < 36.0 C (> 100.9 F or < 96.8 F) • Heart rate (pulse) > 90 • Respiration > 20 per minute • White blood cell count > 12,000 or < 4,000 or > 10% bands C. Organ dysfunction, evidenced by any one of the following: • Systolic blood pressure (SBP) < 90 mmHg, or mean arterial pressure < 65 mmHg, or a systolic blood pressure decrease of more than 40 mmHg. Physician/APN/PA documentation must be present in the medical record indicating a > 40 mmHg decrease in SBP has occurred and is related to infection, severe sepsis or septic shock and not other causes. • Acute respiratory failure as evidenced by a new need for invasive or non-invasive mechanical ventilation. To use acute respiratory failure as a sign of organ dysfunction there must be: • Documentation of acute respiratory failure AND • Documentation the patient is on mechanical ventilation • Invasive mechanical ventilation requires an endotracheal or tracheostomy tube. Non-invasive mechanical ventilation may be referred to as BiPAP or CPAP. • New need for mechanical ventilation indicates the patient was not using the same type of mechanical ventilation prior to the current acute respiratory failure. • Use the time at which there is documentation the patient has both acute respiratory failure and is on mechanical ventilation. -
Antimicrobial Stewardship Guidance
Antimicrobial Stewardship Guidance Federal Bureau of Prisons Clinical Practice Guidelines March 2013 Clinical guidelines are made available to the public for informational purposes only. The Federal Bureau of Prisons (BOP) does not warrant these guidelines for any other purpose, and assumes no responsibility for any injury or damage resulting from the reliance thereof. Proper medical practice necessitates that all cases are evaluated on an individual basis and that treatment decisions are patient-specific. Consult the BOP Clinical Practice Guidelines Web page to determine the date of the most recent update to this document: http://www.bop.gov/news/medresources.jsp Federal Bureau of Prisons Antimicrobial Stewardship Guidance Clinical Practice Guidelines March 2013 Table of Contents 1. Purpose ............................................................................................................................................. 3 2. Introduction ...................................................................................................................................... 3 3. Antimicrobial Stewardship in the BOP............................................................................................ 4 4. General Guidance for Diagnosis and Identifying Infection ............................................................. 5 Diagnosis of Specific Infections ........................................................................................................ 6 Upper Respiratory Infections (not otherwise specified) .............................................................................. -
Below Are the CLSI Breakpoints for Selected Bacteria. Please Use Your Clinical Judgement When Assessing Breakpoints
Below are the CLSI breakpoints for selected bacteria. Please use your clinical judgement when assessing breakpoints. The lowest number does NOT equal most potent antimicrobial. Contact Antimicrobial Stewardship for drug selection and dosing questions. Table 1: 2014 MIC Interpretive Standards for Enterobacteriaceae (includes E.coli, Klebsiella, Enterobacter, Citrobacter, Serratia and Proteus spp) Antimicrobial Agent MIC Interpretive Criteria (g/mL) Enterobacteriaceae S I R Ampicillin ≤ 8 16 ≥ 32 Ampicillin-sulbactam ≤ 8/4 16/8 ≥ 32/16 Aztreonam ≤ 4 8 ≥ 16 Cefazolin (blood) ≤ 2 4 ≥ 8 Cefazolin** (uncomplicated UTI only) ≤ 16 ≥ 32 Cefepime* ≤ 2 4-8* ≥ 16 Cefotetan ≤ 16 32 ≥ 64 Ceftaroline ≤ 0.5 1 ≥ 2 Ceftazidime ≤ 4 8 ≥ 16 Ceftriaxone ≤ 1 2 ≥ 4 Cefpodoxime ≤ 2 4 ≥ 8 Ciprofloxacin ≤ 1 2 ≥ 4 Ertapenem ≤ 0.5 1 ≥ 2 Fosfomycin ≤ 64 128 ≥256 Gentamicin ≤ 4 8 ≥ 16 Imipenem ≤ 1 2 ≥ 4 Levofloxacin ≤ 2 4 ≥ 8 Meropenem ≤ 1 2 ≥ 4 Piperacillin-tazobactam ≤ 16/4 32/4 – 64/4 ≥ 128/4 Trimethoprim-sulfamethoxazole ≤ 2/38 --- ≥ 4/76 *Susceptibile dose-dependent – see chart below **Cefazolin can predict results for cefaclor, cefdinir, cefpodoxime, cefprozil, cefuroxime axetil, cephalexin and loracarbef for uncomplicated UTIs due to E.coli, K.pneumoniae, and P.mirabilis. Cefpodoxime, cefinidir, and cefuroxime axetil may be tested individually because some isolated may be susceptible to these agents while testing resistant to cefazolin. Cefepime dosing for Enterobacteriaceae ( E.coli, Klebsiella, Enterobacter, Citrobacter, Serratia & Proteus spp) Susceptible Susceptible –dose-dependent (SDD) Resistant MIC </= 2 4 8 >/= 16 Based on dose of: 1g q12h 1g every 8h or 2g every 8 h Do not give 2g q12 Total dose 2g 3-4g 6g NA Table 2: 2014 MIC Interpretive Standards for Pseudomonas aeruginosa and Acinetobacter spp. -
