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
Mivacron Side Effects, and Drug Interactions - Mivacurium
Mivacron Side Effects, and Drug Interactions - Mivacurium
SIDE EFFECTS
Observed in Clinical Trials
MIVACRON (a mixture
of three stereoisomers) was well tolerated during extensive clinical
trials in inpatients and outpatients. Prolonged neuromuscular block,
which is an important adverse experience
associated with neuromuscular blocking agents as a class, was reported
as an adverse experience
in three of 2,074 patients administered MIVACRON. The most commonly
reported adverse experience following the administration
of MIVACRON was transient, dose-dependent cutaneous flushing about
the face, neck, and/or chest. Flushing was most frequently noted
after the initial dose
of MIVACRON and was reported in about 25% of adult
patients who received 0.15 mg/kg MIVACRON over 5 to 15 seconds.
When present, flushing typically began within 1 to 2 minutes after
the dose of MIVACRON and
lasted for 3 to 5 minutes. Of 105 patients who experienced flushing
after 0.15 mg/kg MIVACRON, two patients also experienced mild hypotension
that was not treated, and one patient
experienced moderate wheezing that was successfully treated.
Overall, hypotension
was infrequently reported as an adverse experience in the clinical
trials of MIVACRON. One of 332 (0.3%) healthy
adults who received 0.15 mg/kg MIVACRON over 5 to 15 seconds and
none of 37 cardiac surgery patients who received 0.15 mg/kg MIVACRON
over 60 seconds were treated for a decrease in blood
pressure in association
with the administration of MIVACRON. One to two percent
of healthy adults given
³0.20 mg/kg MIVACRON over 5 to 15
seconds, 2% to 3% of healthy
adults given 0.20 mg/kg over 30 seconds, none of 100 healthy
adults given 0.25 mg/kg as a divided dose
(0.15 mg/kg followed in 30 seconds by 0.10 mg/kg), and 2% to 4%
of cardiac surgery
patients given ³0.20 mg/kg over
60 seconds were treated for a decrease in blood
pressure. None of the 63 children who received the recommended dose
of 0.20 mg/kg MIVACRON was treated for a decrease in blood
pressure in association
with the administration
of MIVACRON.
The following adverse experiences were reported in patients administered
MIVACRON (all events judged by investigators during the clinical
trials to have a possible causal relationship):
Incidence Greater Than 1%
- Cardiovascular: Flushing (16%)
Incidence Less Than 1%
- Cardiovascular: Hypotension, tachycardia,
bradycardia, cardiac
arrhythmia, phlebitis
- Respiratory: Bronchospasm, wheezing,
hypoxemia
- Dermatological: Rash, urticaria,
erythema, injection
site reaction
- Nonspecific: Prolonged drug
effect
- Neurologic: Dizziness
- Musculoskeletal: Muscle spasms
Observed in Clinical Practice
Based on initial clinical
practice experience
in patients who received MIVACRON, spontaneously reported adverse
events are uncommon. Some of these events occurred at recommended
doses and required treatment. There are insufficient data to establish
a causal relationship or to support
an estimate of their incidence. Adverse events reported during clinical
practice include:
- General: Allergic reactions which, in rare instances,
were severe
- Musculoskeletal: Diminished drug
effect, prolonged drug
effect
- Cardiovascular: Hypotension (rarely severe), flushing
- Respiratory: Bronchospasm
- Integumentary: Rash
DRUG INTERACTIONS
Although MIVACRON (a mixture
of three stereoisomers) has been administered safely following succinylcholine-facilitated
tracheal intubation,
the interaction between MIVACRON and succinylcholine has not been
systematically studied. Prior administration
of succinylcholine can potentiate
the neuromuscular blocking effects of nondepolarizing agents. Evidence
of spontaneous recovery
from succinylcholine should be observed before the administration
of MIVACRON.
The use of MIVACRON before succinylcholine to attenuate
some of the side effects of succinylcholine has not been studied.
There are no clinical
data on the use of MIVACRON with other nondepolarizing neuromuscular
blocking agents.
Isoflurane and enflurane (administered with nitrous
oxide/oxygen to achieve 1.25 M.C.
decrease the ED50 of MIVACRON by as much as 25% (see
CLINICAL PHARMACOLOGY: Pharmacodynamics
and Individualization
of Dosages). These agents may also prolong the clinically
effective duration of action
and decrease the average
infusion requirement
of MIVACRON by as much as 35% to 40%. A greater potentiation
of the neuromuscular
blocking effects of MIVACRON may be expected with higher concentrations
of enflurane or isoflurane. Halothane has little or no
effect on the ED50
, but may prolong the duration
of action and decrease
the average infusion
requirement by as much as 20%.
Other drugs which may enhance the neuromuscular
blocking action
of nondepolarizing agents such
as MIVACRON include certain antibiotics (e.g., aminoglycosides,
tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin,
colistin, and sodium
colistimethate), magnesium
salts, lithium, local
anesthetics, procainamide, and quinidine. The neuromuscular
blocking effect
of MIVACRON may be enhanced by drugs that reduce
plasma cholinesterase
activity (e.g., chronically
administered oral contraceptives,
glucocorticoids, or certain monoamine oxidase
inhibitors) or by drugs that irreversibly inhibit plasma cholinesterase
(see PRECAUTIONS: Reduced
Plasma Cholinesterase Activity subsection).
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 MIVACRON are unknown, slightly shorter durations of neuromuscular
block may be anticipated
and infusion rate
requirements may be higher.
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