产地国家：美国

处方药：是

所属类别： 4毫克/片 10片/盒

包装规格： 4毫克/片 10片/盒

计价单位：盒

生产厂家英文名：PAR PHARM

原产地英文商品名：ZUPLENZ SOLUBLE FILMS 4mg/tab 10tabs/box

原产地英文药品名：ONDANSETRON

中文参考商品译名：ZUPLENZ水溶性薄膜片 4毫克/片 10片/盒

中文参考药品译名：昂丹司琼

简介：

昂丹司琼口服制剂Zuplenz（ondansetran）

药理分类：选择性5 - HT3受体拮抗剂。

活性成分：恩丹西酮（如基地）4毫克，8mg;口服水溶性薄膜；薄荷味。

适应症：恶心呕吐的预防和致吐性化疗与高度，包括顺铂≥50mg/m2。恶心和呕吐的预防与中等致吐性化疗初期和重复的课程。恶心和呕吐的预防与接受全身照射，单次大剂量分形在腹部，或每日分数到腹部放射治疗。预防后运恶心和/或呕吐。

药理作用：恩丹西酮是一种血清素5 -HT3受体拮抗剂。这些受体位于外周迷走神经末梢以及在化学感受器触发区集中。恩丹西酮的止吐作用可能是由于血清素抑制外周活动，集中，或在这两个网站。然而，细胞毒性化疗似乎与血清素从小肠肠嗜铬细胞释放有关。此外，尿排泄5-羟酸，血清素的主要代谢产物，在平行的行政顺铂与呕吐发病增加。对在迷走神经末梢的5 - HT3受体拮抗释放血清素可能通过抑制呕吐反射。

临床试验：

口服恩丹西酮被证明是统计上显着优于化疗引起的恶心和呕吐的预防安慰剂两个双盲，单一疗法试验中接受高度致吐性化疗的患者，以及多种学习的成人和儿童患者接受初次和重复致吐性化疗疗程的适度。第一个试验比较357例成人口服剂量恩丹西酮接受高度致吐含顺铂化疗方案≥50mg/m2。在主要终点，66恩丹西酮24mg每日一次接受患者％，55％接受8mg，每天两次，55％接受32mg每日一次完成，没有情节，没有呕吐的止吐药物抢救24小时学习时间。所有3个剂量均表现显着优于安慰剂。在67例接受适度进行的一项研究环磷酰胺致吐性为基础的化疗含阿霉素，61％的患者接受恩丹西酮经历没有呕吐次数较安慰剂组（P“0.001）至6％。不受控制的研究评估课程，在随后的化疗148例（396个）给予昂丹司琼昂丹司琼预防呕吐表明，以下79重新疗程％。三个开放标签，不加控制的试验中进行了4-18年谁是癌症患者给予顺铂和非顺铂治疗方案的各种旧的182儿童。盐酸恩丹西酮注射液的初始剂量其次为口服恩丹西酮给药3天。在这些研究中，58％的患者有170评估的第一天没有呕吐发作。

三双盲研究评估了口服昂丹司琼在辐射引起的恶心和呕吐的预防效果。第一次随机研究，涉及20例，结果显示，口服昂丹司琼在每次的分数给予全身辐射明显比安慰剂有效防止呕吐。第二项研究比较恩丹西酮口服胃复安105个以上的接收到腹部≥八十平方厘米前或后场大小单次大剂量放射治疗病人。恩丹西明显比胃复安有效地实现呕吐的完全控制（0呕吐集）。在第三个试验，涉及135例，口服恩丹西酮显着更有效的实现相比，prochlorperazine接受呕吐1例完全控制 - 4周较分割放疗过程中的>一零零平方厘米场大小的腹部。

在预防后运恶心和呕吐的疗效研究口服昂丹司琼两个双盲涉及865住院接受手术的女性患者的试验。患者接受昂丹一小时前，麻醉诱导。恩丹西被证明是预防后运恶心，呕吐明显比安慰剂更有效。成人：每片膜剂解散前的4-20秒吞咽舌头。高致吐性：24mg（给每片先后在三8mg）30分钟前，单日化疗（多天，单剂量没有研究）的开始。中度致吐：8mg剂量为每8小时2化疗前30分钟开始，然后8mg化疗后1-2天，每12小时完成。全身照射：8mg 1放疗前给予每2小时，每天一小部分。单次大剂量放射治疗腹部分数：8mg 1放疗前2小时，然后每隔8小时8mg一日后1-2天剂量照射后完成。每日分次放射治疗腹部：8mg 1放疗前2小时，然后每隔8小时后，第一8mg每一天放疗剂量。后运预防：16mg（鉴于先后为两个8mg电影）麻醉诱导前1小时。对于所有：严重肝功能不全：最大8mg/day。儿童：高致吐性化疗，放疗，后运预防或<4yrs年龄：不推荐。每片膜剂允许解散之前采取的下一片膜剂完全。解散前的4-20秒吞咽舌头。 4 -11yrs：中度致吐：4毫克每4小时3剂量化疗前30分钟开始，然后每隔1-2天8小时4毫克化疗后完成。

