DOCSLIB.ORG

INVANZ, INN-Ertapenem

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
INVANZ, INN-Ertapenem SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINE {(Invented) name} 1 g powder for solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cefazolin sodium equivalent to 1 g cefazolin. Excipient(s) with known effect: Each vial of {(Invented) name} 1 g contains 50.56 mg (2.2 mmol) sodium. 3. PHARMACEUTICAL FORM Powder for solution for injection/infusion. White or almost white powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Cefazolin is indicated in adults, adolescents, children and infants older than one month for the treatment of the following infections caused by cefazolin-sensitive microorganisms: • skin and soft tissue infections • bone and joint infections Perioperative prophylaxis: Perioperative administration of cefazolin may reduce the incidence of postoperative infections in contaminated or potentially contaminated surgery. Susceptibility of causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Dosage and method of administration Dosage The dosage depends on the susceptibility of the micro-organisms and the severity of the disease. • Adults and adolescents (above 12 years of age and ≥ 40 kg bodyweight). In infections caused by very sensitive gram-positive micro-organisms the usual dosage in adults and adolescents is 1 to 2 g/day in two or three equal doses. • In infections caused by less sensitive gram-positive organisms and gram-negative organisms, the usual dosage is 3 to 4 g/day in three or four equal doses. {(Invented) name} has been administered up to doses of a maximum 6 g/day in cases of severe infections, such as endocarditis. In adult and adolescent patients with renal insufficiency a lower dosage should be adhered to, in order to avoid accumulation. This lower dose can be determined by assessing the blood levels. Should this not be possible, the dosage can be determined by BUN and/or creatinine clearance. After an initial dose of 500 mg the following guidelines can be used as guide for the maintenance 3 dosage. Maintenance therapy with {(Invented) name} in patients with reduced renal function. Dose Kidney BUN Creatinine Gram- Gram- Serum half- function (mg %) clearance positive negative life-time (ml/min) infections infections (hours) Mild 20-34 70-40 250-500 mg 500 mg-1 g 3-5 impairment every 8 hours every 8 hours Moderate 35-49 40-20 125-250 mg 250-600 mg 6-12 impairment every 12 hours every 12 hours Severe 50-75 20-5 75-150 mg 150-400 mg 15-30 impairment every 24 hours every 24 hours Also see section 4.4 “Special warnings and precautions for use” Perioperative prophylaxis In order to avoid a postoperative infection in (possibly) infectious surgeries, these are the recommended dosages: a. 1 g administered 30 minutes to 1 hr prior to surgery. b. For longer operations (2 hours or more), 500 mg to 1 g administered intravenously during the surgery (administration to be amended depending on the duration of the surgery). c. 500 mg to 1 g administered intravenously, every 6 to 8 hours during 24 hours postoperative. It is important that (1) the perioperative dose is administered shortly prior to the start of the operation (30 mins to 1 hr), so that adequate levels of antibiotic are reached in the serum and tissues at the time of the first surgical incisions; and (2) cefazolin, if need be, is administered at set times during the surgery - at moments of increased exposure to micro-organisms - in order to reach sufficiently high antibiotic levels. The prophylaxis with cefazolin should reasonably be terminated within 24 hours after the end of the surgery. In surgeries where the risk of infections poses a particularly great risk (open heart surgery or prosthetic arthroplasty) the prophylaxis should be continued up to 3 to 5 days postoperative. Paediatric population Children and infants older than one month In infections caused by very sensitive gram-positive micro-organisms a dosage of 25 to 50 mg/kg of body weight divided in two or four doses a day will be efficient. In infections caused by less sensitive gram-positive micro-organisms and by the gram-negative causative agent, a dosage of max 100 mg/kg is recommended in three or four equal doses. In children and infants older than one month with renal insufficiency a lower dose may be recommended in order to avoid accumulation. This lower dose can be determined by assessing the blood levels. Should this not be possible, the dosage can be determined by the creatinine clearance according to the following guidelines. In children and infants older than one month with moderate renal insufficiency (creatinine clearance of 40-20 ml/min) 25 % of the normal daily dosage, divided in doses every 12 hours, will be sufficient. In children