Label: CICLOPIROX OLAMINE cream

For Topical Use Only

Not for use in eyes

Rx Only

Ciclopirox Olamine Cream 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(1H)-pyridone, 2-aminoethanol salt.

The CAS Registry Number is 41621-49-2. The chemical structure is:

Ciclopirox olamine cream has a pH of 7.

Mechanism of Action

Ciclopirox is a hydroxypyridone antifungal agent that acts by chelation of polyvalent cations (Fe3+ or Al3+), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell.

Pharmacokinetics

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 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 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 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.

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

Ciclopirox olamine 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 olamine cream, treatment should be discontinued and appropriate therapy instituted.

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.

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.

Ciclopirox Olamine Cream USP, 0.77% is available as follows:

90 g tube (NDC 63629-8626-1)

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

Store at 20-25ºC (68-77ºF) [see USP Controlled Room Temperature].

To report SUSPECTED ADVERSE REACTIONS, contact Padagis® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by Padagis®

Yeruham, Israel

www.padagis.com

Rev 02-23

3D9B9 RC PH1

Ciclopirox Olamine 0.77% Cream, #90