Hydrocortisone Acetate
Suppository · Rectal, Topical
Uses
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.
Dosage and administration
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.
Contraindications
Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.
Precautions
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. 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 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.
Side effects
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 AARNA USA INC at 1-877-225-6999.
Overdosage
If signs and symptoms of systemic overdosage occur, discontinue use.
Description
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 25 mg suppository for rectal administration contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable base. Each 30 mg suppository for rectal administration contains hydrocortisone acetate, USP 30 mg in a specially blended hydrogenated vegetable base. Chemical Structure
How supplied
Hydrocortisone acetate suppositories 25mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 82568-0150-1 Box of 24 suppositories, NDC 82568-0150-2 Hydrocortisone acetate suppositories 30mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 82568-0160-1 STORAGE 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. PHARMACIST: This product is not an Orange Book rated product, therefore all prescriptions using this product shall be subject to state and federal statutes as applicable. This product has not been subjected to FDA therapeutic or other equivalency testing. There are no claims of bioequivalence or therapeutic equivalence. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information contained within the enclosed prescribing information.
Storage
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.
Label text from the FDA structured product label by AARNA USA INC. (revised Apr 16, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Hydrocortisone Acetate in 27 products
Hydrocortisone Acetate NDC products (27)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 47832-205 | Hydrocortisone Acetate 10 mg/g Cream | Bentlin Products LLC | OTC MONOGRAPH DRUG |
| 51672-2069 | Hydrocortisone Acetate 1 g/100g Cream | Sun Pharmaceutical Industries, Inc. | OTC MONOGRAPH DRUG |
| 50090-6331 | Hydrocortisone Acetate 25 mg/1 Suppository | A-S Medication Solutions | UNAPPROVED DRUG OTHER |
| 82568-0160 | Hydrocortisone Acetate 30 mg/1 Suppository | AARNA USA INC. | UNAPPROVED DRUG OTHER |
| 82568-0150 | Hydrocortisone Acetate 25 mg/1 Suppository | AARNA USA INC. | UNAPPROVED DRUG OTHER |
| 24689-103 | Hydrocortisone Acetate 30 mg/1 Suppository | APNAR PHARMA LP | UNAPPROVED DRUG OTHER |
| 24689-102 | Hydrocortisone Acetate 25 mg/1 Suppository | APNAR PHARMA LP | UNAPPROVED DRUG OTHER |
| 50268-411 | Hydrocortisone Acetate 25 mg/1 Suppository | AvPAK | UNAPPROVED DRUG OTHER |
| 63629-2531 | Hydrocortisone Acetate 30 mg/1 Suppository | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 63629-2530 | Hydrocortisone Acetate 25 mg/1 Suppository | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 0713-0493 | Hydrocortisone Acetate 30 mg/1 Suppository | Cosette Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
| 51407-665 | Hydrocortisone Acetate 25 mg/1 Suppository | Golden State Medical Supply, Inc. | UNAPPROVED DRUG OTHER |
| 0904-7340 | Hydrocortisone Acetate 25 mg/1 Suppository | Major Pharmaceuticals | UNAPPROVED DRUG OTHER |
| 10135-751 | Hydrocortisone Acetate 25 mg/1 Suppository | Marlex Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
| 75834-147 | Hydrocortisone Acetate 25 mg/1 Suppository | Nivagen Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
| 68071-2259 | Hydrocortisone Acetate 25 mg/1 Suppository | NuCare Pharmaceuticals,Inc. | UNAPPROVED DRUG OTHER |
| 0574-7093 | Hydrocortisone Acetate 30 mg/1 Suppository | Padagis US LLC | UNAPPROVED DRUG OTHER |
| 0574-7090 | Hydrocortisone Acetate 25 mg/1 Suppository | Padagis US LLC | UNAPPROVED DRUG OTHER |
| 39328-129 | Hydrocortisone Acetate 30 mg/1 Suppository | Patrin Pharma Inc. | UNAPPROVED DRUG OTHER |
| 39328-029 | Hydrocortisone Acetate 25 mg/1 Suppository | Patrin Pharma Inc. | UNAPPROVED DRUG OTHER |
| 68788-4190 | Hydrocortisone Acetate 25 mg/1 Suppository | Preferred Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
| 71205-976 | Hydrocortisone Acetate 25 mg/1 Suppository | Proficient Rx LP | UNAPPROVED DRUG OTHER |
| 70752-169 | Hydrocortisone Acetate 25 mg/1 Suppository | QUAGEN PHARMACEUTICALS LLC | UNAPPROVED DRUG OTHER |
| 16571-164 | Hydrocortisone Acetate 30 mg/1 Suppository | Rising Pharma Holdings, Inc. | UNAPPROVED DRUG OTHER |
| 16571-676 | Hydrocortisone Acetate 25 mg/1 Suppository | Rising Pharma Holdings, Inc. | UNAPPROVED DRUG OTHER |
| 69367-243 | Hydrocortisone Acetate 25 mg/1 Suppository | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 69367-260 | Hydrocortisone Acetate 30 mg/1 Suppository | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
Hydrocortisone Acetate recalls
- D-0550-2021 Jun 2, 2021 · Class II · Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Frequently asked questions
What is Hydrocortisone Acetate used for?
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.
What are the side effects of Hydrocortisone Acetate?
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 AARNA USA INC at 1-877-225-6999. See the full label for the complete list.
Who makes Hydrocortisone Acetate?
Hydrocortisone Acetate is listed by 20 labelers in the FDA NDC directory, including Bentlin Products LLC, Sun Pharmaceutical Industries, Inc., A-S Medication Solutions, AARNA USA INC..
Has Hydrocortisone Acetate been recalled?
The FDA enforcement database lists 1 recall for Hydrocortisone Acetate, most recently D-0550-2021 (class ii): CGMP Deviations: Intermittent exposure to temperature excursion during storage.