and infants older than one month with severe renal insufficiency (creatinine clearance 20-5 ml/min) 10 % of the normal daily dosage, administered every 24 hours, will be sufficient. All these guidelines apply after an initial starting dose. Also see section 4.4 “Special warnings and precautions for use” 4 Prematures and infants below the age of 1 month As the safety of use in premature babies and infants younger than one month has not been established, the use of {(Invented) name} in these patients is not recommended. Also see section 4.4 “Special warnings and precautions for use”. Guidelines for paediatric dosage 1 g vial to be prepared with 4 ml of diluent. Dilution = 225 mg/ml. Weight in kg 25 mg/kg/day in 3 doses 25 mg/kg/day in 4 doses doses in mg every volume in ml doses in mg every volume in ml 8 hours needed 6 hours needed 5 42 0.2 31 0.15 10 85 0.4 62 0.3 15 125 0.5 94 0.4 20 167 0.7 125 0.5 25 208 0.9 156 0.7 Weight in kg 50 mg/kg/day in 3 doses 50 mg/kg/day in 4 doses doses in mg every volume in ml doses in mg every volume in ml 8 hours needed 6 hours needed 5 83 0.4 63 0.3 10 166 0.7 125 0.6 15 250 1.1 188 0.8 20 333 1.5 250 1.1 25 417 1.9 313 1.4 Elderly patients No dose adjustments are needed in elderly patients with normal renal function. Duration of treatment Depends on the course of the disease. In keeping with the general principles of antibiotic therapy, treatment with {(Invented) name} should be continued for at least 2 to 3 days after the fever has subsided or proof has been obtained for the eradication of the causative agent. Method of administration {(Invented) name} may be administered intramuscular as well as intravenous. Intramuscular injection Dissolved in sterile water for injection, according to the following dilution table. Shake well until all the powder has been dissolved. Product after reconstitution is clear, almost colourless solution. {(Invented) name} must be injected into a major muscle mass. A reconstituted {(Invented) name} solution remains stable for 24 hours in the refrigerator (2°C - 8°C). Dilution table Content of the vial to be added diluent obtained volume Average concentration 1 g 2.5 ml 3.0 ml 330 mg/ml Intravenous administration: {(Invented) name} may be administered directly into a vein, either as a continuous or an intermittent 5 drip. The total daily dose is the same as for intramuscular administration. Intermittent and continuous infusion {(Invented) name} can be administered in combination with an existing intravenous therapy, either in the primary drip or in the secondary infusion drip. 1 g {(Invented) name} may be dissolved in 100 ml 9 ml/ml (0.9 %) sodium chloride intravenous solution. In these intravenous solutions {(Invented) name} remains stable for 24 hours in the refrigerator (2°C - 8°C). Direct intravenous injection: Dilute 1 g {(Invented) name} solution further with at least 10 ml water for injection, inject slowly during 3 to 5 minutes. In no case should the injection be shorter than 3 minutes. This should be done straight into the vein or into the tube in which the patient is administered the abovementioned intravenous solution. CAUTION: One-off doses of more than 1g need to be administered over thirty to sixty minutes. 4.3 Contraindications • Hypersensitivity to the active substance or to any other cephalosporins. • Prior severe allergic reactions to penicillin or any other type of β-lactam antibiotics. • When administered to children younger than 1 year, cefazolin should not be dissolved in a lidocaine solution. 4.4 Special warnings and precautions for use • Before the administration of cefazolin, previous hypersensitivity reactions to cephalosporins and penicillins should be investigated. Cephalosporins should not be used in patients known to develop an immediate allergic reaction to cephalosporins. In case of doubt, a doctor should be present during the initial administration in order to be able to treat any anaphylactic reactions. There is a cross- allergy between penicillin and cephalosporin. • When an allergic reaction occurs caused by {(Invented) name}, the administration of the product must be stopped immediately and appropriate treatment for the patient must be sought. • Although cefazolin seldom causes kidney function impairments, it is recommended to examine the kidney function, especially in seriously ill patients, who get maximum amounts administered and in patients who get other potentially nephrotoxic drugs administered at the same time, such as amino glycosides or powerful diuretics (e.g. furosemide or etacrynic acid).
Load more

Recommended publications
  • 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 ........................................................................................................................
