Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin and Triamcinolone Acetonide Ointment supplied in 15 gram, 30 gram and 60 gram tubes. 15 gram Tube NDC 33342-483-15 (1 tube per carton) 30 gram Tube NDC 33342-483-30 (1 tube per carton) 60 gram Tube NDC 33342-483-60 (1 tube per carton) STORAGE 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]. Avoid freezing. Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA Rev. 09/2021; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin and triamcinlone acetonide Ointment USP, 100000 units per gram and 1 mg/gram Pack Count: 15 gms Tube NDC: 33342-483-15 Nystatin and triamcinlone acetonide Ointment USP, 100000 units per gram and 1 mg/gram Pack Count: 15 gms Carton NDC: 33342-483-15 Nystatin and triamcinlone acetonide Ointment USP, 100000 units per gram and 1 mg/gram Pack Count: 30 gms Tube NDC: 33342-483-30 Nystatin and triamcinlone acetonide Ointment USP, 100000 units per gram and 1 mg/gram Pack Count: 30 gms Carton NDC: 33342-483-30 Nystatin and triamcinlone acetonide Ointment USP, 100000 units per gram and 1 mg/gram Pack Count: 60 gms Tube NDC: 33342-483-60 Nystatin and triamcinlone acetonide Ointment USP, 100000 units per gram and 1 mg/gram Pack Count: 60 gms Carton NDC: 33342-483-60 nyst-triam-tube-15gm-label nyst-triam-carton-15gm-label nyst-triam-tube-30gm-label nyst-triam-carton-30gm-label nyst-triam-tube-60gm-label nyst-triam-carton-60gm-label
- HOW SUPPLIED Nystatin and Triamcinolone Acetonide Ointment supplied in 15 gram, 30 gram and 60 gram tubes. 15 gram Tube NDC 33342-483-15 (1 tube per carton) 30 gram Tube NDC 33342-483-30 (1 tube per carton) 60 gram Tube NDC 33342-483-60 (1 tube per carton) STORAGE 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]. Avoid freezing. Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA Rev. 09/2021
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin and triamcinlone acetonide Ointment USP, 100000 units per gram and 1 mg/gram Pack Count: 15 gms Tube NDC: 33342-483-15 Nystatin and triamcinlone acetonide Ointment USP, 100000 units per gram and 1 mg/gram Pack Count: 15 gms Carton NDC: 33342-483-15 Nystatin and triamcinlone acetonide Ointment USP, 100000 units per gram and 1 mg/gram Pack Count: 30 gms Tube NDC: 33342-483-30 Nystatin and triamcinlone acetonide Ointment USP, 100000 units per gram and 1 mg/gram Pack Count: 30 gms Carton NDC: 33342-483-30 Nystatin and triamcinlone acetonide Ointment USP, 100000 units per gram and 1 mg/gram Pack Count: 60 gms Tube NDC: 33342-483-60 Nystatin and triamcinlone acetonide Ointment USP, 100000 units per gram and 1 mg/gram Pack Count: 60 gms Carton NDC: 33342-483-60 nyst-triam-tube-15gm-label nyst-triam-carton-15gm-label nyst-triam-tube-30gm-label nyst-triam-carton-30gm-label nyst-triam-tube-60gm-label nyst-triam-carton-60gm-label
Overview
Nystatin and Triamcinolone Acetonide Ointment, USP for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin, USP is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder, Freely soluble in dimethylformamide and in dimethyl sulfoxide; very slightly soluble in methanol; practically insoluble or insoluble in water, in alcohol, in n-propyl alcohol, in n-butyl alcohol, in chloroform and in ether. Structural formula: C 47 H 75 NO 17 MW= 926.13 Triamcinolone acetonide, USP 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, Sparingly soluble in dehydrated alcohol, in chloroform and in methanol, Practically insoluble in water. Structural formula: C 24 H 31 FO 6 MW= 434.50 Nystatin and Triamcinolone Acetonide Ointment USP, is a yellowish translucent ointment, Each gram of Nystatin and Triamcinolone Acetonide Ointment provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide USP in an ointment base of mineral oil and white petrolatum. structure-nystatin structure-triamcinolone
Indications & Usage
Nystatin and Triamcinolone Acetonide Ointment, USP 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 & Administration
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.
Warnings & Precautions
No warnings available yet.
Contraindications
These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.
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, perioral secondary infection, skin atrophy, striae and miliaria.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.