【警告和注意事项】 strong>
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。
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【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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