Do not insert any part of the aerosol container directly into the anus. Avoid contact with the eyes. 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). If there is no evidence of clinical improvement within two or three weeks after starting Proctofoam®-HC therapy, or if the patient's condition worsens, discontinue the drug. Keep this and all medicines out of the reach of children.
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.
Pediatric patients may absorb proportionally larger amounts of topical corticosteroids
and thus be more susceptible to systemic toxicity. (see PRECAUTIONS - Pediatric
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:
- This medication is to be used as directed by the physician. It is for
anal or perianal use only. Avoid contact with eyes.
- Be advised not to use this medication for any disorder other than for which
it has been prescribed.
- Report any signs of adverse reactions. Laboratory tests
The following tests may be helpful in evaluating the HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test
Carcinogenesis, mutagenesis, 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.
Teratogenic Effects. 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, well-controlled studies of teratogenic effects from topically
applied corticosteroids in pregnant women. 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.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast 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 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.
Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious using the least amount compatible with an effective therapeutic regimen and reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.