    [Show full text]
  • Product Monograph
    Product Monograph PrORB-CEFUROXIME Cefuroxime Axetil Tablets, USP 250 mg and 500 mg cefuroxime/tablet Antibiotic Orbus Pharma Inc. Date of Preparation: February 25, 2009 20 Konrad Crescent Markham, Ontario Control #: 117041 L3R8T4 1 Product Monograph PrORB-CEFUROXIME Cefuroxime Axetil Tablets, USP 250 mg and 500 mg cefuroxime/tablet Antibiotic Actions and Clinical Pharmacology Cefuroxime axetil is an orally active prodrug of cefuroxime. After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to release cefuroxime into the blood stream. Conversion to cefuroxime, the microbiologically active form, occurs rapidly. The inherent properties of cefuroxime are unaltered after its administration as cefuroxime axetil. Cefuroxime exerts its bactericidal effect by binding to an enzyme or enzymes referred to as penicillin-binding proteins (PBPs) involved in bacterial cell wall synthesis. This binding results in inhibition of bacterial cell wall synthesis and subsequent cell death. Specifically, cefuroxime shows high affinity for PBP 3, a primary target for cefuroxime in gram- negative organisms such as E. coli. Comparative Bioavailability Studies A two-way crossover, randomized, blinded, single-dose bioequivalence study was performed on 22 normal, healthy, non-smoking male subjects under fasting conditions. The rate and extent of absorption of cefuroxime axetil was measured and compared following a single oral dose (1 x 500 mg tablet)
    [Show full text]
  • AMEG Categorisation of Antibiotics
    12 December 2019 EMA/CVMP/CHMP/682198/2017 Committee for Medicinal Products for Veterinary use (CVMP) Committee for Medicinal Products for Human Use (CHMP) Categorisation of antibiotics in the European Union Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals Agreed by the Antimicrobial Advice ad hoc Expert Group (AMEG) 29 October 2018 Adopted by the CVMP for release for consultation 24 January 2019 Adopted by the CHMP for release for consultation 31 January 2019 Start of public consultation 5 February 2019 End of consultation (deadline for comments) 30 April 2019 Agreed by the Antimicrobial Advice ad hoc Expert Group (AMEG) 19 November 2019 Adopted by the CVMP 5 December 2019 Adopted by the CHMP 12 December 2019 Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. Categorisation of antibiotics in the European Union Table of Contents 1. Summary assessment and recommendations .......................................... 3 2. Introduction ............................................................................................ 7 2.1. Background ........................................................................................................
    [Show full text]
  • Cephalosporins Can Be Prescribed Safely for Penicillin-Allergic Patients ▲
    JFP_0206_AE_Pichichero.Final 1/23/06 1:26 PM Page 106 APPLIED EVIDENCE New research findings that are changing clinical practice Michael E. Pichichero, MD University of Rochester Cephalosporins can be Medical Center, Rochester, NY prescribed safely for penicillin-allergic patients Practice recommendations an allergic reaction to cephalosporins, ■ The widely quoted cross-allergy risk compared with the incidence of a primary of 10% between penicillin and (and unrelated) cephalosporin allergy. cephalosporins is a myth (A). Most people produce IgG and IgM antibodies in response to exposure to ■ Cephalothin, cephalexin, cefadroxil, penicillin1 that may cross-react with and cefazolin confer an increased risk cephalosporin antigens.2 The presence of of allergic reaction among patients these antibodies does not predict allergic, with penicillin allergy (B). IgE cross-sensitivity to a cephalosporin. ■ Cefprozil, cefuroxime, cefpodoxime, Even penicillin skin testing is generally not ceftazidime, and ceftriaxone do not predictive of cephalosporin allergy.3 increase risk of an allergic reaction (B). Reliably predicting cross-reactivity ndoubtedly you have patients who A comprehensive review of the evidence say they are allergic to penicillin shows that the attributable risk of a cross- U but have difficulty recalling details reactive allergic reaction varies and is of the reactions they experienced. To be strongest when the chemical side chain of safe, we often label these patients as peni- the specific cephalosporin is similar to that cillin-allergic without further questioning of penicillin or amoxicillin. and withhold not only penicillins but Administration of cephalothin, cepha- cephalosporins due to concerns about lexin, cefadroxil, and cefazolin in penicillin- potential cross-reactivity and resultant IgE- allergic patients is associated with a mediated, type I reactions.
