Pneumonia (Community-Acquired): Antimicrobial Prescribing
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Efficacy of Amoxicillin and Amoxicillin/Clavulanic Acid in the Prevention of Infection and Dry Socket After Third Molar Extraction
Med Oral Patol Oral Cir Bucal. 2016 Jul 1;21 (4):e494-504. Amoxicillin in the prevention of infectious complications after tooth extraction Journal section: Oral Surgery doi:10.4317/medoral.21139 Publication Types: Review http://dx.doi.org/doi:10.4317/medoral.21139 Efficacy of amoxicillin and amoxicillin/clavulanic acid in the prevention of infection and dry socket after third molar extraction. A systematic review and meta-analysis María-Iciar Arteagoitia 1, Luis Barbier 2, Joseba Santamaría 3, Gorka Santamaría 4, Eva Ramos 5 1 MD, DDS, PhD, Associate Professor, Stomatology I Department, University of the Basque Country (UPV/EHU), BioCruces Health Research Institute, Spain; Consolidated research group (UPV/EHU IT821-13) 2 MD PhD, Chair Professor, Maxillofacial Surgery Department, BioCruces Health Research Institute, Cruces University Hos- pital, University of the Basque Country (UPV/EHU), Spain; Consolidated research group (UPV/EHU IT821-13) 3 MD, DDS, PhD, Professor and Chair, Maxillofacial Surgery Department, Bio Cruces Health Research Institute, Cruces University Hospital, University of the Basque Country (UPV/EHU), Bizkaia, Spain; Consolidated research group (UPV/EHU IT821-13) 4 DDS, PhD, Associate Professor, Stomatology I Department, University of the Basque Country (UPV/EHU), BioCruces Health Research Institute, Spain; Consolidated research group (UPV/EHU IT821-13) 5 PhD, Degree in Farmacy, BioCruces Health Research Institute, Cruces University Hospital. Spain Correspondence: Servicio Cirugía Maxilofacial Hospital Universitario de Cruces Plaza de Cruces s/n Arteagoitia MI, Barbier L, Santamaría J, Santamaría G, Ramos E. Ef- Barakaldo, Bizkaia, Spain ficacy of amoxicillin and amoxicillin/clavulanic acid in the prevention [email protected] of infection and dry socket after third molar extraction. -
Antimicrobial Resistance Benchmark 2020 Antimicrobial Resistance Benchmark 2020
First independent framework for assessing pharmaceutical company action Antimicrobial Resistance Benchmark 2020 Antimicrobial Resistance Benchmark 2020 ACKNOWLEDGEMENTS The Access to Medicine Foundation would like to thank the following people and organisations for their contributions to this report.1 FUNDERS The Antimicrobial Resistance Benchmark research programme is made possible with financial support from UK AID and the Dutch Ministry of Health, Welfare and Sport. Expert Review Committee Research Team Reviewers Hans Hogerzeil - Chair Gabrielle Breugelmans Christine Årdal Gregory Frank Fatema Rafiqi Karen Gallant Nina Grundmann Adrián Alonso Ruiz Hans Hogerzeil Magdalena Kettis Ruth Baron Hitesh Hurkchand Joakim Larsson Dulce Calçada Joakim Larsson Marc Mendelson Moska Hellamand Marc Mendelson Margareth Ndomondo-Sigonda Kevin Outterson Katarina Nedog Sarah Paulin (Observer) Editorial Team Andrew Singer Anna Massey Deirdre Cogan ACCESS TO MEDICINE FOUNDATION Rachel Jones The Access to Medicine Foundation is an independent Emma Ross non-profit organisation based in the Netherlands. It aims to advance access to medicine in low- and middle-income Additional contributors countries by stimulating and guiding the pharmaceutical Thomas Collin-Lefebvre industry to play a greater role in improving access to Alex Kong medicine. Nestor Papanikolaou Address Contact Naritaweg 227-A For more information about this publication, please contact 1043 CB, Amsterdam Jayasree K. Iyer, Executive Director The Netherlands [email protected] +31 (0) 20 215 35 35 www.amrbenchmark.org 1 This acknowledgement is not intended to imply that the individuals and institutions referred to above endorse About the cover: Young woman from the Antimicrobial Resistance Benchmark methodology, Brazil, where 40%-60% of infections are analyses or results. -
Zinforo, INN Ceftaroline Fosamil
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Zinforo 600 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains ceftaroline fosamil acetic acid solvate monohydrate equivalent to 600 mg ceftaroline fosamil. After reconstitution, 1 ml of the solution contains 30 mg of ceftaroline fosamil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. A pale yellowish-white to light yellow powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Zinforo is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1): • Complicated skin and soft tissue infections (cSSTI) • Community-acquired pneumonia (CAP) Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration Posology For the treatment of cSSTI and CAP, the recommended dose is 600 mg administered every 12 hours by intravenous infusion over 60 minutes in patients aged 18 years or older. The recommended treatment duration for cSSTI is 5 to 14 days and the recommended duration of treatment for CAP is 5 to 7 days. Special populations Elderly patients (≥ 65 years) No dosage adjustment is required for the elderly with creatinine clearance values > 50 ml/min (see section 5.2). Renal impairment The dose should be adjusted when creatinine clearance (CrCL) is ≤ 50 ml/min, as shown below (see sections 4.4 and 5.2). Creatinine clearance Dosage regimen Frequency (ml/min) > 30 to ≤ 50 400 mg intravenously (over 60 minutes) every 12 hours 2 There is insufficient data to make specific dosage adjustment recommendations for patients with severe renal impairment (CrCL ≤ 30 ml/min) and end-stage renal disease (ESRD), including patients undergoing haemodialysis (see section 4.4). -
