MICU Antibiotics and Associated Drug Interactions
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Charm II Antibiotic Analysis—Grain
Charm ii Antibiotic Analysis for Grain Products PROCeDURAL FLOWCHART + Binding Tracer Reagent Tablet Tablet Sample Charm ii 7600 analyzer Incubate START STOP Centrifuge Families DeteCteD = Aminoglycosides = Amphenicols/Chloramphenicol Resuspend = Beta-lactams = Macrolides = Sulfonamides C2Soft = Tetracyclines (optional) Count Results SAMPLE SIZe 50 to 100 g Computer Report SAMPLE PREPARATION Homogenize product in extraction solution for 60 seconds. Filter or centrifuge for 3 minutes. sample printout Test supernatant. Date = 08/23/10 preparation time Approximately 10-15 minutes, Time = 14:28:12 depending on the number of Operator = 1 samples. Time Counted = 60 Sample I.D. = 7764 ASSAY TIME Approximately 10 minutes, depending on drug family. Assay = Chloramphenicol CAPACITY 6 to 12 samples in assay, Lot# = ATBL 014 depending on drug family. Control Point = 2564 Sample (CPM) = 3676 Interpretation = Not Found Charm sciences, inc. 659 Andover Street, Lawrence, MA 01843, USA | Tel: +1.978.687.9200 | www.charm.com Charm ii Antibiotic Analysis for Grain Products Charm ii Kit Drug test sensitivity 1 (ppb) aminoglycosides (STIIHG) Streptomycin 2000 Dihydrostreptomycin 7500 Gentamicin 5000 aminoglycosides (GIIHG) Gentamicin 1000 Neomycin 500 Beta-lactams (PIIG) Penicillin-G 200 Amoxicillin 450 Ampicillin 400 Cephapirin 200 Ceftiofur 500 Cloxacillin 2500 Oxacillin 3750 Dicloxacillin 2500 Cefazolin 1500 Cefodroxil 1500 Cefotaxime 400 Cephalexin 1500 Cephradine 1500 Cefquinome 1000 Hetacillin 400 Nafcillin 3000 Penethamate 200 Piperacillin 1000 Ticarcillin 3500 Chloramphenicol Chloramphenicol 40 Florfenicol 160 & other amphenicols (CIIHG) Thiamphenicol 200 Chloramphenicol (AIIHG) Chloramphenicol 5 macrolides (EIIG) Erythromycin 1000 Tylosin 1000 Spiramycin 1000 Pirlimycin 2000 Tilmicosin 1000 Lincomycin 2500 sulfonamides (SMIIHG) Sulfamethazine 500 Sulfadimethoxine 200 Sulfathiazole 400 Sulfadiazine 200 tetracyclines (TIIHG) Tetracycline 100 Chlortetracycline 800 Oxytetracycline 800 1 Exceed 90% positive at a 95% confidence limit Charm sciences, inc. -
Clinical Review (Cubicin)
Clinical Review Amol Purandare, MD NDA 021572 Cubicin (Daptomycin for injection) CLINICAL REVIEW Application Type NDA supplement Application Number(s) 21572 Priority or Standard Priority Submit Date(s) June 30, 2016 Received Date(s) June 30, 2016 PDUFA Goal Date March 30, 2017 (Major amendment) Division / Office DAIP/OAP Reviewer Name(s) Amol Purandare, MD Review Completion Date March 23, 2017 Established Name Daptomycin (Proposed) Trade Name Cubicin Therapeutic Class Cyclic Lipopeptide Applicant Cubist Pharmaceuticals Formulation(s) Injection Dosing Regimen 5 mg/kg (12-<18 years), 7 mg/kg (7-11 years), 9 mg/kg (2-6 years), and 10 mg/kg (1-< 2 years) Indication(s) Complicated Skin and Skin Structure Infections 1 Reference ID: 4075320 Clinical Review Amol Purandare, MD NDA 021572 Cubicin (Daptomycin for injection) Intended Population(s) Ages 1 year to <18 years Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT..........................................6 1.1 Recommendation on Regulatory Action ..............................................................6 1.2 Risk Benefit Assessment .....................................................................................6 1.3 Recommendations for Postmarket Risk Evaluation and Mitigation Strategies ....6 1.4 Recommendations for Postmarket Requirements and Commitments.................7 2 INTRODUCTION AND REGULATORY BACKGROUND .........................................7 2.1 Product Information .............................................................................................7 -
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) .............................................................................. -
Summary of Product Characteristics
SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Augmentin 125 mg/31.25 mg/5 ml powder for oral suspension Augmentin 250 mg/62.5 mg/5 ml powder for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted, every ml of oral suspension contains amoxicillin trihydrate equivalent to 25 mg amoxicillin and potassium clavulanate equivalent to 6.25 mg of clavulanic acid. Excipients with known effect Every ml of oral suspension contains 2.5 mg aspartame (E951). The flavouring in Augmentin contains maltodextrin (glucose) (see section 4.4). This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium- free’. When reconstituted, every ml of oral suspension contains amoxicillin trihydrate equivalent to 50 mg amoxicillin and potassium clavulanate equivalent to 12.5 mg of clavulanic acid. Excipients with known effect Every ml of oral suspension contains 2.5 mg aspartame (E951). The flavouring in Augmentin contains maltodextrin (glucose) (see section 4.4). This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium- free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral suspension. Off-white powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Augmentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): • Acute bacterial sinusitis (adequately diagnosed) • Acute otitis media • Acute exacerbations of chronic bronchitis (adequately diagnosed) • Community acquired pneumonia • Cystitis • Pyelonephritis 2 • Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis • Bone and joint infections, in particular osteomyelitis. -
Penicillin Allergy Guidance Document
Penicillin Allergy Guidance Document Key Points Background Careful evaluation of antibiotic allergy and prior tolerance history is essential to providing optimal treatment The true incidence of penicillin hypersensitivity amongst patients in the United States is less than 1% Alterations in antibiotic prescribing due to reported penicillin allergy has been shown to result in higher costs, increased risk of antibiotic resistance, and worse patient outcomes Cross-reactivity between truly penicillin allergic patients and later generation cephalosporins and/or carbapenems is rare Evaluation of Penicillin Allergy Obtain a detailed history of allergic reaction Classify the type and severity of the reaction paying particular attention to any IgE-mediated reactions (e.g., anaphylaxis, hives, angioedema, etc.) (Table 1) Evaluate prior tolerance of beta-lactam antibiotics utilizing patient interview or the electronic medical record Recommendations for Challenging Penicillin Allergic Patients See Figure 1 Follow-Up Document tolerance or intolerance in the patient’s allergy history Consider referring to allergy clinic for skin testing Created July 2017 by Macey Wolfe, PharmD; John Schoen, PharmD, BCPS; Scott Bergman, PharmD, BCPS; Sara May, MD; and Trevor Van Schooneveld, MD, FACP Disclaimer: This resource is intended for non-commercial educational and quality improvement purposes. Outside entities may utilize for these purposes, but must acknowledge the source. The guidance is intended to assist practitioners in managing a clinical situation but is not mandatory. The interprofessional group of authors have made considerable efforts to ensure the information upon which they are based is accurate and up to date. Any treatments have some inherent risk. Recommendations are meant to improve quality of patient care yet should not replace clinical judgment. -
Eml-2017-Antibacterials-Eng.Pdf
Consideration of antibacterial medicines as part of the revisions to 2017 WHO Model List of Essential Medicines for adults (EML) and Model List of Essential Medicines for children (EMLc) Section 6.2 Antibacterials including Access, Watch and Reserve Lists of antibiotics This summary has been prepared by the Health Technologies and Pharmaceuticals (HTP) programme at the WHO Regional Office for Europe. It is intended to communicate changes to the 2017 WHO Model List of Essential Medicines for adults (EML) and Model List of Essential Medicines for children (EMLc) to national counterparts involved in the evidence-based selection of medicines for inclusion in national essential medicines lists (NEMLs), lists of medicines for inclusion in reimbursement programs, and medicine formularies for use in primary, secondary and tertiary care. This document does not replace the full report of the WHO Expert Committee, 2017 and this summary