H. 36. The present study addresses the influence of lipid composition and drug substance lipid solubility o … Hydrocortisone butyrate is a corticosteroid that comes in one of the following forms: Hydrocortisone-17-butyrate — CID 26133 from PubChem; Hydrocortisone-21-butyrate — CID 23144 from PubChem; It is a group IV corticosteroid under US classification. D07AB02 This page was last edited on 31 December 2018, at 20:57 (UTC). )* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name1% with Bacitracin Zinc 400 units (of bacitracin) per g, Neomycin Sulfate 0.5% (0.35% of neomycin), and Polymyxin B Sulfate 5000 units (of polymyxin B) per g1% with Neomycin Sulfate 0.5% (0.35% of neomycin), and Polymyxin B Sulfate 10,000 units (of polymyxin B) per gHydrocortisone is also commercially available in combination with antihistamines, astringents, keratolytics, local anesthetics, and vasoconstrictors. )Response may vary from one topical corticosteroid preparation to another.Anti-inflammatory activity may vary considerably depending on the vehicle, drug concentration, site of application, disease, and individual patient.Topical treatment of infected dermatoses in combination with topical anti-infectives (e.g., neomycin, polymyxin B) or antifungals.If a topical corticosteroid is used in combination with a topical anti-infective, weigh benefits against risks.Hydrocortisone acetate paste used as an adjunct for temporary symptomatic relief of oral inflammatory or ulcerative lesions resulting from trauma.Used rectally as a retention enema for adjunctive treatment of mild or moderate acute ulcerative colitis limited to the rectosigmoid or left colon.Used rectally as a retention enema for mild acute ulcerative colitis of the transverse or descending colon.Retention enema usually is effective in mild or moderate acute rectosigmoid ulcerative colitis when response to sulfasalazine (generally considered the maintenance drug of choice) is inadequate or when sulfasalazine cannot be given.Systemic corticosteroids and/or corticosteroid enemas are more effective than sulfasalazine in acute ulcerative colitis attacks, but if surgery is required, it should not be delayed in favor of corticosteroid therapy.Hydrocortisone acetate rectal suppositories or suspension (foam), may be effective as adjunctive treatment of rectal ulcerative colitis.Hydrocortisone acetate rectal suppositories also are used in the treatment of other anorectal inflammatory conditions (e.g., inflamed hemorrhoids, postirradiation or factitial proctitis, cryptitis, pruritus ani).Fixed-combination preparations of a corticosteroid and local anesthetic may be useful for symptomatic relief of anorectal conditions (e.g., hemorrhoids), but combinations with antihistamines, astringents, keratolytics, and/or vasoconstrictors are of questionable efficacy.Consider location of the lesion and the condition being treated when choosing a dosage form.Lotions are probably best for treatment of weeping eruptions, especially in areas subject to chafing (e.g., axilla, foot, groin).Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercial preparations with another vehicle may decrease effectiveness.Patients applying a topical corticosteroid to a large surface area and/or to areas under occlusion should be evaluated periodically for evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression by appropriate endocrine testing (e.g., ACTH stimulation, plasma cortisol, urinary free cortisol).For dermatologic use only; avoid contact with eyes.Apply creams, lotions, ointments, solutions, and aerosol foams topically to the skin or scalp.Apply rectal creams and ointments externally to the anal area; some commercially available creams also may be applied externally to the anogenital areas.The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating.Apply cream, lotion, ointment, or solution sparingly in a thin film and rub gently into affected area.For scalp dermatoses, part the hair and apply small amount of lotion or solution directly to the affected area; rub gently into scalp.To dispense foam, shake container well (for 5–10 seconds) immediately prior to use.For use in the mouth, press a small amount of paste to the lesion without rubbing until a thin film develops.After a favorable response is achieved, frequency of application or concentration (strength) may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible.Occlusive dressings may be used for severe or resistant dermatoses (e.g., psoriasis).Soak or wash the affected area to remove scales; apply a thin film of cream, lotion, or ointment; rub gently into the lesion; and apply another thin film.If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape.Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.Frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of the corticosteroid are essential at each dressing change.Occlusive dressing is usually left in place for 12–24 hours and therapy is repeated as needed.The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion.Administer rectally as a retention enema, suppository, or aerosol foam.Administer retention enema, suppository, or foam carefully according to manufacturer’s instructions.Available as hydrocortisone (dosage expressed in terms of the base) and as hydrocortisone acetate, buteprate, butyrate, and valerate (dosage expressed in terms of the salt).Administer the least amount of topical preparations that provides effective therapy.Nonprescription hydrocortisone preparations should not be used in children <2 years of age unless directed and supervised by a clinician.Children ≥2 years of age: Apply appropriate cream, lotion, ointment, or solution sparingly 1–4 times daily.Apply appropriate cream, lotion, ointment, or solution sparingly 1–4 times daily.Apply aerosol foam to affected area 2–4 times daily.Nonprescription preparations should not be used for If the condition worsens or symptoms persist, discontinue and consult a clinician.Apply a small amount of paste to the lesion 2 or 3 times daily after meals and at bedtime.If substantial regeneration or repair of oral tissues does not occur after 7 days, further investigate etiology of the lesions.Adjunctive treatment of ulcerative colitis: 100 mg nightly.Usually given for 21 days or until clinical and proctologic remissions are achieved.Lay on left side during and for 30 minutes after administration to distribute drug throughout the left colon.Symptoms may improve in 3–5 days, followed by proctologic improvement.Protologic remission may require 2–3 months of therapy.Following treatment for >21 days, gradually withdraw use; give every other night for 2–3 weeks, then discontinue.Ulcerative proctitis of the distal rectum: 90 mg (1 applicatorful of a 10% aerosol foam suspension) 1 or 2 times daily for 2–3 weeks.Adjunctive treatment of ulcerative colitis of the rectum and other inflammatory conditions of the anorectum: 25 mg in the morning and at night for 2 weeks.Severe proctitis: 25 mg 3 times daily or 50 mg twice daily.Adjunctive treatment of postirradiation or factitial proctitis: 25 mg in the morning and at night for 6–8 weeks (or less if an adequate response is attained).For internal hemorrhoid symptoms and adjunctive treatment of other anorectal inflammatory conditions: 10 mg in the morning and at night for 2–6 days.Known hypersensitivity to hydrocortisone or any ingredient in the formulation.Rectal corticosteroid therapy in patients with intestinal obstruction, abscess, impending perforation, peritonitis, extensive fistulas, and fresh intestinal anastomoses or sinus tracts.Allergic contact dermatitis may manifest as failure to heal rather than irritation as occurs with other topical preparations that do not contain corticosteroids; confirm with diagnostic patch testing.Topically applied corticosteroids can be absorbed in sufficient amounts to reversibly suppress the HPA axis.Perform periodic HPA-axis evaluation by appropriate testing (e.g., ACTH stimulation, morning plasma cortisol, urinary free cortisol), especially in patients applying a topical corticosteroid to a large surface area or to areas under occlusion.If HPA-axis suppression occurs, withdraw the drug, reduce the frequency of application, and/or substitute a less potent corticosteroid.HPA-axis function recovery generally is prompt and complete following drug discontinuance.Rarely, glucocorticosteroid insufficiency may require systemic corticosteroid therapy.Systemic absorption following topical administration may result in manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.Adverse systemic effects may occur when corticosteroids are used on large areas of the body, for prolonged periods of time, with an occlusive dressing, and/or concurrently with other corticosteroid-containing preparations.Infants and children may be more susceptible to adverse systemic effects.Possible adverse local reactions (e.g., irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, miliaria); may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.Prolonged use of topical corticosteroids may cause atrophy of the epidermis and subcutaneous tissue;If irritation occurs, discontinue drug and initiate appropriate therapy.If concurrent skin infection is present or develops, initiate appropriate anti-infective therapy.When topical corticosteroids and topical anti-infectives are used concomitantly, consider that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation.Do not use occlusive dressings in patients with primary skin infection.Some manufacturers state that topical corticosteroids are contraindicated in patients with tuberculosis of the skin, dermatologic fungal infections, and cutaneous or systemic viral infection (including vaccinia and varicella and herpes simplex of the eye or adjacent skin); however, most clinicians believe topical corticosteroids may be used with caution if the infection is treated.Use rectally with caution in severe ulcerative disease and only after