What Is Triamcinolone Acetonide Cream 0.1 Used to Treat?

Description

The topical corticosteroids institute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this course include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-Fluoro-11β, 16α, 17,21-tetrahydroxypregna-ane,iv-diene-three,xx-dione circadian 16,17-acetal with acetone.

C24H31FOvi, Molecular Weight: 434.l

Each gram of 0.1% triamcinolone acetonide cream provides i mg triamcinolone acetonide, respectively, in a vanishing foam base containing cetyl alcohol, cetyl esters wax, glyceryl monostearate, isopropyl palmitate, polysorbate-sixty, polysorbate-80, propylene glycol and purified water.

CLINICAL PHARMACOLOGY

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The machinery of anti-inflammatory activeness of the topical corticosteroids is unclear. Diverse 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 propose that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous assimilation 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 exist absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increment percutaneous assimilation. Occlusive dressings substantially increase the percutaneous assimilation 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 and then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

INDICATIONS AND USAGE

Triamcinolone acetonide cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

PRECAUTIONS

Full general

Systemic assimilation of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing'southward syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic assimilation include the awarding of the more potent steroids, use over large surface areas, prolonged apply, and the improver of occlusive dressings.

Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area or nether an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment of thermal homeostasis. If HPA centrality suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of awarding, substitute a less stiff steroid, or use a sequential arroyo when utilizing the occlusive technique.

Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Occasionally, a patient may develop a sensitivity reaction to a particular occlusive dressing material or adhesive and a substitute material may be necessary.

Children may absorb proportionally larger amounts of topical corticosteroids and thus exist more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use).

If irritation develops, topical corticosteroids should exist discontinued and advisable therapy instituted.

In the presence of dermatological infections, the utilize of an advisable antifungal or antibacterial amanuensis should be instituted. If a favorable response does non occur promptly, the corticosteroid should exist discontinued until the infection has been adequately controlled.

These preparations are not for ophthalmic utilize.

Data for the Patient

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to exist used every bit directed past the physician. It is for dermatologic use but. Avoid contact with the optics.
2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
3. The treated skin surface area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the md.
4. Patients should study any signs of local agin 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

A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis suppression.

Carcinogenesis, Mutagenesis, and 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 showed negative results.

Pregnancy

Teratogenic Furnishings

Category C

Corticosteroids are mostly teratogenic in laboratory animals when administered systemically at relatively depression dosage levels. The more strong corticosteroids take been shown to be teratogenic after dermal awarding in laboratory animals. At that place are no adequate and well-controlled studies in meaning women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should exist used during pregnancy only if the potential benefit justifies the potential take a chance to the fetus. Drugs of this course should non be used extensively on significant patients, in large amounts, or for prolonged periods of fourth dimension.

Nursing Mothers

It is non known whether topical assistants of corticosteroids could upshot in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into chest milk in quantities not likely to have a deleterious consequence on the infant. Yet, 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.

HPA axis suppression, Cushing's syndrome, and intracranial hypertension take been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, depression plasma cortisol levels, and absenteeism of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be express to the least amount uniform with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Adverse REACTIONS

The post-obit local agin reactions are reported infrequently with topical corticosteroids, merely may occur more frequently with the utilize of occlusive dressings (reactions are listed in an judge decreasing guild of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the peel, secondary infection, skin atrophy, striae, and miliaria.

OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (encounter PRECAUTIONS, General).

DOSAGE AND Administration

Employ triamcinolone acetonide foam USP, 0.1% as appropriate, to the affected expanse two to three times daily. Rub in gently.

Occlusive Dressing Technique

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a pocket-sized corporeality of cream into the lesion until it disappears. Reapply the preparation leaving a sparse blanket on the lesion, cover with pliable nonporous film, and seal the edges. If needed, boosted moisture may be provided by covering the lesion with a dampened make clean cotton textile before the nonporous film is applied or by briefly wetting the affected area with h2o immediately prior to applying the medication. The frequency of irresolute dressings is all-time determined on an individual ground. It may be convenient to apply triamcinolone acetonide cream USP, 0.1% nether an occlusive dressing in the evening and to remove the dressing in the forenoon (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional cream should exist applied, without occlusion, during the day. Reapplication is essential at each dressing modify. If an infection develops, the employ of occlusive dressings should exist discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

Triamcinolone Acetonide Cream USP, 0.1% in fifteen g (NDC 51672-1282-1), thirty g (NDC 51672-1282-2) and 80 g (NDC 51672-1282-8) tubes.

Shop at controlled room temperature xx° to 25°C (68° to 77°F). Avert freezing.

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist. past: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Revised: November
2019 PK-4831-5 39

PRINCIPAL Display Panel - 15 g Tube Carton

NDC 51672-1282-1

15 thou

Triamcinolone
Acetonide Foam USP, 0.1%

FOR EXTERNAL Utilize Simply.
NOT FOR OPHTHALMIC Utilize.

Rx simply

Keep this and all medications out of the reach of children.

TARO

Taro Pharmaceuticals U.S.A., Inc.

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Source: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e7e16fc2-0222-44f5-925b-928d249f55cf&type=display