Texacort

Name: Texacort

What should I discuss with my healthcare provider before using Texacort (hydrocortisone topical)?

You should not use this medicine if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

  • diabetes;

  • liver disease; or

  • problems with your adrenal gland.

It is not known whether hydrocortisone topical will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

It is not known whether hydrocortisone topical passes into breast milk or if it could affect a nursing baby. Ask a doctor before using this medicine if you are breast-feeding.

Do not use this medicine on a child without medical advice.

Uses For Texacort

Hydrocortisone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Texacort Description

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 β)-. The molecular weight is 362.47. Its empirical formula is C21H30O5 and the structural formula is:

Each milliliter contains 25 mg of hydrocortisone (2.5% W/V) in a specially formulated vehicle containing alcohol (48.8% W/W), purified water, polysorbate 20 and isoceteth-20.

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 institiuted.

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.

Information for the Patient

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.

Laboratory Tests

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 effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

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 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.

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.

Texacort Dosage and 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 therapy instituted.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle, with Applicator Carton

NDC 0178-0455-01

Texacort™
Topical
Solution 2.5%

HYDROCORTISONE TOPICAL SOLUTION

Paraben and Lipid-Free

Contains hydrocortisone 2.5% (W/V)
In a vehicle of alcohol (48.8% W/W),
purified water, polysorbate 20 and
isoceteth-20.

Rx ONLY

1 fl. oz. (30 mL)

Texacort 
hydrocortisone solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0178-0455
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydrocortisone (Hydrocortisone) Hydrocortisone 25 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
alcohol  
water  
polysorbate 20  
isoceteth-20  
Packaging
# Item Code Package Description
1 NDC:0178-0455-01 1 BOTTLE, WITH APPLICATOR (BOTTLE) in 1 CARTON
1 30 mL in 1 BOTTLE, WITH APPLICATOR
2 NDC:0178-0455-03 3 mL in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA081271 12/15/2011
Labeler - Mission Pharmacal Company (008117095)
Establishment
Name Address ID/FEI Operations
Sonar Products, Inc 104283945 MANUFACTURE
Revised: 03/2012   Mission Pharmacal Company
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