Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3149
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MIVACRON (Injection, Solution)
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MIVACRON SHOULD ONLY BE
ADMINISTERED INTRAVENOUSLY. The
dosage information provided below is intended as a guide only. Doses of MIVACRON
should be individualized (see CLINICAL PHARMACOLOGY -Individualization of Dosages). Factors that may warrant dosage
adjustment include but may not be limited to: the presence of significant
kidney, liver, or cardiovascular disease, obesity (patients weighing���30% more than ideal body weight for height), asthma, reduction in plasma cholinesterase
activity, and the presence of inhalational anesthetic agents. When using MIVACRON or other neuromuscular blocking agents
to facilitate tracheal intubation, it is important to recognize that the most
important factors affecting intubation are the depth of general anesthesia
and the level of neuromuscular block. Satisfactory intubating conditions
can usually be achieved before complete neuromuscular block is attained if
there is adequate anesthesia. The use of a peripheral
nerve stimulator will permit the most advantageous use of MIVACRON, minimize
the possibility of overdosage or underdosage, and assist in the evaluation
of recovery. When using a stimulator to monitor onset of neuromuscular block,
clinical studies have shown that all four twitches of the train-of-four response
may be present, with little or no fade,at the times recommended for intubation.
Therefore, as with other neuromuscular blocking agents, it is important to
use other criteria, such as clinical evaluation of the status of relaxation
of jaw muscles and vocal cords, in conjunction with peripheral muscle twitch
monitoring, to guide the appropriate time of intubation. The onset of conditions suitable for tracheal intubation occurs
earlier after a conventional intubating dose of succinylcholine than after
recommended doses of MIVACRON.<br/>Adults:<br/>Initial Doses: Doses of 0.15 mg/kg administered over 5 to 15
seconds, 0.20 mg/kg administered over 30 seconds, or 0.25 mg/kg
administered in divided doses (0.15 mg/kg followed in 30 seconds by 0.10
mg/kg) are recommended for facilitation of tracheal intubation for most patients
(see Table 7). The purpose of slowed or divided
dosing of MIVACRON at doses above 0.15 mg/kg is to minimize the transient
decreases in blood pressure observed in some patients given these doses over
5 to 15 seconds (see CLINICAL PHARMACOLOGY, PRECAUTIONS, and ADVERSE REACTIONS).
The quality of intubation conditions does not significantly differ for the
times and doses of MIVACRON recommended in Table 7, but the onset of suitable
intubation conditions may be reached earlier with higher doses. The choiceof a particular dose and regimen should be based on individual circumstances
and patient requirements (see CLINICAL PHARMACOLOGY
- Individualization of Dosages). In
patients with clinically significant cardiovascular disease and in patients
with any history suggesting a greater sensitivity to the release of histamine
or other mediators (e.g., asthma), the dose of MIVACRON should be 0.15
mg/kg or less, administered over 60 seconds (see PRECAUTIONS ). No data are available on the use of doses of MIVACRON above
0.15 mg/kg in patients with clinically significant kidney or liver disease. Clinically effective neuromuscular block may be expected
to last for 15 to 20 minutes (range: 9 to 38) and spontaneous recovery may
be expected to be 95% complete in 25 to 30 minutes (range: 16 to 41) following
0.15 mg/kg MIVACRON administered to patients receiving opioid/nitrous oxide/oxygen
anesthesia. The expected duration of clinically effective block and time
to 95% spontaneousrecovery following 0.20 mg/kg MIVACRON are approximately
20 and 30 minutes, respectively, and following 0.25 mg/kg MIVACRON are
approximately 25 and 35 minutes. Initiation of maintenance dosing during
opioid/nitrous oxide/oxygen anesthesia is generally required approximately
15, 20 and 25 minutes following initial doses of 0.15, 0.20, and 0.25 mg/kg
MIVACRON, respectively (see Table 1). Maintenance doses of 0.10 mg/kg each
provide approximately 15 minutes of additional clinically effective block.
For shorter or longer durations of action, smaller or larger maintenance
doses may be administered. The neuromuscular
blocking action of MIVACRON is potentiated by isoflurane or enflurane anesthesia.
