部份中文盐酸舍曲林处方资料（仅供参考） 通用名：盐酸舍曲林片 商品名：Zoloft 英文名：Sertraline Hydrochloride Tablets 汉语拼音名：Yansuan Shequlin Pian 主要成分 本品主要成份为盐酸舍曲林，其化学名称为：(1S-顺式)-4-(3,4-二氯苯基)-1,2,3,4-四氢-N-甲基-1-萘啶胺盐酸盐。 分子式C17H17NCl2·HCl 分子量342.7 结构式 性状 本品为白色薄膜衣片，片芯也为白色。 药理毒理 舍曲林在体外是神经元强效和特异的5-羟色胺再摄取抑制剂，能导致动物体内5-羟色胺效应的增强。舍曲林对神经元中去甲肾上腺素和多巴胺的再摄取仅有极轻微的作用。在临床剂量下，舍曲林阻断人类血小板对5-羟色胺的摄取。在动物体内，舍曲林没有中枢兴奋作用、镇静作用、抗胆碱能作和和心脏毒性。在健康志愿者所做的对照研究中，舍曲林不引起镇静作用，因而不影响各种精神运动的操作。由于它选择性地抑制5-羟色胺的再摄取，因此它并不增强儿茶酚类神经介质的活性。舍曲林与毒蕈碱受体（胆碱能）、5-羟色胺能受体、多巴胺受体、肾上腺素受体、组织胺受体、GABA受体以及苯二氮䓬类受体没有亲和性。动物长期给予舍曲林后可使脑内去甲肾上腺素受体下调，这与临床其它抗抑郁药物作用相一致。 与三环类抗抑郁药物不同，舍曲林在治疗抑郁症和强迫症的临床对照研究中并不引起体重增加，某些病人可能会出现体重减轻。 舍曲林未表现出滥用的可能性。在舍曲林、阿普唑仑和右旋苯丙胺的安慰剂对照、双盲随机研究中，比较它们的滥用倾向，舍曲林没有产生滥用倾向所特有的正性主观效应。试验对象在一些反映药物滥用的指标如对药物的喜欢程度、欣快和滥用倾向方面都评价阿普唑仑和右旋苯丙胺显著地大于安慰剂。舍曲林既没有右旋苯丙胺伴随的兴奋刺激和焦虑作用，也没有阿普唑仑伴随的镇静作用对精神运动功能的损伤。舍曲林既没有在功能上成为经训练后可自行摄用可卡因的恒河猴的正性增强剂，也没有做为对恒河猴的选择性刺激物而取代右旋丙胺或苯巴比妥。 长期给药的动物试验表明：舍曲林具有良好的安全性。应用相当于临床有效治疗剂量数倍的药物剂量动物也能够良好耐受。舍曲林无致畸作用。 药代动力学 男性，每日口服舍曲林一次50～200mg，舍曲林表现出与用药剂量成正比的药代动力学特性，连续用药14天，服药4.5～8.4小时人体血药浓度达峰值（Cmax）。青少年和老年人的药代动力学参数与18～65岁之间成人无明显差别。舍曲林平均半衰期为22～36小时。与终末清除半衰期相一致，每天给药一次，一星期后达稳态浓度，在这过程中有两倍的浓度蓄积。舍曲林的血浆蛋白结合率为98%。动物实验结果表明，舍曲林有较大的分布容积。 舍曲林主要首先通过肝脏代谢，血浆中的主要代谢产物N-去甲基舍曲林的药理活性在体外明显低于舍曲林，约是舍曲林的1/20，没有证据表明其在抗抑郁模型体内有药理活性，它的半衰期是62～104小时。舍曲林和N-去甲基舍曲林的最终代谢产物从粪便和尿中等量排泄，只有少量（＜0.2%）舍曲林以原形从尿中排出。 食物对舍曲林片剂的生物利用度无明显的影响。 用法用量 舍曲林片每日一次口服给药，早或晚服用均可。 舍曲林片可与食物同时服用，也可单独服用。 初始治疗：每日服用舍曲林50mg。 剂量调整：对于每日服用50mg疗效不佳而对药物耐受性较好的患者可增加剂量，至少需一周时间将剂量升至最大20mg/日。 服药七日内可见疗效。完全起效则需要更长的时间，强迫症的治疗尤其如此。 维持治疗：长期用药应根据疗效调整剂量，并维持最低有效治疗剂量。 适应证 舍曲林用于治疗抑郁症的相关症状，包括伴随焦虑、有或无躁狂史的抑郁症。疗效满意后，继续服用舍曲林可有效地防止抑郁症的复发和再发。 舍曲林也用于治疗强迫症，初始治疗有反应后，舍曲林在治疗强迫症二年的时间内，仍保持它的有效性、安全性和耐受性。 生产厂家 辉瑞制药有限公司 Generic Name: sertraline (SER tra leen) Brand Names: Zoloft Indications for ZOLOFT ZOLOFT is approved by the FDA to treat in adults Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Panic Disorder, Posttraumatic Stress Disorder (PTSD), Premenstrual Dysphoric Disorder (PMDD), and Social Anxiety Disorder. It is also approved to treat Obsessive-Compulsive Disorder (OCD) in children and adolescents aged 6-17 years. IMPORTANT SAFETY INFORMATION Suicidality and Antidepressant Drugs Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults especially within the first few months of treatment. Depression and certain other serious mental illnesses are important causes of suicidal thoughts and actions. