The following Structured Product Label (SPL) was submitted to the FDA by Salix Pharmaceuticals, Inc for the product Anusol Hc (NDC 65649-411). 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, contraindication, 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.
Each Anusol-HC® 25-mg Suppository contains 25 mg hydrocortisone acetate in a hydrogenated vegetable oil base. Hydrocortisone acetate is a corticosteroid. Chemically, hydrocortisone acetate is pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy (11ß)- with the following structural formula:
Structural Formula (Anusol Hc 7335 Figure 1 2 17 2011 2 31 54 Pm)
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, anti-pruritic and vasoconstrictive action.
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.
Anusol-HC® 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, the corticosteroid 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.
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. Anusol-HC® suppositories should only be used during pregnancy if the potential benefit justifies the risk of 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 Anusol-HC® 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 corticosteroid suppositories.
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 has not been reported in patients treated with Anusol-HC® suppositories.
If signs and symptoms of systemic overdosage occur, discontinue use.
Usual dosage: One suppository in the rectum morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times daily; or two suppositories twice daily. In factitial proctitis, recommended therapy is six to eight weeks or less, according to response.
Anusol-HC® 25-mg Suppositories are white, cylinder shaped, with one end tapered. Package of 12 suppositories (NDC 65649-411-12) and package of 24 suppositories (NDC 65649-411-24).
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
Opening Instructions (900177a6 Ffb4 4a0e Aa77 94959a9faaf5 00)
OPENING INSTRUCTIONS
Avoid excessive handling of the suppository. It is designed to melt at body temperature.
1. Separate plastic film at top opening and pull downward.
2. Continue pulling downward to almost the full length of the suppository.
3. Gently remove the suppository from the film pocket.
Rev. 04/2016
9520700
2201318
9B500 9L J1
PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Anusol-HC® 12 Suppositories Carton Label
NDC 65649-411-12
Rx only
Anusol-HC®
(Hydrocortisone Acetate in a
Hydrogenated Vegetable Oil Base)
For rectal use only.
Not for oral use.
12 Suppositories
* Please review the disclaimer below.
