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详细处方信息以本药内容附件PDF文件（201952217014418.pdf）的“原文Priscribing Information”为准
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部分中文Naloxone Hydrochloride处方资料（仅供参考）

【英文名称】Naloxone Hydrochloride

【适用证】

盐酸纳洛酮注射用于阿片类药物抑制的完全或部分逆转，包括由天然和合成阿片类药物（包括丙氧芬，美沙酮和某些混合激动剂 - 拮抗剂镇痛药：纳布啡，喷他佐辛，布托啡诺和环克拉辛）诱导的呼吸抑制。

盐酸纳洛酮也可用于诊断疑似或已知的急性阿片类药物过量。 盐酸纳洛酮注射液可用作辅助剂，以增加脓毒性休克管理中的血压（参见临床药理学：脓毒性休克中的辅助性用药）。

【用法用量】

盐酸纳洛酮注射液可以静脉内，肌肉内或皮下给药。通过静脉内给药实现最快的起效，这在紧急情况下是推荐的。

由于某些阿片类药物的作用持续时间可能超过纳洛酮，因此患者应继续接受监测。必要时应给予重复剂量的纳洛酮。

静脉输液：

盐酸纳洛酮注射液可以在0.9％氯化钠或5％葡萄糖注射液中稀释用于静脉输注。在500mL任一溶液中加入2mg盐酸纳洛酮，浓度为0.004mg / mL。混合物应在24小时内使用。 24小时后，必须丢弃剩余的未使用的溶液。应根据患者的反应滴定给药速度。盐酸纳洛酮注射液不应与含有亚硫酸氢盐，偏亚硫酸氢盐，长链或高分子量阴离子的制剂或任何具有碱性pH的溶液混合。盐酸纳洛酮注射液中不应加入药物或化学试剂，除非首先确定其对溶液的化学和物理稳定性的影响。

一般

当溶液和容器允许时，应在给药前肉眼检查肠外药物产品的颗粒物和变色。

成人用法

阿片类药物过量 - 已知或疑似：静脉注射0.4 mg至2 mg盐酸纳洛酮的初始剂量。如果未获得所需的反作用程度和呼吸功能的改善，则可以以2至3分钟的间隔重复进行。如果在给予10mg盐酸纳洛酮后没有观察到反应，则应该质疑阿片类药物诱导或部分阿片类药物诱导的毒性的诊断。如果没有静脉途径，可能需要肌内或皮下给药。

【禁忌】

盐酸纳洛酮注射液禁用于已知对其过敏的患者或盐酸纳洛酮中的任何其他成分。

【使用注意】

药物依赖性：

对于已知或怀疑身体依赖阿片类药物的母亲的新生儿，应谨慎使用盐酸纳洛酮。在这种情况下，阿片类药物作用的突然和完全逆转可能会导致急性戒断综合症。在体力依赖于阿片类药物的患者中阿片类药物戒断的体征和症状可包括但不限于以下：身体疼痛，腹泻，心动过速，发烧，流鼻涕，打喷嚏，毛发直立，出汗，打哈欠，恶心或呕吐，紧张，烦躁或烦躁，颤抖或颤抖，腹部绞痛，虚弱和血压升高。在新生儿中，阿片类药物戒断还可能包括：抽搐，过度哭闹和反应过度。

除盐酸纳洛酮外，还应提供其他复苏措施，如维持自由气道，人工通气，心脏按摩和血管加压剂，并在必要时使用，以对抗急性阿片类药物中毒。突然出现术后阿片类药物抑郁症逆转可能导致恶心，呕吐，出汗，颤抖，心动过速，血压升高，癫痫发作，室性心动过速和心房纤颤，肺水肿和心脏骤停，可能导致死亡。术后患者过量服用盐酸纳洛酮可能导致镇痛效果明显逆转，并可引起躁动（见注意事项，剂量和用药;成人术后阿片类药物抑郁症的使用）

【INDICATIONS AND USAGE】

Naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine.

Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone hydrochloride injection may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY: Adjunctive Us e in Septic Shock).

【CONTRAINDICATIONS】

Naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to it or to any of the other ingredients in naloxone hydrochloride.

【WARNINGS AND PRECAUTIONS】

Drug Dependence：

Naloxone hydrochloride should be administered cautiously to persons including newborns of mothers who are known or suspected to be physically dependent on opioids. In such cases an abrupt and complete reversal of opioid effects may precipitate an acute withdrawal syndrome. The signs and symptoms of opioid withdrawal in a patient physically dependent on opioids may include, but are not limited to, the following: body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In the neonate, opioid withdrawal may also include: convulsions, excessive crying, and hyperactive reflexes.

In addition to naloxone hydrochloride, other resuscitative measures such as maintenance of a free airway, artificial ventilation, cardiac massage, and vasopressor agents should be available and employed when necessary to counteract acute opioid poisoning. Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, increased blood pressure, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest which may result in death. Excessive doses of naloxone hydrochloride in postoperative patients may result in significant reversal of analgesia and may cause agitation (see PRECAUTIONS and DOSAGE AND ADMINISTRATION; Usage in AdultsPostoperative Opioid Depression).

【DOSAGE AND ADMINISTRATION】

Naloxone hydrochloride injection may be administered intravenously, intramuscularly, or subcutaneously. The most rapid onset of action is achieved by intravenous administration, which is recommended in emergency situations.

Since the duration of action of some opioids may exceed that of naloxone, the patient should be kept under continued surveillance. Repeated doses of naloxone should be administered, as necessary.

Intravenous Infusion：

Naloxone hydrochloride injection may be diluted for intravenous infusion in 0.9% sodium chloride or 5% dextrose injection. The addition of 2 mg of naloxone hydrochloride in 500 mL of either solution provides a concentration of 0.004 mg/mL. Mixtures should be used within 24 hours. After 24 hours, the remaining unused solution must be discarded. The rate of administration should be titrated in accordance with the patient's response. Naloxone hydrochloride injection should not be mixed with preparations containing bisulfite, metabisulfite, long-chain or high molecular weight anions, or any solution having an alkaline pH. No drug or chemical agent should be added to naloxone hydrochloride injection unless its effect on the chemical and physical stability of the solution has first been established.

General

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Usage in Adults

Opioid Overdose – Known or Suspected: An initial dose of 0.4 mg to 2 mg of naloxone hydrochloride may be administered intravenously. If the desired degree of counteraction and improvement in respiratory functions is not obtained, it may be repeated at two to three minute intervals. If no response is observed after 10 mg of naloxone hydrochloride have been administered, the diagnosis of opioid-induced or partial opioid-induced toxicity should be questioned. Intramuscular or subcutaneous administration may be necessary if the intravenous route is not available.

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详细处方信息以本药内容附件PDF文件（201952217014418.pdf）的“原文Priscribing Information”为准
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