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Name:Texacort
Manufacturer:Jsj Pharmaceuticals
Category:Prescription Marketed Drugs


Texacort Topical Solution 2.5% Patient Information

TEXACORT   - hydrocortisone solution 
JSJ Pharmaceuticals

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Texacort Topical Solution 2.5% Patient Information

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 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.

Image of Chemical Structure

CLINICAL PHARMACOLOGY

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive
actions.  The mechanisms 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.

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.

INDICATIONS AND USAGE

Texacort Topical Solution 2.5% 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 preparation.

PRCAUTIONS

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.

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 Monthers


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 Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced
HPA axis supression and Cishing'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.

ADVERSE REACTIONS

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, miliaria.

OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amount to produce systemic effects
(See PRECAUTIONS).

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
therapy instituted.

HOW SUPPLIED


Texacort Topical Solution 2.5% is available in a
1 fl. oz. plastic bottle with an applicator tip
(NDC 68712-011-01).

Store at controlled room temperature:
15° - 30° C (59° - 86° F).

Rx Only

Manufactured for:
JSJ Pharmaceuticals
Charleston SC  29401
1-800-499-4468 www.jsjpharm.com

Image of bottle label




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TEXACORT  
hycrocortisone solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68712-011
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 48.8 mg  in 1 mL
Water  
Polysorbate 20  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68712-011-02 10 PACKET ( PACKET) in 1 CARTON contains a PACKET
1 3 mL in 1 PACKET This package is contained within the CARTON (68712-011-02)
2 NDC:68712-011-01 30 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA081271 08/01/2009

Labeler - JSJ Pharmaceuticals (615074866)

Revised: 02/2010 JSJ Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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