英文药名: Xyzal(LEVOCETIRIZINE DIHYDROCHLORIDE) 中文药名: 优泽（盐酸左西替利嗪片） 药品说明 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 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。 用法用量： 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。 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。 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： 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: 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。 -------------------------------------------------- 有効成分に関する理化学的知見 商標名 Xyzal Tablets 5mg 一般名 レボセチリジン塩酸塩（Levocetirizine hydrochloride） 化学名 2-（2-｛4-［（R）-（4-Chlorophenyl）phenylmethyl］piperazin-1-yl｝ethoxy）acetic acid dihydrochloride 分子式 C21H25ClN2O3・2HCl 分子量 461.81 構造式 性状 白色の粉末である。 分配係数（logP） 1.32（pH7.4、1-オクタノール/水系） 包装 *ザイザル錠5mg：100錠（10錠×10）PTP、500錠（10錠×50）PTP 製造販売元（輸入） グラクソ・スミスクライン株式会社 完整处方附件：http://www.info.pmda.go.jp/go/pack/4490028F1027_1_03/ ----------------------------------------------------- Xyzal Generic Name: Levocetirizine (LEE-voe-se-TIR-i-zeen)Brand Name: Xyzal Xyzal is used for: Treating allergy symptoms and chronic hives. It may also be used for other conditions as determined by your doctor. Xyzal is an antihistamine. It works by blocking a substance in the body called histamine. This helps to decrease allergy symptoms and hives. Do NOT use Xyzal if: you are allergic to any ingredient in Xyzal or to cetirizine you have severe kidney problems or you are receiving dialysis the patient is a child 6 months to 11 years old who has kidney problems Contact your doctor or health care provider right away if any of these apply to you. Before using Xyzal : Some medical conditions may interact with Xyzal . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you: if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have kidney or liver problems Some MEDICINES MAY INTERACT with Xyzal . Tell your health care provider if you are taking any other medicines, especially any of the following: Ritonavir or theophylline because they may increase the risk of Xyzal 's side effects This may not be a complete list of all interactions that may occur. Ask your health care provider if Xyzal may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine. How to use Xyzal : Use Xyzal as directed by your doctor. Check the label on the medicine for exact dosing instructions. Take Xyzal by mouth with or without food. Take it in the evening unless your doctor tells you otherwise. If you miss a dose of Xyzal , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Ask your health care provider any questions you may have about how to use Xyzal . Important safety information: Xyzal may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Xyzal with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Xyzal ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. The risk of drowsiness may be greater if you take Xyzal in high doses. Do NOT take more than the recommended dose without checking with your doctor. Use Xyzal with caution in the ELDERLY; they may be more sensitive to its effects. Xyzal should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xyzal while you are pregnant. Xyzal is found in breast milk. Do not breast-feed while taking Xyzal . Possible side effects of Xyzal : All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome: Drowsiness; dry mouth; sore throat; tiredness. Seek medical attention right away if any of these SEVERE side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); dark urine; fainting; fever; irregular heartbeat; mental or mood changes (eg, aggression, agitation); seizure; severe or persistent dizziness; shortness of breath; yellowing of the eyes or skin. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch. If OVERDOSE is suspected: Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include agitation; irritability; restlessness; severe drowsiness. Proper storage of Xyzal : Store Xyzal between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Xyzal out of the reach of children and away from pets. General information: If you have any questions about Xyzal , please talk with your doctor, pharmacist, or other health care provider. Xyzal is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. This information is a summary only. It does not contain all information about Xyzal . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider. ----------------------------------------------------- 产地国家: 西班牙 原产地英文商品名: XYZAL TABLET 5mg/tab 20tabs/box 原产地英文药品名: LEVOCETIRIZINE DIHYDROCHLORIDE 中文参考商品译名: 优泽片剂 5毫克/片 20片/盒 中文参考药品译名: 盐酸左西替利嗪 中文参考化合物名称: (R)-(-) -2-[2-[4-[（4-氯苯基）苯甲基]-1-哌嗪基]乙氧基]乙酸二盐酸盐 生产厂家中文参考译名: UCB INC 生产厂家英文名: UCB INC -------------------------------------------------------- 产地国家: 日本 原产地英文商品名: XYZAL TABLET 5mg/tab 100tabs/box 原产地英文药品名: Levocetirizine hydrochloride 中文参考商品译名: 优泽片剂 5毫克/片 100片/盒 中文参考药品译名: 盐酸左西替利嗪 中文参考化合物名称: (R)-(-) -2-[2-[4-[（4-氯苯基）苯甲基]-1-哌嗪基]乙氧基]乙酸二盐酸盐 生产厂家中文参考译名: 葛兰素史克KK 生产厂家英文名: GlaxoSmithKline KK