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Colocort (Hydrocortisone Rectal) - Description and Clinical Pharmacology

 
 



Disposable Unit for Rectal Use Only

DESCRIPTION

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.

CLINICAL PHARMACOLOGY

Hydrocortisone is a naturally occurring glucocorticoid (adrenal corticosteroid), similar to its acetate and sodium hemisuccinate derivatives, is partially absorbed following rectal administration. Absorption studies in ulcerative colitis patients have shown up to 50% absorption of hydrocortisone administered as hydrocortisone rectal suspension and up to 30% of hydrocortisone acetate administered in an identical vehicle.

Colocort® provides the potent anti-inflammatory effect of hydrocortisone. Because this drug is absorbed from the colon, it acts both topically and systemically. Although rectal hydrocortisone, used as recommended for hydrocortisone rectal suspension, has a low incidence of reported adverse reactions, prolonged use presumably may cause systemic reactions associated with oral dosage forms.

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