A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Acticin Warnings, Precautions, Pregnancy, Nursing, Abuse - Permethrin
Acticin Warnings, Precautions, Pregnancy, Nursing, Abuse - Permethrin
WARNINGS
If hypersensitivity
to permethrin cream
occurs, discontinue use.
PRECAUTIONS
General
Scabies infestation
is often accompanied by pruritis, edema and erythema. Treatment
with permethrin cream
may temporarily exacerbate these conditions.
Information for Patients
Patients wlth scabies
should be advised that itching, mild burning and
or stinging may occur after application of permethrin
cream. In clinical
trials, approximately 75% of patients treated with permethrin
cream who continued to
manifest pruritis at
2 weeks had cessation by 4 weeks. If irritation
persists, they should consult their physician. Permethrin cream
may be very mildly irritating to the eyes. Patients should be advised
to avoid contact with
eyes during application and to flush
with water immediately
if permethrin cream
gets in the eyes.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Six carcinogenicity bioassays were evaluated with permethrin, three
each in rats and mice. No tumorigenicity was seen in the rat
studies. However, species-specific increases in pulmonary
adenomas, a common benign
tumor of mice of high
spontaneous background incidence, were seen in the three mouse
studies. In one of these studies there was an increased incidence
of pulmonary alveolar-
cell carcinomas and benign
liver adenomas only in
female mice when permethrin
was given in their food
at a concentration
of 5000 ppm. Mutagenicity assays, which give useful correlative
data for interpreting results from carcinogenicity bioassays in
rodents, were negative. Permethrin showed no
evidence of mutagenic
potential in a battery
of in vitro and in vivo genetic
toxicity studies.
Permethrin did not have any adverse effect
on reproductive
function at a dose of 180
mg/ kg/ day orally in a three-generation rat
study.
Pregnancy
Teratogenic Effects: Pregnancy Category B: Reproduction
studies have been performed in mice, rats, and rabbits (200 to 400
mg/ kg/ day orally) and have revealed no
evidence of impaired
fertility or harm
to the fetus due to permethrin.
There are, however, no adequate
and well- controlled studies in pregnant
women. Because animal
reproduction studies are not always predictive of human
response, this drug should
be used during pregnancy
only if clearly needed.
Nursing Mothers
It is not known whether this drug
is excreted in human milk.
Because many drugs are excreted in human
milk and because of the
evidence for tumorigenic
potential of permethrin
in animal studies, consideration
should be given to discontinuing nursing
temporarily or withholding the drug
while the mother is nursing.
Pediatric Use
Permethrin cream is safe
and effective in pediatric patients two months of age
and older. Safety and effectiveness
in pediatric patients less than two months of age
have not been established.
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