Piperacillin/Tazobactam Drug Class1 Antibiotic – Penicillin with Β-Lactamase Inhibitor
Monographs for Commonly Administered Intravenous Medications in Home and Community Care Piperacillin/Tazobactam Drug Class1 Antibiotic – penicillin with β-lactamase inhibitor Spectrum1 Refer to product monograph for complete spectrum For β-lactamase producing bacteria strains (e.g., Haemophilus influenza, Escherichia coli, and Staphylococcus aureus). Also to susceptible Acinetobacter species, Klebsiella pneumonia, Pseudomonas aeruginosa often combined with aminoglycoside). Cross Sensitivities / Allergies1 Cross sensitivities with penicillin and possibly cephalosporin and/or beta-lactam inhibitors Indications1,2 Intra-abdominal Respiratory tract Skin and skin structure Septicemia Gynecological Urinary tract Other conditions based on culture and sensitivity results Outpatient Considerations1 For patients with a documented allergy to penicillin, cephalosporin or beta-lactam inhibitor, the first dose should be administered in a hospital or clinic setting. Must be able to access laboratory monitoring (either at outpatient laboratory or by arranging in-home lab) if using an interacting oral medication (see Potential Drug Interactions section) Prescribing Considerations At time of ordering please provide the following to the pharmacist: and Dosage in Adults1,2 Height, weight Most recent serum creatinine with date obtained Indication (infection being treated) Usually dosed every 6 to 8 hours. Available as 2 g/0.25 g, 3 g/0.375 g, 4 g/0.5 g piperacillin/tazobactam (dose selected based on indication) Maximum 18 g/ 2.25 g piperacillin/tazobactam daily Dose and administration interval require adjustment for renal impairment Errors have occurred due to unusual ordering as combined dose of piperacillin and tazobactam. Order may be expressed only as piperacillin component or as a total of piperacillin + tazobactam (8:1 ratio). -
CEFTIN® Tablets CEFTIN® for Oral Suspension
PRODUCT INFORMATION CEFTIN® Tablets (cefuroxime axetil tablets) CEFTIN® for Oral Suspension (cefuroxime axetil powder for oral suspension) DESCRIPTION: CEFTIN Tablets and CEFTIN for Oral Suspension contain cefuroxime as cefuroxime axetil. CEFTIN is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration. Chemically, cefuroxime axetil, the 1-(acetyloxy) ethyl ester of cefuroxime, is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5- thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula: CEFTIN Tablets are film-coated and contain the equivalent of 125, 250, or 500 mg of cefuroxime as cefuroxime axetil. CEFTIN Tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 1 (250- and 500-mg tablets only), hydrogenated vegetable oil, hydroxypropyl methylcellulose, methylparaben, microcrystalline cellulose, propylene glycol, propylparaben, sodium benzoate (125-mg tablets only), sodium lauryl sulfate, and CEFTIN® Tablets (cefuroxime axetil tablets) CEFTIN® for Oral Suspension (cefuroxime axetil powder for oral suspension) titanium dioxide. CEFTIN for Oral Suspension, when reconstituted with water, provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL of suspension. CEFTIN for Oral Suspension contains the inactive ingredients povidone K30, stearic acid, sucrose, and tutti-frutti flavoring. CLINICAL PHARMACOLOGY: Absorption and Metabolism: After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to cefuroxime. -
Management of Penicillin and Beta-Lactam Allergy
