Nystatin And Triamcinolone Acetonide
Aleor Dermaceuticals Limited
Human Prescription Drug
NDC 71589-016Nystatin And Triamcinolone Acetonide is a human prescription drug labeled by 'Aleor Dermaceuticals Limited'. National Drug Code (NDC) number for Nystatin And Triamcinolone Acetonide is 71589-016. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Nystatin And Triamcinolone Acetonide drug includes Nystatin - 100000 [USP'U]/g Triamcinolone Acetonide - 1 mg/g . The currest status of Nystatin And Triamcinolone Acetonide drug is Active.
Drug Information:
| Drug NDC: | 71589-016 |
| 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: | Nystatin And Triamcinolone Acetonide |
| 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: | Nystatin And Triamcinolone Acetonide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Aleor Dermaceuticals Limited |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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: | NYSTATIN - 100000 [USP'U]/g
TRIAMCINOLONE ACETONIDE - 1 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: | 15 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 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: | ANDA214186 |
| 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: | Aleor Dermaceuticals Limited
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1053697
|
| 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: | 0371589016158
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175498
M0017172
N0000175576
N0000175450
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | BDF1O1C72E
F446C597KA
|
| 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: | Corticosteroid Hormone Receptor Agonists [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 EPC: | Polyene Antifungal [EPC]
Corticosteroid [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: | Polyenes [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: | Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
Polyene Antifungal [EPC]
Polyenes [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 |
|---|
| 71589-016-15 | 1 TUBE in 1 CARTON (71589-016-15) / 15 g in 1 TUBE | 15 Mar, 2022 | N/A | No |
| 71589-016-30 | 1 TUBE in 1 CARTON (71589-016-30) / 30 g in 1 TUBE | 15 Mar, 2022 | N/A | No |
| 71589-016-60 | 1 TUBE in 1 CARTON (71589-016-60) / 60 g in 1 TUBE | 15 Mar, 2022 | 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:
Nystatin and triamcinolone acetonide nystatin and triamcinolone acetonide nystatin nystatin triamcinolone acetonide triamcinolone acetonide mineral oil petrolatum
Indications and Usage:
Indications and usage nystatin and triamcinolone acetonide ointment is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
Dosage and Administration:
Dosage and administration a thin film of nystatin and triamcinolone acetonide ointment is usually applied to the affected areas twice daily in the morning and evening. the preparation should be discontinued if symptoms persist after 25 days of therapy (see precautions, laboratory tests ). nystatin and triamcinolone acetonide ointment should not be used with occlusive dressings.
Contraindications:
Contraindications these preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.
Adverse Reactions:
Adverse reactions a single case (approximately one percent of patients studied) of acneiform eruption occurred with use of combined nystatin and triamcinolone acetonide in clinical studies. nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups, even during prolonged use. rarely, irritation may occur. the following local adverse reactions are reported infrequently with topical corticosteroids (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, perioral secondary infection, skin atrophy, striae and miliaria.
Use in Pregnancy:
Pregnancy there are no teratogenic studies with combined nystatin and triamcinolone acetonide. corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. the more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. therefore, any topical corticosteroid preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. topical preparations containing corticosteroids should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Pediatric Use:
Pediatric use in clinical studies of a limited number of pediatric patients ranging from two months through 12 years, nystatin and triamcinolone acetonide cream formulation cleared or significantly ameliorated the disease state in most patients. pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (hpa) axis suppression and cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. hpa axis suppression, cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. administration of topical corticosteroids to children should be limited to t
Read more...he least amount compatible with an effective therapeutic regimen. chronic corticosteroid therapy may interfere with the growth and development of children.
Overdosage:
Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see precautions, general ); however, acute overdosage and serious adverse effects with dermatologic use are unlikely.
Description:
Description nystatin and triamcinolone acetonide ointment, usp for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. nystatin is a polyene antimycotic obtained from streptomyces noursei . it is a yellow to light tan powder with a cereal-like odor, practically insoluble or insoluble in water and in alcohol. structural formula: c 47 h 75 no 17 mw = 926.23 triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17- [(1-methylethylidene)bis(oxy)]-, (11β,16α)-9-fluoro-11b,16a,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17- acetal with acetone. the white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. structural formula: c 24 h 31 fo 6 mw = 434.51 each gram of nystatin and triamcinolone acetonide ointment, usp provides 100,000 usp nystatin units and 1 mg triamcinolone acetonide usp in an ointment base of mineral oil and white petrolatum. image image
Clinical Pharmacology:
Clinical pharmacology nystatin nystatin exerts its antifungal activity against a variety of pathogenic and nonpathogenic yeasts and fungi by binding to sterols in the cell membrane. the binding process renders the cell membrane incapable of functioning as a selective barrier. nystatin provides specific anticandidal activity to candida (monilia) albicans and other candida species, but is not active against bacteria, protozoa, trichomonads, or viruses. nystatin is not absorbed from intact skin or mucous membranes. triamcinolone acetonide triamcinolone acetonide is primarily effective because of its anti-inflammatory, antipruritic and vasoconstrictive actions, characteristic of the topical corticosteroid class of drugs. the pharmacologic effects of the topical corticosteroids are well known; however, the mechanisms of their dermatologic actions are unclear. various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of
Read more... the topical corticosteroids. there is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. pharmacokinetics the extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see dosage and administration ). topical corticosteroids can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin increase percutaneous absorption. occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see dosage and administration ). once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees. corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. some of the topical corticosteroids and their metabolites are also excreted into the bile. nystatin and triamcinolone acetonide during clinical studies of mild to severe manifestations of cutaneous candidiasis, patients treated with nystatin and triamcinolone acetonide showed a faster and more pronounced clearing of erythema and pruritus than patients treated with nystatin or triamcinolone acetonide alone.
How Supplied:
How supplied nystatin and triamcinolone acetonide ointment, usp is a yellow to brownish orange color ointment supplied as follows: 15 g tube (ndc 71589-016-15) 30 g tube (ndc 71589-016-30) 60 g tube (ndc 71589-016-60)
Package Label Principal Display Panel:
Package label.principal display panel ndc 71589-016-15 15 g nystatin and triamcinolone acetonide ointment usp for dermatologic use only. not for ophthalmic use. rx only keep out of reach of children. aleor dermaceuticals ltd., ndc 71589-016-15 15g nystatin and triamcinolone acetonide ointment usp for dermatological use only. not for ophthalmic use. rx only keep out of reach of children. aleor dermaceuticals ltd., 15 g tube 15 g carton