    [Show full text]
  • A Thesis Entitled an Oral Dosage Form of Ceftriaxone Sodium Using Enteric
    A Thesis entitled An oral dosage form of ceftriaxone sodium using enteric coated sustained release calcium alginate beads by Darshan Lalwani Submitted to the Graduate Faculty as partial fulfillment of the requirements for the Master of Science Degree in Pharmaceutical Sciences with Industrial Pharmacy Option _________________________________________ Jerry Nesamony, Ph.D., Committee Chair _________________________________________ Sai Hanuman Sagar Boddu, Ph.D, Committee Member _________________________________________ Youssef Sari, Ph.D., Committee Member _________________________________________ Patricia R. Komuniecki, PhD, Dean College of Graduate Studies The University of Toledo May 2015 Copyright 2015, Darshan Narendra Lalwani This document is copyrighted material. Under copyright law, no parts of this document may be reproduced without the expressed permission of the author. An Abstract of An oral dosage form of ceftriaxone sodium using enteric coated sustained release calcium alginate beads by Darshan Lalwani Submitted to the Graduate Faculty as partial fulfillment of the requirements for the Master of Science Degree in Pharmaceutical Sciences with Industrial Pharmacy option The University of Toledo May 2015 Purpose: Ceftriaxone (CTZ) is a broad spectrum semisynthetic, third generation cephalosporin antibiotic. It is an acid labile drug belonging to class III of biopharmaceutical classification system (BCS). It can be solvated quickly but suffers from the drawback of poor oral bioavailability owing to its limited permeability through
    [Show full text]
  • Citrobacter Spp. THOMAS D
    ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, May 1984, p. 591-595 Vol. 25, No. 5 0066-4804/84/050591-05$02.00/0 Copyright C 1984, American Society for Microbiology Development of Resistance to Cephalosporins in Clinical Strains of Citrobacter spp. THOMAS D. GOOTZ,t* DAVID B. JACKSON, AND JOHN C. SHERRIS Department of Microbiology and Immunology, University of Washington, Seattle, Washington 98195 Received 28 September 1983/Accepted 21 February 1984 The predominant beta-lactam antibiogram of Citrobacterfreundii resembles that of Enterobacter cloacae in demonstrating resistance to cephalothin and cefoxitin with susceptibility to the newer cephalosporins. Four representative strains of C. freundii were reversibly induced to high-level beta-lactamase production by cefoxitin, and mutants with stable, high-level production were selected with cefamandole. The mutants were resistant to several second- and third-generation cephalosporins. Comparisons of isoelectric points and substrate profiles of beta-lactamases from wild-type, induced wild-type, and mutant organisms suggested a close relationship to those from E. cloacae and indicated that C. freundii mutants, like those of E. cloacae, were derepressed for production of beta-lactamase. One primary isolate of C. freundii resembled the mutants in all characteristics. In contrast, most strains of Citrobacter diversus were susceptible to all cephalosporins, and two representative strains showed neither inducible nor mutational resistance. Cefoxitin induction to enhanced beta-lactamase production was demonstrated in a cephalothin- resistant isolate, and a derepressed mutant was selected with cefotaxime. The beta-lactamase from this C. diversus strain differed substantially in substrate profile from that of E. cloacae and C. freundii. In recent studies, a mechanism responsible for resistance diversus strains isolated during 1982 in the Clinical Microbi- of Enterobacter species to many beta-lactam antibiotics has ology Laboratories of the University of Washington Medical been characterized (4, 7, 8, 21).
    [Show full text]
  • Cefuroxime Axetil Tablets, USP)
    PRODUCT MONOGRAPH PrNOVO–CEFUROXIME (Cefuroxime Axetil Tablets, USP) 125 mg, 250 mg and 500 mg cefuroxime/tablet Antibiotic Control Number: 031000 Novopharm Limited Date of Preparation: Toronto, Canada April 03, 2008 PrNOVO–CEFUROXIME (Cefuroxime Axetil Tablets, USP) 125 mg, 250 mg and 500 mg cefuroxime/tablet Antibiotic ACTIONS AND CLINICAL PHARMACOLOGY Cefuroxime axetil is an orally active prodrug of cefuroxime. After oral administration, NOVO- CEFUROXIME (cefuroxime axetil) is absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to release cefuroxime into the blood stream. Conversion to cefuroxime, the microbiologically active form, occurs rapidly. The inherent properties of cefuroxime are unaltered after its administration as cefuroxime axetil. Cefuroxime exerts its bactericidal effect by binding to an enzyme or enzymes referred to as penicillin-binding proteins (PBPs) involved in bacterial cell wall synthesis. This binding results in inhibition of bacterial cell wall synthesis and subsequent cell death. Specifically, cefuroxime shows high affinity for PBP 3, a primary target for cefuroxime in gram-negative organisms such as E. coli. A comparative, two-way, single-dose, fasting bioavailability study was performed on two 250 mg cefuroxime axetil products, NOVO-CEFUROXIME 250 mg tablets and Ceftin® 250 mg tablets. The pharmacokinetic data calculated for cefuroxime axetil in the NOVO- CEFUROXIME and Ceftin® tablet formulations is tabulated in Table 1. Table 1 Geometric Mean Arithmetic Mean (C.V.) Novo-Cefuroxime Ceftin®** Percentage of Ceftin® (2 x 250 mg) (2 x 250 mg) AUCT 15.65 16.44 (ng•hr/mL) 16.33 (28) 17.48 (36) 95 AUCI 16.36 17.12 (ng•hr/mL) 16.97 (27) 18.16 (35) 96 Cmax 5.39 5.50 (ng/mL) 5.63 (28) 5.76 (32) 98 Tmax* (hr) 1.33 (0.25) 1.74 (0.97) --- T1/2* (hr) 1.26 (0.20) 1.32 (0.19) --- *For the Tmax and T1/2 parameters these are the arithmetic means (standard deviation).
