Beta-Lactam Allergy Tip Sheet
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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 ........................................................................................................................ -
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. -
National Antibiotic Consumption for Human Use in Sierra Leone (2017–2019): a Cross-Sectional Study
Tropical Medicine and Infectious Disease Article National Antibiotic Consumption for Human Use in Sierra Leone (2017–2019): A Cross-Sectional Study Joseph Sam Kanu 1,2,* , Mohammed Khogali 3, Katrina Hann 4 , Wenjing Tao 5, Shuwary Barlatt 6,7, James Komeh 6, Joy Johnson 6, Mohamed Sesay 6, Mohamed Alex Vandi 8, Hannock Tweya 9, Collins Timire 10, Onome Thomas Abiri 6,11 , Fawzi Thomas 6, Ahmed Sankoh-Hughes 12, Bailah Molleh 4, Anna Maruta 13 and Anthony D. Harries 10,14 1 National Disease Surveillance Programme, Sierra Leone National Public Health Emergency Operations Centre, Ministry of Health and Sanitation, Cockerill, Wilkinson Road, Freetown, Sierra Leone 2 Department of Community Health, Faculty of Clinical Sciences, College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone 3 Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, 1211 Geneva, Switzerland; [email protected] 4 Sustainable Health Systems, Freetown, Sierra Leone; [email protected] (K.H.); [email protected] (B.M.) 5 Unit for Antibiotics and Infection Control, Public Health Agency of Sweden, Folkhalsomyndigheten, SE-171 82 Stockholm, Sweden; [email protected] 6 Pharmacy Board of Sierra Leone, Central Medical Stores, New England Ville, Freetown, Sierra Leone; [email protected] (S.B.); [email protected] (J.K.); [email protected] (J.J.); [email protected] (M.S.); [email protected] (O.T.A.); [email protected] (F.T.) Citation: Kanu, J.S.; Khogali, M.; 7 Department of Pharmaceutics and Clinical Pharmacy & Therapeutics, Faculty of Pharmaceutical Sciences, Hann, K.; Tao, W.; Barlatt, S.; Komeh, College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown 0000, Sierra Leone 8 J.; Johnson, J.; Sesay, M.; Vandi, M.A.; Directorate of Health Security & Emergencies, Ministry of Health and Sanitation, Sierra Leone National Tweya, H.; et al. -
Empiric Antimicrobial Therapy for Diabetic Foot Infection
Empiric Antimicrobial Therapy for Diabetic Foot Infection (NB Provincial Health Authorities Anti-Infective Stewardship Committee, September 2019) Infection Severity Preferred Empiric Regimens Alternative Regimens Comments Mild Wound less than 4 weeks duration:d Wound less than 4 weeks duration:e • Outpatient management • Cellulitis less than 2 cm and • cephalexin 500 – 1000 mg PO q6h*,a OR • clindamycin 300 – 450 mg PO q6h (only if recommended ,a • cefadroxil 500 – 1000 mg PO q12h* severe delayed reaction to a beta-lactam) without involvement of deeper • Tailor regimen based on culture tissues and susceptibility results and True immediate allergy to a beta-lactam at MRSA Suspected: • Non-limb threatening patient response risk of cross reactivity with cephalexin or • doxycycline 200 mg PO for 1 dose then • No signs of sepsis cefadroxil: 100 mg PO q12h OR • cefuroxime 500 mg PO q8–12h*,b • sulfamethoxazole+trimethoprim 800+160 mg to 1600+320 mg PO q12h*,f Wound greater than 4 weeks duration:d Wound greater than 4 weeks duratione • amoxicillin+clavulanate 875/125 mg PO and MRSA suspected: q12h*,c OR • doxycycline 200 mg PO for 1 dose then • cefuroxime 500 mg PO q8–12h*,b AND 100 mg PO q12h AND metroNIDAZOLE metroNIDAZOLE 500 mg PO q12h 500 mg PO q12h OR • sulfamethoxazole+trimethoprim 800+160 mg to 1600/320 mg PO q12h*,f AND metroNIDAZOLE 500 mg PO q12h Moderate Wound less than 4 weeks duration:d Wound less than 4 weeks duration:e • Initial management with • Cellulitis greater than 2 cm or • ceFAZolin 2 g IV q8h*,b OR • levoFLOXacin 750 -
Novel Antimicrobial Agents Inhibiting Lipid II Incorporation Into Peptidoglycan Essay MBB
