Hydrocortisone Acetate description, usages, side effects, indications, overdosage, supplying and lots more!

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Hydrocortisone Acetate

Paddock Laboratories, LLC

Hydrocortisone Acetate Suppositories 25 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

HYDROCORTISONE ACETATE 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:

Hydrocortisone Acetate

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.

HYDROCORTISONE ACETATE 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.

HYDROCORTISONE ACETATE 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.

HYDROCORTISONE ACETATE ADVERSE REACTIONS

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

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

    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.

    HYDROCORTISONE ACETATE 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's NDC 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

    Hydrocortisone Acetate

    Hydrocortisone Acetate

    HYDROCORTISONE ACETATE SUPPOSITORY

    Product Information

    Product Type Human prescription drug label Item Code (Source) NDC:0574-7090
    Route of Administration RECTAL DEA Schedule

    Active Ingredient/Active Moiety

    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE ACETATE HYDROCORTISONE 25 mg

    Product Characteristics

    Color Size Shape
    WHITE 35 mm BULLET

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1 in 1 PACKET
    2 NDC:0574-7090-12 12 in 1 BOX

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    1990-07-01


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