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.

About This Disease

For more information on the conditions treated by Epifoam, please visit www.webmd.com.

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Please See Full Prescribing Information PDF

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

Epifoam® is a registered trademark of SRZ Properties Inc.

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