Hydrocortisone Acetate | Hydrocortisone Acetate
Rectal Suppositories, 25 mg
Each Hydrocortisone Acetate 25 mg Suppository contains 25 mg hydrocortisone acetate in a hydrogenated vegetable oil base. Hydrocortisone acetate is a corticosteroid. Chemically, hydrocortisone acetate is a pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula:
In normal subjects, about 26% of hydrocortisone acetate is absorbed when the suppository is applied to the rectum. Absorption of hydrocortisone acetate may vary across abraded or inflamed surfaces.
Topical steroids are primarily effective because of their anti-inflammatory, anti-pruritic and vasoconstrictive action.
For use in inflamed hemorrhoids, postirradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani.
Hydrocortisone Acetate Suppositories are contraindicated in those patients having a history of hypersensitivity to any of the components.
Do not use unless adequate proctologic examination is made.
If irritation develops, the product should be discontinued and appropriate therapy instituted.
In the presence of an infection, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the hydrocortisone acetate should be discontinued until the infection has been adequately controlled.
Carcinogenesis : No long term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.
Pregnancy Category C : In laboratory animals, topical steroids have been associated with an increase in the incidence of fetal abnormalities when gestating females have been exposed to rather low dosage levels. There are no adequate and well controlled studies in pregnant women. Hydrocortisone Acetate Suppositories should only be used during pregnancy if the potential benefit justifies the risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
It is not known whether this drug is excreted in human milk and because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Hydrocortisone Acetate Suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
The following local adverse reactions have been reported with hydrocortisone acetate suppositories; burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection.
Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.
If signs and symptoms of systemic overdosage occur, discontinue use.
For rectal administration. Detach one suppository from strip of suppositories. Remove the wrapper. Avoid excessive handling of the suppository which is designed to melt at body temperature. Insert suppository into the rectum with gentle pressure, pointed end first. Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times a day or two suppositories twice daily. In factitial proctitis, the recommended duration of therapy is six to eight weeks or less, according to the response of the individual case.
Box of 12 suppositories - NDC 21695-731-12
Store at 20°–25°C (68°–77°F). See USP Controlled Room Temperature. Store away from heat. Protect from freezing.
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County Line Pharmaceuticals, LLC
Brookfield, WI 53005
Rebel Distributors Corp
Thousand Oaks, CA 91320
Rebel Distributors Corp
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Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induc...
To test overall efficacy of hydrocortisone on reexperience of traumatic memories (intrusions) and overall symptomatology in patients meeting criteria of complex chronic PTSD.
Seven-month study in pediatric patients (2-11 years) with moderate to severe AD who were considered to benefit from vaccination to prevent invasive disease caused by Neisseria meningitides...
The primary purpose of this study is to examine whether IV hydrocortisone can speed up the time required for Venlafaxine XR to work.
The purpose of this study is to investigate the effect of hydrocortisone on glucose-induced insulin secretion and sensitivity, by means of an intravenous glucose tolerance test with freque...
A calcipotriol/hydrocortisone combination ointment has been developed for treating psoriasis on sensitive skin areas such as the face. The efficacy and safety of two calcipotriol/hydrocortisone dose c...
Concomitant hydrocortisone and arginine vasopressin therapy increases arginine vasopressin plasma levels and may improve survival in septic shock. The objective of this post hoc analysis of a prospect...
PURPOSE: Postoperative shivering is commonly observed in patients after general anesthesia. A double-blind randomized controlled trial was conducted in patients undergoing day care knee arthroscopy to...
OBJECTIVE.: To study demographic, clinical, and histopathological data as well as treatment outcome in women with papular colpitis. MATERIALS AND METHODS.: Data of women (n = 18) visiting the Rotterda...
The role of stress-dose hydrocortisone in the management of trauma patients is currently unknown.