LOPROX® Lotion (ciclopirox lotion) 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® Lotion (ciclopirox lotion) , treatment should be discontinued and appropriate therapy instituted.
Carcinogenesis, Mutagenesis, Impairment of Fertility
A carcinogenicity study in female mice dosed cutaneously twice per week for
50 weeks followed by a 6-month drug-free observation period prior to necropsy
revealed no evidence of tumors at the application site. The following in
vitro and in vivo genotoxicity tests have been conducted with ciclopirox
olamine: studies to evaluate gene mutation in the Ames Salmonella/Mammalian
Microsome Assay (negative) and Yeast Saccharomyces Cerevisiae Assay (negative)
and studies to evaluate chromosome aberrations in vivo in the Mouse Dominant
Lethal Assay and in the Mouse Micronucleus Assay at 500 mg/kg (negative). The
following battery of in vitro genotoxicity tests were conducted with
ciclopirox: a chromosome aberration assay in V79 Chinese Hamster Cells,
with and without metabolic activation (positive); a gene mutation assay in the
HGPRT - test with V79 Chinese Hamster Cells (negative); and a primary DNA damage
assay (i.e., unscheduled DNA Synthesis Assay in A549 Human Cells (negative)).
An in vitroCell Transformation Assay in BALB/C3T3 Cells was negative
for cell transformation. In an in vivo Chinese Hamster Bone Marrow Cytogenetic
Assay, ciclopirox was negative for chromosome aberrations at 5000 mg/kg.
Pregnancy Category B
Reproduction studies have been performed in the mouse, rat, rabbit, and monkey, via various routes of administration, at doses 10 times or more the topical human dose and have revealed no significant evidence of impaired fertility or harm to the fetus due to ciclopirox. There are, however, no adequate or 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.
It is not known whether this drug is excreted in human milk. Caution should be exercised when LOPROX® Lotion (ciclopirox lotion) is administered to a nursing woman.
Safety and effectiveness in pediatric patients below the age of 10 years have not been established.