NYSTATIN AND TRIAMCINOLONE ACETONIDE- nystatin and triamcinolone acetonide_ointment

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 albicans Candida 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 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.

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.

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.

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.

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

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.
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.
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.

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. For Dermatologic Use Only. Not for Ophthalmic Use. Manufactured for: Aleor Dermaceuticals Ltd., Karakhadi, Vadodara 391450 India. Manufactured by: Aleor Dermaceuticals Ltd., Karakhadi, Vadodara 391450 India. Mfg License. No.: G/25/2216 Revised: 3/2022

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.
OVERDOSAGE
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General

Aleor Dermaceuticals Limited

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