DROPERIDOL injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DROPERIDOL (UNII: O9U0F09D5X) (DROPERIDOL - UNII:O9U0F09D5X)

Available from:

Hospira, Inc.

INN (International Name):

DROPERIDOL

Composition:

DROPERIDOL 2.5 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Droperidol injection is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures. 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).

Product summary:

Droperidol Injection, USP 2.5 mg/mL is supplied in 2 mL (5 mg) single-dose ampuls packaged in cartons of ten (List No. 1187). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DROPERIDOL- DROPERIDOL INJECTION, SOLUTION
HOSPIRA, INC.
----------
DROPERIDOL
Injection, USP
For Intravenous or Intramuscular
Use Only
AMPUL
R only
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 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 droperidol. Based on these reports, all patients
should undergo a 12-lead
ECG prior to administration of droperidol 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, droperidol should NOT be administered. For patients in whom
the potential benefit of
droperidol treatment is felt to outweigh the risks of potentially
serious arrhythmias, ECG
monitoring should be performed prior to treatment and continued for
2-3 hours after completing
treatment to monitor for arrhythmias.
Droperidol is contraindicated in patients with known or suspected QT
prolongation, including
patients with congenital long QT syndrome.
Droperidol 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, a