LOPROX® Gel (ciclopirox gel) is not for ophthalmic, oral, or intravaginal use.
Keep out of reach of children.
If a reaction suggesting sensitivity or chemical irritation should occur with
the use of LOPROX® Gel (ciclopirox gel) , treatment should be discontinued and appropriate
therapy instituted. A transient burning sensation may occur, especially after
application to sensitive areas. Avoid contact with eyes. Efficacy of LOPROX®
Gel in immunosuppressed individuals has not been studied. Seborrheic dermatitis
in association with acne, atopic dermatitis, Parkinsonism, psoriasis and rosacea
has not been studied with LOPROX® Gel (ciclopirox gel) . Efficacy in the treatment of plantar
and vesicular types of tinea pedis has not been established.
Carcinogenesis, Mutagenesis, Impairment of Fertility
A carcinogenicity study of ciclopirox (1% and 5% solutions in polyethylene glycol 400) 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 battery of in vitro genotoxicity tests was conducted with
ciclopirox: evaluation of gene mutation in the Ames Salmonella and E.
coli assays (negative); chromosome aberration assays in V79 Chinese hamster
cells, with and without metabolic activation (positive); gene mutation assays
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 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 5000 mg/kg.
Teratogenic effects: Pregnancy Category B
Reproduction studies of ciclopirox revealed no significant evidence of impaired
fertility in rats exposed orally up to 5 mg/kg body weight (approximately 5
times the maximum recommended topical human dose based on surface area). No
fetotoxicity was shown due to ciclopirox in the mouse, rat, rabbit, and monkey
at oral doses up to 100, 30, 30, and 50 mg/kg body weight, respectively (approximately
37.5, 30, 44, and 77 times the maximum recommended topical human dose based
on surface area). By the dermal route of administration, no fetotoxicity was
shown due to ciclopirox in the rat and rabbit at doses up to 120 and 100 mg/kg
body weight, respectively (approximately 121 and 147 times, respectively, the
maximum recommended topical human dose based on surface area).
There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. LOPROX® Gel (ciclopirox gel) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when LOPROX® Gel (ciclopirox gel) is administered to a nursing woman.
The efficacy and safety of LOPROX® Gel (ciclopirox gel) in pediatric patients below the age of 16 years have not been established.