Indications and uses
For use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani.
Hydrocortisone Acetate
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Effective date
- 2018-07-24
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:53:17
Label at a glance#
ProductHydrocortisone Acetate
Active ingredientHYDROCORTISONE ACETATE
Label structure12 sections
Dosage and administration
One suppository in the rectum morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times daily; or two suppositories twice daily. In factitial proctitis, recommended therapy is six to eight weeks or less, according to response.
Label contents#
Full prescribing information#
DESCRIPTION
Each suppository for rectal administration contains 25 mg hydrocortisone acetate USP in a hydrogenated cocoglyceride base. Hydrocortisone acetate is a corticosteroid.
Chemically, hydrocortisone acetate is pregn-4-ene-3, 20 dione, 21- (acetyloxy)-11, 17-dihydroxy-, (11β)- with the following structural formula:
CLINICAL PHARMACOLOGY
In normal subjects, about 26 percent 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, antipruritic and vasoconstrictive action.
INDICATIONS AND USAGE
For use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani.
CONTRAINDICATIONS
Hydrocortisone acetate suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components.
PRECAUTIONS
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 corticosteroid 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.
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.
It is not known whether this drug is excreted in human milk.
Until adequate studies in pregnant or lactating women have been conducted, this drug should be used during pregnancy or by nursing mothers only when clearly needed and when the potential benefits outweigh the potential risks.
ADVERSE REACTIONS
The following local adverse reactions have been reported with corticosteroid suppositories:
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DRUG ABUSE AND DEPENDENCE
Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.
OVERDOSAGE
If signs and symptoms of systemic overdosage occur, discontinue use.
DOSAGE AND ADMINISTRATION
Usual dosage:
One suppository in the rectum morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times daily; or two suppositories twice daily. In factitial proctitis, recommended therapy is six to eight weeks or less, according to response.
HOW SUPPLIED
Hydrocortisone acetate suppositories are easy to open, color coded and available in cartons of:
12's | NDC 68788-9662-1 |
STORAGE AND HANDLING SECTION
Store at controlled room temperature 15° to 30°C (59° to 86°F). Protect from freezing.
SPL UNCLASSIFIED SECTION
Manufactured By
Perrigo
®
Minneapolis, MN 55427
(01-12)
Relabeled By: Preferred Pharmaceuticals Inc.
PRINCIPAL DISPLAY PANEL - 25 mg Packet Label
Hydrocortisone Acetate 25 mg
Suppository
(01)10305747090121
Manufactured by Perrigo®
Minneapolis, MN 55427
Relabeled By: Preferred Pharmaceuticals Inc.
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 39 | hydrocortisone-02.jpg |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68788-9662-1 | 2020-11-13 | C162847 | 48780-1 | 9d75b9d1-1221-f424-e053-dadaa90a57ce | Hydrocortisone Acetate Suppositories 25 mg |
| 68788-9662-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1221-f424-e053-dadaa90a57ce | Hydrocortisone Acetate Suppositories 25 mg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0574-7090-12 | EA - Each | 0574-7090 | eaf18863-12fa-4274-ab1d-bdaf82986ca9 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| HYDROCORTISONE ACETATE | ACTIVE INGREDIENT | 3X7931PO74 | 1 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | 1 |
Products#
Every source-derived product name is available through these pages.
- Hydrocortisone Acetate
- HYDROCORTISONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68788-9662 | 68788-9662-1 |
| 0574-7090 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROCORTISONE ACETATE | 3X7931PO74 | ACTIB |
Source Document#
openFDA label cross-check#
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 | Padagis US LLC | 2fdb9940-6da8-49b0-a236-9817943f7a4b | 2022-05-31 | Adverse reactions | 0574-7090 |
| 72e3c08c-3b1e-4e8f-b8c4-6d4495aeccbd | 39e14cf5-2463-41e1-95cc-5df97b2a3052 | 2020-11-11 | Adverse reactions | 39e14cf5-2463-41e1-95cc-5df97b2a3052 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.