Triamcinolone Acetonide Ointment USP, 0.5%, For Dermatologic Use Only, Not For Ophthalmic Use

DESCRIPTION

id: 6988b4be-1963-8286-e053-2991aa0a5f0f
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. Triamcinolone acetonide is designated chemically as 9-fluoro-11b, 16a,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. C
₂₄H
₃₁FO
₆, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.5% contains 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum.

CLINICAL PHARMACOLOGY

id: 6985b062-b225-4b97-e053-2991aa0ae06a
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.

INDICATIONS AND USAGE

id: 6985b062-b227-4b97-e053-2991aa0ae06a
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

id: 6985b062-b228-4b97-e053-2991aa0ae06a
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 preparations.

ADVERSE REACTIONS

id: 6985b062-b233-4b97-e053-2991aa0ae06a
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. To report
SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

id: 6985b062-b234-4b97-e053-2991aa0ae06a
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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

DOSAGE AND ADMINISTRATION

id: 6985b062-b235-4b97-e053-2991aa0ae06a
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Apply a thin film of triamcinolone acetonide ointment 0.5%, as appropriate, to the affected area two to three times daily.

OCCLUSIVE DRESSING TECHNIQUE

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Apply a thin film of ointment to the lesion, cover with a 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 ointment 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 ointment 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. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

id: 6985b062-b236-4b97-e053-2991aa0ae06a
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone Acetonide Ointment USP, 0.5% is available as follows: 15 g tube (NDC 52565-048-15)

STORAGE

id: 6985b062-b237-4b97-e053-2991aa0ae06a
displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Mfd. and Dist by:

Teligent Pharma, Inc.

Buena, NJ 08310

Revised: 12/16