Nystatin And Triamcinolone Acetonide
Nystatin And Triamcinolone Acetonide Prescribing Information
Nystatin and Triamcinolone Acetonide Cream 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.
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
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.
Nystatin and Triamcinolone Acetonide Cream should not be used with occlusive dressings.
These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.
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.
Nystatin and Triamcinolone Acetonide Cream for dermatologic use 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 like odor, practically insoluble in water and 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 crystalline powder is practically insoluble in water, and very soluble in alcohol. Structural formula:
Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a yellow to tan color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate.
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
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
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).
Nystatin and Triamcinolone Acetonide Cream should not be used with occlusive dressings.
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
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).
Nystatin and Triamcinolone Acetonide Cream should not be used with occlusive dressings.
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.