- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
There is wide variation between individuals in the pharmacokinetics of amikacin in neonates. The clearance increases most in the first 2 months of life, reaching a plateau at about 2 years of age, after which it slowly increases until 7 years of age. In contrast, the volume of distribution decreases in the first 2 months, and then remains stable until about 2 years of age, after which the volume of distribution decreases some more until a reading time of 7 years [Treluyer]. The following kinetic parameters were found:
| Premature infants |
1-2 days old (n=18)(Vucivecic 2014) |
3-28 days old (n=13)(Vucivecic 2014) | > 6 months old | |
|---|---|---|---|---|
| Vd | 0.68 l/kg | 0.62 l/kg | ||
| Cl | 65.11 ml/hour/kg | 79.98 ml/hour/kg79.98 ml/hour/kg | ||
| t½ | 7-8 hours | 6.94 hours | 5.64 hours | 1.6-2.9 hours |
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Infection in cystic fibrosis |
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| Short-term treatment of severe infections caused by amikacin-sensitive strains of Gram-negative microorganisms, including Pseudomonas species, particularly if they are resistant to other aminoglycosides. |
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Renal impaiment in children > 3 months
Adjustment in renal impairment as specified:
GFR 50-80 ml/min/1.73 m2
Dose reduction and interval lengthening: Depending on the levels (see warnings and precautions)GFR 30-50 ml/min/1.73 m2
Dose reduction and interval lengthening: Depending on the levels (see warnings and precautions)GFR 10-30 ml/min/1.73 m2
Dose reduction and interval lengthening: Depending on the levels (see warnings and precautions)GFR < 10 ml/min/1.73 m2
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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
Side effects in children
Nephrotoxicity, ototoxicity, neuromuscular blockade and allergic reactions.
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
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
Warnings & precautions in children
Amikacin doses should be adjusted depending on the plasma concentrations. The length of treatment must be as short as possible, preferably no longer than 7 days and not exceeding 10 days. If the treatment lasts any longer, the risk of ototoxicity and nephrotoxicity increases, as it does for continuous high peak and trough concentrations, renal function disorders, previous use of aminoglycosides, premature infants and neonates. In these cases, good hydration (to reduce the risk of kidney damage) and checks of the renal function and hearing are extremely important.
In premature infants and neonates, the kidney function is not yet fully developed, so the half-life of the drug is extended.
Target concentrations (Dutch Association of Hospital Pharmacists – Therapeutic drug monitoring of amikacin)
Peak concentration: 15-30 mg/l
Trough level: < 5 mg/l
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Interactions
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 | ||
|---|---|---|
| J01GB03 | ||
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References
- Hartwig NC, et al, Vademecum pediatrische antimicrobiele therapie, 2005
- Wilhelm, B et al, Toegepaste farmokinetiek: Amikacin TDM, www.nvza.nl
- Allegaert K, et al, Limited predictability of amikacin clearance in extreme premature neonates at birth, Br J Clin Pharmacol, 2005, 61, 39-48
- Botha JH, et al, Determination of population pharmacokinetic parameters for amikacin in neonates using mixed-effect models, Eur J Clin Pharmacol, 1998, 53, 337-41
- Bouffet E, et al, Once daily antibiotic regimen in paediatric oncology, Arch Dis Child, 1994, 70, 484-7
- Forsyth NB, et al, A comparison of two amikacin dosing regimens in paediatric surgical patients, Ann Trop Paediatr, 1997, 17, 253-61
- Guadalupe Vásquez-Mendoza M, et al, Efficacy and renal toxicity of one daily dose of amikacin versus conventional dosage regime, Am J Perinatol, 2007, 24, 141-6
- Kenyon CF, et al, Amikacin pharmacokinetics and suggested dosage modifications for the preterm infant., Antimicrob Agents Chemother, 1990, 34, 265-8
- Krivoy N, et al, Pharmacokinetic analysis of amikacin twice and single daily dosage in immunocompromised pediatric patients, Infection, 1998, 26, 396-8
- Kotze A, et al, Once versus twice daily amikacin in neonates: prospective study on toxicity, J Paediatr Child Health, 1999, 35, 283-6
- Langhendries JP, et al, Adaptation in neonatology of the once-daily concept of aminoglycoside administration: evaluation of a dosing chart for amikacin in an intensive care unit., Biol Neonate., 1998, 74, 351-62
- Langhendries JP, et al, Once-a-day administration of amikacin in neonates: assessment of nephrotoxicity and ototoxicity, Dev Pharmacol Ther, 1993, 20, 220-30
- Marik PE, et al, The pharmacokinetic of amikacin in critically ill adult and paediatric patients: comparison of once- versus twice-daily dosing regimens, J Antimicrob Chemother, 1991, 27, 81-9
- Padovani EM, et al, Pharmacokinetics of amikacin in neonates, Dev Pharmacol Ther, 1993, 20, 167-73
- Sherwin CM, et al, Individualised dosing of amikacin in neonates: a pharmacokinetic/pharmacodynamic analysis., Eur J Clin Pharmacol, 2009, 65, 705-13
- Tréluyer JM, et al, Nonparametric population pharmacokinetic analysis of amikacin in neonates, infants, and children, Antimicrob Agents Chemother, 2002, 46, 1381-7
- Vogelstein B, et al, The pharmacokinetics of amikacin in children., J Pediatr., 1977, 91 (2), 333-9
- Pacifici GM. , Clinical pharmacokinetics of aminoglycosides in the neonate: a review. , Eur J Clin Pharmacol., 2009, Apr:65(4), 419-27
- Smits A et al., Prospective Evaluation of a Model-Based Dosing Regimen for Amikacin in Preterm and Term Neonates in Clinical Practice. , Antimicrob Agents Chemother. , 2015, Oct;59(10), 6344-6351
- Sturkenboom MGG et al, Therapeutic drug monitoring: amikacine, www.tdm-monografie.org, 16-10-2014
- Vucicevic K et al. , Pharmacokinetic variability of amikacin after once-daily and twice-daily dosing regimen in full-term neonates. , J Pharmacol Sci., 2014, 124(2), 138-43
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Changes
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