DROPERIDOL injection solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Cardinal Health

INN (International Nazwa):

DROPERIDOL

Skład:

DROPERIDOL 2.5 mg in 1 mL

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

DROPERIDOL- DROPERIDOL INJECTION, SOLUTION
CARDINAL HEALTH
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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 such a