Label: HYDROCORTISONE ACETATE suppository
- NDC Code(s): 69680-144-12, 69680-144-24
- Packager: Vitruvias Therapeutics
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated June 4, 2021
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- Official Label (Printer Friendly)
- Description
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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, anti–pruritic and vasoconstrictive action.
- Indications and Usage
- Contraindication
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Precautions
1. Do not use unless adequate proctologic examination is made.
2. If irritation develops, the product should be discontinued and appropriate therapy instituted.
3. 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.
Carcinogenic
No long–term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.
Information for Patients
Staining of fabric may occur with use of the suppository. Precautionary measures are recommended.
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 suppositories should only be used during pregnancy if the potential benefit justifies the risk to 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 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 suppositories: Burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergy contact dermatitis, secondary infection.
To report suspected adverse reactions, contact Vitruvias Therapeutics at 1–844–451–5944 or FDA @ 1–800–FDA–1088 or www.fda.gov/medwatch.
- Drug Abuse and Dependence
- Overdosage
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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 the response of the individual case.
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic or other equivalency testing. No representation is made as to generic status or bioequivalency. 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 provided herein.
- How is hydrocortisone acetate Suppository Supplied
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Opening Instructions
Avoid excessive handling of the suppository. It is designed to melt at body temperature.
1. Separate plastic film at top opening and pull downward.
2. Continue pulling downward to almost the full length of the suppository.
3. Gently remove the suppository from the film pocket.
Manufactured by:
Graxcell Pharmaceutical, LLC.
136 Oak Drive
Syosset , NY 11791Manufactured for:
Vitruvias Therapeutics
Auburn, AL 36830I144 0321R0
Revised 03/2021
- PRINCIPAL DISPLAY PANEL - 25 mg Suppository Blister Pack Carton
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE ACETATE
hydrocortisone acetate suppositoryProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69680-144 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 COCO-GLYCERIDES (UNII: XDD37N2GPR) Product Characteristics Color WHITE (off-white) Score Shape BULLET Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69680-144-12 2 in 1 CARTON 06/01/2021 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:69680-144-24 4 in 1 CARTON 06/01/2021 2 6 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 06/01/2021 Labeler - Vitruvias Therapeutics (079200795) Establishment Name Address ID/FEI Business Operations Graxcell Pharmaceutical, LLC. 080805631 MANUFACTURE(69680-144) , ANALYSIS(69680-144) , PACK(69680-144)
