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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗癌药物->治疗黑色素瘤药物
处方药:处方药
包装规格: 20毫克/1 30粒/瓶
计价单位:
  点击放大  
生产厂家英文名:
Allergan USA, Inc.
该药品相关信息网址1:
https://www.fetzima.com/
原产地英文商品名:
Fetzima ER CAPSULE 20mg/1 30CAPSULE/BOTTLE
原产地英文药品名:
LEVOMILNACIPRAN HYDROCHLORIDE
中文参考商品译名:
盐酸左米那普仑缓释胶囊 20毫克/1 30粒/瓶
中文参考药品译名:
盐酸左米那普仑
原产地国家批准上市年份:
2013/07/25
英文适应病症1:
for the short-term symptomatic relief of major depressive disorder (MDD).
临床试验期:
完成
中文适应病症参考翻译1:
重度抑郁症(MDD)的短期症状缓解
药品信息:

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 详细处方信息以本药内容附件PDF文件(201912721122228.pdf)的“原文Priscribing Information”为准
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 部分中文盐酸左米那普仑处方资料(仅供参考)


【英文名称】
Fetzima


【中文名称】
盐酸左米那普仑

【适应症和临床用途】

位: FETZIMA(levomilnacipran缓释胶囊)适用于重度抑郁症(MDD)的短期症状缓解。

FETZIMA的疗效建立在长达8周的随机,双盲,安慰剂对照试验中(见临床试验)。长期维持效果尚未确定。

老年病学(> 65岁):

应该谨慎对待老年人。 FETZIMA的临床研究未包括足够数量的65岁以上的受试者,以确定他们对年轻受试者的反应是否不同。老年患者的剂量选择应谨慎(参见警告和注意事项,特殊人群)。

儿科(<18岁):FETZIMA不适用于18岁以下的患者。儿科人群的安全性和有效性尚未确定(见警告和注意事项,与行为和情绪变化的潜在关联) ,包括自我伤害)。

【禁忌】

超敏反应:对左旋咪唑,米那普仑或容器配方或组分中的任何成分过敏的患者。有关完整列表,请参阅产品专论的剂量形式,组成和包装部分。

5-羟色胺综合症和单胺氧化酶抑制剂(MAOIs):FETZIMA(左旋米那普仑延长释放胶囊)不应与MAOI联合使用,包括利奈唑胺,抗生素,亚甲蓝,某些手术中使用的染料,或两周内使用的染料用MAOI终止治疗。在停止FETZIMA治疗后2周,不应开始用MAOI治疗。 MAOI与选择性5-羟色胺再摄取抑制剂(SSRI)或5-羟色胺去甲肾上腺素再摄取抑制剂(SNRI)治疗或与其他5-羟色胺能药物共同给药可导致严重的,有时是致命的药物相互作用。症状包括震颤,肌阵挛,发汗,恶心,呕吐,潮红,头晕,体温过多,具有类似神经安定性恶性综合征的特征,癫痫发作,僵硬,自主神经不稳定以及可能的生命体征快速波动,以及精神状态的变化,包括极度激动进展至谵妄和昏迷。

【警告和注意事项】

与行为和情绪变化的潜在关联,包括自我伤害。

儿科:安慰剂对照的临床试验数据

最近对选择性5-羟色胺再摄取抑制剂(SSRIs)和其他新型抗抑郁药的安慰剂对照临床试验安全数据库的分析表明,在18岁以下的患者中使用这些药物可能与行为和情绪变化有关,包括 与安慰剂相比,自杀意念和行为的风险增加。

临床试验数据库中的小分母以及安慰剂比率的变异性排除了这些药物相对安全性的可靠结论。

【INDICATIONS AND CLINICAL USE】

Adults:

FETZIMA (levomilnacipran extended-release capsules) is indicated for the short-term symptomatic relief of major depressive disorder (MDD).

The efficacy of FETZIMA was established in randomized, double-blind, placebo-controlled trials of up to 8 weeks (see CLINICAL TRIALS). Long-term maintenance of effect has not been established.

Geriatrics (> 65 years of age):

Caution should be exercised in treating the elderly. Clinical studies of FETZIMA did not include sufficient numbers of subjects over 65 years of age to determine whether they respond differently from younger subjects. Dose selection for elderly patients should be cautious (See WARNINGS AND PRECAUTIONS, Special Populations).

Pediatrics (< 18 years of age): FETZIMA is not indicated for use in patients under the age of 18. Safety and efficacy in the pediatric population have not been established (see WARNINGS AND PRECAUTIONS, Potential Association with Behavioural and Emotional Changes, Including Self-Harm).
 

【CONTRAINDICATIONS】

Hypersensitivity: Patients who are hypersensitive to levomilnacipran, milnacipran or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.

Serotonin Syndrome and Monoamine Oxidase Inhibitors (MAOIs): FETZIMA (levomilnacipran extended-release capsules) should not be used in combination with MAOIs, including linezolid, an antibiotic, methylene blue, a dye used in certain surgeries, or within two weeks of terminating treatment with MAOIs. Treatment with MAOIs should not be started until 2 weeks after discontinuation of FETZIMA therapy. Co-administration of MAOIs with selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) treatment or with other serotonergic drugs can lead to serious, sometimes fatal, drug interactions. Symptoms include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma.
 

【WARNINGS AND PRECAUTIONS】

POTENTIAL ASSOCIATION WITH BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM.

Pediatrics: Placebo-Controlled Clinical Trial Data

 Recent analyses of placebo-controlled clinical trial safety databases from selective serotonin reuptake inhibitors (SSRIs) and other newer antidepressants suggest that use of these drugs in patients under the age of 18 may be associated with behavioural and emotional changes, including an increased risk of suicidal ideation and behaviour over that of placebo.

 The small denominators in the clinical trials database, as well as the variability in placebo rates, preclude reliable conclusions on the relative safety profiles among these drugs.
 

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 详细处方信息以本药内容附件PDF文件(201912721122228.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-1-29
附件:
201912721122228.pdf    

 
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