MYCOSTER

USP, 0.77% is for topical use.

Each gram of ciclopirox olamine cream contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible, vanishing cream base consisting of benzyl alcohol (1% as a preservative), cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and stearyl alcohol.

Ciclopirox olamine cream contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine).

The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, 2-aminoethanol salt.

Number is 41621-49-2.

The chemical structure is

Ciclopirox olamine cream has a pH of 7.

Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.

Ciclopirox is a hydroxypyridone antifungal agent that 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.

Pharmacokinetic studies in men with tagged ciclopirox solution in polyethylene glycol 400 showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm on the back followed by occlusion for 6 hours.

The biological half-life was 1.7 hours and excretion occurred via the kidney.

Two days after application only 0.01% of the dose applied could be found in the urine.

Fecal excretion was negligible.

Penetration studies in human cadaverous skin from the back, with ciclopirox olamine cream with tagged ciclopirox showed the presence of 0.8 to 1.6% of the dose in the stratum corneum 1.5 to 6 hours after application.

The levels in the dermis were still to 15 times above the minimum inhibitory concentrations.

Autoradiographic studies with human cadaverous skin showed that ciclopirox penetrates into the hair and through the epidermis and hair follicles into the sebaceous glands and dermis, while a portion of the drug remains in the stratum corneum.

Assay, 21-Day Cumulative Irritancy study, Phototoxicity study, and Photo-Draize study conducted in a total of 142 healthy male subjects showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity, and no photo-contact sensitization due to ciclopirox olamine cream.

In all controlled clinical studies with 514 patients using ciclopirox olamine cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low.

This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox olamine cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.fda.gov/medwatch.

Ciclopirox olamine cream is not for ophthalmic use.

Keep out of reach of children.

Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Gently massage ciclopirox olamine cream into the affected and surrounding skin areas twice daily, in the morning and evening.

Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment.

If a patient shows no clinical improvement after four weeks of treatment with ciclopirox olamine cream the diagnosis should be redetermined.

Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

USP, 0.77% is available as follows: 15 g tube (NDC 45802 - 138 -35) 30 g tube (NDC 45802 - 138 -11) 90 g tube (NDC 45802 - 138 -18).

Store at 20-25ºC (68-77ºF) .

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 ciclopirox olamine cream is administered to a nursing woman.

Safety and effectiveness in pediatric patients below the age of 10 years have not been established.