近日，美国食品和药品管理局（FDA）批准Taclonex（卡泊三醇和二丙酸倍他米松）0.005％/0.064％的外用悬浮剂，用于体表斑块型银屑病的治疗。Taclonex外用悬浮剂适用于头皮和身体斑块型银屑病的治疗，治疗期为8周，是目前一线的单一药物治疗方案。
牛皮癣是一种非传染性、免疫系统慢性疾病，全球估计有1.25亿人患病。
（1）最常见形式是斑块型银屑病（寻常型银屑病），大约占80％。它的特点是凸起的、微红的皮肤上覆盖着银白色的鳞屑。许多患者不单身体上有，头皮上也有。
（2）Taclonex外用悬浮剂是唯一的、每日一次的含类固醇类外用治疗药，它结合了二种活性成分的优势，一种是维生素D类似物（卡泊三醇），另外一种是皮质类固醇激素（二丙酸倍他米松）。
批准日期：2012年10月26日 公司：LEO制药
TACLONEX（卡泊三烯和倍他米松二丙酸酯[calcipotriene and betamethasone dipropionate]）局部悬浮液，0.005％/0.064％
美国最初批准：2006年
作用机制
Taclonex®局部悬浮液结合了卡泊三烯水合物作为合成维生素D3类似物和倍他米松二丙酸酯作为合成皮质类固醇的药理作用。然而，虽然他们的药理和临床效果已知，但他们在斑块状银屑病中的确切机制尚不清楚。
适应症和用法
Taclonex®局部悬液是维生素D类似物和皮质类固醇组合产品，适用于局部治疗：
18岁及以上患者的头皮和身体斑块状银屑病。
12至17岁患者的头皮斑块状银屑病。
剂量和给药
使用前摇瓶。
每天一次将Taclonex局部悬浮液涂抹在患处，最长可达8周。在实现控制时停止治疗。
成人患者每周不应超过100克。
年龄在12至17岁之间的患者每周不应超过60克。
除非医生指示，否则不要使用封闭敷料。
避免在面部，腹股沟或腋窝使用，或者如果治疗部位出现皮肤萎缩。
剂量形式和强度
局部悬浮液，0.005％/0.064％
禁忌症
没有
警告和注意事项
已报道高钙血症和高钙尿症。如果发生任何一种情况，则停止直至钙代谢参数正常化
Taclonex®局部悬液可引起可逆性下丘脑-垂体-肾上腺（HPA）轴抑制，在治疗期间和之后可能存在糖皮质激素功能不全。风险因素包括使用高效局部皮质类固醇，在大面积区域使用或在闭塞区域使用，长期使用，改变皮肤屏障，肝功能衰竭以及在儿科患者中使用。修改使用应该HPA轴抑制发展。
不良反应
最常见的不良反应（≥1％）是毛囊炎和皮肤烧灼感。
包装提供/存储和处理
提供
Taclonex®局部悬浮液是一种粘稠，几乎无味，几乎透明，无色至略带灰白色的悬浮液。它可用作：
ACLONEX SCALP SUS 60GM CALCIPOTRIENE/BETAMETHASONE  LEO PHARMA INC 50222050106
存储
储存在20°C-25°C（68°F-77°F）之间; 允许的偏差在15°C-30°C（59°F-86°F）之间。 [见USP控制的室温]
不要冷藏。
不使用时，将瓶子放在外纸箱中。 瓶子打开六个月后应丢弃未使用的产品。
处理
在使用前摇匀。
请将本品放在儿童不能接触的地方
完整说明资料附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=757c914f-dd8d-43cc-a973-212d591af4af
INDICATIONS AND USAGE
Taclonex(calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment is approved for use on the skin to treat psoriasis vulgaris (plaque psoriasis) in adults 18 years of age and older and should be applied to affected areas once daily for up to 4 weeks.
Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension is approved to treat moderate to severe psoriasis vulgaris of the scalp in adults 18 years and older and should be applied to affected areas on the scalp once a day for 2 weeks or until cleared.
If the affected area is not cleared,
Taclonex Scalp Topical Suspension may be continued for up to 8 weeks.
Do not exceed the recommended weekly dose of 100 grams for either product. Neither product is recommended for use on children.
IMPORTANT SAFETY INFORMATION ABOUT TACLONEX OINTMENT AND TACLONEX SCALPTOPICAL SUSPENSION FOR TOPICAL USE ONLY.
Do not use Taclonex® Ointment or Taclonex Scalp® Topical Suspension on your face, under your arms, or on your groin. Do not get either product in your eyes, mouth, or vaginal area.
Do not swallow Taclonex Ointment or Taclonex Scalp Topical Suspension.
You should not use Taclonex Ointment or Taclonex Scalp Topical Suspension if you are allergic to any of their ingredients, have thin skin (atrophy) at the treatment site, have known or suspected calcium metabolism disorders (too much or too little calcium in your blood or urine), have erythrodermic, exfoliative, or pustular psoriasis, or have severe kidney or severe liver disease. Avoid excessive exposure to either natural or artificial sunlight if you apply Taclonex Ointment to exposed portions of your body or use Taclonex Scalp Topical Suspension.
Tell your doctor if you have a skin infection, are getting phototherapy treatments for your psoriasis, are pregnant, or planning to become pregnant, or are breastfeeding.
Also tell your doctor about other medicines you are taking, especially other corticosteroids, products containing calcipotriene, or medicines for your psoriasis.
Taclonex Ointment and Taclonex Scalp Topical Suspension may cause serious side effects if you use too much, use it for too long, or use it with other medicines that contain corticosteroids or calcipotriene.
Taclonex Ointment and Taclonex Scalp Topical Suspension contain the same medicine to treat psoriasis vulgaris.
If you use both medicines to treat your psoriasis vulgaris, be sure to follow your doctor’s directions carefully so that you do not use too much of one or both of these medicines.
Taclonex Ointment and Taclonex Scalp Topical Suspension can pass through your skin.
Serious side effects may include too much calcium in your blood or urine or adrenal gland problems. Your doctor may do special blood and urine tests to check your calcium levels and adrenal gland function while you are using Taclonex Ointment or Taclonex Scalp Topical Suspension.
The most common side effects of Taclonex Ointment are itching and rash. Other less common side effects with Taclonex Ointment include redness of the skin, inflamed hair pores (folliculitis), psoriasis, skin irritation, skin burning, change of skin color (at the site of application), rash with pus-filled papules, thinning of the skin,
and swollen fine blood vessels (this makes your skin appear red at the site of application).
The most common side effects of Taclonex Scalp Topical Suspension are inflamed hair pores (folliculitis) and burning sensation of the skin. Other side effects include itching, worsening of psoriasis, redness of the skin, and skin pain or irritation.