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  药店国别: 美国药房
产地国家: 英国
所属类别: 皮肤科药物->皮肤炎症
处方药:处方药
包装规格: 60毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
NYCOMED US
生产厂家英文名:
NYCOMED US
该药品相关信息网址1:
http://www.netdoctor.co.uk/medicines/100000643.html
该药品相关信息网址2:
http://www.theodora.com/drugs/cutivate_ointment_glaxosmithkline.html
原产地英文商品名:
CUTIVATE 0.05% LOTION 60mls/bottle
原产地英文药品名:
FLUTICASONE PROPIONATE
中文参考商品译名:
克廷肤0.05%乳液 60毫升/瓶
中文参考药品译名:
丙酸氟替卡松
中文参考化合物名称:
(6α,11β,16α,17α)-6,9- 二 氟-11- 羟-16- 甲 基-3- 氧 代-17-(1- 氧 代丙 氧 基)- 雄 甾-1,4- 二 烯-17- 硫 代 羧 酸, S- 氟 甲 基 酯
原产地国家批准上市年份:
2005/03/31
英文适应病症1:
Inflammatory
英文适应病症2:
Pruritic
英文适应病症3:
Dermatoses
临床试验期:
完成
中文适应病症参考翻译1:
炎症
中文适应病症参考翻译2:
搔痒症
中文适应病症参考翻译3:
皮肤病
药品信息:

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 详细处方信息以本药内容附件PDF文件(201152418301016.pdf)的“原文Priscribing Information”为准
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部分中文丙酸氟替卡松处方资料(仅供参考)

【药品名称】
通用名称:丙酸氟替卡松乳膏
商品名称:克廷肤®
英文名称:Fluticasone Propionate Cream
汉语拼音:Bingsuan Futicasong Rugao

【成份】
化学名称: (6α,11β,16α,17α)-6,9- 二 氟-11- 羟-16- 甲 基-3- 氧 代-17-(1- 氧 代丙 氧 基)- 雄 甾-1,4- 二 烯-17- 硫 代 羧 酸, S- 氟 甲 基 酯;

【性状】本品为乳剂型基质的白色软膏。

【适应症】
成人:
适用于各种皮质激素可缓解的炎症性和瘙痒性皮肤病,如:湿疹包括特异性湿疹和盘状湿疹;结节性痒疹;银屑病(泛发斑块型除外);神经性皮肤病包括单纯性苔藓;扁平苔藓;脂溢性皮炎;接触性过敏;盘形红斑狼疮;泛发性红斑全身类固醇激素治疗的辅助用药,虫咬皮炎;粟疹。
儿童:
低效皮质激素无效的一岁以上(含一岁)儿童在医生的指导下可用本品缓解特异性皮炎引起的炎症和瘙痒。患有皮质激素可缓解的其他皮肤病的儿童使用本品前应咨询医生。

【用法用量】
湿疹/ 皮炎
成人及一岁以上(含一岁)儿童,每日一次将一薄层乳膏涂于患处。
其它适应症
每日两次将一薄层乳膏涂于患处。
使用持续时间应每日使用本品直至疾病症状得到控制。用药频率应控制在最低有效剂量。
儿童应用本品时,若治疗7-14 天未改善症状,则应停药并进行重新评估。若症状得到控制(通常于7-14 天内),则需减少用药频率至最小有效剂量及最短用药时间。建议连续使用本品不长于4周。本品供局部使用。

【不良反应】
丙酸氟替卡松具有较好的耐受性,在安慰剂对照的临床试验中,最常见的副作用是:皮肤感染、感染性湿疹、病毒疣、单纯疱疹、脓疱疮、特异性皮炎、湿疹、湿疹恶化、红斑、烧灼感、刺痛、皮肤刺激、瘙痒、瘙痒恶化、毛囊炎、水疱、手指麻痹和皮肤干燥等。在儿童进行的开放临床试验中,常见的副作用是:灼烧感、暗黑色红斑、红斑疹、面部毛细血管扩张、非面部毛细管扩张、风疹。若出
现过敏现象应立即停药。发炎、毛囊炎、痤疮样皮疹、色素减退、口周皮炎、过敏性接触性皮炎、继发感染、皮肤萎缩、皮纹和痱子等不良反应少见,但当采用封包疗法时其发生频率明显增加。长期和大量使用皮质激素,可引起局部皮肤萎缩,表现为:皮肤变薄,出现萎缩纹,毛细血管扩张,多毛及色素减退。
长期大量或大面积应用皮质激素,可通过充分的全身吸收而出现肾上腺皮质功能亢进。此现象更易见于婴幼儿及采用封包治疗的患者。婴儿涂药后使用尿布也应视为封包治疗。
在使用皮质激素治疗银屑病过程中或停药后诱发脓疱型银屑病的情况罕见。曾有用药后皮肤病和过敏性接触性皮炎的症状和体症加重的报告。

