Prescribing and Administration of IV Amoxicillin ...



Canberra Hospital and Health ServicesClinical ProcedurePrescribing and Administration of IV Amoxicillin-Clavulanic Acid (Amoxiclav Juno?) in Adults and Children (not Neonates)Contents TOC \h \z \t "Heading 1,1" Contents PAGEREF _Toc508199976 \h 1Purpose PAGEREF _Toc508199977 \h 2Alerts PAGEREF _Toc508199978 \h 2Scope PAGEREF _Toc508199979 \h 2Section 1 – Prescribing and Dosing PAGEREF _Toc508199980 \h 2Section 2 – Administration PAGEREF _Toc508199981 \h 4Section 3 – Precautions, Contraindications, and Monitoring PAGEREF _Toc508199982 \h 5Implementation PAGEREF _Toc508199983 \h 5Related Policies, Procedures, Guidelines and Legislation PAGEREF _Toc508199984 \h 5References PAGEREF _Toc508199985 \h 6Search Terms PAGEREF _Toc508199986 \h 6PurposeThe purpose of this procedure is to provide Canberra Hospital and Health Services (CHHS) staff with information about:the recommended prescribing of IV amoxicillin-clavulanic acid and instructions for medication administration and precautions, cautions and monitoring. Back to Table of ContentsAlertsIV amoxicillin-clavulanic acid requires an Antimicrobial Stewardship (AMS) approval code within 24 hours of prescribing, in a similar manner to RED antimicrobials. See the Antimicrobial Stewardship Procedure for more information regarding requesting AMS approval. Back to Table of ContentsScopeThis document applies to the following CHHS staff, working within their scope of practice:Medical OfficersNurses and MidwivesPharmacistsHealthcare students under direct supervision.Back to Table of ContentsSection 1 – Prescribing and DosingIntravenous amoxicillin-clavulanic acid is a broad spectrum antibiotic that covers gram-positive, gram-negative and anaerobic organisms where Pseudomonas cover is not required. IV gentamicin and IV ceftriaxone should be used preferentially where recommended as first line therapy in Therapeutic Guidelines. IV amoxicillin-clavulanic acid is recommended for empiric therapy at CHHS instead of piperacillin-tazobactam for the following indications:Bite wounds and clenched fist injuries Moderate to severe diabetic foot infection without Pseudomonas risk factors Pseudomonas coverage is not required in the majority of cases - risk factors include frequent exposure to water or moist environment (e.g. wet dressings, soaking, hot tubs, whirlpools), previous pseudomonas colonisation, warm climateHospital acquired pneumonia with risk factors for Staphylococcus aureusEmpyemaLung abscess In combination with IV gentamicin for empiric broad spectrum coverage, for example inpatient sepsis of unknown origin Presumptive therapy (delayed debridement > 8 hours from time of injury) or empirical therapy (severe tissue damage or evidence of infection) for open fracturesIV amoxicillin-clavulanic acid may also be recommended for other indications by the Infectious Diseases or Antimicrobial Stewardship teams. All prescriptions outside of the ICU require a valid AMS approval code to be obtained within 24 hours of initiation (see AMS Procedure).IV amoxicillin-clavulanic acid should not be used where cultures or clinical history indicate that Pseudomonas may be the causative organism – seek specialist advice if required. Dosing GuidelinesADULT and CHILDREN >40kg: Doses are expressed in terms of total amoxicillin/clavulanic acid contentCrCl (ml/min)General Ward patientICU/critical illness/deep seated infection>501.2g every 8 hours1.2g every 6 hoursIn patients with augmented renal clearance in ICU (e.g. estimated CrCL> 130ml/min), consider extending the infusion time for each dose to 3 hours*30-501.2g every 8 hours1.2g every 8 hours<30ml/min or HD1.2g every 12 hours600mg every 8 hours or 1.2g every 12 hoursCRRTNASeek specialist advice*Specify infusion duration on the medication order if prescribing an extended infusionCHILDREN <40kg (excluding neonates)Dose refers to the amoxicillin component only.WeightGeneral Ward patientICU/critical illness/deep seated infection< 4kg25mg/kg every 12 hoursSeek specialist adviceBetween 4 and 40kg25mg/kg (max 1g) every 8 hours25mg/kg (max 1g) every 6 hoursThe infusion time for each dose can be extended to 1-3 hours for improved efficacy if desired**Specify infusion duration on the medication order if prescribing an extended infusionThese dosing guidelines are based on estimated dosing requirements (40-50% fT>MIC or 100% fT>MIC depending on severity of illness) for susceptible organisms with MIC values of 4mg/L or less, based on local microbiology MIC distribution data An alternative dosing regimen may be required based on specific microbiology or patient considerations (e.g. obesity, directed therapy)Consult the