DOCSLIB.ORG

United States Patent 19 11 Patent Number: 5,763,603 Trickes 45 Date of Patent: Jun

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
United States Patent 19 11 Patent Number: 5,763,603 Trickes 45 Date of Patent: Jun USOO5763603A United States Patent 19 11 Patent Number: 5,763,603 Trickes 45 Date of Patent: Jun. 9, 1998 54 CRYSTALLINE TAZOBACTAM, AND ITS 4,912,211 3/1990 Bonfanti................................. 540/222 PRODUCTION AND USE FOREIGN PATENT DOCUMENTS (75) Inventor: Georg Trickes, Loerrach, Germany 63-66187 3/1988 Japan. 73) Assignee: Taiho Pharmaceutical Co., Ltd., OTHER PUBLICATIONS Tokyo, Japan Chemical Patents Index Basic Abstracts Journal, Section (21) Appl. No.: 403829 B:FARMDOC, 1988, Derwent Publications, week 88.18, 29 22 PCT Filed: Nov. 2, 1994 Jun. 1988, 88-122648/18. 86 PCT No.: PCTAJP94/01855 Primary Examiner-Mukund J. Sham Assistant Examiner-Pavanaram K. Sripada S371 Date: Mar 21, 1995 Attorney, Agent, or Firm-Sughrue. Mion. Zinn. Macpeak S 102(e) Date: Mar. 21, 1995 & Seas, PLLC 87 PCT Pub. No.: WO95/12601 57 ABSTRACT Crystalline sodium 20-methyl-2B-(1,2,3-triazol-1-yl) PCT Pub. Date: May 11, 1995 -methylpenan-3o-carboxylate-1,1-dioxide monohydrate 30 Foreign Application Priority Data (crystalline tazobactam sodium monohydrate) obtainable by adding to a concentrated aqueous solution of sodium Nov. 6, 1993 EP European Pat. Off. .............. 93.18.016 20-methyl-23-(1,2,3-triazol-1-yl)-methylpenam-30 (51) Int. Cl. ... ... CO7D 499/00; A61K 31/425 carboxylate-1,1-dioxide (tazobactam sodium) a solvent 52) U.S. Cl. ............................................ 540/310: 514/210 selected from acetone and ethanol in an amount correspond 58) Field of Search .............................. 540/310; 514/210 ing to a solvent to water ratio of between about 95:5 and 99:1 v/v and crystallizing the desired product from the solvent 56) References Cited mixture. The crystalline tazobactam sodium monohydrate exhibits a high B-lactamase inhibitory activity in combina U.S. PATENT DOCUMENTS tion with B-lactam antibiotics. 4,562,073 12/1985 Micetich et al. ........................ 424/114 4,774.238 9/1988 Brown et al. ....... ... 514/192 30 Claims, 4 Drawing Sheets U.S. Patent Jun. 9, 1998 Sheet 1 of 4 5,763,603 FIG. 1 Weight change (%) 25.0 15.0 c - as as a re - a - - - - - - - - - - -a - - - - - - - - - - - - d. are as a sks as - - - - - - as - as all - - - a - -n - - - - - 10.0 - - - - - - - - - - - - - - - - - - - - - - - - - - - 40 50 60 70 80 90 100 Rel. humidity (%) U.S. Patent Jun. 9, 1998 Sheet 2 of 4 5,763,603 FIG.2 Weight change (%) 50.0 X With drying 400 30.0 20.0 10.0 0.0 Rel, humidity (%) U.S. Patent Jun. 9, 1998 Sheet 4 of 4 5,763,603 No. 2THETA d RELI (%). MAX INTEQI WDTH 0.20 8.6645 25.) 665. 3864.75 0.36 2 .300 7.824 86.8 2290. 659.83 0.69 3 3.820 6.4026 8.2 2063. 3733.20 0.56 4 6.300 5.4336 57.4 54. O84.79 0.58 5 6.59 5.2858 28. 743. 4429.26 0.40 6 8.4 4.886), 4.5 096. 740.80 0.53 7 8.459 4.8027 89.2 23SS. 560.33 0.56 8 8.979 4.67.23 46.5 227. 8882.84 0.70 9 2006 4.4.226 000 2639. 1900.20 0.59 O 2.439 4.44 55.0 45. 1027.94 0.65 22.679 3.977 37. 979. 85.03.04 0.204 23.060 3.8538 8.8 497. 2898. 0.37 3 23.34 3.8080 6. 425. 2749.36 0.5) 4 23.600 3.7668 3.7 362. 205.66 0.33 5 24.739 3.5959 67.3 776. 239.30 0.63 6 25.779 3.453 T).7 98. 995.60 0.47 7 26.80 3.40 28.7 758. 479.2 0.46 8 26.42 3.3707 25. 679. 426.59 0.47 9 27.99 3.93 57.4 54. 84.2 0.13 20 28.340 3.467 2.6 333. 3437.5 0.243 29,079 3.0683 39.8 050. 290.46 0.63 22 30.380 2.9398 22.4 59). 430.54 0.7 23 30.640 2.955 3. 