form of U-cort Generic Name: hydrocortisone acetate Dosage Form: cream Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons U-cort (HYDROCORTISONE ACETATE CREAM USP, 1%) Rx only U-cort Description Hydrocortisone Acetate Cream USP, 1% is intended for topical administration. The active component is the corticosteroid hydrocortisone acetate, which has the chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17-dihydroxy-11β)-. It has the following structural formula: Molecular Weight: 404.50 Molecular Formula: C 23 H 32 O 6 Each gram of the cream contains: 10 mg Hydrocortisone Acetate, USP in a water-washable cream base containing carbomer 940, cetyl alcohol, edetate disodium, isopropyl myristate, isopropyl palmitate, perfume, polypropylene 26 oleate, propylene glycol, purified water, sodium lauryl ether, sodium metabisulfite, stearic acid, trolamine, urea (10%) and xanthan gum. Slideshow 7 First Aid Kit Must Haves For Your Medicine Cabinet U-cort - Clinical Pharmacology Topical corticosteroids share anti-inflammatory, anti-pruritic 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. Indications and Usage for U-cort U-cort , (Hydrocortisone Acetate Cream USP, 1%) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Contraindications Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Warnings Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. Precautions General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitaryadrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the additions of occlusive dressings. Therefore, patients receiving a large dose of potent topical steroids applied to a large surface area, or under an occlusive dressing, should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS-Pediatric Use .) If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use. In the presence of dermatological infections, 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. Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to 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 topical corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use Pediatric patients may demonstrate greater susceptibility to a topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. Adverse Reactions The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence beginning with column 1: Burning Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria Overdosage Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS .) U-cort Dosage and Administration U-cort , (Hydrocortisone Acetate Cream USP, 1%) is generally applied to the affected area as a thin film 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 appropri-ate antimicrobial therapy instituted. How is U-cort Supplied U-cort (Hydrocortisone Acetate Cream USP, 1%) is supplied in a 1 oz (28.35 g) (NDC 51672-3009-2) tube. Store at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature]. Protect from freezing. Pharmacist: Dispense in tight containers as specified in USP. Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Distributed by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 U-cort and TaroPharma are registered trademarks of Taro Pharmaceuticals U.S.A., Inc. and/or its affiliates. Revised: October, 2010 PK-4385-6 100 PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton 1% CREAM U-cort Hydrocortisone Acetate Cream USP, 1% NET WT 1OZ (28.35 g) NDC 51672-3009-2 Rx only TaroPharma U-cort hydrocortisone acetate cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51672-3009 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone Acetate (Hydrocortisone) Hydrocortisone Acetate 10 mg in 1 g Inactive Ingredients Ingredient Name Strength carbomer homopolymer type c cetyl alcohol edetate disodium isopropyl myristate isopropyl palmitate propylene glycol water sodium metabisulfite stearic acid trolamine urea xanthan gum Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:51672-3009-2 1 TUBE (TUBE) in 1 CARTON 1 28.35 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089472 06/13/1988 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-3009) Revised: 03/2012 Taro Pharmaceuticals U.S.A., Inc. Next Interactions Print this page Add to My Med List More about U-Cort (hydrocortisone topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: topical steroids Consumer resources U-Cort U-Cort (Advanced Reading) Professional resources Hydrocortisone topical (AHFS Monograph) Hydrocortisone in Absorbase (FDA) Other brands: Proctozone HC , Westcort , Anucort-HC , Proctocort , ... +18 more Related treatment guides Atopic Dermatitis Dermatitis Eczema Intertrigo ... +4 more} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Topical steroids Related Drugs topical steroids fluticasone topical , triamcinolone topical , hydrocortisone topical , clobetasol topical Eczema prednisone , fluticasone topical , triamcinolone topical , hydrocortisone topical , dexamethasone , clobetasol topical , More... Atopic Dermatitis prednisone , fluticasone topical , triamcinolone topical , hydrocortisone topical , dexamethasone , methylprednisolone , More... Pruritus hydroxyzine , lidocaine topical , hydrocortisone topical , diphenhydramine , Benadryl , More... 5 more conditions... U-Cort Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } really extraordinary
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