R & C
Action And Clinical Pharmacology: Action appears to be due to a local anti-inflammatory effect of hydrocortisone on the mucosa rather than as a result of a systemic effect.
Indications And Clinical Uses: As adjunctive therapy in the treatment of ulcerative colitis of the sigmoid colon, proctosigmoiditis, granular proctitis and ulcerative proctitis.
Contra-Indications: 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, varicella, vaccinia, and acute psychosis are usually considered contraindications to the use of corticosteroids.
Other contraindications include 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.
In systemic fungal infection and in the presence of hypersensitivity to any of its components.
Manufacturers’ Warnings In Clinical States: Caution: Contents are flammable and the aerosol container may explode if heated.
Do not insert any part of the aerosol container into the anus. Do not use in presence of open flame or spark. Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50°C. Because the drug is not expelled, systemic hydrocortisone absorption may be greater from the foam than from corticosteroid enema formulations. If there is no evidence of clinical or proctologic improvement within 2 or 3 weeks after starting therapy, or if the patient’s condition worsens, discontinue the drug.
Signs and symptoms of intestinal perforation and peritonitis may be difficult to detect during corticosteroid treatment.
Precautions: A complete rectal examination to rule out serious pathology and extension of the disease process should be completed before instituting therapy.
Do not use on infected lesions unless accompanied with anti-infective agents.
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. These include gradual withdrawal of therapy to allow for possible adrenal insufficiency and awareness of possible growth suppression in children. 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.
Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.
Pregnancy: Steroids should not be used during pregnancy since safety during pregnancy has not been fully established.
If corticosteroids must be administered during pregnancy, particularly during the third trimester, the newborn infant must be observed closely for signs of hypoadrenalism, and the appropriate therapy administered if needed.
Lactation: Mothers using hydrocortisone should be advised not to nurse.
Adverse Reactions: 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, hypokalemia, adrenal insufficiency, necrotizing angiitis, hypertension, pancreatitis and increased intraocular pressure. In children, 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 hypokalemia 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.
Local effects of itching and burning have been reported following rectal use.
Symptoms And Treatment Of Overdose: Symptoms: Acute toxicity, even with massive doses is not a clinical problem. Chronic toxicity involves manifestations of the physiologic effects described above and include Cushingoid appearance, muscle weakness, osteoporosis, posterior subcapsular cataracts, peptic ulcers, hypertension, psychosis, and growth suppression in children. Glaucoma, pancreatitis, reactivation of tuberculosis and poor wound healing may occur. Sodium and fluid retention with potassium loss occur to varying degrees, depending upon the mineralocorticoid effects of the particular corticosteroid.
Treatment: Acute overdosage probably requires no treatment. Acute overdosage requires no tapering as in withdrawal of patients on long-term administration. If there is any question that other drugs have been ingested simultaneously, then standard measures for those drugs should be followed as per instructions for their management. Avoid chronic dosage for durations greater than 3 weeks when possible.
When chronic dosage for periods greater than 3 weeks is essential, attempts should be made to manage the underlying disease if possible with alternate day dosage using single daily doses on alternate mornings of shorter acting preparations such as prednisone, prednisolone or methylprednisolone.
Even with alternate day dosage of appropriate agents, continued attempts should be made to minimize dosage compatible with maintained control of the underlying disease.
The diet should have adequate protein content but caloric restrictions should be considered because of the apparent appetite stimulating properties of the corticosteroids.
The ultimate treatment of toxicity should be avoidance of inappropriate usage or if toxicity is already present, withdrawal of the corticosteroids and conventional management of those effects which are treatable such as peptic ulcers, cataracts and hypertension.
Dosage: Usual dose is 1 applicatorful once or twice daily for 2 or 3 weeks, and every second day thereafter, administered rectally. The patient direction insert describes how to use the aerosol container and applicator. Satisfactory response usually occurs within 5 to 7 days marked by a decrease in symptoms. Symptomatic improvement 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.
Availability And Storage: Each applicatorful delivers approximately 900 mg of foam containing approximately 80 mg of hydrocortisone (as hydrocortisone acetate 90 mg). Nonmedicinal ingredients: cetyl alcohol, ethoxylated stearyl alcohol, methylparaben, polyoxyethylene-10 stearyl ether, propylene glycol, propylparaben, triethanolamine, water and inert propellants, isobutane and propane. Aerosol containers of 15 g with a special rectal applicator will deliver approximately 14 applications.
Contents are flammable and are under pressure. Do not use in presence of open flame or spark. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50°C.
CORTIFOAM R & C Hydrocortisone Acetate Rectal Anti-inflammatory
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