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 with in two weeks after starting Proctofoam-HC therapy, or if the patient's condition worsens, discontinue the drug.
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.
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, discontinue use.
If dermatological infection develops, use appropriate antifungal or antibacterial agents. If patient does not respond promptly to these treatments, discontinue use of the corticosteroid.
Proctofoam HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.
You are encouraged to report suspected adverse reactions. Contact Meda at 1-877-999-8401 or the FDA at 1-855-543-3784 or visit www.fda.gov/medwatch.