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
Tracrium Side Effects, and Drug Interactions - Atracurium Besylate
Tracrium Side Effects, and Drug Interactions - Atracurium Besylate
SIDE EFFECTS
Observed in Controlled Clinical Studies
TRACRIUM was well tolerated and produced few adverse reactions
during extensive clinical
trials. Most adverse reactions were suggestive
of histamine release. In
studies including 875 patients, TRACRIUM was discontinued in only
one patient (who required
treatment for bronchial
secretions), and six other patients required treatment
for adverse reactions attributable to TRACRIUM (wheezing in one,
hypotension in five).
Of the five patients who required treatment
for hypotension,
three had a history
of significant cardiovascular disease. The overall incidence
rate for clinically important
adverse reactions, therefore, was 7/ 875 or 0.8%. Table 1 includes
all adverse reactions reported attributable to TRACRIUM during clinical
trials with 875 patients.
Table 1: Percent of Patients Reporting Adverse
Reactions Initial Dose of TRACRIUM (mg/kg)
|
Adverse Reaction
|
Initial Dose of TRACRIUM (mg/ kg)
|
|
0.00-0.30
(n = 485)
|
0.31-0.50*
(n = 366)
|
³
0.60
(n = 24)
|
Total
(n = 875)
|
| Skin Flush
Erythema
Itching
Wheezing/Bronchial Secretions
Hives
|
1.0%
0.6%
0.4%
0.2%
0.2%
|
8.7%
0.5%
0%
0.3%
0%
|
29.2%
0%
0%
0%
0%
|
5.0%
0.6%
0.2%
0.2%
0.1%
|
| * Includes the recommended
initial dosage range
for most patients. |
Most adverse reactions were of little clinical
significance unless they were associated with significant
hemodynamic changes. Table 2 summarizes the incidences of substantial
vital sign
changes noted during clinical trials of TRACRIUM with 530 patients,
without cardiovascular
disease, in whom these
parameters were assessed.
Table 2: Percent of Patients Showing >30%
Vital Sign Changes Following Administration of TRACRIUM
|
Vital Sign Change
|
Initial Dose of TRACRIUM (mg/ kg)
|
|
0.00-0.30
(n = 365)
|
0.31-0.50*
(n = 144)
|
³
0.60
(n = 21)
|
Total
(n = 530)
|
| Mean Arterial
Pressure
Increase
Decrease
|
1.9%
1.1%
|
2.8%
2.1%
|
0%
14.3%
|
2.1%
1.9%
|
| Heart Rate
Increase
Decrease
|
1.6%
0.8%
|
2.8%
0%
|
4.8%
0%
|
2.1%
0.6%
|
| * Includes the recommended
initial dosage
range for most patients.
|
Observed in Clinical Practice
Based on initial clinical
practice experience
in approximately 3 million patients who received TRACRIUM in the
US and in the United Kingdom, spontaneously reported adverse reactions
were uncommon (approximately 0.01% to 0.02%). The following adverse
reactions are among the most frequently reported, but there are
insufficient data to support
an estimate of their incidence:
General: Allergic reactions (anaphylactic or anaphylactoid
responses) which, in rare instances, were severe (e.g., cardiac
arrest).
Musculoskeletal: Inadequate block, prolonged block.
Cardiovascular: Hypotension, vasodilatation
(flushing), tachycardia, bradycardia.
Respiratory: Dyspnea, bronchospasm,
laryngospasm.
Integumentary: Rash, urticaria,
reaction at injection
site.
There have been rare spontaneous
reports of seizures in ICU
patients following long-term infusion
of atracurium to support
mechanical ventilation. There are insufficient data to define the
contribution, if any, of atracurium and/or its metabolite
laudanosine. (See PRECAUTIONS: Long-Term
Use in Intensive Care Unit [ICU]).
DRUG INTERACTIONS
Drugs which may enhance the neuromuscular
blocking action
of TRACRIUM include: enflurane; isoflurane; halothane; certain antibiotics,
especially the aminoglycosides and polymyxins; lithium; magnesium
salts; procainamide; and quinidine.
If other muscle relaxants
are used during the same procedure, the possibility of a synergistic
or antagonist effect
should be considered.
The prior administration
of succinylcholine does not enhance the duration, but quickens the
onset and may increase the depth, of neuromuscular
block induced by TRACRIUM. TRACRIUM should not be administered until
a patient has recovered from succinylcholine-induced neuromuscular
block.
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