药品信息:
友情提示：OPANA为二级管制药。
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详细处方信息以本药内容附件PDF文件（20097602535127）的“原文Priscribing Information”为准
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Important Safety Information
OPANA® ER has a boxed warning as follows:
WARNING: OPANA ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.
Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
OPANA ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
OPANA ER is NOT intended for use as an as needed analgesic.
OPANA ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone.
Patients must not consume alcoholic beverages, or prescription or nonprescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.
OPANA® ER Indication
OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time
OPANA ER is NOT intended for use as an as needed analgesic
OPANA ER is not indicated for pain in the immediate post-operative period (12-24 hours following surgery) for patients not previously taking opioids because of the risk of oversedation and respiratory depression requiring reversal with opioid antagonists
OPANA ER is not indicated for pain in the post-operative period if the pain is mild or not expected to persist for an extended period of time
恩多制药（Endo Pharmaceuticals）公司的盐酸羟吗啡酮缓释片（商品名：Opana ER），用于镇痛。
新的口服阿片类镇痛药缓释片Opana ER适用于长期需持续24小时使用阿片类药物（而不作为基础）治疗的患者解除中度至严重疼痛。这是羟吗啡酮首次以口服缓释制剂上市，Opana ER的剂量规格：5 mg/片，10 mg/片，20 mg/片，40 mg/片。
羟吗啡酮缓释片代表了恩多公司首次在国际上开发的新药申请获得美国FDA批准。Opana ER的临床计划代表了阿片类镇痛药迄今最广泛的研究之一，15项Ⅱ期和Ⅲ期临床研究总共3000多例。在这些研究中，第一项研究对慢性中度至严重下背部疼痛的患者进行双盲安慰剂对照Ⅲ期临床研究。有两项对不同患者的研究：一项对未接触过阿片类药物患者，另一项对以前使用过阿片类药物的患者。结果显示逐渐增加剂量有效，且对Opana ER治疗剂量耐受性好。服用12周，Opana ER的平均镇痛作用显著优于安慰剂（P<0.0001）。此数据证明，逐渐增加Opana ER至适当的有效剂量，可向各种疼痛类型患者提供持久的镇痛作用。
Opana ER将在长效强效阿片类镇痛药市场上竞争，该市场2005年销售额为32亿美元。本品的临床研究表明，当逐渐递增剂量有效可持续以一日2次的给药方案，患者耐受性好。Opana ER还显示在长达3个月关键的临床研究期间可以稳定的剂量有效控制疼痛。Opana ER采用专门提供12小时持续释药的专利技术制成，有助于患者持久解除疼痛。
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详细处方信息以本药内容附件PDF文件（20097602535127）的“原文Priscribing Information”为准
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