制造商：
赛诺菲安万特
药理分类：
抗抑郁剂（aminoketone）
活性成分（补）：
安非他酮氢溴酸174mg（equiv.盐酸安非他酮150毫克），348mg（盐酸安非他酮300毫克equiv.），522mg（equiv.盐酸安非他酮500毫克）;分机- REL的标签。
指示（补）：
主要的抑郁症。
药理作用：
Aplenzin是每日一次，缓释片安非他酮氢溴酸制定。对安非他酮在治疗抑郁症的作用机制尚不清楚，但有可能是由去甲肾上腺素和多巴胺介导的影响。
临床试验：
对Aplenzin批准其生物等效性基础，以另一种形式的bupropion，Wellbutrin加大码（盐酸安非他酮，从葛兰素史克）。在为期10天的比较了Aplenzin 348mg每天一次300毫克Wellbutrin加大码使用一次日常的学习，峰值水平和吸收母体药物及其代谢产物的程度和被证明是等价的。
对安非他酮在治疗抑郁症的有效性，建立使用两个4周的安慰剂对照试验的一对成年住院病人盐酸安非他酮短效配方，并在成年门诊病人6周的研究。这些研究表明，盐酸安非他酮对汉密尔顿抑郁量表总分，从该项目规模情绪低落，临床整体印象严重程度评分的有效性。在另一项试验中，一个44周的研究表明，在安非他酮反应的长期疗效。
法律分类：
接收
成人：
燕子的整体。您可以在上午。最初174mg每日一次，可能会增加维修的目标第4天一次348mg每日最多可再增加至每日一次522mg 4周后，如果不充分的反应。严重肝硬化：最大174mg/48小时。肾或轻中度肝功能不全：减少剂量和/或频率。其他形式的转换：可使用一次的剂量相当于每天。定期重新评估。
儿童：
不推荐。
禁忌（补）：
癫痫症。贪食。神经性厌食症。单胺氧化抑制剂后14天。突然撤离镇静剂或酒精。伴随其他形式的安非他酮（例如，载班，Wellbutrin）。
警告/注意事项：
海关检获的危险或历史。如果出现停止发作，不要重新启动。躁郁症。精神病。不稳定心脏病。瑞士法郎。最近的心肌梗塞。肝，肾功能不全。自杀倾向（监视器）。维持在最低有效剂量。写实际金额最小的接收。劳动和交付。妊娠（Cat.C）。哺乳母亲：不推荐。
互动（补）：
见禁忌。避免饮酒。可能会增强了CYP2B6基板或抑制剂，依非韦伦，氟伏沙明，奈非那韦，帕罗西汀，利托那韦，舍曲林。注意与药物（如抗精神病药）或因素（如阿片类药物成瘾，酒精或镇静剂，糖尿病过度使用）低扣押的门槛。注意与左旋多巴，金刚烷胺，并与CYP2B6或CYP2D6的代谢，包括三环抗忧郁药物，SSRIs类药物，抗精神病药物，β-受体阻滞剂，抗心律失常药1C类药物;考虑降低剂量。拮抗卡马西平，苯巴比妥，苯妥英。监控与尼古丁贴片高血压。
不良反应（补）：
中枢神经系统的刺激，口干，胃肠不适，头晕，咽炎，心慌，腹痛，出汗，耳鸣，食欲减退，频尿，皮疹（可能是严重，例如，Stevens - Johnson综合征），肌肉酸痛，神经的影响。
如何提供：
制表- 30
最后更新：
2009年7月23日
APLENZIN
Manufacturer:
Sanofi-aventis
Pharmacological Class:
Antidepressant (aminoketone)
Active Ingredient(s):
Bupropion HBr 174mg (equiv. to bupropion HCl 150mg), 348mg (equiv. to bupropion HCl 300mg), 522mg (equiv. to bupropion HCl 500mg); ext-rel tabs.
Indication(s):
Major depressive disorder.
Pharmacology:
Aplenzin is a once-daily, extended-release tablet formulation of bupropion HBr. The mechanism of action of bupropion in treating depression is not known, but it is likely mediated by its effects on norepinephrine and dopamine.
Clinical Trials:
The approval of Aplenzin was based on its bioequivalence to another form of bupropion, Wellbutrin XL (bupropion HCl, from GlaxoSmithKline). In a 10-day study comparing the use of Aplenzin 348mg once daily to Wellbutrin XL 300mg once daily, the peak levels and the extent of absorption for the parent drug and its metabolites were shown to be equivalent.
The effectiveness of bupropion in the treatment of depression was established using a short-acting formulation of bupropion HCl in two 4-week placebo-controlled trials in adult inpatients and a 6-week study in adult outpatients. These studies showed the effectiveness of bupropion HCl on the Hamilton Depression Rating Scale total score, the depressed mood item from that scale, and the Clinical Global Impressions severity score. In another trial, a 44-week study demonstrated the long-term efficacy of bupropion in responders.
Legal Classification:
Rx
Adults:
Swallow whole. Take in the AM. Initially 174mg once daily; may increase to target maintenance 348mg once daily on day 4; may then increase to max 522mg once daily if inadequate response after 4 weeks. Severe hepatic cirrhosis: max 174mg/48 hours. Renal or mild-moderate hepatic dysfunction: reduce dose and/or frequency. Switching from other forms: may use equivalent dose on once-daily basis. Reevaluate periodically.
Children:
Not recommended.
Contraindication(s):
Seizure disorder. Bulimia. Anorexia nervosa. Within 14 days of MAOIs. Abrupt withdrawal of sedatives or alcohol. Concomitant other forms of bupropion (eg, Zyban, Wellbutrin).
Warnings/Precautions:
Seizure risk or history. Discontinue if seizure occurs; do not restart. Bipolar disorder. Psychosis. Unstable heart disease. CHF. Recent MI. Hepatic or renal dysfunction. Suicidal tendencies (monitor). Maintain at lowest effective dose. Write Rx for smallest practical amount. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interaction(s):
See Contraindications. Avoid alcohol. May be potentiated by CYP2B6 substrates or inhibitors, efavirenz, fluvoxamine, nelfinavir, paroxetine, ritonavir, sertraline. Caution with drugs (eg, antipsychotics) or factors (eg, opiate addiction, excessive use of alcohol or sedatives, diabetes) that lower seizure threshold. Caution with levodopa, amantadine, and with drugs metabolized by CYP2B6 or CYP2D6 including tricyclic antidepressants, SSRIs, antipsychotics, β-blockers, Class 1C antiarrhythmics; consider dose reduction. Antagonized by carbamazepine, phenobarbital, phenytoin. Monitor for hypertension with nicotine patches.
Adverse Reaction(s):
CNS stimulation, dry mouth, GI upset, dizziness, pharyngitis, palpitation, abdominal pain, sweating, tinnitus, anorexia, urinary frequency, rash (may be serious, eg, Stevens-Johnson syndrome), myalgia, neuropsychiatric effects.
How Supplied:
Tabs—30