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DEPROMEL TABLETS(Fluvoxamine Maleate)马来酸氟伏沙明
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 50毫克/片 100片/盒 
包装规格 50毫克/片 100片/盒 
计价单位: 盒 
生产厂家中文参考译名:
明治制果制药社
生产厂家英文名:
Meiji Seika Pharma Co
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/1179039F1028_1_36/
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
DEPROMEL TABLETS(デプロメール錠)50mgmg/TABLETS 100TABLETS/box
原产地英文药品名:
Fluvoxamine Maleate
中文参考商品译名:
DEPROMEL(デプロメール錠)50毫克/片 100片/盒
中文参考药品译名:
马来酸氟伏沙明
曾用名:
简介:

 

部份中文马来酸氟伏沙明处方资料(仅有供参考)
中文别名:(E)-5-甲氧基-1-(4-三氟甲苯基)-O-(2-胺乙肟基)-1-戊酮马来酸盐
英文别名:1-Pentanone, 5-methoxy-1-(4-(trifluoromethyl)phenyl)-, O-(2-aminoethyl)oxime, (E)-, (Z)-2-butenedioate (1:1);
[1] 
分子式:C15H21F3N2O2·C4H4O
分子量:434.409
适应症及用法用量
适应症
抑郁症及相关症状的治疗。强迫症症状治疗。
用法用量
抑郁症
建议起始剂量为每日50mg或100mg,晚上一次服用。逐渐增量直至有效。常用有效剂量为每天100mg,且可根据个人反应调节。个别病例可增至每日300mg。若每日剂量超过150mg,可分次服用。
世界卫生组织要求,患者症状缓解后,继续服用抗抑郁剂至少6个月。本药用于预防抑郁症复发的推荐剂量为每日100mg。
强迫症
推荐的起始剂量为每日50mg,服用3-4天,通常有效剂量在每日100-300mg之间。应逐渐增量直至达到有效剂量。成人每日最大剂量为300mg,8岁以上儿童和青少年的每日最大剂量为200mg。单剂量口服可增至每日150mg,睡前服。若每日剂量超过150mg,可分2-3次服。如已获得良好的治疗效果,可继续应用此根据个人反应调整的剂量。如果服药10周内症状没有改善应继续使用本品。尽管尚无系统资料提示应用氟伏沙明持续治疗的最长时间,由于强迫症是一慢性疾病,治疗时间可大于10周。根据病人情况仔细调整剂量,使病人接受尽可能低的有效剂量。并应定期评估是否继续治疗。也可考虑同时采用行为疗法。
不良反应
恶心,有时伴呕吐,服药2周后通常会消失。
在对照的临床观察中出现的发生率大于1%或大于安慰剂组的其它不良反应报告有 :
中枢神经系统 :嗜睡、眩晕、头痛、失眠、紧张、激动、焦虑、震颤 ;
消化系统 :便秘、厌食、消化不良、腹泻、腹部不适、口干 ;
皮肤 :多汗 ;
其它 :无力、心悸、心动过速。轻微心率减慢(2-6次/分)。
与其它五羟色胺再摄取抑制剂类似,极个别报道有低钠血症,停用本药,此情况逆转。一些患者可能由于抗利尿激素分泌异常综合征引起,大部分病例为老年患者。
出血性疾病 :见“注意事项”。
体重增加或减少偶有报道。
如突然停用本药,下列症状偶有发生 :头痛、恶心、头晕和焦虑。
上述症状有些可能因患者本身的抑郁症所致,而不一定与药物相关。
禁忌症
禁用于对马来酸氟伏沙明或其他辅料过敏的患者。
孕妇及哺乳期妇女用药
动物繁殖实验未发现高剂量的本药对繁殖能力的损害及致畸作用。但通常孕期应慎服任何药物。本药可少量排入乳汁,故服药期间应停止哺乳。
儿童用药
因临床数据不足,本品不推荐给儿童使用。
老年患者用药
老年人常规用量与年轻患者相比无显著临床差异。然而,对老年患者调整剂量时,应缓慢增量.
药物相互作用
本品禁与单胺氧化酶抑制剂合用,如果病人由服用单胺氧化酶抑制剂改服本品,治疗初期应注意 :如为不可逆转的单胺氧化酶抑制剂,至少应停药2周 ;如为可逆转的单胺氧化酶抑制剂(如吗氯贝胺),可于停药后1天改服本品。
若停用本品治疗,在改用单胺氧化酶抑制剂之前至少应停药1周。
本品可使经肝脏代谢的药物分解速度减慢。当与华法令、苯妥英、茶碱和卡马西平等合用时,即会产生明显的临床效应。如合用,请调节这些药物的剂量。
本药可增加经氧化代谢的苯丙二氮的血浆浓度。有报告表明,本药可增加三环类抗抑郁药原有的稳态血浆浓度。建议本品不与三环类抗抑郁药同时应用。
本品可提高心得安的血浆水平,同服时建议减少心得安的剂量。
本品与华法令合用两周,华法令的血浆浓度明显增加且凝血时间延长。患者在口服抗凝剂和氟伏沙明时,应监测凝血时间,并相应调整氟伏沙明的剂量。
治疗严重的,已抗药的抑郁患者,本品可与锂剂合用。但锂和色氨酸可能加重氟伏沙明的5—羟色胺能作用。
未观察到本品与地高辛和阿替洛尔的协同反应。
与其它精神科用药一样,在本药用药期间应避免摄入酒精。
药物过量
症状 最常见的是胃肠症状 (恶心、呕吐、腹泻)、精神不振、眩晕。其它如心脏症状(心动过速、心动过缓、低血压)、肝功异常、惊厥及昏迷等也有报道。迄今为止,报告过量服用本药已超过300例。最高剂量为10,000mg,该患者经对症治疗完全康复。偶有患者因有意服用过量本药,并合用其它药物而致较严重的合并症。
治疗 尚无本品的特异性拮抗剂。如服用过量,应尽快排空胃内容物并对症治疗。建议反复使用活性碳。利尿和透析未见良好效果。
用药须知
宜用水吞服,不应咀嚼。
贮藏/有效期
本品应保存在干燥、避光处。
DEPROMEL TABLETS 50(デプロメール錠50)
Brand name : DEPROMEL TABLETS 50
 Active ingredient: Fluvoxamine maleate
