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Date: | Sat, 18 Jul 1998 20:07:01 -0400 |
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There was a question about a doctor who wouldn't prescribe Diflucan
for thrush because of the possibility of liver damage. The
suggestion was made to contact Pfizer so I had a look at their web
site. This is what I found.
Pfizer's web site is:
http://www.pfizer.com/main.html
There page on diflucan
http://www.pfizer.com/kpw/well/PI's/diflucanpi.html
has this to say:
"Hepatobiliary: In combined clinical trials and marketing
experience, there
have been rare cases of serious hepatic reactions during
treatment with
DIFLUCAN. (See WARNINGS.) The spectrum of these hepatic
reactions
has ranged from mild transient elevations in
transaminases to clinical
hepatitis, cholestasis and fulminant hepatic failure,
including fatalities.
Instances of fatal hepatic reactions were noted to occur
primarily in patients
with serious underlying medical conditions (predominantly
AIDS or
malignancy) and often while taking multiple concomitant
medications.
Transient hepatic reactions, including hepatitis and
jaundice, have occurred
among patients with no other identifiable risk factors.
In each of these cases,
liver function returned to baseline on discontinuation of
DIFLUCAN."
"Nursing Mothers
Fluconazole is secreted in human milk at concentrations
similar to plasma.
Therefore, the use of DIFLUCAN in nursing mothers is not
recommended."
"Experience with DIFLUCAN in neonates is limited to pharmacokinetic
studies in premature newborns. (See CLINICAL
PHARMACOLOGY.)
Based on the prolonged half-life seen in premature
newborns (gestational
age 26 to 29 weeks), these children, in the first two
weeks of life, should
receive the same dosage (mg/kg) as in older children, but
administered every
72 hours. After the first two weeks, these children
should be dosed once
daily. No information regarding DIFLUCAN pharmacokinetics
in full-term
newborns is available"
--
Janet Vandenberg, RN, BScN,
Newmarket, Ontario, Canada
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