Management of Penicillin and Beta-Lactam Allergy (NB Provincial Health Authorities Anti-Infective Stewardship Committee, September 2017) Key Points • Beta-lactams are generally safe; allergic and adverse drug reactions are over diagnosed and over reported • Nonpruritic, nonurticarial rashes occur in up to 10% of patients receiving penicillins. These rashes are usually not allergic and are not a contraindication to the use of a different beta-lactam • The frequently cited risk of 8 to 10% cross-reactivity between penicillins and cephalosporins is an overestimate based on studies from the 1970’s that are now considered flawed • Expect new intolerances (i.e. any allergy or adverse reaction reported in a drug allergy field) to be reported after 0.5 to 4% of all antimicrobial courses depending on the gender and specific antimicrobial. Expect a higher incidence of new intolerances in patients with three or more prior medication intolerances1 • For type-1 immediate hypersensitivity reactions (IgE-mediated), cross-reactivity among penicillins (table 1) is expected due to similar core structure and/or major/minor antigenic determinants, use not recommended without desensitization • For type-1 immediate hypersensitivity reactions, cross-reactivity between penicillins (table 1) and cephalosporins is due to similarities in the side chains; risk of cross-reactivity will only be significant between penicillins and cephalosporins with similar side chains • Only type-1 immediate hypersensitivity to a penicillin manifesting as anaphylaxis, bronchospasm, -
Antibiotic Use for Sepsis in Neonates and Children: 2016 Evidence Update
Antibiotic Use for Sepsis in Neonates and Children: 2016 Evidence Update Aline Fuchsa, Julia Bielickia,b, Shrey Mathurb, Mike Sharlandb, Johannes N. Van Den Ankera,c a Paediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, Basel, Switzerland b Paediatric Infectious Disease Research Group, Institute for Infection and Immunity, St George's University of London, London, United Kingdom c Division of Clinical Pharmacology, Children’s National Health System, Washington, DC, USA WHO-Reviews 1 TABLE OF CONTENTS 1. INTRODUCTION ............................................................................................................................... 3 1.1. Aims ......................................................................................................................................... 3 1.2. Background ............................................................................................................................. 3 1.2.1. Definition and diagnosis ................................................................................................. 3 Neonatal Sepsis ............................................................................................................................... 3 Paediatric Sepsis ............................................................................................................................. 4 Community versus hospital acquired sepsis .................................................................................. 5 1.2.2. Microbiology .................................................................................................................. -
Comparative Activity of Newer Antibiotics Against Gram-Negative Bacilli
CONTRIBUTION • Comparative activity of newer antibiotics against gram-negative bacilli CYNTHIA C. KNAPP, MS AND JOHN A. WASHINGTON, MD • The in vitro activities of cefoperazone, cefotaxime, ceftriaxone, ceftazidime, azlocillin, mezlocillin, piperacillin, ticarcillin/clavulanate, aztreonam, imipenem, and ciprofloxacin were concurrently deter- mined against over 1,000 isolates of gram-negative bacilli from clinical specimens of patients at the Cleve- land Clinic. Cephalosporins, penicillins, and aztreonam were active against species of Enterobacteriaceae other than Citrobacter freundii, Enterobacter aerogenes, and Enterobacter cloacae. Ceftazidime was the most active cephalosporin against Pseudomonas aeruginosa. Against the Enterobacteriaceae, the rank order of activity of penicillins was ticarcillin/clavulanate > piperacillin > mezlocillin > azlocillin. Against P. aer- uginosa, the rank order of activity of penicillins was piperacillin > ticarcillin/clavulanate > azlocillin > mezlocillin. Aztreonam was less active v P. aeruginosa than ceftazidime, cefoperazone, or piperacillin. The most active antimicrobials against all isolates tested were imipenem and ciprofloxacin. • INDEX