Recommended initial doses of MIVACRON may be used to facilitate tracheal
intubation prior to the administration of these agents; however, if MIVACRON
is first administered after establishment of stable-state isoflurane or enflurane
anesthesia (administered with nitrous oxide/oxygen to achieve 1.25 MAC), the
initial dose of MIVACRON may be reduced by as much as 25%. Greater reductions
in the dose of MIVACRON may be required with higher concentrations of enflurane
or isoflurane. With halothane, which has only a minimal potentiating effect
on MIVACRON, a smaller dosage reduction may be considered.<br/>Continuous Infusion: Continuous infusion of MIVACRON may be used to
maintain neuromuscular block. Upon early evidence of spontaneous recovery
from an initial dose, an initial infusion rate of 9 to 10 mcg/kg/min is recommended.
If continuous infusion is initiated simultaneously with the administration
of an initial dose, a lower initial infusion rate should be used (e.g., 4
mcg/kg/min). In either case, the initial infusion rate should be adjusted
according to the response to peripheral nerve stimulation and to clinical
criteria. On average, an infusion rate of 5 to 7 mcg/kg/min (range: 1 to
15) may be expected to maintain neuromuscular block within the range of 89%
to 99% for extended periods in adults receiving opioid/nitrous oxide/oxygen
anesthesia. In some patients, particularly those with higher infusion requirements
(>8 mcg/kg/min) during the first 30 minutes, the infusion rate required to
maintain 89% to 99% Tsuppression may decrease gradually (by���30%) with time over a 4- to 6-hour period of infusion (see CLINICAL
PHARMACOLOGY - Pharmacodynamics). Reduction of the infusion rate
by up to 35% to 40% should be considered when MIVACRON is administered during
stable-state conditions of isoflurane or enflurane anesthesia (administered
with nitrous oxide/oxygen to achieve 1.25 MAC). Greater reductions in the
infusion rate of MIVACRON may be required with greater concentrations of enflurane
or isoflurane. With halothane, smaller reductions in infusion rate may be
required.<br/>Children:<br/>Initial Doses: Dosage requirements for MIVACRON on a mg/kg basis
are higher in children than in adults. Onset and recovery of neuromuscularblock occur more rapidly in children than in adults (see CLINICAL
PHARMACOLOGY). The recommended
dose of MIVACRON for facilitating tracheal intubation in children 2 to
12 years of age is 0.20 mg/kg administered over 5 to 15 seconds. When administered
during stable opioid/nitrous oxide/oxygen anesthesia, 0.20 mg/kg of MIVACRON
produces maximum neuromuscular block in an average of 1.9 minutes (range:
1.3 to 3.3) and clinicallyeffective block for 10 minutes (range: 6 to 15).
Maintenance doses are generally required more frequently in children than
in adults. Administration of doses of MIVACRON above the recommended range
(>0.20 mg/kg) is associated with transient decreases in MAP in some children
(see CLINICAL PHARMACOLOGY - Hemodynamics).
MIVACRON has not been studied in pediatric patients below the age of 2 years.<br/>Continuous Infusion: Children require higher infusion rates of MIVACRON
than adults. During opioid/nitrous oxide/oxygen anesthesia, the infusion
rate required to maintain 89% to 99% neuromuscular block averages 14 mcg/kg/min
(range: 5 to 31). The principles for infusion of MIVACRON in adults are
also applicable to children (see above).<br/>Infusion Rate Tables: For adults and children the amount of infusion solution
required per hour depends upon the clinical requirements of the patient, the
concentration of MIVACRON in the infusion solution, and the patient's
weight. The contribution of the infusion solution to the fluid requirements
of the patient must be considered.Table 8 provides guidelines for delivery
in mL/hr (equivalent to microdrops/min when 60 microdrops = 1 mL) of MIVACRON
Injection (2 mg/mL).<br/>MIVACRON Injection Compatibility and Admixtures:<br/>Y-site Administration: MIVACRON Injection may not be compatible with
alkaline solutions having a pH greater than 8.5 (e.g., barbiturate solutions). Studies have shown that MIVACRON Injection is compatible
with: Compatibility studies with other parenteral products
have not been conducted.<br/>Dilution Stability: MIVACRON Injection diluted to 0.5 mg mivacurium
per mL in 5% Dextrose Injection, USP, 5% Dextrose and 0.9% Sodium Chloride
Injection, USP, 0.9% Sodium Chloride Injection, USP, Lactated Ringer's
Injection, USP, or 5% Dextrose in Lactated Ringer's Injection is physically
and chemically stable when stored in PVC (polyvinylchloride) bags at 5��to 25��C (41��to 77��F) for up to 24 hours. Aseptic techniques
should be used to prepare the diluted product. Admixtures of MIVACRON should
be prepared for single patient use only and used within 24 hours of preparation.
