The following Structured Product Label (SPL) was submitted to the FDA by Marlex Pharmaceuticals, Inc. for the product Hydrocortisone Acetate (NDC 10135-751). 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, carcinogenesis, pregnancy category c, adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Each Hydrocortisone Acetate Suppository for rectal administration contains hydrocortisone acetate USP in a hydrogenated palm kernel oil base.
Hydrocortisone acetate is a corticosteroid. The molecular weight of hydrocortisone acetate is 404.50. Chemically, hydrocortisone acetate is pregn-4-ene-3, 20 dione, 21- (acetyloxy)-11, 17-dihydroxy-, (11β)- with an empirical formula of C23 H32O6 and the following structural formula:
Struct (Structure)
In normal subjects, about 26 percent of hydrocortisone acetate is absorbed when the hydrocortisone acetate 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, antipruritic 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, other inflammatory conditions of the anorectum, and pruritus ani.
Hydrocortisone Acetate Suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components.
Do not use 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 Suppositories should be discontinued until the infection has been adequately controlled.
No long-term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.
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. 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, and secondary infection.
To report SUSPECTED ADVERSE REACTIONS, contact Marlex Pharmaceuticals at 1-888-582-1953 or [email protected] 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.
For rectal administration: Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis.ln 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.
Detach and hold one suppository upright(point upward). Separate tabs at top opening and pull downward to almost the full length of the suppository. Carefully remove the suppository, avoiding excessive handling, which is designed to melt at body temperature. Insert suppository into the rectum, pointed end first, with gentle pressure.
25mg (12 count) NDC 10135-0751-12
25mg (24 count) NDC 10135-0751-24
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store away from heat. Protect from freezing.
Manufactured for/ Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
Rev. 07/22 ID
NDC 10135-0751-12
Rx Only
Hydrocortisone Acetate
Suppositories
25 mg
FOR RECTAL USE ONLY
12 Suppositories
12-count (12 Suppositories Label)
NDC 10135-0751-24
Rx Only
Hydrocortisone Acetate
Suppositories
25 mg
FOR RECTAL USE ONLY
24 Suppositories
24-count (24 Suppositories Label)
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