禁忌：伴随阿朴吗啡：深刻低血压或意识丧失的危险。

警告/注意事项：可能掩盖渐进性肠梗阻和/或胃扩张（特别是腹部手术或化疗引起的恶心/呕吐的病人）。不要使用替代鼻饲吸力。肝功能障碍。妊娠（Cat.B）。哺乳的母亲。

互动：强效CYP3A4的诱导剂（如苯妥英，卡马西平，利福平）有可能增加恩丹西酮清除。可减少曲马多镇痛作用。

不良反应：头痛，全身乏力/疲劳，便秘，腹泻；罕见：支气管痉挛，过敏性反应，瞬间心电图改变，包括QT间期延长。

剂型：水溶性薄膜。

英文版说明书：

ZuplenzGeneric Name: ondansetronDate of Approval: July 2, 2010Company: Strativa PharmaceuticalsTreatment for: Prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomitingFDA Approves ZuplenzThe U.S. Food and Drug Administration (FDA) has approved Zuplenz (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medication.Zuplenz Patient InformationRead the Patient Information that comes with Zuplenz before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.What is Zuplenz?Zuplenz is a prescription medicine that is used in adults to prevent nausea and vomiting:caused by certain cancer chemotherapy medicines, radiation therapy to your stomach-area (abdomen), or radiation therapy to your entire body.that may happen after surgeryIn children aged 4 years and older, Zuplenz is only used to prevent nausea and vomiting due to certain cancer chemotherapy medicines.It is not known if Zuplenz is safe and works in children to prevent nausea and vomiting with radiation therapy, or nausea and vomiting that may happen after surgery in children.Who should not take Zuplenz?Do not take Zuplenz if you take apomorphine hydrochloride (Apokyn).Do not take Zuplenz if you have had an allergic reaction to Zuplenz or are allergic to any of its ingredients. See the end of this leaflet for a complete list of ingredients in Zuplenz.Ask your doctor if you are not sure.Before taking ZuplenzBefore you take Zuplenz oral soluble film, tell you doctor if you:have liver problemshave any other medical conditions are pregnant or plan to become pregnant. It is not known if Zuplenz will harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if Zuplenz passes into your breast milk.have had an allergic reaction to another medicine for nausea and vomiting Tell your doctor about all the medicines you take, including prescription and non-prescription, vitamins, and herbal supplements.Some medicines may affect how Zuplenz works, and Zuplenz may affect how other medicines work. Using Zuplenz with certain other medicines may cause serious side effects.Especially tell your doctor if you take:apomorphine hydrochloride (Apokyn) or tramadol hydrochloride (Ultram, Ultram ER, Ryzolt) Ask your doctor or pharmacist if you are not sure if your medicine is listed above.Know the medicines you take. Keep a list of them to show to your doctor or pharmacist each time you start a new medicine.How should I take Zuplenz?Take Zuplenz exactly as your doctor tells you to take it.An adult should help a young child use this medicine.See the "Instructions for Use" at the end of this leaflet.Zuplenz side effectsZuplenz may cause serious side effects, including:severe allergic reactions. Stop taking Zuplenz and tell your doctor right away if you have any of these signs or symptoms of an allergic reaction with Zuplenz:rashhivesitchingtrouble breathingchest tightness or chest painswelling of your mouth, face, lips, or tongue heart rhythm changes.The most common side effects of Zuplenz are:headachetiredness and body discomfortconstipationdiarrheaThese are not all the possible side effects of Zuplenz. For more information, ask your doctor or your pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.How should I store Zuplenz ?Store Zuplenz at room temperature, 68°F to 77°F (20°C to 25°C).Keep the film in the foil pouch until ready to use. Keep foil pouches in the carton.Use the film strip right away, after you take it from the pouch.Keep Zuplenz and all medicines out of the reach of children.General information about ZuplenzMedicines are sometimes used for purposes other than those listed in Patient Information leaflets. Do not use Zuplenz for a condition for which it was not prescribed. Do not give Zuplenz to other people, even if they have the same condition that you have.It may harm them.This Patient Information leaflet summarizes the most important information about Zuplenz. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Zuplenz that is written for healthcare professionals.What are the ingredients in Zuplenz?Active ingredient: ondansetronInactive ingredients: butylated hydroxytoluene, calcium carbonate, colloidal silicon dioxide, erythritol, hydroxypropyl methylcellulose, monoammonium glycyrrhizinate, peppermint flavor, polyethylene oxide, sodium bicarbonate, sucralose, titanium oxide and xanthan gum.Instructions for useOral Soluble FilmKeep the film in the foil pouch until ready to use. Use the film right away, after you take it from the pouch.Make sure your hands are dry.Fold the pouch along the dotted line to expose the tear notch.While still folded, tear the pouch carefully along the edge.Take the Zuplenz film strip from the pouch.Put the Zuplenz film on top of your tongue, where it will dissolve in 4 to 20 seconds.Do not chew or swallow the film whole.Swallow after the film dissolves. You may swallow the dissolved film with or without liquid.Wash your hands after taking Zuplenz.