Anusol hc - Hydrocortisone cream prescribing information
INDICATIONS AND USAGE
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
DOSAGE AND ADMINISTRATION
Anusol-HC ® 2.5% (hydrocortisone cream, USP) should be applied to the affected area two to four times daily depending on the severity of the condition.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
CONTRAINDICATIONS
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
ADVERSE REACTIONS
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:
Burning | Acneiform eruptions | Skin atrophy |
Itching | Hypopigmentation | Striae |
Irritation | Perioral dermatitis | Miliaria |
Dryness | Allergic contact dermatitis | |
Folliculitis | Maceration of the skin | |
Hypertrichosis | 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.
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Anusol-HC ® 2.5% (hydrocortisone cream, USP) is a topical corticosteroid with hydrocortisone 2.5% (active ingredient) in a water-washable cream containing the following inactive ingredients: benzyl alcohol, petrolatum, stearyl alcohol, propylene glycol, isopropyl myristate, polyoxyl 40 stearate, carbomer homopolymer, sodium lauryl sulfate, edetate disodium, sodium hydroxide to adjust the pH, and purified water.
Hydrocortisone has the chemical name Pregn-4-ene-3,20-dione, 11,17, 21, trihydroxy-,(11β) - and the following chemical structure:
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
Pharmacokinetics:
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION ).
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
HOW SUPPLIED
Anusol-HC 2.5% (hydrocortisone cream, USP) is supplied as follows: NDC 65649-401-30 30 g tube
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM FREEZING.
- Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA
- Anusol-HC is a registered trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2023 Salix Pharmaceuticals, Inc. or its affiliates
- Manufactured by:
- Padagis ® US LLC
- Minneapolis, MN 55427 USA
Anusol-HC is a registered trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2023 Salix Pharmaceuticals, Inc. or its affiliates
- Rev. 06/2023
- 9521003
- 2204609 7C800 9L PH4
