quelicin
Generic Name: (
Succinylcholine Chloride)
Dosage Type: injection, solution Organization: HOSPIRA, INC.
A short-acting depolarizing
skeletal muscle relaxant.
Abboject® Syringe
Fliptop Vial
Rx only
WARNING
RISK OF CARDIAC ARREST FROM HYPERKALEMIC
RHABDOMYOLYSIS
There have
been rare reports of acute rhabdomyolysis with hyperkalemia followed by ventricular
dysrhythmias, cardiac arrest and death after the administration of succinylcholine
to apparently healthy pediatric patients who were subsequently found to have
undiagnosed skeletal muscle myopathy, most frequently Duchennes muscular
dystrophy.
This syndrome often presents as peaked T-waves
and sudden cardiac arrest within minutes after the administration of the drug
in healthy appearing pediatric patients (usually, but not exclusively, males,
and most frequently 8 years of age or younger). There have also been reports
in adolescents.
Therefore, when a healthy appearing
infant or child develops cardiac arrest soon after administration of succinylcholine,
not felt to be due to inadequate ventilation, oxygenation or anesthetic overdose,
immediate treatment for hyperkalemia should be instituted. This should include
administration of intravenous calcium, bicarbonate, and glucose with insulin,
with hyperventilation. Due to the abrupt onset of this syndrome, routine resuscitative
measures are likely to be unsuccessful. However, extraordinary and prolonged
resuscitative efforts have resulted in successful resuscitation in some reported
cases. In addition, in the presence of signs of malignant hyperthermia, appropriate
treatment should be instituted concurrently.
Since there
may be no signs or symptoms to alert the practitioner to which patients are
at risk, it is recommended that the use of succinylcholine in pediatric patients
should be reserved for emergency intubation or instances where immediate securing
of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach,
or for intramuscular use when a suitable vein is inaccessible (see PRECAUTIONS:
Pediatric Use and DOSAGE AND ADMINISTRATION).
This drug should be used only by individuals familiar with
its actions, characteristics and hazards.
DESCRIPTION
Quelicin (Succinylcholine Chloride Injection, USP) is a sterile,
nonpyrogenic solution to be used as a short-acting, depolarizing, skeletal
muscle relaxant. See HOW SUPPLIED for summary of content and characteristics
of the solutions. The solutions are for I.M. or I.V. use.
Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4 and
its molecular weight is 361.31.
It has the following
structural formula:
Succinylcholine is a diquaternary
base consisting of the dichloride salt of the dicholine ester of succinic
acid. It is a white, odorless, slightly bitter powder, very soluble in water.
The drug is incompatible with alkaline solutions but relatively stable in
acid solutions. Solutions of the drug lose potency unless refrigerated.
Solutions intended for multiple dose administration contain 0.18% methylparaben
and 0.02% propylparaben as preservatives (List Nos. 6629 and 9085). Solutions
intended for single-dose administration contain no preservatives. Unused solution
should be discarded. Products not requiring dilution (multiple-dose fliptop
vial and Abboject syringe) contain sodium chloride to render isotonic. May
contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH is
3.6 (3.0 to 4.5). See table in HOW SUPPLIED for characteristics.
Sodium Chloride, USP, chemically designated NaCl, is a white crystalline compound
freely soluble in water.
CLINICAL PHARMACOLOGY
Succinylcholine is a depolarizing skeletal muscle relaxant.
As does acetylcholine, it combines with the cholinergic receptors of the motor
end plate to produce depolarization. This depolarization may be observed as
fasciculations. Subsequent neuromuscular transmission is inhibited so long
as adequate concentration of succinylcholine remains at the receptor site.
Onset of flaccid paralysis is rapid (less than one minute after intravenous
administration), and with single administration lasts approximately 4 to 6
minutes.
