Sanofi-Aventis(SNY)与UCB(UCBJF)周二宣佈，食品和药品管理局(FDA)已批准Xyzal用于治疗季节性和周年性过敏，以及慢性荨麻疹。
Xyzal是UCB研制的一种日服一次的抗组胺处方药，该公司于2006年7月向FDA提交了此产品的新药申请。
2006年9月，Sanofi与UCB达成了在美国推出和联合营销该药的协议。

商品名：优泽

药物中文通用名：盐酸左西替利嗪

药物英文通用名：Levocetirizine Hydrochloride

化学名：(R)-(-) -2-[2-[4-[（4-氯苯基）苯甲基]-1-哌嗪基]乙氧基]乙酸二盐酸盐

其他名称：迪皿，盐酸左西替利嗪口服溶液，盐酸左西替利嗪片，强溢，盐酸左西替利嗪胶囊，盐酸左西替利嗪分散片，安施达，畅然，西可新，优泽，诺思达，齐平，Levocetirizine Hydrochloride Tablets，Levocetirizine Hydrochloride Oral Solution，Levocetirizine Hydrochloride Tables，Levocetirizine Dihydrochloride    Levocetirizine Dihydrochloride Tablets，Levocetirizine Dihydrochloride Dispersible Tablets    Levocetirizine Hydrochloride Capsules，Xyzal    

用法用量：人、6岁及以上儿童 ：每日口服1片（5 mg），空腹或餐中或餐后均可服用。肾功能损害的患者 ：轻度肾功能损害患者无需调整剂量，中重度肾功能损害患者用法用量如下调整 ：中度肾功能损害（肌酐清除率为30-49 mL/分） ：每2日1次，5 mg ；重度肾功能损害（肌酐清除率<30 mL/分） ：每3日1次，5 mg。肾病晚期-采用透析疗法的患者（肌酐清除率<10 mL/分） ：禁忌使用。血清肌酐清除率(CLcr mL/分)= [140-年龄(年)] x 体重(kg) /72 x 血清肌酐(mg/dl)。女性患者 ：用上述计算值乘以0.85。肝功能损害患者 ：仅有肝功能损害的患者，无需调整给药剂量 ；如伴有肾功能损害的患者，请参照"肾功能损害患者"的用法用量。

禁忌：禁用于对本品任何成分过敏者或者对哌嗪类衍生物过敏者 ；肌酐清除率<10 mL/分的肾病晚期患者。

功能主治/适应症：治疗下述疾病的过敏相关症状，如季节性过敏性鼻炎、常年性过敏性鼻炎、慢性特发性荨麻疹。

不良反应：优泽(盐酸左西替利嗪片)可能会使个别患者产生头痛、嗜睡、口干、疲倦、衰弱、腹痛等不良反应。

注意事项：虽然目前暂无研究资料，但当某些敏感的病人同时服用左西替利嗪和酒精或中枢神经系统抑制剂时可能会对其中枢神经系统产生影响。对驾驶和操作机械能力的影响 ：对照临床试验证实，左西替利嗪在推荐剂量下不会削弱人的警戒性、反应和驾驶的能力。如果患者需要驾驶、从事有潜在危险性的活动或操作机械时，切勿过量服用并考虑其对本品的反应 ；合并服用酒精或其他中枢神经系统抑制剂可能导致其警戒性降低和操作能力削弱。

妇女用药：左西替利嗪在动物生殖毒性研究中未见不良反应，尚无其应用于孕妇的临床资料，不推荐孕妇使用本品。左西替利嗪会从乳汁中分泌，不建议哺乳妇女使用本品。

儿童用药：不建议6岁以下儿童使用本品，由于目前可使用的该产品的薄膜包衣片仍未无法允许调整剂量。

贮藏：贮藏于25℃以下干燥处。

药物相互作用：尚无左西替利嗪与其他药物相互作用的相关研究资料，至今未有西替利嗪与其他药物相互作用的报导。

药理毒理：药理作用:优泽(盐酸左西替利嗪片)为口服选择性组胺H1受体拮抗剂。无明显抗胆碱和抗5-羟色胺的作用，中枢抑制作用较小。 毒理研究:遗传毒性 ：本品Ames试验、人淋巴细胞染色体畸变试验、小鼠淋巴瘤试验和大鼠微核试验结果均为阴性。

