药品详情：
【米氮平片mirtazapine 简述】
米氮平片mirtazapine又名米氮平片/米氮平口腔崩解片/瑞美隆(REMERON)，可改善抑郁症状以及患者睡眠结构，提高睡眠质量；较少引起性功能障碍，提高患者依从性；使用方便、较少药物相互作用、耐受性好。
【米氮平片mirtazapine 适应症】
本品适用于抑郁症治疗。
【米氮平片mirtazapine 规格】
本品为片剂，每片含有效成份15mg/30mg/45mg三种规格，每瓶30片装。
【米氮平片mirtazapine 服用方法】
每日一次，有效剂量通常为每日15～45mg。治疗起始剂量应为15mg或30mg。
【米氮平片mirtazapine 注意事项】
警告：
临床症状的恶化和自杀风险：
患有抑郁症的成年和儿童患者，无论是否服用抗抑郁药物，他们的抑郁症都有可能恶化，并有可能出现自杀意念和自杀行为以及行为异常变化，这种风险一直会持续到病情发生明显缓解时为止。已知抑郁和某些精神障碍与自杀风险有关，并且这些精神障碍本身为自杀的最强的预兆。然而，长期以来一直有这些的担忧：在某些患者治疗早期，抗抑郁药物可能对诱导抑郁症状恶化、以及产生自杀意念、行为中起着作用。抗抑郁药物(选择性5-羟色胺再摄取抑制剂和其他药物)短期安慰剂对照研究汇总分析显示，在患有抑郁症(MMD)和其他精神障碍的儿童、青少年和青年（18～24岁）中，与安慰剂相比，抗抑郁药物增加了产生自杀想法和实施自杀行为（自杀意念、行为）的风险。在短期的临床试验没有显示，在年龄大于24岁的成年人中，与安慰剂相比，使用抗抑郁药物会增加自杀意念、行为的风险；在年龄65岁及以上的成年人中，使用抗抑郁药物后，自杀意念、行为的风险有所降低。
在患有抑郁症、强迫症(OCD)或其他精神障碍的儿童和青少年中进行的安慰剂对照试验（共计24项短期临床试验，9种抗抑郁药物，包括4400例患者）和在患有抑郁症或其他精神障碍的成年患者中进行的安慰剂对照试验（共计295项短期临床试验，中位持续时间为2个月，11种抗抑郁药物，约77000例患者）中，各种药物引起的自杀意念、行为的风险有很大的差异，但大部分的药物研究显示在较年轻患者有自杀风险增加的趋势。在各个不同的适应症中，自杀意念、行为的绝对风险不同，在抑郁症中的绝对风险最高。虽然在各个适应症中的绝对风险有所不同（药物与安慰剂相比），但是，在不同适应症的年龄层中风险相对稳定。表3提供了风险差异（每1000名患者中药物和安慰剂治疗产生的自杀意念、行为风险差异的例数）。
【米氮平片mirtazapine 不良反应】
全身：常见： 不适、腹痛、急腹症；偶见： 寒战、发热、面部水肿、溃疡、光敏反应、颈强直、颈部疼痛、腹胀；罕见： 蜂窝组织炎、胸痛（胸骨下）。
心血管系统： 常见：高血压、血管舒张；偶见：心绞痛、心肌梗死、心动过缓、室性期外收缩、晕厥、偏头痛、低血压；罕见：房性心律失常、二联律、血管性头痛、肺栓塞、脑缺血、心脏扩大、静脉炎、左心功能衰竭。
消化系统： 常见：呕吐、厌食；偶见：嗳气、舌炎、胆囊炎、恶心和呕吐、牙龈出血、口腔炎、结肠炎、肝功能检查异常；罕见：舌变色、溃疡性口腔炎、唾液腺肥大、流涎增加、肠梗阻、胰腺炎、口疮性口腔炎、肝硬化、胃炎、胃肠炎、口腔念珠菌病、舌肿胀。
内分泌系统：罕见： 甲状腺肿、甲状腺功能减退。
血液和淋巴系统：罕见：淋巴结病、白细胞减少症、瘀点、贫血、血小板减少症、淋巴细胞增多症、全血细胞减少症。
代谢和营养异常：常见：口渴；偶见： 脱水、体重减轻；罕见：痛风、天门冬氨酸氨基转移酶(AST)升高、伤口愈合异常、酸性磷酸酶升高、丙氨酸氨基转移酶(ALT)升高、糖尿病、低钠血症。
肌肉骨骼系统：常见：肌无力、关节痛；偶见：关节炎、腱鞘炎；罕见：病理性骨折、骨质疏松性骨折、骨痛、肌炎、肌腱断裂、关节病、滑囊炎。
神经系统： 常见：感觉减退、情感淡漠、抑郁、运动功能减退、眩晕、颤搐、激越、焦虑、健忘、运动机能亢进、感觉异常；偶见：共济失调、谵妄、错觉、人格解体、运动障碍、锥体外系综合征、性欲增强、协调能力异常、构音障碍、幻觉、躁狂反应、神经官能症、肌张力障碍、敌对行为、反射增强、情绪不稳定、欣快症、偏执狂样反应；罕见： 失语症、眼球震颤、静坐不能（精神运动性坐立不安）、木僵、痴呆、复视、药物依赖、麻痹、癫痫大发作、肌张力减退、肌阵挛、精神病性抑郁症、停药综合征、5－羟色胺综合征。
呼吸系统： 常见：咳嗽增多、鼻窦炎；偶见：鼻衄、支气管炎、哮喘、肺炎；罕见： 窒息、喉炎、气胸、呃逆。
皮肤：常见：瘙痒、皮疹；偶见：痤疮、剥脱性皮炎、皮肤干、单纯疱疹、脱发；罕见： 荨麻疹、带状疱疹、皮肤增生、脂溢性皮炎、皮肤溃疡。
特殊感觉： 偶见：眼痛、调节异常、结膜炎、耳聋、角膜结膜炎、流泪障碍、青光眼、 听觉过敏、耳痛；罕见：睑炎、部分暂时性耳聋、中耳炎、味觉丧失、嗅觉倒错。
泌尿生殖系统：常见：泌尿道感染；偶见：肾结石、膀胱炎、排尿困难、尿失禁、尿潴留、阴道炎、血尿、乳房疼痛、闭经、痛经、白带、阳痿；罕见：多尿、尿道炎、子宫不规则出血、月经过多、异常射精、乳房充血、乳房增大、尿急。
mirtazapine
Mirtazapine, sold under the brand name Remeron among others, is an antidepressant primarily used to treat depression.[7][8] Its full effect may take more than four weeks to occur, with some benefit possibly as early as one to two weeks.[9][8] Often it is used in depression complicated by anxiety or trouble sleeping.[7][10] It is taken by mouth.[8]
Common side effects include increased weight, sleepiness, and dizziness.[8] Serious side effects may include mania, low white blood count, and increased suicide among children.[8]Withdrawal symptoms may occur with stopping.[11] It is not recommended together with an MAO inhibitor.[8] It is unclear if use during pregnancy is safe.[8] How it works is not clear but may involve blocking certain adrenergic and serotonin receptors.[7][8] Chemically, it is a tetracyclic antidepressant (TeCA).[8] It also has strong antihistamine effects.[7][8]
Mirtazapine came into medical use in the United States in 1996.[8] The patent expired in 2004, and generic versions are available.[12][8] In the United States the wholesale cost as of 2018 is about US$3 per month.[13] In the United Kingdom a month supply costs less than 20 pounds per month.[11] In the United States about 5.5 million prescriptions were written for mirtazapine in 2016.[14]