your pharmacist or the AMS team for further advice if requiredA 2.2g formulation is available if higher dosing is recommended by AMS or Infectious Diseases, but is not routinely stocked by the CHHS pharmacy departmentAn Individual Patient Use Application to the Drugs and Therapeutics Committee is required before using this formulation for a specific patient.Back to Table of ContentsSection 2 – AdministrationReconstitution of powder:Reconstitute contents of 1.2 g vial in 20 mL of Water for Injection B.P. (final volume 20.9 mL).AdministrationAmoxicillin/clavulanic acid may be administered either by infusion over 30 minutes (adults and children of all ages), or by slow intravenous injection over 5 minutes (adults and children aged more than 3 months). Extended infusions over 3 hours may be required for certain patient groups (see dosing table above)Dilution volume for doses 600mg or less = 50 mL sodium chloride 0.9%Dilution volume for doses greater than 600mg = 100mL sodium chloride 0.9%The diluted solution is stable for 4 hours at 25 degrees CelsiusAlert:Do not dilute with glucose for infusions due to poor drug stability. This medicine is not suitable for intramuscular administration.IV amoxicillin-clavulanic acid is not suitable for use in Hospital in the Home due to inadequate stability. Contact AMS via ext. 43378 or the HITH registrar for advice if required.For further information refer to the latest edition of the Australian Injectable Drugs Handbook.Back to Table of Contents Section 3 – Precautions, Contraindications, and MonitoringAdverse effects:The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting. Clostridium difficile infection should be excluded with a stool sample if diarrhoea develops after starting therapy.Contraindications: Documented allergy to penicillins or beta-lactam/beta-lactamase inhibitor combinationsHistory of cholestatic jaundice or hepatic dysfunction associated with beta-lactam/beta-lactamase inhibitor combinationsNote: Pre-existing hepatic impairment is not a contraindicationPrecautionsSodium restriction, heart failure – each vial contains 2.7 mmoL (62.9 mg) of sodiumAvoid rapid IV administration of large doses as this may result in seizuresSeptic shock – consider consulting Infectious Diseases or AMS on antibiotic choiceMonitoringRenal, hepatic, and haematological function should be monitored weekly with prolonged therapy (i.e. longer than 2 weeks)Alert:This medication should be protected from light when being storedFor more information, refer to the Australian Medicines Handbook. Back to Table of Contents Implementation Provision of education to Plastics and Vascular teams, Day Surgery and 6B wardsDissemination to Pharmacy, Infectious Diseases, and MOSCETUBack to Table of ContentsRelated Policies, Procedures, Guidelines and LegislationPoliciesMedication Handling PolicyProceduresAntimicrobial Stewardship ProcedureBack to Table of ContentsReferencesMIMS Australia Pty Ltd. MIMS [online]. St Leonards (NSW): CMPMedica Australia Pty Ltd; accessed online 3rd July 2017.Australian Medicines Handbook Pty Ltd. Australian Medicines Handbook [online] Adelaide (SA): Australian Medicines Handbook Pty Ltd accessed online 1 Jan 2018.Lipsky BA, et al. 2012 Infectious Diseases Society of America Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections. CID. 2012;54:132-173.Grayson ML et al. Kucers’ The Use of Antibiotics Sixth Edition: A Clinical Review of Antibacterial, Antifungal and Antiviral Drugs. 2010. p.167-173.Carlier M, et al. Population pharmacokinetics and dosing simulations of amoxicillin/clavulanic acid in critically ill patients. JAC. 2013; 68:2600-2608.De Cock P, et al. Augmentin Renal Clearance implied a need for increased amoxicillin-clavulanic acid dosing in critically ill children. AAC. 2015; 59(11):7027-35.Back to Table of ContentsSearch Terms Augmentin, Amoxiclav, amoxicillin, amoxicillin-clavulanate, amoxicillin-clavulanic acid, antibiotic, AMS, diabetic foot, bite, antimicrobial, antibiotic, drug, clavulanic, clavulanate, DFI, Fist, Clenched, infectionsBack to Table of ContentsDisclaimer: This document has been developed by ACT Health, Canberra Hospital and Health Services specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Health Directorate assumes no responsibility whatsoever.Policy Team ONLY to complete the following:Date AmendedSection AmendedDivisional ApprovalFinal Approval 21 February 2018Complete reviewLisa Gilmore, ED CSSCHHS Policy CommitteeThis document supersedes the following: Document NumberDocument NameCHHS17/140Prescribing and Administration of IV Amoxicillin-Clavulanic Acid (Amoxiclav Juno?) ................
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