Label: CICLOPIROX OLAMINE cream
- NDC Code(s): 63629-8625-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 45802-138
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 17, 2023
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- SPL UNCLASSIFIED SECTION
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DESCRIPTION
Ciclopirox Olamine Cream USP, 0.77% is for topical use. Each gram of Ciclopirox Olamine Cream USP, 0.77% 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.
Ciclopirox Olamine Cream USP, 0.77% 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 :
Ciclopirox Olamine Cream USP, 0.77% has a pH of 7.
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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 vitroagainst isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporumcanis, 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 2on 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.
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INDICATIONS AND USAGE
Ciclopirox Olamine Cream USP, 0.77% 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
- WARNINGS
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PRECAUTIONS
If a reaction suggesting sensitivity or chemical irritation should occur with the use of Ciclopirox Olamine Cream USP, 0.77%, 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 vitroand in vivogenotoxicity 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 vivoin the Mouse Dominant Lethal Assay and in the Mouse Micronucleus Assay at 500 mg/kg (negative).
The following battery of in vitrogenotoxicity 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 vitroCell Transformation Assay in BALB/C3T3 Cells was negative for cell transformation. In an in vivoChinese 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.
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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.
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DOSAGE AND ADMINISTRATION
Gently massage Ciclopirox Olamine Cream USP, 0.77% 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, 0.77% the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.
- HOW SUPPLIED
- STORAGE
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CICLOPIROX OLAMINE
ciclopirox olamine creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-8625(NDC:45802-138) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CICLOPIROX OLAMINE (UNII: 50MD4SB4AP) (CICLOPIROX - UNII:19W019ZDRJ) CICLOPIROX 7.7 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CETYL ALCOHOL (UNII: 936JST6JCN) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) LIGHT MINERAL OIL (UNII: N6K5787QVP) MYRISTYL ALCOHOL (UNII: V42034O9PU) OCTYLDODECANOL (UNII: 461N1O614Y) POLYSORBATE 60 (UNII: CAL22UVI4M) WATER (UNII: 059QF0KO0R) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-8625-1 1 in 1 CARTON 07/19/2006 1 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077364 07/19/2006 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 repack(63629-8625) , relabel(63629-8625)
