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  药店国别: 美国药房
产地国家: 美国
所属类别: 神经系统药物->镇痛药
处方药:处方药
包装规格: 1毫克/毫升 1毫升/小瓶 10小瓶/盒
计价单位:
  点击放大  
生产厂家英文名:
Hospira, Inc.
该药品相关信息网址1:
https://www.rxlist.com/stadol-side-effects-drug-center.htm
原产地英文商品名:
Butorphanol Tartrate 1mg/mL 1mL/vial 10vials/box
原产地英文药品名:
Butorphanol Tartrate
中文参考商品译名:
酒石酸布托啡诺 1毫克/毫升 1毫升/小瓶 10小瓶/盒
中文参考药品译名:
酒石酸布托啡诺
原产地国家批准上市年份:
2005/09/23
英文适应病症1:
preoperative or pre-anesthetic medication
英文适应病症2:
as a supplement to balanced anesthesia
英文适应病症3:
or the relief of pain during labor
临床试验期:
完成
中文适应病症参考翻译1:
术前或麻醉前用药
中文适应病症参考翻译2:
平衡麻醉的补充
中文适应病症参考翻译3:
缓解分娩时的疼痛
药品信息:

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详细处方信息以本药内容附件PDF文件(201962616425813.pdf)的“原文Priscribing Information”为准
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部分中文酒石酸布托啡诺处方资料(仅供参考)

【英文名称】Butorphanol Tartrate

【适用证】

---作为术前或麻醉前用药

---作为平衡麻醉的补充

---用于缓解分娩时的疼痛,以及

---用于治疗严重到足以需要阿片类镇痛剂并且替代治疗方法不足的疼痛。

使用限制

由于阿片类药物成瘾,滥用和滥用的风险,即使按推荐剂量[见警告],也可以使用酒石酸布托啡诺用于替代治疗方案的患者[例如 非阿片类镇痛药]

- 未被容忍,或预计不会被容忍

- 未提供足够的镇痛,或预计不会提供足够的镇痛效果

【用法用量】

重要剂量​​和管理说明

使用最短有效剂量,持续时间与个体患者治疗目标一致(见警告)。

根据患者的疼痛严重程度,患者反应,先前的镇痛治疗经验以及成瘾,滥用和误用的风险因素,单独为每位患者开始给药方案(见警告)。

密切监测患者的呼吸抑制情况,特别是在开始治疗的前24至72小时内,使用布托啡诺酒石酸盐注射液增加剂量后,相应调整剂量(见警告)。

初始剂量

确定剂量时需要考虑的因素包括年龄,体重,身体状况,潜在病理状况,其他药物的使用,使用的麻醉类型以及所涉及的手术程序。在老年人,肝病或肾病患者或分娩患者中使用需要格外小心(参见预防措施部分和临床药理学:剂量个体化部分)。以下剂量适用于没有肝功能或肾功能受损且未使用CNS活性剂的患者。

用于疼痛

静脉内

如果需要,通常推荐的静脉内给药单剂量为每3至4小时重复1mg。根据疼痛的严重程度,有效剂量范围为每3至4小时重复0.5至2mg。

肌内

如果发生嗜睡或头晕,通常推荐的IM给药单剂量为2 mg患者,能够保持卧姿。必要时,这可以每三到四小时重复一次。取决于疼痛严重程度的有效剂量范围是每3-4小时重复1至4mg。没有足够的临床数据推荐超过4毫克的单剂量。

【禁忌】

布托啡诺酒石酸盐注射液禁用于:

⭕️患有严重呼吸抑制的患者(见警告)

⭕️患有急性严重支气管哮喘的患者,在不受监控的情况下或没有复苏设备(见警告)

⭕️患有已知或疑似胃肠道阻塞的患者,包括麻痹性肠梗阻(见警告)

⭕️对酒石酸布托啡诺或任何配方辅料过敏的患者(如过敏反应)(见警告)

【INDICATIONS AND USAGE】

Butorphanol Tartrate Injection is indicated

---as a preoperative or pre-anesthetic medication

---as a supplement to balanced anesthesia

---for the relief of pain during labor, and

---for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve butorphanol tartrate for use in patients for whom alternative treatment options [e.g. non-opioid analgesics]

--Have not been tolerated, or are not expected to be tolerated

--Have not provided adequate analgesia, or are not expected to provide adequate analgesia

【DOSAGE AND ADMINISTRATION】

Important Dosage and Administration Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse (see WARNINGS).

Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with Butorphanol Tartrate Injection and adjust the dosage accordingly (see WARNINGS).

Initial Dosage

Factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and surgical procedure involved. Use in the elderly, patients with hepatic or renal disease, or in labor requires extra caution (see PRECAUTIONS section and CLINICAL PHARMACOLOGY:Individualization of Dosage section). The following doses are for patients who do not have impaired hepatic or renal function and who are not on CNS active agents.

Use for Pain

Intravenous

The usual recommended single dose for IV administration is 1 mg repeated every three to four hours as necessary. The effective dosage range, depending on the severity of pain, is 0.5 to 2 mg repeated every three to four hours.

Intramuscular

The usual recommended single dose for IM administration is 2 mg in patients who will be able to remain recumbent, in the event drowsiness or dizziness occurs. This may be repeated every three to four hours, as necessary. The effective dosage range depending on the severity of pain is 1 to 4 mg repeated every three to four hours. There are insufficient clinical data to recommend single doses above 4 mg.

【CONTRAINDICATIONS】

Butorphanol Tartrate Injection is contraindicated in:

⭕️Patients with significant respiratory depression (see WARNINGS)

⭕️Patients with acute of severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see WARNINGS)

⭕️Patients with known or suspected gastrointestinal obstruction, including paralytic ileus (see WARNINGS)

⭕️Patients with hypersensitivity to butorphanol tartrate or any of the formulation excipients (e.g., anaphylaxis) (see WARNINGS)

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详细处方信息以本药内容附件PDF文件(201962616425813.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2019-6-25
附件:
201962616425813.pdf    

 
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