产地国家：美国 处 方 药：是 所属类别：0.5毫克/片 60片/瓶 包装规格：0.5毫克/片 60片/瓶 计价单位：瓶 生产厂家中文参考译名：辉瑞公司 生产厂家英文名：Pfizer Inc 原产地英文商品名：XANAX XR Tablets 0.5mg/tab 60tabs/bottles 原产地英文药品名：ALPRAZOLAM 中文参考商品译名：XANAX缓释片 0.5毫克/片 60片/瓶 中文参考药品译名：阿普唑仑

简介

部份中文阿普唑仑处方资料(仅供参考) 【适应症】 主要用于焦虑、紧张、激动，也可用于催眠或焦虑的辅助用药，也可作为抗惊恐药，并能缓解急性酒精戒断症状。对有精神抑郁的病人应慎用。 【用法用量】 成人常用量：抗焦虑，开始一次0.4mg，一日3次，用量按需递增，最大限量一日可达4mg。镇静催眠：0.4～0.8mg，睡前服。抗惊恐0.4mg，一日3次，用量按需递增，每日最大量可达10mg。18岁以下儿童，用量尚未确定。 【不良反应】 (1)常见的不良反应：嗜睡、头昏、乏力等，大剂量偶见共济失调、震颤、尿潴留、黄疸。 (2)罕见的有皮疹、光敏、白细胞减少。 (3)个别病人发生兴奋，多语，睡眠障碍，甚至幻觉。停药后，上述症状很快消失。 (4)有成瘾性，长期应用后，停药可能发生撤药症状，表现为激动或忧郁。 (5)少数病人有口干、精神不集中、多汗、心悸、便秘或腹泻、视物模糊、低血压。 【禁忌】 慎用： ①中枢神经系统处于抑制状态的急性酒精中毒; ②肝肾功能损害; ③重症肌无力; ④急性或易于发生的闭角型青光眼发作; ⑤严重慢性阻塞性肺部病变; ⑥驾驶员、高空作业者、危险精细作业者。 【注意事项】 ①对苯二氮 类药物过敏者，可能对本药过敏; ②肝肾功能损害者能延长本药清除半衰期; ③癫痫患者突然停药可导致发作; ④严重的精神抑郁可使病情加重，甚至产生自杀倾向，应采取预防措施;⑤避免长期大量使用而成瘾，如长期使用需停药时不宜骤停，应逐渐减量; ⑥出现呼吸抑制或低血压常提示超量; ⑦对本类药耐受量小的患者初用量宜小，逐渐增加剂量; ⑧高空作业、驾驶员、精细工作、危险工作慎用。 【孕妇及哺乳期妇女用药】 ①在妊娠三个月内，本药有增加胎儿致畸的危险; ②孕妇长期服用可引起依赖，使新生儿呈现撤药症状，妊娠后期用药影响新生儿中枢神经活动，分娩前及分娩时用药可导致新生儿肌张力较弱，孕妇应尽量避免使用; ③本药可以分泌入乳汁，哺乳期妇女应慎用。 【儿童用药】18岁以下儿童，用量尚未有具体规定。 【老年用药】本药对老年人较敏感，开始用小剂量，一次0.2mg，一日3次，逐渐增加至最大耐受量。 【药物相互作用】 ①与中枢抑制药合用可增加呼吸抑制作用; ②与易成瘾和其他可能成瘾药合用时，成瘾的危险性增加; ③与酒及全麻药、可乐定、镇痛药、吩噻嗪类、单胺氧化酶A型抑制药和三环类抗抑郁药合用时，可彼此增效，应调整用量; ④与抗高血压药和利尿降压药合用，可使降压作用增强; ⑤与西咪替丁、普奈洛尔合用本药清除减慢，血浆半衰期延长; ⑥与扑米酮合用由于减慢后者代谢，需调整扑米酮的用量; ⑦与左旋多巴合用时，可降低后者的疗效; ⑧与利福平合用，增加本品的消除，血药浓度降低; ⑨异烟肼抑制本品的消除，致血药浓度增高; ⑩与地高辛合用，可增加地高辛血药浓度而致中毒。 【药物过量】 出现持续的精神错乱、严重嗜睡、抖动、语言不清、蹒跚、心跳异常减慢、呼吸短促或困难、严重乏力。超量或中毒宜及早对症处理，包括催吐或洗胃以及呼吸循环方面的支持疗法，中毒出现兴奋异常时，不能用巴比妥类药。苯二氮 受体拮抗剂氟马西尼(flumazenil)可用于该类药物过量中毒的解救和诊断。 【药理毒理】 药理作用 本品为苯二氮 类催眠镇静药和抗焦虑药。该药作用于中枢神经系统的苯二氮 受体(BZR)，加强中枢抑制性神经递质γ-氨基丁酸(GABA)与GABAA受体的结合，促进氯通道开放，使细胞超极化，增强GABA能神经元所介导的突触抑制，使神经元的兴奋性降低。BZ受体分为I型和II型，据认为I型受体兴奋可以解释BZ类药物的抗焦虑作用，而II型受体与该类药物的镇静和骨骼肌松弛等作用有关。可引起中枢神经系统不同部位的抑制，随着用量的加大，临床表现可自轻度的镇静到催眠甚至昏迷。可通过胎盘，可分泌入乳汁。有成瘾性，少数患者可引起过敏。 毒理研究 未进行该项实验且无可靠参考文献。 【药代动力学】 口服吸收快而完全，血浆蛋白结合率约为80%。口服后1～ 2小时血药浓度达峰值。2～3天血药浓度达稳态。T1/2一般为12～15小时，老年人为19小时。经肝脏代谢，代谢产物α-羟基阿普唑仑，该产物也有一定药理活性。经肾排泄。体内蓄积量极少，停药后清除快。 【贮藏】遮光，密封保存。 注：本品属管控药。 生产厂家：美国辉瑞公司

