CHHS18/081

Canberra Hospital and Health ServicesClinical ProcedurePrescribing and Administration of IV Amoxicillin-Clavulanic Acid (Amoxiclav Juno®) in Adults and Children (not Neonates)Contents

Contents....................................................................................................................................1

Purpose.....................................................................................................................................2

Alerts.........................................................................................................................................2

Scope........................................................................................................................................ 2

Section 1 – Prescribing and Dosing...........................................................................................2

Section 2 – Administration........................................................................................................4

Section 3 – Precautions, Contraindications, and Monitoring....................................................5

Implementation........................................................................................................................ 5

Related Policies, Procedures, Guidelines and Legislation.........................................................5

References................................................................................................................................ 6

Search Terms............................................................................................................................ 6

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Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register

CHHS18/081

Purpose

The 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.

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Alerts

IV 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.

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Scope

This document applies to the following CHHS staff, working within their scope of practice: Medical Officers Nurses and Midwives Pharmacists Healthcare students under direct supervision.

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Section 1 – Prescribing and Dosing

Intravenous 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 climate

Hospital acquired pneumonia with risk factors for Staphylococcus aureus Empyema Lung abscess

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In combination with IV gentamicin for empiric broad spectrum coverage, for example inpatient sepsis of unknown origin

Empirical therapy (severe tissue damage or evidence of infection) for open fractures

IV 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 content

CrCl (ml/min) General Ward patient ICU/critical illness/deep seated infection

>50 1.2g every 8 hours

1.2g every 6 hours

In patients with augmented renal clearance in ICU (e.g. estimated CrCL> 130ml/min), consider extending the infusion time for each dose to 3 hours*

30-50 1.2g every 8 hours 1.2g every 8 hours

<30ml/min or HD 1.2g every 12 hours 600mg every 8 hours or 1.2g every 12 hours

CRRT NA Seek specialist advice*Specify infusion duration on the medication order if prescribing an extended infusion

CHILDREN <40kg (excluding neonates)Dose refers to the amoxicillin component only.

Weight General Ward patient ICU/critical illness/deep seated infection

< 4kg 25mg/kg every 12 hours Seek specialist advice

Between 4 and 40kg 25mg/kg (max 1g) every 8 hours

25mg/kg (max 1g) every 6 hours

The 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 infusion

These 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

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An alternative dosing regimen may be required based on specific microbiology or patient considerations (e.g. obesity, directed therapy)o Consult the your pharmacist or the AMS team for further advice if required

A 2.2g formulation is available if higher dosing is recommended by AMS or Infectious Diseases, but is not routinely stocked by the CHHS pharmacy departmento An Individual Patient Use Application to the Drugs and Therapeutics Committee is

required before using this formulation for a specific patient.

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Section 2 – Administration

Reconstitution 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 Celsius

Alert: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.

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Section 3 – Precautions, Contraindications, and Monitoring

Adverse 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 combinations History of cholestatic jaundice or hepatic dysfunction associated with beta-lactam/beta-

lactamase inhibitor combinationso Note: Pre-existing hepatic impairment is not a contraindication

Precautions Sodium restriction, heart failure – each vial contains 2.7 mmoL (62.9 mg) of sodium Avoid rapid IV administration of large doses as this may result in seizures Septic shock – consider consulting Infectious Diseases or AMS on antibiotic choice

Monitoring Renal, 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 stored

For more information, refer to the Australian Medicines Handbook.

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Implementation

Provision of education to Plastics and Vascular teams, Day Surgery and 6B wards Dissemination to Pharmacy, Infectious Diseases, and MOSCETU

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Related Policies, Procedures, Guidelines and Legislation

Policies Medication Handling Policy

Procedures Antimicrobial Stewardship Procedure

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References

1. MIMS Australia Pty Ltd. MIMS [online]. St Leonards (NSW): CMPMedica Australia Pty Ltd; accessed online 3rd July 2017.

2. Australian Medicines Handbook Pty Ltd. Australian Medicines Handbook [online] Adelaide (SA): Australian Medicines Handbook Pty Ltd accessed online 1 Jan 2018.

3. 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.

4. Grayson ML et al. Kucers’ The Use of Antibiotics Sixth Edition: A Clinical Review of Antibacterial, Antifungal and Antiviral Drugs. 2010. p.167-173.

5. Carlier M, et al. Population pharmacokinetics and dosing simulations of amoxicillin/clavulanic acid in critically ill patients. JAC. 2013; 68:2600-2608.

6. 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.

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Search Terms

Augmentin, Amoxiclav, amoxicillin, amoxicillin-clavulanate, amoxicillin-clavulanic acid, antibiotic, AMS, diabetic foot, bite, antimicrobial, antibiotic, drug, clavulanic, clavulanate, DFI, Fist, Clenched, infections

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Disclaimer: 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 Amended Section Amended Divisional Approval Final Approval 21 February 2018 Complete review Lisa Gilmore, ED CSS CHHS Policy Committee

This document supersedes the following: Document Number Document NameCHHS17/140 Prescribing and Administration of IV Amoxicillin-Clavulanic Acid (Amoxiclav Juno®)

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Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register