Ciclopirox Topical Suspension

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 Trichophytonrubrum, Trichophytonmentagrophytes, Epidermophytonfloccosum, Microsporumcanis, and 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 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.

Autoradiographic studies with human cadaver 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.

In vitro penetration studies in frozen or fresh excised human cadaver and pig skin indicated that the penetration of ciclopirox olamine topical suspension, 0.77% is equivalent to that of ciclopirox (ciclopirox olamine) cream 0.77%. Therapeutic equivalence of cream and suspension formulations was also indicated by studies of experimentally induced guinea pig and human trichophytosis.

Gently massage Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) 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 Topical Suspension USP, 0.77% (w/w) (Lotion) the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) is available as follows:

30 mL bottle (NDC 45802-400-49)

60 mL bottle (NDC 45802-400-46)

Bottle space provided to allow for vigorous shaking before each use.

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

Manufactured By Perrigo

Bronx, NY 10457

Distributed By

Perrigo® Allegan, MI 49010 • www.perrigo.com

Rev 05-14

: 1F200 RC J3