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英文药名：LOTRIGA Soft Capsules（3 fatty acid ethyl esters）
中文药名：欧米茄（3脂肪酸乙酯颗粒）
生产厂家：武田制药
药品介绍
2012年9月29日，武田（Takeda）与生物制药公司Pronova联合宣布，Lotriga颗粒胶囊（2g，通用名：ω-3-酸乙酯）获日本卫生劳动福利部（MHLW）批准，用于高血脂症的治疗。
治疗类别名称
EPA·DHA配方
适应症：
和低脂饮食一起用于降低高甘油三脂血症。Lovaza对心血管病的发病率和死亡率的影响尚无结论。还没有证明，使用Lovaza可预防心脏病发作或中风。
用法：
使用Lovaza之前及之中应采取降脂饮食。本药应和低脂、低胆固醇饮食一起用于降低高甘油三脂血症。
贮存：
25°C，短期内允许15° to 30°C。不能冰冻。
禁忌症：
对其成分过敏者。
副作用：
胃部不适，打嗝，感冒症状，背痛，皮疹，口内异味。如果这些反应持续或加重，应告知医师；如果发生严重的副作用：易出血，黑便，呕出咖啡色物，应尽快告知医师。严重的过敏反应有：皮疹，痒，肿，头晕眼花，呼吸困难。
注意事项：
应把过敏史，对鱼或大豆等过敏告诉医师。孕妇只有明确适应症时使用。目前还不清楚该药是否进入乳汁中。
下列情况应告知医师：每日饮酒2杯以上；糖尿病；甲状腺疾病；肝病；鱼过敏；怀孕或准备怀孕；哺乳。告诉医师用药情况，包括维生素和草药。特别是阿司匹林，华法林等抗凝药。以避免危险。
包装规格
2g*56包、2g*280包
生产厂商
武田药品有限公司
完整处方资料：http://www.info.pmda.go.jp/go/pack/2189019M1020_1_03/
Lotriga will be the first prescription medicine in Japan that contains both EPA-E and DHA-E.
The results of the Phase III clinical trial conducted in Japan evaluated the efficacy and safety of Lotriga for Japanese patients with hypertriglyceridemia [baseline triglyceride level, 150 to 750 mg/dL], in comparison with an active comparator EPA (eicosapentaenoic acid, 0.6g thrice daily, recommended daily dose) product.
The trial demonstrated that 2g (once daily) of Lotriga was equally, and 4g (2g twice daily) of Lotriga was statistically superior to the EPA, in lowering the percent change from baseline in triglycerides. Lotriga was safe and well tolerated, with a safety profile comparable to the EPA.
According to the Takeda website, the recommended dosage of Lotriga in adults is 2g of Omega-3-acid ethyl esters is orally administered immediately after meals once a day. In the case of high triglyceride level, the dose can be increased to 2g twice a day.
Brand name : Lotriga 2g
Active ingredient: Omega-3-Acid ethyl esters
Dosage form: colorless to light-yellow clear spherical capsule, major axis 4 mm
Print on wrapping: (Face)ロトリガ粒状カプセル2g, 2g, 2001, (Back)LOTRIGA 2g
Effects of this medicine
This medicine inhibits lipid (triglyceride) secretion from the liver and promotes disappearance of triglyceride from the blood, to lower the blood level of triglycerides.
Usually, used for treatment of hyperlipidemia.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have bleeding (hemophilia, capillary fragility, urinary tract bleeding, gastrointestinal ulceration, hemoptysis, vitreous hemorrhage, ets.).
If you are scheduled for surgery.
•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>>
•In general, for adults, take 1 pack at a time per day, just after a meal. The dosage should be increased according to triglyceride level, but 1 pack at a time, twice a day, is the upper limit of dosage. Strictly follow the instructions.
•You should take this medicine just after a meal because its absorption is decreased by taking on an empty stomach.
•You should take this medicine without chewing.
•If you miss a dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•Strictly adhere to dietary instructions given and to kinesitherapy prescribed.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include diarrhea, rash, and itching. If any of these symptoms occur, consult with your doctor or pharmacist.
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.
No pertinent entries.
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.
Internal
Published: 1/2013
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