【禁忌】
1、禁用于对本品中任一成份过敏者。
2、禁用于玫瑰痤疮、寻常痤疮、酒渣鼻、口周皮炎、原发性皮肤病毒感染(如:
单纯疱疹,水痘)。
3、禁用于肛周及外阴瘙痒。
4、禁用于真菌或细菌引发的原发皮肤感染。
5、禁用于一岁以下婴儿的皮肤病,包括皮炎和尿布疹。

【注意事项】
1、局部应用皮质激素的全身吸收能可逆性抑制下丘脑-垂体-肾上腺轴,从而导致治疗停止后糖皮质激素不足。局部应用皮质激素的全身吸收患者可见库欣综合征,高血糖症和糖尿病。
2、局部大面积使用皮质激素并采用封包疗法的患者应定期采用ACTH兴奋试验、午前血浆类固醇测定和尿液游离类固醇测定以检测下丘脑-垂体-肾上腺轴功能。
3、出现下丘脑-垂体-肾上腺轴功能抑制,应撤药、减少用药频率或使用低效类固醇。通常停止局部应用皮质激素后HPA轴功能可恢复。罕见糖皮质激素不足,此时需全身应用皮质激素。若需全身应用皮质激素,请参见其使用说明书。
4、儿童的相对体表面积较大,使用相同剂量时吸收量多,较易出现全身毒性,故用药时应尽可能采用最低有效治疗剂量。
5、儿童应尽量避免长期持续使用本品。连续应用丙酸氟替卡松4周以上的安全性和有效性尚未确定。
6、应在医生指导下使用本品。本品仅供外用。用于眼睑时应小心以防止药物进入眼内,从而避免局部刺激或诱发青光眼。
7、本品可引起皮肤不良反应,出现局部不良反应应及时告知医生。
8、除非有医生指导,否则使用本品时不应封包,也不应用于面部、腋下、腹股沟处。
9、本品不能用于尿布皮炎。因使用尿布被视作封包,故本品不应用于尿布包裹处。
10、若出现刺激,应立即停药并采取适当的治疗措施。皮质醇引起的过敏性接触性皮炎通过治愈的失败及适宜的临床检测来诊断。
11、面部在长期外用皮质激素进行治疗后较身体其他部位更易出现皮肤萎缩,在治疗银屑病、盘状红斑狼疮、严重湿疹时须谨记。
12、外用皮质激素治疗银屑病存在一些危险,如:停药后反跳复发,出现耐药、诱发脓疱型银屑病、皮肤防御功能受损所致局部或全身毒性。所以银屑病患者使用本品治疗时,监测病情很重要。应用本品治疗儿童牛皮癬前应咨询医生。
13、炎症性皮肤损伤合并感染时,应进行适宜的抗微生物治疗。皮肤感染时应停用外用皮质激素制剂,而采用抗生素全身给药治疗。封包治疗使局部温暖湿润易引发细菌感染,所以封包治疗前应清洁皮肤。
14、本品赋形剂包括咪唑烷脲,其可释放微量降解产物甲醛。甲醛可造成所接触的皮肤出现过敏或刺激。
15、运动员慎用。

【孕妇及哺乳期妇女用药】孕妇禁用,哺乳期妇女慎用。

【儿童用药】一岁以下儿童禁用本品。儿童用药时应尽可能采用最低有效治疗剂量并避免长期持续使用本品。

【老年用药】无特殊要求,参见【用法用量】。

【药物相互作用】尚不明确。

【药物过量】
局部应用本品有可能吸收足够的量而产生全身反应。急性过量几乎不可能发生。慢性过量应用或误用可引起肾上腺皮质功能亢进。在这种情况下应逐渐停用类固醇。但因可能出现急性肾上腺抑制,应在医生指导下停药。