The unused portion of diluted MIVACRON should be discarded after each case. NOTE: Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration whenever solution and container permit. Solutions
which are not clear and colorless should not be used.
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dailymed-instance:descripti... |
MIVACRON (mivacurium chloride) is a short-acting,
nondepolarizing skeletal muscle relaxant for intravenous (IV) administration.
Mivacurium chloride is [R-[R*,R*-(E)]]-2,2'-[(1,8-dioxo-4-octene-1,8-diyl)bis(oxy-3,1-propanediyl)]bis[1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-[(3,4,5-trimethoxyphenyl)methyl]isoquinolinium]
dichloride. The molecular formula is CHClNOand
the molecular weight is 1100.18. The structural formula is: The partition coefficient
of the compound is 0.015 in a 1-octanol/distilled water system at 25��C. Mivacurium chloride is a mixture of three stereoisomers:
(1R,1'R, 2S, 2'S), the trans-trans diester;
(1R,1'R, 2R, 2'S), the cis-trans diester;
and (1R,1'R, 2R, 2'R), the cis-cis diester.
The trans-trans and cis-trans stereoisomers comprise 92% to 96% of mivacurium chloride and their
neuromuscular blocking potencies are not significantly different from each
other or from mivacurium chloride. The cis-cis diester has been estimated from studies in cats to have one-tenth
the neuromuscular blocking potency of the other two stereoisomers. MIVACRON Injection is a sterile, non-pyrogenic solution (pH
3.5 to 5.0) containing mivacurium chloride equivalent to 2 mg/mL mivacurium
in Water for Injection. Hydrochloric acid may have been added to adjust pH.
Multiple-dose vials contain 0.9% w/v benzyl alcohol.
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MIVACRON (a mixture of three stereoisomers) binds
competitively to cholinergic receptors on the motor end-plate to antagonize
the action of acetylcholine, resulting in a block of neuromuscular transmission.
This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine.<br/>Pharmacodynamics: The time to maximum neuromuscular block is similarfor recommended doses of MIVACRON and intermediate-acting agents (e.g., atracurium),
but longer than for the ultra-short-acting agent, succinylcholine. The clinically
effective duration of action of MIVACRON (a mixture of three stereoisomers)
is one-third to one-half that of intermediate-acting agents and 2 to 2.5 times
that of succinylcholine. The average ED(dose
required to produce 95% suppression of the adductor pollicis muscle twitch
response to ulnar nerve stimulation) of MIVACRON is 0.07 mg/kg (range: 0.05
to 0.09) in adults receiving opioid/nitrous oxide/oxygen anesthesia. The
pharmacodynamics of doses of MIVACRON���EDadministered
over 5 to 15 seconds during opioid/nitrous oxide/oxygen anesthesia are summarized
in Table 1. The mean time for spontaneous recovery of the twitch response
from 25% to 75% of control amplitude is about 6 minutes (range: 3 to 9, n
= 32) following an initial dose of 0.15 mg/kg MIVACRON and 7 to 8 minutes
(range: 4 to 24, n = 85) following initial doses of 0.20 or 0.25 mg/kg MIVACRON. Volatile anesthetics may decrease the dosing requirement
for MIVACRON and prolong the duration of action; the magnitude of these effects
may be increased as the concentration of the volatile agent is increased.
Isoflurane and enflurane (administered with nitrous oxide/oxygen to achieve
1.25 MAC [Minimum Alveolar Concentration]) may decrease the effective dose
of MIVACRON by as much as 25%, and may prolong the clinically effective duration
of action and decrease the average infusion requirement by as much as 35%
to 40%. At equivalent MAC values, halothane has little or no effect on the
EDof MIVACRON, but may prolong the duration of action and decrease
the average infusion requirement by as much as 20% (see CLINICAL
PHARMACOLOGY - Individualization of Dosages subsection and PRECAUTIONS - Drug Interactions). Administration of MIVACRON over 30 to
60 seconds does not alter the time to maximum neuromuscular block or the duration
of action. The duration of action of MIVACRON may be prolonged in patients
with reduced plasma cholinesterase (pseudocholinesterase) activity (see PRECAUTIONS - Reduced Plasma Cholinesterase Activity and CLINICAL PHARMACOLOGY - Individualization of Dosages
subsection). Interpatient variability in duration
of action occurs with MIVACRON as with other neuromuscular blocking agents.
