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Subject:
From:
"Kathleen Bruce by way of Kathleen Bruce <[log in to unmask]>" <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Tue, 19 Mar 1996 23:56:03 -0500
Content-Type:
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text/plain (53 lines)
Date:    Wed, 8 Nov 1995 18:18:22 -0600
From:    "Dr. Tom Hale" <[log in to unmask]>
Subject: Re: Diflucan and Yeast

I just spoke with the manufacturer(Roerig) of Diflucan(fluconazole)(and my
Pedi ID colleague)   and received a new Brief Report published in Pediatric
Infectious Diseases concerning the milk levels of fluconazole,  and more
information on the pediatric formulations and the companies FDA approvals
for pediatric use.

Fluconazole passes into human milk with a Milk:Plasma ratio of about 0.85.
Following a single 150 mg dose( in a 29 year old mom at 12 weeks postpartum)
the following levels were reported  in  Pediatric Infectious Disease J.
14(3):235-236, 1995:


Hours           2            5             24               48
-------------------------------------------------------------------------

Milk            2.93       2.66        1.76           0.98  ug/ml

Plasma        6.4         2.79         2.52           1.19  ug/ml

M:P          0.46         0.85          0.85          0.83

Plasma Half-life  =  35 hrs
BM   Half-life    =   30 hrs

>From these concentrations and estimating milk volume you can calculate the
dose received by the infant, which is rather small,  and is probably not
enough to treat the infant.

The manufacturer has two relatively new pediatric formulations  with 10
mg/cc and 40 mg/cc that have been out for several months.  Their FDA
approved indications are from 6 months to 17 years of age.  However,  they
have an FDA  approved Safety Profile from  ONE  day of age to 17 years.
Pediatric doses provided are 6 mg/kg loading dose, followed by 3-6 mg/kg
daily thereafter depending on indication(oraopharyngeal candidiasis or
candidemia and disseminated Candida).

In 577 children aged 1 day to 17 years,  the most common treatment-related
side effects were vomiting (5.4%), abdominal pain (2.8%), nausea (2.3%), and
diarrhea (2.1%)    (Manufacture's info).

Ask your Roerig rep for handouts,  they have several pediatric pamplets.
The most common question asked is how long  to continue therapy.  So I asked
my pediatric infectious disease expert in my department.   He said generally
7-10 days and then go from there.  Basically that means a week may be
optimal,  but your physician may opt for longer, particularly in the more
persistent forms of candida.   Finally,  No,  I don't own Roerig stock !!!

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