refer to Ciclodan Cream Generic Name: ciclopirox olamine Dosage Form: cream Overview Side Effects Dosage Professional Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons Ciclodan Cream (Ciclopirox Olamine Cream USP, 0.77%) Medimetriks Pharmaceuticals, Inc. For Dermatologic Use Only Not For Use In Eyes Rx Only Slideshow Prednisone: 12 Things You Should Know Ciclodan Cream 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(1 H )-pyridone,2-aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is : Chemical Structure Image Ciclodan Cream has a pH of 7. Ciclodan Cream - 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 cm 2 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. Indications and Usage for Ciclodan Cream 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. Contraindications Ciclodan Cream is contraindicated in individuals who have shown hypersensitivity to any of its components. Warnings 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. 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. 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. Adverse Reactions 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. Ciclodan Cream 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 is Ciclodan Cream 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 for: Medimetriks Pharmaceuticals, Inc. 363 Route 46 West, Fairfield, NJ 07004 www.medimetriks.com MANUFACTURED BY PERRIGO BRONX, NY 10457 Iss. 1/12 IP025 Principal Display Panel - 90 g Tube Carton NDC 43538-520-90 Rx Only Ciclodan Cream (CICLOPIROX OLAMINE CREAM USP, 0.77%) FOR DERMATOLIGIC USE ONLY NOT FOR USE IN EYES Net Wt. 90 g MEDIMETRIKS PHARMACEUTICALS, INC. Principal Display Panel - Kit Carton NDC 43538-521-90 Rx Only Ciclodan Cream (CICLOPIROX OLAMINE CREAM USP, 0.77%) KIT CONTENTS: 1 - Ciclodan (Ciclopirox Olamine Cream USP, 0.77) Cream - Net wt. 90 g 1 - Rehyla Hair & Body Cleanser Bottle - Net wt. 16 oz. (454 g) MEDIMETRIKS PHARMACEUTICALS, INC. Established Pharmacological Class Substance Pharmacological Class Rehyla Hair and Body Cleanser Cleansing (cold creams, cleansing lotions, liquids, and pads) CICLODAN ciclopirox olamine cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-520 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ciclopirox olamine (ciclopirox) ciclopirox 7.7 mg in 1 g Inactive Ingredients Ingredient Name Strength benzyl alcohol cetyl alcohol lactic acid light mineral oil myristyl alcohol octyldodecanol polysorbate 60 water sorbitan monostearate stearyl alcohol Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:43538-520-90 1 TUBE in 1 CARTON 1 90 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077364 06/15/2012 CICLODAN ciclopirox olamine kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-521 Packaging # Item Code Package Description 1 NDC:43538-521-90 1 KIT in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 90 g Part 2 1 BOTTLE, PUMP 454 g Part 1 of 2 CICLODAN ciclopirox olamine cream Product Information Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ciclopirox olamine (ciclopirox) ciclopirox 7.7 mg in 1 g Inactive Ingredients Ingredient Name Strength benzyl alcohol cetyl alcohol lactic acid light mineral oil myristyl alcohol octyldodecanol polysorbate 60 water sorbitan monostearate stearyl alcohol Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 90 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077364 06/15/2012 Part 2 of 2 REHYLA HAIR AND BODY CLEANSER inert cream Product Information Route of Administration TOPICAL DEA Schedule Ingredients Ingredient Name Quantity water sodium C14-16 olefin Sulfonate glyceryl stearate SE glycerin cocamidopropyl betaine cetyl alcohol PEG-7 glyceryl cocoate dimethicone cocamidopropyl hydroxysultaine disodium lauryl sulfosuccinate caprylyl glycol cholesterol decyl glucoside propylene glycol phenoxyethanol edetate disodium hexylene glycol salicylic acid chamaemelum nobile flower hyaluronate sodium mica titanium dioxide xanthan gum Packaging # Item Code Package Description 1 454 g in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 06/15/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077364 06/15/2012 Labeler - Medimetriks Pharmaceuticals, Inc. (019903816) Establishment Name Address ID/FEI Operations Perrigo 078846912 MANUFACTURE Revised: 06/2012 Medimetriks Pharmaceuticals, Inc. Next Pregnancy Warnings Print this page Add to My Med List More about Ciclodan (ciclopirox topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Support Group Pricing & Coupons 1 Review Add your own review/rating Consumer resources Ciclodan Ciclodan Kit Ciclodan Topical (Advanced Reading) Professional resources Ciclodan (FDA) Ciclopirox Olamine (AHFS Monograph) Other brands: Penlac , Loprox , CNL8 Nail Related treatment guides Cutaneous Candidiasis Onychomycosis, Fingernail Onychomycosis, Toenail Seborrheic Dermatitis ... +4 more} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Related Drugs Seborrheic Dermatitis prednisone , hydrocortisone topical , ketoconazole topical , dexamethasone , Decadron , Deltasone , More... Onychomycosis, Toenail terbinafine , Lamisil , ciclopirox topical , Penlac , itraconazole , Jublia , More... Tinea Corporis clotrimazole topical , ketoconazole topical , Lotrisone , terbinafine topical , Lamisil , More... 5 more conditions... Ciclodan Rating 1 User Review 10 /10 1 User Review 10 Rate it!} } learn how to
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