Succinylcholine is rapidly hydrolyzed by
plasma cholinesterase to succinylmonocholine (which possesses clinically insignificant
depolarizing muscle relaxant properties) and then more slowly to succinic
acid and choline (see PRECAUTIONS). About 10% of the drug is excreted unchanged
in the urine. Succinylcholine levels were reported to be below the detection
limit of 2 µg/mL after 2.5 minutes of an IV bolus dose of 1 or 2
mg/kg in fourteen (14) anesthetized patients. The paralysis following administration
of succinylcholine is progressive, with differing sensitivities of different
muscles. This initially involves consecutively the levator muscles of the
face, muscles of the glottis and finally the intercostals and the diaphragm
and all other skeletal muscles.
Succinylcholine has
no direct action on the uterus or other smooth muscle structures. Because
it is highly ionized and has low fat solubility, it does not readily cross
the placenta.
Tachyphylaxis occurs with repeated administration
(see PRECAUTIONS).
Depending on the dose and duration
of succinylcholine administration, the characteristic depolarizing neuromuscular
block (Phase I block) may change to a block with characteristics superficially
resembling a non-depolarizing block (Phase II block). This may be associated
with prolonged respiratory muscle paralysis or weakness in patients who manifest
the transition to Phase II block. When this diagnosis is confirmed by
peripheral nerve stimulation, it may sometimes be reversed with anticholinesterase
drugs such as neostigmine (see PRECAUTIONS). Anticholinesterase drugs may
not always be effective. If given before succinylcholine is metabolized by
cholinesterase, anticholinesterase drugs may prolong rather than shorten paralysis.
Succinylcholine has no direct effect on the myocardium. Succinylcholine stimulates
both autonomic ganglia and muscarinic receptors which may cause changes in
cardiac rhythm, including cardiac arrest. Changes in rhythm, including cardiac
arrest, may also result from vagal stimulation, which may occur during surgical
procedures, or from hyperkalemia, particularly in pediatric patients (see
PRECAUTIONS: Pediatric Use). These effects are enhanced by halogenated anesthetics.
Succinylcholine causes an increase in intraocular pressure immediately after
its injection and during the fasciculation phase, and slight increases which
may persist after onset of complete paralysis (see WARNINGS).
Succinylcholine may cause slight increases in intracranial pressure immediately
after its injection and during the fasciculation phase (see PRECAUTIONS).
As with other neuromuscular blocking agents, the potential for releasing histamine
is present following succinylcholine administration. Signs and symptoms of
histamine mediated release such as flushing, hypotension and bronchoconstriction
are, however, uncommon in normal clinical usage.
Succinylcholine
has no effect on consciousness, pain threshold or cerebration. It should be
used only with adequate anesthesia (see WARNINGS).
INDICATIONS AND USAGE
Succinylcholine chloride is indicated as an adjunct to general
anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle
relaxation during surgery or mechanical ventilation.
CONTRAINDICATIONS
Succinylcholine is contraindicated in persons with personal
or familial history of malignant hyperthermia, skeletal muscle myopathies
and known hypersensitivity to the drug. It is also contraindicated in patients
after the acute phase of injury following major burns, multiple trauma, extensive
denervation of skeletal muscle, or upper motor neuron injury, because succinylcholine
administered to such individuals may result in severe hyperkalemia which may
result in cardiac arrest (see WARNINGS). The risk of hyperkalemia in these
patients increases over time and usually peaks at 7 to 10 days after the injury.
The risk is dependent on the extent and location of the injury. The precise
time of onset and the duration of the risk period are not known.
WARNINGS
SUCCINYLCHOLINE SHOULD BE USED ONLY BY THOSE SKILLED IN THE
MANAGEMENT OF ARTIFICIAL RESPIRATION AND ONLY WHEN FACILITIES ARE INSTANTLY
AVAILABLE FOR TRACHEAL INTUBATION AND FOR PROVIDING ADEQUATE VENTILATION OF
THE PATIENT, INCLUDING THE ADMINISTRATION OF OXYGEN UNDER POSITIVE PRESSURE
AND THE ELIMINATION OF CARBON DIOXIDE. THE CLINICIAN MUST BE PREPARED TO ASSIST
OR CONTROL RESPIRATION.
