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 详细处方信息以本药内容附件PDF文件（201031623431228.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。

DRUG DESCRIPTION

DERMATOP® Ointment (prednicarbate ointment) 0.1% contains the non-halogenated prednisolone derivative prednicarbate. The topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic agents. Each gram of DERMATOP Ointment 0.1% contains 1.0mg of prednicarbate in a base consisting of white petrolatum, octyldodecanol, glyceryl oleate, propylene glycol, citric acid, and propyl gallate.

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INDICATIONS

DERMATOP Ointment 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

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DOSAGE AND ADMINISTRATION

Apply a thin film of DERMATOP Ointment 0.1% to the affected skin areas twice daily. Rub in gently.

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SIDE EFFECTS

In controlled clinical studies, the incidence of adverse reactions associated with the use of DERMATOP Ointment 0.1% was approximately 1.5%. Reported reactions including burning, pruritis, drying, scaling, cracking and pain and irritant dermatitis. The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings and especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae and miliaria.

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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 receiving a large dose of a higher potency topical steroid applied 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 Ointment 0.1% did not produce significant HPA-axis suppression when used at a dose of 60 grams per day for a week in patients with exten- sive psoriasis or atopic dermatitis.

However, 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 corticosteroid. Recovery of HPA-axis function is generally prompt and complete 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. (See PRECAUTIONS-Pediatric Use.)

If irritation develops, DERMATOP Ointment 0.1% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as 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 Ointment (prednicarbate ointment) 0.1% should be discontinued until the infection has been adequately controlled.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

In a study of the effect of prednicarbate on fertility, pregnancy and postnatal development in rats, no effect was noted on the fertility or pregnancy of the parent animals or postnatal development of the offspring after administration of up to 0.80 mg/kg of prednicarbate subcutaneously.

Prednicarbate has been evaluated in the Salmonella reversion test (Ames test) over a wide range of concentrations in the presence and absence of an S-9 liver microsomal fraction and did not demonstrate mutagenic activity. Similarly, prednicarbate did not produce any significant changes in the numbers of micronuclei seen in erythrocytes when mice were given doses ranging from 1 to 160 mg/kgof the drug.

Pregnancy

Teratogenic effects: Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Prednicarbate has been shown to be teratogenic and embryotoxic in Wistar rats and Himalayan rabbits when given subcutaneously during gestation at doses 1900times and 45times, respectively, the recommended topical human dose, assuming a percutaneous absorption of approximately 3%.

In the rats, slightly retarded fetal development and an incidence of thickened and wavy ribs which was higher than the spontaneous rate were noted.

In rabbits, there was noted increased liver weights and slight increase in the fetal intrauterine death rate. The fetuses delivered exhibited reduced placental weight, increased frequency of cleft palate, ossification disorders in the sternum, omphalocele, and anomalous posture of the forelimbs.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects of prednicarbate. Therefore, DERMATOP Ointment (prednicarbate ointment) 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when DERMATOP Ointment (prednicarbate ointment) 0.1% is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of DERMATOP Ointment 0.1% in pediatric patients below the age of 10 years have not been established. 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 when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in pediatric patients. (See PRECAUTIONS.) 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. Manifesta- tions of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

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 详细处方信息以本药内容附件PDF文件（201031623431228.pdf）的“原文Priscribing Information”为准
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