adequate proctologic examination; risk of intestinal perforation.Adverse systemic corticosteroid effects may occur with use of occlusive dressings on large areas of the body and for prolonged periods of time; monitor accordingly.Adverse local reactions may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.Do not use occlusive dressings on weeping or exudative lesions.Do not use occlusive dressings in patients with primary skin infection.Remove occlusive dressings covering large areas if body temperature increases; thermal homeostasis may be impaired.Use plastic occlusive material with care to avoid the risk of suffocation.When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.Not known whether topical hydrocortisone is distributed into milk.Nonprescription hydrocortisone preparations should not be used in children <2 years of age unless directed and supervised by a clinician.Tight-fitting diapers or plastic pants should not be used on a child being treated in the diaper area, since such garments may constitute occlusive dressings.Children are more susceptible to topical corticosteroid-induced HPA-axis suppression and Cushing’s syndrome than mature individuals because of a greater skin surface area-to-body weight ratio,Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol concentrations, and lack of response to corticotropin (ACTH) stimulation.Children also are at greater risk of glucocorticoid insufficiency during and/or after withdrawal of treatment.Intracranial hypertension has occurred in children; manifestations include bulging fontanelles, headaches, and bilateral papilledema.Striae has been reported in children treated inappropriately with topical corticosteroids.Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic efficacy; chronic topical corticosteroid therapy may interfere with growth and development.Burning, stinging, itching, irritation, dry skin, erythema, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection.Potential pharmacologic interaction with other corticosteroid-containing preparationsConcurrent use of corticosteroids reportedly may result in false-negative resultsPercutaneous penetration of corticosteroids following topical application to the skin varies among individuals and may be increased by occlusive dressings, high corticosteroid concentrations, and certain vehicles.Only minimal amounts of topical corticosteroid reach the dermis and subsequently the systemic circulation after application to most normal skin areas; more absorption occurs from the scrotum, axilla, eyelid, face, and scalp than from the forearm, knee, elbow, palm, and sole.Absorption is markedly increased by loss of the skin’s keratin layer and by inflammation and/or diseases of the epidermal barrier (e.g., psoriasis, eczema).Occlusive dressings used with hydrocortisone for 96 hours substantially enhance percutaneous penetration;In healthy individuals, up to 30–90% of hydrocortisone administered rectally as a retention enema may be absorbed.Not known whether topical hydrocortisone is distributed into milk.Once absorbed through the skin, topically applied corticosteroids are metabolized primarily in the liver.Topical corticosteroids and metabolites are excreted by the kidneys and, to a lesser extent, in the bile.Room temperature; consult product information for specific recommendations.Room temperature; consult product information for specific recommendations.Produces anti-inflammatory, antipruritic, and vasoconstrictor actions, possibly resulting in part from steroid receptor binding.Precise mechanism of action for topical anti-inflammatory activity is unknown; therapeutic benefit in the management of corticosteroid-responsive dermatoses mediated primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions.Anti-inflammatory effects may occur through induction of phospholipase ADecreases inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation; and possibly by other mechanisms as yet unknown.Importance of using only as directed, only for the disorder for which it was prescribed, and for no longer than prescribed;Importance of informing patients that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a clinician.Importance of informing parents of children receiving the drug that if hydrocortisone is applied in the diaper area, tight-fitting diapers or plastic pants should not be used since they may act as an occlusive dressing.Importance of reporting any local adverse reactions, especially those occurring under occlusive dressings, to a clinician.Potential for hydrocortisone acetate suppositories to stain fabric; take appropriate precautionary measures.Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs; other corticosteroid-containing preparations should not be used without first consulting with clinician.Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.Importance of informing patients of other important precautionary information.

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