【药理毒理】
药理作用
丙酸氟替卡松是一高效,具有局部抗炎作用的糖皮质激素。经皮给药后,对HPA轴的抑制作用很弱,因此,其治疗指数高于大多数常用的类固醇制剂。
皮下注射给药会产生强效全身性糖皮质激素作用,但口服作用弱,可能为代谢失活所致。体外试验表明本药对人体的糖皮质激素受体有强亲和力和激动作用。丙酸氟替卡松无预期外激素作用,对中枢神经系统、周围神经系统、胃肠道、心血管系统、呼吸系统无明显影响。
毒理研究
遗传毒性
丙酸氟替卡松体外三致试验结果显示标准Ames 试验,E. coli 变异测验, S.cereviseiae 基因转变试验,中国仓鼠卵巢细胞分析均未见致突变现象。小鼠微核试验和培养人淋巴细胞试验未见致染色体畸变现象。
生殖毒性
生殖毒性试验结果显示雌性大鼠每日皮下注射丙酸氟替卡松50μg/kg ,雄性大鼠每日皮下注射丙酸氟替卡松100μg/kg( 后期减至每日50μg/kg) 对交配和生殖力均无影响(分别为70kg 体重每天局部使用0.05%丙酸氟替卡松乳膏15g,透皮吸收为近3%
时全身暴露水平的15倍和30倍。)全身给药时在较低剂量下皮质类固醇就有致畸作用。有些皮质类固醇皮肤给药后亦产生致畸作用。试验结果显示小鼠每日皮下给予丙酸氟替卡松45μg/kg 和150μg/kg( 分别为人外用剂量的14和45倍)就出现致畸现象(腭裂)。

【药代动力学】
吸收:丙酸氟替卡松为活性成分。多种因素(如赋形剂和表皮屏障的完整性)影响局部应用皮质类固醇的透皮吸收。封闭性敷裹可增加渗透。局部应用皮质类固醇可从正常完整皮肤吸收。皮肤炎症和/或其他皮肤疾病可增加透皮吸收。
12名健康男性连续3周,每日2次使用0.05%丙酸氟替卡松乳膏12.5g,血药浓度一般都低于可检测水平(0.05ng/mL)。6名健康男性在封包下连续5天使用0.05%丙酸氟替卡松乳膏25g,血药浓度在0.07ng/mL 至0.39ng/mL之间。大鼠局部应用1g/kg 放射标记的0.05%丙酸氟替卡松乳膏和软膏24小时。7日末药物消除近80%,其中大多数(73%)从用药部位消除。用药部位皮肤内消除小于1%。大约5%的药物透皮后全身吸收。在研究的7日内本品持续吸收,提示丙酸氟替卡松在用药部位有较长的驻留时间。分布:健康受试者静脉给予1mg丙酸氟替卡松,分布迅速,与其高脂溶性和高组织结合的特性一致。表观分布容积为4.2L/kg(2.3 – 16.7 L/kg)。血浆蛋白结合率为91%。丙酸氟替卡松与红细胞的结合弱且可逆。丙酸氟替卡松与人皮质素传递蛋
白无明显结合。代谢:体外将放射标记的丙酸氟替卡松和人皮肤组织匀浆共同孵育未检测到丙酸氟替卡松的代谢物。静脉给予1mg 丙酸氟替卡松,血浆清除为1093mL/min(618 –1702 mL/min),肾清除少于总量的0.02%。丙酸氟替卡松在肝脏经细胞色素P4503A4介导的5-氟甲基硫代羰酸酶群水解,生成无活性的17-β- 羧酸代谢物(人体能检测到的唯一代谢物)。体外试验结果显示该代谢物与人肺细胞糖皮质激素受体的亲和力不到丙酸氟替卡松的1/2000,其药理活性可忽略不计。在体外用培养人肝细胞试验检测到的其他代谢物在人体均未检测到。排泄:健康受试者静脉给予1mg丙酸氟替卡松,呈多指数动力学特征,平均终末半衰期为7.2小时。

【贮藏】30°C 以下保存。

Cutivate cream/ointment
How does it work?
Cutivate cream and ointment all contain the active ingredient fluticasone propionate, which is a type of medicine called a topical corticosteroid.

Corticosteroids are medicines used for reducing inflammation. Inflammation of the skin happens as a result of allergy or irritation of the skin, and is caused by the release of various substances that are important in the immune system. These substances cause blood vessels to widen and result in the irritated area becoming red, swollen, itchy and painful, such as is seen in dermatitis or eczema.

