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 详细处方信息以本药内容附件PDF文件（201031623110221.pdf）的“原文Priscribing Information”为准
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部分中文DERMATOP处方资料（仅供参考）

英文药名: Dermatop (Prednicarbate Cream)

中文药名: 强碳松,泼尼卡酯霜

简介
泼尼卡酯（强炭松Ｐｒｅｄｎｉｃａｒｂａｔｅ）亦为不含卤素的局部外用强效皮质激素，在氢化泼尼松Ｃ－１７位上接乙基碳酸酯、Ｃ－２１位上接丙酸酯，国外双盲对照试验表明本品的临床疗效相 当于倍他米松戊酸酯、去氧米松等含卤素皮质激素，迄今尚未发现本品患处大面积使用后出现抑制 体内肾上腺皮质激素合成的全身性不良反应。市场上销售制剂有霜剂和软膏，商品名为Ｄｅｒｍａｔｏｐ。

药理作用
１．抗炎作用通过血管收缩，降低毛细血管通透性，渗出减少；稳定溶酶体膜，阻止溶酶体酶的释放；抑制前列腺素Ｅ２和Ｅ２ａ合成；增加细胞基质对粘多糖酸酶的抵抗力，减轻间质水肿；保持细胞膜的完整性，防止细胞过度肿胀，从而达到缓解或减轻炎症反应。皮质激素对多种炎症（放射性、机械性、化学性、药理性、免疫性及感染性炎 症）均有抑制作用。
２．抗有丝分裂作用皮质激素与细胞膜受体结合，激活腺苷酸环化酶，使ＡＴＰ转化为ｃＡＭＰ，ｃＡＭＰ有抑制细胞有丝分裂的作用，对良性增殖性皮肤病如银屑病有效。
３．抗过敏作用皮质激素能抑制和减轻各种变态反应，但外用时这种作用一般较小，对变应性皮肤病有效，主要是抗炎作用的结果。
４．对皮肤色素作用由于皮质激素的免疫抑制作用，从而使黑色素细胞及黑色素的破坏减少，色素得以重生，对某些类型的白癜风有效。

适应症
皮质激素对皮肤功能的影响有多方面，可促进出汗，减少汗里盐份；刺激头发生长；减少皮脂；升高皮肤温度；增加皮肤毛细血管的血流；促进风团消退；减弱结核菌素样反应和贴斑反应，但不影 响皮下注射所致的反应性风团。临床上可利用其中的某些作用以治疗皮肤病，如各种湿疹、接触性 皮炎、药疹、多形红斑、虫咬皮炎、扁平苔癣、局限性血管神经性水肿、红斑性狼疮、皮肌炎、局限性硬皮病、结节性红斑、天疱疮、大疱性表皮松解症、局限性神经性皮炎、局限性瘙痒症、玫瑰糠疹、脂溢性皮炎、局限性银屑病、酒渣鼻、白癜风、斑秃、瘢痕疙瘩、老年角化病、粘膜白斑等。

Dermatop Emollient Cream

FOR DERMATOLOGIC USE ONLY
NOT FOR USE IN EYES.
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Dermatop Cream Description

DERMATOP® Emollient Cream (prednicarbate emollient cream) 0.1% contains prednicarbate, a synthetic corticosteroid for topical dermatologic use. The chemical name of prednicarbate is 11β, 17, 21-trihydroxypregna-1,4-diene- 3,20-dione 17-(ethyl carbonate) 21-propionate. Prednicarbate has the empirical formula C27H36O8 and a molecular weight of 488.58. Topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

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Indications and Usage for Dermatop Cream

DERMATOP Emollient Cream 0.1% is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. DERMATOP 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 been established. Since safety and efficacy of DERMATOP 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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Contraindications

DERMATOP 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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Precautions

General
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.

Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or under occlusion should be evaluated periodically for evidence of HPA-axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. DERMATOP Emollient Cream 0.1% did not produce significant HPA-axis suppression when used at a dose of 30g/day for a week in 10 adult patients with extensive psoriasis or atopic dermatitis.

DERMATOP Emollient Cream 0.1% did not produce HPA-axis suppression in any of 59 pediatric patients with extensive atopic dermatitis when applied BID for 3 weeks to > 20% of the body surface.

If HPA-axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of the application, or to substitute a less potent corticosteroid. Recovery of HPA-axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios.

If irritation develops, DERMATOP Emollient Cream 0.1% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as observed with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used.

If a favorable response does not occur promptly, use of DERMATOP Emollient Cream 0.1% should be discontinued until the infection has been adequately controlled.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

1、This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2、This medication should not be used for any disorder other than that for which it was prescribed.
3、The treated skin area should not be bandaged, otherwise covered or wrapped so as to be occlusive, unless directed by the physician.
4、Patients should report to their physician any signs of local adverse reactions.
5、Parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis. This medication should not be applied in the diaper area as diapers or plastic pants may constitute occlusive dressing (See DOSAGE AND ADMINISTRATION).
6、This medication should not be used on the face, underarms, or groin areas.
7、Contact between prednicarbate and latex containing products (eg. condoms, diaphragm etc.) should be avoided since paraffin in contact with latex can cause damage and reduce the effectiveness of any latex containing products.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, contact the physician.

Pediatric Use

DERMATOP Emollient Cream 0.1% may be used with caution in pediatric patients 1 year of age or older, although the safety and efficacy of drug use longer than 3 weeks have not been established. The use of DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% is supported by results of a three-week, uncontrolled study in 59 pediatric patients between the ages of 4 months and 12 years of age with atopic dermatitis. None of the 59 pediatric patients showed evidence of HPA-axis suppression. Safety and efficacy of DERMATOP Emollient Cream 0.1% in pediatric patients below 1 year of age have not been established, therefore use in this age group is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA-axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. In an uncontrolled study in pediatric patients with atopic dermatitis, the incidence of adverse reactions possibly or probably associated with the use of DERMATOP 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 two patients (2/59, 3%) developed thinness. Three patients (3/59, 5%) were observed with mild telangiectasia. It is unknown whether prior use of topical corticosterioids was a contributing factor in the development of telangiectasia in 2 of the patients. Adverse effects including striae have also been reported with inappropriate use of topical corticosteroids in infants and children. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk for HPA-axis suppression.HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.DERMATOP Emollient Cream 0.1% should not be used in the treatment of diaper dermatitis.

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Adverse Reactions

In controlled adult clinical studies, the incidence of adverse reactions probably or possibly associated with the use of DERMATOP 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 DERMATOP 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 (See PRECAUTIONS, Pediatric Use.)

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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Dermatop Cream Dosage and Administration

Apply a thin film of DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% to the affected skin areas twice daily. Rub in gently.DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1 % may be used in pediatric patients 1 year of age or older. Safety and efficacy of DERMATOP 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.

DERMATOP Emollient Cream 0.1% should not be used with occlusive dressings unless directed by the physician.

DERMATOP 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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 详细处方信息以本药内容附件PDF文件（201031623110221.pdf）的“原文Priscribing Information”为准
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