CICLOPIROX TOPICAL SUSPENSION, USP
0.77% (w/w) (LOTION)

Rx only
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

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

Each gram of Ciclopirox Topical Suspension, USP 0.77% (Lotion) contains 7.7 mg of ciclopirox (as ciclopirox olamine) in a water miscible lotion base consisting of purified water USP, cocamide DEA, octyldodecanol NF, mineral oil USP, stearyl alcohol NF, cetyl alcohol NF, polysorbate 60 NF, myristyl alcohol NF, sorbitan monostearate NF, lactic acid USP, and benzyl alcohol NF (1%) as a preservative.

Ciclopirox Topical Suspension, USP 0.77% (Lotion) 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 Topical Suspension, USP 0.77% (Lotion) 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 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 Topical Suspension, USP 0.77% (Lotion) is equivalent to that of Ciclopirox Cream 0.77%. Therapeutic equivalence of cream and lotion formulations also was indicated by studies of experimentally induced guinea pig and human trichophytosis.

Ciclopirox Topical Suspension, USP 0.77% (Lotion) 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 0.77% (Lotion) 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 0.77% (Lotion), treatment should be discontinued and appropriate therapy instituted.

The patient should be told to:

• Use the medication for the full treatment time even though signs/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, oozing) indicative of possible sensitization.
• Avoid the use of occlusive wrappings or dressings.

In the controlled clinical trial with 89 patients using Ciclopirox Topical Suspension, USP 0.77% (Lotion) and 89 patients using the lotion vehicle, the incidence of adverse reactions was 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, USP 0.77% (Lotion) and one patient using the lotion vehicle; and burning, which occurred in one patient using Ciclopirox Topical Suspension, USP 0.77% (Lotion).

Gently massage Ciclopirox Topical Suspension, USP 0.77% (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 Topical Suspension, USP 0.77% (Lotion) 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% (Lotion) is supplied in:

•  30 mL bottles (NDC 0168-0314-30)
•  60 mL bottles (NDC 0168-0314-60)

Bottle space provided to allow for vigorous shaking before each use.
Store between 5°-25°C (41°-77°F).

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

I2314/IF2314
R6/04
#218