346. 204806 0.39 24 3.78 2.8664. 28.6 SS. 4686.6 0.46 25 3.399 2.8467 7.2 455. 2606.58 0.35 26 3.37 27830 8.2 28. 603.78 0.73 27 32.779 2.7300 20.5 S4. 375. 0.63 28 33.26 2.695 9. S03. 3562.67 0.66 9 34.299 2.6.24 4.6 385. 2552.69 0.56 30 34.480 ).599 6. 424. 2592.66 0.44 3. 35.680 ). 544 30.) 197. S869.09 0.73 3) 36:40 2.4768 20.4 537. 3974.05 0.74 33 36.89 2.439) 30.6 808. 5662.38 0.65 34 31.40 2.488 . 309. I4.79 0.3 35 38.320 2.3470 7.4 96. 844.75 0.22 36 39.400 2.285 4.4 380. 342.37 0.94 IENTENSITY 5,763,603 1. 2 CRYSTALLINE TAZOBACTAM, AND ITS 30-carboxylate-1,1-dioxide monohydrate (crystalline tazo PRODUCTION AND USE bactam sodium monohydrate) is characterized by adding to a concentrated aqueous solution of sodium 20-methyl-2,3- TECHNICAL FIELD (1,2,3-triazol-1-yl) -methylpenam-30-carboxylate-1,1- dioxide (tazobactam sodium) a solvent selected from The present invention relates to a novel crystalline peni acetone and ethanolin an amount corresponding to a solvent cillin derivative, crystalline 20-methyl-23-(1,2,3-triazol-1- to water ratio of between about 95:5 v/v and about 99:1 wifv yl)-methylpenam-3o-carboxylic acid-1,1-dioxide, and its and crystallizing the desired product from the solvent mix production and use in a medicine. ture. BACKGROUND ART 10 The tazobactam sodium can be obtained in accordance with a method described, for example, in EPOS 97 446. In EPOS 97 446 certain penicillin derivatives are dis The concentrated aqueous solution of tazobactam sodium closed; in particular, 20-methyl-2B-(11.2,3-triazol-1-yl)- used for this crystallization process should contain about 0.1 methylpenam-3o-carboxylic acid-1.1-dioxide of the for to 0.4 g preferably about 0.25 to 0.35 g of water per g of mula 15 tazobactam equivalent present, The ratio of acetone or ethanol to water is critical. Already at a ratio of 9:1 viv it is not possible to crystallize the product even at -20° C. Suitable ratios for crystallization are about 95:5 to 99:1 viv. Preferred ratios are about 96:4 to 98:2. particularly about 97:3. The crystallization is preferably carried out at a temperature of about -10° to +30° C. more cooH preferably +5° C. to a room temperature, for about 1 to 30 (hereinbelow "tazobactam") and its pharmaceutically hours. acceptable salts, notably the sodium salt, are reported to be 25 The most preferable solvent is acetone. The acetone, in useful as B-lactamase inhibitory agents in combination with the amount dictated by the above recommended acetone to known B-lactam antibiotics, viz. increasing the antimicro water ratio, can be added at once and the mixture be left for bial activity of the B-lactam antibiotics. a sufficient time, e.g. about 10 to 30 hours to crystallize. However, up to the present tazobactam sodium has been However, preferably the acetone to be added is divided in obtained in solid form only in the amorphous state, e.g. as 3 volumes, which are added successively to the concentrated a lyophilisate. Such solid forms are hygroscopic, possess aqueous tazobactam solution a about room temperature. The inferior stability, and their purification require laborious, e.g. first volume is about 23 to 27% of the total acetone volume, lyophilizing procedures. the second volume is about 24 to 28% of the total acetone Thus, there is a need for a crystalline modification of volume and the third volume is about 46 to 52% of the total tazobactam sodium, which overcomes all these drawbacks. 