英文药名: TAMIFLU(Oseltamivir Phosphate Capsule)

中文药名: 达菲（磷酸奥司他韦胶囊）

生产厂家:中外制药

タミフルカプセル75

治疗类别名称
抗流感病毒剂
批准上市日期：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
白色至用细灰白色粉末或质量的粉末。易溶于水和甲醇，乙醇（95）微溶于N，微溶于N-二甲基乙酰胺，并在乙腈中几乎不溶。
熔点
192〜195℃（分解）
分配系数
在酸性至中性区域分配到水相中，它是分散在油相中在碱性区域。
条件批准
对于国内和国外的研究成果和有关尊重的抗流感病毒的药物目前的信息，在任何时间，上报监管部门。
药效药理
1.体外抗病毒活性
磷酸奥塞米韦是一种前药，被转化为活性形式通过代谢，显示出抗病毒活性之后。
磷酸奥塞米韦的活性形式是A型和B型流感病毒在体外的低浓度的副本是由（实验室菌株的IC 50：<0.35微米：0.6-155nM，临床分离株的IC 50）抑制。
2.在体内抗病毒活性
在小鼠和雪貂的A型和B型流感病毒感染的模型，磷酸奥塞米韦（0.1-100毫克/kg/天）口服给药，增加，这取决于生存的剂量，减少症状与感染有关，观察到的治疗效果，如在病毒滴度的降低。此外，从病毒感染前24小时在鸡感染模型（10,100mg/千克，1天两次），对病毒感染的抑制作用，例如在生存增加观察到的口服给药。
3.作用机理
磷酸奥塞米韦的活性形式选择性地抑制人A型和B型流感病毒的神经氨酸苷酶：通过抑制从所述新形成的病毒感染细胞的释放（IC 500.1〜为3nM），病毒抑制生长。
4. 耐性
在发病的成人和抗病毒的青少年相对于国外和国内的临床试验目前剂（例4/1245）0.32％，为4.1％，在1至12岁儿童（N=464分之19）。所有耐药病毒是由A型流感病毒来源，出现在B型进行了观察。抗病毒韩元，在感染的小鼠和雪貂的减少进行观察，生长在感染部位，传播力被认为是低的。的抗病毒韩元，氨基酸突变的神经氨酸酶已观察。
适应病症
○A型或B型流感病毒感染及其预防
用法与用量
1.在治疗中使用
成人和重量37.5千克以上的孩子，每天二次，每次75毫克，连5天口服给药。
2.在使用预防
(1) 成人
每天一次，每次为75mg，连口服给药7至10天。
（2）重量37.5千克以上的孩子
每天一次，每次为75mg，连口服10天。
＜参考＞

治療	予防	予防
対象	成人及び体重37.5kg以上の小児	成人	体重37.5kg以上の小児
投与法	1回75mg 1日2回	1回75mg 1日1回	1回75mg 1日1回
投与期間	5日間経口投与	7～10日間経口投与	10日間経口投与

包装规格
胶囊
75毫克:10胶囊（胶囊PTP10×1）

75毫克：100粒（PTP10胶囊×10）

制造厂商
中外制药有限公司
完整资料附件：http://www.info.pmda.go.jp/go/pack/6250021M1027_1_32/
TAMIFLU Capsule（Oseltamivir phosphate）
TAMIFLU Capsule 75[for prevention]（タミフルカプセル75［予防用］） 
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: タミフル75mg
TAMIFLU Capsule 75[for treatment]（タミフルカプセル75［治療用］）
Brand name : TAMIFLU Capsule 75[for treatment]
　Active ingredient: Oseltamivir phosphate
　Dosage form: pale yellow/light gray capsule (major axis: approx. 17.8mm)
　Print on wrapping: タミフル75mg
Effects of this medicine
This medicine blocks influenza virus from leaving the infected cell in order to suppress viral reproduction.
It is usually used to prevent 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 in principle unless they are a high risk patient. The decision of "a high risk patient" will be made from their complications 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, general dullness, 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
•There have been reports of abnormal behavior in patients aged 10 or over but under 20, of cases resulting in fall accidents. The relation between this medicine and those events are unknown. Parents or guardians with children/minor patients should pay attention to these precautions as follows;
-After starting this medication, a patient may behave abnormally.
-If the patient is treated at home, please be sure not to leave your child/minors 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, ischemic colitis. 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, hives, impaired judgment/mind, pale face, palpitation, shortness of breath, breathing difficulty, general dullness, 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, general dullness, itch, loss of appetite, nausea, vomiting [fulminant hepatitis, hepatic function disorder, jaundice]
•general dullness, 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, general dullness, breathing difficulty, 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.)]
•fever, nausea, vomiting, feeling sick at the stomach, sudden abdominal pain, severe abdominal pain, diarrhea, bloody stool [hemorrhagic colitis, ischemic 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.