HYDROCORTISONE ACETATE

County Line Pharmaceuticals, LLC
County Line Pharmaceuticals, LLC

Hydrocortisone Acetate Suppositories 25 mg For Rectal Administration Rx Only

FULL PRESCRIBING INFORMATION: CONTENTS*

• HYDROCORTISONE ACETATE DESCRIPTION
• CLINICAL PHARMACOLOGY
• HYDROCORTISONE ACETATE INDICATIONS AND USAGE
• HYDROCORTISONE ACETATE CONTRAINDICATIONS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• PREGNANCY CATEGORY C
• HYDROCORTISONE ACETATE ADVERSE REACTIONS
• DRUG ABUSE AND DEPENDENCE
• OVERDOSAGE
• HYDROCORTISONE ACETATE DOSAGE AND ADMINISTRATION
• OPENING INSTRUCTIONS
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - CARTON
• PRINCIPAL DISPLAY PANEL - DOSE PACK

FULL PRESCRIBING INFORMATION

HYDROCORTISONE ACETATE DESCRIPTION

Each Hydrocortisone Acetate 25 mg Suppository contains 25 mg hydrocortisone acetate in a hydrogenated vegetable oil base.  Hydrocortisone acetate is a corticosteroid.  Chemically, hydrocortisone acetate is a pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17- dihydroxy (11β)- with the following structural formula:

C₂₃H₃₂O₆

MW 404.50

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, anti-pruritic 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 pruritis 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 hydrocortisone acetate 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.

INFORMATION FOR PATIENTS

Staining of fabric may occur with use of the suppository.  Precautionary measures are recommended.

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 to 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.

HYDROCORTISONE ACETATE ADVERSE REACTIONS

The following local adverse reactions have been reported with corticosteroid suppositories:  burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis and 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.

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.

OPENING INSTRUCTIONS

Avoid excessive handling of the suppository, it is designed to melt at body temperature.

• Detach one (1) suppository slowly from the strip of suppositories.
  
• Separate tabs at top opening and pull downward slowly.
  
• Continue pulling downward slowly to almost the full length of the suppository.
• Gently remove the suppository from the package.
• Insert suppository into the rectum, pointed end first, with gentle pressure.
  

HOW SUPPLIED

PRINCIPAL DISPLAY PANEL - CARTON

NDC 43199-021-12

12 Suppositories

For Rectal Administration

Rx Only

Hydrocortisone Acetate

Suppositories 25 mg

County Line Pharmaceuticals, LLC

Hydrocortisone Acetate Suppositories 25 mg

12 Suppositories

TAMPER EVIDENT:  DO NOT USE IF FILM IS TORN OR BROKEN

PRINCIPAL DISPLAY PANEL - DOSE PACK

HYDROCORTISONE ACETATE

25 mg SUPPOSITORY

Mfd for:  County Line Pharmaceuticals, LLC

Brookfield, WI  53005