Nystatin, Triamcinolone Acetonide
FDA Drug Information • Also known as: Nystatin And Triamcinolone Acetonide
- Brand Names
- Nystatin And Triamcinolone Acetonide
- Drug Class
- Polyene Antifungal [EPC], Corticosteroid [EPC]
- Route
- TOPICAL
- Dosage Form
- CREAM
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION: 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, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula: C 47 H 75 N0 17 MW = 926.13 Triamcinolone acetonide is designated chemically as 9-fluoro-11ß, 16ɑ, 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: C 24 H 31 F0 6 MW = 434.50 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 a cream base with aluminum hydroxide, cetearyl alcohol and ceteareth 20, glyceryl monostearate, methylparaben, polyethylene glycol monostearate, polysorbate 60, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium hydroxide, sorbic acid, sorbitol, titanium dioxide, and white petrolatum. structural formula 1.jpg structural formula 2.jpg
What Is Nystatin, Triamcinolone Acetonide Used For?
INDICATIONS AND USAGE: 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.
Dosage and Administration
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). Nystatin and Triamcinolone Acetonide Cream should not be used with occlusive dressings.
Side Effects (Adverse Reactions)
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, secondary infection, skin atrophy, striae and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Contraindications
CONTRAINDICATIONS: This preparation is contraindicated in those patients with a history of hypersensitivity to any of its components.
Overdosage
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.
How Supplied
HOW SUPPLIED: Nystatin and Triamcinolone Acetonide Cream is supplied in 30 g (NDC 68071-2491-3) tubes. STORAGE: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing. Made in Israel Manufactured By Perrigo Yeruham, Israel Distributed By Perrigo® Allegan, MI 49010
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.