When fluticasone is applied to the skin it works by acting inside the cells to decrease the release of these inflammatory substances. This reduces swelling, redness and itch. Fluticasone is a potent corticosteroid.

Cutivate cream and ointment are formulated with a moisturising base that provides a layer of oil on the surface of the skin, helping to prevent water from evaporating from the skin surface. This helps reduce the dryness, scaling and itching of skin conditions such as eczema.

What is it used for?
An eruption of hard nodules in the skin accompanied by intense itching (prurigo nodularis).
Area of thickened itchy skin caused by rubbing and scratching (lichen simplex).
Eczema.
Skin inflammation due to allergies or irritants (allergic contact dermatitis or irritant contact dermatitis).
Inflammatory skin condition with greasy, red and scaly areas (seborrhoeic dermatitis).
Inflammatory skin disease known as discoid lupus erythematosus (DLE).
Intense and widespread reddening of the skin (generalised erythroderma) in combination with oral or injected corticosteroids.
Psoriasis.
Skin disorder causing a flat, itchy, violet rash, usually on the wrists, shins, lower back and genitals (lichen planus).
Thickened skin rash caused by excessive scratching to relieve itching (neurodermatitis).

Warning!
This medicine is for external use on the skin only.
This medicine should be applied thinly and evenly to the affected area(s) as directed by your doctor.
Wash your hands thoroughly after applying this medicine, unless the hands are the area being treated.
Avoid contact of this medicine with open wounds and with the eyes and the moist membranes lining the inside of certain parts of the body, eg mouth, nasal passages (mucous membranes). Rinse with cold water if accidental contact occurs.
If your doctor has advised you to use dressings with this medicine, the skin should be cleansed before reapplying the cream under a fresh dressing.
If corticosteroids are used long term, on large areas of skin, raw skin, skin folds, or under airtight dressings (including nappies) they are absorbed into the body more. This increases the risk of local side effects such as skin thinning, and those on other parts of the body, such as a decrease in the production of natural hormones by the adrenal glands. For this reason, continuous, long-term use of this medicine should be avoided wherever possible, particularly in children and on large areas of skin. You should only use airtight dressings over the affected area if instructed by your doctor.
This medicine should not be used for longer than five days on the face or in children.
Consult your doctor if your symptoms don't improve, or get worse in the first seven days of treatment. Do not use this medicine for longer than five days without consulting your doctor.
If you think the area of skin you are treating has become infected you should stop using this medicine and consult your doctor.

Use with caution in
Children.

Not to be used in
Fungal skin infections, eg athlete's foot, ringworm, candida skin infections.
Viral skin infections such as chickenpox or herpes simplex.
Tuberculosis affecting the skin.
Acne rosacea.
Acne vulgaris.
Inflammatory rash around the mouth (perioral dermatitis).
Skin ulcers.
Itchy skin around the genitals or anus.
Children under three months old.
Widespread plaque psoriasis.
Areas of skin that are very thin and fragile or have broken veins.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used during pregnancy unless considered essential by your doctor. If it is prescribed by your doctor it should not be used on large areas of skin, underneath airtight dressings, or for prolonged periods of time. Consult your doctor for further information.
This medicine should not be used during breastfeeding unless considered essential by your doctor. If it is prescribed by your doctor it should not be used on large areas of skin, underneath airtight dressings or for prolonged periods of time. If it is applied to the breasts it should be washed off carefully before breastfeeding and then reapplied afterwards.

Label warnings
This medication is to be spread thinly and sparingly on the skin.

Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Skin irritation, eg itching, burning, stinging.
Thinning of the skin.
Changes in skin pigmentation.
Stretch marks (striae).
Groupings of fine blood vessels becoming prominent under the skin (telangiectasia).
Excessive hair growth (hypertrichosis).
Hypersensitivity.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?
There are no significant interactions reported with this medicine. However, with long-term use on large areas of skin there may be sufficient fluticasone absorbed into the body to affect other medicines that you are taking. Consult your doctor or pharmacist for further information.

Other medicines containing the same active ingredients
There are currently no other skin products available in the UK that contain fluticasone propionate as the active ingredient.

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 详细处方信息以本药内容附件PDF文件(201152418301016.pdf)的“原文Priscribing Information”为准
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更新日期: 2011-5-25
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