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Trianexointment.com

INDICATIONS AND USAGE
(Triamcinolone Acetonide Ointment, USP)
Trianex® 0.05% (Triamcinolone Acetonide Proprietary Hydrous Emulsifi ed Base
Ointment, USP) is indicated for the relief of the infl ammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Topical corticosteroids, such as Trianex® 0.05% Trianex® 0.05% (Triamcinolone Acetonide Oint- (Triamcinolone Acetonide Ointment, USP), ment, USP) is contraindicated in those patients constitute a class of primarily synthetic ste- with a history of hypersensitivity to any of the roids used as anti-infl ammatory and antipruritic components of the preparation. PRECAUTIONS
Each gram of Trianex® 0.05% (Triamcinolone Acetonide Ointment, USP) contains 0.5 mg Systemic absorption of topical corticosteroids of Triamcinolone Acetonide USP in a water- has produced reversible hypothalamic-pituitary- in-oil emulsion composed of Light Mineral adrenal (HPA) axis suppression, manifestations Oil NF, Purifi ed Water USP, White Petrolatum of Cushing's syndrome, hyperglycemia, and USP, Heavy Mineral Oil USP, Mineral Wax, and glucosuria in some patients. Lanolin Alcohols NF. The white ointment is for topical use only.
Conditions which augment systemic absorption include the application of the more potent ste- Triamcinolone Acetonide has the molecular roids, use over large surface areas, prolonged formula of C H FO and is designated chemically use, and the addition of occlusive dressings.
as Pregna- 1, 4-diene-3, 20-dione, 9-fl uoro-11, 21- dihydroxy - 16, 17- [(1-methylethylidene)bis Therefore, patients receiving a large dose of a (oxy)]-, (11ß, 16α)-. It has a molecular weight potent topical steroid applied to a large surface of 434.50 and the following structural formula: 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 sup-pression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent Topical corticosteroids share anti-infl am- Recovery of HPA axis function is generally matory, antipruritic and vasoconstrictive prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of The mechanism of anti-infl ammatory activity steroid withdrawal may occur, requiring supple-of the topical corticosteroids is unclear. Various mental systemic corticosteroids.
laboratory methods, including vasoconstrictor Children may absorb proportionally larger assays, are used to compare and predict poten- amounts of topical corticosteroids and thus be cies and/or clinical effi cacies of the topical corti- more susceptible to systemic toxicity (see PRE-
costeroids. There is some evidence to suggest CAUTIONS-Pediatric Use).
that a recognizable correlation exists between If irritation develops, topical corticosteroids vasoconstrictor potency and therapeutic effi - should be discontinued and appropriate thera- cacy in man.
py instituted.
In the presence of dermatological infections, The extent of percutaneous absorption of top- the use of an appropriate antifungal or antibac- ical corticosteroids is determined by many terial agent should be instituted. If a favorable factors including the vehicle, the integrity of response does not occur promptly, the cortico- the epidermal barrier, and the use of occlusive steroid should be discontinued until the infec- tion has been adequately controlled.
Topical corticosteroids can be absorbed from normal intact skin. Infl ammation and/or other Information for the Patient
Patients using topical corticosteroids should re- disease processes in the skin increase per- ceive the following information and instructions: cutaneous absorption. Occlusive dressings substantially increase the percutaneous ab- 1. This medication is to be used as directed sorption of topical corticosteroids. Thus, oc- by the physician. It is for external use only. clusive dressings may be a valuable therapeutic Avoid contact with the eyes.
adjunct for treatment of resistant dermatoses 2. Patients should be advised not to use this (see DOSAGE AND ADMINISTRATION). Once
medication for any disorder other than that absorbed through the skin, topical corticoste- for which it was prescribed.
roids are handled through pharmacokinetic pathways similar to systemically administered 3. The treated skin area should not be ban-corticosteroids. Corticosteroids are bound to daged or otherwise covered or wrapped plasma proteins in varying degrees. Corticoste- so as to be occlusive unless directed by the roids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the 4. Patients should report any signs of local ad- topical corticosteroids and their metabolites are verse reactions especially under occlusive also excreted into the bile.
