Drugs for Bacterial Infections
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Cefditoren Pivoxil) Tablets 200 and 400 Mg
SPECTRACEF® (cefditoren pivoxil) Tablets 200 and 400 mg. To reduce the development of drug-resistant bacteria and maintain the effectiveness of SPECTRACEF® and other antibacterial drugs, SPECTRACEF® should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION SPECTRACEF® tablets contain cefditoren pivoxil, a semi-synthetic cephalosporin antibiotic for oral administration. It is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active cefditoren. Chemically, cefditoren pivoxil is (-)-(6R,7R)-2,2-dimethylpropionyloxymethyl 7-[(Z)-2-(2-aminothiazol-4-yl)-2-methoxy iminoacetamido]-3-[(Z)-2-(4-methylthiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. The empirical formula is C25H28N6O7S3 and the molecular weight is 620.73. The structural formula of cefditoren pivoxil is shown below: cefditoren pivoxil The amorphous form of cefditoren pivoxil developed for clinical use is a light yellow powder. It is freely soluble in dilute hydrochloric acid and soluble at levels equal to 6.06 mg/mL in ethanol and <0.1 mg/mL in water. SPECTRACEF® (cefditoren pivoxil) tablets contain 200 mg or 400 mg of cefditoren as cefditoren pivoxil and the following inactive ingredients: croscarmellose sodium, D-mannitol, hydroxypropyl cellulose, hypromellose, magnesium stearate, sodium caseinate (a milk protein), and sodium tripolyphosphate. The tablet coating contains carnauba wax, hypromellose, polyethylene glycol, and titanium dioxide. Tablets are printed with ink containing D&C Red No. 27, FD&C Blue No. 1, propylene glycol, and shellac. CLINICAL PHARMACOLOGY Pharmacokinetics Absorption Oral Bioavailability Following oral administration, cefditoren pivoxil is absorbed from the gastrointestinal tract and hydrolyzed to cefditoren by esterases. -
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 -
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%. -
The Antibacterial Activity of Cefpodoxime and the Novel Β
Session-198 b SATURDAY-279 The Antibacterial Activity of Cefpodoxime and the Novel -lactamase Inhibitor ETX1317 Against Recent Clinical Isolates of b-lactamase-producing Enterobacteriaceae Entasis Therapeutics S. McLeod1, M. Hackel2, R. Badal2, A. Shapiro1, J. Mueller1, R. Tommasi1, and A. Miller1 1-781-810-0120 1Entasis Therapeutics, Waltham, MA and 2IHMA, International Health Management Associates, Schaumburg, IL USA www.entasistx.com Abstract In vitro activity of ETX1317 vs. comparator BLIs Cumulative activity vs. 911 ESBL-enriched Enterobacteriaceae from 2013-2015 Activity vs. 35 sequenced KPC+ and/or MBL+ Enterobacteriaceae MIC (mg/L) Background β-lactamase inhibition (IC50, µM) Strain ID Species encoded bla genes IPM CAZ-AVI CPD-ETX1317 ETX1317 ETX1317 is a novel, diazabicyclooctenone inhibitor of serine β-lactamases that Number (cumulative %) of isolates inhibited at MIC (mg/L) Class A Class C Class D Drug %S* ARC3528*¥ E. cloacae AmpC [∆308-313(SKVALA)] 0.25 32 0.125 4 restores β-lactam activity against multidrug-resistant Enterobacteriaceae. ETX0282, < 0.03 0.06 0.12 0.25 0.5 1 2 4 8 16 32 > 32 ARC4165*¥ C. freundii CMY-2; AmpC [N366Y]; TEM-1; SHV-5 2 32 ≤0.03 4 the oral prodrug of ETX1317, is currently under investigation in combination with BLI CTX-M-15 SHV-5 KPC-2 TEM-1 AmpC* P99 OXA-24/40 OXA-48 0 5 6 14 19 34 20 27 17 18 18 733 3 CPD 10.8 ARC6479* K. oxytoca NDM-1 16 >32 32 32 cefpodoxime proxetil (CPDP), which is hydrolyzed in vivo to release cefpodoxime 0% 0.5% 1% 3% 5% 9% 11% 14% 16% 18% 20% 100% (CPD). -
'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. -
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) .............................................................................. -
