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CORTIFOAM® (hydrocortisone acetate) 10% Rectal Foam contains hydrocortisone acetate 10% in a base containing propylene glycol, emulsifying wax, polyoxyethylene-10-stearyl ether, cetyl alcohol, methylparaben, propylparaben, trolamine, purified water and inert propellants: isobutane and propane.
Each application delivers approximately 900 mg of foam containing 80 mg of hydrocortisone (90 mg of hydrocortisone acetate).
Molecular weight: Hydrocortisone acetate 404.51
Solubility of hydrocortisone acetate in water: 1 mg/100 mL
Chemical name: Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11(beta))-.
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CORTIFOAM provides effective topical administration of an anti-inflammatory corticosteroid as adjunctive therapy of ulcerative proctitis.
CORTIFOAM is indicated as adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas. Direct observations of methylene blue-containing foam have shown staining about 10 centimeters into the rectum.
Local contraindications to the use of intrarectal steroids include obstruction, abscess, perforation, peritonitis, fresh intestinal anastomoses, extensive fistulas and sinus tracts. Tuberculosis (active, latent or questionably healed), ocular herpes simplex and acute psychosis are usually considered absolute contraindications to the use of corticosteroids. Relative contraindications include active peptic ulcer, acute glomerulonephritis, myasthenia gravis, osteoporosis, diverticulitis, thrombophlebitis, psychic disturbances, pregnancy, diabetes, hyperthyroidism, acute coronary disease, hypertension, limited cardiac reserve, and local or systemic infections, including fungal or exanthematous diseases. Where these conditions exist, the expected benefits from steroid therapy must be weighed against the risks involved in its use. Pregnancy is a relative contraindication to corticosteroids, particularly during third trimester. If corticosteroids must be administered in pregnancy, watch newborn infant closely for signs of hypoadrenalism, and administer appropriate therapy if needed.
Do not insert any part of the aerosol container directly into the anus. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperature above 120°F. Because CORTIFOAM is not expelled, systemic hydrocortisone absorption may be greater from CORTIFOAM than from corticosteroid enema formulations. If there is not evidence of clinical or proctologic improvement within two or three weeks after starting CORTIFOAM therapy, or if the patient' condition worsens, discontinue the drug.
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune pediatric patients or adults on corticosteroids. In such pediatric patients or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information). If chickenpox develops, treatment with antiviral agents may be considered.
General
Steroid therapy should be administered with caution in patients with severe ulcerative disease because these patients are predisposed to perforation of the bowel wall. Where surgery is imminent, it is hazardous to wait more than a few days for a satisfactory response to medical treatment. General precautions common to all corticosteroid therapy should be observed during treatment with CORTIFOAM. These include gradual withdrawal of therapy to allow for possible adrenal insufficiency and awareness to possible growth suppression in pediatric patients. Patients should be kept under close observation for, as with all drugs, rare individuals may react unfavorably under certain conditions. If severe reactions or idiosyncrasies occur, steroids should be discontinued immediately and appropriate measures instituted. Do not employ in immediate or early postoperative period following ileorectostomy.
Information for Patients
Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. (Please see and ADVERSE REACTIONS for additional information.)
Corticosteroid therapy may produce side effects which include moon face, fluid retention, excessive appetite and weight gain, abnormal fat deposits, mental symptoms, hypertrichosis, acne, ecchymosis, increased sweating, pigmentation, dry scaly skin, thinning scalp hair, thrombophlebitis, decreased resistance to infection, negative nitrogen balance with delayed bone and wound healing, menstrual disorders, neuropathy, peptic ulcer, decreased glucose tolerance, hypopotassemia, adrenal insufficiency, necrotizing angiitis, hypertension, pancreatitis and increased intraocular pressure. In pediatric patients, suppression of growth may occur. Increased intracranial pressure may occur and possibly account for headache, insomnia and fatigue. Subcapsular cataracts may result from prolonged usage. Long-term use of all corticosteroids results in catabolic effects characterized by negative protein and calcium balance. Osteoporosis, spontaneous fractures and aseptic necrosis of the hip and humerus may occur as part of this catabolic phenomenon. Where hypopotassemia and other symptoms associated with fluid and electrolyte imbalance call for potassium supplementation and salt poor or salt-free diets, these may be instituted and are compatible with diet requirements for ulcerative proctitis.
Usual dose is one applicatorful once or twice daily for two or three weeks, and every second day thereafter, administered rectally. Directions for use, below and on the carton, describe how to use the aerosol container and applicator. Satisfactory response usually occurs within five to seven days marked by a decrease in symptoms. Symptomatic improvement in ulcerative proctitis should not be used as the sole criterion for evaluating efficacy. Sigmoidoscopy is also recommended to judge dosage adjustment, duration of therapy and rate of improvement.
Directions For Use
1) Shake foam container vigorously for 5-10 seconds before each use. Do not remove container cap during use of the product. 2) Hold container upright on a level surface and gently place the tip of the applicator onto the nose of the container cap. CONTAINER MUST BE HELD UPRIGHT TO OBTAIN PROPER FLOW OF MEDICATION. 3) Gently withdraw applicator plunger past the fill line on the applicator barrel. 4) To fill applicator barrel, press down slowly on cap flanges and release, pause, and allow foam to enter and expand in applicator barrel. Repeat until foam in the applicator reaches fill line. Remove applicator from container cap. Allow some foam to remain on the applicator tip. 5) Hold applicator firmly by barrel, making sure thumb and middle finger are positioned securely underneath and resting against barrel wings. Place index finger over the plunger. Gently insert tip into anus. Once in place, push plunger to expel foam, then withdraw applicator. CAUTION: Do not insert any part of the aerosol container directly into the anus. Apply to anus only with enclosed applicator. 6) After each use, applicator parts should be pulled apart for thorough cleaning with warm water. The container cap and underlying tip should also be pulled apart and rinsed to help prevent build-up of foam and possible blockage.
CORTIFOAM is supplied in an aerosol container with a special rectal applicator. Each applicator delivers approximately 900 mg of foam containing approximately 80 mg of hydrocortisone as 90 mg of hydrocortisone acetate. When used correctly, the aerosol container will deliver a minimum of 14 applications.
NDC 0091-0695-20 15 g
Store upright at controlled room temperature 15°-30°C (59°-86°F).
DO NOT REFRIGERATE.
PC2080B Rev. 8/99
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