35 acetone volume preferably, the first volume is about 24 to Initial attempts to crystallize the product did not offer the 25% of the total acetone volume, the second volume is about required result: Due to the high solubility of tazobactam 26to 27% of the total acetone volume and the third volume sodium in water it was not expected that the product could is about 48 to 50% of the total acetone volume. The first be crystallized from an aqueous medium. This assumption volume is preferably added together with a small volume of was supported by findings, according to which concentrated methanol so as to postpone crystallization until the addition aqueous tazobactam sodium solutions could not be crystal of the second volume. To that end the methanol added to the lized from methanol due to the solubility of the product in first volume of acetone is preferably about 1 to 4% w/v of the that solvent; moreover, attempts with methyl ethyl ketone acetone totally added. The second volume of acetone will water 95:5 v/v and with ethyl acetate?water 95:5 viv as start crystallization which can be promoted by scratching the solvent failed due to a separation of phases, without crys 45 wall of the vessel or by seeding with a small amount of tallization. Therefore, crystallization in the absence of water tazobactam sodium monohydrate seed crystals. After addi was attempted: Based on a known procedure, tazobactam tion of the third volume of acetone the crystal yield can be was suspended in methanol, and one equivalent of sodium improved by cooling the mixture, e.g.
Load more

Recommended publications
  • Cefoxitin Versus Piperacillin– Tazobactam As Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy: Protocol for a Randomised Controlled Trial
    Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2020-048398 on 4 March 2021. Downloaded from Cefoxitin versus piperacillin– tazobactam as surgical antibiotic prophylaxis in patients undergoing pancreatoduodenectomy: protocol for a randomised controlled trial Nicole M Nevarez ,1 Brian C Brajcich,2 Jason Liu,2,3 Ryan Ellis,2 Clifford Y Ko,2 Henry A Pitt,4 Michael I D'Angelica,5 Adam C Yopp1 To cite: Nevarez NM, ABSTRACT Strengths and limitations of this study Brajcich BC, Liu J, et al. Introduction Although antibiotic prophylaxis is Cefoxitin versus piperacillin– established in reducing postoperative surgical site tazobactam as surgical ► A major strength of this study is the multi- infections (SSIs), the optimal antibiotic for prophylaxis in antibiotic prophylaxis institutional, double- arm, randomised controlled in patients undergoing pancreatoduodenectomy (PD) remains unclear. The study trial design. objective is to evaluate if administration of piperacillin– pancreatoduodenectomy: ► A limitation of this study is that all perioperative care protocol for a randomised tazobactam as antibiotic prophylaxis results in decreased is at the discretion of the operating surgeon and is controlled trial. BMJ Open 30- day SSI rate compared with cefoxitin in patients not standardised. 2021;11:e048398. doi:10.1136/ undergoing elective PD. ► All data will be collected through the American bmjopen-2020-048398 Methods and analysis This study will be a multi- College of Surgeons National Surgical Quality ► Prepublication history for institution, double- arm, non- blinded randomised controlled Improvement Program, which is a strength for its this paper is available online. superiority trial. Adults ≥18 years consented to undergo PD ease of use but a limitation due to the variety of data To view these files, please visit for all indications who present to institutions participating included.
