Hydrocortisone Acetate
FDA Drug Information • Also known as: American Safety And First Aid, Anti-Itch Vulva Cream 1 Hydrocortisone Acetate, Anucort-Hc, Anusol...
- Brand Names
- American Safety And First Aid, Anti-Itch Vulva Cream 1 Hydrocortisone Acetate, Anucort-Hc, Anusol Hc, Cortifoam, Hemmorex-Hc, Hydrocortisone, Hydrocortisone Acetate, Hydrocortisone Acetate Antipruritic (Anti-Itch), Medi First Plus, Medi-First, Medi-First 1% Hydrocortisone, Medi-First Hydrocortisone 1%, Poli-A, Proctocort, Procure, Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula, Walgreens Eczema Relief
- Dosage Form
- POWDER
- Product Type
- BULK INGREDIENT
Description
DESCRIPTION Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11ß) with the following structural formula: Each suppository for rectal administration contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable base. structure
What Is Hydrocortisone Acetate Used For?
INDICATIONS AND USAGE Hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani.
Dosage and Administration
DOSAGE AND ADMINISTRATION For rectal administration. Detach one suppository from strip of suppositories. Hold suppository upright. Separate tabs at top opening and pull downward from the pointed end. Continue pulling downward to almost the full length of the suppository. Carefully remove the suppository from the pocket. 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.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS 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 an adverse event, please contact Quagen Pharmaceuticals LLC. at 1-888-344-9603, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Contraindications
CONTRAINDICATIONS Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.
Pregnancy and Breastfeeding
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. Hydrocortisone acetate 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 hydrocortisone acetate 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.
Overdosage
OVERDOSAGE If signs and symptoms of systemic overdosage occur, discontinue use.
How Supplied
HOW SUPPLIED Hydrocortisone acetate suppositories 25 mg are white to off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 70752-169-02 Box of 24 suppositories, NDC 70752-169-23 STORAGE Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Excursions permitted to 15°-30°C (59°-86°F). Store away from heat. Protect from freezing. Avoid contact with eyes. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Rx Only Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52030 Rev.01/21
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.