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VIVITROL(naltrexone for extended‐
elease injectable suspension)
Vivitrol为纳曲酮缓释制剂,它通过阻断大脑中的阿片受体来抑制吗啡、海洛因和其它阿片类药物对大脑的作用。
FDA曾在2006年批准Vivitrol用于治疗酒精依赖
对于Vivitrol治疗阿片药物依赖症的安全性和有效性问题,研究人员已经进行了6个月研究,在结束戒毒和身体上不再依赖阿片药物的患者中进行了Vivitrol和安慰剂的比较治疗试验。
研究发现,Vivitrol治疗组患者更加倾向于接受治疗和不再使用阿片药物,其比例为36%,而这一比例在安慰剂组为23%。
研究人员指出,当患者开始使用Vivitrol后,他们被禁止服用任何阿片药物;否则,会出现痛苦的戒毒症状。若错过一次用药或Vivitrol治疗结束后,患者重新使用阿片药物,可能会出现用药过量的情况。
使用Vivitrol的患者可能出现某些副反应,包括恶心、疲劳、头痛、头晕、呕吐、食欲下降、关节疼痛和肌肉痉挛;严重者可能出现注射部位反应(可能需要外科干预)、肝损害、过敏反应(如荨麻疹)、皮肤疹、面部肿胀、肺炎等。
Vivitrol只能用特殊注射针头通过肌内注射给药,不可用任何其它针头注射。推荐剂量为每月注射一次。
VIVITROL Rx
Generic Name and Formulations:
Naltrexone 380mg/vial; ext-rel susp for IM inj; contains polylactide-co-glycolide (PLG).
Company:
Alkermes
Indications for VIVITROL:
Alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting, in conjunction with psychosocial support (eg, counseling or group therapy). Prevention of relapse to opioid dependence following opioid detoxification.
Adult:
Give by IM inj into alternating buttocks. 380mg once every 4 weeks. Switching from buprenorphine, buprenorphine/naloxone, or methadone: monitor for precipitation of withdrawal symptoms and treat with non-opioid drugs.
Children:
Not established.
Pharmacological Class:
Opioid antagonist.
Contraindications:
Concomitant opioids. Current physiologic opioid dependence. Acute opiate withdrawal. Failed naloxone challenge test. Positive urine test for opioids. Previous hypersensitivity to PLG or carboxymethylcellulose (in diluent).
Warnings/Precautions:
Vulnerability to opioid overdose (eg, at end of a dosing interval, after missing a dose, or after discontinuing treatment). Precipitation of opioid withdrawal: consider naloxone challenge test before treating to exclude recent (7–10 days) opioid use. Moderate to severe renal dysfunction. Risk of hepatic injury; discontinue if acute hepatitis develops. Risk of eosinophilic pneumonia; follow-up if respiratory symptoms occur. Monitor for depression and/or suicidality. Advise patient of reduced post-treatment opioid tolerance and of danger of attempting to overcome opioid blockade; advise use of medication alert documentation. Coagulation disorders. Discontinue if hypersensitivity reactions develop. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions:
See Contraindications. Antagonizes opioids (eg, antitussives, antidiarrheals, analgesics); use non-opioids, and/or anesthesia if pain management is necessary. May interfere with urine opioid tests.
Adverse Reactions:
Nausea, vomiting, muscle cramps, somnolence/sedation, fatigue, headache, dizziness, decreased appetite, inj site reactions (may be serious; eg, induration, cellulitis, hematoma, abscess, sterile abscess, necrosis), hepatotoxicity; rare: allergic (eosinophilic) pneumonia.
REMS:
YES
How Supplied:
Vial—1 (w. supplies)
注：本品属控制药，不供个人
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