LOPROX® Cream is not for ophthalmic use.
Keep out of reach of children.
If a reaction suggesting sensitivity or chemical
irritation should occur with the use of LOPROX® Cream, treatment
should be discontinued and appropriate therapy instituted.
Carcinogenesis, Mutagenesis, Impairment of Fertility
A 104-week dermal carcinogenicity study in mice was
conducted with ciclopirox cream applied at doses up to 1.93% (100 mg/kg/day or
300 mg/m²/day). No increase in drug related neoplasms was noted when
compared to control.
The following in vitro genotoxicity tests have been
conducted with ciclopirox: evaluation of gene mutation in the Ames Salmonella
and E. coli assays (negative); chromosome aberration assays in V79 Chinese
hamster lung fibroblast cells, with and without metabolic activation
(positive); chromosome aberration assays in V79 Chinese hamster lung fibroblast
cells in the presence of supplemental Fe3+, with and without
metabolic activation (negative); gene mutation assays in the HGPRT-test with
V79 Chinese hamster lung fibroblast cells (negative); and a primary DNA damage
assay (i.e., unscheduled DNA synthesis assay in A549 human cells) (negative).
An in vitro cell transformation assay in BALB/c 3T3 cells was negative for cell
transformation. In an in vivo Chinese hamster bone marrow cytogenetic assay,
ciclopirox was negative for chromosome aberrations at a dosage of 5000 mg/kg
A combined oral fertility and embryofetal developmental
study was conducted in rats with ciclopirox olamine. No effect on fertility or
reproductive performance was noted at the highest dose tested of 3.85 mg/kg/day
ciclopirox (approximately 1.2 times the maximum recommended human dose based on
body surface area comparisons).
Teratogenic Effects - Pregnancy Category B
There are no adequate or well-controlled studies in
pregnant women. Therefore, LOPROX Cream should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.
Oral embryofetal developmental studies were conducted in
mice, rats, rabbits and monkeys. Ciclopirox or ciclopirox olamine was orally
administered during the period of organogenesis. No maternal toxicity, embryotoxicity
or teratogenicity were noted at the highest doses of 77, 125, 80 and 38.5
mg/kg/day ciclopirox in mice, rats, rabbits and monkeys, respectively
(approximately 11, 37, 51 and 24 times the maximum recommended human dose based
on body surface area comparisons, respectively).
Dermal embryofetal developmental studies were conducted
in rats and rabbits with ciclopirox olamine dissolved in PEG 400. Ciclopirox
olamine was topically administered during the period of organogenesis. No
maternal toxicity, embryotoxicity or teratogenicity were noted at the highest
doses of 92 mg/kg/day and 77 mg/kg/day ciclopirox in rats and rabbits,
respectively (approximately 27 and 49 times the maximum recommended human dose
based on body surface area comparisons, respectively).
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 LOPROX ® Cream is administered to a nursing woman.
Safety and effectiveness in pediatric patients below the
age of 10 years have not been established.