"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
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.
DOSAGE AND ADMINISTRATION
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.
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: 2/21/2008This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/12/2008
Additional Cortenema Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.