Clotrimazole
Padagis Us Llc
Human Prescription Drug
NDC 0574-0107Clotrimazole is a human prescription drug labeled by 'Padagis Us Llc'. National Drug Code (NDC) number for Clotrimazole is 0574-0107. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Clotrimazole drug includes Clotrimazole - 10 mg/1 . The currest status of Clotrimazole drug is Active.
Drug Information:
| Drug NDC: | 0574-0107 |
| 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: | Clotrimazole |
| 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: | Clotrimazole |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Padagis Us Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lozenge |
| 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: | CLOTRIMAZOLE - 10 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | 01 Dec, 2005 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 03 Jan, 2026 |
| 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: | ANDA076763 |
| 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: | Padagis US LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 309371
|
| 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. |
| NUI: | N0000175487
M0002083
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | G07GZ97H65
|
| 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 EPC: | Azole Antifungal [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Azoles [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Azole Antifungal [EPC]
Azoles [CS]
|
| 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 |
|---|
| 0574-0107-14 | 140 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-14) | 01 Dec, 2005 | N/A | No |
| 0574-0107-70 | 70 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-70) | 01 Dec, 2005 | N/A | No |
| 0574-0107-77 | 70 PACKET in 1 BOX (0574-0107-77) / 1 LOZENGE in 1 PACKET | 01 Dec, 2005 | 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:
Clotrimazole clotrimazole clotrimazole clotrimazole dextrose, unspecified form microcrystalline cellulose povidone, unspecified magnesium stearate pad;0107
Indications and Usage:
Indications and usage clotrimazole lozenges are indicated for the local treatment of oropharyngeal candidiasis. the diagnoses should be confirmed by a koh smear and/or culture prior to treatment. clotrimazole lozenges are also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. there are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence. (see dosage and administration .)
Warnings:
Warning clotrimazole lozenges are not indicated for the treatment of systemic mycoses including systemic candidiasis.
Dosage and Administration:
Dosage and administration clotrimazole lozenges must be slowly dissolved in the mouth. the recommended dose is one lozenge five times a day for fourteen consecutive days. only limited data are available on the safety and effectiveness of the clotrimazole lozenge after prolonged administration; therefore, therapy should be limited to short term use, if possible. for prophylaxis to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation, the recommended dose is one lozenge three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.
Contraindications:
Contraindications clotrimazole lozenges are contraindicated in patients who are hypersensitive to any of its components.
Adverse Reactions:
Adverse reactions abnormal liver function tests have been reported in patients treated with clotrimazole lozenges; elevated sgot levels were reported in about 15% of patients in the clinical trials (see precautions section). nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the lozenge.
Use in Pregnancy:
Usage in pregnancy: pregnancy category c: clotrimazole has been shown to be embryotoxic in rats and mice when given in doses 100 times the adult human dose (in mg/kg), possibly secondary to maternal toxicity. the drug was not teratogenic in mice, rabbits, and rats when given in doses up to 200, 180, and 100 times the human dose. clotrimazole given orally to mice from nine weeks before mating through weaning at a dose 120 times the human dose was associated with impairment of mating, decreased number of viable young, and decreased survival to weaning. no effects were observed at 60 times the human dose. when the drug was given to rats during a similar time period at 50 times the human dose, there was a slight decrease in the number of pups per litter and decreased pup viability. there are no adequate and well controlled studies in pregnant women. clotrimazole lozenges should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric Use:
Pediatric use safety and effectiveness of clotrimazole in children below the age of 3 years have not been established; therefore, its use in such patients is not recommended. the safety and efficacy of the prophylactic use of clotrimazole lozenges in children have not been established.
Geriatric Use:
Geriatric use clinical studies of clotrimazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Overdosage:
Overdosage no data available.
Description:
Description each clotrimazole lozenge contains 10 mg clotrimazole [1-(o-chloro-α, α-diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical use in the mouth. structural formula: chemical formula: c 22 h 17 cln 2 the lozenge dosage form is a large, slowly dissolving tablet (troche) containing 10 mg of clotrimazole dispersed in dextrose, microcrystalline cellulose, povidone, and magnesium stearate. chemical structure
Clinical Pharmacology:
Clinical pharmacology clotrimazole is a broad-spectrum antifungal agent that inhibits the growth of pathogenic yeasts by altering the permeability of cell membranes. the action of clotrimazole is fungistatic at concentrations of drug up to 20 mcg/ml and may be fungicidal in vitro against candida albicans and other species of the genus candida at higher concentrations. no single-step or multiple-step resistance to clotrimazole has developed during successive passages of candida albicans in the laboratory; however, individual organism tolerance has been observed during successive passages in the laboratory. such in vitro tolerance has resolved once the organism has been removed from the antifungal environment. after oral administration of a 10 mg clotrimazole lozenge to healthy volunteers, concentrations sufficient to inhibit most species of candida persist in saliva for up to three hours following the approximately 30 minutes needed for a lozenge to dissolve. the long term persistence o
Read more...f drug in saliva appears to be related to the slow release of clotrimazole from the oral mucosa to which the drug is apparently bound. repetitive dosing at three hour intervals maintains salivary levels above the minimum inhibitory concentrations of most strains of candida; however, the relationship between in vitro susceptibility of pathogenic fungi to clotrimazole and prophylaxis or cure of infections in humans has not been established. in another study, the mean serum concentrations were 4.98 ± 3.7 and 3.23 ± 1.4 nanograms/ml of clotrimazole at 30 and 60 minutes, respectively, after administration as a lozenge.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis: an 18 month dosing study with clotrimazole in rats has not revealed any carcinogenic effect.
How Supplied:
How supplied clotrimazole lozenges, 10 mg, white discoid, uncoated tablets, debossed with "pad" over "0107" on one side and plain on the other, are supplied as follows: strength ndc code lozenge identification bottles of 70: 10 mg 0574-0107-70 pad 0107 bottles of 140: 10 mg 0574-0107-14 pad 0107 boxes of 70 foil packs: 10 mg 0574-0107-77 pad 0107 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature] avoid freezing. rx only
Package Label Principal Display Panel:
Principal display panel rx only ndc 0574- 0107 -70 clotrimazole lozenge (clotrimazole troche) 10 mg unit dose for institutional use only 70 foiled lozenges the following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. clotrimazole-lozenge-carton serialization-template