    [Show full text]
  • 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
    [Show full text]
  • 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.
    [Show full text]
  • )&F1y3x PHARMACEUTICAL APPENDIX to THE
    )&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE
    [Show full text]
  • 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.
    [Show full text]
  • PHARMACEUTICAL APPENDIX to the TARIFF SCHEDULE 2 Table 1
    Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names INN which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service CAS registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known.
    [Show full text]
  • Fosfomycin Resistance in Escherichia Coli Isolates from South Korea and in Vitro Activity of Fosfomycin Alone and in Combination with Other Antibiotics
    antibiotics Article Fosfomycin Resistance in Escherichia coli Isolates from South Korea and in vitro Activity of Fosfomycin Alone and in Combination with Other Antibiotics Hyeri Seok 1 , Ji Young Choi 2, Yu Mi Wi 3, Dae Won Park 1, Kyong Ran Peck 4 and Kwan Soo Ko 2,* 1 Division of Infectious Diseases, Department of Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan 15355, Korea; [email protected] (H.S.); [email protected] (D.W.P.) 2 Department of Microbiology, Sungkyunkwan University School of Medicine, Suwon 16419, Korea; [email protected] 3 Division of Infectious Diseases, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon 51353, Korea; [email protected] 4 Division of Infectious Diseases, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea; [email protected] * Correspondence: [email protected]; Tel.: +82-31-299-6223 Received: 17 February 2020; Accepted: 3 March 2020; Published: 6 March 2020 Abstract: We investigated fosfomycin susceptibility in Escherichia coli clinical isolates from South Korea, including community-onset, hospital-onset, and long-term care facility (LTCF)-onset isolates. The resistance mechanisms and genotypes of fosfomycin-resistant isolates were also identified. Finally, the in vitro efficacy of combinations of fosfomycin with other antibiotics were examined in susceptible or extended spectrum β-lactamase (ESBL)-producing E. coli isolates. The fosfomycin resistance rate was 6.7% and was significantly higher in LTCF-onset isolates than community-onset and hospital-onset isolates. Twenty-one sequence types (STs) were identified among 19 fosfomycin-resistant E. coli isolates, showing diverse genotypes. fosA3 was found in only two isolates, and diverse genetic variations were identified in three genes associated with fosfomycin resistance, namely, GlpT, UhpT, and MurA.
    [Show full text]
  • Piperacillin/Tazobactam Drug Class1 Antibiotic – Penicillin with Β-Lactamase Inhibitor
    Monographs for Commonly Administered Intravenous Medications in Home and Community Care Piperacillin/Tazobactam Drug Class1 Antibiotic – penicillin with β-lactamase inhibitor Spectrum1 Refer to product monograph for complete spectrum For β-lactamase producing bacteria strains (e.g., Haemophilus influenza, Escherichia coli, and Staphylococcus aureus). Also to susceptible Acinetobacter species, Klebsiella pneumonia, Pseudomonas aeruginosa often combined with aminoglycoside). Cross Sensitivities / Allergies1 Cross sensitivities with penicillin and possibly cephalosporin and/or beta-lactam inhibitors Indications1,2 Intra-abdominal Respiratory tract Skin and skin structure Septicemia Gynecological Urinary tract Other conditions based on culture and sensitivity results Outpatient Considerations1 For patients with a documented allergy to penicillin, cephalosporin or beta-lactam inhibitor, the first dose should be administered in a hospital or clinic setting. Must be able to access laboratory monitoring (either at outpatient laboratory or by arranging in-home lab) if using an interacting oral medication (see Potential Drug Interactions section) Prescribing Considerations At time of ordering please provide the following to the pharmacist: and Dosage in Adults1,2 Height, weight Most recent serum creatinine with date obtained Indication (infection being treated) Usually dosed every 6 to 8 hours. Available as 2 g/0.25 g, 3 g/0.375 g, 4 g/0.5 g piperacillin/tazobactam (dose selected based on indication) Maximum 18 g/ 2.25 g piperacillin/tazobactam daily Dose and administration interval require adjustment for renal impairment Errors have occurred due to unusual ordering as combined dose of piperacillin and tazobactam. Order may be expressed only as piperacillin component or as a total of piperacillin + tazobactam (8:1 ratio).