27 -7-2019 Novel antimicrobial agents inhibiting lipid II incorporation into peptidoglycan Essay MBB Mark Nijland S3265978 Supervisor: Prof. Dr. Dirk-Jan Scheffers Molecular Microbiology University of Groningen Content Abstract..............................................................................................................................................2 1.0 Peptidoglycan biosynthesis of bacteria ........................................................................................3 2.0 Novel antimicrobial agents ...........................................................................................................4 2.1 Teixobactin ...............................................................................................................................4 2.2 tridecaptin A1............................................................................................................................7 2.3 Malacidins ................................................................................................................................8 2.4 Humimycins ..............................................................................................................................9 2.5 LysM ........................................................................................................................................ 10 3.0 Concluding remarks .................................................................................................................... 11 4.0 references ................................................................................................................................. -
Brilacidin First-In-Class Defensin-Mimetic Drug Candidate
Brilacidin First-in-Class Defensin-Mimetic Drug Candidate Mechanism of Action, Pre/Clinical Data and Academic Literature Supporting the Development of Brilacidin as a Potential Novel Coronavirus (COVID-19) Treatment April 20, 2020 Page # I. Brilacidin: Background Information 2 II. Brilacidin: Two Primary Mechanisms of Action 3 Membrane Disruption 4 Immunomodulatory 7 III. Brilacidin: Several Complementary Ways of Targeting COVID-19 10 Antiviral (anti-SARS-CoV-2 activity) 11 Immuno/Anti-Inflammatory 13 Antimicrobial 16 IV. Brilacidin: COVID-19 Clinical Development Pathways 18 Drug 18 Vaccine 20 Next Steps 24 V. Brilacidin: Phase 2 Clinical Trial Data in Other Indications 25 VI. AMPs/Defensins (Mimetics): Antiviral Properties 30 VII. AMPs/Defensins (Mimetics): Anti-Coronavirus Potential 33 VIII. The Broader Context: Characteristics of the COVID-19 Pandemic 36 Innovation Pharmaceuticals 301 Edgewater Place, Ste 100 Wakefield, MA 01880 978.921.4125 [email protected] Innovation Pharmaceuticals: Mechanism of Action, Pre/Clinical Data and Academic Literature Supporting the Development of Brilacidin as a Potential Novel Coronavirus (COVID-19) Treatment (April 20, 2020) Page 1 of 45 I. Brilacidin: Background Information Brilacidin (PMX-30063) is Innovation Pharmaceutical’s lead Host Defense Protein (HDP)/Defensin-Mimetic drug candidate targeting SARS-CoV-2, the virus responsible for COVID-19. Laboratory testing conducted at a U.S.-based Regional Biocontainment Laboratory (RBL) supports Brilacidin’s antiviral activity in directly inhibiting SARS-CoV-2 in cell-based assays. Additional pre-clinical and clinical data support Brilacidin’s therapeutic potential to inhibit the production of IL-6, IL-1, TNF- and other pro-inflammatory cytokines and chemokines (e.g., MCP-1), identified as central drivers in the worsening prognoses of COVID-19 patients. -
Cefalexin in the WHO Essential Medicines List for Children Reject
Reviewer No. 1: checklist for application of: Cefalexin In the WHO Essential Medicines List for Children (1) Have all important studies that you are aware of been included? Yes No 9 (2) Is there adequate evidence of efficacy for the proposed use? Yes 9 No (3) Is there evidence of efficacy in diverse settings and/or populations? Yes 9 No (4) Are there adverse effects of concern? Yes 9 No (5) Are there special requirements or training needed for safe/effective use? Yes No 9 (6) Is this product needed to meet the majority health needs of the population? Yes No 9 (7) Is the proposed dosage form registered by a stringent regulatory authority? Yes 9 No (8) What action do you propose for the Committee to take? Reject the application for inclusion of the following