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Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol is provided by Meda Pharmaceuticals Inc., headquartered in Somerset, New Jersey. We invite your comments and questions about Proctofoam HC or any information you see on our website. You can contact Meda Pharmaceuticals about Proctofoam HC at:

Meda Pharmaceuticals Inc.
265 Davidson Avenue
Somerset, NJ 08873-4120
(866) 210-5948

Indications

Proctofoam HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.

More Important Safety Information

Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Instruct the patient not to insert any part of the aerosol container directly into the anus and avoid contact with the eyes.

Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store in temperatures above 120°F (49°C).

If there is no evidence of clinical improvement within two weeks after starting Proctofoam-HC therapy, or if the patient’s condition worsens, discontinue the drug.

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.

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, attempt to withdraw the drug, reduce the frequency of application, or 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.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen.

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.

The following adverse reactions have been reported:

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For additional information, please see Full Prescribing Information.