Tasmanian Health Organisation - North

LAUNCESTON GENERAL HOSPITAL / WOMENS AND CHILDRENS SERVICES SDMS Id No.: P2010/0396-001 WACS Procedure No.: 4.22/12

Newborn Gentamicin Administration Procedure

Application: Summary: Approved by: Effective Date: Custodian and Review Responsibility: Review Date: Version: Replaces: Key Words: Medical and Nursing staff working with newborns at the LGH Procedure for the safe intravenous administration of Gentamicin to newborns Co-Directors Womens and Childrens Services 17 December 2012 Quality and Clinical Improvement Nurse 4K/4N

17 December 2015 1 Newborn Gentamicin Administration WACSClinProc4.22/08 Gentamicin, newborn

Background
This protocol has been developed to ensure the safe administration and prescribing of intravenous gentamicin to newborns.

Procedure
Indications for Use
o o Empirical therapy for those infants with risk factors for perinatal sepsis in the first week of life. Proven neonatal sepsis with bacteria known to be sensitive Early onset sepsis (< 48hrs) in combination with penicillin Late onset sepsis (> 48hrs) in combination with Flucloxacillin

Duration of antibiotic treatment depends upon the clinical condition of the infant and the organism identified on culture: Where the likelihood of infection is low, with a baby in good condition and infective indices are negative, antibiotics can be ceased if cultures are negative after 48hrs. If sepsis is strongly suspected despite negative blood culture at 48 hours, it is advisable to continue antibiotics for at least 5 days providing infective indices

Note: PLEASE DESTROY PRINTED COPIES. The electronic version of this Procedure is the approved and current version and is located on the departments intranet. Any printed version is uncontrolled and therefore not current.

have normalised. Another approach is to continue antibiotics for 48 hours after indices have normalised. Proven sepsis: 10 to 14 days+ depending on culture and sensitivities.

Administration
All patients should have a baseline creatinine and urea checked this can be done at the time of IV insertion and need not delay administration of the first dose. The creatinine level will be repeated after 24hrs if the initial test was done within 6hrs of birth. Administration is by IM injection or IV infusion. For details of administration please refer to the Royal Childrens Hospital Paediatric Injectable Guidelines Edition 4 and follow recommendations.

Dosage
> 30 weeks 30 to 37 weeks 37 weeks (term) and to 1 week of age Over 1 week of age (term infants) to 10yrs Precautions Caution in neonates with renal dysfunction Caution in concurrent therapy with cephalosporins, diuretics and neuromuscular blocking agents Concurrent administration with other ototoxic and/or nephrotoxic drugs 2.5mg/ kg 3.5mg/ kg 5mg/kg 7.5mg/ kg

Possible Adverse Reactions

Venous irritation, soft tissue injury at intravenous site Pain, tissue injury at intramuscular injection site Gastrointestinal disturbances nausea, vomiting, diarrhoea Nephrotoxicity Ototoxicity (irreversible vestibular injury) Neurotoxicity (lethargy, muscle twitching) Blood dyscrasias rare Hypersensitivity rash, urticaria, fever, laryngeal oedema

Monitoring Therapeutic Range Trough levels immediately prior to next dose < 1mg/L.
Note: PLEASE DESTROY PRINTED COPIES. The electronic version of this Procedure is the approved and current version and is located on the departments intranet. Any printed version is uncontrolled and therefore not current.

Nursing staff are to monitor for poor feeding and low urine output. Newborns with Normal Renal Function 1 to 3 doses: No monitoring necessary >3 doses: Trough level prior to fourth dose and then every 3 to 5 days If trough level is >1mg/L increase dosing interval to 36 hourly with gentamicin level checked prior to administration. Newborns with Known or Suspected Abnormal Renal Function Adjust dose and/or dose interval with suspected or proven renal impairment or reduced renal clearance eg: due to sepsis or extreme immaturity. Where there are significant risk factors for reduced renal clearance administration of further doses of gentamicin must await the result of drug levels. Minor degrees of renal impairment require closer drug level monitoring. In this situation a trough level should be taken prior to the third dose and then every 2 to 3 days. It may be necessary to give the dose less frequently (eg. 36 to 48 hourly) or to give a lower daily dose. Once stable levels have been established, subsequent monitoring may be achieved by following trough levels and serum creatinine every 2 to 3 days (and peak levels as required).

Responsibilities/Delegations
Medical and Nursing staff working with neonates at the Launceston General Hospital.

Related Documents/Legislation
1 2 3 4 5 6 Australian Injectable Drug Handbook Online: http://www.use.hcn.com.au/profiles/resource00005/index.php Royal Prince Alfred Hospital Newborn Care Drug Database Online: http://www.cs.nsw.gov.au/rpa/neonatal/default.htm Royal Womens Hospital Neonatal Handbook, Sepsis Online: http://www.rch.org.au/nets/handbook/index.cfm?doc_id=898 The Royal Childrens Hospital, 2011, Paediatric Injectable Guidelines 4 th Ed. The Royal Childrens Hospital Melbourne Clinical Practice Guidelines 2005, Drug Doses Online: http://www.rch.org.au/clinicalguide/forms/drugDoses.cfm Therapeutic Guidelines Online: http://proxy9.use.hcn.com.au/

Note: PLEASE DESTROY PRINTED COPIES. The electronic version of this Procedure is the approved and current version and is located on the departments intranet. Any printed version is uncontrolled and therefore not current.

Prepared by Through Through Cleared by Cleared by

Malcolm Gulliver Chris Coker Judy Frith Sue McBeath Dr Amanda Dennis

Quality and Clinical Improvement Nurse 4K/4N Nurse Unit Manager 4N Clinical Nurse Educator 4N Co-Director Womens and Childrens Services Co-Director Womens and Childrens Services

6348 7374 6348 8944 6348 8944 6348 8972 6348 8972

19 November 2012 19 November 2012 19 November 2012 19 November 2012 3 December 2012

AUTHORISED BY CO-DIRECTOR WACS (Nursing) ... Sue McBeath 17 December 2012 Date

AUTHORISED BY CO-DIRECTOR WACS (Medical) ... Dr Amanda Dennis 12 December 2012 Date

Note: PLEASE DESTROY PRINTED COPIES. The electronic version of this Procedure is the approved and current version and is located on the departments intranet. Any printed version is uncontrolled and therefore not current.