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Movantik Tablets 12.5mg(naloxegol)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 12.5毫克/片 30片/瓶 
包装规格 12.5毫克/片 30片/瓶 
计价单位: 瓶 
生产厂家中文参考译名:
AstraZeneca
生产厂家英文名:
AstraZeneca
该药品相关信息网址1:
http://www.smartprescriptionsavings.com/movantik-Coupon
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
MOVANTIK tab 12.5mg/tab 30tabs/bottle
原产地英文药品名:
naloxegol
中文参考商品译名:
MOVANTIK片 12.5毫克/片 30片/瓶
中文参考药品译名:
naloxegol
曾用名:
简介:

 

近日,阿斯利康(AZN)与合作伙伴第一三共制药(Daiichi Sankyo)联合在美国推出便秘新药Movantik(naloxegol),该药是一种外周作用μ-阿片受体拮抗剂(PAMORA),专门用于治疗患者在服用阿片类药物时所引发的便秘(OIC),这是阿片类止痛药一种常见的副作用。
批准日期:2014年9月16日;公司:AstraZeneca制药 LP
MOVANTIK(naloxegol)片,为口服使用,C-II
美国初始批准:2014
作用机制
Naloxegol是一种阿片拮抗剂结合在µ-阿片受体。当在推荐剂量水平给药时,naloxegol功能作为一种外周作用µ-阿片受体拮抗剂在组织中例如胃肠道,因此减低阿片类药物的便秘效应。
Naloxegol是纳洛酮聚二醇化衍生物,和对P-糖蛋白转运蛋白(P-gp)的底物。还有,在naloxegol中聚乙二醇部分的存在减低其被动通透性当与纳洛酮比较。由于减低通透性和的增加外排naloxegol跨越血脑屏障,与P-gp底物相关性质,预计在推荐剂量水平,naloxegol的CNS穿透是可忽略不计限制与中枢性介导阿片类镇痛干扰潜能。.
适应证和用途
MOVANTIK(naloxegol)是一个阿片拮抗剂适用为在有慢性非癌症疼痛成年患者阿片-诱导便秘(OIC)的治疗。
剂量和给药方法
⑴MOVANTIK开始前终止维持润肠通便治疗;如患者服用MOVANTIK共3天后有阿片-诱导便秘[OTC]症状可恢复缓泻药。
⑵开始MOVANTIK前不需要改变镇痛给药方案。
⑶在曾服用阿片类药物共至少4周患者中MOVANTIK曾被显示是有效。
⑷服用当天首次进餐前至少空胃1小时或餐后2小时。
⑸整吞片,不要压碎或咀嚼。
⑹避免消耗葡萄柚或葡萄柚汁。
⑺如终止治疗也终止用阿片痛药物。
推荐剂量:
⑻25mg每天1次;如不能耐受,减低至12.5mg每天1次。
⑼肾受损(CLcr < 60mL/min):12.5mg每天1次;如耐受增加至25mg每天1次和监视不良反应。
剂型和规格
片:12.5mg和25mg。
禁忌证
⑴患者有已知或怀疑胃肠道阻塞和处在复发阻塞风险增加。
⑵与强CYP3A4抑制剂同时使用(如,克拉霉素[clarithromycin],酮康唑[ketoconazole])
⑶对MOVANTIK或任何其赋形剂已知严重或严重超敏性反应。
警告和注意事项
⑴胃肠道穿孔:在有已知或怀疑GI道病变患者中开率总体风险获益。监视严重,持续或恶化腹痛;如症状发生终止。
⑵阿片类戒断:在有对血-脑屏障破坏患者中考虑总体风险获益。监视阿片类戒断症状。
不良反应
在临床试验中最常见不良反应(3%)是:腹痛,腹泻,恶心,胀气,呕吐,和头痛。
药物相互作用
⑴中度CYP3A4抑制剂(如,地尔硫卓[diltiazem],红霉素[erythromycin],[维拉帕米]verapamil):增加naloxegol浓度;避免同时使用;如不可避免,减低剂量至12.5mg每天1次和监视不良反应。
⑵强CYP3A4诱导剂(如,利福平[rifampin]):naloxegol浓度减低;不建议同时使用。
⑶其他阿片拮抗剂:对相加作用潜能和阿片类戒断增加的风险;避免同时使用。
特殊人群中使用
⑴妊娠:在胎儿中可能促进阿片类戒断。
⑵哺乳母亲:终止药物或哺乳考虑药物对母亲的重要性。
⑶肝受损:在严重受损中避免使用。
如何供应/贮存和处置
MOVANTIK(naloxegol)片被供应如下:
NDC 0310-1969-30:12.5 mg,30片瓶
NDC 0310-1969-90:12.5 mg,90片瓶
NDC 0310-1969-39:12.5 mg,100片单位剂量吸塑纸盒(只为HUD)
NDC 0310-1970-30:25 mg,30片瓶
NDC 0310-1970-90:25 mg, 90片瓶
NDC 0310-1970-39:25 mg,100片单位剂量吸塑纸盒(只为HUD) 
US FDA Approves MOVANTIK™ (naloxegol) Tablets C-II
On September 16, the US Food and Drug Administration approved MOVANTIK™ (naloxegol) tablets C-II as the first once-daily oral peripherally acting mu-opioid receptor antagonist (PAMORA) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
Generic Name: naloxegol (nal OX ee gol)
Brand Names: Movantik
IMPORTANT SAFETY INFORMATION ABOUT MOVANTIK
•MOVANTIK®  (naloxegol) is contraindicated in:
◦Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction, due to the potential for GI perforation
◦Patients receiving strong CYP3A4 inhibitors (eg, clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms
◦Patients with a known serious or severe hypersensitivity reaction to MOVANTIK or any of its excipients
•Cases of GI perforation have been reported with the use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract. Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops
•Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with MOVANTIK. Patients receiving methadone as therapy for their pain condition were observed in the clinical trials to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. These patients (eg, multiple sclerosis, recent brain injury, Alzheimer’s disease, and uncontrolled epilepsy) were not enrolled in the clinical studies. Take into account the overall risk-benefit profile when using MOVANTIK in such patients. Monitor for symptoms of opioid withdrawal when using MOVANTIK in such patients
•Avoid concomitant use of moderate CYP3A4 inhibitors (eg, diltiazem, erythromycin, verapamil) because they may increase the risk of adverse reactions. Use of strong CYP3A4 inducers (eg, rifampin, carbamazepine, St. John’s Wort) is not recommended because they may decrease the efficacy of MOVANTIK. Avoid concomitant use of MOVANTIK with another opioid antagonist due to the increased risk of opioid withdrawal
•The use of MOVANTIK during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. MOVANTIK should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Due to the potential for serious adverse reactions, including opioid withdrawal, in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
•The most common adverse reactions with MOVANTIK in clinical trials were: abdominal pain (21%), diarrhea (9%), nausea (8%), flatulence (6%), vomiting (5%), headache (4%), and hyperhidrosis (3%)
INDICATION
MOVANTIK (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non‑cancer pain.

How Supplied:
Tabs—30, 90

LAST UPDATED:
4/28/2015 

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