Colocort
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Questions & Answers
Side Effects & Adverse Reactions
In severe ulcerative colitis, it is hazardous to delay needed surgery while awaiting response to medical treatment.
Damage to the rectal wall can result from careless or improper insertion of an enema tip.
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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:
Colocort® 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.
Sources
Colocort Manufacturers
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Paddock Laboratories, Llc
![Colocort (Hydrocortisone) Suspension [Paddock Laboratories, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Colocort | Paddock Laboratories, Llc
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.
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