However, analysis of data from 224 patients in clinical studies receiving
various doses of MIVACRON during opioid/nitrous oxide/oxygen anesthesia with
a variety of premedicants and varying lengths of surgery indicated that approximately
90% of the patients had clinically effective durations of block within 8 minutes
of the median duration predicted from the dose-response data shown in Table 1.
Variations in plasma cholinesterase activity, including values within the
normal range and values as low as 20% below the lower limitof the normal
range, were not associated with clinically significant effects on duration.
The variability in duration, however, was greater in patients with plasma
cholinesterase activity at or slightly below the lower limit of the normal
range. When administered during the induction
of adequate anesthesia using thiopental or propofol, nitrous oxide/oxygen,
and co-induction agents such as fentanyl and/or midazolam, doses of 0.15 mg/kg
(2 x ED) MIVACRON administered over 5 to 15 seconds or 0.20
mg/kg MIVACRON administered over 30 seconds produced generally good-to-excellent
tracheal intubation conditions in 2.5 to 3 and 2 to 2.5 minutes, respectively.
A dose of 0.25 mg/kg MIVACRON administered as a divided dose (0.15 mg/kg
followed 30 seconds later by 0.10 mg/kg) produced generally good-to-excellent
intubation conditions in 1.5 to 2 minutes after initiating the dosing regimen. Repeated administration of maintenance doses or continuous
infusion of MIVACRON for up to 2.5 hours is not associated with development
of tachyphylaxis or cumulative neuromuscular blocking effects in ASA Physical
Status I-II patients. Based on pharmacokinetic studies in 82 adults receiving
infusions of MIVACRON for longer than 2.5 hours, spontaneous recovery of neuromuscular
function after infusion is independent of the duration of infusion and comparable
to recovery reported for single doses (Table 1). MIVACRON
was administered as an infusion for as long as 4 to 6 hours in 20 adult patients
and 19 geriatric patients. In most patients, after a brief period of adjustment,
the rate of MIVACRON required to maintain 89% to 99% Tsuppression
remained relatively constant over time. There was a subset of patients in
each group whose infusion rates did not stabilize quickly and decreased (by���30%) over the period of infusion. The rate of spontaneous recovery
in these patients was comparable with that of patients having stable infusion
rates and not dependent on the duration of infusion. These patients, however,
tended to have higher infusion requirements (i.e.,>8 mcg/kg/min) during
the first 30 minutes of infusion than patients with stable infusion rates,
although their final infusion rates were similar to those with stable infusion
rates. There were no clinically important differences in infusion rate requirements
between geriatric and young patients (see Pharmacokinetics
-Special Populations - Geriatric Patients). The neuromuscular block produced
by MIVACRON is readily antagonized by anticholinesterase agents. As seen
with other nondepolarizing neuromuscular blocking agents, the more profound
the neuromuscular block at the time of reversal, the longer the time and the
greater the dose of anticholinesterase agent required for recovery of neuromuscular
function. In children (2 to 12 years), MIVACRON
has a higher ED(0.10 mg/kg), faster onset, and shorter duration
of action than in adults. The mean time for spontaneous recovery of the twitch
response from 25% to 75% of control amplitude is about 5 minutes (n = 4) following
an initial dose of 0.20 mg/kg MIVACRON. Recovery following reversal is faster
