Proctofoam Hc Information
Proctofoam hc (Hydrocortisone acetate/pramoxine hcl) Description
Proctofoam®-HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam for anal use containing hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a hydrophilic base containing cetyl alcohol, emulsifying wax, methylparaben, polyoxyethylene-10-stearyl ether, propylene glycol, propylparaben, purified water, trolamine and inert propellants: isobutane and propane.
Proctofoam®-HC contains a synthetic corticosteroid used as an anti-inflammatory/antipruritic agent and a local anesthetic.
Proctofoam hc (Hydrocortisone acetate/pramoxine hcl) Clinical Pharmacology
Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
Pramoxine hydrochloride is a surface or local anesthetic which is not chemically related to the "caine" types of local anesthetics. Its unique chemical structure is likely to minimize the danger of cross-sensitivity reactions in patients allergic to other local anesthetics.
Proctofoam hc (Hydrocortisone acetate/pramoxine hcl) Indications And Usage
Proctofoam®-HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.
Proctofoam hc (Hydrocortisone acetate/pramoxine hcl) Contraindications
Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Proctofoam hc (Hydrocortisone acetate/pramoxine hcl) Warnings
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.
Proctofoam hc (Hydrocortisone acetate/pramoxine hcl) Precautions
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 - .)
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 tests may be helpful in evaluating the HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test
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.
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.
Proctofoam hc (Hydrocortisone acetate/pramoxine hcl) 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.
Proctofoam hc (Hydrocortisone acetate/pramoxine hcl) Overdosage
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See .)
Proctofoam hc (Hydrocortisone acetate/pramoxine hcl) Dosage And Administration
Apply to affected area 3 to 4 times daily. Use the applicator supplied for anal administration. For perianal use, transfer a small quantity to a tissue and rub in gently.
Proctofoam hc (Hydrocortisone acetate/pramoxine hcl) How Supplied
Proctofoam®-HC is supplied in an aerosol container with a special anal applicator. When used correctly, the aerosol container will deliver a minimum of 14 applications.
NDC 0091-0690-1010 g
Proctofoam hc (Hydrocortisone acetate/pramoxine hcl) Patient Instructions For
(hydrocortisone acetate 1% and pramoxine hydrochloride 1%)
TOPICAL AEROSOL
