DailyMed Label: ANUCORT-HC

DailyMed Label: ANUCORT-HC

2023

DailyMed Prescription

ANUCORT-HC

Hydrocortisone Acetate

Cosette Pharmaceuticals, Inc.

NDC: 0713-0503

NDC: 0713-0503

NDC: 0713-0503

NDC: 0713-0503

NDC: 0713-0503

NDC: 0713-0503

Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene 3, 20-dione,21-(acetyloxy)-11, 17-dihydroxy-(11ß) with the following structural formula: Each rectal suppository contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable oil base. structural formula

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.

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 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.

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

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.

The following local adverse reactions have been reported with hydrocortisone acetate suppositories: burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection.

Boxes of 12 suppositories NDC 0713-0503-12 Boxes of 24 suppositories NDC 0713-0503-24 Boxes of 100 suppositories NDC 0713-0503-01

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.

NDC 0713-0503-12 ANUCORT-HC TM Hydrocortisone Acetate Suppositories 25 mg Rx only For Rectal Administration 12 Adult Suppositories Cosette Pharmaceuticals, Inc. NDC 0713-0503-24 ANUCORT-HC TM Hydrocortisone Acetate Suppositories 25 mg Rx only For Rectal Administration 24 Adult Suppositories Cosette Pharmaceuticals, Inc. NDC 0713-0503-01 ANUCORT-HC TM Hydrocortisone Acetate Suppositories 25 mg Rx only For Rectal Administration 100 Adult Suppositories Cosette Pharmaceuticals, Inc. carton-12 carton-24 carton-100