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Fougera Hydrocortisone Ointment 2.5% is a topical corticosteroids used to reduces the actions of chemicals in the body that cause inflammation, redness, and swelling. Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis. How to Apply: Apply hydrocortisone cream to the affected area as a thin film 2 to 4 times daily depending on the severity of the condition. It is not likely other drugs you take orally or inject will have an effect on topically applied hydrocortisone. But many drugs can interact with each other. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, hydrocortisone should be used only when prescribed. Infants born to mothers who have been using this medication for an extended period of time may have hormone problems. Tell your doctor if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn. This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding. Each gram of Hydrocortisone Cream, USP 2.5% contains 25 mg of hydrocortisone in a water-washable base of cetyl alcohol, isopropyl palmitate, methylparaben, mineral oil/lanolin alcohol, polysorbate 40, propylene glycol, propylene glycol stearate, propylparaben, purified water, sorbic acid, sorbitan palmitate, stearyl alcohol and xanthan gum. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11,17, 21-trihydroxy-, (11β)-] with the molecular formula (C21H30O5) and is represented by the following structural formula:  Its molecular weight is 362.47 and its CAS Registry Number is 50–23–7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone Cream 2.5% - Clinical PharmacologyTopical 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. PharmacokineticsThe 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 Hydrocortisone Cream 2.5%Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ContraindicationsTopical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. PrecautionsGeneralSystemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (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 addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid 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. 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 PatientPatients using topical corticosteroids should receive the following information and instructions:
Laboratory TestsThe following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test Carcinogenesis, Mutagenesis and Impairment of FertilityLong-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. PregnancyTeratogenic effects: 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 MothersIt is not known whether topical administration of 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 a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric UsePediatric patients may demonstrate greater susceptibility to 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 pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients 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 pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients. Adverse ReactionsThe 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, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. OverdosageTopically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS). Hydrocortisone Cream 2.5% Dosage and AdministrationTopical corticosteroids are generally applied to the affected area as a thin film from 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. HOW SUPPLIED:Hydrocortisone Cream, USP 2.5% is available as follows:
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Distributed by: L7058 C-A225 PRINCIPAL DISPLAY PANELNDC 0527-5122-80 Hydrocortisone 2.5% Rx Only Lannett HYDROCORTISONE Product InformationProduct TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0527-7781Route of AdministrationTOPICALDEA Schedule Active Ingredient/Active MoietyIngredient NameBasis of StrengthStrengthHYDROCORTISONE (HYDROCORTISONE)HYDROCORTISONE25 mg in 1 g Inactive IngredientsIngredient NameStrengthCETYL ALCOHOLISOPROPYL PALMITATEMETHYLPARABENMINERAL OILLANOLIN ALCOHOLSPOLYSORBATE 40PROPYLENE GLYCOLPROPYLENE GLYCOL STEARATEPROPYLPARABENWATERSORBIC ACIDSORBITAN MONOPALMITATESTEARYL ALCOHOLXANTHAN GUM Packaging#Item CodePackage Description1NDC:0527-7781-781 TUBE in 1 CARTON130 g in 1 TUBE2NDC:0527-7781-97454 g in 1 JAR Marketing InformationMarketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End DateANDAANDA04050303/12/2004 Is 2.5 percent hydrocortisone cream strong?Hydrocortisone 2.5% is typically going to be stronger than 1%, if you are comparing the same salt forms. Hydrocortisone topical medications come in many salt forms; certain ones are stronger than others, so you can't always compare the numbers.
How long does hydrocortisone 2.5 cream take to work?Typically results from applying the hydrocortisone topical cream will take anywhere from 3-7 days to show up. If you do not see results or your eczema symptoms are worsening, you should contact your dermatologist for a different treatment plan.
Is hydrocortisone 2.5 A strong steroid?Topical Steroid Class VII
These topical steroids are considered the least potent: Hytone (hydrocortisone) 2.5% cream and lotion11. Hydrocortisone 1% (many over-the-counter brands of creams, ointments, and lotions)
Where do you apply hydrocortisone cream?To use hydrocortisone topical, apply a small amount of ointment, cream, solution, spray, or lotion to cover the affected area of skin with a thin even film and rub it in gently. This medication is only for use on the skin. Do not let hydrocortisone topical get into your eyes or mouth and do not swallow it.
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What is hydrocortisone 2.5 ointment used for
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