triamcinolone acetonide 0.1 % Topical Cream
Generic Name: TRIAMCINOLONE ACETONIDE
Brand Name: Triamcinolone acetonide
- Substance Name(s):
- TRIAMCINOLONE ACETONIDE
OVERDOSAGE
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.
Triamcinolone acetonide is a member of this class.
Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a).
Its structural formula is: Each gram of Triamcinolone Acetonide Cream USP, 0.025 % contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.
Each gram of Triamcinolone Acetonide Cream USP, 0.1 % contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.
Each gram of Triamcinolone Acetonide Cream USP, 0.5 % contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.
Triamcinolone Acetonide Structure
HOW SUPPLIED
Triamcinolone acetonide cream USP 0.1% is supplied in 30 GRAM in a TUBE (0440-0251-30) 45 GRAM in a JAR (0440-0251-45) 80 GRAM in a TUBE (0440-0251-80) 15 GRAM in a TUBE (0440-0251-15) Store at 20-25°C (68°-77°F) [see USP Controlled Room Temperature].
Avoid excessive heat.
Protect from freezing.
PRINTED IN USA Packaged by: AIDAREX PHARMACEUTICALS LLC.
CORONA, CA 92880.
Revised: 07/2016
INDICATIONS AND USAGE
INDICATIONS & USAGE Triamcinolone acetonide cream 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, Cushings’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 not 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.
NUSRING MOTHERS
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
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 for which it was prescribed.
The treated skin area should not be bandaged or otherwise covered or wrapped 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
DOSAGE & ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film from two to three times daily depending on the severity of the condition.
Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted.