部分中文磷酸奥司他韦处方资料（仅供参考）
英文名：Oseltamivir Phosphate
商品名：Tamiflu Capsule
中文名：磷酸奥司他韦胶囊
生产商：中外制药
药品简介
Tamiflu（Oseltamivir Phosphate，磷酸奥司他韦）是一种作用于神经氨酸酶的特异性抑制剂，其抑制神经氨酸酶的作用，可以抑制成熟的流感病毒脱离宿主细胞，从而抑制流感病毒在人体内的传播以起到治疗流行性感冒的作用。
タミフルカプセル75
药用类别名称
抗流感病毒剂
批准日期：2001年2月
商標名
TAMIFLU
一般名
オセルタミビルリン酸塩
（Oseltamivir Phosphate）（JAN）
化学名
(-)-Ethyl(3R,4R,5S)-4-acetamido-5-amino-3-(1-ethylpropoxy)cyclohex-1-ene-1-carboxylate monophosphate
構造式
分子式
C16H28N2O4・H3PO4
分子量
410.40
性　状
它是一种白色到细淡黄色白色粉末或肿块的粉末。易溶于水和甲醇, 微溶于乙醇(95)、N, 微溶于n-二甲基乙酰胺, 微溶于乙腈。
熔点
192-195°c(分解)
分布系数
分布在酸性至中性区的水相, 并分布在碱性区域的油相。
批准条件
随时向监管机构报告国内和国际发现以及有关流感病毒对这种药物的耐药性的信息。
药用药理学
1. 体外抗病毒作用
磷酸奥司他米韦是一种亲药, 经代谢转化为活性体, 显示出抗病毒活性。
A型和b型流感病毒(实验室菌株ic50:0.6~155nM, 临床分离株ic 50:<μm) 的奥司他米林磷酸盐低浓度复制体在体外受到抑制。
2. 体内抗病毒作用
在小鼠和雪貂a型和b型流感病毒感染模型中, 通过口服磷酸奥司他韦(0.1~100mg/kg/day day), 生存数量的增加取决于剂量、与感染相关的症状, 观察到病毒滴度减少等治疗效果。此外, 口服给药从24小时前的病毒感染模型(10, 100公斤, 每天两次), 对病毒感染的抑制作用, 如提高存活率观察。
3. 作用机制
磷酸奥司他莫维的活性体通过抑制新形成的病毒感染细胞的释放, 选择性地抑制人A型和b型流感病毒(IC 50:0.1至3nM) 的神经氨酸酶, 抑制病毒的扩散。
4. 阻力
在国内外临床试验中, 这种药物的耐药病毒发病率在成人和青少年(13岁或以上) 中为0.67(152261例), 在幼儿(1至12岁)、新生儿、婴儿(1岁以下)中, 发生率为4.24(721698 例), 18.31(13/71例)。所有耐药病毒均来源于A病毒, 在B型病毒中没有观察到任何外观。在已获得抵抗力的病毒中, 观察到小鼠和雪貂的传染性下降, 受感染部位的增殖, 传播力被认为较低。在具有抗性的病毒中, 观察到神经氨酸酶的氨基酸突变。
适应症
A型或B型流感病毒感染及其预防
用法与用量
1. 治疗
通常情况下, 成人和体重37.5公斤或更多的儿童每天两次75毫克作为奥司他韦, 口服5天。
2. 用于预防时
(1) 成人
通常情况下, 每天一次75毫克一次, 口服7至10天。
(2) 体重37.5公斤或以上的儿童
通常情况下, 每天一次75毫克一次, 口服10天。
＜参考＞
包装
胶囊
75:10 胶囊 (PTP10 胶囊 x1)
75:100 胶囊 (PTP10 胶囊 x10)
制造和销售
中外制药株式会社
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明附件：
https://www.info.pmda.go.jp/go/pack/6250021M1027_1_39/
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TAMIFLU Capsule 75（Oseltamivir phosphate）
TAMIFLU Capsule 75[for prevention]（タミフルカプセル75）
Brand name : TAMIFLU Capsule 75[for prevention]
　Active ingredient: Oseltamivir phosphate
　Dosage form: pale yellow/light gray capsule (major axis: approx. 17.8mm)
　Print on wrapping: Rocheタミフル75mg
Effects of this medicine
This medicine blocks influenza virus from leaving the cell infected with it in order to suppress viral reproduction.
