Half life however is shorter and clearance higher in children than in adults [SmPC].
The t½, Cl and Vd in neonates vary widely. The t½ varies between 4.9 and 14.6 hours, the Cl varies between 0.53 and 1.72 ml/kg/min and the Vd varies between 0.45 and 0.75 l/kg [Pacifici et al. 2009].
In children from 0-20 months and ≥ 5 kg, a Vd of 0.39 l/kg and a Cmax of 17.6 mg/l were observed [Zakova et al. 2009].
Vd in adolescents is 0,25 l/kg [SmPC].
The following kinetic parameters have been observed [Avent et al. 2002]:
| < 1200 g | 1200-2000 g | > 2000 g | |
|---|---|---|---|
| t½ | 10.3 hours | 6 hours | 5.9 hours |
| Vd | 0.66 l/kg | 0.58 l/kg | 0.57 l/kg |
| Cmax | 8 mg/l | 8.6 mg/l | 8.9 mg/l |
The clearance of gentamicin is reduced in neonates who suffer hypothermia in hypoxic ischemic encephalopathy (HIE) [Frymoyer et al., Mark et al., Ting et al.]
In neonates during ECMO Vd can be increased to 0,5 - 0,75 l/kg and t1/2 prolonged to 7,6 - 10 h [Buck 2003, Moffett 2018].
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| Severe infection, Gram-negative microorganisms |
|---|
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| Infection in hypoxic ischemic encephalopathy (HIE), treated with hypothermia |
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| Plague |
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| Tularemia |
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Adjustment in renal impairment as specified:
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Ototoxicity and nephrotoxicity
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Check the renal, hearing and balance functions regularly during the treatment, particularly in the elderly, in young children, neonates and premature infants (determine the creatinine twice a week). In cases of impaired renal function, the possibility of accumulation cannot be excluded, so plasma concentration measurements are indicated.
Target levels in neonates and children [Dutch Association of Hospital Pharmacists – Therapeutic drug monitoring of gentamicin]:
Neonates:
Peak level: 8-12 mg/l (in infections with microorganisms for which the MIC is < 1 mg/l)
Trough level: < 0.5-1 mg/l
Children aged > 1 month
Peak level: 15-20 mg/l
Trough level: < 0.5-1 mg/l
Use caution in pediatric patients on ECMO-therapy: the pharmacokinetics of aminoglykosides might change [Buck 2003, Moffett 2018].
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The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Other aminoglycosides | ||
|---|---|---|
| J01GB06 | ||
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