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NDC 42494-0341-12 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 Cameron Pharmaceuticals, Limited Liability Company. 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: 42494-0341-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Rectal
Product Information
| NDC | 42494-0341 |
|---|---|
| Product ID | 42494-341_b9ed6ad3-0833-45c8-8f10-2e7675675b3f |
| 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 | Cameron Pharmaceuticals, Limited Liability Company |
| 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 42494-0341-12 (42494034112)
| NDC Package Code | 42494-341-12 |
|---|---|
| Billing NDC | 42494034112 |
| Package | 1 BLISTER PACK in 1 BOX (42494-341-12) / 12 SUPPOSITORY in 1 BLISTER PACK |
| Marketing Start Date | 2022-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL df6203a0-25ec-472e-a117-58bc0842b698 Details
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 suppository for rectal administration contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable base.
CLINICAL PHARMACOLOGY
In normal subjects, about 26% 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
CONTRAINDICATIONS
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 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.
ADVERSE REACTIONS
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 Cameron Pharmaceuticals, LLC at 1-888-767-7913.
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.
HOW SUPPLIED
Hydrocortisone acetate suppositories 25mg are off-white, smooth surfaced and bullet shaped with one pointed end.
Box of 12 suppositories, NDC 42494-341-12
Box of 24 suppositories, NDC 42494-341-24
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.
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 25 mg Suppository Blister Pack Box
INGREDIENTS AND APPEARANCE
| HYDROCORTISONE ACETATE
hydrocortisone acetate suppository |
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| Labeler - Cameron Pharmaceuticals, Limited Liability Company (078371442) |