should be read in conjunction with the full report (WHO Technical Report Series, No. 1006; http://apps.who.int/iris/bitstream/10665/259481/1/9789241210157-eng.pdf?ua=1). The revised lists of essential medicines (in English) are available as follows: 2017 WHO Model List of Essential Medicines for adults (EML) http://www.who.int/medicines/publications/essentialmedicines/20th_EML2017_FINAL_amend edAug2017.pdf?ua=1 2017 Model List of Essential Medicines for children (EMLc) http://www.who.int/medicines/publications/essentialmedicines/6th_EMLc2017_FINAL_amend edAug2017.pdf?ua=1 Summary of changes to Section 6.2 Antibacterials: Section 6 of the EML covers anti-infective medicines. Disease-specific subsections within Section 6, such as those covering medicines for tuberculosis, HIV, hepatitis and malaria, have been regularly reviewed and updated, taking into consideration relevant WHO treatment guidelines. -
Staphylococcus Aureus Bloodstream Infection Treatment Guideline
Staphylococcus aureus Bloodstream Infection Treatment Guideline Purpose: To provide a framework for the evaluation and management patients with Methicillin- Susceptible (MSSA) and Methicillin-Resistant Staphylococcus aureus (MRSA) bloodstream infections (BSI). The recommendations below are guidelines for care and are not meant to replace clinical judgment. The initial page includes a brief version of the guidance followed by a more detailed discussion of the recommendations with supporting evidence. Also included is an algorithm describing management of patients with blood cultures positive for gram-positive cocci. Brief Key Points: 1. Don’t ignore it – Staphylococcus aureus isolated from a blood culture is never a contaminant. All patients with S. aureus in their blood should be treated with appropriate antibiotics and evaluated for a source of infection. 2. Control the source a. Removing infected catheters and prosthetic devices – Retention of infected central venous catheters and prosthetic devices in the setting of S. aureus bacteremia (SAB) has been associated with prolonged bacteremia, treatment failure and death. These should be removed if medically possible. i. Retention of prosthetic material is associated with an increased likelihood of SAB relapse and removal should be considered even if not clearly infected b. Evaluate for metastatic infections (endocarditis, osteomyelitis, abscesses, etc.) – Metastatic infections and endocarditis are quite common in SAB (11-31% patients with SAB have endocarditis). i. All patients should have a thorough history taken and exam performed with any new complaint evaluated for possible metastatic infection. ii. Echocardiograms should be strongly considered for all patients with SAB iii. All patients with a prosthetic valve, pacemaker/ICD present, or persistent bacteremia (follow up blood cultures positive) should undergo a transesophageal echocardiogram 3. -
A New Trigger of Morbilliform Eruption in the Setting of Atypical Infectious
A New Trigger of Morbilliform Eruption in the Setting of Atypical Infectious Mononucleosis Roxanne Rajaii, DO,* Megan Furniss, DO,** John Pui, MD,*** Brett Bender, DO**** *Dermatology Resident, PGY2, Beaumont Hospital - Farmington Hills, Farmington Hills, MI **Dermatology Resident, PGY4, Beaumont Hospital - Farmington Hills, Farmington Hills, MI ***Dermatopathologist, Beaumont Hospital - Farmington Hills, Farmington Hills, MI ****Dermatologist, Beaumont Hospital - Farmington Hills, Farmington Hills, MI Disclosures: None Correspondence: Roxanne Rajaii, DO; [email protected] Abstract Morbilliform eruptions, also commonly referred to as exanthematous or maculopapular drug eruptions, are the most common type of hypersensitivity reaction and can vary in etiology. Antibiotics are a common trigger, most notably amoxicillin or ampicillin in the setting of a concomitant and acute Epstein-Barr virus (EBV) infection. However, other antibiotics have been identified to cause a similar reaction in the setting of EBV. Cephalexin, a commonly used cephalosporin, is the only antibiotic in its class that has been implicated in causing such a phenomenon. We present a unique case of a morbilliform eruption in