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.

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
Fougera
PHARMACEUTICAL INC.
Melville, New York 11747

I2314C/IF2314C
R08/14
#218

NDC 0168-0314-30

Fougera^®

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

Rx Only

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

Keep out of reach of children.
Bottle space provided to allow for
vigorous shaking before each use.

30 mL

NDC 0168-0314-30

Fougera^®

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

Rx Only

FOR DERMATOLOGIC
USE ONLY
NOT FOR OPHTHALMIC USE

Keep out of reach
of children.

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

30 mL