Generic Name for INAPSINE
Droperidol 2.5mg/mL; soln for IV or IM inj.
Legal Classification:
Rx
Pharmacological Class for INAPSINE
Neuroleptic.
Manufacturer of INAPSINE
Akorn, Inc.
Indications for INAPSINE
To reduce incidence of nausea and vomiting associated with surgical and diagnostic procedures.
Adult dose for INAPSINE
Max initial dose: 2.5mg IM or slow IV; may give additional 1.25mg doses to achieve desired effect.
Children's dosing for INAPSINE
<2yrs: not recommended. ≥2: max initial dose: 0.1mg/kg.
Contraindications for INAPSINE
QT prolongation (including congenital long QT syndrome).
Warnings/Precautions for INAPSINE
Perform ECG prior to administration to determine if prolonged QT interval present; if prolonged, do not administer unless treatment outweighs risks; if treating, monitor for arrhythmias: perform ECG prior to treatment and 2–3 hours after completion. Risk factors for QT prolongation: CHF, bradycardia, cardiac hypertrophy, hypokalemia, hypomagnesemia, >65yrs, alcohol abuse. Pheochromocytoma. Hepatic or renal impairment. Elderly. Debilitated. Critically ill. Labor & delivery: not recommended. Pregnancy (Cat.C). Nursing mothers.
Interactions for INAPSINE
Risk of QT prolongation with concomitant Class I and III antiarrhythmics, MAOIs, antimalarials, calcium channel blockers, benzodiazepines, volatile anesthetics, IV opiates, other drugs that prolong QT interval. Caution with drugs that induce hypokalemia, hypomagnesemia (eg, diuretics, laxatives). Additive effects with CNS depressants (eg, barbiturates, tranquilizers, opioids, general anesthetics). Possible hypertension with concomitant fentanyl citrate inj.
Adverse Reactions for INAPSINE
Hypotension, tachycardia, dysphoria, drowsiness, restlessness, hyperactivity, anxiety, QT prolonation, torsade de pointes, cardiac arrest, ventricular tachycardia, neuroleptic malignant syndrome, post-op hallucinatory episodes.
How is INAPSINE supplied?
Ampules (1mL, 2mL)—10; Vials (1mL, 2mL)—25
HOW SUPPLIED
INAPSINE® (droperidol) Injection is available as:
NDC 17478-010-01, 2.5 mg/mL, 1 mL ampules in packages of 10
NDC 17478-010-02, 2.5 mg/mL, 2 mL ampules in packages of 10
NDC 17478-531-01, 2.5 mg/mL, 1 mL vials in packages of 25
NDC 17478-531-02, 2.5 mg/mL, 2 mL vials in packages of 25
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.
【中文名称】 氟哌利多注射液
【英文名称】 Droperidol Injection
【功效主治】
1、用于精神分裂症和躁狂症兴奋状态。
2、本品有神经安定作用及增强镇痛药的镇痛作用,与芬太尼合用静脉注射时,可使病人产生特殊麻醉状态,称为神经安定镇痛术,用于大面积烧伤换药,各种内窥镜检查。
【化学成分】
本品主要成分为氟哌利多,其化学名称为:1-[1-[3-(对-氟苯甲酰基)丙基]-1,2,3,6-四氢-4-吡啶基]-2-苯并咪唑啉酮。
【药理作用】
本品属丁酰苯类抗精神病药,抗精神病作用与其阻断脑内多巴胺受体,并可促进脑内多巴胺的转化有关。其特点是体内代谢快,作用维持时间短,还具有安定和增强镇痛作用。
【药物相互作用】
1 本品与乙醇或其他中枢神经系统抑制药合用,中枢抑制作用增强。
2 本品与抗高血压药合用,易致体位性低血压。
【不良反应】
1 锥体外系反应较重且常见,急性肌张力障碍在儿童和青少年更易发生,出现明显的扭转痉挛,吞咽困难,静坐不能及类帕金森病。
2 可出现口干、视物模糊、乏力、便秘、出汗等。
3 可引起血浆中泌乳素浓度增加,可能有关的症状为:溢乳、男子女性化乳房、月经失调、闭经。
4 少数病人可能引起抑郁反应。
5 可引起注射局部红肿、疼痛、硬结。
6 较少引起低血压。
7 偶见过敏性皮疹及恶性综合征。
【禁 忌 症】 基底神经节病变、帕金森病、帕金森综合征、严重中枢神经抑制状态者、抑郁症及对本品过敏者。
【规 格】 2ml:5mg
【用法用量】 用于控制急性精神病的兴奋躁动:肌内注射一日5~10mg。用于神经安定镇痛:5mg加入0.1mg枸橼酸芬太尼,在2~3分钟内缓慢静脉注射。
【贮藏方法】 遮光,密闭,阴凉处保存。
【注意事项】