NASODIS

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-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-(11β16α) Its structural formula is: 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.

is indicated for the treatment of symptoms of seasonal and perannual allergic rhinitis of adults and children 2 years of age and older.

The potential for a rapid onset of the brain is not known.

Topical corticosteroids share anti-inflammatory, antipruritic 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.

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.

Pharmacotherapeutic group

Glucocorticoid locally, ATC code: R01AD11. (R: Respiratory system).

Triamcinolone acetonide is a glucocorticoid.

It has a local anti-inflammatory activity.

It is a more potent derivative than triamcinolone, its activity is approximately 8 times greater than that of prednisone.

In clinical studies in adults and children 6 years of age and older, at intranasal doses up to 440 micrograms/day, and in children 2-5 years of age at intranasal doses of 110 micrograms/day, no suppression of hypothalamic-pituitary-adrenal axis (HPS axis) was observed.

The classification of adverse events as a function of their frequency is as follows: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10 000 and <1/1000), very rare (<1/1000), not known (cannot be estimated from the available data) System classes d-organs Frequency Adverse reactions Immune system disorders Not known Hypersensitivity including pruritus or rash Endocrine disorders Not known Steroid withdrawal syndrome Common Headaches Not known Dysgueusia, parosmia Ocular disorders Very rare Cataractus, glaucoma Not known Fluidity, increased intraocular pressure, increased renal pain, abnormality of the brain, abnormality of the brain, abnormality of the brain, abnormality of the brain, abnormality of the brain, abnormality of the nose, oropharyngeal sensation of the nose, dryness of the mucous membranes, irregularity of the brain, abnormality of the brain, abnormality of the brain, abnormality of the brain, abnormality of the brain, abnormality of the brain, abnormality of the brain.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.

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

& ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film two to four times daily for the 0.025% strength and two or three times daily for the 0.1% and 0.5% strength 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.

USP, 0.1%, 30 g.

• (2 Tubes) 30 grams 2 tubes NDC 73086-104-60 Store at 20°–25°C (68°–77°F) .

Avoid excessive heat.

Protect from freezing.

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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.

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 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.