Management of Penicillin and Beta-Lactam Allergy
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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. -
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 -
Synergistic Activity of Ampicillin and Cloxacillin
144 THE JOURNAL OF ANTIBIOTICS APR. 1969 SYNERGISTIC ACTIVITY OF AMPICILLIN AND CLOXACILLIN PROTECTIVE EFFECT OF CLOXACILLIN ON ENZYMATIC DEGRADATION OF AMPICILLIN BY PENICILLINASE, AND THERAPEUTIC ACTIVITY OF MIXTURES OF AMPICILLIN AND CLOXACILLIN MlNORUNlSHIDA, YASUHIROMlNE Research Laboratories, Fujisawa Pharmaceutical Co., Ltd., Osaka, Japan and Shogo Kuwahara Department of Microbiology, Toho University School of Medicine, Tokyo, Japan (Received for publication February 15, 1969) A mixture of ampicillin (aminobenzyl penicillin, AB-PC) and cloxacillin (methylchlorophenylisoxazolyl penicillin, MCI-PC) showed an excellent bacteri- cidal activity even at low concentrations in which either of the penicillins alone did not have any activity against a clinically isolated strain of Escherichia colt, resistant to both of these penicillins. In this case, the microbial degrada- ion of AB-PC, caused by penicillinase (PC-ase), was strongly inhibited in the presence of MCI-PC. The enzymatic hydrolysis of AB-PC by extracellular nd cell-bound PC-ase, obtained from an AB-PC resistant strain of Staphylo- coccus aureus, was also inhibited in the presence of MCI-PC. Against that, t a under comparable conditions, penicillin G (PC-G) was almost completely destroyed by cell-bound PC-ase from this organism. An in vivo synergism was observed when mixtures of AB-PC and MCI-PC were applied for the treatment of mice challenged with a clinically isolated strain of E. coli resistant to both of these penicillins. Similar results were obtained in the treatment of mice experimentally infected with a strain of Staphylococcus aureus, which is highly resistant to AB-PC, but sensitive to MCI-PC. A decrease in the rate of hydrolysis of methicillin (dimethoxyphenyl penicillin, DMP-PC) by staphylococcal penicillinase (PC-ase) was first noted by Rolinson and his co-workers^. -
Cusumano-Et-Al-2017.Pdf
International Journal of Infectious Diseases 63 (2017) 1–6 Contents lists available at ScienceDirect International Journal of Infectious Diseases journal homepage: www.elsevier.com/locate/ijid Rapidly growing Mycobacterium infections after cosmetic surgery in medical tourists: the Bronx experience and a review of the literature a a b c b Lucas R. Cusumano , Vivy Tran , Aileen Tlamsa , Philip Chung , Robert Grossberg , b b, Gregory Weston , Uzma N. Sarwar * a Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, USA b Division of Infectious Diseases, Department of Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, USA c Department of Pharmacy, Nebraska Medicine, Omaha, Nebraska, USA A R T I C L E I N F O A B S T R A C T Article history: Background: Medical tourism is increasingly popular for elective cosmetic surgical procedures. However, Received 10 May 2017 medical tourism has been accompanied by reports of post-surgical infections due to rapidly growing Received in revised form 22 July 2017 mycobacteria (RGM). The authors’ experience working with patients with RGM infections who have Accepted 26 July 2017 returned to the USA after traveling abroad for cosmetic surgical procedures is described here. Corresponding Editor: Eskild Petersen, Methods: Patients who developed RGM infections after undergoing cosmetic surgeries abroad and who ?Aarhus, Denmark presented at the Montefiore Medical Center (Bronx, New York, USA) between August 2015 and June 2016 were identified. A review of patient medical records was performed. Keywords: Results: Four patients who presented with culture-proven RGM infections at the sites of recent cosmetic Mycobacterium abscessus complex procedures were identified. -
Anthem Blue Cross Drug Formulary
Erythromycin/Sulfisoxazole (generic) INTRODUCTION Penicillins ...................................................................... Anthem Blue Cross uses a formulary Amoxicillin (generic) (preferred list of drugs) to help your doctor Amoxicillin/Clavulanate (generic/Augmentin make prescribing decisions. This list of drugs chew/XR) is updated quarterly, by a committee Ampicillin (generic) consisting of doctors and pharmacists, so that Dicloxacillin (generic) the list includes drugs that are safe and Penicillin (generic) effective in the treatment of diseases. If you Quinolones ..................................................................... have any questions about the accessibility of Ciprofloxacin/XR (generic) your medication, please call the phone number Levofloxacin (Levaquin) listed on the back of your Anthem Blue Cross Sulfonamides ................................................................ member identification card. Erythromycin/Sulfisoxazole (generic) In most cases, if your physician has Sulfamethoxazole/Trimethoprim (generic) determined that it is medically necessary for Sulfisoxazole (generic) you to receive a brand name drug or a drug Tetracyclines .................................................................. that is not on our list, your physician may Doxycycline hyclate (generic) indicate “Dispense as Written” or “Do Not Minocycline (generic) Substitute” on your prescription to ensure Tetracycline (generic) access to the medication through our network ANTIFUNGAL AGENTS (ORAL) _________________ of community -
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. -
(CUA) and Cefprozil (CZ) in Pharmaceutical Drugs by RP-HPLC
American Journal of www.biomedgrid.com Biomedical Science & Research ISSN: 2642-1747 --------------------------------------------------------------------------------------------------------------------------------- Research Article Copyright@ MA Alfeen New Development Method for Determination of Cefuroxime Axetil (CUA) and Cefprozil (CZ) in Pharmaceutical Drugs by RP-HPLC MA Alfeen1* and Y Yildiz2 1Department of Chemistry, Al-Baath University, Syria 2Science Department, Centenary University, USA *Corresponding author: MA Alfeen, Department of Chemistry, Faculty of Second Science, Al-Baath University, Homs, Syria. To Cite This Article: MA Alfeen.New Development Method for Determination of Cefuroxime Axetil (CUA) and Cefprozil (CZ) in Pharmaceutical Drugs by RP-HPLC. Am J Biomed Sci & Res. 2019 - 4(1). AJBSR.MS.ID.000759. DOI: 10.34297/AJBSR.2019.04.000759 Received: June 29, 2019 | Published: July 17, 2019 Abstract High performance liquid chromatography was one of the most important technologies used in drug control and pharmaceutical quality control. In this study, an analytical method was developed using chromatography method for determination of two Cephalosporin as like: Cefuroxime Axetil (CUA), and Cefprozil (CZ) in pharmaceutical Drug Formulations. Isocratic separation was performed on an Enable C18 column (125mm × 4.6mm i.d, 5.0μm, 10A˚) Using Triethylamine: Methanol: Acetonitrile: Ultra-Pure Water (0.1: 5: 25: 69.9 v/v/v/v %) as a mobile phase at flow rate of 1.5 mL\min. The PDA detection wavelength was set at 262nm. The linearity was observed over a concentration range of (0.01–50μg\mL) for RP-HPLC method (correlation coefficient=0.999). The developed method was validated according to ICH guidelines. The relative standard deviation values for the method precision studies were < 1%, and an accuracy was > 98%. -
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. -
Cefixime (Suprax) Division of Disease Control What Do I Need to Know?
Division of Disease Control What Do I Need To Know? Cefixime (Suprax) About your medicine: Cefixime is used to treat bacterial infections in many different parts of the body. This medicine will not work for colds, flu, or other viral infections. It may be used to other problems as determined by your healthcare provider. These instructions will help you receive the optimum benefits from Cefixime. Before taking this medication: Tell your doctor, nurse or healthcare provider if you… . Have any allergies to medications (especially cephalosporins and penicillin) . Take any other medications . Have medical condition (especially kidney or eye problems) . Are pregnant, breast-feeding or trying to become pregnant . History of convulsions Possible side effects of this medicine: If these symptoms continue or become severe, call your health care provider… . Nausea, vomiting, diarrhea . Gas . Indigestion . Dyspepsia (upset stomach) . Abdominal pain . Muscle cramps, stiffness, spasms . If your symptoms do not improve within a few days, notify your healthcare provider How to take this medicine: . This is the only dose of this medicine you will receive . Take this medication with a full glass (8 ounces) of water, preferably after a meal . DO NOT take with milk or other dairy products, or any products containing magnesium or calcium (such as antacids), iron or aluminum within 2 hours of the time you take this medicine . Drink several additional glasses of water today Warning: Call a healthcare professional immediately if you develop any of the following: . Difficulty breathing . Hives/skin rash Sexual Behavior: Abstain from any type of sexual activity for 7 days after treatment of self and partner For more information, contact the NDDoH STD Program at 701.328.2378 or toll-free 800.472.2180 Page 1 of 1 Last Updated: 4/3/2012 . -
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