Clotrimazole
Hikma Pharmacuticals Usa Usa Inc.
Human Prescription Drug
NDC 0054-4146Clotrimazole is a human prescription drug labeled by 'Hikma Pharmacuticals Usa Usa Inc.'. National Drug Code (NDC) number for Clotrimazole is 0054-4146. 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: | 0054-4146 |
| 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: | Hikma Pharmacuticals Usa Usa Inc. |
| 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
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 Jul, 2004 |
| 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: | ANDA076387 |
| 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: | Hikma Pharmacuticals USA USA Inc.
|
| 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. |
| UPC: | 0300544146227
0300548146223
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 0054-4146-22 | 70 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-22) | 29 Jul, 2004 | N/A | No |
| 0054-4146-23 | 140 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-23) | 29 Jul, 2004 | 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 croscarmellose sodium dextrates magnesium stearate microcrystalline cellulose povidone, unspecified 54;552 clotrimazole clotrimazole clotrimazole clotrimazole croscarmellose sodium dextrates magnesium stearate povidone, unspecified microcrystalline cellulose 54;552
Indications and Usage:
Indications and usage clotrimazole is indicated for the local treatment of oropharyngeal candidiasis. the diagnosis should be confirmed by a koh smear and/or culture prior to treatment. clotrimazole is 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 is not indicated for the treatment of systemic mycoses including systemic candidiasis.
Dosage and Administration:
Dosage and administration clotrimazole is administered only as a lozenge that must be slowly dissolved in the mouth. the recommended dose is one troche five times a day for fourteen consecutive days. only limited data are available on the safety and effectiveness of the clotrimazole troche 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 troche three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.
Contraindications:
Contraindications clotrimazole is 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 troches; elevated sgot levels were reported in about 15% of patients in the clinical trials (see precautions ). nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the troche.
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 troches in children have not been established.
Overdosage:
Overdosage no data available.
Description:
Description each clotrimazole troche (lozenge) usp contains 10 mg clotrimazole usp [1-(o-chloro-α,α-diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical use in the mouth. structural formula: c 22 h 17 cln 2 the troche dosage form is a large, slowly dissolving tablet (lozenge) containing 10 mg of clotrimazole usp dispersed in croscarmellose sodium, dextrates, magnesium stearate, microcrystalline cellulose and povidone. chemical structure.jpg
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 troche 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 troche to dissolve. the long term persistence of
Read more...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 troche.
How Supplied:
How supplied clotrimazole troche (lozenges) usp 10 mg troche is supplied as white, round, flat face beveled edge troche with product identification â54 552â on one side and plain on the other side. ndc 0054-4146-22: bottle of 70 troches ndc 0054-4146-23: bottle of 140 troches ndc 0054-8146-22: 7x10 unit-dose troches store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] avoid freezing. distributed by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 c50000435/01 revised july 2021
Package Label Principal Display Panel:
Package/label principal display panel fpl-bl-10mg-70troches-07.jpg
Package/label principal display panel fpl-fc-10mg-70troches-06.jpg