部份中文替比培南处方资料（仅供参考） 中文名称：替比培南10%颗粒剂 英文名称：Tebipenem pivoxil 商品名称：Orapenem 剂型及规格：10%颗粒剂，100mg/1g，50g/ 适应症：碳青酶烯类新广谱抗生素，抗细菌感染；主要用于耳鼻喉感染、上呼吸道感染、中耳炎、细菌性肺炎 【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。 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 【产品特点】 该产品用于儿科病人耳鼻喉和上呼吸道感染的治疗。它是第一个用于肺炎链球菌抗药株感染的治疗，包括持续性中耳炎和细菌性肺炎的培南类药物。 替比培南酯是替比培南的前体药物，口服后被酯酶水解释放出母体药物替比培南，与细菌青霉素结合蛋白（PBP）结合，抑制细菌细胞壁的合成，是目前唯一一个可以口服的碳青霉烯类抗生素。替比培南酯对抗肺炎链球菌、大肠杆菌、肺炎克雷白菌、流感嗜血菌、肺炎军团菌的抑制活性，强于对照药如亚胺培南、头孢地尼、阿莫西林和左氧氟沙星等。 替比培南的结构，特点是在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 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 欧文商標名 ORAPENEM FINE GRANULES 10% FOR PEDIATRIC 性　状 テビペネム　ピボキシルは白色の結晶性の粉末である。 本品はメタノール及びアセトニトリルに溶けやすく、エタノール（99.5）にやや溶けやすく、エーテルに溶けにくく、水には極めて溶けにくい。 一般名 テビペネム　ピボキシル　Tebipenem Pivoxil 略　号 TBPM-PI 化学名 (＋)-hydroxymethyl(4R,5S,6S)-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-3-{[1-(2-thiazolin-2-yl)-3-azetidinyl]thio}-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate,2-pivalate 分子式 C22H31N3O6S2 分子量 497.63 構造式 融　点 134℃ 分配係数 （１-オクタノール/薄めたMcIlvaine緩衝液） （下表参照） pH3.0  pH4.0  pH5.0  pH6.0  pH7.0  0.0216  0.123  0.977  7.82  64.0 取扱い上の注意 防湿のため、ボトル入製剤は調剤後必ず密栓すること。ボトル入製剤を分包した場合は、湿気を避けて保存すること。また、分包製剤は湿気を避けて保存し、服用時に開封するよう指示すること。 承認条件 使用施設を把握すると共に施設の抽出率、施設数を考慮して以下の対策を講ずること。 1. 適切な製造販売後調査（感受性調査を含む）を継続し、情報を収集すること。 2. 収集した情報を解析し、適正な使用を確保するために医療機関に対し、必要な情報提供を継続すること。 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 Meiji Seika ファルマ株式会社[明治制果药业] 完整资料附件：http://www.kegg.jp/medicus-bin/japic_med?japic_code=00056939 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. 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   Effects of this medicine This medicine is a carbapenem antibiotic to inhibit bacterial cell wall synthesis, and shows antimicrobial effect. It is usually used in the treatment of pneumonia, otitis media and sinusitis. Before using this medicine, be sure to tell your doctor and pharmacist •If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. 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>> •General dosage regimen: For children, take 0.04 g/kg (4 mg of the active ingredient [titer]/kg) at a time, twice daily, after meals. The dosage may be increased up to 0.06 g/kg (6 mg [titer]/kg) as needed. Strictly follow the instructions of your doctor/pharmacist. •Standard duration of administration is for 7 days or less. •Take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose. •If you took too much of the medicine (more than ordered), check with your doctor/pharmacist. •Do not stop taking the medicine without the instructions of your doctor. Precautions while taking this medicine • Possible adverse effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: diarrhea, loose stool, etc. The symptoms described below are rarely seen as initial symptoms of the adverse effects 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.