in children than in adults (Table 1).<br/>Hemodynamics: Administration of MIVACRON in doses up to and including
0.15 mg/kg (2 x ED) over 5 to 15 seconds to ASA Physical Status
I-II patients during opioid/nitrous oxide/oxygen anesthesia is associated
with minimal changes in mean arterial blood pressure (MAP) or heart rate (HR)
(Table 2). Higher doses of���0.20 mg/kg (���3 x ED) may be associated with transient decreases in MAP and
increases in HR in some patients. These decreases in MAP are usually maximal
within 1 to 3 minutes following the dose, typically resolve without treatment
in an additional 1 to 3 minutes, and are usually associated with increases
in plasma histamine concentration. Decreases in MAP can be minimized by administering
MIVACRON over 30 to 60 seconds (see CLINICAL PHARMACOLOGY
- Individualization of Dosages subsection and PRECAUTIONS
- General). Analysis of 426 patients
in clinical studies receiving initial doses of MIVACRON up to and including
0.30 mg/kg during opioid/nitrous oxide/oxygen anesthesia showed that highinitial doses and a rapid rate of injection contributed to a greater probability
of experiencing a decrease of���30% in MAP after administration of
MIVACRON. Obese patients also had a greater probability of experiencing a
decrease of���30% in MAP when dosed on the basis of actual body weight,
thereby receiving a larger dose than if dosed on the basis of ideal body weight
(see CLINICAL PHARMACOLOGY - Individualization
of Dosages subsection and PRECAUTIONS - General). Children experience minimal changes
in MAP or HR after administration of doses of MIVACRON up to and including
0.20 mg/kg over 5 to 15 seconds, but higher doses (���0.25 mg/kg)
may be associated with transient decreases in MAP (Table 2). Following a dose of 0.15 mg/kg MIVACRON administered over
60 seconds, adult patients with significant cardiovascular disease undergoing
coronary artery bypass grafting or valve replacement procedures showed no
clinically important changes in MAP or HR. Transient decreases in MAP were
observed in some patients after doses of 0.20 to 0.25 mg/kg MIVACRON administered
over60 seconds. The number of patients in whom these decreases in MAP required
treatment was small.<br/>Pharmacokinetics: MIVACRON is a mixture of isomers which do not interconvert in vivo. The cis-trans and trans-trans isomers
(92% to 96% of the mixture) are equipotent. The steady-state concentrations
of the cis-trans and trans-trans isomers doubled after the infusion rate was increased from 5 to
10 mcg/kg/min, indicating that their pharmacokinetics is dose-proportional. The cis-cis isomer
(6% of the mixture) has approximately one-tenth the neuromuscular blocking
potency of the trans-trans and cis-trans isomers in cats. Neuromuscular blocking
effects due to the cis-cis isomer cannot
be ruled out in humans; however, modeling of clinical pharmacokinetic-pharmacodynamic
data suggests that the cis-cis isomer
produces minimal (<5%) neuromuscular block during a 2-hour infusion.
In studies of ASA Physical Status I-II patients receiving infusions of MIVACRON
lasting as long as 4 to 6 hours, the 5% to 25% and the 25% to 75% recovery
indices were independent of the duration of infusion, suggesting that the cis-cis isomer does not affect the rate of post-infusion
recovery.<br/>Distribution: The volume of distribution of cis-trans and trans-trans isomers
in healthy surgical patients is relatively small, reflecting limited tissue
distribution (Table 3). The volume of distribution of cis-cis isomers is also small and averaged 335 mL/kg (range 192 to 523)
in the 18 healthy surgical patients whose data are displayed in Table 3.
