Label: HYDROCORTISONE ACETATE suppository
- NDC Code(s): 68071-2259-2
- Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 69367-243
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated February 7, 2022
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- SPL UNCLASSIFIED SECTION
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.
- INDICATIONS AND USAGE
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.
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.
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
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 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.
Hydrocortisone acetate suppositories 25mg are off-white, smooth surfaced and bullet shaped with one pointed end.
Box of 12 suppositories, NDC 68071-2259-2
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.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 12 Suppository Carton
INGREDIENTS AND APPEARANCE
hydrocortisone acetate suppository
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2259(NDC:69367-243) Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 25 mg Inactive Ingredients Ingredient Name Strength HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP) Product Characteristics Color white Score Shape BULLET Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-2259-2 12 in 1 CARTON; Type 0: Not a Combination Product 09/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/05/2020 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-2259)