Label: ANUSOL HC- hydrocortisone acetate suppository
- NDC Code(s): 65649-411-12, 65649-411-24
- Packager: Salix Pharmaceuticals, Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated July 1, 2024
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- Official Label (Printer Friendly)
- DESCRIPTION
-
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
- CONTRAINDICATION
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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:
-
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.
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ADVERSE REACTIONS
The following local adverse reactions have been reported with corticosteroid suppositories.
- 1.
- Burning
- 2.
- Itching
- 3.
- Irritation
- 4.
- Dryness
- 5.
- Folliculitis
- 6.
- Hypopigmentation
- 7.
- Allergic contact dermatitis
- 8.
- 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
- OVERDOSAGE
- DOSAGE AND ADMINISTRATION
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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 suppositoriesStore 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
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANUSOL HC
hydrocortisone acetate suppositoryProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65649-411 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 25 mg Inactive Ingredients Ingredient Name Strength HYDROGENATED PALM OIL (UNII: 257THB963H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65649-411-12 12 in 1 BOX; Type 0: Not a Combination Product 06/01/2004 2 NDC:65649-411-24 24 in 1 BOX; Type 0: Not a Combination Product 06/01/2004 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/01/2004 Labeler - Salix Pharmaceuticals, Inc (793108036) Establishment Name Address ID/FEI Business Operations Paddock Laboratories, LLC 967694121 MANUFACTURE(65649-411)