Ciclodan Cream Generic Name: ciclopirox olamine cream Brand Name: Ciclodan side effects drug center ciclodan (ciclopirox olamine cream) drug Related Drugs Acanya Accutane Amnesteem Atralin Azelex BenzaClin Ciclodan Topical Solution Differin Cream Differin Gel .1 Differin Gel .3 Differin Lotion .1 Duac Finacea Onexton Drug Comparison Ciclodan vs. Kerydin PROFESSIONAL CONSUMER SIDE EFFECTS Contents Drug Description Indications & Dosage Side Effects & Drug Interactions Warnings & Precautions Overdosage & Contraindications Clinical Pharmacology Medication Guide Drug Description What is Ciclodan Cream and how is it used? Ciclodan Cream is a prescription medicine used to treat the symptoms of Mild to Moderate Onychomycosis of Fingernails and Toenails, fungal infections such as Athlete’s Foot (Tinea Pedis), Ringworm (Tinea Corporis), Jock Itch (Tinea Cruris), Cutaneous Candidiasis, Tinea Vesicolor and Seborrheic Dermatitis of the Scalp. Ciclodan Cream may be used alone or with other medications. Ciclodan Cream belongs to a class of drugs called Antifungals, Topical. It is not known if Ciclodan Cream is safe and effective in children younger than 10 years of age. What are the possible side effects of Ciclodan Cream? Ciclodan Cream may cause serious side effects including: hives, difficulty breathing, swelling of your face, lips, tongue, or throat, unusual or severe itching, redness, burning, dryness, or irritation of treated skin, and discoloration of other changes in the nails Get medical help right away, if you have any of the symptoms listed above. The most common side effects of Ciclodan Cream include: mild burning, itching, or redness Tell the doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Ciclodan Cream. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For Dermatologic Use Only Not For Use in Eyes DESCRIPTION Ciclodan®Cream is for topical use. Each gram of Ciclodan®Cream contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible, vanishing cream base consisting of benzyl alcohol (1% as a preservative), cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and stearyl alcohol. Ciclodan®Cream 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: Ciclodan®Cream has a pH of 7. Indications & Dosage INDICATIONS Ciclodan®Cream 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. DOSAGE AND ADMINISTRATION Gently massage Ciclodan®Cream 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 Ciclodan®Cream the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment. HOW SUPPLIED Ciclodan®Cream is available as follows: 90 g tube (NDC 43538-520-90) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured by: Perrigo, Bronx, NY 10457. Revised: July 2015 Side Effects & Drug Interactions SIDE EFFECTS In all controlled clinical studies with 514 patients using ciclopirox olamine cream and 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 and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream. DRUG INTERACTIONS No Information Provided Warnings & Precautions WARNINGS General Ciclodan®Cream is not for ophthalmic use. Keep out of reach of children. PRECAUTIONS If a reaction suggesting sensitivity or chemical irritation should occur with the use of Ciclodan®Cream, treatment should be discontinued and appropriate therapy instituted. Carcinogenesis, Mutagenesis, Impairment Of Fertility A carcinogenicity study in female mice dosed cutaneously twice per week for 50 weeks followed by a 6-month drug-free observation period prior to necropsy revealed no evidence of tumors at the application site. The following in vitro and in vivo genotoxicity tests have been conducted with ciclopirox olamine: studies to evaluate gene mutation in the Ames Salmonella/Mammalian Microsome Assay (negative) and Yeast Saccharomyces Cerevisiae Assay (negative) and studies to evaluate chromosome aberrations in vivo in the Mouse Dominant Lethal Assay and in the Mouse Micronucleus Assay at 500 mg/kg (negative). The following battery of in vitro genotoxicity tests were conducted with ciclopirox: a chromosome aberration assay in V79 Chinese Hamster Cells, with and without metabolic activation (positive); a gene mutation assay in the HGPRT - test with V79 Chinese Hamster Cells (negative); and a primary DNA damage assay (i.e., unscheduled DNA Synthesis Assay in A549 Human Cells (negative)). An in vitro Cell Transformation Assay in BALB/C3T3 Cells was negative for cell transformation. In an in vivo Chinese Hamster Bone Marrow Cytogenetic Assay, ciclopirox was negative for chromosome aberrations at 5,000 mg/kg. Pregnancy Category B Reproduction studies have been performed in the mouse, rat, rabbit, and monkey (via various routes of administration) at doses 10 times or more the topical human dose and have revealed no significant evidence of impaired fertility or harm to the fetus due to ciclopirox. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ciclodan®Cream is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients below the age of 10 years have not been established. Overdosage & Contraindications OVERDOSE No Information Provided CONTRAINDICATIONS Ciclodan®Cream is contraindicated in individuals who have shown hypersensitivity to any of its components. Clinical Pharmacology 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, Epidermophyton 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 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 male subjects showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity, and no photo-contact sensitization due to ciclopirox olamine cream. Medication Guide PATIENT INFORMATION 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.
