Product Description.:
Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water.
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.
INDICATIONS
CORTENEMA* 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.
SIDE EFFECTS
Local pain or burning, and rectal bleeding attributed to CORTENEMA* 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.
