HYDROCORTISONE ACETATE- hydrocortisone acetate suppository 
Paddock Laboratories, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Hydrocortisone Acetate
Suppositories 25 mg

DESCRIPTION

Each suppository for rectal administration contains 25 mg hydrocortisone acetate USP in a hydrogenated cocoglyceride base. Hydrocortisone acetate is a corticosteroid.

Chemically, hydrocortisone acetate is pregn-4-ene-3, 20 dione, 21- (acetyloxy)-11, 17-dihydroxy-, (11β)- with the following structural formula:

Chemical Structure

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

For use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani.

CONTRAINDICATIONS

Hydrocortisone acetate suppositories are contraindicated in those patients with a history of hypersensitivity to 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.

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.

It is not known whether this drug is excreted in human milk.

Until adequate studies in pregnant or lactating women have been conducted, this drug should be used during pregnancy or by nursing mothers only when clearly needed and when the potential benefits outweigh the potential risks.

ADVERSE REACTIONS

The following local adverse reactions have been reported with corticosteroid suppositories:

1.
Burning
2.
Itching
3.
Irritation
4.
Dryness
5.
Folliculitis
6.
Hypopigmentation
7.
Allergic Contact Dermatitis
8.
Secondary Infection

DRUG ABUSE AND DEPENDENCE

Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

OVERDOSAGE

If signs and symptoms of systemic overdosage occur, discontinue use.

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 response.

HOW SUPPLIED

Hydrocortisone acetate suppositories are easy to open, color coded and available in cartons of:

12'sNDC 0574-7090-12

Store at controlled room temperature 15° to 30°C (59° to 86°F). Protect from freezing.

Manufactured By
Perrigo®
Minneapolis, MN 55427
(01-12)

PRINCIPAL DISPLAY PANEL - 25 mg Packet Label

Hydrocortisone Acetate 25 mg
Suppository

(01)10305747090121
Manufactured by Perrigo®
Minneapolis, MN 55427

PRINCIPAL DISPLAY PANEL - 25 mg Packet Label
HYDROCORTISONE ACETATE 
hydrocortisone acetate suppository
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0574-7090
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE25 mg
Product Characteristics
ColorWHITEScoreno score
ShapeBULLETSize35mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0574-7090-1212 in 1 BOX
11 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER07/01/1990
Labeler - Paddock Laboratories, LLC (967694121)
Establishment
NameAddressID/FEIBusiness Operations
Paddock Laboratories, LLC967694121MANUFACTURE(0574-7090)

Revised: 8/2012
Document Id: ddc26de3-4e5e-418a-b6db-5af37842d6a7
Set id: 2fdb9940-6da8-49b0-a236-9817943f7a4b
Version: 1
Effective Time: 20120816
 
Paddock Laboratories, LLC