 Dosage form: yellow tablet (φ: 6.1 mm, thickness: 3.0 mm)
 Print on wrapping: デプロメール50mg, MS-50, DEPROMEL50mg
Effects of this medicine
This medicine relieves depressive mood and feeling disappointed by inhibiting serotonin reuptake in the brain.
It is usually used in the treatment of depression, depressive state, obsessive-compulsive disorder and social anxiety disorder.
Before using this medicine, be sure to tell your doctor and pharmacist
If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you are pregnant or breastfeeding.
If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
General dosage regimen: For adults, take 50 mg of the active ingredient daily as the initial dose, then the dosage may be increased up to 150 mg to take them in two divided doses. The dosage may be adjusted according to the disease, age or symptoms. This preparation contains 75 mg of the active ingredient in a tablet. Strictly follow the instructions of your doctor/pharmacist.
Take the medicine with adequate amount of water without chewing. If you chew the tablet, it tastes bitter and you may have numbness of tongue.
Take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose.
If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.
Do not stop taking the medicine without the instructions of your doctor. Sudden withdrawal of the medicine may cause headache, nausea, dizziness, anxiety, insomnia and mental concentration decreased.
Precautions while taking this medicine
The medicine may cause sleepiness and disturbed consciousness such as depressed level of consciousness and loss of consciousness. Avoid driving a car or operating machinery.
Alcohol may intensify the effects of the medicine. Avoid drinking alcohol while taking the medicine as much as possible.
Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: nausea, sleepiness, dry mouth, constipation, malaise, dizziness, etc.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
convulsion, mild disturbed consciousness, impaired mind  [convulsion, delirium, confusion, hallucination, delusion]
faint consciousness, loss of consciousness  [disturbed consciousness]
sudden facial pallor, cold sweat, breathing difficulty  [shock, anaphylactoid symptoms]
anxiety, excitation, sweating [serotonin syndrome]
sudden fever, muscle stiffness, tremor of hands and feet  [malignant syndrome]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
Discard the remainder. Do not store them.
http://www.info.pmda.go.jp/go/pack/1179039F1028_1_36/ 

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