Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2432
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Prednicarbate (Cream)
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| dailymed-instance:dosage |
Apply a thin film of prednicarbate emollient cream 0.1% to the affected skin areas twice daily. Rub in gently. Prednicarbate emollient cream 0.1 % may be used in pediatric patients 1 year of age or older. Safety and efficacy of prednicarbate emollient cream 0.1% in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Prednicarbate emollient cream 0.1% should not be used with occlusive dressings unless directed by the physician. Prednicarbate emollient cream 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.
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| dailymed-instance:descripti... |
Prednicarbate emollient cream 0.1% contains prednicarbate, a synthetic corticosteroid for topical dermatologic use. The chemical name of prednicarbate is 11��, 17, 21-trihydroxypregna-1,4-diene-3,20-dione 17-(ethyl carbonate) 21-propionate. Prednicarbate has the empirical formula CHOand a molecular weight of 488.58. Topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The CAS Registry Number is 73771-04-7. The chemical structure is: Prednicarbate is a practically odorless white to yellow-white powder insoluble to practically insoluble in water and freely soluble in ethanol. Each gram of prednicarbate emollient cream 0.1% contains 1.0 mg of prednicarbate in a base consisting of white petrolatum USP, purified water USP, isopropyl myristate NF, lanolin alcohols NF, mineral oil USP, cetostearyl alcohol NF, aluminum stearate, edetate disodium USP, lactic acid USP, and magnesium stearate DAB 9.
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| dailymed-instance:clinicalP... |
In common with other topical corticosteroids, prednicarbate has anti-inflammatory, antipruritic, and vasoconstrictive properties. In general, the mechanism of the anti-inflammatory activity of topical steroids is unclear. However, corticosteroids are thought to act by the induction of phospholipase Ainhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A<br/>Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Use of occlusive dressings with hydrocortisone for up to 24 hours have not been shown to increase penetration; however, occlusion of hydrocortisone for 96 hours does markedly enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Studies performed with prednicarbate emollient cream 0.1 % indicate that the drug product is in the medium range of potency compared with other topical corticosteroids.
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| dailymed-instance:contraind... |
Prednicarbate emollient cream 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparations.
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| dailymed-instance:supply |
Prednicarbate emollient cream 0.1% is supplied in 15 g (NDC 66993-880-15) and 60 g (NDC 66993-880-61) tubes. Store between 41 and 77��F (5 and 25��C).
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... |
dailymed-ingredient:aluminum_stearate,
dailymed-ingredient:cetostearyl_alcohol,
dailymed-ingredient:edetate_disodium,
dailymed-ingredient:isopropyl_myristate,
dailymed-ingredient:lactic_acid,
dailymed-ingredient:lanolin_alcohols,
dailymed-ingredient:magnesium_stearate_DAB_9,
dailymed-ingredient:mineral_oil,
dailymed-ingredient:water,
dailymed-ingredient:white_petrolatum
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| dailymed-instance:overdosag... |
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.
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| dailymed-instance:genericMe... |
Prednicarbate
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| dailymed-instance:fullName |
Prednicarbate (Cream)
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| dailymed-instance:adverseRe... |
In controlled adult clinical studies, the incidence of adverse reactions probably or possibly associated with the use of prednicarbate emollient cream 0.1% was approximately 4%. Reported reactions included mild signs of skin atrophy in 1% of treated patients, as well as the following reactions which were reported in less than 1% of patients: pruritis, edema, paresthesia, urticaria, burning, allergic contact dermatitis and rash. In an uncontrolled study in pediatric patients with atopic dermatitis, the incidence of adverse reactions possibly or probably associated with the use of prednicarbate emollient cream 0.1 % was limited. Mild signs of atrophy developed in 5 patients (5/59, 8%) during the clinical trial, with 2 patients exhibiting more than one sign. Two patients (2/59, 3%) developed shininess, and 2 patients (2/59, 3%) developed thinness. Three patients (3/59, 5 %) were observed with mild telangiectasia. It is unknown whether prior use of topical corticosteroids was a contributing factor in the development of telangiectasia in 2 of the patients The following additional local adverse reactions have been 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: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, striae and miliaria.
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| dailymed-instance:indicatio... |
Prednicarbate emollient cream 0.1% is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Prednicarbate emollient cream 0.1% may be used with caution in pediatric patients 1 year of age or older. The safety and efficacy of drug use for longer than 3 weeks in this population have not beenestablished. Since safety and efficacy of prednicarbate emollient cream 0.1% have not been established in pediatric patients below 1 year of age, its use in this age group is not recommended.
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| dailymed-instance:name |
Prednicarbate
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