制造商：
国王制药公司
药理分类：
阿片类阿片拮抗剂+
指示（补）：
中度至重度疼痛管理当连续的，昼夜阿片类药物是需要相当长的一段时间。不适用于按需使用。
药理作用：
商品名Embeda包含一对阿片类镇痛药，周边纳曲酮，一μ-阿片受体拮抗剂扣押核心吗啡缓释微丸的制定。纳曲酮是为了在不影响本产品时采取的指示，但是，如果是压碎或咀嚼时，纳曲酮将被释放。纳曲酮逆转吗啡通过竞争结合主观和镇痛在μ-阿片受体的作用。
临床试验：
对商品名Embeda疗效进行了评估，在骨关节炎患者的12周试验的中度至重度疼痛。患者最初滴定在一个开放标签使用商品名Embeda阶段的疼痛控制，然后随机分为安慰剂与商品名Embeda或延续。在每周的疼痛从随机考核成绩的研究结束时的平均变化有统计学显着优于使用商品名Embeda相比，那些服用安慰剂的病人。
法律分类：
印度工业联合会
成人：
整粒吞服，或洒在苹果酱微丸，不要咀嚼颗粒。见文献。不要给吴经或胃管。 ≥18岁：个性化;给予24小时或12小时的时间表。阿片类药物天真的：以最低剂量开始。在调整的间隔时间至少2天。逐步撤出。
儿童：
<18年：不推荐。
禁忌（补）：
伴随酒精（增加吗啡的吸收;可能是致命的）。显着的呼吸抑制，急性或严重哮喘或高碳酸血症（在设置或在不受监督的复苏设备的情况下）。麻痹性肠梗阻。过程中或在14天的单胺氧化抑制剂。
警告/注意事项：
篡改产品的摄入可能促成对阿片类戒断症状耐，在阿片类药物过量天真。 100 / 4强的阿片类药物耐受只。头部受伤。颅内压增高。慢性阻塞性肺病。肺心病。侧后凸。夺取混乱。冲击。中枢神经系统抑郁症。中毒性精神病。受损的肺，肾，肝，甲状腺，或肾上腺皮质功能。 GI或顾阻塞。胆道疾病。急性胰腺炎。急腹症。容积枯竭。急性酒精中毒。震颤性谵妄。前24小时停止cordotomy。老人。虚弱。妊娠（Cat.C）。劳动和分娩，哺乳期妇女：不推荐。
互动（补）：
见禁忌。抑郁症的中枢神经系统，中枢神经系统抑制剂（如止吐药，吩噻嗪类，镇静药，安眠药，肌肉松弛剂，减少了1 / 2或剂量）。麻痹性肠梗阻与抗胆碱能药物。可能会增强为PGP抑制剂（如奎尼丁）。拮抗利尿剂。具有混合激动剂/拮抗剂阿片类戒断症状的可能。
不良反应（补）：
便秘，胃肠不适，嗜睡，呼吸抑制/逮捕，呼吸，循环抑制，心跳骤停，低血压，休克。
如何提供：
帽- 100
最后更新：
2009年10月22日
EMBEDA 20mg/0.8mg
Manufacturer:
King Pharmaceuticals, Inc.
Pharmacological Class:
Opioid + opioid antagonist
Active Ingredient(s):
Morphine sulfate 20mg, naltrexone HCl 0.8mg; ext-rel caps.
Also:
Embeda 30mg/1.2mg
Morphine sulfate 30mg, naltrexone HCl 1.2mg; ext-rel caps.
Embeda 50mg/2mg
Morphine sulfate 50mg, naltrexone HCl 2mg; ext-rel
caps.
Embeda 60mg/2.4mg
Morphine sulfate 60mg, naltrexone HCl 2.4mg; ext-rel caps.
Embeda 80mg/3.2mg
Morphine sulfate 80mg, naltrexone HCl 3.2mg; ext-rel caps.
Embeda 100mg/4mg
Morphine sulfate 100mg, naltrexone HCl 4mg; ext-rel
caps.
Indication(s):
Moderate to severe pain management when continuous, around-the-clock opioid is needed for an extended time period. Not for as-needed use.
Pharmacology:
Embeda contains pellets of an extended-release formulation of the opioid analgesic, morphine surrounding a sequestered core of naltrexone, a mu-opioid antagonist. The naltrexone is intended to have no effect when this product is taken as directed; however, if it is crushed or chewed, the naltrexone will be released. Naltrexone reverses the subjective and analgesic effects of morphine by competitively binding at mu-opioid receptors.
Clinical Trials:
The efficacy of Embeda was evaluated in a 12-week trial in osteoarthritis patients with moderate to severe pain. The patients were initially titrated to pain control in an open-label phase using Embeda, then randomized to either continuation with Embeda or placebo. The mean change in the weekly pain assessment score from randomization to the end of the study was statistically significantly superior for patients using Embeda compared to those given placebo.
Legal Classification:
CII
Adults:
Swallow whole, or sprinkle pellets on applesauce; do not chew pellets. See literature. Do not give via NG or gastric tubes. ≥18 years: individualize; give on 24 hour or 12 hour schedule. Opioid-naive: start at lowest dose. Adjust at intervals of at least 2 days. Withdraw gradually.
Children:
<18 years: not recommended.
Contraindication(s):
Concomitant alcohol (increases morphine absorption; may be fatal). Significant respiratory depression, acute or severe asthma or hypercapnia (in unmonitored settings or in absence of resuscitative equipment). Paralytic ileus. During or within 14 days of MAOIs.
Warnings/Precautions:
Ingestion of tampered product may precipitate withdrawal symptoms in opioid-tolerant; overdose in opioid-naive. 100/4 strength for opioid-tolerant only. Head injury. Increased intracranial pressure. COPD. Cor pulmonale. Kyphoscoliosis. Seizure disorders. Shock. CNS depression. Toxic psychosis. Impaired pulmonary, renal, hepatic, thyroid, or adrenocortical function. GI or GU obstruction. Biliary tract disease. Acute pancreatitis. Acute abdomen. Volume-depleted. Acute alcoholism. Delirium tremens. Discontinue 24 hours before cordotomy. Elderly. Debilitated. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended.
Interaction(s):
See Contraindications. CNS depression with CNS depressants (eg, antiemetics, phenothiazines, sedatives, hypnotics, muscle relaxants; reduce dose of either by 1/2). Paralytic ileus with anticholinergics. May be potentiated by PGP-inhibitors (eg, quinidine). Antagonizes diuretics. Possible withdrawal symptoms with mixed agonist/antagonist opioids.
Adverse Reaction(s):
Constipation, GI upset, somnolence; respiratory depression/arrest, apnea, circulatory depression, cardiac arrest, hypotension, shock.
How Supplied:
Caps—100