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
Nimbex Side Effects, and Drug Interactions - Cisatracurium Besylate
Nimbex Side Effects, and Drug Interactions - Cisatracurium Besylate
SIDE EFFECTS
Observed in Clinical Trials of Surgical Patients
Adverse experiences were uncommon among the 945 surgical
patients who received NIMBEX in conjunction with other drugs in
US and European clinical studies in the course of a wide variety
of procedures in patients receiving opioid, propofol, or inhalation
anesthesia. The following adverse experiences were judged by investigators
during the clinical
trials to have a possible causal relationship to administration
of NIMBEX:
Incidence Greater than 1%: None.
Incidence Less than 1%:
- Cardiovascular: Bradycardia (0.4%), hypotension
(0.2%), flushing (0.2%).
- Respiratory: Bronchospasm (0.2%).
- Dermatological: Rash (0.1%).
Observed in Clinical Trials of Intensive Care Unit Patients
Adverse experiences were uncommon among the 68 ICU
patients who received NIMBEX in conjunction with other drugs in
US and European clinical
studies. One patient
experienced bronchospasm. In
one of the two ICU studies,
a randomized and double-blind study of ICU
patients using TOF neuromuscular monitoring, there were two reports
of prolonged recovery
(167 and 270 minutes) among 28 patients administered NIMBEX and
13 reports of prolonged recovery (range: 90 minutes to 33 hours)
among 30 patients administered vecuronium.
Observed During Clinical Practice
In addition to adverse
events reported from clinical
trials, the following events have been identified during post-approval
use of cisatracurium besylate in conjunction with one or more anesthetic
agents in clinical
practice. Because they are reported voluntarily from a population
of unknown size, estimates of frequency
cannot be made. These events have been chosen for inclusion due
to a combination of their seriousness, frequency
of reporting, or potential
causal connection to cisatracurium besylate.
General: Hypersensitivity reactions including anaphylactic
or anaphylactoid responses which, in rare instances, were severe. There are rare reports of wheezing, laryngospasm, bronchospasm, rash and itching following administration of Nimbex in children. These reported adverse events were not serious and their etiology could not be established with certainty.
Musculoskeletal: Prolonged neuromuscular
block, inadequate neuromuscular block.
DRUG INTERACTIONS
NIMBEX has been used safely following varying degrees of recovery
from succinylcholine-induced neuromuscular
block. Administration of 0.1-mg/kg (2 x ED95) NIMBEX
at 10% or 95% recovery
following an intubating dose of succinylcholine (1 mg/kg) produced
³95% neuromuscular block. The time
to onset of maximum
block following NIMBEX
is approximately 2 minutes faster with prior administration
of succinylcholine. Prior administration
of succinylcholine had no
effect on the duration
of neuromuscular block
following initial or
maintenance bolus doses
of NIMBEX. Infusion requirements of NIMBEX in patients administered
succinylcholine prior to infusions of NIMBEX were comparable to
or slightly greater than when succinylcholine was not administered.
The use of NIMBEX before succinylcholine to attenuate
some of the side effects of succinylcholine has not been studied.
Although not studied systematically in clinical
trials, no drug
interactions were observed when vecuronium, pancuronium, or atracurium
were administered following varying degrees of recovery
from single doses or infusions of NIMBEX.
Isoflurane or enflurane administered with nitrous
oxide/oxygen to achieve 1.25 MAC
[Minimum Alveolar Concentration] may prolong the clinically effective
duration of action of
initial and maintenance
doses of NIMBEX and decrease the required infusion
rate of NIMBEX. The magnitude
of these effects may depend on the duration
of administration
of the volatile agents.
Fifteen to 30 minutes of exposure
to 1.25 MAC isoflurane or
enflurane had minimal effects on the duration
of action of initial
doses of NIMBEX and therefore, no adjustment
to the initial dose
should be necessary when NIMBEX is administered shortly after initiation
of volatile agents.
In long surgical
procedures during enflurane or isoflurane anesthesia,
less frequent maintenance dosing, lower maintenance doses, or reduced
infusion rates of NIMBEX
may be necessary. The average
infusion rate
requirement may be decreased by as much as 30% to 40%.
In clinical studies
propofol had no
effect on the duration
of action or dosing requirements for NIMBEX. Other drugs which may
enhance the neuromuscular blocking action
of nondepolarizing agents such
as NIMBEX include certain antibiotics (e. g., aminoglycosides, tetracyclines,
bacitracin, polymyxins, lincomycin, clindamycin, colistin, and sodium
colistemethate), magnesium salts, lithium, local
anesthetics, procainamide, and quinidine. Resistance to the neuromuscular
blocking action
of nondepolarizing neuromuscular
blocking agents has been demonstrated in patients chronically administered
phenytoin or carbamazepine. While the effects of chronic
phenytoin or carbamazepine
therapy on the action
of NIMBEX are unknown, slightly shorter durations of neuromuscular
block may be anticipated
and infusion rate
requirements may be higher.
Drug/Laboratory Test Interactions
None known.
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