Ciclopirox Topical Suspension USP, 0.77% w/w

Rx Only

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

Ciclopirox Topical Suspension USP, 0.77% is for topical use.

Each gram of Ciclopirox Topical Suspension USP contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible suspension base consisting of cetyl alcohol, cocamide DEA, lactic acid, mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, stearyl alcohol, and benzyl alcohol (1%) as preservative.

Ciclopirox Topical Suspension USP 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.

The CAS Registry Number is 41621-49-2.

The chemical structure is:

Ciclopirox Topical Suspension USP 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 vitroagainst isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, 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 cm ²on 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 vitropenetration studies in frozen or fresh excised human cadaver and pig skin indicated that the penetration of Ciclopirox Topical Suspension USP is equivalent to that of Ciclopirox Cream USP. Therapeutic equivalence of cream and suspension formulations also was indicated by studies of experimentally induced guinea pig and human trichophytosis.

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, and Microsporum canis; cutaneous candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.

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

If a reaction suggesting sensitivity or chemical irritation should occur with the use of Ciclopirox Topical Suspension USP, treatment should be discontinued and appropriate therapy instituted.

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.

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.

Ciclopirox Topical Suspension USP, 0.77% is supplied in 30 mL (NDC 51672-1323-3) and 60 mL (NDC 51672-1323-4) bottles.

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

Mfd. by: Taro Pharmaceuticals Inc.
Brampton, Ontario, Canada L6T 1C1
Issued: November 2004

PK- 4740-0

0205-0

126

60 mL

NDC 51672-1323-4

Ciclopirox

Topical Suspension

USP, 0.77% (w/w)

FOR DERMATOLOGIC
USE ONLY.

NOT FOR
OPHTHALMIC USE.

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

Keep this and all
medications out of the
reach of children.

Rx only

TARO