TRIAMCINOLONE ACETONIDE LOTION, USP 0.1%, FOR TOPICAL USE ONLY, Rx only

DESCRIPTION

id: 90a95089-beed-8dbb-8080-d49af875d3a5
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Triamcinolone Acetonide Lotion, USP is supplied in the following strength: 0.1%. Each mL of Triamcinolone Acetonide Lotion, USP, 0.1%, contains 1 mg triamcinolone acetonide, USP in a lotion base containing citric acid, cetyl alcohol, simethicone emulsion 30%, polysorbate 20, propylene glycol, purified water, sorbitan monopalmitate, and stearyl alcohol.

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

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

id: afd3ecec-74a2-17f0-4077-e86a25b12334
displayName: PHARMACOKINETICS SECTION
FDA Article Code: 43682-4

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 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 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 AND USAGE

id: 181d5d42-de54-6952-414d-b133e4cdc2e5
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: ebed6041-b7a3-41b7-6f5e-a0f6fac3a4f1
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.

General

id: 57cc36ac-f24e-22ff-ead8-163c3ec6f9f7
displayName: GENERAL PRECAUTIONS SECTION
FDA Article Code: 34072-9

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia and glycosuria in some patients.

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 PRECAUTIONS-Pediatric Use).

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

The following tests may be helpful in evaluating the HPA axis suppression:
          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

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

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

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts or for prolonged periods of time.

Nursing Mothers

id: d98396bd-fa64-991d-7a95-d673d1da52c1
displayName: NURSING MOTHERS SECTION
FDA Article Code: 34080-2

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.

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

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

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

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                                   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
www.fda.gov/medwatch
.

OVERDOSAGE

id: 29174136-6e23-6795-fcc2-e2344eaba4ac
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: ee19ecd8-b6e9-6c02-43d8-971dcdab5675
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: 0ba02887-d304-be16-f21c-521e4f4f49ab
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone Acetonide Lotion, USP 0.1% is supplied in the following size: 60 mL.

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