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
Naftin Gel Warnings, Precautions, Pregnancy, Nursing, Abuse - Naftifine
Naftin Gel Warnings, Precautions, Pregnancy, Nursing, Abuse - Naftifine
WARNINGS
NAFTIN Gel 1% is for topical
use only and not for ophthalmic
use.
PRECAUTIONS
General
NAFTIN Gel 1% is for external
use only. If irritation
or sensitivity develop with the use of NAFTIN Gel 1%, treatment
should be discontinued and appropriate
therapy instituted.
Diagnosis of the disease
should be confirmed either by direct microscopic examination
of a mounting of infected
tissue in a solution
of potassium hydroxide
or by culture on an
appropriate medium.
Information for Patients
The patient should
be told to:
- Avoid the use of occlusive
dressings or wrappings unless otherwise directed by the physician.
- Keep NAFTIN Gel 1% away from the eyes, nose, mouth
and other mucous membranes.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies to evaluate the carcinogenic
potential of NAFTIN
Gel 1% have not been performed. In
vitro and animal studies
have not demonstrated any mutagenic effect
or effect on fertility.
Pregnancy
Teratogenic Effects: Pregnancy Category B: Reproduction
studies have been performed in rats and rabbits (via oral
administration) at doses 150 times or more than the topical
human dose
and have revealed no evidence
of impaired fertility
or harm to the fetus due
to naftifine. 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, caution should be exercised when NAFTIN Gel 1% is administered
to a nursing woman.
Pediatric Use
Safety and effectiveness
in pediatric patients
have not been established.
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