Hydrocortisone acetate suppository

Spl unclassified section

Ascend Laboratories, LLC
HYDROCORTISONE ACETATE, 25 mg
Rectal Suppositories

Description section

DESCRIPTION:Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene 3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11) with the following structural formula:

Structural Formual

Each rectal suppository contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable oil base.

Clinical pharmacology section

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 vasoconstrictive action.

Indications & usage section

INDICATIONS AND USAGE:Hydrocortisone acetate suppositories are indicated for 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 pruritus ani.

Contraindications section

CONTRAINDICATIONS:Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.

Precautions section

PRECAUTIONS:Do not use hydrocortisone acetate suppositories 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, hydrocortisone acetate should be discontinued until the infection has been adequately controlled.

Carcinogenesis: 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. 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.

Adverse reactions section

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.

Drug abuse and dependence section

DRUG ABUSE AND DEPENDENCE:Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

Overdosage section

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

Dosage & administration section

DOSAGE AND ADMINISTRATION:For rectal administration. Detach one suppository from strip of suppositories. Remove the wrapper. Avoid excessive handling of the suppository which is designed to melt at body temperature. Insert suppository into the rectum with gentle pressure, pointed end first. Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times a day or two suppositories twice daily. In factitial proctitis, the recommended duration of therapy is six to eight weeks or less, according to the response of the individual case.

How supplied section

HOW SUPPLIED:Hydrocortisone acetate suppository is off-white, smooth surfaced and rod shaped with one pointed end.

Box of 12 suppositories NDC 67877-312-12

Box of 24 suppositories NDC 67877-312-24

Store between 1530C (5986F). Protect from freezing.

Caution: Federal law prohibits dispensing without prescription.

Manufactured for:
Ascend Laboratories, LLC
Montvale, NJ 07665 Rev. 08/13

Ingredients and appearance - Product information

Hydrocortisone acetate suppository- Hydrocortisone acetate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 67877-312
Route of Administration Rectal

Active Ingredient/Active Moiety

Ingredient Name Strength
Hydrocortisone acetate ( UNII: 3X7931PO74)( Hydrocortisone - UNII: WI4X0X7BPJ ) 25 mgin 1

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

Labeler - Ascend Laboratories, LLC( 141250469)

Establishment

Name ID/FEI Business Operations
Ascend Laboratories, LLC 141250469 manufacture( 67877-312)

Package label.principal display panel



PRINCIPAL DISPLAY PANEL

ASCEND
Laboratories, LLC
NDC 67877-312-24

Hydrocortisone
Acetate
Suppositories
25 mg


For Rectal Administration


Rx Only 24 Adult
Suppositories