The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Hydrocortisone Acetate (NDC 0904-7340). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, clinical pharmacology, indications and usage, contraindications, precautions, information for patients, pregnancy category c, adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11ß) with the following structural formula:
Structure (Structure)
Each suppository for rectal administration contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable base.
In normal subjects, about 26% of hydrocortisone acetate is absorbed when the hydrocortisone acetate 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.
Hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani.
Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.
Do not use hydrocortisone acetate suppositories 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, 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.
Staining of fabric may occur with use of the suppository. Precautionary measures are recommended.
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 of 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.
To report an adverse event, please contact Rising Pharma Holdings, Inc. at 1-844-874-7464, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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. Hold suppository upright. Separate tabs at top opening and pull downward from the pointed end. Continue pulling downward to almost the full length of the suppository. Carefully remove the suppository from the pocket. 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.
Hydrocortisone acetate suppositories 25 mg are white to off-white, smooth surfaced and bullet shaped with one pointed end.
Carton of 12 suppositories, NDC 0904-7340-12
Carton of 24 suppositories, NDC 0904-7340-24
Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Excursions permitted to 15°-30°C (59°-86°F). Store away from heat. Protect from freezing. Avoid contact with eyes.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Rx Only
Manufactured by:
Quagen Pharmaceuticals LLC
West Caldwell, NJ 07006
Distributed By:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268 USA
52030
Rev.01/21
Hydrocortisone Acetate Suppositories
25 mg
12 Adult Suppositories
Pre-printed Box (Image 01)
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