Vancomycin Prescribing Guideline for Infants on the Neonatal Unit

Publication: 25/11/2011  
Last review: 20/09/2018  
Next review: 29/09/2021  
Clinical Guideline
CURRENT 
ID: 2764 
Approved By: Improving Antimicrobial Prescribing Group 
Copyright© Leeds Teaching Hospitals NHS Trust 2018  

 

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.

Vancomycin Prescribing Guideline for Infants on the Neonatal Unit

Introduction

This document provides guidelines for healthcare professionals involved in neonatal care regarding the situations in which it would be appropriate to consider the use of Vancomycin Description: electronic Medicines Compendium information on Vancomycin. This document is supplementary to, and should be used in conjunction with, the summary of product characteristics.
The use of Vancomycin Description: electronic Medicines Compendium information on Vancomycin can be considered within its currently approved LTHT Drugs and Therapeutics Committee [DTC] applications and as indicated in LTHT neonatal guidelines.

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Antimicrobial activity

Vancomycin Description: electronic Medicines Compendium information on Vancomycin is a glycopeptide bactericidal antibiotic active against aerobic and anaerobic Gram positive organisms including multi-resistant staphylococci. There are however reports of glycopeptide-resistant enterococci and reduced susceptibility of some staphylococcal species.

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Contraindications and allergies (patient conditions and concomitant medicines)

Contraindicated in confirmed cases of previous hypersensitivity reaction. (BNFc) [Evidence level C]

Avoid rapid infusion (<1 hour) as risk of anaphylactoid reaction. (BNFc) [Evidence level C]

Caution in renal failure or oliguria as Vancomycin Description: electronic Medicines Compendium information on Vancomycin is cleared via the kidney and so may accumulate. (BNFc) [Evidence level C]

Caution when simultaneous administration of nephrotoxic drugs such as aminoglycosides. (Linder et al., 1993). [Evidence level B]

Possible increased risk of ototoxicity when given with gentamicin or loop diuretics such as furosemide. (Neonatal formulary 6) [Evidence level C]

Vancomycin Description: electronic Medicines Compendium information on Vancomycin enhances the effect of suxamethonium. (BNFc) [Evidence level C]]

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Prophylaxis-indications

Prophylactic use is not routinely indicated in the neonatal population.

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Treatment - indications

Vancomycin Description: electronic Medicines Compendium information on Vancomycin [with ceftazidime] is the second line antibiotic given for suspected perinatal sepsis and for the treatment of infections caused by Gram positive cocci.
See Neonatal Sepsis Guideline

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Dose/Routes of administration

Dose

Corrected gestation*

Age

Dose

<29/40

<10 days

20mg/kg - 18 hourly

<29/40

≥10 days

15mg/kg - 12 hourly

≥29/40

<10 days

15mg/kg - 12 hourly

≥29/40

≥10 days

15mg/kg - 8 hourly

*gestation is corrected gestation, ie. the baby’s gestation at the start of the Vancomycin Description: electronic Medicines Compendium information on Vancomycin course
The following should also be considered when calculating the dose

  • Renal function
    • If baby is anuric / oliguric (<0.5mL/kg/hr) or creatinine >100micromol/L then increase the initial dose interval by 4-6 hours. [Evidence level D]
      e.g. if recommended dose is 15mg/kg, 12hourly and renal impairment present then start at 15mg/kg, 18hourly
    • If there is concern over renal function then closer monitoring of levels is required (see therapeutic drug monitoring section below)
  • Recent course
    • If the baby has recently completed a course of Vancomycin Description: electronic Medicines Compendium information on Vancomycin and levels were satisfactory, then it is usually sensible to restart on the previous regime (dose and interval).

Note: The dose calculation used in Leeds is not the same as found in the BNFc. See appendix for details.

Prescribing
The Neonatal Vancomycin Description: electronic Medicines Compendium information on Vancomycin prescription chart should be used. This should be used in addition to the drug chart on eMeds (and be cross-referenced on here).

Use the 24 hour clock format, although avoid midday and midnight dose timings as they can cause confusion. An indication and review date is mandatory.
Always round the dose to the nearest whole milligram.

Administration
Avoid rapid infusion (give over at least 1 hour) as there is an increased risk of hypotension and cardiovascular collapse. [Evidence level C]

The drug must be administered within 1 hour of the prescribed time. If this is not possible the reason for non-compliance must be recorded and discussed with a doctor or ward pharmacist. [Evidence level D]

Two nurses must check the prescription. Nurses checking the prescription must wear a red tabard and avoid interruptions. [Evidence level D]

In cases of suspected central line infection, and where line removal is not possible, Vancomycin Description: electronic Medicines Compendium information on Vancomycin should be given via the potentially infected line. [Evidence level D]

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Pharmacokinetics

Vancomycin Description: electronic Medicines Compendium information on Vancomycin is predominantly (80-90%) cleared by the kidney although there is a variable non-renal component (Dawson, 2002).

Pharmacokinetic data on Vancomycin in the neonatal population is limited. It is known that while there are large inter-individual variations in volume of distribution and clearance rates; the baby’s weight, renal function and post maturational age are major factors in clearance variability (Neonatal formulary 6).

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Side effects

Vancomycin has been associated with nephrotoxicity however the risk to the neonatal population appears to be small (Linder et al., 1993).

