Ciclopirox Topical Solution, 8%, (Nail Lacquer), is not
for ophthalmic, oral, or intravaginal use. For use on nails and immediately
adjacent skin only.
If a reaction suggesting sensitivity or chemical
irritation should occur with the use of Ciclopirox Topical Solution, 8%, (Nail
Lacquer), treatment should be discontinued and appropriate therapy instituted.
So far there is no relevant clinical experience with
patients with insulin dependent diabetes or who have diabetic neuropathy. The
risk of removal of the unattached, infected nail, by the health care professional
and trimming by the patient should be carefully considered before prescribing
to patients with a history of insulin dependent diabetes mellitus or diabetic
Information For Patients
Patients should have detailed instructions regarding
the use of Ciclopirox Topical Solution, 8%, (Nail Lacquer), as a component of a
comprehensive management program for onychomycosis in order to achieve maximum
benefit with the use of this product.
The patient should be told to:
- Use Ciclopirox Topical Solution, 8%, (Nail Lacquer), as
directed by a health care professional. Avoid contact with the eyes and mucous
membranes. Contact with skin other than skin immediately surrounding the
treated nail(s) should be avoided. Ciclopirox Topical Solution, 8%, (Nail
Lacquer), is for external use only.
- Ciclopirox Topical Solution, 8%, (Nail Lacquer), should
be applied evenly over the entire nail plate and 5 mm of surrounding skin. If
possible, Ciclopirox Topical Solution, 8%, (Nail Lacquer), should be applied to
the nail bed, hyponychium, and the under surface of the nail plate when it is
free of the nail bed (e.g., onycholysis). Contact with the surrounding skin may
produce mild, transient irritation (redness).
- Removal of the unattached, infected nail, as frequently
as monthly, by a health care professional is needed with use of this medication.
Inform a health care professional if they have diabetes or problems with
numbness in your toes or fingers for consideration of the appropriate nail
- Inform a health care professional if the area of
application shows signs of increased irritation (redness, itching, burning, blistering,
- Up to 48 weeks of daily applications with Ciclopirox
Topical Solution, 8%, (Nail Lacquer), and professional removal of the unattached,
infected nail, as frequently as monthly, are considered the full treatment
needed to achieve a clear or almost clear nail (defined as 10% or less residual
- Six months of therapy with professional removal of the unattached,
infected nail may be required before initial improvement of symptoms is
- A completely clear nail may not be achieved with use of
this medication. In clinical studies less than 12% of patients were able to
achieve either a completely clear or almost clear toenail.
- Do not use the medication for any disorder other than
that for which it is prescribed.
- Do not use nail polish or other nail cosmetic products on
the treated nails.
- Avoid use near heat or open flame, because product is
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No carcinogenicity study was conducted with Ciclopirox
Topical Solution, 8%, (Nail Lacquer), formulation. A carcinogenicity study of ciclopirox
(1% and 5% solutions in polyethylene glycol 400) in female mice dosed topically
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 sites.
In human systemic tolerability studies following daily
application (~340 mg of Ciclopirox Topical Solution, 8%, (Nail Lacquer)) in
subjects with distal subungual onychomycosis, the average maximal serum level
of ciclopirox was 31±28 ng/mL after two months of once daily applications. This
level was 159 times lower than the lowest toxic dose and 115 times lower than
the highest nontoxic dose in rats and dogs fed 7.7 and 23.1 mg ciclopirox (as
The following in vitro genotoxicity tests have been
conducted with ciclopirox: evaluation of gene mutation in Ames Salmonella
and E. coli assays (negative); chromosome aberration assays in V79 Chinese
hamster lung fibroblasts, with and without metabolic activation (positive);
gene mutation assay in the HGPRT-test with V79 Chinese hamster lung fibroblasts
(negative); unscheduled DNA synthesis in human A549 cells (negative); and
BALB/c3T3 cell transformation assay (negative). In an in vivo Chinese hamster
bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations
at 5,000 mg/kg.
The following in vitro genotoxicity tests were conducted
with Ciclopirox Topical Solution, 8%, (Nail Lacquer): Ames Salmonella test
(negative); unscheduled DNA synthesis in the rat hepatocytes (negative); cell
transformation assay in BALB/c3T3 cell assay (positive). The positive response
of the lacquer formulation in the BALB/c3T3 test was attributed to its butyl
monoester of poly [methylvinyl ether/maleic acid] resin component (Gantrez® ES-435),
which also tested positive in this test. The cell transformation assay may have
been confounded because of the film-forming nature of the resin. Gantrez® ES-435
tested nonmutagenic in both the in vitro mouse lymphoma forward mutation assay
with or without activation and unscheduled DNA synthesis assay in rat
Oral reproduction studies in rats at doses up to 3.85 mg
ciclopirox (as ciclopirox olamine)/kg/day [equivalent to approximately 1.4
times the potential exposure at the maximum recommended human topical dose
(MRHTD)] did not reveal any specific effects on fertility or other reproductive
parameters. MRHTD (mg/m²) is based on the assumption of 100% systemic
absorption of 27.12 mg ciclopirox (~340 mg Ciclopirox Topical Solution, 8%,
(Nail Lacquer)) that will cover all the fingernails and toenails including 5 mm
proximal and lateral fold area plus onycholysis to a maximal extent of 50%.
Pregnancy Category B
Teratology studies in mice, rats, rabbits, and monkeys at
oral doses of up to 77, 23, 23, or 38.5 mg, respectively, of ciclopirox as
ciclopirox olamine/kg/day (14, 8, 17, and 28 times MRHTD), or in rats and rabbits
receiving topical doses of up to 92.4 and 77 mg/kg/day, respectively (33 and 55
times MRHTD), did not indicate any significant fetal malformations.
There are no adequate or well-controlled studies of
topically applied ciclopirox in pregnant women. Ciclopirox Topical Solution,
8%, (Nail Lacquer), 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
Ciclopirox Topical Solution, 8%, (Nail Lacquer), is administered to a nursing
Based on the safety profile in adults, Ciclopirox Topical
Solution, 8%, (Nail Lacquer), is considered safe for use in children twelve
years and older. No clinical trials have been conducted in the pediatric
Clinical studies of Ciclopirox Topical Solution, 8%,
(Nail Lacquer), did not include sufficient numbers of subjects aged 65 and over
to determine whether they respond differently from younger subjects. Other
reported clinical experience has not identified differences in responses
between elderly and younger patients.