Triamcinolone (topical)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]
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Overview
Triamcinolone (topical) is a long-acting synthetic corticosteroid that is FDA approved for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Common adverse reactions include burning, itching, irritation, dryness, folliculitis and hypertrichosis.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage
- Topical corticosteroids are generally applied to the affected area as a thin film from two to four 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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
- There is limited information regarding Off-Label Guideline-Supported Use of Triamcinolone (topical) in adult patients.
Non–Guideline-Supported Use
- There is limited information regarding Off-Label Non–Guideline-Supported Use of Triamcinolone (topical) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Triamcinolone (topical) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
- There is limited information regarding Off-Label Guideline-Supported Use of Triamcinolone (topical) in pediatric patients.
Non–Guideline-Supported Use
- There is limited information regarding Off-Label Non–Guideline-Supported Use of Triamcinolone (topical) in pediatric patients.
Contraindications
- Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Warnings
Precautions
General
- Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria 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 a potent topical steroid 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.
Adverse Reactions
Clinical Trials Experience
- 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, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Postmarketing Experience
There is limited information regarding Triamcinolone (topical) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Triamcinolone (topical) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
- 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 the 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.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Triamcinolone (topical) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Triamcinolone (topical) during labor and delivery.
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.
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.
Geriatic Use
There is no FDA guidance on the use of Triamcinolone (topical) in geriatric settings.
Gender
There is no FDA guidance on the use of Triamcinolone (topical) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Triamcinolone (topical) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Triamcinolone (topical) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Triamcinolone (topical) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Triamcinolone (topical) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Triamcinolone (topical) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Triamcinolone (topical) Administration in the drug label.
Monitoring
There is limited information regarding Triamcinolone (topical) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Triamcinolone (topical) and IV administrations.
Overdosage
- Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.
Pharmacology
Mechanism of Action
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.
Structure
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(0xy)]-,(11β,16α)-. C24H31FO6, and M.W. of 434.51; CAS Reg. No.76-25-5.
Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Cream USP contains 0.25 mg, 1 mg, or 5 mg triamcinolone acetonide respectively, in a washable cream base of cetyl alcohol, cetyl esters wax, glycerin, glyceryl monostearate, isopropyl palmitate, polysorbate-60, propylene glycol, purified water, sorbic acid, and sorbitan monostearate.
Pharmacodynamics
There is limited information regarding Triamcinolone (topical) Pharmacodynamics in the drug label.
Pharmacokinetics
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 increase 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.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility - 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 had negative results.
Clinical Studies
There is limited information regarding Triamcinolone (topical) Clinical Studies in the drug label.
How Supplied
- Triamcinolone Acetonide Cream USP, 0.025% is available as follows:
- 15 g tube (NDC 45802-063-35)
- 80 g tube (NDC 45802-063-36)
- 454 g jar (NDC 45802-063-05)
- Triamcinolone Acetonide Cream USP, 0.1% is available as follows:
- 15 g tube (NDC 45802-064-35)
- 80 g tube (NDC 45802-064-36)
- 454 g jar (NDC 45802-064-05)
- Triamcinolone Acetonide Cream USP, 0.5% is available as follows:
- 15 g tube (NDC 45802-065-35)
Storage
- Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
- 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 the 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.
Precautions with Alcohol
Alcohol-Triamcinolone (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Triamcinolone (topical) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Triamcinolone (topical) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.