COLOCORT- hydrocortisone suspension
Paddock Laboratories, LLC
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-,(11?)- and the following structural formula:
Chemical Structure
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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.
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.
