DESCRIPTION
id: 61cc9ff8-2b6b-4f87-a313-5f7c66fc4c36
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide.
Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5.
The structural formula is:
Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.
Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.
Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.
CLINICAL PHARMACOLOGY
id: c47994e2-2829-40c3-952a-98c172d8cb9b
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is 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. 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. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (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.
INDICATIONS & USAGE
id: 86b00bc7-05b4-4ca8-9efd-f714f6ef3d16
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Triamcinolone cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
CONTRAINDICATIONS
id: 8121aaae-27d5-437c-881b-cf7428b94673
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
ADVERSE REACTIONS
id: 26037f7a-73ec-407b-9a8e-fd52ae2a9f0e
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These 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.
OVERDOSAGE
id: 37c53324-da55-4fca-8219-f093ebf13752
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).
DOSAGE & ADMINISTRATION
id: 933d604b-4c8f-4368-aca7-572829b2c550
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Apply Triamcinolone Acetonide Cream 0.025% to the affected area two to four times daily. Rub in gently.
Apply the 0.1% or the 0.5% Triamcinolone Acetonide Cream, as appropriate, to the affected area two to three times daily. Rub in gently.
Occlusive Dressing Technique
Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream into the lesion until it disappears.
Reapply the preparation leaving a thin coating on the lesion, cover with pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply triamcinolone acetonide cream under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
HOW SUPPLIED
id: 8637f156-408e-4078-ba9f-bd9395cec2f8
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Triamcinolone Acetonide Cream USP, 0.025%15 gram tubes NDC 33342-327-1580 gram tubes NDC 33342-327-80Triamcinolone Acetonide Cream USP, 0.1%15 gram tubes NDC 33342-329-1580 gram tubes NDC 33342-329-801 Lb jars NDC 33342-329-54Triamcinolone Acetonide Cream USP, 0.5%15 gram tubes NDC 33342-328-15Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing.Manufactured for: Macleods Pharma USA, Inc.Plainsboro, NJ 08536Manufacturer:Macleods Pharmaceuticals LimitedAt Oxalis Labs
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
id: 82622a16-fcdd-4552-9901-68f7c30e1808
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Rx only
Triamcinolone Acetonide Cream, 0.025%, 15 grams tube
NDC: 33342-327-15
Rx only
Triamcinolone Acetonide Cream, 0.025%, 15 grams carton
NDC: 33342-327-15
Rx only
Triamcinolone Acetonide Cream, 0.025%, 80 grams tube
NDC: 33342-327-80
Rx only
Triamcinolone Acetonide Cream, 0.025%, 80 grams carton
NDC: 33342-327-80
Rx only
Triamcinolone Acetonide Cream, 0.1%, 15 grams tube
NDC: 33342-329-15
Rx only
Triamcinolone Acetonide Cream, 0.1%, 15 grams carton
NDC: 33342-329-15
Rx only
Triamcinolone Acetonide Cream, 0.1%, 80 grams tube
NDC: 33342-329-80
Rx only
Triamcinolone Acetonide Cream, 0.1%, 80 grams carton
NDC: 33342-329-80
Rx only
Triamcinolone Acetonide Cream, 0.1%, 454 grams jar
NDC: 33342-329-54
Rx only
Triamcinolone Acetonide Cream, 0.5%, 15 grams tube
NDC: 33342-328-15
Rx only
Triamcinolone Acetonide Cream, 0.5%, 15 grams carton
NDC: 33342-328-15
