Proctocort Dailymed
Generic: hydrocortisone acetate is used for the treatment of Adrenal Insufficiency Adrenal Hyperplasia, Congenital Colitis, Ulcerative Dermatitis, Contact Dermatomycoses Facial Dermatoses Foot Dermatoses Hand Dermatoses Hemorrhoids Inflammation Leg Dermatoses Pruritus Ani Rheumatic Diseases Scalp Dermatoses Shock Skin Diseases, Parasitic Status Asthmaticus Tuberculosis, Cutaneous Skin Diseases, Viral
Go PRO for all pill images
Description
Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula:
Â
Each rectal suppository contains hydrocortisone acetate, USP 30 mg in a specially blended hydrogenated vegetable oil base.
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.
Indications And Usage
Proctocort ®Suppositories are indicated for use in inflamed hemorrhoids, postirradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani.
Contraindications
Proctocort ®Suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.
Precautions
Do not use Proctocort ®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 anti-bacterial agent should be instituted. If a favorable response does not occur promptly, Proctocort ®Suppositories 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.
Pregnancy Category C: 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. Proctocort ®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.
Nursing Mothers: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 Proctocort ®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.Â
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.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 And Administration
For rectal administration. Detach one suppository from strip of suppositories. Remove the foil wrapper. 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.
How Supplied
Box of 12 suppositories - 30 mg - NDC 65649-511-12
Box of 24 suppositories - 30 mg - NDC 65649-511-24
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store away from heat. PROTECT FROM FREEZING.
Distributed by:Salix Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA
Proctocort is a trademark of Salix Pharmaceuticals, Inc. or its affiliates.
© 2024 Salix Pharmaceuticals, Inc. or its affiliates
Rev. 07/2024
9521401
Package Label.principal Display Panel
PACKAGE LABEL PRINCIPAL DISPLAY PANEL - PROCTOCORT ® 30 mg Carton Label
NDC65649-511-12
Rx only
PROCTOCORT ®
Hydrocortisone Acetate Rectal Suppositories
For rectal use only.
Not for oral use.
30 mg                       12 SuppositoriesÂ
Â
Â
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
