| 简介：
部份中文非达霉素处方资料（仅供参考）
英文名：fidaxomycin
商品名：Dafclir Tablets
中文名：非达霉素片
生产商：安斯泰来制药
药品介绍
近日，由安斯泰来制药开发的传染性肠炎的口服片剂fidaxomycin（商品名 Dafclir ダフクリア錠 ）已获得日本批准上市，用于治疗传染性肠炎，假膜性结肠炎。
ダフクリア錠200mg
药物分类名称
艰难梭菌感染治疗
批准日期：2018年8月
商標名
Dafclir Tablets 200mg
一般名
フィダキソマイシン（Fidaxomicin）
略号
FDX
化学名
（3E,5E,8S,9E,11S,12R,13E,15E,18S）-3-（{[6-Deoxy-4-O-（3,5-dichloro-2-ethyl-4,6-dihydroxybenzoyl）-2-O-methyl-β-D-mannopyranosyl]oxy}methyl）-12-{[6-deoxy-5-C-methyl-4-O-（2-methylpropanoyl）-β-D-lyxo-hexopyranosyl]oxy}-11-ethyl-8-hydroxy-18-[（1R）-1-hydroxyethyl]-9,13,15-trimethyloxacyclooctadeca-3,5,9,13,15-pentaen-2-one
構造式
分子式
C52H74Cl2O18
分子量
1058.04
融点
177～180℃
分配係数
3.7
性状
非达霉素是白色粉末。易溶于四氢呋喃，二甲基亚砜和甲醇，微溶于丙酮，微溶于乙酸乙酯，乙醇（99.5），二氯甲烷和乙腈，溶于异丙醇，不溶于Britton-Robinson缓冲液（pH 8）几乎不溶于Britton-Robinson缓冲液（pH 4,6和7）。
批准条件
制定药品风险管理计划并适当实施。
药用药理学
1.抗菌作用
非达霉素对包括艰难梭菌在内的一些革兰氏阳性菌具有抗菌活性，并且对大多数革兰氏阴性菌没有显示出抗菌活性。
2.作用机制
通过抑制细菌RNA聚合酶，它显示出抗菌活性。
适应症
<真菌种类>
艰难梭菌对该药敏感
<适应症>
传染性肠炎（包括伪膜性结肠炎）
用法与用量
成人；每天一次，每次口服200mg。
包装
片剂
200毫克：20片（10片x 2）
制造销售
安斯泰来制药公司
注：以上中文资料不够完整，使用者以原处方资料为准。
完整处方资料附件：
https://www.info.pmda.go.jp/go/pack/6119001F1025_1_02/?view=frame&style=SGML&lang=ja
Dafclir Tablets 200mg（Fidaxomicin）
Brand name:Dafclir Tablets 200mg
Active ingredient:Fidaxomicin
Dosage form:pale yellow red tablet, major axis: approx. 13.1 mm, minor axis:approx. 7.0 mm, thickness : approx. 5.1 mm
Print on wrapping:(Face) ダフクリア 200 mg, house-mark,(Back) ダフクリア 200 mg, 感染性腸炎治療剤, house-mark
Effects of this medicine
This medicine suppresses RNA polymerase necessary for bacterial growth and shows antibactrial activities.
It is usually used for the treatment of infectious enterocolitis (including pseudomembranous colitis) by Clostridiumdifficile.
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 pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinaleffects.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 tablet (200 mg of the active ingredient) at a time, twice a day. Strictly follow theinstructions.
・If you miss a dose, please take immediately when you notice. However, if it is almost time for the next dose, skip themissed dose and continue your regular dosing schedule. Do not take two tablets at once.
・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
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include constipation, nausea, and vomiting. If any of these symptomsoccur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicatedin brackets. If any of these symptoms occur, stop taking this medicine and see your doctorimmediately.
・rash, itching, angioedema, dyspnea [anaphylaxis]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with yourdoctor 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: 08/2018
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It isimportant to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,patients should understand their medication and cooperate with the treatment.
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