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2014年4月3日，美国FDA批准阿片类药物用于过量者的处方药，它可由家人或护理人员治疗已知或怀疑使用阿片类药物过量者。Evzio（naloxone hydrochloride injection，盐酸纳洛酮注射液）能通过一种手持式自动注射器迅速传输单次剂量纳络酮药液。该注射器可存放在口袋或药柜中。
这种制剂用于紧急治疗已知或可疑的阿片类药物过量，其症状特点是呼吸或心脏速率减弱，或意识丧失。
药物过量死亡，主要由处方药过量造成的死亡在美国是受伤死亡的首要原因，已经超过车祸。2013年，美国疾病控制和预防中心报告：吸毒过量死亡的人数持续上升已超过十年。
纳洛酮是一种能迅速逆转阿片类药物过量作用的药物，是治疗毒品过量的标准药物。但是，现有的纳洛酮给药需要使用注射器，通常需要由在急诊科和救护车受过培训的医务人员进行注射。
“误用和滥用处方和非法阿片类药物（毒品）导致的过量和死亡已成为美国的一个重要的公共卫生问题，” FDA药物评价和研究中心麻醉、镇痛和成瘾药品部门主任Bob Rappaport博士说，“ Evzio是首个提供在卫生保健机构外使用的单剂量纳洛酮-注射器组合制剂产品。它可在紧急情况下迅速使用，以挽救生命。”
Evzio可肌肉或皮下注射。一经打开，该注射器会提供口头指令向使用者说明如何给药，像自动去纤颤器一样。家人或护理人员应熟悉使用说明，了解使用步骤。
纳洛酮一次注射无法奏效时可能需使用重复剂量。Evzio不能替代紧急医治，病人在注射Evzio后应该立即就医。
在一项30名病人参与的药代动力学研究中，单次剂量Evzio注射相比标准注射器注射单剂量纳洛酮作用等同。阿片类药物依赖者使用Evzio可能会导致严重的阿片类戒断症。阿片类抑制作用突然逆转可能会导致恶心、呕吐、出汗、心率加快、血压上升、震颤、痉挛和心搏骤停。
美国FDA通过优先审查和快速审批程序批准了Evzio。原定计划在2014年6月20日作出审批决定。
EVZIO Rx
Pharmacological Class:
Opioid antagonist.
Active Ingredient(s):
Naloxone HCl 0.4mg/0.4mL; soln in a prefilled auto-injector for IM or SC inj; latex-free.
Company
kaleo, Inc.
Indication(s):
Emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or CNS depression.
Pharmacology:
Naloxone HCl antagonizes opioid effects by competing for the same receptor sites. It reverses the effects of opioids, including respiratory depression, sedation, and hypotension. Also, naloxone HCl can reverse the psychotomimetic and dysphoric effects of agonist-antagonists such as pentazocine.
When naloxone HCl is administered intravenously, the onset of action is generally apparent within two minutes. The time to onset of action is shorter for intravenous compared to subcutaneous or intramuscular routes of administration. The duration of action is dependent upon the dose and route of administration of naloxone HCl.
Legal Classification:
Rx
Adults & Children:
<1 year: Pinch thigh muscle while administering; monitor inj site for residual needle parts and/or infection. ≥1 year: Inject IM or SC into the anterolateral aspect of the thigh (through clothing, if necessary) according to label instructions. All: may give additional doses every 2–3 minutes until desired response or emergency medical assistance available. Repeated doses depending on amount, type, and route of administration of the opioid being antagonized may be required.
Warnings/Precautions:
Not a substitute for emergency medical care. Monitor patients with satisfactory response due to long duration of some narcotics. Have other resuscitative measures available. Known or suspected opioid dependence; abrupt reversal may precipitate acute withdrawal syndrome. Post-op use in pre-existing cardiac disorders; monitor. Neonates. Elderly. Pregnancy (Category B). Nursing mothers.
Interaction(s)
Caution with cardiotoxic drugs. Incomplete reversal of mixed agonists/antagonists (eg, buprenorphine, pentazocine); may require higher naloxone dose.
Adverse Reaction(s)
Post-op reversal of opioid depression: nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Also, excessive naloxone doses in post-op: reversal of analgesia, agitation.
How Supplied:
Prefilled auto-injectors—2 (w. Trainer)
LAST UPDATED:
7/18/2014 | 
