Overview
DESCRIPTION Droperidol Injection, USP, is a sterile, non-pyrogenic, aqueous solution for intravenous or intramuscular use only. Each mL contains: Droperidol…………………………………….2.5 mg Water for Injection………………………........q.s. pH adjusted between 3.0 and 3.8 with lactic acid and, if necessary, with sodium hydroxide. Droperidol is a neuroleptic (tranquilizer) agent.
Mechanism of Action
CLINICAL PHARMACOLOGY Droperidol produces marked tranquilization and sedation. It allays apprehension and provides a state of mental detachment and indifference while maintaining a state of reflex alertness. Droperidol produces an antiemetic effect as evidenced by the antagonism of apomorphine in dogs. It lowers the incidence of nausea and vomiting during surgical procedures and provides antiemetic protection in the postoperative period. Droperidol potentiates other CNS depressants. It produces mild alpha-adrenergic blockade, peripheral vascular dilatation and reduction of the pressor effect of epinephrine. It can produce hypotension and decreased peripheral vascular resistance and may decrease pulmonary arterial pressure (particularly if it is abnormally high).
Indications
- INDICATIONS AND USAGE Droperidol Injection is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures.
Common Doses
- 2.5 mg
- 1.25 mg
- 0.1 mg
Dosage
DOSAGE AND ADMINISTRATION Dosage should be individualized . Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved. Vital signs and ECG should be monitored routinely. Adult Dosage: The maximum recommended initial dose of droperidol is 2.5 mg IM or slow IV. Additional 1.25 mg doses of droperidol may be administered to achieve the desired effect.
Black Box Warning
WARNING Cases of QT prolongation and/or torsade de pointes have been reported in patients receiving droperidol 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, droperidol 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...
Contraindications
- CONTRAINDICATIONS Droperidol is contraindicated in patients with known or suspected QT prolongation (i.e., QTc interval greater than 440 msec for males or 450 msec for females). This would include patients with congenital long QT syndrome. Droperidol is contraindicated in patients with known hypersensitivity to the drug. Droperidol is not recommended for any use other than for the treatment of perioperative nausea and vomiting in patients for whom other treatments are ineffective or inappropriate (see WARNINGS ).
Side Effects
- ADVERSE REACTIONS QT interval prolongation, torsade de pointes, cardiac arrest, and ventricular tachycardia have been reported in patients treated with droperidol. Some of these cases were associated with death. Some cases occurred in patients with no known risk factors, and some were associated with droperidol doses at or below recommended doses. Physicians should be alert to palpitations, syncope, or other symptoms suggestive of episodes of irregular cardiac rhythm in patients taking droperidol and promptly evaluate such cases (see WARNINGS, Effects on Cardiac Conduction ).
Interactions
- Drug Interactions Potentially Arrhythmogenic Agents: Any drug known to have the potential to prolong the QT interval should not be used together with droperidol. Possible pharmacodynamic interactions can occur between droperidol and potentially arrhythmogenic agents such as class I or III antiarrhythmics, antihistamines that prolong the QT interval, antimalarials, calcium channel blockers, neuroleptics that prolong the QT interval, and antidepressants.