Anusol Hc 25 Mg Rectal Suppository
DESCRIPTION
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 (11β)- with the following structural formula:
CLINICAL PHARMACOLOGY
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.
INDICATIONS AND USAGE
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.
CONTRAINDICATION
Anusol-HC® suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components.
PRECAUTIONS
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.
Information for Patients:
Staining of fabric may occur with use of the suppository. Precautionary measures are recommended.
Pregnancy:
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.
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 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.
ADVERSE REACTIONS
The following local adverse reactions have been reported with corticosteroid 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 has not been reported in patients treated with Anusol-HC® suppositories.
OVERDOSAGE
If signs and symptoms of systemic overdosage occur, discontinue use.
DOSAGE AND ADMINISTRATION
HOW SUPPLIED
Anusol-HC® 25 mg Suppositories are white, cylinder shaped, with one end tapered.
NDC 65649-411-12 25 mg 12 suppositories
NDC 65649-411-24 25 mg 24 suppositories
Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA
Anusol-HC is a trademark of Salix Pharmaceuticals, Inc. or its affiliates.
© 2024 Salix Pharmaceuticals, Inc. or its affiliates
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. 07/2024
9520702
ASK A DOCTOR
For rectal use only.
Not for oral use.