HYDROCORTISONE ACETATE suppository

Hydrocortisone Acetate by

Drug Labeling and Warnings

Hydrocortisone Acetate by is a Prescription medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

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:

• Burning Itching Irritation Dryness:
  • Folliculitis
  • Hypopigmentation
  • Allergic Contact Dermatitis
  • 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

Product: 50090-0381

NDC: 50090-0381-0 1 SUPPOSITORY in a PACKET / 12 in a BOX

SPL UNCLASSIFIED SECTION

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

HYDROCORTISONE ACETATE

INGREDIENTS AND APPEARANCE

HYDROCORTISONE ACETATE 
hydrocortisone acetate suppository

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 50090-0381(NDC:0574-7090)
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	25 mg

Product Characteristics
Color	WHITE	Score	no score
Shape	BULLET	Size	35mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-0381-0	12 in 1 BOX	06/29/2016
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		07/01/1990

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-0381)