DESCRIPTION
id: 59645ba3-95ec-4125-be9a-08bff79fbb0c
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Triamcinolone Acetonide Lotion, USP is supplied in the following strengths: 0.025%, 0.1%. Each mL of 0.025% and 0.1% Triamcinolone Acetonide Lotion provides 0.25 mg and 1 mg triamcinolone acetonide, USP respectively, in a lotion base containing citric acid anhydrous, cetyl alcohol, simethicone, polysorbate 20, propylene glycol, purified water, sorbitan monopalmitate and stearyl alcohol.
Triamcinolone Acetonide is a topical corticosteroid known chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1,4- diene-3,20-dione cyclic 16,17-acetal with acetone.
The molecular formula is C24H31FO6. It has the following structure:
CLINICAL PHARMACOLOGY
id: 15861317-7e16-4a4c-8971-069944a5dcdf
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: 1b16ee3b-6ebf-4e66-8127-00affa117b60
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: dcffbdc8-f22f-40cc-87f8-f320d929c4da
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: f93e9ee8-45ea-422d-b54d-47f94d47bfb1
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
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Hypertrichosis
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Maceration of the skin
|
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Itching
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Acneiform eruptions
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Secondary infection
|
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Irritation
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Hypopigmentation
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Skin Atrophy
|
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Dryness
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Perioral dermatitis
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Striae
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Folliculitis
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Allergic contact dermatitis
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Miliaria
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OVERDOSAGE
id: 8762cbcc-1204-4fc4-9f26-909a4525a958
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: dae52c52-9f3e-4fb6-9b9b-40cb0aa18888
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Topical corticosteroids are generally applied to the affected area as a thin film from three to four times daily depending on the severity of the condition.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
HOW SUPPLIED
id: 80f80ada-efe9-48bf-93ff-bae08ee56002
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
Triamcinolone Acetonide Lotion USP, 0.1% is supplied in the following size: 60 mL (NDC 61748-220-60).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
AVOID FREEZING
SHAKE WELL BEFORE USING
Rx only
Manufactured by:
Ei LLC
Kannapolis, NC 28083
Marketed by:
VersaPharm Incorporated
Marietta, GA 30062
IVP22060-00
Issued: 05-17-2013
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-0.025% 60 mL Bottle Label
id: beeed793-e59b-429e-acec-112e0a9f4c92
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 61748-219-60
TRIAMCINOLONE
ACETONIDE
LOTION, USP 0.025%
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
Rx Only
NET: 60 mL
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-0.1% 60 mL Bottle Label
id: 4244b91a-d4c3-4b9c-9861-a01eea309abd
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 61748-220-60
TRIAMCINOLONE
ACETONIDE
LOTION, USP 0.1%
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
Rx Only
NET: 60 mL
