PediPak
Generic name: ciclopirox and urea
Dosage form: kit
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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Ciclopirox Topical Solution, 8% (Nail Lacquer)
For use on fingernails and toenails and immediately adjacent skin only
Not for use in eyes
PediPak Description
Ciclopirox Topical Solution, 8% (Nail Lacquer) contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin.
Each gram of Ciclopirox Topical Solution, 8% (Nail Lacquer) contains 80 mg ciclopirox in a solution base consisting of ethyl acetate, NF; isopropyl alcohol, USP; and butyl monoester of poly[methylvinyl ether/maleic acid] in isopropyl alcohol. Ethyl acetate and isopropyl alcohol are solvents that vaporize after application.
Ciclopirox Topical Solution, 8% (Nail Lacquer) is a clear, colorless to slightly yellowish solution.
The chemical name for ciclopirox is 6-cyclohexyl- 1-hydroxy-4-methyl-2(1H)- pyridone, with the molecular formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is:
PediPak - Clinical Pharmacology
Microbiology
Mechanism of ActionThe mechanism of action of ciclopirox has been investigated using various in vitro and in vivo infection models. One in vitro study suggested that ciclopirox acts by chelation of polyvalent cations (Fe+3 or Al+3) resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell. The clinical significance of this observation is not known.
