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
Zemuron Side Effects, and Drug Interactions - Rocuronium
Zemuron Side Effects, and Drug Interactions - Rocuronium
SIDE EFFECTS
Clinical studies in the U.S. (n=1,137) and Europe (n=1,394) totaled 2,531 patients.
Prolonged neuromuscular block is associated with neuromuscular blockers as a
class. Prolonged neuromuscular block (166 minutes) occurred after 0.6 mg/kg
ZEMURON® (rocuronium bromide) Injection in an obese 67 year-old female with
hepatic dysfunction who had received gentamicin before surgery. The patients
exposed in the U.S. clinical studies provide the basis for calculation of adverse
reaction rates. The following adverse experiences were reported in patients
administered ZEMURON® Injection (all events judged by investigators during the
clinical trials to have a possible causal relationship):
Adverse experiences in greater than 1% patients: NONE
Adverse experiences in less than 1% of patients Probably Related or Relationship
Unknown:
|
Cardiovascular:
|
arrhythmia, abnormal electrocardiogram, tachycardia
|
|
Digestive:
|
nausea, vomiting
|
|
Respiratory:
|
asthma (bronchospasm, wheezing, or rhonchi), hiccup
|
|
Skin and Appendages:
|
rash, injection site edema, pruritus
|
In the European studies, the most commonly reported adverse experiences were
transient hypotension (2%) and hypertension (2%); it is in greater frequency
than the U.S. studies (0.1% and 0.1%). Changes in heart rate and blood pressure
were defined differently from the U.S. studies in which changes in cardiovascular
parameters were not considered as adverse events unless judged by the investigator
as unexpected, clinically significant, or thought to be histamine related.
In clinical practice, there have been rare reports of allergic reactions (anaphylactic
and anaphylactoid) with ZEMURON® (rocuronium bromide) Injection.
DRUG INTERACTIONS
Drug Interactions: The use of ZEMURON® (rocuronium bromide)
Injection before succinylcholine, for the purpose of attenuating some of the
side effects of succinylcholine, has not been studied.
If ZEMURON® is administered following administration of succinylcholine, it
should not be given until recovery from succinylcholine has been observed. The
median duration of action of ZEMURON® 0.6 mg/kg administered after a 1 mg/kg
dose of succinylcholine when T 1 returned to 75% of control was 36
minutes (range 14-57, n=12) vs. 28 minutes (17-51, n=12) without succinylcholine.
There are no controlled studies documenting the use of ZEMURON® before or after
other nondepolarizing muscle relaxants. Interactions have been observed when
other nondepolarizing muscle relaxants have been administered in succession.
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