It is usually used to treat influenza type A and type B infection.
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 are a patient with renal function disorder.
If 48 or more hours have been passed since you had influenza symptoms.
•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 and children weighing 37.5kg or more, take 1 capsule (75mg of oseltamivir) at a time, twice a day, for 5 consecutive days. Strictly follow the instructions.
•Patients aged 10 or over but under 20 cannot take this medicine unless they are high risk patients. Whether they are high risk patients will be judged from their complicating disease or health history.
•If you miss a dose, take the missed dose as soon as possible. However, 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. Even influenza infection will cause symptoms such as fever, runny nose, sore throat, muscle pain, headache, cough, loss of appetite, lassitude, chills and diarrhea. So, in some cases, it is difficult to tell the difference between influenza symptoms and side effects of this medicine.
Precautions while taking this medicine
•In patients aged 10 or over but under 20 who were receiving this medicine, there have been reports of abnormal behavior in rare cases resulting in fall accidents. The contribution of medicine to those events is unknown. If a patient is a child aged under 20, pay attention to these precautions as follows;
-After starting this medication, a patient may behave abnormally.
-In the case that your child aged under 20 is treated at home, please be careful not to leave him/her alone for at least 2 days.
-Please note that influenza-associated encephalopathy is reported to have the same kinds of symptoms as mentioned above.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include abdominal pain, diarrhea, nausea, vomiting, hypothermia, rash, shock, anaphylaxis, fulminant hepatitis, hepatic function disorder, jaundice, mucocutaneous ocular syndrome, toxic epidermal necrolysis, acute renal failure, psycho-neurologic symptoms (consciousness disorder, abnormal behavior, delirium, hallucination, delusion, convulsion, etc.), hemorrhagic colitis, etc. 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.
•cold sweat, dizziness, hoarseness, swelling around the eye and lips, urticaria, impaired judgment/mind, pale face, palpitation, shortness of breath, breathlessness, lassitude, glow, faint consciousness, lightheadedness [shock, anaphylaxis]
•fever, chills, cough/phlegm, shortness of breath [pneumonia]
•fever, loss of consciousness, decreased consciousness, impaired judgment/mind, headache, flapping tremor in hands, yellowness in the skin and/or the white of the eye, yellow urine, lassitude, itch, loss of appetite, nausea, vomiting [fulminant hepatitis, hepatic function disorder, jaundice]
•lassitude, fever, inflamed eyelid and eye, conjunctival sore, lip/intraoral sore, loss of appetite, red rash, red rash with dropsical swelling in the center, red spots and breakable blisters (bullas) all over the body, pain in the genitalia, joint pain [mucocutaneous ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (TEN)]
•decreased urinary volume, urinary retention, decreased consciousness, easy fatigability, headache, lassitude, breathlessness, swollen body/eyes [acute renal failure]
•fever, sore throat [leukopenia]
•nose/gum bleeding, continuous bleeding, blue spot, subcutaneous bleeding [thrombocytopenia]
•decreased consciousness, impaired mind/judgment, unusual bizarre behavior, abnormal behavior, seeing or hearing something that is not really there, groundless belief, strong belief in something untrue, convulsion [psycho-neurologic symptoms (consciousness disorder, abnormal behavior, delirium, hallucination, delusion, convulsion, etc.)]
•diarrhea, severe abdominal pain, bloody stool [hemorrhagic colitis]
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 at room temperature (1-30℃), away from direct sunlight and moisture.
•Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.
Chugai Pharmaceutical Co., Ltd.Internal
Revised: 11/2013
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions(risks)as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.