关联病症：季节性过敏性鼻炎 常年性过敏性鼻炎 慢性特发性荨麻疹

药代动力学：优泽(盐酸左西替利嗪片)的药代动力学特征是血浆浓度水平和给药剂量呈线性关系，个体间差异小。左西替利嗪在人体内的吸收迅速且完全，进食可能导致左西替利嗪的吸收速度和血药浓度峰值下降，但是总的吸收度不会降低，左西替利嗪的吸收程度与给药剂量无关。临床试验结果显示，5 mg左西替利嗪片剂的相对生物利用度近100%，人给药后约0.9小时血药浓度达到峰值 ；左西替利嗪和血浆蛋白结合牢固，血浆蛋白结合率约为90%，表观分布容积为0.4 L/kg ；血浆消除半衰期为7.9±1.9小时，每日1次给药5 mg，连续2天后血药浓度达到稳态 ；单剂量给药5 mg后血药浓度峰值为270 ng/mL，再次给药5 mg后血药浓度稳态峰值为308 ng/mL。左西替利嗪的代谢没有首过效应，其在人体内的代谢率小于给药剂量的14%，因此推测肝酶的个体差异性或合并服用肝酶抑制剂对其影响甚微，与其它物质产生相互作用的可能性小。左西替利嗪平均85.4%以原型由尿液排出，12.9%由粪便排出。在吸收和清除的过程中左西替利嗪不会转换为右西替利嗪。

Xyzal
Generic Name: levocetirizine (LEE voe se TIR a zeen)
Brand Names: Xyzal
What is Xyzal?
Xyzal (levocetirizine) is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Xyzal works by blocking the actions of histamine.

Xyzal is used to treat symptoms of year-round (perennial) allergies in adults and children who are at least 6 months old. Xyzal is also used to treat symptoms of seasonal allergies in adults and children who are at least 2 years old.

Xyzal is also used to treat itching and swelling caused by chronic urticaria (hives) in adults and children who are at least 6 months old.

Important information about Xyzal
You should not use Xyzal if you are allergic to levocetirizine or cetirizine (Zyrtec). Do not take levocetirizine if you have end-stage kidney disease or if you are on dialysis. Any child under 12 with kidney disease should not take Xyzal.

Before taking Xyzal, tell your doctor if you are allergic to any drugs, or if you have kidney or liver disease, or gallbladder problems.

It is very important not to give a child more than the prescribed dose of this medication. A child's body absorbs twice as much of the same dose size of Xyzal as an adult's body. This medicine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of Xyzal. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Xyzal. Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.
Before taking Xyzal
You should not use Xyzal if you are allergic to levocetirizine or cetirizine (Zyrtec). Do not take this medicine if you have end-stage kidney disease or if you are on dialysis. Any child under 12 with kidney disease should not take levocetirizine.

Before taking Xyzal, tell your doctor if you are allergic to any drugs, or if you have:
kidney disease;
liver disease; or
gallbladder problems.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Xyzal.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Xyzal can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give Xyzal to a child younger than 6 months old.

How should I take Xyzal?
Take Xyzal exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

It is very important not to give a child more than the prescribed dose of this medication. A child's body absorbs twice as much of the same dose size of Xyzal as an adult's body.

You may take this medication with or without food. Xyzal is usually taken once per day, in the evening.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever. Store Xyzal at room temperature away from moisture and heat.

What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or agitated, and then feeling drowsy.

What should I avoid while taking Xyzal?
Xyzal can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of Xyzal. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Xyzal.

Xyzal side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Xyzal: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:
feeling like you might pass out;
nosebleed (especially in a child);
confusion, hallucinations, unusual thoughts;
numbness or tingling around your lips or mouth;
jaundice (yellowing of your skin or eyes);
dark-colored urine, foul-smelling stools; or
fever, stomach pain, loss of appetite.

Less serious Xyzal side effects may include:
drowsiness, weakness;
stuffy nose, sinus pain, sore throat, cough;
tired feeling;
dry mouth; or
weight gain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Xyzal?
Before you take Xyzal, tell your doctor if you also take ritonavir (Norvir, Kaletra).

There may be other drugs that can interact with Xyzal. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?
Your pharmacist can provide more information about Xyzal.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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