Ciclopirox Olamine

Padagis Israel Pharmaceuticals Ltd
Human Prescription Drug
NDC 45802-400

Ciclopirox Olamine is a human prescription drug labeled by 'Padagis Israel Pharmaceuticals Ltd'. National Drug Code (NDC) number for Ciclopirox Olamine is 45802-400. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Ciclopirox Olamine drug includes Ciclopirox Olamine - 7.7 mg/100mL . The currest status of Ciclopirox Olamine drug is Active.

Drug Information:

Drug NDC:	45802-400
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 Olamine
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 Olamine
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Padagis Israel Pharmaceuticals Ltd
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Suspension
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 OLAMINE - 7.7 mg/100mL
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 Dec, 2006
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 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:	ANDA077676
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, 2024
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:	Padagis Israel Pharmaceuticals Ltd
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	309290
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.
UNII:	50MD4SB4AP
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:	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
45802-400-46	1 BOTTLE in 1 CARTON (45802-400-46) / 60 mL in 1 BOTTLE	29 Dec, 2006	N/A	No
45802-400-49	1 BOTTLE in 1 CARTON (45802-400-49) / 30 mL in 1 BOTTLE	29 Dec, 2006	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.

Other medicines with the same generic name

Loprox

Ciclopirox Olamine

Suspension
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NDC: 43538-550

Ciclopirox Olamine

Suspension
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NDC: 45802-400

Ciclopirox Olamine

Cream
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NDC: 68462-297

Ciclopirox Olamine

Cream
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NDC: 0713-0638

Ciclopirox Olamine

Cream
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Ciclopirox Olamine

Suspension
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NDC: 63629-2522

Ciclopirox Olamine

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NDC: 69315-309

Product Elements:

Ciclopirox olamine ciclopirox olamine ciclopirox olamine ciclopirox benzyl alcohol cetyl alcohol lactic acid, unspecified form light mineral oil myristyl alcohol octyldodecanol polysorbate 60 water sorbitan monostearate stearyl alcohol

Indications and Usage:

Indications and usage ciclopirox olamine topical suspension usp, 0.77% (w/w) (lotion) 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; cutaneous candidiasis (moniliasis) due to candida albicans; and tinea (pityriasis) versicolor due to malassezia furfur .

Warnings:

Warnings general - ciclopirox olamine topical suspension usp, 0.77% (w/w) (lotion) is not for ophthalmic use. keep out of reach of children.

Dosage and Administration:

Dosage and administration gently massage ciclopirox olamine topical suspension usp, 0.77% (w/w) (lotion) 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 topical suspension usp, 0.77% (w/w) (lotion) the diagnosis should be redetermined. patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

Contraindications:

Contraindications ciclopirox olamine topical suspension usp, 0.77% (w/w) (lotion) is contraindicated in individuals who have shown hypersensitivity to any of its components.

Adverse Reactions:

Adverse reactions in the controlled clinical trial with 89 patients using ciclopirox olamine topical suspension and 89 patients using the vehicle, the incidence of adverse reactions was low. those considered possibly related to treatment or occurring in more than one patient were pruritus, which occurred in two patients using ciclopirox olamine topical suspension and one patient using the suspension vehicle, and burning, which occurred in one patient using ciclopirox olamine topical suspension.

Use in Pregnancy:

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.

Pediatric Use:

Pediatric use - safety and effectiveness in pediatric patients below the age of 10 years have not been established.

Description:

Description ciclopirox olamine topical suspension usp, 0.77% (w/w) (lotion) is for topical use. each gram of ciclopirox olamine topical suspension usp, 0.77% (w/w) (lotion) contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible suspension 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 topical suspension usp, 0.77% (w/w) (lotion) 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. ciclopirox olamine topical suspension usp, 0.77% (w/w) (lotion) has a ph of 7. the chemical structure is: structural formula

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 radiolabeled 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. autoradiographic studies with human cadaver 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 st Read more...

ratum corneum. in vitro penetration studies in frozen or fresh excised human cadaver and pig skin indicated that the penetration of ciclopirox olamine topical suspension, 0.77% is equivalent to that of ciclopirox (ciclopirox olamine) cream 0.77%. therapeutic equivalence of cream and suspension formulations was also indicated by studies of experimentally induced guinea pig and human trichophytosis.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

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 synt Read more...

hesis 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 5000 mg/kg.

How Supplied:

How supplied ciclopirox olamine topical suspension usp, 0.77% (w/w) (lotion) is available as follows: 30 ml bottle (ndc 45802- 400 -49) 60 ml bottle (ndc 45802- 400 -46) bottle space provided to allow for vigorous shaking before each use.

Information for Patients:

Information for patients - the patient should be told to: 1. use the medication for the full treatment time even though signs/symptoms may have improved and notify the physician if there is no improvement after four weeks. 2. inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization. 3. avoid the use of occlusive wrappings or dressings.

Package Label Principal Display Panel:

Principal display panel - carton ndc 45802-400-49 rx only ciclopirox olamine topical suspension usp, 0.77% (w/w) (lotion) for dermatologic use only. not for ophthalmic use. keep out of reach of children. bottle space provided to allow for vigorous shaking before each use. 30 ml carton

Comments/ Reviews:

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