NDC 54868-2470 Nystatin And Triamcinolone

NDC Product Code 54868-2470

NDC CODE: 54868-2470

Proprietary Name: Nystatin And Triamcinolone What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

NDC Code Structure

  • 54868 - Physicians Total Care, Inc.

NDC 54868-2470-0

Package Description: 1 TUBE in 1 CARTON > 30 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Nystatin And Triamcinolone with NDC 54868-2470 is a product labeled by Physicians Total Care, Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1053697.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • MINERAL OIL (UNII: T5L8T28FGP)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Physicians Total Care, Inc.
Labeler Code: 54868
Start Marketing Date: 03-03-2005 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Nystatin and Triamcinolone

Nystatin and Triamcinolone is pronounced as (nye stat' in) (trye am sin' oh lone)

Why is nystatin and triamcinolone medication prescribed?
The combination of nystatin and triamcinolone is used to treat fungal skin infections. It relieves itching, inflammation, and pain.This medication is sometimes prescribed...
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Nystatin And Triamcinolone Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx onlyFOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Description

Nystatin and Triamcinolone Acetonide Cream and Ointment 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 cereallike odor, very slightly soluble in
water, and slightly to sparingly soluble in alcohol. Structural formula:Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 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:Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a
light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1
mg Triamcinolone Acetonide in an aqueous perfumed vanishing cream base with
polysorbate-60, aluminum hydroxide, titanium dioxide, glyceryl monostearate,
polyethylene glycol monostearate, simethicone emulsion, sorbic acid, propylene
glycol, white petrolatum, polyoxyethylene fatty alcohol ether, methylparaben,
propylparaben and sorbitol.Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000
USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of
mineral oil and white petrolatum.

Clinical Pharmacology

NystatinNystatin 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 AcetonideTriamcinolone 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 the topical corticosteroids. There is some evidence to
suggest that a recognizable correlation exists between vasoconstrictor potency
and therapeutic efficacy in man.PharmacokineticsThe 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 AcetonideDuring 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.

Indications And Usage

Nystatin and Triamcinolone Acetonide Cream and Ointment are
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.

Contraindications

These preparations are contraindicated in those patients with a
history of hypersensitivity to any of their components.

Precautions

  • GeneralSystemic absorption of topical corticosteroids has produced
  • Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations
  • Of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
  • Conditions that augment systemic absorption include application of the more
  • Potent steroids, use over large surface areas, prolonged use, and the addition
  • Of occlusive dressings (see DOSAGE AND
  • ADMINISTRATION).Therefore, patients receiving a large dose of any potent topical steroid
  • Applied to a large surface area should be evaluated periodically for evidence of
  • HPA axis suppression by using the urinary free cortisol and ACTH stimulation
  • Tests, and for impairment of internal homeostasis. If HPA axis suppression or
  • Elevation of the body temperature occurs, an attempt should be made to withdraw
  • The drug, to reduce the frequency of application, or substitute a less potent
  • Steroid.Recovery of HPA axis function and thermal homeostasis are generally prompt
  • And complete upon discontinuation of the drug. Infrequently, signs and symptoms
  • Of steroid withdrawal may occur, requiring supplemental systemic
  • Corticosteroids.Children may absorb proportionally larger amounts of topical corticosteroids
  • And thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use).If irritation or hypersensitivity develops with the combination nystatin and
  • Triamcinolone acetonide, treatment should be discontinued and appropriate
  • Therapy instituted.Information for the PatientPatients using this medication should receive the following
  • Information and instructions:This medication is to be used as directed by the physician. It is for
  • External use only. Avoid contact with the eyes.Patients should be advised not to use this medication for any disorder other
  • Than for which it was prescribed.The treated skin area should not be bandaged or otherwise covered or wrapped
  • As to be occluded (see DOSAGE AND
  • ADMINISTRATION).Patients should report any signs of local adverse reactions.When using this medication in the inguinal area, patients should be advised
  • To apply the cream or ointment sparingly and to wear loose fitting
  • Clothing.Parents of pediatric patients should be advised not to use tight-fitting
  • Diapers or plastic pants on a child being treated in the diaper area, as these
  • Garments may constitute occlusive dressings.Patients should be advised on preventive measures to avoid
  • Reinfection.Laboratory TestsIf there is a lack of therapeutic response, appropriate
  • Microbiological studies (e.g. KOH smears and/or cultures) should be repeated to
  • Confirm the diagnosis and rule out other pathogens, before instituting another
  • Course of therapy.A urinary free cortisol test and ACTH stimulation test may be helpful in
  • Evaluating hypothalamic-pituitary-adrenal (HPA) axis suppression due to
  • Corticosteroids.Carcinogenesis, Mutagenesis, and Impairment of
  • FertilityLong-term animal studies have not been performed to evaluate
  • Carcinogenic or mutagenic potential, or possible impairment of fertility in
  • Males or females.Pregnancy Category CThere 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.Nursing MothersIt is not known whether any component of this preparation is
  • Excreted in human milk. Because many drugs are excreted in human milk, caution
  • Should be exercised during the use of this preparation by a nursing woman.Pediatric UseIn 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
  • The least amount compatible with an effective therapeutic regimen. Chronic
  • Corticosteroid therapy may interfere with the growth and development of
  • Children.

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.

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.

Dosage And Administration

Nystatin and Triamcinolone Acetonide Cream is usually applied to
the affected areas twice daily in the morning and evening by gently and
thoroughly massaging the preparation into the skin. The cream should be
discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS, Laboratory Tests).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 Cream and Ointment should not be used
with occlusive dressings.

How Supplied

Nystatin and Triamcinolone Acetonide Ointment is supplied in 30 gram tubeNDC 54868-2470-0STORAGEStore at 20°-25°C (68°-77°F) [see USP
Controlled Room Temperature]. Avoid freezing.Mfd. by:Taro Pharmaceuticals Inc.,Brampton, Ontario, Canada L6T
1C1Revised: September, 2004PK-1111-2141Relabeling of "Additional" label by:Physicians Total Care, Inc.Tulsa, OK    74146

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