presentations of cefalexin: • Tablets/ capsules 250mg • Oral suspensions 125mg/5ml and 125mg/ml (9) Additional comment, if any. In order to identify any additional literature, the following broad and sensitive search was conducted using the PubMed Clinical Query application: (cephalexin OR cefalexin AND - 1 - pediatr*) AND ((clinical[Title/Abstract] AND trial[Title/Abstract]) OR clinical trials[MeSH Terms] OR clinical trial[Publication Type] OR random*[Title/Abstract] OR random allocation[MeSH Terms] OR therapeutic use[MeSH Subheading]) Only one small additional study was identified, which looked at the provision of prophylactic antibiotics in patients presenting to an urban children's hospital with trauma to the distal fingertip, requiring repair.1 In a prospective randomised control trial, 146 patients were enrolled, of which 69 were randomised to the no-antibiotic group, and 66 were randomised to the antibiotic (cefalexin) group. -
General Items
Essential Medicines List (EML) 2019 Application for the inclusion of imipenem/cilastatin, meropenem and amoxicillin/clavulanic acid in the WHO Model List of Essential Medicines, as reserve second-line drugs for the treatment of multidrug-resistant tuberculosis (complementary lists of anti-tuberculosis drugs for use in adults and children) General items 1. Summary statement of the proposal for inclusion, change or deletion This application concerns the updating of the forthcoming WHO Model List of Essential Medicines (EML) and WHO Model List of Essential Medicines for Children (EMLc) to include the following medicines: 1) Imipenem/cilastatin (Imp-Cln) to the main list but NOT the children’s list (it is already mentioned on both lists as an option in section 6.2.1 Beta Lactam medicines) 2) Meropenem (Mpm) to both the main and the children’s lists (it is already on the list as treatment for meningitis in section 6.2.1 Beta Lactam medicines) 3) Clavulanic acid to both the main and the children’s lists (it is already listed as amoxicillin/clavulanic acid (Amx-Clv), the only commercially available preparation of clavulanic acid, in section 6.2.1 Beta Lactam medicines) This application makes reference to amendments recommended in particular to section 6.2.4 Antituberculosis medicines in the latest editions of both the main EML (20th list) and the EMLc (6th list) released in 2017 (1),(2). On the basis of the most recent Guideline Development Group advising WHO on the revision of its guidelines for the treatment of multidrug- or rifampicin-resistant (MDR/RR-TB)(3), the applicant considers that the three agents concerned be viewed as essential medicines for these forms of TB in countries. -
Structure of a Penicillin Binding Protein Complexed with a Cephalosporin-Peptidoglycan Mimic M.A
Structure of a Penicillin Binding Protein Complexed with a Cephalosporin-Peptidoglycan Mimic M.A. McDonough1, W. Lee2, N.R. Silvaggi1, L.P. Kotra 2, Z-H. Li2, Y. Takeda2, S .O. Mobashery2, and J.A. Kelly1 1Department of Molecular and Cell Biology and Institute for Materials Science, Univ. of Connecticut, Storrs, CT 2Institute for Drug Design and the Department of Chemistry, Wayne State Univ., Detroit, MI Many bacteria that are responsible for causing dis- lactams. Also, one questions why ß-lactamases hydro- eases in humans are rapidly developing mutant strains lyze ß-lactams and release them rapidly but they do resistant to existing antibiotics. Proliferation of these not react with peptide substrates. mutant strains is likely to be a serious health-care prob- To help answer these questions, structural studies lem of increasing proportions. Almost sixty percent of of the Streptomyces sp. R61 D-Ala-D-Ala-peptidase all clinically used antibiotics are beta-lactams, which have been undertaken to investigate how the enzyme stop the growth of bacteria by interfering with their cell- wall biosynthesis. The cell walls are made of glycan chains that polymerize to form a structure that gives strength and shape to the bacteria. An understanding of the process how the cell wall is synthesized may help in designing more potent antibiotics. D-Ala-D-Ala-carboxypeptidase/transpeptidases (DD-peptidases) are penicillin-binding proteins (PBPs), the targets of ß-lactam antibiotics such as penicillins and cephalosporins (Figure 1A). These enzymes cata- lyze the final cross-linking step of bacterial cell wall bio- synthesis. In vivo inhibition of PBPs by ß-lactams re- sults in the cessation of bacterial growth. -
