DailyMed - HYDROCORTISONE ACETATE suppository

NDC Code(s): 69367-243-12, 69367-243-24, 69367-260-12
Packager: Westminster Pharmaceuticals, LLC

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: unapproved drug other

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Drug Label Information

Updated December 4, 2024

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SPL UNCLASSIFIED SECTION
For Rectal Administration - Rx Only

For Rectal Administration

Rx Only
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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 ...

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.
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CLINICAL PHARMACOLOGY
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 ...

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.
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INDICATIONS AND USAGE
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 ...

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.
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CONTRAINDICATIONS
Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.

Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.
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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 ...

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.

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ADVERSE REACTIONS
The following local adverse reactions have been reported with hydrocortisone acetate suppositories; burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact ...

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.
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DRUG ABUSE AND DEPENDENCE
Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.
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OVERDOSAGE
If signs and symptoms of systemic overdosage occur, discontinue use.

If signs and symptoms of systemic overdosage occur, discontinue use.
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DOSAGE AND ADMINISTRATION
FOR RECTAL 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 ...

FOR RECTAL 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.

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HOW SUPPLIED
Hydrocortisone acetate suppositories 25mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 69367-243-12 - Box of 24 suppositories, NDC ...

Hydrocortisone acetate suppositories 25mg are off-white, smooth surfaced and bullet shaped with one pointed end.

Box of 12 suppositories, NDC 69367-243-12
Box of 24 suppositories, NDC 69367-243-24

Hydrocortisone acetate suppositories 30mg are off-white, smooth surfaced and bullet shaped with one pointed end.

Box of 12 suppositories, NDC 69367-260-12

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.

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SPL UNCLASSIFIED SECTION
Rx Only - Manufactured for: Westminster Pharmaceuticals, LLC - Nashville, TN 37217 - Rev. 10/24

Rx Only

Manufactured for:
Westminster Pharmaceuticals, LLC
Nashville, TN 37217

Rev. 10/24
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PRINCIPAL DISPLAY PANEL - 25 mg Suppository Carton
NDC 69367-243-12 - Rx Only - Hydrocortisone Acetate - Suppositories 25 mg - FOR RECTAL USE ONLY - Westminster - Pharmaceuticals - 12 Suppositories - Unit Dose

NDC 69367-243-12
Rx Only

Hydrocortisone Acetate
Suppositories 25 mg

FOR RECTAL USE ONLY

Westminster
Pharmaceuticals

12 Suppositories
Unit Dose

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PRINCIPAL DISPLAY PANEL - 30 mg Suppository Carton
NDC 69367-260-12 - Rx Only - Hydrocortisone Acetate - Suppositories 30 mg - FOR RECTAL USE ONLY - Westminster - Pharmaceuticals - 12 Suppositories - Unit Dose

NDC 69367-260-12
Rx Only

Hydrocortisone Acetate
Suppositories 30 mg

FOR RECTAL USE ONLY

Westminster
Pharmaceuticals

12 Suppositories
Unit Dose

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INGREDIENTS AND APPEARANCE

Product Information

HYDROCORTISONE ACETATE hydrocortisone acetate suppository

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:69367-243
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	25 mg

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)

Product Characteristics
Color	WHITE (Off-White)	Score
Shape	BULLET	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69367-243-12	12 in 1 CARTON; Type 0: Not a Combination Product	02/05/2020
2	NDC:69367-243-24	24 in 1 CARTON; Type 0: Not a Combination Product	02/05/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		02/05/2020

HYDROCORTISONE ACETATE hydrocortisone acetate suppository

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:69367-260
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	30 mg

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)

Product Characteristics
Color	WHITE (Off-White)	Score
Shape	BULLET	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69367-260-12	12 in 1 CARTON; Type 0: Not a Combination Product	11/25/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		11/25/2024

Labeler - Westminster Pharmaceuticals, LLC (079516651)

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Published Date (What is this?)	Version	Files
Dec 6, 2024	7 (current)	download
Feb 12, 2024	6	download
Feb 27, 2023	5	download
Oct 12, 2021	3	download
Jul 9, 2021	2	download
Feb 13, 2020	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1291082	hydrocortisone acetate 25 MG Rectal Suppository	PSN
2	1291082	hydrocortisone acetate 25 MG Rectal Suppository	SCD
3	1291085	hydrocortisone acetate 30 MG Rectal Suppository	PSN
4	1291085	hydrocortisone acetate 30 MG Rectal Suppository	SCD

Label: HYDROCORTISONE ACETATE suppository

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Drug Label Info

Safety

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Drug Label Information

Carcinogenesis

Pregnancy Category C

FOR RECTAL ADMINISTRATION

STORAGE

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

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Safety

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More Info on this Drug

	NDC
1	69367-243-12
2	69367-243-24
3	69367-260-12

Label: HYDROCORTISONE ACETATE suppository

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Carcinogenesis

Pregnancy Category C

FOR RECTAL ADMINISTRATION

STORAGE

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

Find additional resources

Safety

Related Resources

More Info on this Drug

HYDROCORTISONE ACETATE suppository

Number of versions: 6

HYDROCORTISONE ACETATE suppository

HYDROCORTISONE ACETATE suppository

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HYDROCORTISONE ACETATE suppository

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.