    [Show full text]
  • Empiric Treatment with Antibiotic Combination Therapy Compared with Monotherapy for Adult Patients with Septic Shock of Unknown
    REPORT 2020 SYSTEMATIC REVIEW: Empiric treatment with antibiotic combination therapy compared with monotherapy for adult patients with septic shock of unknown pathogen and origin Utgitt av Norwegian Institute of Public Health Division for Health Services Title Empiric treatment with antibiotic combination therapy compared with monotherapy for adult patients with septic shock of unknown pathogen and origin: a systematic review Norwegian title Hva er effekten av empirisk kombinasjonsbehandling med antibiotika sammen- lignet med monoterapi for voksne pasienter med septisk sjokk forårsaket av ukjent patogen og ukjent opprinnelse: en systematisk oversikt Responsible Camilla Stoltenberg, Director General Authors Jan PW Himmels, project leader, seniorrådgiver, Norwegian Institute of Public Health Gunn Elisabeth Vist, seniorforsker, Norwegian Institute of Public Health Liv Giske, seniorforsker, Norwegian Institute of Public Health Eva Helene Arentz-Hansen, seniorforsker, Norwegian Institute of Public Health Gyri Hval, bibliotekar, Norwegian Institute of Public Health ISBN 978-82-8406-084-2 Project number RL035 Type of report Systematic Review No. of pages 26 (32 inklusiv vedlegg) Client Helsedirektoratet Subject Septic shock, antibiotic dual treatment, antibiotic monotherapy, antimicrobi- heading(MeSH) otic ressistance (AMR) Citation Himmels JPW, Vist GE, Giske L, Arentz-Hansen EH, Hval G. Empiric treatment with antibiotic combination therapy compared with monotherapy for adult patients with septic shock of unknown pathogen and origin: a systematic
    [Show full text]
  • Pharmacokinetic Evaluation of Amoxicillin/Clavulanicacid And
    PHARMACOKINETIC EVALUATION OF AMOXICILLIN/CLAVULANICACID AND ANTACID INTERACTION Anab Fatima B.Pharm, M.Phil.(Pharmaceutics) Thesis submitted for the award of degree of Ph.D In Pharmaceutics DEPARTMENT OF PHARMACEUTICS FACULTY OF PHARMACY UNIVERSITY OF KARACHI. 1 2 In the name of ALLAH The most Beneficient and tha most Merciful………………. ALLAHUMA SALLEY ALA SYEDENA MAULANA MUHAMMEDUN WA ALA AALEHYY WA ASHABHI BARIK WASALLIM WA SALLO ALEHEY SURAT AL-FATIHAH 1. IN THE NAME OF ALLAH,THE MOST GRACIOUS,THE MOST MERCIFUL. 3 2. ALL THE PRAISES AND THANKS BE TO ALLAH,THE LORD OF THE A LAMIN(MANKIND,JINN AND ALL THAT EXIST). 3. THE MOST GRACIOUS,THE MOST MERCIFUL. 4. THE ONLY OWNER(AND THE ONLY RULING JUDGE)OF THE DAY OF RECOMPENSE(THE DAY OF RESURRECTION). 5. YOU(ALONE) WE WORSHIP,AND YOU(ALONE) WE ASK FOR HELP(FOR EACH AND EVERY THING). 6. GUIDE US TO STRAIGHT WAY. 7. THE WAY OF THOSE WHOM YOU HAVE BESTOWED YOUR GRACE,NOT(THE WAY) OF THOSE WHO EARNED YOUR ANGER NOR OF THOSE WHO WENT ASTRAY.(AAMEEN) 4 DEDICATED TO: My beloved Parentral Grand Father(late),Grand Mother(late),Parents and all those persons whose prayers bring me to this stage. ACKNOWLEDGEMENT “If ALLAH assist you, then there is none that can overcome you” (Holy Quran 3:160) All praise to Almighty Allah who gives me strength, confidence and courage to complete the thesis. I am heartiest thankful to my research supervisor Prof.Dr.S.Baqir.S.Naqvi for his valuable guidance, sincere advice, moral support and encouragement throughout the research project.
