CICLOPIROX CREAM 0.77%
(Ciclopirox Olamine Cream USP)

Rx only

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC USE

Ciclopirox Cream 0.77% is for topical use.

Each gram of Ciclopirox cream 0.77% contains 7.70 mg of Ciclopirox

(as Ciclopirox Olamine) in a water miscible vanishing cream base consisting of purified water USP, cetyl alcohol NF, mineral oil USP, octyldodecanol NF, stearyl alcohol NF, cocamide DEA, polysorbate 60 NF, myristyl alcohol, sorbitan monostearate NF, lactic acid USP, and benzyl alcohol NF (1%) as preservative.

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

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

The CAS Registry Number is 41621-49-2.

The chemical structure is:

Ciclopirox Cream has a pH of 7.

Ciclopirox is a broad-spectrum, antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and Malassezia furfur. Ciclopirox exhibits fungicidal activity in vitro against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, and Candida albicans.

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 cm² 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 cream 0.77% 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 10 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.

Draize Human Sensitization Assay, 21-Day Cumulative Irritancy study, Phototoxicity study, and Phot-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 Cream 0.77%.

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

Ciclopirox Cream 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 Ciclopirox Cream, treatment should be discontinued and appropriate therapy instituted.

The patient should be told to:

• Use the medication for the full treatment time even though symptoms may have improved and notify the physician if there is no improvement after four weeks.
• Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, bulering, swelling, or oozing) indicative of possible sensitization.
• Avoid the use of occlusive wrappings or dressings.

In all controlled clinical studies with 514 patients using Ciclopirox 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 cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.

Gently massage Ciclopirox Cream 0.77% 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 Cream the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

Ciclopirox Cream 0.77% (Ciclopirox Olamine Cream USP) is supplied in:

NDC 0168-0313-15  15 gram tube

NDC 0168-0313-30  30 gram tube

NDC 0168-0313-90  90 gram tube

Store at 20°-25°C (68°-77°F). [see USP Controlled Room Temperature]

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747

I2313

R1/03

#99