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. -
Australian Public Assessment Refport for Ceftaroline Fosamil (Zinforo)
Australian Public Assessment Report for ceftaroline fosamil Proprietary Product Name: Zinforo Sponsor: AstraZeneca Pty Ltd May 2013 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) • The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices. • The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. • The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. • To report a problem with a medicine or medical device, please see the information on the TGA website <http://www.tga.gov.au>. About AusPARs • An Australian Public Assessment Record (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. • AusPARs are prepared and published by the TGA. • An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations, and extensions of indications. • An AusPAR is a static document, in that it will provide information that relates to a submission at a particular point in time. • A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA. -
Ceftaroline in the Management of Complicated Skin and Soft Tissue Infections and Community Acquired Pneumonia
Journal name: Therapeutics and Clinical Risk Management Article Designation: Review Year: 2015 Volume: 11 Therapeutics and Clinical Risk Management Dovepress Running head verso: Mpenge and MacGowan Running head recto: Ceftaroline in the management of cSSTI and CAP open access to scientific and medical research DOI: http://dx.doi.org/10.2147/TCRM.S75412 Open Access Full Text Article REVIEW Ceftaroline in the management of complicated skin and soft tissue infections and community acquired pneumonia Mbiye A Mpenge¹ Abstract: Ceftaroline is a new parenteral cephalosporin approved by the European Medicines Alasdair P MacGowan² Agency (EMA) and the US Food and Drug Administration (FDA) for the treatment of com- plicated skin and soft tissue infections (cSSTIs) including those due to methicillin-resistant ¹Department of Medical Microbiology, University Hospitals Bristol NHS Staphylococcus aureus (MRSA), and community-acquired pneumonia (CAP). Ceftaroline has Trust, Bristol Royal Infirmary, Bristol, broad-spectrum activity against gram-positive and gram-negative bacteria and exerts its bacteri- England; ²Department of Medical Microbiology, North Bristol NHS cidal effects by binding to penicillin-binding proteins (PBPs), resulting in inhibition of bacterial Trust, Southmead Hospital, Bristol, cell wall synthesis. It binds to PBP 2a of MRSA with high affinity and also binds to all six PBPs England in Streptococcus pneumoniae. In in vitro studies, ceftaroline demonstrated potent activity against Staphylococcus aureus (including MRSA and vancomycin-intermediate isolates), Streptococ- For personal use only. cus pneumoniae (including multidrug resistant isolates), Haemophilus influenzae, Moraxella catarrhalis, and many common gram-negative pathogens, excluding extended spectrum beta- lactamase (ESBL)-producing Enterobacteriaceae and Pseudomonas aeruginosa. In Phase II and Phase III clinical trials, ceftaroline was noninferior to its comparator agents and demonstrated high clinical cure rates in the treatment of cSSTIs and CAP. -
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 ........................................................................................................ -
DICLOXACILLIN MYLAN Dicloxacillin Sodium Capsules
AUSTRALIAN PRODUCT INFORMATION DICLOXACILLIN MYLAN Dicloxacillin sodium capsules 1 NAME OF THE MEDICINE Dicloxacillin (as dicloxacillin sodium) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains dicloxacillin sodium equivalent to 250 mg or 500 mg dicloxacillin as the active ingredient. