Ciclopirox
Glenmark Pharmaceuticals Inc., Usa
Human Prescription Drug
NDC 68462-455Ciclopirox is a human prescription drug labeled by 'Glenmark Pharmaceuticals Inc., Usa'. National Drug Code (NDC) number for Ciclopirox is 68462-455. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Ciclopirox drug includes Ciclopirox - 7.7 mg/g . The currest status of Ciclopirox drug is Active.
Drug Information:
| Drug NDC: | 68462-455 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Ciclopirox |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Ciclopirox |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glenmark Pharmaceuticals Inc., Usa |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CICLOPIROX - 7.7 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 29 Feb, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA091595 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Glenmark Pharmaceuticals Inc., USA
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 313941
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0368462455470
|
| UPC stands for Universal Product Code. |
| NUI: | N0000008577
N0000008841
N0000008853
N0000000150
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 19W019ZDRJ
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Protein Synthesis Inhibitors [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class PE: | Decreased DNA Replication [PE]
Decreased Protein Synthesis [PE]
Decreased RNA Replication [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Decreased DNA Replication [PE]
Decreased Protein Synthesis [PE]
Decreased RNA Replication [PE]
Protein Synthesis Inhibitors [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 68462-455-35 | 30 g in 1 TUBE (68462-455-35) | 29 Feb, 2012 | N/A | No |
| 68462-455-47 | 45 g in 1 TUBE (68462-455-47) | 29 Feb, 2012 | N/A | No |
| 68462-455-94 | 100 g in 1 TUBE (68462-455-94) | 29 Feb, 2012 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Ciclopirox ciclopirox ciclopirox ciclopirox carbomer homopolymer type c (allyl pentaerythritol crosslinked) isopropyl alcohol medium-chain triglycerides sodium hydroxide sodium lauryl sulfate water
Indications and Usage:
Indications and usage superficial dermatophyte infections ciclopirox gel is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to trichophyton rubrum, trichophyton mentagrophytes, or epidermophyton floccosum . seborrheic dermatitis ciclopirox gel is indicated for the topical treatment of seborrheic dermatitis of the scalp.
Warnings:
Warnings ciclopirox gel is not for ophthalmic, oral, or intravaginal use. keep out of reach of children.
Dosage and Administration:
Dosage and administration superficial dermatophyte infections gently massage ciclopirox gel into the affected areas and surrounding skin twice daily, in the morning and evening immediately after cleaning or washing the areas to be treated. interdigital tinea pedis and tinea corporis should be treated for 4 weeks. if a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed. seborrheic dermatitis of the scalp apply ciclopirox gel to affected scalp areas twice daily, in the morning and evening for 4 weeks. clinical improvement usually occurs within the first week with continuing resolution of signs and symptoms through the fourth week of treatment. if a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed.
Contraindications:
Contraindications ciclopirox gel is contraindicated in individuals who have shown hypersensitivity to any of its components.
Adverse Reactions:
Adverse reactions in clinical trials, 140 (39%) of 359 subjects treated with ciclopirox gel reported adverse experiences, irrespective of relationship to test materials, which resulted in 8 subjects discontinuing treatment. the most frequent experience reported was skin burning sensation upon application, which occurred in approximately 34% of seborrheic dermatitis patients and 7% of tinea pedis patients. adverse experiences occurring between 1% to 5% were contact dermatitis and pruritus. other reactions that occurred in less than 1% included dry skin, acne, rash, alopecia, pain upon application, eye pain, and facial edema.
Use in Pregnancy:
Pregnancy teratogenic effects: pregnancy category b there are no adequate or well-controlled studies in pregnant women. therefore, ciclopirox gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral embryofetal developmental studies were conducted in mice, rats, rabbits and monkeys. ciclopirox or ciclopirox olamine was orally administered during the period of organogenesis. no maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 77, 125, 80 and 38.5 mg/kg/day ciclopirox in mice, rats, rabbits and monkeys, respectively (approximately 11, 37, 51 and 24 times the maximum recommended human dose based on body surface area comparisons, respectively). dermal embryofetal developmental studies were conducted in rats and rabbits with ciclopirox olamine dissolved in peg 400. ciclopirox olamine was topically administered during the period of organogenesis. no maternal toxicity, embryotoxicity or teratogenici
Read more...ty were noted at the highest doses of 92 mg/kg/day and 77 mg/kg/day ciclopirox in rats and rabbits, respectively (approximately 27 and 49 times the maximum recommended human dose based on body surface area comparisons, respectively).
Pediatric Use:
Pediatric use the efficacy and safety of ciclopirox gel in pediatric patients below the age of 16 years have not been established.
