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Colocort (Hydrocortisone Rectal) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Colocort® is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and leftsided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons.

DOSAGE AND ADMINISTRATION

The use of Colocort® Hydrocortisone Rectal Suspension, USP is predicated upon the concomitant use of modern supportive measures such as rational dietary control, sedatives, antidiarrheal agents, antibacterial therapy, blood replacement if necessary, etc.

The usual course of therapy is one Colocort® nightly for 21 days, or until the patient comes into remission both clinically and proctologically. Clinical symptoms usually subside promptly within 3 to 5 days. Improvement in the appearance of the mucosa, as seen by sigmoidoscopic examination, may lag somewhat behind clinical improvement. Difficult cases may require as long as 2 or 3 months of Colocort® treatment. Where the course of therapy extends beyond 21 days, Colocort® 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 Colocort®, 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 Colocort® are printed on this carton. 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 antidiarrheal medication, especially early in therapy when the urge to evacuate is great.

HOW SUPPLIED

Colocort®, Hydrocortisone Rectal Suspension, USP, (Retention) 100 mg/60 mL, is supplied as disposable single-dose bottles with lubricated rectal applicator tips, in boxes of seven x 60 mL (NDC 0574-2020-07) and boxes of one x 60 mL (NDC 0574-2020-01).

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Rx Only

Manufactured By Perrigo

Minneapolis, MN 55427

2200881 Rev 03-13 A

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