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----------Texacort Topical Solution 2.5% Patient Information
Topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory
and antipruritic agents. Texacort Topical Solution contains hydrocortisone as the active corticosteroid, having the
chemical formula of Pregn-4-ene-3, 20-dione, 11,17, 21 -trihydroxy-, (11 ß)-. The molecular weight is 362.47. Its
empirical formula is C21H30O5 and the structural formula is:
Each milliliter contains 25 mg of hydrocortisone in a specially formulated vehicle containing S.D. Alcohol
(48.8%), purified water, polysorbate 20, and isoceteth-20.
Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive
PharmacokineticsThe 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.
INDICATIONS AND USAGE
Texacort Topical Solution 2.5% is indicated for the relief of the inflammatory and
Topical corticosteroids are contraindicated in those patients with a history of
hypersensitivity to any of the components of the preparation.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal
Conditions which augment systemic absorption include the application of the more potent steroids, use over large
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently,
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
Information for the Patient
Patients using topical corticosteroids should receive the following information
1. This medication is to be used as directed by the physician. It is for external use only.
The following tests may be helpful in evaluating the HPA axis suppression:
Urinary free cortisol test ACTH stimulation test
Carcinogenesis, Mutagenesis and Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
Pregnancy Category CCorticosteroids 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 inbre ast 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
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have
Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective
The following local adverse reactions are reported infrequently with topical
Topically applied corticosteroids can be absorbed in sufficient amount to produce systemic effects
DOSAGE & ADMINISTRATION
Topical corticosteroids are generally applied to the affected area
as a thin film for three or four times daily 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
Texacort Topical Solution 2.5% is available in a
1 fl. oz. plastic bottle with an applicator tip
Store at controlled room temperature:
15° - 30° C (59° - 86° F).
Charleston SC 29401
Revised: 02/2010 JSJ Pharmaceuticals
Reproduced with permission of U.S. National Library of Medicine
Copyright © 2017
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