Clinical Information
Gen. Code and Des.
6858 hydrocortisone acetate RECTAL SUPP.RECT 25 MG
GCN and Des.
27941 hydrocortisone acetate RECTAL SUPP.RECT 25 MG
Strength
Dose Form
SUPPOSITORY, RECTAL
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
84060800 CORTICOSTEROIDS (SKIN, MUCOUS MEMBRANE)
Active Ingredients
2148 hydrocortisone acetate 50033
ANUCORT-HC hydrocortisone acetate suppository
G&W Laboratories, Inc.
DESCRIPTION
Hydrocortisone Acetate is corticosteroid designated chemically as pregn-4-ene 3, 20-dione,21-(acetyloxy)-11, 17-dihydroxy-(11?)
Each rectal suppository contains hydrocortisone acetate, USP 25 mg in specially blended hydrogenated vegetable oil base.
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
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
Hydrocortisone acetate suppositories are contraindicated in those patients having history of hypersensitivity to hydrocortisone acetate or any of the components.
info. FOR PATIENTS
Staining of fabric may occur with use of the suppository. Precautionary measures are recommended.
PREGNANCY CATEGORY C
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
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 ADMINISTRATION
For rectal administration. Detach one suppository from strip of suppositories. Hold suppository upright. Separate tabs at top opening and pull downward from the pointed end. Continue pulling downward to almost the full length of the suppository. Carefully remove the suppository from the pocket. Avoid excessive handling of the suppository which is designed to melt at body temperature. Insert suppository into the rectum with 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 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
Boxes of 12 suppositories NDC 0713-0503-12
Boxes of 24 suppositories NDC 0713-0503-24
Boxes of 100 suppositories NDC 0713-0503-01
STORAGE AND HANDLING
Store between 15?-30?C (59?-86?F). Protect From Freezing.
8-0503GW6
Rev. 12/10
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0713-0503-24
G&W
ANUCORT-HCTM Hydrocortisone Acetate Suppositories 25 mg
Rx only
For Rectal Administration
24 Adult Suppositories
Each suppository contains: Hydrocortisone Acetate 25 mg in specially blended hydrogenated vegetable oil base. FOR RECTAL ADMINISTRATION.
DOSAGE AND ADMINISTRATION: Read package insert for complete info. before use.
DIRECTIONS FOR USE: Detach one suppository from strip of suppositories. Hold suppository upright. Separate tabs at top opening and pull downward from the pointed end. Continue pulling downward to almost the full length of the suppository. Carefully remove the suppository from the pocket. Avoid excessive handling of the suppository, which is designed to melt at body temperature. Insert suppository into rectum with gentle pressure, pointed end first.
Store between 15?- 30?C (59?- 86?F). Protect from freezing.
