药品名称: 通用名称：地奈德洗剂 英文名称：DesOwen (Desonide Lotion) 商品名称：莱索文 成份: 地奈德 适应症: 本品为中弱效皮质类固醇，可减轻皮质类固醇治疗有效的皮肤病的炎症和瘙痒反应。规格: 0.05%(W/W) 用法用量: 将本品在患处涂一薄层，根据患病严重程度，每日二至三次。使用前充分振摇本品。与其他皮质类固醇合用时，当症状得到控制，应停用本品，如使用本品后二周内症状无改善，应另行诊断。本品不应使用封包疗法。 不良反应: 在临床对照试验中，与地奈德有关的不良反应发生率约8%，其中：刺痛和灼热感约占3%；刺激，接触性皮炎、病情加重、脱皮、痒、暂时性红斑和干燥/脱屑各少于2%。另外，有报道下列局部不良反应在外用其他皮质类固醇时偶有发生。而且多发生在封包疗法中，特别是用强效皮质类固醇时。这些不良反应按发生顺序依次递减为：毛囊炎、痤疮样皮疹、色素减退、口周皮炎、继发感染、皮肤萎缩、萎缩纹和痱子。 禁忌: 本品禁用于对该制剂中任何成份过敏者。 注意事项: 概述： 系统外用皮质类固醇吸收后可产生可逆性下丘脑-垂体-肾上腺轴（HPA）抑制，从而可能产生停药后糖皮质激素不足。外用皮质类固醇治疗过程中系统吸收可引起柯兴氏综合征、高血糖和尿糖。患者大面积外用或封包外用时应定期检查HPA轴的抑制情况。可通过ACTH刺激试验、检测早上血浆可的松水平和尿游离可的松水平来判断。 外用超强效皮质类固醇一次不能超过2周，并只能小面积使用，否则可能增加HPA轴抑制的危险。如果发现HPA轴的抑制，应当停药，减少用药次数或用相对弱效的皮质类固醇替代治疗。当停止外用皮质类固醇后，HPA轴的功能一般很快完全恢复。偶尔，当出现皮质类固醇缺乏的体征和症状时，需要系统补充皮质类固醇。关于系统补充皮质类固醇的方法请参照有关产品说明书。儿童患者因体表面积与体重之比更大，所以对同等剂量的皮质类固醇其系统毒性更敏感（参照注意-婴幼儿和儿童）。如果发生刺激，应当停用本品，并给予适当治疗。皮质类固醇引起的接触过敏性皮炎通常根据治疗无效而判断，而不是如多数外用非皮质激素药物那样根据病情加重来判断。皮质类固醇引起的接触过敏性皮炎的诊断应当用斑贴试验证实。如果并发皮肤感染，应当使用适当的抗真菌或抗细菌药物。如果抗感染药物没有很快起效，应当停用本品，直至感染被完全控制。 患者须知： 患者在使用外用皮质类固醇药物时应当得到下列忠告和指导： 1． 本药只能在医生指导下使用，并且只能外用，避免接触眼睛。 2． 本药不能用于处方以外的其他疾病。 3． 如果没有医生指导，用药局部皮肤不能包扎、覆盖或封包。 4． 患者应当向医生报告任何局部不良反应。 孕妇及哺乳期妇女用药: 孕妇,致畸作用： 对孕妇的影响为C级。 体内服用低剂量皮质类固醇药物对试验动物有致畸性。某些皮质类固醇药物用于皮肤时对试验动物有致畸性。没有关于本品对动物生育力影响的研究。尚不知道孕妇使用本品后是否对. 儿童用药: 儿童的安全性和有效性尚未研究。因为儿童的体表面积与体重之比更大，当外用皮质类固醇激素时，儿童出现HPA轴抑制的危险性比成人更高。儿童在停药后出现糖皮质激素不足或治疗中发生柯兴氏综合征的危险性更高。 药物过量: 过量外用本品可引起体内反应（见注意事项）。 毒理研究: 与其他外用皮质类固醇相同，地奈德有抗炎、止痒和血管收缩的特性。外用皮质类固醇的抗炎活性机制仍不清楚。不过，皮质类固醇被认为通过诱导磷酸脂酶A2抑制蛋白（统称脂皮质素）的产生而起到抗炎作用。 药代动力学: 外用皮质类固醇的透皮吸收是由基质和表皮屏障功能的完整性等许多因素决定的。外用氢化可的松封包24小时未证明透皮吸收增加，然而封包96小时透皮吸收明显增加。外用皮质类固醇可被正常完整皮肤吸收。 性状: 本品为白色或类白色乳状粘稠液体。 贮藏: 保存于2-30oC 包装: 树脂瓶，每瓶59毫升， 每瓶118毫升 DESOWEN - desonide cream  DESOWEN - desonide ointment  DESOWEN - desonide lotion  Galderma Laboratories, L.P. ---------- DesOwen® (desonide cream, ointment and lotion) cream 0.05% ointment 0.05% and lotion 0.05% For Dermatologic Use Only – Not for Ophthalmic Use – Rx Only DESCRIPTION DesOwen® Cream 0.05%, Ointment 0.05%, and Lotion 0.05% contain desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17 [(1methylethylidene) bis(oxy)]-,(11β,16α)- a synthetic nonfluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide is C24H32O6. It has the following structural formula: Desonide has the molecular weight of 416.51. It is a white to off white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of DesOwen® Cream contains 0.5 mg of desonide in a base of citric acid, emulsifying wax, isopropyl palmitate, polysorbate 60, potassium sorbate, propyl gallate, propylene glycol, purified water, sodium hydroxide, sorbic acid, stearic acid, and synthetic beeswax. Each gram of DesOwen® Ointment contains 0.5 mg of desonide in a base of mineral oil and polyethylene. Each gram of DesOwen® Lotion contains 0.5 mg of desonide in a base of cetyl alcohol, edetate sodium, glyceryl stearate SE, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, sorbitan monostearate, and stearyl alcohol. May contain citric acid and/or sodium hydroxide for pH adjustment. CLINICAL PHARMACOLOGY Like other topical corticosteroids, desonide has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory 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 A2. