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NDC 69680-0144-12 Hydrocortisone Acetate 25 mg/1 Details
Hydrocortisone Acetate 25 mg/1
Hydrocortisone Acetate is a RECTAL SUPPOSITORY in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Vitruvias Therapeutics. The primary component is HYDROCORTISONE ACETATE.
MedlinePlus Drug Summary
Rectal hydrocortisone is used along with other medications to treat proctitis (swelling in the rectum) and ulcerative colitis (a condition which causes swelling and sores in the lining of the large intestine and rectum). It is also used to relieve itching and swelling from hemorrhoids and other rectal problems. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Related Packages: 69680-0144-12Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Rectal
Product Information
| NDC | 69680-0144 |
|---|---|
| Product ID | 69680-144_a2a2c475-b0da-4c91-ad4f-10801861271a |
| Associated GPIs | 89100010105230 |
| GCN Sequence Number | 006858 |
| GCN Sequence Number Description | hydrocortisone acetate SUPP.RECT 25 MG RECTAL |
| HIC3 | Q3A |
| HIC3 Description | RECTAL PREPARATIONS |
| GCN | 27941 |
| HICL Sequence Number | 002863 |
| HICL Sequence Number Description | HYDROCORTISONE ACETATE |
| Brand/Generic | Generic |
| Proprietary Name | Hydrocortisone Acetate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | HYDROCORTISONE ACETATE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUPPOSITORY |
| Route | RECTAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | HYDROCORTISONE ACETATE |
| Labeler Name | Vitruvias Therapeutics |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 69680-0144-12 (69680014412)
| NDC Package Code | 69680-144-12 |
|---|---|
| Billing NDC | 69680014412 |
| Package | 2 BLISTER PACK in 1 CARTON (69680-144-12) / 6 SUPPOSITORY in 1 BLISTER PACK |
| Marketing Start Date | 2021-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 290de58f-fb3f-4120-aea7-4561cdf60fee Details
Description
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
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.
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
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
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 11791
Manufactured for:
Vitruvias Therapeutics
Auburn, AL 36830
I144 0321R0
Revised 03/2021
PRINCIPAL DISPLAY PANEL - 25 mg Suppository Blister Pack Carton
INGREDIENTS AND APPEARANCE
| HYDROCORTISONE ACETATE
hydrocortisone acetate suppository |
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| Labeler - Vitruvias Therapeutics (079200795) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Graxcell Pharmaceutical, LLC. | 080805631 | MANUFACTURE(69680-144) , ANALYSIS(69680-144) , PACK(69680-144) | |