FDA Label for Hydrocortisone Acetate
View Indications, Usage & Precautions
- GRAXCELL PHARMACEUTICAL, LLC. DISCLAIMER: THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELLING HAS NOT BEEN APPROVED BY FDA. HYDROCORTISONE ACETAE, 25MG. RECTAL SUPPOSITORIES.
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- CONTRAINDICATIONS
- PRECAUTIONS
- ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- DRUG ABUSE AND DEPENDENCE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Hydrocortisone Acetate Product Label
The following document was submitted to the FDA by the labeler of this product Graxcell Pharmaceutical, Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Graxcell Pharmaceutical, Llc. Disclaimer: This Drug Has Not Been Found By Fda To Be Safe And Effective, And This Labelling Has Not Been Approved By Fda. Hydrocortisone Acetae, 25Mg. Rectal Suppositories.
Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula:
Each rectal suppository contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable oil base
Clinical Pharmacology
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 vasconstrictive action.
Indications & Usage
Hydrocortisone acetate suppositories are indicated for the use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and puritus ani.
Contraindications
Hydrocortisone Acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components
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, 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.
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 suspected adverse reactions, contact
Graxcell pharmaceutical, llc.
1-888-266-8818 or
FDA @ 1-800-FDA-1088 or
www.fda.gov/medwatch
Overdosage
If signs and symptoms of systemic overdosage occur, discontinue use.
Dosage & 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 in six to eight weeks or less, according to the response of the individual case.
Rx only.
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 suppsitory from the film pocket.
How Supplied
Hydrocortisone Acetate suppositories 25mg are white,cyclinder shaped, with one end tapered.
Package of 12 NDC 70795-2412-1
and
Package of 24 NDC 70795-2412-2
Storage And Handling
Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Store away from heat. Protect from freezing.
Manufactured for:
Graxcell pharmaceutical, LLC.
130 knickerbocker ave,Bohemia, NY 11716
Manufactured by:
Graxcell pharmaceutical, llc.
136 OAk Drive,
syosset, NY 11791
1-888-266-8818.
Drug Abuse And Dependence
Drug abuse and dependece have not been reported in patients treated with Hydrocortisone acetate suppositories.
Package Label.Principal Display Panel
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