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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.
Thanks all,
Tim
R. Timothy Gendron, RPh, BCPS
Pharmacy Department
Naval Medical Center
Portsmouth, Virginia 23708
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Dear Tim:
There are a lot a articles about amikacin Once Daily Dose (ODD); but
in cystic
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
bronchial
diffusion of single daily dose amikacin in cystic fibrosis patients.
J Antimicrob
Chemother. 1997 Mar;39(3):431-3) have published several works with
experiences
(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:
Pharmacokinetics of
once-daily amikacin dosing in patients with cystic fibrosis. J
Antimicrob Chemother.
1998 Jan;41(1):142-4. But levels obtained, in many cases, are not
acceptable. In
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
cystic fibrosis.
Cas Lek Cesk 2004;143(3):187-90, but (again) although they used very
small number
of patients, they concluded that routine "use of ODD amikacin
administration could
not be recommended until the clinical data confirming efficiency of
this dose modality
are available".
Even Cantopoulus-Ioannidis et al published a review about
aminoglycosides ODD,
where they included cystic fibrosis patients. You can read this
article (full text) and
our response too in: http://pediatrics.aappublications.org/cgi/
content/full/114/1/e111
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
intravenous tobramycin
available (not cheap), so on these days we are beginning a controlled
study with
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
inexistant.
We are presenting some of our results in FIP Congress 2007 (Beijing,
China:
www.fip.org). Some of these are: population PK parameters were:
volume of
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
in this
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.
Best regards.
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
E-mail: pcaceres.aaa.garrahan.gov.ar
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