欧必亭片NAVOBAN(TROPISETRON)说明书

产地国家：瑞士 处方药：是 所属类别： 5毫克/片 5片/盒 包装规格： 5毫克/片 5片/盒 计价单位：盒 生产厂家英文名：Novartis Pharma Schweiz AG 原产地英文商品名：NAVOBAN 5mg/tab 5tabs/box 原产地英文药品名：TROPISETRON 中文参考商品译名：欧必亭 5毫克/片 5片/盒 中文参考药品译名：托烷司琼

简介：

部分中文托烷司琼处方资料(仅供参考)欧必亭Navoban中文别名：托烷司琼药品类别：止吐、催吐药及胃肠动力药化学成分：盐酸托烷司琼 tropisetron HCl药理药动：托烷司琼是一种外周神经元及中枢神经系统5-HT3受体的高效、高选择性竞争拮抗剂。某些常用癌症化疗药物可引起肠粘膜类嗜铬细胞释放出5 -羟色胺(5-HT)，从而诱发伴恶心的呕吐反射。托烷司琼能选择性地阻断外周神经元突触前5-HT3受体的兴奋;在中枢神经系统内，本品对调节传入最后区的迷走神经活动的5-HT3受体可能有直接作用。本药的作用时限为24小时，故只需每天给药一次。本药的临床研究表明，在2-3个癌症化疗周期中连续使用本品也不会减低疗效。本药用于预防细胞毒药物引起的恶心和呕吐。临床研究表明不引起锥体外系副作用。 适应症：预防细胞毒药物引起的恶心和呕吐。 用法用量：在每一个治疗周期中，最多可以连续应用本品6天。成人 每日剂量为5 mg。建议在治疗的第1-6日静脉给药。2岁以上儿童　推荐剂量为200 μg/kg，最大剂量为5mg/日，最好静脉给药，疗程为6天，用法如成人。本药也可以作为口服液给药，应至少于早餐前1小时服用。如果单独使用本药反应不佳，可以通过同时应用地塞米松提高抗呕吐疗效，不需要增加剂量。肝、肾功能不全患者静脉给药时剂量应减半。高血压未控制的患者，用量不宜超过10 mg。 不良反应：临床研究中最常见的不良反应为，应用2 mg时的头痛(22%)和应用5mg时的便秘(11%)。这些反应在代谢不良者中的发生率更高。偶有关于头晕、疲劳和腹痛、腹泻等胃肠功能紊乱的报道(0.1-5%)。与其它5-HT3受体拮抗剂相似，个别病例出现虚脱、晕厥、心血管意外，但未明确本药与这些不良反应的关系，有可能是由于细胞毒药物或原有疾病所引起。与其它5 -HT3受体拮抗剂相似，有包括以下一种或多种表现的I型过敏反应的个别报道：面色潮红和/或全身荨麻疹，胸部压迫感，呼吸困难，急性支气管痉挛和低血压。 禁忌症：对托烷司琼或其它5-HT3受体拮抗剂(如恩丹西酮和格拉司琼)过敏者，以及孕妇禁用。 注意事项：对于金雀花碱/异喹胍代谢不良患者(约8%的白种人)，虽然其清除半衰期与代谢正常者相比长4-5倍，应用本药的推荐剂量时未见药物引起的毒性副作用的报道，故不需减量。在急性肝炎或脂肪肝患者中，托烷司琼的药代动力学无改变，但肝硬化或肾功能损害患者与金雀花碱/异喹胍代谢正常的健康志愿者相比，血浆药物浓度高50%，因此，静脉给药时需降低剂量50%。因本药有引起血压进一步升高的危险，故高血压未控制的患者用量不宜超过10 mg。本药对驾车或操作机器的能力无影响，但应注意本药的不良反应有疲劳和头晕。 用药须知：化疗前，将1安瓿药物溶于100mL常用的输注液如生理盐水、林格氏液或5%葡萄糖液中，缓慢静脉滴注，不少于15分钟，或缓慢静脉注射(2mg/分，每安瓿约注射3分钟)，也可缓慢加入已有滴注液中。口服本药时，可从安瓿中取所用量，用橙汁或可乐稀释后立即服用，至少在早餐前1小时服用。 药物相互作用：托烷司琼胶囊与食物同时摄入可能延缓吸收，绝对生物利用度有轻度增加(从约60%至约80%)，但无相应的临床表现。与利福平或其它肝酶诱导药物(如苯巴比妥和保泰松)合用，可使托烷司琼的血浆浓度降低。细胞色素P450抑制剂如西米替丁对托烷司琼的血浆浓度影响极微，无需调整剂量。 药品过量：大剂量长期用药可导致幻视，并可使高血压患者的血压升高。出现用药过量时应对症治疗，应严密监测患者重要的生命体征。 贮藏：30°C以下贮存。

英文版说明书：

Navoban 5mg(discontinued in the UK)Main use：Nausea and vomitingActive ingredient：Tropisetron 5mgManufacturer：Novartis How does it work?Tropisetron is a medicine known as a 5-HT3 receptor blocker.Serotonin (5-HT) is a chemical produced by the nervous system.Specific receptors in the body bind with serotonin with different results. 5-HT3 receptors are present in the brain and gut.Stimulation of these receptors by serotonin contributes to the sensation of nausea and the reflex action of vomiting.Tropisetron acts directly on 5-HT3 receptors in the gut to block serotonin thereby preventing nausea and vomiting.It is also thought to block 5-HT3 receptors in the brain, further preventing nausea and vomiting.Tropisetron is highly effective in the prevention of chemotherapy-induced nausea and vomiting.It may be given as capsules or injection and is given as a single dose daily for six days starting on the first day chemotherapy is received. What is it used for?Prevention of chemotherapy-induced nausea and vomiting Warning!This medicine may cause fatigue and dizziness. You should take care when performing potentially hazardous activites, such as driving or operating machinery, until you know how this medicine affects you and are sure you can perform such activities safely. Use with caution inDisturbed heart rhythm or nerve conduction within the heart People taking and anti-arrhythmia or beta-blocking medicines Uncontrolled high blood pressure (hypertension) Not to be used inChildrenPregnancyThis medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately. Pregnancy and BreastfeedingCertain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.The manufacturer states not to use this medicine during pregnancy and breastfeeding as there is insufficient safety information available. Seek medical advice from your doctor. Label warningsTake this medication an hour before food or on an empty stomach. Side effectsMedicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.FatigueDisturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain Dizziness Allergy to active ingredients (hypersensitivity) such as facial flushing, skin rash, itch, narrowing of airways (bronchospasm) or swelling of lips, tongue or throat (angioedema) Headache The side effects listed above may not include all of the side effects reported by the drug's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist. 附件:2010102721133731.pdf