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NYSTATIN AND TRIAMCINOLONE
Overview
What is NYSTATIN AND TRIAMCINOLONE?
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:
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.
What does NYSTATIN AND TRIAMCINOLONE look like?
What are the available doses of NYSTATIN AND TRIAMCINOLONE?
Sorry No records found.
What should I talk to my health care provider before I take NYSTATIN AND TRIAMCINOLONE?
Sorry No records found
How should I use NYSTATIN AND TRIAMCINOLONE?
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.
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 ).
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 ).
Nystatin and Triamcinolone Acetonide Cream and Ointment should not be used
with occlusive dressings.
What interacts with NYSTATIN AND TRIAMCINOLONE?
These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.
What are the warnings of NYSTATIN AND TRIAMCINOLONE?
Sorry No Records found
What are the precautions of NYSTATIN AND TRIAMCINOLONE?
Systemic 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 ).
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 ).
If irritation or hypersensitivity develops with the combination nystatin and
triamcinolone acetonide, treatment should be discontinued and appropriate
therapy instituted.
Information for the Patient
Patients using this medication should receive the following information and instructions:
Information for the Patient
Laboratory Tests
If 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.
Laboratory Tests
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Pregnancy Category C
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.
Pregnancy Category C
Nursing Mothers
It 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.
Nursing Mothers
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 the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
Pediatric Use
What are the side effects of NYSTATIN AND TRIAMCINOLONE?
Sorry No records found
What should I look out for while using NYSTATIN AND TRIAMCINOLONE?
These preparations are contraindicated in those patients with a
history of hypersensitivity to any of their components.
What might happen if I take too much NYSTATIN AND TRIAMCINOLONE?
Topically applied corticosteroids can be absorbed in sufficient
amounts to produce systemic effects (see ); however, acute overdosage
and serious adverse effects with dermatologic use are unlikely.
How should I store and handle NYSTATIN AND TRIAMCINOLONE?
Store at 20° to 25°C (68° - 77°F) [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container. A Schedule Controlled Substance. Store at 20° to 25°C (68° - 77°F) [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container. A Schedule Controlled Substance. Store at 20° to 25°C (68° - 77°F) [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container. A Schedule Controlled Substance. Gemfibrozil Tablets, USP are supplied as white, oval, film-coated, scored, engraved with 'WW45' tablets, each containing 600 mg gemfibrozil, and available as follows:Bottles of 30Bottles of 60Bottles of 500Gemfibrozil Tablets, USP are supplied as white, oval, film-coated, scored, engraved with 'WW45' tablets, each containing 600 mg gemfibrozil, and available as follows:Bottles of 30Bottles of 60Bottles of 500
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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
(Monilia)
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 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.
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 ).
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 ).
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.
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.
Non-Clinical Toxicology
These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.Systemic 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 ).
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 ).
If irritation or hypersensitivity develops with the combination nystatin and triamcinolone acetonide, treatment should be discontinued and appropriate therapy instituted.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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