The protein binding of mivacurium has not been determined due to its rapid
hydrolysis by plasma cholinesterase.<br/>Metabolism: Enzymatic hydrolysis by plasma cholinesterase
is the primary mechanism for inactivation of mivacurium and yields a quaternary
alcohol and a quaternary monoester metabolite. Tests in which these two metabolites
were administered to cats and dogs suggest that each metabolite is unlikely
to produce clinically significant neuromuscular, autonomic, or cardiovascular
effects following administration of MIVACRON. The
mean��S.D. in vitro tvalues
of the trans-trans and the cis-trans isomers were 1.3��0.3
and 0.8��0.2 minutes, respectively, in human plasma from healthy male
(n = 5) and female (n = 5) volunteers. The mean in
vivo tvalues for the more potent trans-trans and cis-trans isomers in
healthy surgical patients (Table 3) were similar to those found in vitro, suggesting that hydrolysis by plasma cholinesterase is the predominant
elimination pathway for these isomers. The mean��S.D. in
vitro tof the less potent cis-cis isomer was 276��130 minutes, while the mean��S.D. in vivo tfor the cis-cis isomer in healthy surgical patients
was 53��20 minutes. These data suggest that in vivo, pathways other than hydrolysis by plasma cholinesterase contribute
to the elimination of the cis-cis isomer.<br/>Elimination: The clearance (CL) values of the two more potent
isomers, cis-trans and trans-trans, are very high and are dependent on plasma cholinesterase activity
(Table 3). The combination of high CL and low distribution volume results
in tvalues of approximately 2 minutes for the two more potent
isomers. The short tand high CL of the more potent isomers
are consistent with the short duration of action of MIVACRON. The CL of the less potent cis-cis isomer is not dependent on plasma cholinesterase. The mean��S.D. CL was 4.6��1.1 mL/min/kg and twas 53��20 minutes in the 18 healthy surgical patients whose data are displayed in
Table 3. Renal and biliary excretion of unchanged
mivacurium are minor elimination pathways; urine and bile are important elimination
pathways for the two metabolites.<br/>Special Populations:<br/>Individualization of Dosages: DOSES OF MIVACRON SHOULD BE INDIVIDUALIZED AND
A PERIPHERAL NERVE STIMULATOR SHOULD BE USED TO MEASURE NEUROMUSCULAR FUNCTION
DURING ADMINISTRATION OF MIVACRON IN ORDER TO MONITOR DRUG EFFECT, DETERMINE
THE NEED FOR ADDITIONAL DOSES, AND CONFIRM RECOVERY FROM NEUROMUSCULAR BLOCK. Based on the known actions of MIVACRON (a mixture of three
stereoisomers) and other neuromuscular blocking agents, the following factors
should be considered when administering MIVACRON:
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dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
MIVACRON is contraindicated in patients known to have
an allergic hypersensitivity to mivacurium chloride or other benzylisoquinolinium
agents, as manifested by reactions such as urticaria or severe respiratory
distress or hypotension. Use of MIVACRON from multiple-dose vials containing
benzyl alcohol as a preservative is contraindicated in patients with a known
hypersensitivity to benzyl alcohol.
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dailymed-instance:supply |
MIVACRON Injection, 2 mg mivacurium in each mL.<br/>STORAGE: Store MIVACRON Injection at room temperature of
15��to 25��C (59��to 77��F). Avoid exposure to direct ultraviolet
light. DO NOT FREEZE. U.S. Patent No. 4,761,418 MIVACRON
is a registered trademark of the GlaxoSmithKline, licensed for use by Abbott
Laboratories. Sufenta, Alfenta, Sublimaze,
Versed, and Inapsine are not trademarks of Abbott Laboratories. ��Abbott, 2005 Manufactured
byHospira, Inc.Lake Forest, IL 60045 USA forAbbott Laboratories,North Chicago, IL 60064
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dailymed-instance:inactiveI... | |
dailymed-instance:overdosag... |
Overdosage with neuromuscular blocking agents may
result in neuromuscular block beyond the time needed for surgery and anesthesia.
The primary treatment is maintenance of a patent airway and controlled ventilation
until recovery of normal neuromuscular function is assured. Once evidence
of recovery from neuromuscular block is observed, further recovery may be
facilitated by administration of an anticholinesterase agent (e.g., neostigmine,
edrophonium) in conjunction with an appropriate anticholinergic agent (see
Antagonism of Neuromuscular Block subsection below). Overdosage may increase
the risk of hemodynamic side effects, especially decreases in blood pressure.
If needed, cardiovascular support may be provided by proper positioning of
the patient, fluid administration, and/or vasopressor agent administration.<br/>Antagonism of Neuromuscular Block: ANTAGONISTS (SUCH AS NEOSTIGMINE) SHOULD NOT BE
ADMINISTERED WHEN COMPLETE NEUROMUSCULAR BLOCK IS EVIDENT OR SUSPECTED. THE
USE OF A PERIPHERAL NERVE STIMULATOR TO EVALUATE RECOVERY AND ANTAGONISM OF
NEUROMUSCULAR BLOCK IS RECOMMENDED. Administration
of 0.030 to 0.064 mg/kg neostigmine or 0.5 mg/kg edrophonium at approximately
10% recovery from neuromuscular block (range: 1 to 15) produced 95% recovery
of the muscle twitch response and a T/Tratio���75% in about 10 minutes. The times from 25% recovery of the muscle twitch
response to T/Tratio���75% following these
doses of antagonists averaged about 7 to 9 minutes. In comparison, average
times for spontaneous recovery from 25% to T/T���75% were 12 to 13 minutes. Patients administered
antagonists should be evaluated for adequate clinical evidence of antagonism,
e.g., 5-second head lift and grip strength. Ventilation must be supported
until no longer required. Antagonism may be
delayed in the presence of debilitation, carcinomatosis, and the concomitant
use of certain broad spectrum antibiotics, or anesthetic agents and other
drugs which enhance neuromuscular block or separately cause respiratory depression
(see PRECAUTIONS - Drug Interactions).
