Gentamicin Prescribing Guideline for Neonates: ( ≤ 28 days ).

Publication: 01/02/2011  --
Last review: 05/10/2017  
Next review: 05/10/2020  
Clinical Guideline
CURRENT 
ID: 2327 
Approved By: Improving Antimicrobial Prescribing Group 
Copyright© Leeds Teaching Hospitals NHS Trust 2017  

 

This Clinical Guideline is intended for use by healthcare professionals within Leeds unless otherwise stated.
For healthcare professionals in other trusts, please ensure that you consult relevant local and national guidance.

Gentamicin Prescribing Guideline for Neonates

Key Links

This document provides guidelines for medical staff regarding the situations in which it would be appropriate to consider the use of gentamicin. This document is supplementary to, and should be used in conjunction with, the summary of product characteristics.

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Introduction

Gentamicin is an antimicrobial agent that can cause nephrotoxicity and ototoxcity. This guideline aims to support the safe prescribing of gentamicin to neonatal patients by medical staff within the Leeds Teaching Hospitals NHS Trust. It will also support the safe administration of gentamicin by neonatal nurses, paediatric nurses and midwives in conjunction with the advice issued by the National Patient Safety Agency in 2010. For infants >28 days old please consult with the neonatal pharmacist and refer to the paediatric gentamicin guideline, if necessary.

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Antimicrobial activity

Gentamicin [with benzylpenicillin] is the first line antibiotic given for perinatal sepsis (sepsis in newborns in first week of life). See Sepsis - Antibiotics for Early Onset Sepsis in the Newborn

Gentamicin is an aminoglycoside bactericidal antibiotic active against most staphylococci (including Staphylococcus aureus) and most gram negative organisms. It does not cover anaerobic bacteria. Gentamicin is not absorbed from the gut so must be given intravenously.

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Dose/Routes of administration/therapeutic drug monitoring

Prior to prescribing
Check urine output and ideally check renal function (but do not delay administration if perinatal sepsis). If anuric give a single dose and check levels (see below)

Dose calculation

Age

Dose

Interval

<7 days

5mg/kg

Every 36 hours

≥7 days

5mg/kg

Every 24 hours

Prescribing

  1. On NNU, post-natal wards, transitional care and delivery suites gentamicin is prescribed on emeds along with the “gentamicin pre-administration checklist”. On paediatric wards the Neonatal Gentamicin Prescription Chart should be used. A "refer to" gentamicin chart should be prescribed on emeds.
    • Use the 24 hour clock format.
    • Write indication and review date.
    • Where possible round to nearest whole milligram (e.g. 1.07kg baby = 5.35mg = 5mg)
    • Take extreme care when transcribing 36 hourly intervals as these can cause confusion.

Administration

The drug must be administered within 1 hour of the prescribed time.
Two nurses must check the prescription.
The nurse checking the prescription must wear a red tabard and avoid interruptions
The Gentamicin pre-administration checklist on emeds must be acknowledged on each occasion. It acts as confirmation that the NPSA checklist has been adhered to.

Once the prompt tool has been completed the dose should be administered as a slow bolus infusion over 3-5 minutes

Monitoring therapeutic levels

  • Therapeutic drug level monitoring should normally take place before (trough, or “pre-dose”) the second dose, so that results are available and reviewed before the third dose is administered.
  • If gentamicin is used for empirical therapy and is likely to stop after 36 hrs and there is no evidence of abnormal renal function then do not routinely check a level unless there is any doubt over the stop date.
  • If anuric then check trough level before second dose is due but DO NOT give dose until trough level is known to be < 2mg/L.
  • In an older infant in whom renal function is established and stable, levels can be measured every third dose.
  • Trough or “pre-dose” levels should be taken just before the dose is given and sent to microbiology. Results will not be processed between 10 pm and 9am unless urgently required.
  • • Ensure that the levels are clearly recorded on emeds using the comment function, the time and date and a signature must be recorded.

Interpretation of levels

Trough levels are to measure clearance: Normal <2 mg/L
Peak levels are to check for bactericidal efficacy and are no longer routinely required in neonates since this dose will provide bactericidal effect. If a patient is >28 days old or on long courses of gentamicin then the dose and monitoring regime should be discussed with a neonatal pharmacist.

Pre level

Action required

<2 mg/L

No change

2-3mg/L

Check U&Es and extend dosing interval between doses by 12 hrs.

>3mg/L

Check U&Es, extend dosing interval by 12 hrs  but check trough level before giving next dose

If very abnormal results (e.g. trough <0.3 mg/L or > 4mg/L) then check prescription and renal function and discuss with pharmacist before the next dose is due.

Subsequent monitoring

If renal function is normal and gentamicin levels are satisfactory then further therapeutic drug monitoring need only be checked every third dose.
Pre-dose levels (trough) should be taken just before the next dose is due. Do not delay administration of the gentamicin dose while waiting for pre-dose levels.

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Allergy advice

Contra-indications and cautions
Contraindicated in myasthenia gravis (impairs neuromuscular transmission)
Caution in renal failure or oliguria as clearance is via the kidney and so may accumulate. Ideally do not prescribe with other ototoxic drugs (e.g. furosemide) but this may be unavoidable, in which case, do not administer the doses concurrently.

If mother is known to have gentamicin induced deafness then use an alternative antibiotic as this can be hereditary.

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Pharmacokinetics

Gentamicin is not absorbed from the gut so must be given intravenously. Gentamicin is not lipid soluble and does not distribute into fatty tissue.

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Side effects

Ototoxicy (vestibular and auditory damage). Nephrotoxicity (particularly if high serum levels). Hypomagnesemia (rare), Colitis (rare).

Prophylaxis-indications

see - Guideline for antimicrobial prophylaxis in neonatal surgery

Treatment - indications

see LTHT guidelines

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Prescribing restriction

None

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Provenance

Record: 2327
Objective:
Clinical condition:

Infections requiring treatment with Gentamicin

Target patient group: Neonates
Target professional group(s): Secondary Care Doctors
Pharmacists
Adapted from:

Evidence base

 

  1. BNF for Children December 2015 update. Accessed via www.medicinescomplete.com
  2. NPSA patient safety alert: safer use of intravenous gentamicin for neonates. NPSA/2010/PSA001. 9th Feb 2010.
  3. Chattopadhyay B. Newborns and gentamicin- how much and how often? J Antimicrobial Chemotherapy 2002;49:13-16
  4. Lanao JM, Calvo MV et al. Pharmacokinetic basis for the use of extended interval dosage regimes of gentamicin in neonates. J Antimicrobial Chemotherapy 2004;54:193-198
  5. Lannigan R, Thomson A. Evaluation of 22 Neonatal Gentamicin Dosage Protocols using a Bayesian approach. Paediatric and Perinatal Drug Therapy. 2001;4:91-100

 

Approved By

Improving Antimicrobial Prescribing Group

Document history

LHP version 1.0

Related information

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