
Prescription Drug Name:
TRIAMCINOLONE ACETONIDE LOTION, USP 0.1%, FOR TOPICAL USE ONLY, Rx only
ID:
82c1efdd-243b-eba5-a456-81694185dd74
Code:
34391-3
DESCRIPTION
id: 90a95089-beed-8dbb-8080-d49af875d3a5
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Triamcinolone Acetonide is a topical corticosteroid known chemically as 9-Fluoro-11β, 16 α, 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: b528e218-7e38-c1bc-1f5c-6590f8189cde
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Pharmacokinetics
id: afd3ecec-74a2-17f0-4077-e86a25b12334
displayName: PHARMACOKINETICS SECTION
FDA Article Code: 43682-4
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increases 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
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 AND USAGE
id: 181d5d42-de54-6952-414d-b133e4cdc2e5
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
CONTRAINDICATIONS
id: ebed6041-b7a3-41b7-6f5e-a0f6fac3a4f1
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
General
id: 57cc36ac-f24e-22ff-ead8-163c3ec6f9f7
displayName: GENERAL PRECAUTIONS SECTION
FDA Article Code: 34072-9
Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use and the addition of occlusive dressings.
Therefore, patients receiving a large dose of potent topical steroids, applied to a large surface area or under an occlusive dressing, should be evaluated periodically for evidence of HPA axis suppression by using the urinary-free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
These preparations are not for ophthalmic use. Information for the Patient
Patients using topical corticosteroids should receive the following information and instructions:
1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with
the eyes.
2. Patients should be advised not to use this medication for any disorder other than for which it was
prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive,
unless directed by a physician.
4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child
being treated in the diaper area, as these garments may constitute occlusive dressings.
Laboratory Tests
id: 2c6be15d-c081-a855-158d-5980defaa3f5
displayName: LABORATORY TESTS SECTION
FDA Article Code: 34075-2
Urinary-free cortisol test
ACTH stimulation
Carcinogenesis, Mutagenesis, and Impairment of Fertility
id: 77708a41-66a2-b3cb-4ff6-b6d0b16f2032
displayName: CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION
FDA Article Code: 34083-6
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
Pregnancy Category C
id: efe85038-1df0-8b5f-ce09-42a5ce35f244
displayName: PREGNANCY SECTION
FDA Article Code: 42228-7
Nursing Mothers
id: d98396bd-fa64-991d-7a95-d673d1da52c1
displayName: NURSING MOTHERS SECTION
FDA Article Code: 34080-2
Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to nursing women.
Pediatric Use
id: bd100526-3e22-841c-7957-0dde93f56152
displayName: PEDIATRIC USE SECTION
FDA Article Code: 34081-0
HPA axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
ADVERSE REACTIONS
id: 94cadb3f-cef8-679e-3e97-ca3eec1adc20
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Burning Perioral dermatitis
Itching Allergic contact dermatitis
Irritation Maceration of the skin
Dryness Secondary infection
Folliculitis Skin Atrophy
Hypertrichosis Striae
Acneiform eruptions Miliaria
Hypopigmentation
To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or
OVERDOSAGE
id: 29174136-6e23-6795-fcc2-e2344eaba4ac
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
DOSAGE AND ADMINISTRATION
id: ee19ecd8-b6e9-6c02-43d8-971dcdab5675
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
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: 0ba02887-d304-be16-f21c-521e4f4f49ab
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. AVOID FREEZING.
SHAKE WELL BEFORE USING
Rx Only
Manufactured For:
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080
Rev. 07/2015
8-0676GW2
Triamcinolone Acetonide Lotion, USP 0.1 %
NDC 0713-0676-53
60 mL Bottle
id: 8a8618a3-6d58-67e1-69d8-dac4020fbb20
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4