the setting of EBV secondary to the use of cefepime, further outlining the importance of conservative antibiotic use and awareness of such a reaction in this specific patient population, not only with penicillins but also with a wider spectrum of antibiotics. Introduction acquired pyelonephritis, as she had been admitted Work-up included the following laboratory tests: Epstein-Barr virus (EBV) infects more than a month prior to that for status asthmaticus. complete blood count, complete metabolic panel, 98% of the world’s adult population and is the Four days later, she presented with an urticarial anti-nuclear antibody, creatinine phosphate kinase, most common cause of infectious mononucleosis morbilliform rash. -
Ceftaroline Fosamil (CPT) Versus DAP Plus Sulfamethoxazole/ Trimethoprim (SMX/TMP) for Methicillin-Resistant Staphylococcus Aureus Bloodstream Infections (BSI) Evan J
Retrospective Evaluation of Daptomycin (DAP) plus Ceftaroline fosamil (CPT) versus DAP plus Sulfamethoxazole/ Trimethoprim (SMX/TMP) for Methicillin-Resistant Staphylococcus aureus Bloodstream Infections (BSI) Evan J. Zasowski, Pharm.D., BCPS1, Kimberly C. Claeys, Pharm.D.1, Karrine D. Roberts, Pharm.D.2,Donald P. Levine, M.D.3, Susan L. Davis, Pharm.D.1,4, Michael J. Rybak, Pharm.D., M.P.H.1, 3 Address correspondence to: ECCMID 2015 1. Anti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy & Health Sciences, Wayne State University, Detroit MI, USA; 2. Department of Pharmacy Services, Detroit Medical Center, Detroit, MI, USA ; P0700 Michael J. Rybak, Pharm.D., M.P.H. 3. Department of Medicine, Division of Infectious Diseases, School of Medicine, Wayne State University, Detroit, MI, USA; 4. Henry Ford Health System, Detroit, MI, USA [email protected] Introduction and Purpose Results • Clinical failure rates and emergence of resistance to first and second- Table 1. Baseline and clinical characteristics Figure 2. Line of therapy* of combination regimen Table 2. Clinical outcomes line treatments for methicillin-resistant Staphylococcus aureus DAP + CPT DAP + SMX/TMP Characteristic p-value 100 DAP + CPT DAP + SMX/TMP N = 23 N = 16 Outcome p-value (MRSA) bloodstream infections (BSI) has led to the exploration of 90 N = 23 N = 16 novel alternative antibiotic treatment strategies Demographics and Comorbid Conditions! 80 Composite failure, n (%)! 7 (30.4)! 7 (43.8)! 0.39! Age, mean (SD)! 57.9 -
Ceftaroline Fosamil As an Alternative for a Severe Methicillin-Resistant Staphylococcus Aureus Infection: a Case Report
Open Access Case Report DOI: 10.7759/cureus.3776 Ceftaroline Fosamil as an Alternative for a Severe Methicillin-resistant Staphylococcus aureus Infection: A Case Report Talha N. Jilani 1 , Syed O. Masood 2 1. Internal Medicine, Ziauddin University, Karachi, PAK 2. Infectious Diseases, University of Cincinnati Medical Center, Cincinnati, USA Corresponding author: Talha N. Jilani, [email protected] Abstract Bacteremia secondary to methicillin-resistant Staphylococcus aureus (MRSA) is a dreaded medical condition that is not only associated with a significant medical cost but also carries high morbidity and mortality. The poor clinical outcomes seen in MRSA patients and the nephrotoxic effects of high-doses of vancomycin are challenging its current status as the first-line treatment for MRSA. Fortunately, vancomycin-intermediate- staphylococcus aureus (VISA) and vancomycin-resistant-staphylococcus aureus (VRSA) are not common in the United States. However, MRSA still presents different treatment challenges. Elevated vancomycin minimum inhibitory concentrations (MICs) commonly result in decreased efficacy and an increased probability of treatment failure, prompting the use of alternative agents. Although daptomycin is an alternative, adverse effects (i.e., elevations in serum creatine phosphokinase (CPK), drug-induced myopathy, peripheral neuropathy, and eosinophilic pneumonia) may limit its use in some patients. In the search for a suitable replacement for vancomycin, great promise has been shown by anti-MRSA cephalosporins. We present a case of MRSA bacteremia and endocarditis requiring a different approach to treatment as compared to traditional treatment with vancomycin alone. This case report describes the successful treatment of MRSA bacteremia with ceftaroline fosamil in a patient who responded poorly to conventional therapy, specifically vancomycin, due to an elevated MIC (2 µg/mL). -
