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Droperidol

Drug Approvals

(British Approved Name, US Adopted Name, rINN)

INNs in other languages (French, Latin, Spanish):

Synonyms: Droperidol; Droperidoli; Droperidolis; Droperidolum; McN-JR-4749; R-4749
BAN: Droperidol
USAN: Droperidol
INN: Droperidol [rINN (en)]
INN: Droperidol [rINN (es)]
INN: Dropéridol [rINN (fr)]
INN: Droperidolum [rINN (la)]
INN: Дроперидол [rINN (ru)]
Chemical name: 1-{1-[3-(4-Fluorobenzoyl)propyl]-1,2,3,6-tetrahydro-4-pyridyl}-benzimidazolin-2-one
Molecular formula: C22H22FN3O2 =379.4
CAS: 548-73-2
ATC code: N01AX01; N05AD08
Read code: y019B [Anaesthesia]; y0206; y08Cr [CNS Use]

Pharmacopoeias. In Europe, Japan, and US.

 

European Pharmacopoeia, 6th ed. (Droperidol). A white or almost white powder. It exhibits polymorphism. Practically insoluble in water sparingly soluble in alcohol freely soluble in dichloromethane and in dimethylformamide. Protect from light.

The United States Pharmacopeia 31, 2008 (Dropendol). A white to light tan amorphous or microcrystalline powder. Practically insoluble in water soluble 1 in 140 of alcohol, 1 in 4 of chloroform, and 1 in 500 of ether. Store under nitrogen in airtight containers at a temperature of 8° to 15°. Protect from light.

Adverse Effects, Treatment, and Precautions

As for Chlorpromazine. There is an increased risk of cardiotoxicity and prolongation of the QT interval with droperidol. Droperidol should not be used in patients with known or suspected QT prolongation it should also be used with extreme caution in patients at risk of arrhythmias, including those with impairment of cardiac function, hypokalaemia, or other electrolyte imbalance. It is recommended that a baseline ECG is performed in all patients before use of droperidol.

Droperidol

Uses and Administration

Droperidol is a butyrophenone with general properties similar to those of haloperidol. The duration of action of droperidol has been reported to last about 2 to 4 hours although alteration of alertness may last for up to 12 hours. One manufacturer of droperidol (Janssen-Cilag) voluntarily withdrew it from the market worldwide in March 2001 after reports of QT prolongation, serious ventricular arrhythmias, or sudden death in association with its use. However, in the USA, droperidol remained available from other manufacturers although its use was restricted to the management of nausea and vomiting after surgical or diagnostic procedures in patients who fail to show an adequate response to other treatments. It is also still available, in some other countries, for use as a premedicant, as an adjunct in anaesthesia, and for the control of agitated patients in acute psychoses and in mania. Droperidol has been used in the management of chemotherapy-induced nausea and vomiting. It has also been used with an opioid analgesic such as fentanyl citrate to maintain patients in a state of neuroleptanalgesia in which they are calm and indifferent to the surroundings and able to cooperate with the surgeon. The longer duration of action of droperidol must be kept in mind when using it with such opioid analgesics.

For the prevention of postoperative nausea and vomiting a maximum initial dose of 2.5 mg intramuscularly or intravenously has been given additional doses of 1.25 mg may be given if necessary. Children aged 2 years and over have been given a maximum initial dose of 100 micrograms/kg intramuscularly or intravenously.

Preparations

British Pharmacopoeia 2008: Droperidol Injection; Droperidol Tablets

The United States Pharmacopeia 31, 2008: Droperidol Injection.

Proprietary Preparations

 

Australia:: Droleptan

Belgium: Dehydrobenzperidol

Brazil: Droperdal

Czech Republic: Dehydrobenzperidol Xomolix

Denmark: Dehydrobenzperidol

Finland: Dehydrobenzperidol

France: Droleptan

Greece: Dehydrobenzperidol Droleptan

India: Droperol

Italy: Sintodian

The Netherlands: Dehydrobenzperidol

New Zealand: Droleptan

Portugal: Dehidrobenzperidol Xomolix

South Africa: Paxical

Spain: Dehidrobenzperidol

Sweden: Dridol

Thailand: Dehydrobenzperidol

USA: Inapsine

Multi-ingredient:

Argentina: Disifelit

Brazil: Nilperidol

Italy: Leptofen

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