Medical uses
Mirtazapine is primarily used for major depressive disorder and other mood disorders.[15][16]Onset of action appears faster than some SSRIs and similar to tricyclic antidepressants.[17][9]
There is also some tentative evidence following conditions and is sometimes prescribed off-label for their treatment:
§ Generalized anxiety disorder[7][18]
§ Social anxiety disorder[19]
§ Obsessive–compulsive disorder[19]
§ Panic disorder[19]
§ Post-traumatic stress disorder[19]
§ Low appetite/underweight[20][21][22]
§ Insomnia[23][24]
§ Nausea and vomiting[10][25][26]
§ Itching[27][28]
§ Headaches and migraine[25][29][30]
Effectiveness and tolerability
In 2010 NICE published a guideline for treating depression that included a review of antidepressants. It recommended generic SSRIs as first line choices, as they are "equally effective as other antidepressants and have a favourable risk–benefit ratio."[31] With respect to mirtazapine, it found: "There is no difference between mirtazapine and other antidepressants on any efficacy measure, although in terms of achieving remission mirtazapine appears to have a statistical though not clinical advantage. In addition, mirtazapine has a statistical advantage over SSRIs in terms of reducing symptoms of depression, but the difference is not clinically important. However, there is strong evidence that patients taking mirtazapine are less likely to leave treatment early because of side effects, although this is not the case for patients reporting side effects or leaving treatment early for any reason."[32]
A 2011 Cochrane review that compared mirtazapine to other antidepressants, found that while it appears to have a faster onset in people for whom it works (measured at 2 weeks), it is about the same as other antidepressants at 6 weeks.[9]
A 2012 review focused on antidepressants and sleep found that in many people with sleep disorders caused by depression, mirtazapine reduces the time it takes to fall asleep and increases the quality of sleep, but that in some people it can disturb sleep, especially at higher doses, causing restless leg syndrome in 8 to 28% of people and in rare cases causes REM sleep behavior disorder.[33]
A 2018 analysis of 21 antidepressants found them to be fairly similar overall.[34] It found tentative evidence for mirtazapine being in the more effective group and middle in tolerability.[34]
After one week of usage, mirtazapine was found to have an earlier onset of action compared to SSRIs.[17][35]
Overdose
Mirtazapine is considered to be relatively safe in the event of an overdose,[35] although it is considered slightly more toxic in overdose than most of the SSRIs (except citalopram).[52] Unlike the tricyclic antidepressants, mirtazapine showed no significant cardiovascular adverse effects at 7 to 22 times the maximum recommended dose.[42] Case reports of overdose with as much as 30 to 50 times the standard dose described the drug as relatively nontoxic, compared to tricyclic antidepressants.[53][54]
Twelve reported fatalities have been attributed to mirtazapine overdose.[55][56] The fatal toxicity index (deaths per million prescriptions) for mirtazapine is 3.1 (95% CI: 0.1 to 17.2). This is similar to that observed with SSRIs.[57]
注：药品如有新包装,以新包装为准。以上资讯来源于网络或由高等医药院校的学生志愿者翻译（如有错漏，请帮忙指正），仅供医护人员内部讨论，不作任何用药依据，具体用药指引，请咨询主治医师。
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