Comparative Study of 5-Day and 10-Day Cefditoren Pivoxil Treatments for Recurrent Group a Β-Hemolytic Streptococcus Pharyngitis in Children
Hindawi Publishing Corporation International Journal of Pediatrics Volume 2009, Article ID 863608, 5 pages doi:10.1155/2009/863608 Clinical Study Comparative Study of 5-Day and 10-Day Cefditoren Pivoxil Treatments for Recurrent Group A β-Hemolytic Streptococcus pharyngitis in Children Hideaki Kikuta, Mutsuo Shibata, Shuji Nakata, Tatsuru Yamanaka, Hiroshi Sakata, Kouji Akizawa, and Kunihiko Kobayashi Pediatric Clinic, Touei Hospital, N-41, E-16, Higashi-ku, Sapporo 007-0841, Japan Correspondence should be addressed to Hideaki Kikuta, [email protected] Received 20 November 2008; Accepted 23 January 2009 Recommended by Samuel Menahem Efficacy of short-course therapy with cephalosporins for treatment of group A β-hemolytic streptococcus (GABHS) pharyngitis is still controversial. Subjects were 226 children with a history of at least one episode of GABHS pharyngitis. Recurrence within the follow-up period (3 weeks after initiation of therapy) occurred in 7 of the 77 children in the 5-day treatment group and in 1 of the 149 children in the 10-day treatment group; the incidence of recurrence being significantly higher in the 5-day treatment group. Bacteriologic treatment failure (GABHS isolation without overt pharyngitis) at follow-up culture was observed in 7 of the 77 children in the 5-day treatment group and 17 of the 149 children in the 10-day treatment group. There was no statistical difference between the two groups. A 5-day course of oral cephalosporins is not always recommended for treatment of GABHS pharyngitis in children who have repeated episodes of pharyngitis. Copyright © 2009 Hideaki Kikuta et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. -
Below Are the CLSI Breakpoints for Selected Bacteria. Please Use Your Clinical Judgement When Assessing Breakpoints
Below are the CLSI breakpoints for selected bacteria. Please use your clinical judgement when assessing breakpoints. The lowest number does NOT equal most potent antimicrobial. Contact Antimicrobial Stewardship for drug selection and dosing questions. Table 1: 2014 MIC Interpretive Standards for Enterobacteriaceae (includes E.coli, Klebsiella, Enterobacter, Citrobacter, Serratia and Proteus spp) Antimicrobial Agent MIC Interpretive Criteria (g/mL) Enterobacteriaceae S I R Ampicillin ≤ 8 16 ≥ 32 Ampicillin-sulbactam ≤ 8/4 16/8 ≥ 32/16 Aztreonam ≤ 4 8 ≥ 16 Cefazolin (blood) ≤ 2 4 ≥ 8 Cefazolin** (uncomplicated UTI only) ≤ 16 ≥ 32 Cefepime* ≤ 2 4-8* ≥ 16 Cefotetan ≤ 16 32 ≥ 64 Ceftaroline ≤ 0.5 1 ≥ 2 Ceftazidime ≤ 4 8 ≥ 16 Ceftriaxone ≤ 1 2 ≥ 4 Cefpodoxime ≤ 2 4 ≥ 8 Ciprofloxacin ≤ 1 2 ≥ 4 Ertapenem ≤ 0.5 1 ≥ 2 Fosfomycin ≤ 64 128 ≥256 Gentamicin ≤ 4 8 ≥ 16 Imipenem ≤ 1 2 ≥ 4 Levofloxacin ≤ 2 4 ≥ 8 Meropenem ≤ 1 2 ≥ 4 Piperacillin-tazobactam ≤ 16/4 32/4 – 64/4 ≥ 128/4 Trimethoprim-sulfamethoxazole ≤ 2/38 --- ≥ 4/76 *Susceptibile dose-dependent – see chart below **Cefazolin can predict results for cefaclor, cefdinir, cefpodoxime, cefprozil, cefuroxime axetil, cephalexin and loracarbef for uncomplicated UTIs due to E.coli, K.pneumoniae, and P.mirabilis. Cefpodoxime, cefinidir, and cefuroxime axetil may be tested individually because some isolated may be susceptible to these agents while testing resistant to cefazolin. Cefepime dosing for Enterobacteriaceae ( E.coli, Klebsiella, Enterobacter, Citrobacter, Serratia & Proteus spp) Susceptible Susceptible –dose-dependent (SDD) Resistant MIC </= 2 4 8 >/= 16 Based on dose of: 1g q12h 1g every 8h or 2g every 8 h Do not give 2g q12 Total dose 2g 3-4g 6g NA Table 2: 2014 MIC Interpretive Standards for Pseudomonas aeruginosa and Acinetobacter spp.