通用中文 | 二丙酸倍他米松/水合钙泊三醇混悬剂 | 通用外文 | Betamethasone Dipropionate/Calcipotriene hydrate |
品牌中文 | 品牌外文 | Taclonex Scalp | |
其他名称 | |||
公司 | LEO PHARM(LEO PHARM) | 产地 | 美国(USA) |
含量 | 60ml | 包装 | 1瓶/盒 |
剂型给药 | 储存 | 室温 | |
适用范围 | 适合局部治疗的稳定性斑块状银屑病。 |
通用中文 | 二丙酸倍他米松/水合钙泊三醇混悬剂 |
通用外文 | Betamethasone Dipropionate/Calcipotriene hydrate |
品牌中文 | |
品牌外文 | Taclonex Scalp |
其他名称 | |
公司 | LEO PHARM(LEO PHARM) |
产地 | 美国(USA) |
含量 | 60ml |
包装 | 1瓶/盒 |
剂型给药 | |
储存 | 室温 |
适用范围 | 适合局部治疗的稳定性斑块状银屑病。 |
简介:
部份中文Taclonex处方资料(仅供参考)
商品名称:Taclonex
通用名称:钙泊三醇倍他米松软膏
英文名称:Calcipotriol Betamethasone Ointment
适应症
主要用于适合局部治疗的稳定性斑块状银屑病。
用法用量
每天用于患病皮肤一次。推荐4周为一个疗程。一个疗程结束后,在医学监测下可重复进行此疗程。每天最大剂量不超过15g,每周最大剂量不超过100g,治疗面积不应超过体面积的30%。
任何疑问,请遵医嘱!
不良反应
迄今为止,超过2500名患者参加了本品临床试验,结果显示大约10%的患者出现轻度的不良反应。根据临床试验及售后适用结果提示药物常见的不良反应(发生率>1/100和<1/10)为瘙痒症、皮疹、皮肤烧灼感。少见的不良反应(发生率>1/1000和<1/100)为皮肤疼痛或者刺激感,皮炎、红斑、银屑病加重,毛囊炎,应用部位色素沉着。罕见的不良反应(>1/10000和<1/1000)为脓疱型银屑病。
注意事项
(1)下列情况患者禁用:不能使用于钙代谢失调的病患,禁用于点状、脱落性脓疱型之干癣,也禁用于肾功能不全或严重肝疾病患者。
(2)本品不可使用于脸部,使用后应将手部清洗干净以避免接触脸部。
(3)本品尚未有使用于头皮、并用其他局部或全身性银屑病(牛皮癣)或光疗法的经验。使用治疗期间,医师可建议病人避免过度暴露于日光下。
(4)同药袋放置于室温之阴凉干燥处避光储存,请勿放在孩童可以取得之处。
(5)使用期间如需服用其它药品,请主动告诉您的医师或药师。
禁忌
对药物的活性成份及任一辅料过敏者。
怀孕及哺乳期妇女用药
孕妇:
尚无足够的数据支持本品可以用于孕妇。动物试验提示糖皮质激素可致生殖毒性。但一些流行病学研究结果并没有显示怀孕期间使用皮质类固醇的妇女产出先天性畸形婴儿。孕妇使用本品的安全性尚不明确。因而,在孕期妇女,只有当利益大于弊端时才可使用本品。
哺乳期妇女:倍他米松可以进入乳汁,但在治疗剂量内对婴儿没有不良影响,数据显示钙泊三醇不在乳汁中分泌。给哺乳期妇女使用本品应该注意,在哺乳期,患者不能将本品涂敷在乳房上。
儿童用药
儿童及18岁以下的青少年不能使用本品。
老年用药
尚不明确。临床试验中有部分老年患者参加。
药物相互作用
应避免与其他的甾体类药物同时使用。
Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension Savings for Eligible Patients
INDICATION AND USAGETaclonex® Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 18 years and older and for plaque psoriasis of the scalp in patients 12 to 17 years. Apply Taclonex® Topical Suspension to affected areas once daily for up to 8 weeks. Therapy should be discontinued when control is achieved. Patients 18 years and older should not use more than 100 g per week and patients 12 to 17 years should not use more than 60 g per week.
IMPORTANT SAFETY INFORMATIONFOR TOPICAL USE ONLY. Taclonex® Topical Suspension is not for oral, ophthalmic, or intravaginal use and should not be applied to the face, axillae, or groin. Do not use if atrophy is present at the treatment site. Do not use with occlusive dressings unless directed by a physician.
Hypercalcemia and hypercalciuria have been observed with use of Taclonex®. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. Taclonex® can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. Use of topical corticosteroids may require that patients be periodically eva luated for HPA axis suppression and calcium abnormalities. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent steroid. Cushing’s syndrome and hyperglycemia may also occur in adults due to the systemic effects of the topical corticosteroid. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity, HPA axis suppression and adrenal insufficiency. Rare systemic toxicities such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients.
In clinical trials, the most common adverse reactions that occurred in ≥1% of subjects treated with Taclonex® and at a rate higher than in subjects treated with vehicle were folliculitis and burning sensation of skin. Other less common adverse reactions (<1% but >0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash. Local adverse reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform dermatitis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria and may be more likely with occlusive use or more potent corticosteroids.
Taclonex® may cause eye irritation. Avoid eye exposures. Patients who apply Taclonex® to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc. There are no adequate and well-controlled studies of Taclonex® Topical Suspension in pregnant women. Taclonex® should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Because many drugs are excreted in human milk, caution should be exercised when Taclonex® Topical Suspension is administered to a nursing woman. The patient should be instructed not to use Taclonex® Topical Suspension on the breast when nursing. Safety and effectiveness of the use of Taclonex® Topical Suspension in pediatric patients under the age of 12 years have not been established.
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