Droperidol

Overview

A butyrophenone with general properties similar to those of haloperidol. It is used in conjunction with an opioid analgesic such as fentanyl to maintain the patient in a calm state of neuroleptanalgesia with indifference to surroundings but still able to cooperate with the surgeon. It is also used as a premedicant, as an antiemetic, and for the control of agitation in acute psychoses. (From Martindale, The Extra Pharmacopoeia, 29th ed, p593)

Indication

Droperidol is used to produce tranquilization and to reduce the incidence of nausea and vomiting in surgical and diagnostic procedures.

Associated Conditions

Agitation
Delirium
Nausea and vomiting

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Droperidol and QTc Interval Changes in ED Patients	2024/12/10	NCT06726811	N/A	Recruiting	CHRISTUS Health
Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery	2022/06/02	NCT05401058	Not Applicable	Recruiting	RenJi Hospital
Droperidol on Prevention of Cannabis Hyperemesis Syndrome	2022/02/17	NCT05244460	Phase 3	Recruiting	Mercy Health Ohio
Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis	2021/10/04	NCT05065567	Phase 3	Terminated	Spectrum Health - Lakeland
Simplified Algorithm for the Prevention of Postoperative Nausea and Vomiting in an Oncological Hospital	2020/06/02	NCT04411069	Phase 2	Completed	Instituto do Cancer do Estado de São Paulo
Gender Influence on Torsadogenic Actions of Droperidol.	2019/05/09	NCT03944681	Not Applicable	Completed	Medical University of Gdansk
Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery	2016/04/20	NCT02744495	Phase 3	Completed	Hôpital Privé de Parly II - Le Chesnay
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis	2015/12/09	NCT02625181	Not Applicable	Completed	Vanderbilt University
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)	2015/11/09	NCT02600741	N/A	Completed	Janssen Scientific Affairs, LLC
Akathisia in Post Operative Outpatients Surgery	2013/09/13	NCT01942343	Phase 3	Completed	University Hospital, Strasbourg, France

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Droperidol	American Regent, Inc.	0517-9702	INTRAMUSCULAR, INTRAVENOUS	2.5 mg in 1 mL	3/20/2023
DROPERIDOL	Hikma Pharmaceuticals USA Inc.	0143-9515	INTRAMUSCULAR, INTRAVENOUS	2.5 mg in 1 mL	6/8/2022
DROPERIDOL	Hikma Pharmaceuticals USA Inc.	0143-9514	INTRAMUSCULAR, INTRAVENOUS	2.5 mg in 1 mL	6/8/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Droperidol Injection	北京双鹭药业股份有限公司	国药准字H11022239	化学药品	注射剂(小容量注射剂)	7/23/2021
Droperidol Injection	上海旭东海普药业有限公司	国药准字H31020895	化学药品	注射剂	10/19/2021
Droperidol Injection	福州基石医药科技有限公司	国药准字H35020522	化学药品	注射剂	11/11/2019
Droperidol Injection	山东华鲁制药有限公司	国药准字H37022102	化学药品	注射剂	6/30/2020
Droperidol Injection	北京市永康药业有限公司	国药准字H11020579	化学药品	注射剂	7/14/2021
Droperidol Injection	北京市永康药业有限公司	国药准字H11020578	化学药品	注射剂(小容量注射剂)	12/29/2020
Droperidol Injection	山东鲁抗辰欣药业有限公司	国药准字H37020967	化学药品	注射剂	5/16/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
DROPERIDOL 2.5 mg/1 mL MEDICIANZ droperidol 2.5 mg/1 mL solution for injection ampoule	353871	Medsurge Pharma Pty Ltd	Medicine	A	12/8/2021
DROPERIDOL PANPHARMA droperidol 5 mg/2 mL solution for injection, ampoule	238347	Panpharma Australia Pty Ltd	Medicine	A	5/17/2016
DROPERIDOL PANPHARMA droperidol 2.5 mg/1 mL solution for injection, ampoule	238342	Panpharma Australia Pty Ltd	Medicine	A	5/17/2016
DROPERIDOL LUPIN droperidol 5 mg/2 mL solution for injection glass ampoule	256892	Southern Cross Pharma Pty Ltd	Medicine	A	3/6/2017
DROLEPTAN droperidol 2.5mg/1mL injection	46841	Phebra Pty Ltd	Medicine	A	11/1/1993
DROPERIDOL 2.5 mg/1 mL MEDSURGE droperidol 2.5 mg/1 mL solution for injection ampoule	353872	Medsurge Pharma Pty Ltd	Medicine	A	12/8/2021
DROPERIDOL PANPHARMA droperidol 1.25 mg/2.5 mL solution for injection, ampoule	238346	Panpharma Australia Pty Ltd	Medicine	A	5/17/2016
DROPERIDOL 1.25 mg/1 mL MEDSURGE droperidol 1.25 mg/1 mL solution for injection ampoule	353873	Medsurge Pharma Pty Ltd	Medicine	A	12/8/2021
DROPERIDOL AJS droperidol 2.5 mg/1 mL solution for injection glass ampoule	256872	Southern Cross Pharma Pty Ltd	Medicine	A	3/6/2017
DROPERIDOL 1.25 mg/1 mL MEDICIANZ droperidol 1.25 mg/1 mL solution for injection ampoule	353874	Medsurge Pharma Pty Ltd	Medicine	A	12/8/2021

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