The following Structured Product Label (SPL) was submitted to the FDA by Salix Pharmaceuticals, Inc for the product Proctocort (NDC 65649-511). 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, adverse reactions, drug abuse and dependence, overdosage, 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-(11β) with the following structural formula:
Proctocort Structural Formula (Proctocort 7216 Figure 1 Proctocort Structural Formula)
Each rectal suppository contains hydrocortisone acetate, USP 30 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.
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.
Proctocort® Suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.
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.
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 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. 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.
Box of 12 suppositories - NDC 65649-511-12
Box of 24 suppositories - 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.
Manufactured for: Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA
Protocort is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
© Valeant Pharmaceuticals North America LLC
Rev. 04/2016
9521400
1P100 9L J1
2201311
PACKAGE LABEL PRINCIPAL DISPLAY PANEL - PROCTOCORT® 30 mg Carton Label
NDC 65649-511-12
Rx only
PROCTOCORT®
Hydrocortisone Acetate
Rectal Suppositories
For rectal use only.
Not for oral use.
30 mg 12 Suppositories
Proctocortcarton.jpg (Proctocortcarton)
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