Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
Topical corticosteroids, such as Trianex™ 0.05% (Triamcinolone Acetonide Ointment, USP), constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.
Each gram of Trianex™ 0.05% (Triamcinolone Acetonide Ointment, USP) contains 0.5 mg of Triamcinolone Acetonide USP in a water-in-oil emulsion composed of Light Mineral Oil NF, Purified Water USP, White Petrolatum USP, Heavy Mineral Oil USP, Mineral Wax, and Lanolin Alcohols NF.
The white ointment is for topical use only.
Triamcinolone Acetonide has the molecular formula of C 24 H 31 FO 6 and is designated chemically as Pregna-1,4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-, (11β, 16α)-.
It has a molecular weight of 434.50 and the following structural formula: Chemical Structure
Trianex™ 0.05% ( Triamcinolone Acetonide Ointment, USP ) is supplied in 17 g tubes (NDC 0245-0136-17) and 85 g tubes (NDC 0245-0136-85).
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Upsher-Smith Laboratories at 1-888-650-3789.
STORE AT CONTROLLED ROOM TEMPERATURE 15°-30° C (59°-86° F).
Dispense in a well-closed container.
CAUTION: For external use only.
Not for ophthalmic use.
INDICATIONS AND USAGE
Trianex™ 0.05% ( Triamcinolone Acetonide Ointment ) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Pediatric Use 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.
Hypothalamic-pituitary-adrenal (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.
Pregnancy Category C 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 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 a nursing woman.
INFORMATION FOR PATIENTS
Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician.
It is for external use only.
Avoid contact with the eyes.
Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
Patients should report any signs of local adverse reactions especially under occlusive dressing.
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.
DOSAGE AND ADMINISTRATION
Trianex™ 0.05% ( Triamcinolone Acetonide Ointment, USP ) is generally applied to the affected area as a thin film from two 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.