Each gram of ciclopirox olamine cream, USP contains 7.70 mg of ciclopirox (as
Ciclopirox Olamine) in a water miscible vanishing cream base consisting of
Purified Water USP, Octyldodecanol NF, Light Mineral Oil NF, Stearyl Alcohol NF,
Cetyl Alcohol NF, Polysorbate 60 NF, Myristyl Alcohol NF, Sorbitan Monostearate
NF, Lactic Acid USP, and Benzyl Alcohol NF (1%) as preservative.
Ciclopirox olamine cream, USP 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 olamine cream, USP has a pH of 7.
CLINICAL PHARMACOLOGY SECTION
CLINICAL PHARMACOLOGY 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, Epidermorphyton floccosum, Microsporum canis, and
Candida albicans.
Pharmacokinetic studies in men with tagged 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.
Penetration studies in human cadaverous skin from the back, with ciclopirox
olamine cream, USP with tagged ciclopirox showed the presence of 0.8 to 1.6% of
the dose in the stratum corneum 1.5 to 6 hours after application. The levels in
the dermis were still 10 to 15 times above the minimum inhibitory
concentrations.
Autoradiographic studies with human cadaverous 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.
Draize Human Sensitization Assay, 21-Day Cumulative Irritancy study,
Phototoxicity study, and Photo-Draize study conducted in a total of 142 healthy
subjects showed no contact sensitization of the delayed hypersensitivity type,
no irritation, no phototoxicity, and no photo-contact sensitization due to
ciclopirox olamine cream, USP.
INDICATIONS & USAGE SECTION
INDICATIONS AND USAGE
Ciclopirox olamine cream, 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; candidiasis (moniliasis) due to Candida
albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.
CONTRAINDICATIONS SECTION
CONTRAINDICATIONS
Ciclopirox olamine cream, USP is contraindicated in individuals
who have shown hypersensitivity to any of its components.
WARNINGS SECTION
WARNINGS
Ciclopirox olamine cream, USP is not for ophthalmic use.
Keep out of reach of children.
PRECAUTIONS SECTION
PRECAUTIONS
If a reaction suggesting sensitivity or chemical irritation
should occur with the use of ciclopirox olamine cream, USP, treatment should be
discontinued and appropriate therapy instituted.
ADVERSE REACTIONS SECTION
ADVERSE REACTIONS
In all controlled clinical studies with 514 patients using
ciclopirox olamine cream, USP and in 296 patients using the vehicle cream, the
incidence of adverse reactions was low. This included pruritus at the site of
application in one patient and worsening of the clinical signs and symptoms in
another patient using ciclopirox olamine cream, USP and burning in one patient
and worsening of the clinical signs and symptoms in another patient using the
vehicle cream.
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION
Gently massage ciclopirox olamine cream, USP 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 cream, USP the diagnosis should be
redetermined. Patients with tinea versicolor usually exhibit clinical and
mycological clearing after two weeks of treatment.
HOW SUPPLIED SECTION
HOW SUPPLIED
Ciclopirox olamine cream, USP is supplied in 15 gram, 30 gram,
and 90 gram tubes.
INFORMATION FOR PATIENTS SECTION
Information for Patients
The patient should be told to:
Use the medication for the full treatment time even though 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, blistering, swelling, or oozing)
indicative of possible sensitization.
Avoid the use of occlusive wrappings or dressings.
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