WARNING
Cases of QT prolongation and/or torsade de pointes have been reported in patients receiving INAPSINE at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal.
Due to its potential for serious proarrhythmic effects and death, INAPSINE should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see Warnings, Adverse Reactions, Contraindications, and Precautions).
Cases of QT prolongation and serious arrhythmias (e.g., torsade de pointes) have been reported in patients treated with INAPSINE. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of INAPSINE to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, INAPSINE should NOT be administered. For patients in whom the potential benefit of INAPSINE treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2 to 3 hours after completing treatment to monitor for arrhythmias.
INAPSINE is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome.
INAPSINE should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome (e.g., congestive heart failure, bradycardia, use of a diuretic, cardiac hypertrophy, hypokalemia, hypomagnesemia, or administration of other drugs known to increase the QT interval). Other risk factors may include age over 65 years, alcohol abuse, and use of agents such as benzodiazepines, volatile anesthetics, and IV opiates. Droperidol should be initiated at a low dose and adjusted upward, with caution, as needed to achieve the desired effect.
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INAPSINE SUMMARY
INAPSINE contains droperidol, a neuroleptic (tranquilizer) agent.
INAPSINE (droperidol) is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures.
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NEWS HIGHLIGHTSMedia Articles Related to Inapsine (Droperidol)
Nausea and Vomiting
Source: MedicineNet Antiemetics Specialty [2008.04.29]
Title: Nausea and Vomiting
Category: Diseases and Conditions
Created: 1/31/2005 8:21:00 AM
Last Editorial Review: 4/29/2008
Published Studies Related to Inapsine (Droperidol)
Droperidol has comparable clinical efficacy against both nausea and vomiting. [2009.09]
BACKGROUND: Droperidol is commonly noted to be more effective at preventing postoperative nausea (PON) than vomiting (POV) and it is assumed to have a short duration of action. This may be relevant for clinical decisions, especially for designing multiple-drug antiemetic regimens... CONCLUSIONS: We conclude that droperidol prevents PON and POV equally well, yet its duration of action is short-lived.
Olanzapine versus droperidol for the treatment of primary headache in the emergency department. [2008.09]
OBJECTIVES: The objective was to determine if there is a difference in pain relief or frequency and severity of side effects in emergency department (ED) patients with primary headache treated with either intramuscular (IM) olanzapine or IM droperidol... CONCLUSIONS: Both olanzapine and droperidol are effective treatments for primary headaches in the ED. No significant differences were found between the medications in terms of pain relief, antiemetic effect, or akathisia. Olanzapine may be used to treat primary headache and it is an effective alternative to droperidol.
Droperidol and ondansetron-induced QT interval prolongation: a clinical drug interaction study. [2008.08]
BACKGROUND: Droperidol and ondansetron have previously been found to prolong the QT interval in the treatment of postoperative nausea and vomiting. However, this adverse effect has never been confirmed and compared with both drugs under controlled conditions. The objective was to study the effects of droperidol and ondansetron alone or in combination on QT interval duration in healthy subjects... CONCLUSIONS: Under controlled conditions, both droperidol and ondansetron either alone or in combination induced significant marked QTc interval prolongation. However, the combination of both drugs did not significantly increase QTc prolongation compared with that induced by droperidol alone.
Postoperative nausea and vomiting after surgery for prognathism: not only a question of patients' comfort. A placebo-controlled comparison of dolasetron and droperidol. [2008.04]
CONCLUSION: Intravenous dolasetron (12.5 mg) is more effective than either intravenous DHB (1.25 mg) or placebo for preventing PONV after surgery for prognathism. It also was significantly superior to either DHB or placebo concerning nausea and vomiting and the need for MCP rescue medication.
The antipruritic and antiemetic effects of epidural droperidol: a study of three methods of administration. [2007.07]
BACKGROUND: In this study, we compared rates of postoperative nausea and vomiting (PONV) and pruritus after using different protocols for administering epidural droperidol... CONCLUSION: Epidural droperidol is effective for reducing pruritus and PONV, regardless of the method of administration.
Clinical Trials Related to Inapsine (Droperidol)
The Effects of the Anti Nausea Drugs Droperidol and Ondansetron on the Way the Heart Recovers Between Beats [Recruiting]
We are investigating a new technique for testing the effect of drugs on electrical activity
in the heart. Disturbances of this electrical activity can cause life-threatening changes to
heart rhythms. A better way of measuring the risk has recently been developed, and our
research team leads the world in using this tool to test the safety of drugs used in
children. Children and their families want to know that the drugs being used are safe, as do
the doctors that care for them. In this study, we will take heartbeat tracings (ECGs) from 60
children before and during their operations. The ECGs will then be checked by a children's
heart specialist. Differences on the ECGs will be related to the presence and amount of drug
(droperidol or ondansetron) given. We expect that the droperidol or ondansetron will not
cause any changes that show increased risk of abnormal heart rhythms. We can then tell
patients, parents and regulatory authorities of the safety profile of this aspect of the
drug; moreover, the study can be used as a model for testing many other drugs used in
hospitals.
Evaluation of 2 Doses of Intravenous Droperidol in the Prevention of Postoperative Nausea [Recruiting]
In this prospective, randomised, placebo-controlled study, the researchers determined
whether 0. 625 mg or 2. 5 mg of IV droperidol given 30 min before emergence from general
anaesthesia reduces the incidence of immediate and delayed post operative nausea and
vomiting (PONV) in thyroid surgical female population. Two hundred and forty six female
patients receiving general anaesthesia for thyroid surgery received either droperidol 0. 625
mg or droperidol 2. 5 mg or placebo before emergence.
Role of Droperidol in Postoperative Vomiting [Recruiting]
Protocol Synopsis
Protocol title: Role of low dose droperidol in postoperative vomiting Purpose: Evaluate the
efficacy of droperidol to postoperative nausea and vomiting when administrated at the
introduction to anesthesia, prior to surgery Design: Prospective, randomized,
placebo-controlled study Patient Population: Male or female subjects 18 years of age or older
who are scheduled for laparoscopic cholecystectomy No. of Subjects: 100 patients divided into
two groups, estimated up to 6 months to enroll Duration of Treatment: Prior operation Duration
of Follow-up: Follow-up will be performed for 24 hours postoperatively Endpoints: To evaluate
the effectiveness of low dose droperidol when administered Prior surgery
Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy [Not yet recruiting]
To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a
group receiving SOC + additional perioperative analgesics in terms of postoperative
abilities, PONV, pain and discharge time from the PACU
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Page last updated: 2009-10-20
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