High Vancomycin Description: electronic Medicines Compendium information on Vancomycin levels may reflect pre-existing renal impairment and any effect on the kidney is likely to be reversible (Neonatal formulary 6)

Ototoxicity secondary to Vancomycin Description: electronic Medicines Compendium information on Vancomycin is unconfirmed and there is no clear relationship between recorded levels or duration of treatment. (DeHoog et al, 2003)

Thrombocytopenia is a recognised side effect of Vancomycin Description: electronic Medicines Compendium information on Vancomycin in neonates (as well as adults) and platelet count should be monitored during treatment (Linder et al., 1993).

Red man syndrome with hypotension, flushing of the upper body, wheezing and pruritus can occur due histamine release caused by too rapid infusion (Neonatal Formulary 6).

Phlebitis is usually not a problem if a concentration of 5mg/mL is not exceeded peripherally.

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Therapeutic drug monitoring (TDM)

Monitoring therapeutic levels

  • Therapeutic drug level monitoring should normally take place prior to the 3rd dose, the dose can then be administered and the level chased so it is available prior to the 4th dose.
  • However if there is evidence of renal impairment then closer monitoring is required
    • Oliguria (<0.5mL/kg/hr) or creatinine >100micromol/L
      • Check level prior to 3rd dose but wait for level to come back before administering dose [Evidence level D]
    • Anuria or creatinine >200micromol/L
      • Check level prior to every dose and wait for levels to come back before administering dose. [Evidence level D]

The lab are usually unable to perform levels after 10pm. Levels can be sent early if necessary and although the results need to be interpreted with caution they will provide some information on how quickly the baby is able to clear Vancomycin Description: electronic Medicines Compendium information on Vancomycin

Ensure that the levels are recorded on the prescription chart with time, date and signature.

Interpretation of levels
Trough levels: Normal 9-17 mg/L. Levels up to 20mg/L should be used for MRSA infections or those caused by less susceptible bacteria if advised by microbiology.

Pre dose level

Action required

>50mg/mL

As per >25mg/mL but also refer to audiology for assessment
*for levels between 25-50mg/mL, use clinical judgement as to whether an audiology referral is required

> 25 mg/L

Withhold next dose until trough level back in range (recheck level within 24 hours) and extend dosing interval as below.

18 – 24 mg/L

Extend interval between doses by 4-6 hours (use dosing intervals of 6, 8, 12, 18 and 24 hourly only).
No dose change.

9 - 17 mg/L

No change

5 – 8 mg/L

Decrease interval by 4-6 hours (to a maximum frequency of 6 hourly)

<5mg/L

Decrease interval by 4-6 hours (to a maximum frequency of 6 hourly) and Increase the dose by 20%

If very abnormal results then check prescription (against weight, age and corrected gestation) and renal function and discuss with pharmacist before the next dose is due. [Evidence level D]

Subsequent monitoring
If renal function is normal and drug levels are stable then they need only be checked every 3 - 6 doses. If oliguric/anuric, renal impairment or levels are unstable then check trough levels more frequently (see above for details). [Evidence level D]

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Prescribing restriction

Use as directed by a senior member of the Neonatal team

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Appendix

Dose calculations
The dosing recommendations in this guideline are different to that found in the BNFc. This reflects the fact there has been a change in target trough level for Vancomycin Description: electronic Medicines Compendium information on Vancomycin without any corresponding change in the BNFc dosing schedule. In addition, Vancomycin clearance is known to be dependent on postnatal age as well as weight and corrected gestation (Neonatal formulary 6, Machado et al 2007) and this is not accounted for in the BNFc. Correcting for all these factors was found to lead to lower rates of sub-therapeutic levels in our local population (see ref 7. Vancomycin Description: electronic Medicines Compendium information on Vancomycin in neonates – as an attachment) and as such we have decided to adopt a modified version of the NeoFax protocol (used widely in the US and cited in the Neonatal Formulary 6).

Provenance

Record: 2764
Objective:
Clinical condition:

Infections requiring vancomycin treatment

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

Evidence base

Evidence base

  1. BNF for Children 2010. BMJ group, RPS publishing.
  2. Dawson, P.M (2002). Vancomycin and Gentamicin in neonates: hindsight, current controversies, and forethought. J Perinat Neonatal Nurs 2002;16: 54-72.
  3. DeHoog M, van Zanten BA, Hop WC et al. Newborn hearing screening:tobramycin and vancomycin are not risk factors for hearing loss. J Pediatr 2003;12:30-5.
  4. Linder N, Edwards R, MeClead R, et al. Safety of vancomycin with or without gentamicin in neonates. Neonatal Netw 1993;12: 27-30.
  5. Machado JKK, Feferbaum R, Kobayashi CE et al. Vancomycin pharmacokinetics in preterm infants. Clinics 2007;62(4):405-10
  6. Neonatal Formulary 6; drug use in pregnancy and the first year of life 2011. Ed by Hey, E. Wiley and Sons.
  7. NeoFax 2011. Young TE. PDR network. 
  8. Wallis S, Williamson K. Vancomycin in Neonates – time to review current dosing recommendations? (2011). Poster presentation at Perinatal Medicine 2011, Harrogate. See attachment

Approved By

Improving Antimicrobial Prescribing Group

Document history

LHP version 1.0

Related information

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