Product
Information
INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
CONTRAINDICATIONS: Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity
to any of the components of the preparation.
WARNINGS: Not for prolonged use. If redness, pain, irritation or swelling persists, discontinue use and consult a physician. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). Keep this and all medicines out of the reach of children.
PRECAUTIONS:
General: Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary-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.
In pediatric patients absorption may result in higher blood levels and thus more susceptibility 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 Patients:
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. Do not use this medication for any disorder other than for which it has been 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. Report any signs of local adverse reactions especially under occlusive dressings.
5. Do not use any tight fitting diapers or plastic pants on a pediatric patient being treated in the diaper area, as these garments may constitute occlusive dressings.
PEDIATRIC USE: Pediatric patients may demonstrate greater susceptibility to topical cortico-steroid-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 pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients 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 pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.
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 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 and miliaria.
About This
Disease
For more information on the conditions treated by Epifoam® please visit www.webmd.com.
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epifoam® (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) Topical aerosol
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Availability
Epifoam® is available by prescription only.
Ask your doctor if Epifoam® is right for you.
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Reference Library
For questions about Epifoam®, please contact: customerservice@alavenpharm.com
For medical information – (888-317-0001)
Epifoam® is a registered trademark of SRZ Properties Inc.
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