CICLOPIROX- ciclopirox_suspension

Ciclopirox is a broad-spectrum, antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and Malassezia furfur in vitro Trichophyton rubrum Trichophyton mentagrophytes Epidermophyton floccosum Microsporum canis Candida albicans Pharmacokinetic studies in men with radiolabeled ciclopirox solution in polyethylene glycol 400 showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm 2 In vitro

Ciclopirox Topical Suspension USP 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 Microsporum canis Candida albicans Malassezia furfur

Gently massage Ciclopirox Topical Suspension USP, 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 Topical Suspension USP, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

In the controlled clinical trial with 89 patients using ciclopirox topical suspension and 89 patients using the vehicle, the incidence of adverse reactions were low. Those considered possibly related to treatment or occurring in more than one patient were pruritus, which occurred in two patients using ciclopirox topical suspension and one patient using the suspension vehicle, and burning, which occurred in one patient using ciclopirox topical suspension.

Ciclopirox Topical Suspension USP is contraindicated in individuals who have shown hypersensitivity to any of its components.

Pregnancy Category B
Reproduction studies have been performed in the mouse, rat, rabbit, and monkey, via various routes of administration, at doses 10 times or more the topical human dose and have revealed no significant evidence of impaired fertility or harm to the fetus due to ciclopirox. There are, however, no adequate or well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Caution should be exercised when Ciclopirox Topical Suspension USP, 0.77% is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 10 years have not been established.

WARNINGS
Ciclopirox Topical Suspension USP is not for ophthalmic use. Keep out of reach of children.
Carcinogenesis,Mutagenesis, Impairment of Fertility
A carcinogenicity study in female mice dosed cutaneously 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 site. The following in vitro in vivo Salmonella in vivo in vitro ciclopirox: in vitro in vivo

Sun Pharmaceutical Industries, Inc.

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