51579_CMP_8pt.indd 1 51579_CMP_8pt.indd 1 5. Parents of pediatric patients should be advised not to use tight-fi tting diapers or The following local adverse reactions are plastic pants on a child being treated in the reported infrequently with topical corticoste-diaper area, as these garments may consti- roids, but may occur more frequently with the tute occlusive dressings.
use of occlusive dressings. These reactions are listed in an approximate decreasing order The following tests may be helpful in evaluating of occurrence:the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis and
Impairment of Fertility
Long-term animal studies have not been Acneiform eruptions performed to evaluate the carcinogenic potential or the effect on fertility of topical Perioral dermatitis Allergic contact dermatitis Studies to determine mutagenicity with pred- Maceration of the skin nisolone and hydrocortisone have revealed Secondary infection negative results.
Pregnancy Category C
Corticosteroids are generally teratogenic in laboratory animals when administered sys- temically at relatively low dosage levels. The Topically applied corticosteroids can be ab-
more potent corticosteroids have been shown sorbed in suffi cient amounts to produce sys-
to be teratogenic after dermal application in temic effects (see PRECAUTIONS).
laboratory animals. There are no adequate and
DOSAGE AND ADMINISTRATION
well-controlled studies in pregnant women on Trianex® 0.05% (Triamcinolone Acetonide teratogenic effects from topically applied cor- Ointment, USP) is generally applied to the ticosteroids. Therefore, topical corticosteroids affected area as a thin fi lm from two to four should be used during pregnancy only if the times daily depending on the severity of the potential benefi t justifi es the potential risk to condition.
the fetus. Drugs of this class should not be used extensively on pregnant patients, in large Occlusive dressings may be used for the man-amounts, or for prolonged periods of time.
agement of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive It is not known whether topical administration dressings should be discontinued and appro-of corticosteroids could result in suffi cient sys- priate antimicrobial therapy instituted.
temic absorption to produce detectable quan- HOW SUPPLIED
tities in breast milk. Systemically administered Trianex® 0.05% (Triamcinolone Acetonide
corticosteroids are secreted into breast milk in Ointment, USP) is supplied in 430 g jars (NDC
quantities not likely to have a deleterious effect 67857-806-19).
on the infant. Nevertheless, caution should be KEEP THIS AND ALL DRUGS OUT OF THE
exercised when topical corticosteroids are ad- REACH OF CHILDREN.
ministered to a nursing woman.
You may report side effects to FDA at 1-800-
FDA-1088. You may also report side effects to
Pediatric patients may demonstrate greater Promius Pharma, LLC at 1-888-966-8766.
susceptibility to topical corticosteroid-in-
duced HPA axis suppression and Cushing's STORE
syndrome than mature patients because of a TEMPERATURE 15°– 30° C (59°– 86° F).
larger skin surface area to body weight ratio.
DISPENSE IN A WELL-CLOSED CONTAINER.
Hypothalamic-pituitary-adrenal (HPA) axis CAUTION: Federal law prohibits dispensing
suppression, Cushing's syndrome and in-
without prescription tracranial hypertension have been reported For external use only.
in children receiving topical corticosteroids. Not for ophthalmic use.
Manifestations of adrenal suppression in chil-dren include linear growth retardation, delayed Distributed by:weight gain, low plasma cortisol levels, and ab- Promius Pharma, LLC sence of response to ACTH stimulation. Man- Princeton, NJ 08540 ifestations of intracranial hypertension include Manufactured by: bulging fontanelles, headaches, and bilateral CMP Pharma, Inc.
Farmville, NC 27828 Administration of topical corticosteroids to children should be limited to the least amount Trianex is a registered trademark ofcompatible with an effective therapeutic reg- CMP Pharma, Inc.
imen. Chronic corticosteroid therapy may interfere with the growth and development of 006735 51579_CMP_8pt.indd 2 51579_CMP_8pt.indd 2

Source: http://trianexointment.com/PI.pdf