Drug: Cortenema

Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione,11,17,21- trihydroxy-,(11β) and the following structural formula: CORTENEMA* is a convenient disposable single-dose hydrocortisone enema designed for ease of self-administration. Each disposable unit (60 mL) contains: Hydrocortisone, 100 mg in an aqueous solution containing carbomer 934P, polysorbate 80, purified water, sodium hydroxide and methylparaben, 0.18% as a preservative.

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Local pain or burning, and rectal bleeding attributed to CORTENEMA (hydrocortisone) * have been reported rarely. Apparent exacerbations or sensitivity reactions also occur rarely. The following adverse reactions should be kept in mind whenever corticosteroids are given by rectal administration. Fluid and Electrolyte Disturbances: Sodium retention; fluid retention; congestive heart failure in susceptible patients; potassium loss; hypokalemic alkalosis; hypertension. Musculoskeletal: Muscle weakness; steroid myopathy; loss of muscle mass; osteoporosis; vertebral compression fractures; asceptic necrosis of femoral and humeral heads; pathologic fracture of long bones. Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage; pancreatitis; abdominal distention; ulcerative esophagitis. Dermatologic: impaired wound healing; thin fragile skin; petechiae and ecchymoses; facial erythema; increased sweating; may suppress reactions to skin tests. Neurological: Convulsions; increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment; vertigo; headache. Endocrine: Menstrual irregularities; development of Cushingoid state; suppression of growth in pediatric patients; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness, decreased carbohydrate tolerance; manifestations of latent diabetes requirements for insulin or oral hypoglycemic agents in diabetics. Opthalmic: Posterior subcapsular cataracts; increased intraocular pressure; glaucoma; exophthalmos. Metabolic: Negative nitrogen balance due to protein catabolism. Read the Cortenema (hydrocortisone) Side Effects Center for a complete guide to possible side effectsLearn More »

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The use of CORTENEMA* hydrocortisone retention enema is predicated upon the concomitant use of modem supportive measures such as rational dietary control, sedatives, anldiarrheal agents, antibacterial therapy, blood replacement if necessary, etc. The usual course of therapy is one CORTENEMA (hydrocortisone) * nightly for 21 days, or until the patient comes into remission both clinically and practologically. Clinical symptoms usually subside promptly within 3 to 5 days. Improvement in appearance of the mucosa, as seen by sigmoidoscope examination, may lag somewhat behind clinical improvement. Difficult cases may require as long as 2 or 3 months of CORTENEMA (hydrocortisone) * treatment. Where the course of therapy extends beyond 21 days, CORTENEMA (hydrocortisone) * should be discontinued gradually by reducing administration to every other night for 2 or 3 weeks. If clinical or proctologic improvement fails to occur within 2 or 3 weeks after starting CORTENEMA® (hydrocortisone) , discontinue its use. Symptomatic improvement, evidenced by decreased diarrhea and bleeding; weight gain; improved appetite; lessened fever; and decrease in leukocytosis, may be misleading and should not be used as the sole criterion in judging efficacy. Sigmoidoscopic examination and X-ray visualization are essential for adequate monitoring of ulcerative colitis. Biopsy is useful for differential diagnosis. Patient instructions for administering CORTENEMA® (hydrocortisone) are enclosed in each box. It is recommended that the patient lie on their left side during administration and for 30 minutes thereafter, so that the fluid will distribute throughout the left colon. Every effort should be made to retain the enema for at least an hour and preferably, all night. This may be facilitated by prior sedation and/or antidianheal medication, especially early in therapy when the urge to evacuate is great.

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No information provided. Read the Cortenema Drug Interactions Center for a complete guide to possible interactions Learn More »

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CORTENEMA (hydrocortisone) * is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons.

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Systemic fungal infections; and ileocolostomy during the immediate or early post- operative period. Last reviewed on RxList: 3/12/2008
This monograph has been modified to include the generic and brand name in many instances.

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No information provided.

Source: http://www.rxlist.com

CORTENEMA® hydrocortisone 100 mg retention enema, is supplied as disposable single-dose bottles with lubricated rectal applicator tips, in boxes of seven x 60 mL (NDC 62559-1110-7) and boxes of one x 60 mL (NDC 62559-1110-1). Store at controlled room temperature 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] Manufactured by ANI Pharmaceuticals, Inc. Baltimore, MD 21244. Rev 09/07. FDA Rev date: 2/21/2008 Last reviewed on RxList: 3/12/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General CORTENEMA* hydrocortisone retention enema should be used with caution where there is a probability of impending perforation, abscess or other pyogenic infection; fresh intestinal anastomoses; obstruction; or extensive fistulas and sinus tracts. Use with caution in presence of active or latent peptic ulcer; diverticulitis; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis. Steroid therapy might impair prognosis in surgery by increasing the hazard of infection. If infection is suspected, appropriate antibiotic therapy must be administered, usually in larger than ordinary doses. Drug-induced secondary adrenocortical insufficiency may occur with prolonged CORTENEMA (hydrocortisone) * therapy. This is minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocoru'coid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroid should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. The lowest possible dose of corticosteroid should be used to control the conditions under treatment, and when reduction in dosage is possible, the reduction should be gradual. Psychic derangement may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Aspirin should be used cautiously In conjunction with corticosteroids in hypoprothrombinemia Pediatric Use Safety and effectiveness in pediatric patients have not been established. Growth and development of pediatric patients on prolonged corticosteroid therapy should be carefully observed. Information for Patients Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay. Last reviewed on RxList: 3/12/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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