    [Show full text]
  • “CRE Mechanisms and Their Importance for Infection Prevention ” Paul C
    MICHIGAN DEPARTMENT OF COMMUNITY HEALTH June 25, 2015 “CRE Mechanisms and their Importance for Infection Prevention ” Paul C. Schreckenberger, Ph.D., D(ABMM), F(AAM) Professor of Pathology Director, Clinical Microbiology Laboratory Loyola University Medical Center [email protected] Financial Disclosures Type of Financial Interest Name of Commercial Interest Salaried Employee Loyola University Medical Center Stocks/Stock Options None Independent Accelerate Dx., Beckman Coulter, contractor/Speaker’s bioMerieux, BioFire, Cepheid, Hardy Bureau Diagnostics, Merck, Thermo Fisher Scientific Consultant/Advisory BioFire, Cempra, Cepheid, GenMark, Committees Quidel, Thermo Fisher Scientific, Theravance Research Grants Accelerate Dx, Becton-Dickinson, Beckman Coulter, BioFire, bioMerieux, Bruker, Cepheid, Learning Objectives At the conclusion of this session, participants will be able to: 1.Describe the five major types of CRE 2.Review conventional and new approaches to detecting CRE 3.Explain the CSTE CRE definition proposal and its implications for labs 4.Evaluate their own laboratories readiness for detecting and reporting CRE 3 Penicillin nucleus S R 1 CH3 5 2 6 CH3 7 4 N 3 O COOH Cephalosporin nucleus 1 S 7 R1 C HN R O O 2 COOH4 13 MODE OF ACTION OF BETA LACTAMS IN GRAM NEGATIVES SUSCEPTIBLE RESISTANT - Lactam Antibiotic Diffusion through Porin Blocks Entry Outer Membrane Efflux Pump Diffusion through Beta-Lactamase Peptidoglycan Hydolyzes Beta-Lactam Penicillin Binding Proteins Changes in PBP results in Cell Death Failure to Bind
    [Show full text]
  • Beta-Lactam Allergy Tip Sheet
    Beta-lactam Allergy Tip Sheet Hypersensitivity Type, Mechanism, and Clinical Manifestations Penicillin allergy Facts • Approximately 10% of all U.S. patients report having an allergic reaction to a penicillin class antibiotic in their past. • However, many patients who report penicillin allergies do not have true IgE-mediated reactions. When evaluated, fewer than 1% of the population have IgE mediated hypersensitivities. • Approximately 80% of patients with IgE-mediated penicillin allergy lose their sensitivity after 10 years. • Broad-spectrum antibiotics are often used as an alternative to penicillins. The use of broad-spectrum antibiotics in patients labeled “penicillin-allergic” is associated with higher healthcare costs, increased risk for antibiotic resistance, and suboptimal antibiotic therapy. • Correctly identifying those who are not truly penicillin-allergic can decrease unnecessary use of broad-spectrum antibiotics. • Reference: Joint Task Force on Practice Parameters representing the American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Drug allergy: an updated practice parameter. Ann Allergy Asthma Immunol. 2010;105(4):259-273. Beta-lactam Allergy Documentation • If a patient states they have a beta-lactam allergy, get a specific medication, reaction, and timing of reaction (immediate vs. delayed) DO NOT accept “penicillin” or “cephalosporin” as an allergy • Update allergy label with specific medications, reactions, and tolerances (i.e. “tolerates ceftriaxone”) Medical Liability Concerns • Fear of litigation has been identified as a potential reason clinicians avoid using β-lactams in a patient with a penicillin allergy. • Since 1959, 27 medical malpractice or negligence cases have been published in which a patient with a penicillin allergy received a β-lactam and experienced an adverse reaction.
