制造商：
Galderma Laboratories公司

药理分类：
维生素D3衍生物

活性成分（补）：
三醇3micrograms /克; oint。
指示（补）：
局部治疗成人≥18岁的轻度至中度牛皮癣。

药理作用：
牛皮癣是一种自身免疫性皮肤病，导致皮肤细胞的生长周期加快。它影响到2至3的美国人口的百分之。斑块型银屑病表现为干燥，红色，鳞片补丁或者通过死亡的皮肤细胞，这些细胞会释放一种银白色的外表覆盖病变。

Vectical包含三醇软膏，是自然发生，维生素D3的活性形式。其在对牛皮癣治疗的作用机制尚未建立。


临床试验：
两个8周的多中心，双盲，车辆控制进行了研究，建立了Vectical膏疗效。一个839轻度或中度牛皮癣患者共随机接受任何Vectical膏或车辆软膏每日两次，8周的治疗。治疗成功的定义是“清除或最小”（至淡红色或粉红色的着色，表面干燥一些白色的色彩，并高于正常皮肤有轻微升高），至少有一个从基线2级的变化。在8周，23.4％和20.5 Vectical软膏治疗，在1和2分别研究，取得了明显或轻微疾病的患者％和2级改善年底相比，14.4％和6.6％的患者治疗与车辆软膏。

的安全性和与红皮，剥脱，或脓疱性银屑病患者Vectical软膏有效性尚未评估。

在对照临床试验Vectical软膏中有实验室监测病人，观察高钙血症24％暴露于药物的患者（七十四分之一十八）和16％的患者暴露于车辆（79分之13）。然而，在钙和白蛋白调整钙水平的增加小于10以上的正常上限％。如果钙代谢参数abberations发生，应停止治疗，直到这些参数都正常。钙代谢的Vectical膏治疗后效果持续时间大于52周没有得到评估。吸收增加可能发生闭塞性使用。


法律分类：
接收

成人：
≥18岁：适用于人体每天两次（上午及下午）影响的地区。每周的最大剂量不应超过200克。

儿童：
<18年：不推荐。



警告/注意事项：
如果发生高钙血症停止（直到normocalcemia回报）。应避免眼睛，嘴唇或面部肌肤。避免过度暴露于自然或人工光（日光棚，太阳灯）。考虑限制或避免使用光疗。妊娠（Cat.C）。哺乳的母亲。

互动（补）：
注意与已知会增加血清钙（如噻嗪类利尿剂），钙补充剂或高剂量的维生素药物同时使用四

不良反应（补）：
高钙血症，实验室测试和尿液异常，牛皮癣，高尿钙症，搔痒。


如何提供：
Oint - 5克，100克

VECTICAL OINTMENT

Indication(s):

Topical treatment of mild to moderate plaque psoriasis in adults ≥18 years of age.

Pharmacology:

Psoriasis is an autoimmune skin disorder that causes acceleration of the skin cell growth cycle. It affects 2 to 3 percent of the U.S. population. Plaque psoriasis presents as dry, red, scaly patches or lesions that are covered with dead skin cells which give off a silvery-white appearance.

Vectical Ointment contains calcitriol, the naturally-occurring, active form of vitamin D₃. Its mechanism of action in the treatment of plaque psoriasis has not been established.

Clinical Trials:

Two 8-week, multicenter, double-blind, vehicle-controlled studies were conducted to establish the efficacy of Vectical Ointment. A total of 839 patients with mild or moderate plaque psoriasis were randomized to receive treatment with either Vectical Ointment or vehicle ointment twice daily for 8 weeks. Treatment success was defined as “Clear or Minimal” (up to light red or pink coloration, surface dryness with some white coloration, and slight elevation above normal skin) with at least a 2-grade change from baseline. At the end of 8 weeks, 23.4% and 20.5% of patients treated with Vectical Ointment, in Studies 1 and 2 respectively, achieved clear or minimal disease and a 2-grade improvement as compared to 14.4% and 6.6% of patients treated with vehicle ointment.

The safety and effectiveness of Vectical Ointment in patients with erythrodermic, exfoliative, or pustular psoriasis have not been evaluated.

In controlled clinical trials with Vectical Ointment, among patients having laboratory monitoring, hypercalcemia was observed in 24% (18/74) of patients exposed to the drug and in 16% (13/79) of patients exposed to vehicle. However, the increases in calcium and albumin-adjusted calcium levels were less than 10% above the upper limit of normal. If abberations in parameters of calcium metabolism occur, treatment should be discontinued until these parameters have normalized. The effects of Vectical Ointment on calcium metabolism following treatment duration greater than 52 weeks have not been evaluated. Increased absorption may occur with occlusive use.

Legal Classification:

Rx

Adults:

≥18 years: Apply to affected areas of the body twice daily (AM & PM). The maximum weekly dose should not exceed 200g.

Children:

<18 years: not recommended.

Warnings/Precautions:

Discontinue if hypercalcemia occurs (until normocalcemia returns). Avoid applying to eyes, lips, or facial skin. Avoid excessive exposure to natural or artificial light (tanning booths, sun lamps). Consider limiting or avoiding use of phototherapy. Pregnancy (Cat.C). Nursing mothers.

Interaction(s):

Caution with concomitant use of medications known to increase serum calcium (eg, thiazide diuretics), calcium supplements or high doses of vitamin D.

Adverse Reaction(s):

Hypercalcemia, lab test and urine abnormalities, psoriasis, hypercalciuria, pruritus.

How Supplied:

Oint—5g, 100g

Last Updated:

4/10/2009