'Cephalosporin Allergy' Label Is Misleading
VOLUME 41 : NUMBER 2 : APRIL 2018 ARTICLE ‘Cephalosporin allergy’ label is misleading Carlo L Yuson SUMMARY Immunology registrar1 Constance H Katelaris Penicillins and cephalosporins can cause a similar spectrum of allergic reactions at a similar rate. Immunologist2 Cross-reactive allergy between penicillins and cephalosporins is rare, as is cross-reaction within William B Smith 1 the cephalosporin group. Patients should therefore not be labelled ‘cephalosporin-allergic’. Immunologist Cross-reactive allergy may occur between cephalosporins (and penicillins) which share similar 1 Clinical Immunology and side chains. Allergy Royal Adelaide Hospital Generally, a history of a penicillin allergy should not rule out the use of cephalosporins, and a 2 Immunology and Allergy history of a specific cephalosporin allergy should not rule out the use of other cephalosporins. Unit Campbelltown Hospital Specialist advice or further investigations may be required when the index reaction was New South Wales anaphylaxis or a severe cutaneous adverse reaction, or when the antibiotics in question share common side chains. Keywords When recording a drug allergy in the patient’s records, it is important to identify the specific drug cephalosporin allergy, hypersensitivity, penicillin suspected (or confirmed), along with the date and nature of the adverse reaction. Records need allergy to be updated after a negative drug challenge. Aust Prescr 2018;41:37–41 as Stevens-Johnson syndrome, toxic epidermal Introduction https://doi.org/10.18773/ necrolysis or acute generalised exanthematous To label an individual with a ‘cephalosporin allergy’ austprescr.2018.008 pustulosis or organ hypersensitivity). is misleading. Given the structural diversity of the cephalosporin family, hypersensitivity is seldom a Structural chemistry and allergy Corrected 3 December 2018 class effect but is much more likely to relate to the Immunological reactivity to small molecules such This is the corrected individual drug. -
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) -
Clavulanic Acid, and Cefaclor Against Experimental Streptococcus Pneumoniae Respiratory Infections in Mice JOHN GISBY,* BARBARA J
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, May 1991, p. 831-836 Vol. 35, No. 5 0066-4804/91/050831-06$02.00/0 Copyright © 1991, American Society for Microbiology Comparative Efficacies of Ciprofloxacin, Amoxicillin, Amoxicillin- Clavulanic Acid, and Cefaclor against Experimental Streptococcus pneumoniae Respiratory Infections in Mice JOHN GISBY,* BARBARA J. WIGHTMAN, AND ANGELA S. BEALE SmithKline Beecham Pharmaceuticals, Brockham Park, Betchworth, Surrey RH3 7AJ, England Received 24 October 1990/Accepted 13 February 1991 Experimental respiratory infections were established in mice by intranasal inoculation of Streptococcus pneumoniae. Inoculation of 107 CFU of either S. pneumoniae 1629 or S. pneumoniae 7 produced a fatal pneumonia in nontreated mice 2 to 3 days after infection. Oral therapy was commenced 1 h after infection and was continued three times a day for 2 days. The doses used in mice produced peak concentrations in serum and lung tissue similar to those measured in humans. Ciprofloxacin failed to eliminate either strain of pneumo- coccus from mouse lungs at any of the doses tested (40, 80, or 160 mg/kg of body weight) by the end of therapy (33 h). Mice that received ciprofloxacin at 160 mg/kg were clear of S. pneumoniae 7 5 days later, whereas persistence and regrowth of S. pneumoniae 1629 resulted in the death of 20% of animals treated with ciprofloxacin. Therapy with cefaclor (20 mg/kg) produced an effect similar to that of ciprofloxacin. In contrast, amoxicillin (10 and 20 mg/kg) and amoxicillin-clavulanic acid (10/5 and 20/10 mg/kg) were significantly (P < 0.05) more effective in eliminating both strains of S.