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Anyone considering the use of ZOLOFT or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. ZOLOFT is not approved for use in pediatric patients except for patients with Obsessive-Compulsive Disorder (OCD). WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition. Tell the doctor immediately if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed. USES: Sertraline is used to treat depression, panic attacks, obsessive compulsive disorder, post-traumatic stress disorder, social anxiety disorder (social phobia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder). This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease fear, anxiety, unwanted thoughts, and the number of panic attacks. It may also reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, and checking) that interfere with daily living. Sertraline is known as a selective serotonin reuptake inhibitor (SSRI). It works by helping to restore the balance of a certain natural substance (serotonin) in the brain. HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using sertraline and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once daily either in the morning or evening. The tablet form of this medication may be taken with or without food. The capsule form is usually taken with food after breakfast or after your evening meal. If you are taking this medication for premenstrual problems, your doctor may direct you to take this drug every day of the month or for only the 2 weeks before your period until the start of your period. The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as mood swings, headache, tiredness, sleep changes, and brief feelings similar to electric shock. Your dose may need to be gradually decreased to reduce side effects. Report any new or worsening symptoms immediately. 本药品完整资料附件https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=9717 ------------------------------------------- 产地国家： 美国 原产地英文商品名: Zoloft 25mg/tab 30tabs/bottles 原产地英文药品名: Sertraline Hcl 中文参考商品译名: Zoloft片 25毫克/片 30片/瓶 中文参考药品译名: 盐酸舍曲林 生产厂家中文参考译名: 辉瑞 生产厂家英文名: Pfizer ------------------------------------------- 产地国家： 美国 原产地英文商品名: Zoloft 50mg/tab 30tabs/bottles 原产地英文药品名: Sertraline Hcl 中文参考商品译名: Zoloft片 50毫克/片 30片/瓶 中文参考药品译名: 盐酸舍曲林 生产厂家中文参考译名: 辉瑞 生产厂家英文名: Pfizer ------------------------------------------- 产地国家： 美国 原产地英文商品名: Zoloft 100mg/tab 30tabs/bottles 原产地英文药品名: Sertraline Hcl 中文参考商品译名: Zoloft片 100毫克/片 30片/瓶 中文参考药品译名: 盐酸舍曲林 生产厂家中文参考译名: 辉瑞 生产厂家英文名: Pfizer