Neonatal Drug Therapy Manual

Gentamicin

Disclaimer: Official controlled document is the CHEO and Ottawa Hospital online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
Garamycin
Classification: 
Antibiotic (Aminoglycoside)
Original Date: 
March 1993
Revised Date: 
December 2020
Indications: 
  • Treatment of infections due to Gram (-) organisms (e.g E. coli, Klebsiella, Proteus, Enterobacter and Serratia)
Administration: 
  • IV intermittent infusion: over 30 minutes
Dosage: 
Gestational Age and Post-Natal-Age Dose* Therapeutic Drug Levels

 

 

 

Preterm (< 36 weeks GA)

0 - 14 days < 28 weeks GA 3 mg/kg/dose Q24h

Traditional Dosing (Pre and Post levels obtained after 48 hours if renal function remains normal)

 

  • Pre (0 - 30 minutes before dose): 0.5 - 2 mg/L

                                        AND

  • Post (30 minutes after end of a 30 minutes infusion): 5 - 10 mg/L
29 - 36 weeks GA 3.5 mg/kg/dose  Q24h
> 14 days < 28 weeks corrected GA 3 - 3.5 mg/kg/dose Q18h
> 29 weeks corrected GA 3 - 3.5 mg/kg/dose Q12h

 

Gestational Age and Post-Natal Age Dose* Therapeutic Drug Levels

 

 

 

 

 

Term (> 37 weeks GA)

 

 

 

 

0 - 7 days

3 - 3.5 mg/kg/dose Q18h

Traditional Dosing

(Pre and Post levels obtained after 48 hours if renal function remains normal)

 

  • Pre (0 - 30 minutes before dose): 0.5 - 2 mg/L

                                    AND

  • Post (30 minutes after end of a 30 minutes infusion): 5 - 10 mg/L
0 - 7 days (Abnormal Renal Function**, Acute HIE/Asphyxia) 3 mg/kg/dose  x 1 Random Gentamicin level 24 hours after initial dose, if < 2.0 mg/L may repeat dose.  Consult pharmacist for further dosing interval recommendations

 

 

 

> 7 days

5 mg/kg/dose Q24h

Extended Interval Dosing (Preferred with normal renal function)

(Pre level only done prior to 3rd dose)

 

  • Pre (0 - 30 minutes before dose): < 0.3 mg/L
2.5 mg/kg/dose Q8h

Traditional Dosing

Pre and Post levels obtained on Day 3. For dosage adjustment and timing of levels in renal impairment, consult pharmacist

  • * For frequency adjustment due to renal dysfunction, consult clinical pharmacist.

 ** This would include neonates with suspected, possible or confirmed hypoxic ischemic events, fluid imbalance, possible or suspected renal thrombosis, congenital renal anomalies or any other conditions that may be associated with transient or prolonged renal dysfunction.

Side Effects: 
  • Hematologic: anemia, granulocytopenia, thrombocytopenia
  • Local: thrombophlebitis
  • Neuromuscular and skeletal: neuromuscular blockade
  • Otic: vestibular/auditory toxicity
  • Renal: nephrotoxicity, increase risk with concurrent use of nephrotoxic drugs (eg. furosemide, indomethacin)
Parameters to Monitor: 
  • Renal: serum creatinine, urea, urine output
  • Therapeutic drug levels: see tables

** When checking level, administer next dose as scheduled. Do not wait for levels to be reported unless otherwise advised

Reconstitution and Stability: 

CHEO:

  • Gentamicin 40 mg/mL (doses < 10 mg)
    • Take 1 mL (40 mg) and add to 39 mL D5W
    • Final concentration: 1 mg/mL
  • Gentamicin 40 mg/mL (doses > 10 mg)
    • Take 1 mL (40 mg) and add to 7 mL D5W or 0.9% NaCl
    • Final concentration: 5 mg/mL

TOH:

  • Gentamicin 40 mg/mL
  • Take 1 mL (40 mg) and add to 39 mL D5W
  • Final concentration: 1 mg/mL
Compatibility: 

- Solutions Compatible: D5W, D10W, 0.9% NaCl, dextrose-saline combinations

- Y-site Compatible:  dexmedetomidine, famotidine, fentanyl, fluconazole, KCl, heparin (low concentrations of 0.5 to 1 unit/mL that are used to maintain IV line patency), insulin, meropenem, midazolam, morphine, penicillin G, ranitidine, TPN (amino acids- dextrose)

Incompatible: acyclovir, ampicillin, azithromycin, cloxacillin,  furosemide, heparin (concentrations greater than 1 unit/mL), indomethacin, pantoprazole, piperacillin/tazobactam, SMOF

Notes: 

Traditional Dosing:

Intermittent dosing initially based on gestational and post-natal age.  Dose modifications may be required based on pre and post levels obtained after 48 hours.

Extended Interval Dosing:

Initial dosing based on Q24 hours schedule to achieve high peak levels in neonates > 7 days of age with no documented or possible abnormal renal function.  Dosage modifications may be required based on pre-dose level obtained at 72 hours.  This dosing is not to be used for preterm neonates.

References: 

- Taketomo CK, Hodding JH, Kraus DM. Pediatric & Neonatal Dosage Handbook 22nd Editions. Hudson: Lexi-Comp Inc.; 2015

- American Society of Health-System Pharmacists (ASHP). Handbook on Injectable Drugs. 19th Edition. Bethesda: ASHP 2017

- Low YS, Tan SL, Wan A. Extended-Interval Gentamicin Dosing in Achieving Therapeutic Concentrations in Malaysian Neonates. J Pediatr Pharmacol Ther. 2015. Mar-Apr, 20 (2): 119-127

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