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We are interested in using "high dose" amikacin administered once-daily
in a cystic fibrosis patient. There is limited literature supporting
doses of 30-35mg/kg q24h. Does anyone out there routinely use such a
regimen, and if so what are your target level parameters? We are most
interested in target AUCs.
R. Timothy Gendron, RPh, BCPS
Naval Medical Center
Portsmouth, Virginia 23708
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There are a lot a articles about amikacin Once Daily Dose (ODD); but
fibrosis patients, ODD is not well proven.
Sanford Guide (Gilbert et al) accepts amikacin serum levels until 64
mcg/ml. I do not
know if those numbers are well studied. I really think they are not...
Some groups (mainly in France: Canis et al. Pharmacokinetics and
diffusion of single daily dose amikacin in cystic fibrosis patients.
Chemother. 1997 Mar;39(3):431-3) have published several works with
(1995-1998) but nobody have reproduced those results, until today (no
that I know).
Beringer et al (in 1998) published a review about that subject:
once-daily amikacin dosing in patients with cystic fibrosis. J
1998 Jan;41(1):142-4. But levels obtained, in many cases, are not
several patients you can obtain more than 100 or 120 mcg/ml.
Halacova et al published in 2004 a very interesting assay: Evaluation
of three dosage
regimens of amikacin using pharmacokinetic models in patients with
Cas Lek Cesk 2004;143(3):187-90, but (again) although they used very
of patients, they concluded that routine "use of ODD amikacin
not be recommended until the clinical data confirming efficiency of
this dose modality
Even Cantopoulus-Ioannidis et al published a review about
where they included cystic fibrosis patients. You can read this
article (full text) and
our response too in: http://pediatrics.aappublications.org/cgi/
ODD is more frequent with tobramycin, bur not with amikacin. Could
you use it? Why
you want to use amikacin and not tobramycin?
In Argentina (and in Latin America in general) we have not
available (not cheap), so on these days we are beginning a controlled
several dosifications schemes (once of them is ODD: 30 mg/kg/day).
Pediatric patients are very usual in this pathology. Studies in
population are almost
We are presenting some of our results in FIP Congress 2007 (Beijing,
www.fip.org). Some of these are: population PK parameters were:
distribution = 0.341 (0.230 - 0.800) L/kg ; elimination half-life =
1.62 (0.84 - 2.89)
hours. (n pediatric patients: 26 - n levels: 65)
Sadly some centers use high dosages (30-35 mg/kg/day ODD) of amikacin
types of patients, but there no information (not enough) to do it
without being SURE
(adverse effects). I think that you will only find "clinical"
evidence without serious
(controlled) clinical trials.
I hope that help you.
Paulo A. Caceres Guido.
Unidad de Farmacocinetica Clinica
Hospital de Pediatria Prof. Dr. Juan P. Garrahan
Combate de los Pozos 1881 - Planta Baja, Laboratorio.
Ciudad Autonoma de Buenos Aires - Argentina - CP: C1245AAM
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