英文版说明书

Xanax XR (Alprazolam) Summary INDICATIONS AND USAGE XANAX XR Tablets are indicated for the treatment of panic disorder, with or without agoraphobia. This claim is supported on the basis of two positive studies with XANAX XR conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The longer-term efficacy of XANAX XR has not been systematically eva luated. Thus, the physician who elects to use this drug for periods longer than 8 weeks should periodically reassess the usefulness of the drug for the individual patient. DOSAGE AND ADMINISTRATION XANAX XR Tablets may be administered once daily, preferably in the morning. The tablets should be taken intact; they should not be chewed, crushed, or broken. The suggested total daily dose ranges between 3 to 6 mg/day. Dosage should be individualized for maximum beneficial effect. While the suggested total daily dosages given will meet the needs of most patients, there will be some patients who require doses greater than 6 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects. Dosing in Special Populations In elderly patients, in patients with advanced liver disease, or in patients with debilitating disease, the usual starting dose of XANAX XR is 0.5 mg once daily. This may be gradually increased if needed and tolerated (see Dose Titration). The elderly may be especially sensitive to the effects of benzodiazepines. Dose Titration Treatment with XANAX XR may be initiated with a dose of 0.5 mg to 1 mg once daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. Slower titration to the dose levels may be advisable to allow full expression of the pharmacodynamic effect of XANAX XR. Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained. Dose Maintenance In controlled trials conducted to establish the efficacy of XANAX XR Tablets in panic disorder, doses in the range of 1 to 10 mg/day were used. Most patients showed efficacy in the dose range of 3 to 6 mg/day. Occasional patients required as much as 10 mg/day to achieve a successful response. The necessary duration of treatment for panic disorder patients responding to XANAX XR is unknown. However, periodic reassessment is advised. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena. Dose Reduction Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE). In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction. In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every three days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens. Switch from XANAX (immediate-release) Tablets to XANAX XR (extended-release) Tablets Patients who are currently being treated with divided doses of XANAX (immediate-release) Tablets, for example 3 to 4 times a day, may be switched to XANAX XR Tablets at the same total daily dose taken once daily. If the therapeutic response after switching is inadequate, the dosage may be titrated as outlined above. HOW SUPPLIED XANAX XR (extended-release) Tablets are available as follows: 0.5 mg (white, pentagonal-shaped tablets debossed with an "X" on one side and "0.5" on the other side) Bottles of 60 NDC 0009-0057-07 1 mg (yellow, square-shaped tablets debossed with an "X" on one side and "1" on the other side) Bottles of 60 NDC 0009-0059-07 2 mg (blue, round-shaped tablets debossed with an "X" on one side and "2" on the other side) Bottles of 60 NDC 0009-0066-07 3 mg (green, triangular-shaped tablets debossed with an "X" on one side and "3" on the other side) Bottles of 60 NDC 0009-0068-07 Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].