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what is nystatin and triamcinolone acetonide ointment used to treat?

What is Nystatin and Triamcinolone Acetonide and how is it used?

Nystatin and Triamcinolone Acetonide is a prescription medicine used to treat the symptoms of fungal or yeast infections on the skin (Cutaneous Candidiasis). Nystatin and Triamcinolone Acetonide may be used alone or with other medications.

Nystatin and Triamcinolone Acetonide belongs to a class of drugs called Antifungal/Corticosteroid Topicals.

What are the possible side effects of Nystatin and Triamcinolone Acetonide?

Nystatin and Triamcinolone Acetonide may crusade serious side effects including:

  • blurred vision,
  • tunnel vision,
  • eye hurting,
  • seeing halos around lights,
  • nausea,
  • vomiting,
  • loss of appetite,
  • weight gain or loss,
  • muscle weakness,
  • worsening tiredness,
  • lightheadedness,
  • feet,
  • depression,
  • irritability,
  • slow wound healing,
  • severe skin irritation where the medication was applied, and
  • signs of skin infection (swelling, redness, warmth, oozing)

Get medical help right away, if you have any of the symptoms listed above.

The nearly common side furnishings of Nystatin and Triamcinolone Acetonide include:

  • increased hair growth,
  • burning or itching of treated skin,
  • skin dryness or irritation,
  • acne,
  • pare rash,
  • redness or crusting effectually your hair follicles,
  • lightened colour of treated peel,
  • stretch marks, and
  • white or "pruned" advent of the pare (caused past leaving wound dressings on for long periods of fourth dimension)

Tell the doctor if you take any side event that bothers y'all or that does non become abroad.

These are non all the possible side effects of Nystatin and Triamcinolone Acetonide. For more information, ask your doctor or pharmacist.

FOR EXTERNAL USE Only. NOT FOR OPHTHALMIC Utilise.

DESCRIPTION

Nystatin and Triamcinolone Acetonide Cream, USP for dermatologic utilize contains 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-similar odor, very slightly soluble in h2o, and slightly to sparingly soluble in alcohol. It has a structural formula of C47H75NO17 and a molecular weight of 926.13.

Nystatin - Structural Formula Illustration

Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-i,four-diene-3,20-dione circadian 16, 17-acetal with acetone. The white to cream crystalline pulverisation has a slight odor, is practically insoluble in water, and very soluble in alcohol. Information technology has a structural formula of C24H31FOhalf dozen and a molecular weight of 434.50.

Triamcinolone - Structural Formula Illustration

Nystatin and Triamcinolone Acetonide Foam, USP is a soft, smooth cream having a light xanthous color. Each gram provides 100,000 Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous perfumed vanishing cream base of operations containing aluminum hydroxide rehydragel, barcroft aluminum hydroxide gel, cetearyl alcohol (and) ceteareth-20, glyceryl monostearate, polyethylene glycol monostearate, propylene glycol, simethicone emulsion, sorbic acid, sorbitol solution, titanium dioxide, and white petrolatum.

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INDICATIONS

Nystatin and Triamcinolone Acetonide Cream, USP is indicated for the handling of cutaneous candidiasis; information technology has been demonstrated that the nystatin-steroid combination provides greater do good than the nystatin component alone during the first few days of treatment.

DOSAGE AND ADMINISTRATION

Nystatin and Triamcinolone Acetonide Cream is usually applied to the afflicted areas twice daily in the morning and the evening by gently and thoroughly massaging the preparation into the skin. The cream should be discontinued if symptoms persist afterward 25 days of therapy (come across PRECAUTIONS, Laboratory Tests).

Nystatin and Triamcinolone Acetonide Cream should not exist used with occlusive dressings.

HOW SUPPLIED

Nystatin and Triamcinolone Acetonide Cream, USP is supplied in xv g, 30 g, and threescore chiliad tubes.

Storage

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Avoid freezing.

