The following Structured Product Label (SPL) was submitted to the FDA by Cosette Pharmaceuticals, Inc. for the product Anucort-hc (NDC 0713-0503). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, clinical pharmacology, indications and usage, contraindications, precautions, information for patients, pregnancy category c, adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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.
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.
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.
Staining of fabric may occur with use of the suppository. Precautionary measures are recommended.
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.
The following local adverse reactions have been reported with hydrocortisone acetate suppositories: burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection.
To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.
If signs and symptoms of systemic overdosage occur, discontinue use.
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.
Boxes of 12 suppositories NDC 0713-0503-12
Boxes of 24 suppositories NDC 0713-0503-24
Boxes of 100 suppositories NDC 0713-0503-01
Store at 20-25°C (68°-77°F) [See USP Controlled Room Temperature]. Store away from heat. Protect From Freezing.
Manufactured by:
Cosette Pharmaceuticals, Inc.
111 Coolidge Street,
South Plainfield, NJ 07080
8-0503CP1 Iss. 09/2019
NDC 0713-0503-12
ANUCORT-HCTM
Hydrocortisone Acetate Suppositories
25 mg
Rx only
For Rectal Administration
12 Adult Suppositories
Cosette Pharmaceuticals, Inc.
Carton-12 (Carton 12)
NDC 0713-0503-24
ANUCORT-HCTM
Hydrocortisone Acetate Suppositories
25 mg
Rx only
For Rectal Administration
24 Adult Suppositories
Cosette Pharmaceuticals, Inc.
Carton-24 (Carton 24) 
NDC 0713-0503-01
ANUCORT-HCTM
Hydrocortisone Acetate Suppositories
25 mg
Rx only
For Rectal Administration
100 Adult Suppositories
Cosette Pharmaceuticals, Inc.
Carton-100 (Carton 100) 
HYDROCORTISONE ACETATE 25mg
Manufactured by:
Cosette Pharmaceuticals, Inc.
111 Coolidge Street,
South Plainfield,NJ 07080
Pack (Pack)
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