    [Show full text]
  • Yungjin-Pharm-Co-Ltd-Party-Content
    Name Yungjin Pharm. Co., Ltd. Foundation •1952 (Public opened in 1973) • 2004 (Merged with KT&G, Korean Tomorrow and Global) Representatives Byung-Hwan Ryoo / President, CEO Location 451-20, Cheonho-3dong, Gangdong-gu, Seoul, Korea Core Business •Manufacturing Pharmaceutical goods (API and Finished Products) •Sales in Domestic and Overseas Markets Employees 538 (Headquarter : 48, Factory : 198, R&D Lab. : 45, MR : 247) Key Facilities Head office (Seoul), 3 Factories (API, Finished Dosage, Drinks) 13 Branches, 1 Central Research Lab. (Synthesis, Formulation) Annual Sales KRW 101 Billion (USD 101 Million), as of Dec. 2011 2 Corporate Profile Since its establishment in 1952, Yungjin Pharm. Co., Ltd has been enjoying the privilege of playing a major role as a forerunner in the Korean pharmaceutical industry for over half a century. In accordance with our inspiring mission statement, “Relieve the suffering mankind from disease with effective and safe pharmaceutical products on our own” we have been contributing to improve lives of human beings for the better. In order to establish a solid foundation, Yungjin Pharm. Co., Ltd. joined the KT&G as a member group on March 29, 2004. This merge enables us to reform ourselves as a company of enduring strength with sufficient resources for R&D sector and further development. Based on our long-term goal, we strive for further growth and expansion. Strong alliance with the worldwide pharmaceutical companies allows us to expand our market into the worldwide and cope with the challenging environment of global pharmaceutical industry. Through active involvement in R&D activities, quality management and overseas business, we will fulfill the expectations of our customers and shareholders.
    [Show full text]
  • Centre for Reviews and Dissemination
    Comparison of antibiotics with placebo for treatment of acute sinusitis: a meta-analysis of randomised controlled trials Falagas ME, Giannopoulou KP, Vardakas KZ, Dimopoulos G, Karageorgopoulos DE CRD summary The review concluded that use of antibiotics for acute sinusitis conferred a small therapeutic benefit over placebo and a corresponding rise in adverse events. The authors' conclusions were supported by the evidence presented, but limitations in the reporting of review process should be taken into consideration when interpreting these results. Authors' objectives To investigate the effectiveness and safety of antibiotics compared with placebo for acute sinusitis. Searching PubMed and Scopus databases were searched up to May 2008; search terms were reported. Bibliographic references of all relevant articles were handsearched. Papers published in languages other than English, Spanish, French, Italian and German or presented as conference abstracts were excluded. Study selection Double-blinded, randomised controlled trials (RCTs) that compared antibiotic treatment with placebo for patients of any age with acute sinusitis (of any location) were eligible for inclusion. Diagnosis of acute sinusitis was required to be determined by either clinical criteria or positive radiological, microbiological or laboratory tests. Trials that included patients with mixed types of sinusitis or mixed types of respiratory tract infections were included only if data on the subgroup of patients with acute sinusitis were reported separately or if a clinical diagnosis of acute sinusitis was supported for more than two thirds of the study population. The most commonly compared antibiotic was amoxicillin, other antibiotics included phenoxymethyl-penicillin, amoxicillin-clavulanic acid, doxycycline, azithromycin, cefuroxime and ciclacillin. All study medications were administered orally.
    [Show full text]