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.
Detach one suppository from strip of suppositories. Hold suppository upright and carefully separate tabs at top opening and pull downward from the pointed end to expose the suppository. Remove the suppository from the pocket. Avoid excessive handling of suppository which is designed to melt at body temperature. Insert one suppository rectally, pointed end first. Insert one suppository in the rectum twice daily, mo...
For Rectal Administration
Rx Only
Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula:
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 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.
No long-term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.
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 Westminster Pharmaceuticals, LLC at 1-844-221-7294.
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.
Detach one suppository from strip of suppositories. Hold suppository upright and carefully separate tabs at top opening and pull downward from the pointed end to expose the suppository. Remove the suppository from the pocket. Avoid excessive handling of suppository which is designed to melt at body temperature. Insert one suppository rectally, 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.
Product: 50090-6331
NDC: 50090-6331-0 12 SUPPOSITORY in a CARTON
Rx Only
Manufactured for:
Westminster Pharmaceuticals, LLC
Nashville, TN 37217
Rev. 12/19
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-6331-0 | Hydrocortisone Acetate | 12 in 1 CARTON | SUPPOSITORY | 12 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-6331 | HYDROCORTISONE ACETATE SUPPOSITORY [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 1 package rows | 20230120_03321951-e338-4955-8622-0f5ea29c6cd9.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-6331-0 | EA - Each | 50090-6331 | 929aab0c-de79-475a-92f0-8b04fe0ab767 | 1 | 2023-02-06 |
| 69367-243-12 | EA - Each | 69367-243 | f6faf4a2-9e75-46af-ad0e-cd69f43b5432 | 1 | 2020-04-20 |
| 69367-243-24 | EA - Each | 69367-243 | e0ffe76e-a61e-4acf-b00e-86bdc752adac | 1 | 2020-04-20 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50090-6331 | 50090-6331-0 |
| 69367-243 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROCORTISONE ACETATE | 3X7931PO74 | ACTIB |
| HYDROGENATED PALM KERNEL OIL | FM8D1RE2VP | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydrocortisone Acetate | HYDROCORTISONE ACETATE | Westminster Pharmaceuticals, LLC | 3a29006f-9124-45e7-84a2-48f08bbb5f9c | 2024-12-04 | Adverse reactions | 69367-243 |
| Hydrocortisone Acetate | HYDROCORTISONE ACETATE | A-S Medication Solutions | 03321951-e338-4955-8622-0f5ea29c6cd9 | 2023-01-18 | Adverse reactions | 50090-6331-0 50090-6331 50090633100 da3e0c05-8fc7-4fd7-a2d1-183a9413da18 03321951-e338-4955-8622-0f5ea29c6cd9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.