英文药名：ORAPENEM FINE GRANULES 10% FOR PEDIATRIC（Tebipenem pivoxil） 中文药名：替比培南10%颗粒剂 生产厂家：明治制果药业 オラペネム小児用細粒10％ 治疗类别名称 口服碳青霉烯类抗生素制剂 中文名称：替比培南 英文名称：Tebipenem pivoxil 商品名称：Orapenem 剂型及规格：10%颗粒剂，100mg/1g，50g/ 【原研厂家】 替比培南酯最早由美国辉瑞公司研发，替比培南酯细粒剂由惠氏立达公司原研开发，之后转让给日本明治制果制药公司（2002年3月，范围包括日本在内的15个亚洲国家），2009年4月在日本获得厚生省批准。 【产品特点】 本品的口服吸收性优于现在已经上市的大多数β-内酰胺类抗生素 替比培南为口服碳青霉烯类新广谱抗生素，由惠氏立达公司原研开发，之后转让给日本明治制果制药公司（2002年3月，范围包括日本在内的15个亚洲国家），2009年4月在日本获得厚生省批准。 替比培南结构特点:是C3位侧链为噻唑基取代的氮杂环丁烷基团，同时通过在C2位羧酸形成匹伏酯形成前药，提高了口服吸收性。本品的口服吸收性优于现在已经上市的大多数β-内酰胺类抗生素。 替比培南抗菌谱广。对大多数临床分离的菌株（除Enterococcus faecium（屎肠球菌）及Pseudomonas aeruginosa（绿脓杆菌）等少部分菌种外），替比培南均表现出比青霉素系列及头孢系列更强的抗菌性，而与其他注射用的碳青霉烯类抗生素相比，替比培南也表现出同程度或更强的抗菌效果。特别是针对近几年引起儿童感染主要原因的PRSP（耐青霉素肺炎链球菌）、MRSP（耐红霉素肺炎链球菌）及Haemophilus influenzae（流感嗜血杆菌）表现出极强的抗菌效果。 本品已经完成成人的Ⅱ期临床实验，并取得相当好的实验结果。但考虑到目前上市的抗生素，对由PRSP（耐青霉素肺炎链球菌）、MRSP（耐红霉素肺炎链球菌）及Haemophilus influenzae（流感嗜血杆菌）引起的儿童患者包括中耳炎在内的上呼吸道感染及细菌性肺炎的治疗表现出局限性，因此明治制果公司绝对率先推出以治疗儿童肺炎、中耳炎、副鼻腔炎的颗粒剂。临床期间患者的年龄包括了从6个月至16岁的各年龄段。 由PRSP（耐青霉素肺炎链球菌）、MRSP（耐红霉素肺炎链球菌）及Haemophilus influenzae（流感嗜血杆菌）所引起的儿童患者包括中耳炎在内的上呼吸道感染及细菌性肺炎，是临床上最常见的儿童感染。由于耐药现象日趋严重，目前临床上常使用的抗生素对于儿童感染的治疗效果已日渐减弱，因此有必要开发新的抗菌效果更强的药物。 包装规格 含 1克：100毫克 *瓶：50克，100G 包装0.5克×120包（60小包×2） 制造厂商 明治制果药业 完整资料附件：http://www.info.pmda.go.jp/go/pack/6139002C1026_1_07/ ORAPENEM FINE GRANULES 10% FOR PEDIATRIC（Tebipenem pivoxil） ORAPENEM FINE GRANULES 10% FOR PEDIATRIC（オラペネム小児用細粒10％） Brand name : ORAPENEM FINE GRANULES 10% FOR PEDIATRIC 　Active ingredient: Tebipenem pivoxil 　Dosage form: yellowish pale red fine granule 　Print on wrapping:  Effects of this medicine This medicine is a carbapenem antibiotic to inhibit bacterial cell wall synthesis, and shows antimicrobial effect. It is usually used to treat pneumonia, otitis media and sinusitis. 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 or any of your parents or siblings are prone to allergic symptoms such as bronchial asthma, rash or hives. If you are a patient with renal disorder, poor ingestion or parenteral nutrition, or poor general status. If you have a history of convulsive diseases such as epilepsy. •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>> •For children: In general, take 0.04 gram per kilogram of body weight (g/kg) (4 mg of the active ingredient [titer]/kg) at a time, twice a day, after meals. The dosage may be increased up to 0.06 g/kg (6 mg [titer]/kg) as needed. Strictly follow the instructions. •Standard duration of administration is for 7 days or less. •If you miss a dose, take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and follow 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 • Possible adverse reactions to this medicine The most commonly reported adverse reactions include diarrhea and loose stool. 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. •convulsion, disturbed consciousness [hypoglycemia associated with hypocarnitinemia] 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 reach of children. Store away from direct sunlight, heat and moisture. •Discard the remainder. Do not store them. Meiji Seika Pharma Co., Ltd.Internal Revised: 1/2013 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.