TERMS: ANTIBIOTICS, LACTAM; GRAM-NEGATIVE BACTERIA • CLEVE CLIN J MED 1989; 56:161-166 HE RECENT introduction of ciprofloxacin for and penicillins, as well as the monobactam, aztreonam, clinical use follows closely a period of active re- and the carbapenem, imipenem.1-3 search in and development of expanded spec- We compared the susceptibility of more than 1,000 trum p-lactam antibiotics, including cephalo- clinical bacterial isolates to four expanded spectrum Tsporins, penicillins, monobactams, and carbapenems. cephalosporins (cefoperazone, cefotaxime, ceftriaxone, Although numerous published studies compare the ac- and ceftazidime), four expanded spectrum penicillins tivity of ciprofloxacin with other quinolones, only a (azlocillin, mezlocillin, piperacillin, and ticarcil- limited number of studies compare the activity of ci- lin/clavulanate), aztreonam, imipenem, and ciproflox- acin. -
Ceftaroline in Complicated Skin and Skin-Structure Infections
Infection and Drug Resistance Dovepress open access to scientific and medical research Open Access Full Text Article REVIEW Ceftaroline in complicated skin and skin-structure infections Paul O Hernandez1 Abstract: Ceftaroline is an advanced-generation cephalosporin antibiotic recently approved by Sergio Lema2 the US Food and Drug Administration for the treatment of complicated skin and skin-structure Stephen K Tyring3 infections (cSSSIs). This intravenous broad-spectrum antibiotic exerts potent bactericidal activity Natalia Mendoza2,4 by inhibiting bacterial cell wall synthesis. A high affinity for the penicillin-binding protein 2a (PBP2a) of methicillin-resistant Staphylococcus aureus (MRSA) makes the drug especially 1University of Texas School of Medicine at San Antonio, beneficial to patients with MRSA cSSSIs. Ceftaroline has proved in multiple well-conducted San Antonio, TX, 2Woodhull clinical trials to have an excellent safety and efficacy profile. In adjusted doses it is also recom- Medical and Mental Health Center, mended for patients with renal or hepatic impairment. Furthermore, the clinical effectiveness Brooklyn, NY, 3Department of Dermatology, University of Texas and high cure rate demonstrated by ceftaroline in cSSSIs, including those caused by MRSA Health Science Center at Houston, and other multidrug-resistant strains, warrants its consideration as a first-line treatment option 4 Houston, TX, USA; Department of for cSSSIs. This article reviews ceftaroline and its pharmacology, efficacy, and safety data to Dermatology, El -
Ertapenem Or Ticarcillin/Clavulanate for the Treatment of Intra-Abdominal Infections Or Acute Pelvic Infections in Pediatric Patients
The American Journal of Surgery 194 (2007) 367–374 Clinical surgery–American Ertapenem or ticarcillin/clavulanate for the treatment of intra-abdominal infections or acute pelvic infections in pediatric patients Albert E. Yellin, M.D.a,*, Jeffrey Johnson, M.D.b, Iliana Higareda, M.D.c, Blaise L. Congeni, M.D.d, Antonio C. Arrieta, M.D.e, Doreen Fernsler, B.S.f, Joseph West, Ph.D.f, Richard Gesser, M.D.f aDepartment of Surgery, Keck School of Medicine of the University of Southern California, 1200 N State St, Rm 9610, Los Angeles, CA 90033, USA bDepartment of Pediatrics, Keck School of Medicine of the University of Southern California, 1240 N Mission Rd, L902, Los Angeles, CA 90089-9300, USA cHospital Civil de Guadalajara, Hospital 278, 4420 El Retiro St, Guadalajara, Jalisco Mexico dAkron Children’s Hospital, Division of Infectious Diseases, Locust Professional Bldg, 300 Locust St, Ste 4, Akron, OH 44308-1062, USA eChildren’s Hospital of Orange County, Pediatric Infectious Diseases, 455 South Main Street, Orange, CA 92868, USA fMerck Research Laboratories, Merck & Co., Inc., 126 East Lincoln Avenue, Rahway, NJ 07065, USA Manuscript received June 20, 2006; revised manuscript January 20, 2007 Abstract Background: Ertapenem, a group I carbapenem antibiotic, has been shown to be safe and effective in treating adults with complicated intra-abdominal (cIAI) or acute pelvic infection (API). This study evaluated ertapenem for treating these infections in children. Methods: In an open-label study, children aged 2 to 17 years with cIAI or API were randomized 3:1 to receive ertapenem or ticarcillin/clavulanate.