近日，美国推出新药Taclonex（calcipotriene and betamethasone dipropionate）局部用药，用于12至17岁患者头皮斑块状银屑病的局部联合治疗12岁青少年患者的第一个适应症 年龄大于头皮斑块状牛皮癣。 批准日期：2014年9月30日 公司：利奥制药 Taclonex（卡泊三烯和倍他米松二丙酸酯[calcipotriene and betamethasone dipropionate]）软膏，0.005％/ 0.064％,用于局部使用 美国最初批准：2006年 作用机制 Taclonex软膏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是已知的，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软膏是一种维生素D类似物和皮质类固醇组合产品，适用于12岁及以上患者的斑块状银屑病局部治疗。 剂量和给药 每天一次将Taclonex软膏涂抹于患处，最长可达4周。在实现控制时停止治疗。 成人患者每周不应超过100克。 12至17岁的患者每周不应超过60克。 不建议治疗体表面积超过30％。 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。 不适用于口服，眼科或阴道内使用。 剂量形式和强度 软膏，0.005％/ 0.064％。 禁忌症 没有。 警告和注意事项 已经观察到高钙血症和高钙尿症。如果发生任何一种情况，停止治疗直至钙代谢参数正常化。 Taclonex软膏可以产生可逆的下丘脑-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，同时使用多种含皮质类固醇的产品，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％）是瘙痒和鳞状皮疹。 包装提供/存储和处理 提供 Taclonex软膏颜色为灰白色至黄色，可用于以下可折叠管： 60克（NDC 50222-227-04） 100克（NDC 50222-227-81） 存储 将Taclonex软膏储存在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] 处理 请将本品放在儿童不能接触的地方。 原处方资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ef43ba2d-20ce-4415-b5c2-e486b836812e Taclonex(calcipotriene and betamethasone dipropionate) Ointment, 0.005%/0.064% 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 SCALP® TOPICAL 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. -------------------------------------------------------------------- 原产地英文商品名: TACLONEX OINTMENT 100G/TUBE 原产地英文药品名: BETAMETHASONE DIPROPIONATE/CALCIPOTRIENE HYDRATE 中文参考商品译名: TACLONEX软膏 100克/管 中文参考药品译名: 二丙酸倍他米松/水合钙泊三醇 生产厂家中文参考译名: LEO PHARM 生产厂家英文名: LEO PHARM ------------------------------------------------------------------ 原产地英文商品名: TACLONEX OINTMENT 60G/TUBE 原产地英文药品名: BETAMETHASONE DIPROPIONATE/CALCIPOTRIENE HYDRATE 中文参考商品译名: TACLONEX软膏 60克/管 中文参考药品译名: 二丙酸倍他米松/水合钙泊三醇 生产厂家中文参考译名: LEO PHARM 生产厂家英文名: LEO PHARM