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Studies performed with DesOwen® (desonide cream, ointment and lotion) Cream, Ointment, and Lotion indicate that they are in the low to medium range of potency as compared with other topical cortico-steroids. INDICATIONS AND USAGE DesOwen® Cream, Ointment and Lotion are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. CONTRAINDICATIONS DesOwen® Cream, Ointment and Lotion are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. 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 to areas 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. Patients receiving superpotent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA axis suppression. 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, DesOwen® Cream, Ointment or Lotion 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 DesOwen® (desonide cream, ointment and lotion) Cream, Ointment or Lotion should be discontinued until the infection has been adequately controlled. Information or Patients Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. This medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician. Patients should report to their physician any signs of local adverse reactions. Laboratory Tests The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test A.M. plasma cortisol test Urinary free cortisol test Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on reproduction with the use of DesOwen® Cream, Ointment, and Lotion. 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. Animal reproduction studies have not been conducted with DesOwen® Cream, Ointment or Lotion. It is also not known whether DesOwen® Cream, Ointment or Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DesOwen® Cream, Ointment and Lotion should be given to a pregnant woman only if clearly needed. 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 DesOwen® Cream, Ointment or Lotion is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients 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 infants and children. 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. ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide was approximately 8%. These were: stinging and burning approximately 3%, irritation, contact dermatitis, condition worsened, peeling of skin, itching, intense transient erythema, and dryness/scaliness, each less than 2%. The following additional local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria. OVERDOSAGE Topically applied DesOwen® (desonide cream, ointment and lotion) Cream, Ointment and Lotion can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS). DOSAGE AND ADMINISTRATION DesOwen® Cream, Ointment or Lotion should be applied to the affected areas as a thin film two or three times daily depending on the severity of the condition. SHAKE LOTION WELL BEFORE USING. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. DesOwen® Cream, Ointment and Lotion should not be used with occlusive dressings. ------------------------------------------------------ 产地国家: 美国 原产地英文商品名: DESOWEN 0.05% CREAM KIT 原产地英文药品名: DESONIDE/EMOLLIENT COMBINATION NO.30 中文参考商品译名: 莱索文 0.05% 1套 中文参考药品译名: 地奈德洗剂 生产厂家中文参考译名: GALDERMA LABS LP 生产厂家英文名: GALDERMA LABS LP 该药品相关信息网址1: http://medlibrary.org/lib/rx/meds/desowen/page/2/