Manufactured by: Chiliad&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 U.s.a.. Revised: Jul 2016

QUESTION

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Side Effects & Drug Interactions

SIDE EFFECTS

A single case (approximately one percent of patients studied) of acneiform eruption occurred with apply 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 post-obit local agin reactions are reported infrequently with topical corticosteroids (reactions are listed in an guess decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the peel, perioral secondary infection, pare atrophy, striae and miliaria.

To study SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories , Inc. at 1-800- 922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

No information provided.

WARNINGS

No information provided.

PRECAUTIONS

General

Systemic assimilation of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) centrality suppression, manifestations of Cushing'south syndrome, hyperglycemia, and glucosuria in some patients. Conditions that augment systemic assimilation include application of the more than potent steroids, use over large surface areas, prolonged utilise, and the addition of occlusive dressings (see DOSAGE AND Assistants).

Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary gratuitous cortisol and ACTH stimulation tests, and for impairment of internal homeostasis. If HPA axis suppression or summit of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of awarding, 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 advisable therapy instituted.

Laboratory Tests

If in that location is a lack of therapeutic response, appropriate microbiological studies (due east.k., KOH smears and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens, before instituting some other course of therapy.

A urinary free cortisol exam and ACTH stimulation exam may be helpful in evaluating hypothalamicpituitary- adrenal (HPA) centrality suppression due to corticosteroids.

Carcinogenesis, Mutagenesis, And Damage Of Fertility

Long-term animal studies accept not been performed to evaluate the carcinogenic or mutagenic potential or possible impairment of fertility in males or females.

Pregnancy

Teratogenic Effects

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 stiff corticosteroids have been shown to exist teratogenic after dermal awarding in laboratory animals. Therefore, whatever topical corticosteroid grooming should exist used during pregnancy just if the potential benefit justifies the potential risk to the fetus.

Topical preparations containing corticosteroids should not be used extensively on significant patients, in big amounts, or for prolonged periods of time.

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 utilise of this grooming by a nursing woman.

Pediatric Utilise

In clinical studies of a limited number of pediatric patients ranging in age 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 area to body weight ratio.

HPA axis suppression, Cushing'due south syndrome, and intracranial hypertension accept been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, depression 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 corporeality compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Overdosage & Contraindications

OVERDOSE

Topically applied corticosteroids can exist absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General); yet, astute overdosage and serious adverse effects with dermatologic use are unlikely.

CONTRAINDICATIONS

This training is contraindicated in those patients with a history of hypersensitivity to any of its components.

CLINICAL PHARMACOLOGY

Nystatin

Nystatin exerts its antifungal activity confronting a multifariousness 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 every bit a selective barrier. Nystatin provides specific anticandidal action to Candida (Monilia) albicans and other Candida species, just it is non 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, anti-pruritic and vasoconstrictive deportment, characteristic of the topical corticosteroid form of drugs. The pharmacological furnishings of the topical corticosteroids are well known; even so, 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 bear witness to propose 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 bulwark, and the use of occlusive dressings (encounter DOSAGE AND Assistants).

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the peel increase percutaneous absorption. Occlusive dressings substantially increment the percutaneous absorption of topical corticosteroids (encounter DOSAGE AND ADMINISTRATION).

One time captivated 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 likewise 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 pruritis than patients treated with nystatin or triamcinolone acetonide lonely.

PATIENT Data

Patients using this medicine should receive the following information and instructions.

  1. This medication is to be used every bit directed by the medico. It is for external use only. Avoid contact with the eyes.
  2. Patients should exist advised not to use this medication for any disorder other than for which it was prescribed.
  3. The treated skin area should not be bandaged or otherwise covered or wrapped every bit to be occluded (encounter DOSAGE AND Administration).
  4. Patients should written report any signs of local agin reactions.
  5. When using this medication in the inguinal area, patients should be advised to apply cream sparingly and to wear loose fitting vesture.
  6. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a kid beingness treated in the diaper expanse, as these garments may constitute occlusive dressings.
  7. Patients should be brash on preventative measures to avert reinfection.

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