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM DICLOXACILLIN : Dicloxacillin 250 mg capsule: Size 2 capsule with white opaque body and cap, MYLAN 250 marked ‘DX’ on the cap and ‘250’ on the body in black DICLOXACILLIN : Dicloxacillin 500 mg capsule: Size 0 capsule with white opaque body and cap, MYLAN 500 marked ‘DX’ on the cap and ‘500’ on the body in black 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of confirmed or suspected staphylococcal and other Gram positive coccal infections, including skin and skin structure and wound infections, infected burns, cellulitis, osteomyelitis and pneumonia (note: benzylpenicillin is the drug of choice for the treatment of streptococcal pneumonia). Bacteriological studies should be performed to determine the causative organisms and their susceptibility to dicloxacillin. Dicloxacillin has less intrinsic antibacterial activity and a narrower spectrum than benzylpenicillin. Dicloxacillin should therefore not be used in infections due to organisms susceptible to benzylpenicillin. Important Note: When it is judged necessary that treatment is initiated before definitive culture and sensitivity results are known, if the microbiology report later indicates that the infection is due to an organism other than a benzylpenicillin resistant staphylococcus sensitive to dicloxacillin, the physician is advised to continue therapy with a drug other than dicloxacillin or any other penicillinase-resistant penicillin. 4.2 DOSE AND METHOD OF ADMINISTRATION Microbiological studies to determine the causative organism and their susceptibility to the penicillinase resistant penicillins should be performed. -
Approximately 15 Units of Penicillinase Were Preincubated with 4 Ml of Phenylisoxazolyl Penicillins (5 Mg/Ml) at 30°C
INACTIVATION OF STAPHYLOCOCCAL PENICILLINASE BY DICLOXACILLIN Hitoshi Sagai and Tetsu Saito Research Laboratories, Toyo Jozo Co., Ltd. Ohito-cho, Shizuoka-ken, 410-23, Japan (Received for publication February 12, 1973) Staphylococcal penicillinase was inactivated by treatment with a relatively low concentration of methyldichlorophenyl-isoxazolyl penicillin (dicloxacillin). Inactivated enzyme was isolated by gel-filtration and reactivated by incubation at 37°C. It is suggested that the inactivated enzyme is penicilloyl enzyme which is readily hydrolyzed to active enzyme. The rates of hydrolysis of /3-lactamase-sensitive penicillins (such as benzylpenicillin and aminobenzylpenicillin) by penicillinase were greatly decreased by the addition of /3-lactamase resistant penicillins1'23. Gourevitch and his coworkers reported that the inactivation of cell-bound staphylococcal penicillinase occurred when the enzyme was preincubated with dimethoxyphenyl penicillin (methicillin), and the amount of inactivated enzyme corresponded to the amount of hydrolyzed methicillin3). On the other hand, Richmond demonstrated that the purified exo-enzyme of staphylococci degraded more than 85% of added methicillin without inactivation of the enzyme4). In this paper, we deal with the inactivation of the extracellular staphylococcal enzyme by dicloxacillin and propose a tentative mechanism to account for the inactivation. Materials and Methods Drugs : Benzylpenicillin potassium.salt, aminobenzylpenicillin (ampicillin) sodium salt, methyl- chlorophenylisoxazolyl penicillin (cloxacillin) sodium salt and dicloxacillin sodium salt (Toyo Jozo Co., Ltd.) were used. Organism: Staphylococcus aureus 0003 was used as the penicillinase source. The strain was of clincal origin and its penicillinase was inducible. Preparation of penicillinase: Partially purified enzyme was prepared according to the method reported by Richmond43. The supernatant fluid of methicillin-induced S. -
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. -
Antibiotic Use for Sepsis in Neonates and Children: 2016 Evidence Update
Antibiotic Use for Sepsis in Neonates and Children: 2016 Evidence Update Aline Fuchsa, Julia Bielickia,b, Shrey Mathurb, Mike Sharlandb, Johannes N. Van Den Ankera,c a Paediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, Basel, Switzerland b Paediatric Infectious Disease Research Group, Institute for Infection and Immunity, St George's University of London, London, United Kingdom c Division of Clinical Pharmacology, Children’s National Health System, Washington, DC, USA WHO-Reviews 1 TABLE OF CONTENTS 1. INTRODUCTION ............................................................................................................................... 3 1.1. Aims ......................................................................................................................................... 3 1.2. Background ............................................................................................................................. 3 1.2.1. Definition and diagnosis ................................................................................................. 3 Neonatal Sepsis ............................................................................................................................... 3 Paediatric Sepsis ............................................................................................................................. 4 Community versus hospital acquired sepsis .................................................................................. 5 1.2.2. Microbiology .................................................................................................................. -
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.