Description:
Description ciclopirox gel 0.77% contains a synthetic antifungal agent, ciclopirox usp. it is intended for topical dermatologic use only. each gram of ciclopirox gel contains 7.70 mg of ciclopirox usp in a gel consisting of carbomer homopolymer, isopropyl alcohol, and medium chain triglycerides, sodium hydroxide, sodium lauryl sulfate, and purified water. ciclopirox gel is a white, slightly fluid gel. the chemical name for ciclopirox usp is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 h )-pyridinone, with the empirical formula c 12 h 17 no 2 and a molecular weight of 207.27. the cas registry number is [29342-05-0]. the chemical structure is: structure
Clinical Pharmacology:
Clinical pharmacology mechanism of action ciclopirox is a hydroxypyridone antifungal agent although the relevance of this property for the indication of seborrheic dermatitis is not known. ciclopirox acts by chelation of polyvalent cations (fe 3+ or al 3+ ), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell. pharmacokinetics a comparative study of the pharmacokinetics of ciclopirox gel and ciclopirox cream (ciclopirox olamine) 0.77% in 18 healthy males indicated that systemic absorption of ciclopirox from ciclopirox gel was higher than that of ciclopirox cream. a 5 gm dose of ciclopirox gel produced a mean (±sd) peak serum concentration of 25.02 (±20.6) ng/ml total ciclopirox and 5 gm of ciclopirox cream produced 18.62 (±13.56) ng/ml total ciclopirox. approximately 3% of the applied ciclopirox was excreted in the urine within 48 hours after application, with a renal elimination half-life of a
Read more...bout 5.5 hours. in a study of ciclopirox gel, 16 men with moderate to severe tinea cruris applied approximately 15 grams/day of the gel for 14.5 days. the mean (±sd) dose- normalized values of c max for total ciclopirox in serum were 100 (±42) ng/ml on day 1 and 238 (±144) ng/ml on day 15. during the 10 hours after dosing on day 1, approximately 10% of the administered dose was excreted in the urine. microbiology ciclopirox is a hydroxypyridinone antifungal agent that inhibits the growth of pathogenic dermatophytes. ciclopirox has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the indications and usage section: trichophyton rubrum, trichophyton mentagrophytes, and epidermophyton floccosum
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility a 104-week dermal carcinogenicity study in mice was conducted with ciclopirox cream formulation applied at doses up to 1.93% (100 mg/kg/day or 300 mg/m 2 /day). no increase in drug related neopalsms was noted when compared to control. the following in vitro genotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in the ames salmonella and e. coli assays (negative); chromosome aberration assays in v79 chinese hamster lung fibroblast cells, with and without metabolic activation (positive); chromosome aberration assays in v79 chinese hamster lung fibroblast cells in the presence of supplemental fe 3+ , with and without metabolic activation (negative); gene mutation assays in the hgprt-test with v79 chinese hamster lung fibroblast 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/c 3t3 cells was
Read more... negative for cell transformation. in an in vivo chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at a dosage of 5000 mg/kg body weight. a combined oral fertility and embryofetal developmental study was conducted in rats with ciclopirox olamine. no effect on fertility or reproductive performance was noted at the highest dose tested of 3.85 mg/kg/day ciclopirox (approximately 1.2 times the maximum recommended human dose based on body surface area comparisons).
How Supplied:
How supplied ciclopirox gel 0.77% is supplied in aluminium tubes and ldpe tubes. 30 g tubes (ndc 68462-455-35), 45 g tubes (ndc 68462-455-47) and 100 g tubes (ndc 68462-455-94). store at 20 to 25°c (68 to 77°f) [see usp controlled room temperature]. manufactured by: glenmark pharmaceuticals limited colvale-bardez, goa 403 513, india manufactured for: glenmark pharmaceuticals inc., usa mahwah, nj 07430 questions? 1 (888)721-7115 www.glenmarkpharma.com/usa january 2017
Information for Patients:
Information for patients the patient should be told the following: 1. use ciclopirox gel as directed by the physician. avoid contact with the eyes and mucous membranes. ciclopirox gel is for external use only. 2. use the medication for fungal infections for the full treatment time even though symptoms may have improved, and notify the physician if there is no improvement after 4 weeks. 3. a transient burning/stinging sensation may be felt. this may occur in approximately 15% to 20% of cases, when ciclopirox gel is used to treat seborrheic dermatitis of the scalp. 4. inform the physician if the area of application shows signs of increased irritation or possible sensitization (redness with itching, burning, blistering, swelling, and/or oozing). 5. avoid the use of occlusive dressings. 6. do not use this medication for any disorder other than that for which it is prescribed.
Package Label Principal Display Panel:
Package/label display panel carton
Package/label display panel tube