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NDC 39328-0029-12 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 Patrin Pharma Inc.. 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: 39328-0029-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Rectal
Product Information
| NDC | 39328-0029 |
|---|---|
| Product ID | 39328-029_b44a8a6e-1239-4b41-8856-9d047ca77958 |
| 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 | Patrin Pharma Inc. |
| 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 39328-0029-12 (39328002912)
| NDC Package Code | 39328-029-12 |
|---|---|
| Billing NDC | 39328002912 |
| Package | 12 SUPPOSITORY in 1 CARTON (39328-029-12) |
| Marketing Start Date | 2022-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7c1d2c8c-26e2-432f-b983-505f259665a9 Details
DESCRIPTION
Each Hydrocortisone Acetate Suppository for rectal administration contains hydrocortisone acetate USP in a hydrogenated palm kernel oil base.
Hydrocortisone acetate is a corticosteroid. T he molecular weight of hydrocortisone acetate is 404.50. Chemically, hydrocortisone acetate is pregn-4-ene-3, 20 dione, 21- (acetyloxy)-11, 17-dihydroxy-, (11β)- with an empirical formula of C23 H32O6 and the following structural formula:
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, antipruritic and vasoconstrictive action.
INDICATIONS AND USAGE
CONTRAINDICATIONS
PRECAUTIONS
Do not use 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 Suppositories 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 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. 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.
ADVERSE REACTIONS
The following local adverse reactions have been reported with Hydrocortisone Acetate Suppositories: burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, and secondary infection.
To report SUSPECTED ADVERSE REACTIONS, contact Patrin Pharma at 1-800-936-3088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG ABUSE AND DEPENDENCE
DOSAGE AND ADMINISTRATION
For rectal administration: Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis.ln 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.
Detach and hold one suppository upright(point upward). Separate tabs at top opening and pull downward to almost the full length of the suppository. Carefully remove the suppository, avoiding excessive handling, which is designed to melt at body temperature. Insert suppository into the rectum, pointed end first, with gentle pressure.
HOW SUPPLIED
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 25 mg Suppository Carton
PRINCIPAL DISPLAY PANEL - 30 mg Suppository Carton
INGREDIENTS AND APPEARANCE
| HYDROCORTISONE ACETATE
hydrocortisone acetate suppository |
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| HYDROCORTISONE ACETATE
hydrocortisone acetate suppository |
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| Labeler - Patrin Pharma Inc. (806841677) |