The Effects of Daptomycin on Chemical Composition and Morphology of Staphylococcus Aureus
15 The Effects of Daptomycin on Chemical Composition and Morphology of Staphylococcus aureus Robert S. Conrad, Marsha J. Howard, Roger C. Garrison, Stacey Winters, and David A. Henderson Oklahoma State University, College of Osteopathic Medicine, Tulsa, OK 74107-1898 The effects of daptomycin on Staphylococcus aureus morphology and chemical composition were studied by comparative analyses of susceptible and daptomycin-resistant strains. The resistant strains were developed from wild-type (WT) susceptible cells by stepwise selection to increasingly higher levels of daptomycin. The minimal inhibitory concentrations of penicillin, streptomycin, tetracycline, and erythromycin were similar among resistant and susceptible strains. Daptomycin-resistant strains were concomitantly resistant to polymyxin B. The cellular percentages and phosphate content of cell walls, readily extractable lipids (REL), and peptidoglycan among the respective strains were similar except for a reduction in the cellular percentage of REL in resistant cells. The phosphate content of lipoteichoic acids that were extracted from resistant cells was drastically reduced. Both susceptible and resistant REL were fractionated by selective elution from silicic acid columns. The primary phospholipids of both strains were diphosphatidyl glycerol, phosphatidyl glycerol, and phosphatidyl serine. Only minor differences in fatty acids were noted. The growth of resistant cells in sublethal concentrations and susceptible cells in lethal concentrations of daptomycin resulted in unusual cell morphology characterized by various cell wall anomalies. (This study was presented in part at the 97th General Meeting of the American Society for Microbiology, Miami Beach, Florida, May 1997.) ©1998 Oklahoma Academy of Science INTRODUCTION Daptomycin (LY146032) is an acidic lipopeptide with a high specificity for gram-positive bacteria (1). -
ESBL Disc Tests - Rev.2 / 19.06.2014 ESBL Disc Tests Disc Tests for Detection of ESBL-Producing Enterobacteriaceae
© Liofilchem® - ESBL Disc Tests - Rev.2 / 19.06.2014 ESBL Disc Tests Disc tests for detection of ESBL-producing Enterobacteriaceae. DESCRIPTION Extended-spectrum β-lactamases (ESBLs) are enzymes hydrolyzing most penicillins and cephalosporins, including oxyimino- β-lactam compunds but not cephamycins and carbapenems. Most ESBLs belong to the Amber class A of β-lactamases and are inhibited by β-lactamases inhibitors: clavulanic acid, sulbatam and tazobactam. ESBL production has been observed mostly in Enterobacteriaceae, particularly Escherichia coli and Klebsiella pnuemoniae, but all other clinically-relevant Enterobacteriaceae species are also common ESBL-producers. In many areas, ESBL detection and characterization is recommended or mandatory for infection control purpose. ESBL detection involves two important steps. The first is a screening test with an indicator cephalosporin which looks for resistance or diminished susceptibility, thus identifying isolates likely to be harboring ESBLs. The second step is a confirmation test which evaluates the synergy between an oxyimino cephalosporin and clavulanic acid, distinguishing isolates with ESBLs from those that are resistant for other reasons. METHOD PRINCIPLE ESBL Disc Screening Disk-diffusion method for ESBL screening can be performed using cefpodoxime, ceftazidime, aztreonam, cefotaxime and ceftriaxone, according to EUCAST and/or CLSI guidelines (table 1). Since the affinity of ESBLs for different substrates is variable, the use of more than one of these agents for screening improves the sensitivity of detection. However, it is adequate to use the couple cefotaxime (or ceftriaxone) and ceftazidime. If only one drug can be used, cefpodoxime is the most sensitive indicator cephalosporin for detection of ESBL production may be used for screening.