Anucort-HC Suppository

Name: Anucort-HC Suppository

Anucort-HC Suppository - 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.

Contraindications

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

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.

Drug abuse and dependence

Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

Storage and handling

Store at 20-25°C (68°-77°F) [See USP Controlled Room Temperature]. Store away from heat. Protect From Freezing.

Manufactured by:
G&W Laboratories, Inc.
South Plainfield, NJ 07080

8-0503GW7
Rev. 11/13

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 a specially blended hydrogenated vegetable oil base. FOR RECTAL ADMINISTRATION.

DOSAGE AND ADMINISTRATION: Read package insert for complete information 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 at 20-25°C (68°-77°F) [See USP Controlled Room Temperature]. Store away from heat. Protect From Freezing.

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

WARNING: Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

G&W Laboratories, Inc.
South Plainfield, NJ 07080
Visit our website @ www.gwlabs.com

ANUCORT-HC  
hydrocortisone acetate suppository
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0713-0503
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydrocortisone Acetate (Hydrocortisone) Hydrocortisone Acetate 25 mg
Inactive Ingredients
Ingredient Name Strength
Hydrogenated Palm Kernel Oil  
Packaging
# Item Code Package Description
1 NDC:0713-0503-12 12 SUPPOSITORY in 1 CARTON
2 NDC:0713-0503-24 24 SUPPOSITORY in 1 CARTON
3 NDC:0713-0503-01 100 SUPPOSITORY in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/15/1990
Labeler - G&W Laboratories, Inc. (001271188)
Registrant - G&W Laboratories, Inc. (001271188)
Establishment
Name Address ID/FEI Operations
G&W Laboratories, Inc. 001271188 MANUFACTURE(0713-0503)
Revised: 01/2012   G&W Laboratories, Inc.
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