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英文药名：DOPRAM injectable（Doxapram Hydrochloride Hydrate）
中文药名：盐酸多沙普伦注射剂
生产厂家：KISSEI药品
ドプラム注射液400mg
类别名称
呼吸加速器
商標名
DOPRAM injectable400mg
一般名：
ドキサプラム塩酸塩水和物（Doxapram Hydrochloride Hydrate）
化学名：
(4RS)-1-Ethyl-4-[2-(morpholin-4-yl)ethyl]-3,3-diphenylpyrrolidin-2-one monohydrochloride monohydrate
構造式：
分子式：
C24H30N2O2・HCl・H2O
分子量：
432.98
性状：
本产品是一种白色结晶或结晶性粉末。它是易溶于甲醇或乙酸（100），水，乙醇（95）或微溶于乙酸酐，并在乙醚中几乎不溶。
熔点：218〜222℃
审批条件
1.建立药品风险管理计划的顶部，要正确实施。
2.从事实，即在早产和这种药物的低出生体重儿使用了原发性呼吸暂停严重的胃肠道疾病很可能是表达，进行适当的调查，及时报告了调查结果。
药效药理
1. 呼吸促进作用
成年男性和手术的女性将已发现增加换气量。
此外，多沙普仑在与狗的实验已经发现，提高动脉血气分压。
2. 唤醒促进作用
成年妇女在手术后麻醉已观察到降低的唤醒时间。
3. 改善呼吸抑制的作用因麻醉性镇痛药
改善呼吸抑制，而不影响麻醉止痛剂的成年男性和女性的镇痛作用。
4. 作用机序
呼吸窘迫行动，通过外围化学感受器的传入神经活动主要发生，它指出，这对呼吸中枢选择性地作用。
适应病症
1. 呼吸抑制，以及在下面的状态觉醒延迟
(1) 麻醉时
(2) 期间由中枢神经系统抑制剂中毒
2. 呼吸暂停时间延长的鉴别诊断
3. 慢性肺疾病与急性附近超上限
4. 在早产和低出生体重儿原发性呼吸暂停（早产儿窒息）然而，只有在无法与黄嘌呤制剂中的治疗得到充分的效果。
用法用量
以原处方用法为准
包装规格
400毫克：1瓶（20毫升）
400毫克：5容器（20ml×5）
制造厂商
KISSEI药品有限公司
注：本品仅供研究，使用以原处方为准：http://www.info.pmda.go.jp/go/pack/2219400A1031_1_05/
DOPRAM injectable 400mg（Doxapram hydrochloride hydrate）
DOPRAM injectable 400mg（ドプラム注射液400mg[用于麻醉，如早产儿/内科/呼吸暂停]）
Brand name : DOPRAM injectable 400mg [Anesthesiology domain]
Active ingredient: Doxapram hydrochloride hydrate
Dosage form: injection
Print on wrapping:
Kissei Pharmaceutical Co.Ltd. Receives Approval in Japan for Additional Indication and Dosage and Administration of DOPRAM® Injectable 400mg for Primary Apnea in Premature and Low-Birth-Weight Infants (Apneic Attack of Prematurity)
Kissei Pharmaceutical Co., Ltd.
.Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto City, Nagano, Japan; President and CEO: Mutsuo Kanzawa; “Kissei”) announced today that it has received approval in Japan for a supplemental New Drug Application (NDA) of a respiratory stimulant DOPRAM® Injectable 400mg (generic name: doxapram hydrochloride hydrate, Japanese Pharmacopoeia) for an additional indication and dosage and administration of an apneic attack of prematurity after submitｔing an application with public knowledge.
Kissei had received an urgent request from healthcare professionals to develop an additional indication of the drug to treat apneic attacks of prematurity, and submitted the supplemental NDA for an additional indication of DOPRAM® in May 2014.
Kissei expects this approval to provide a new treatment option for patients and healthcare professionals.
Reference
Indication, Dosage and Administration (about apneic attack of prematurity)
Indication
Primary apnea in premature and low-birth-weight infants (apneic attack of prematurity), only when the desired effect is not obtained on treatment with xanthine preparations.
Dosage and Administration
Primary apnea in premature and low-birth-weight infants
(apneic attack of prematurity):
Usually, doxapram (1.5 mg/kg) is administered as an intravenous infusion over 1 h. This is followed by a continuous intravenous infusion of doxapram at 0.2 mg/kg/h. If the initial dose is ineffective, the dose should be increased to 0.4 mg/kg/h.
Primary apnea in premature and low-birth-weight infants (apnea of prematurity)
Apnea of prematurity is characterized by respiratory pauses that last for at least 20 seconds or by respiratory pauses that last for less than 20 seconds but are accompanied by bradycardia (<100 beats/min) or cyanosis in infants born after less than 37 weeks of gestation, with no underlying disorders that cause apnea. The risk increases with earlier gestational age, affecting about 25% of preterm infants and almost all infants born at less than 28 weeks of gestation.
Application with public knowledge
This application category is applicable to cases in which the efficacy and safety of the off-label use (e.g., indication) of a drug have been confirmed by medical and pharmaceutical knowledge in the public domain, allowing an application for the addition of a particular off-label use to be submitted without the need for a complete or partial clinical trial program.
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