    [Show full text]
  • Critically Important Antimicrobials for Human Medicine – 5Th Revision. Geneva
    WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) Critically Important Antimicrobials for Human Medicine 5th Revision 2016 Ranking of medically important antimicrobials for risk management of antimicrobial resistance due to non-human use Critically important antimicrobials for human medicine – 5th rev. ISBN 978-92-4-151222-0 © World Health Organization 2017, Updated in June 2017 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial- ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/ igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. Critically important antimicrobials for human medicine – 5th rev. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO.
    [Show full text]
  • Phenomenon of Resistance to Augmentin Associated With
    J Clin Pathol: first published as 10.1136/jcp.36.6.670 on 1 June 1983. Downloaded from J Clin Pathol 1983;36:670-673 Phenomenon of resistance to Augmentin associated with sensitivity to ampicillin: occurrence and explanation W BRUMFITT, JMT HAMILTON-MILLER, SHIRLEY DIXSON, RA GARGAN, ANN GOODING From the Department ofMedical Microbiology, Royal Free Hospital and School ofMedicine, Pond Street, London NW3 2QG SUMMARY Ampicillin was found to be some tenfold more active than amoxycillin against Enterobacter cloacae. This finding explains the observation that some Ent cloacae strains are sensitive to ampicillin in the disc test but resistant to Augmentin. Ampicillin was also found to be more active than amoxycillin against Citrobacter freundii and Serratia marcescens. In view of these findings, the practice of using ampicillin discs to predict sensitivity to amoxycillin should be reconsidered. The use of both ampicillin and amoxycillin discs is appropriate if errors are to be avoided. Amoxycillin has been shown to be at least as active Material and methods in vitro as ampicillin against many pathogenic bac- copyright. terial with notable exceptions, such as Haemophilus ANTIBIOTICS influenzae. Its bactericidal action in vitro and its Ampicillin trihydrate and amoxycillin trihydrate effectiveness in vivo seems to be superior to that of were Laboratory Reference Standards nos 29 and ampicillin.23 Further, amoxycillin is absorbed by 12, respectively, from Beecham Research mouth almost twice as well as ampicillin.' Because Laboratories. Sodium ampicillin was obtained from of these properties, amoxycillin can be given in a the hospital pharmacy. Sodium amoxycillin and smaller dose and less frequently than ampicillin, and potassium clavulanate were generously supplied by http://jcp.bmj.com/ it now enjoys wide clinical use.
    [Show full text]
  • Cephalosporins: a Focus on Side Chains and -Lactam Cross-Reactivity
    pharmacy Review Cephalosporins: A Focus on Side Chains and β-Lactam Cross-Reactivity Saira B. Chaudhry 1,2, Michael P. Veve 3,* and Jamie L. Wagner 4 1 Department of Pharmacy Practice and Administration, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ 08854, USA 2 Department of Infectious Diseases, Jersey Shore University Medical Center, Neptune, NJ 07753, USA 3 Department of Clinical Pharmacy and Translational Science, College of Pharmacy, University of Tennessee Health Science Center, Knoxville, TN 37920, USA 4 Department of Pharmacy Practice, School of Pharmacy, University of Mississippi, Jackson, MS 39216, USA * Correspondence: [email protected] Received: 27 June 2019; Accepted: 26 July 2019; Published: 29 July 2019 Abstract: Cephalosporins are among the most commonly prescribed antibiotic classes due to their wide clinical utility and general tolerability, with approximately 1–3% of the population reporting a cephalosporin allergy. However, clinicians may avoid the use of cephalosporins in patients with reported penicillin allergies despite the low potential for cross-reactivity. The misdiagnosis of β-lactam allergies and misunderstanding of cross-reactivity among β-lactams, including within the cephalosporin class, often leads to use of broader spectrum antibiotics with poor safety and efficacy profiles and represents a serious obstacle for antimicrobial stewardship. Risk factors for cephalosporin allergies are broad and include female sex, advanced age, and a history of another antibiotic or penicillin allergy; however, cephalosporins are readily tolerated even among individuals with true immediate-type allergies to penicillins. Cephalosporin cross-reactivity potential is related to the structural R1 side chain, and clinicians should be cognizant of R1 side chain similarities when prescribing alternate β-lactams in allergic individuals or when new cephalosporins are brought to market.
    [Show full text]