DROPERIDOL injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Regent, 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 available as: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DROPERIDOL- DROPERIDOL INJECTION, SOLUTION
AMERICAN REGENT, INC.
----------
DROPERIDOL INJECTION, USP
For IV or IM Use Only
RX 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 CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and
ADVERSE REACTIONS).
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, and use
of agents