Hypotension, Orthostatic Hypotension, and Bradycardia:
IGALMI causes dose-dependent hypotension, orthostatic hypotension, and
bradycardia. Because IGALMI decreases sympathetic nervous system
activity, hypotension and/or bradycardia may be more pronounced in
patients with hypovolemia, diabetes mellitus, or chronic hypertension,
and in geriatric patients. Avoid use of IGALMI in patients with
hypotension, orthostatic hypotension, advanced heart block, severe
ventricular dysfunction, or history of syncope. After IGALMI
administration, patients should be adequately hydrated and should sit or
lie down until vital signs are within normal range. If a patient is
unable to remain seated or lying down, precautions should be taken to
reduce the risk of falls. Ensure that a patient is alert and not
experiencing orthostatic hypotension or symptomatic hypotension prior to
allowing them to resume ambulation.
QT Interval Prolongation: IGALMI prolongs
the QT interval. Avoid use of IGALMI in patients at risk of torsades de
pointes or sudden death, including those with known QT prolongation, a
history of other arrhythmias, symptomatic bradycardia, hypokalemia, or
hypomagnesemia, and in patients receiving other drugs known to prolong
the QT interval.
Somnolence: IGALMI can cause somnolence. Patients
should not perform activities requiring mental alertness, such as operating
a motor vehicle or operating hazardous machinery, for at least eight hours
after taking IGALMI.
Risk of Withdrawal Reactions, Tolerance, and Tachyphylaxis:
IGALMI was not studied for longer than 24 hours after the first dose.
There may be a risk of physical dependence, a withdrawal syndrome,
tolerance, and/or tachyphylaxis if IGALMI is used in a manner other than