A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Brevibloc Side Effects, and Drug Interactions - Esmolol
Brevibloc Side Effects, and Drug Interactions - Esmolol
SIDE EFFECTS
The following adverse reaction
rates are based on use of BREVIBLOC® (esmolol HCl)
in clinical trials
involving 369 patients with supraventricular tachycardia and over
600 intraoperative
and postoperative patients enrolled in clinical
trials. Most adverse effects observed in controlled clinical trial
settings have been mild and transient. The most important adverse
effect has been hypotension
(see WARNINGS). Deaths have
been reported in post-marketing experience
occurring during complex clinical
states where BREVIBLOC was presumably being used simply to control
ventricular rate
(see WARNINGS/Cardiac Failure).
Cardiovascular - Symptomatic hypotension
(diaphoresis, dizziness) occurred in 12% of patients, and therapy
was discontinued in about 11%, about half of whom were symptomatic.
Asymptomatic hypotension
occurred in about 25% of patients. Hypotension resolved during BREVIBLOC
(esmolol HCl) infusion
in 63% of these patients and within 30 minutes after discontinuation
of infusion in 80%
of the remaining patients. Diaphoresis accompanied hypotension in
10% of patients. Peripheral ischemia
occurred in approximately 1% of patients. Pallor, flushing, bradycardia
(heart rate less than 50
beats per minute), chest
pain, syncope,
pulmonary edema
and heart block
have each been reported in less than 1% of patients. In
two patients without supraventricular tachycardia
but with serious coronary
artery disease
(post inferior myocardial
infarction or unstable
angina), severe bradycardia/sinus pause/asystole has developed,
reversible in both
cases with discontinuation of treatment.
Central Nervous System - Dizziness has occurred in 3% of
patients; somnolence in 3%; confusion,
headache, and agitation
in about 2%; and fatigue in about 1% of patients. Paresthesia, asthenia,
depression, abnormal
thinking, anxiety, anorexia,
and lightheadedness were reported in less than 1% of patients. Seizures
were also reported in less than l% of patients, with one death.
Respiratory - Bronchospasm, wheezing,
dyspnea, nasal
congestion, rhonchi, and rales have each been reported in less than
1% of patients.
Gastrointestinal - Nausea was reported in 7% of patients.
Vomiting has occurred in about 1% of patients. Dyspepsia, constipation,
dry mouth, and abdominal
discomfort have each occurred in less than 1% of patients. Taste
perversion has also
been reported.
Skin (Infusion Site) - Infusion site
reactions including inflammation and induration
were reported in about 8% of patients. Edema, erythema, skin discoloration,
burning at the infusion
site, thrombophlebitis,
and local skin necrosis
from extravasation
have each occurred in less than 1% of patients.
Miscellaneous - Each of the following has been reported
in less than 1% of patients: Urinary retention,
speech disorder, abnormal
vision, midscapular pain,
rigors, and fever.
DRUG INTERACTIONS
Catecholamine-depleting drugs, e.g., reserpine, may have an additive
effect when given with beta
blocking agents. Patients
treated concurrently with BREVIBLOC (esmolol HCl) and a catecholamine
depletor should therefore be closely observed for evidence
of hypotension or
marked bradycardia, which may result in vertigo, syncope,
or postural hypotension.
A study of interaction between BREVIBLOC and warfarin showed that
concomitant administration of BREVIBLOC and warfarin does not alter
warfarin plasma levels. BREVIBLOC concentrations were equivocally
higher when given with warfarin, but this is not likely to be clinically
important.
When digoxin and BREVIBLOC
were concomitantly administered intravenously to normal
volunteers, there was a 10-20% increase in digoxin
blood levels at some time
points. Digoxin did not affect
BREVIBLOC pharmacokinetics. When intravenous
morphine and BREVIBLOC
were concomitantly administered in normal
subjects, no effect
on morphine blood
levels was seen, but BREVIBLOC steady-state blood
levels were increased by 46% in the presence of morphine. No other
pharmacokinetic parameters were changed.
The effect of BREVIBLOC
on the duration of
succinylcholine-induced neuromuscular blockade was studied in patients
undergoing surgery. The onset of neuromuscular blockade by succinylcholine
was unaffected by BREVIBLOC, but the duration of neuromuscular
blockade was prolonged
from 5 minutes to 8 minutes.
Although the interactions observed in these studies do not appear
to be of major clinical
importance, BREVIBLOC should be titrated with caution in patients
being treated concurrently with digoxin, morphine, succinylcholine
or warfarin.
While taking beta blockers,
patients with a history
of severe anaphylactic reaction to a variety
of allergens may be more reactive to repeated challenge, either
accidental, diagnostic, or therapeutic. Such patients may be unresponsive
to the usual doses of epinephrine
used to treat allergic
reaction.
Caution should be exercised when considering the use of BREVIBLOC
and verapamil in patients with depressed
myocardial function.
Fatal cardiac arrests have occurred in patients receiving both drugs.
Additionally, BREVIBLOC should not be used to control
supraventricular
tachycardia in the
presence of agents which are vasoconstrictive
and inotropic such
as dopamine, epinephrine, and norepinephrine
because of the danger of blocking
cardiac contractility
when systemic vascular
resistance is high.
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