Under such circumstances the management is the same as that of prolonged
neuromuscular block (see OVERDOSAGE).
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dailymed-instance:genericMe... |
mivacurium chloride
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dailymed-instance:fullName |
MIVACRON (Injection, Solution)
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dailymed-instance:adverseRe... |
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 2074 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���0.20 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���0.20 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):<br/>Incidence Greater Than 1%:<br/>Incidence Less Than 1%:<br/>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. Anaphylaxis/Anaphylactoid Reactions: From post-marketing surveillance, MIVACRON has been associated
with reports of anaphylactic/anaphylactoid reactions. In some of these reports,
sensitivity to MIVACRON was confirmed using skin test procedures. Other adverse reaction data from clinical practice are insufficient
to establish a causal relationship or to support an estimate of their incidence.
These adverse events include:<br/>Musculoskeletal: Diminished drug effect, prolonged drug effect<br/>Cardiovascular: Hypotension (rarely severe), flushing<br/>Respiratory: Bronchospasm<br/>Integumentary: Rash
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dailymed-instance:warning |
MIVACRON SHOULD BE ADMINISTERED IN CAREFULLY ADJUSTED
DOSAGE BY OR UNDER THE SUPERVISION OF EXPERIENCED CLINICIANS WHO ARE FAMILIAR
WITH THE DRUG'S ACTIONS AND THE POSSIBLE COMPLICATIONS OF ITS USE. THE
DRUG SHOULD NOT BE ADMINISTERED UNLESS PERSONNEL AND FACILITIES FOR RESUSCITATION
AND LIFE SUPPORT (TRACHEAL INTUBATION, ARTIFICIAL VENTILATION, OXYGEN THERAPY),
AND AN ANTAGONIST OF MIVACRON ARE IMMEDIATELY AVAILABLE. IT IS RECOMMENDED
THAT A PERIPHERAL NERVE STIMULATOR BE USED TO MEASURE NEUROMUSCULAR FUNCTION
DURING THE ADMINISTRATION OF MIVACRON IN ORDER TO MONITOR DRUG EFFECT, DETERMINE
THE NEED FOR ADDITIONAL DRUG, AND CONFIRM RECOVERY FROM NEUROMUSCULAR BLOCK. MIVACRON HAS NO KNOWN EFFECT ON CONSCIOUSNESS, PAIN THRESHOLD,
OR CEREBRATION. TO AVOID DISTRESS TO THE PATIENT, NEUROMUSCULAR BLOCK SHOULD
NOT BE INDUCED BEFORE UNCONSCIOUSNESS. MIVACRON
IS METABOLIZED BY PLASMA CHOLINESTERASE AND SHOULD BE USED WITH GREAT CAUTION,
IF AT ALL, IN PATIENTS KNOWN TO BE OR SUSPECTED OF BEING HOMOZYGOUS FOR THE
ATYPICAL PLASMA CHOLINESTERASE GENE. MIVACRON
Injection is acidic (pH 3.5 to 5.0) and may not be compatible with alkaline
solutions having a pH greater than 8.5 (e.g., barbiturate solutions). Multiple-dose vials of MIVACRON contain benzyl alcohol. In
newborn infants, benzyl alcohol has been associated with an increased incidence
of neurological and other complications which are sometimes fatal. Single-use
vials do not contain benzyl alcohol (see PRECAUTIONS
- Pediatric Use).
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MIVACRON is a short-acting neuromuscular blocking
agent indicated for inpatients and outpatients, as an adjunct to general anesthesia,
to facilitate tracheal intubation and to provide skeletal muscle relaxation
during surgery or mechanical ventilation.
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dailymed-instance:routeOfAd... | |
dailymed-instance:name |
MIVACRON
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