TO AVOID DISTRESS TO THE PATIENT,
SUCCINYLCHOLINE SHOULD NOT BE ADMINISTERED BEFORE UNCONSCIOUSNESS HAS BEEN
INDUCED. IN EMERGENCY SITUATIONS, HOWEVER, IT MAY BE NECESSARY TO ADMINISTER
SUCCINYLCHOLINE BEFORE UNCONSCIOUSNESS IS INDUCED.
SUCCINYLCHOLINE IS METABOLIZED BY PLASMA CHOLINESTERASE AND SHOULD BE USED
WITH CAUTION, IF AT ALL, IN PATIENTS KNOWN TO BE OR SUSPECTED OF BEING HOMOZYGOUS
FOR THE ATYPICAL PLASMA CHOLINESTERASE GENE.
Hyperkalemia: (SEE BOX WARNING) Succinylcholine
should be administered with GREAT CAUTION to
patients suffering from electrolyte abnormalities and those who may have massive
digitalis toxicity, because in these circumstances succinylcholine may induce
serious cardiac arrhythmias or cardiac arrest due to hyperkalemia.
GREAT CAUTION should be observed if succinylcholine
is administered to patients during the acute phase of injury following major
burns, multiple trauma, extensive denervation of skeletal muscle, or upper
motor neuron injury (see CONTRAINDICATIONS). The risk of hyperkalemia in these
patients increases over time and usually peaks at 7 to 10 days after the injury.
The risk is dependent on the extent and location of the injury. The precise
time of onset and the duration of the risk period are undetermined. Patients
with chronic abdominal infection, subarachnoid hemorrhage, or conditions causing
degeneration of central and peripheral nervous systems should receive succinylcholine
with GREAT CAUTION because of the potential
for developing severe hyperkalemia.
Malignant
Hyperthermia: Succinylcholine administration has been associated
with acute onset of malignant hyperthermia, a potentially fatal hypermetabolic
state of skeletal muscle. The risk of developing malignant hyperthermia following
succinylcholine administration increases with the concomitant administration
of volatile anesthetics. Malignant hyperthermia frequently presents as intractable
spasm of the jaw muscles (masseter spasm) which may progress to generalized
rigidity, increased oxygen demand, tachycardia, tachypnea and profound hyperpyrexia.
Successful outcome depends on recognition of early signs, such as jaw muscle
spasm, acidosis, or generalized rigidity to initial administration of succinylcholine
for tracheal intubation, or failure of tachycardia to respond to deepening
anesthesia. Skin mottling, rising temperature and coagulopathies may occur
later in the course of the hypermetabolic process. Recognition of the syndrome
is a signal for discontinuance of anesthesia, attention to increased oxygen
consumption, correction of acidosis, support of circulation, assurance of
adequate urinary output and institution of measures to control rising temperature.
Intravenous dantrolene sodium is recommended as an adjunct to supportive measures
in the management of this problem. Consult literature references and the dantrolene
prescribing information for additional information about the management of
malignant hyperthermic crisis. Continuous monitoring of temperature and expired
CO2 is recommended as an aid to early recognition of malignant
hyperthermia.
Other: In
both adults and pediatric patients the incidence of bradycardia, which may
progress to asystole, is higher following a second dose of succinylcholine.
The incidence and severity of bradycardia is higher in pediatric patients
than adults. Whereas bradycardia is common in pediatric patients after an
initial dose of 1.5 mg/kg, bradycardia is seen in adults only after repeated
exposure. Pretreatment with anticholinergic agents (e.g., atropine) may reduce
the occurrence of bradyarrhythmias.
Succinylcholine
causes an increase in intraocular pressure. It should not be used in instances
in which an increase in intraocular pressure is undesirable (e.g., narrow
angle glaucoma, penetrating eye injury) unless the potential benefit of its
use outweighs the potential risk.
Succinylcholine
is acidic (pH = 3.5) and should not be mixed with alkaline solutions having
a pH greater than 8.5 (e.g., barbiturate solutions).
PRECAUTIONS
(SEE BOX WARNING)
General:
When succinylcholine is given over a prolonged period of
time, the characteristic depolarization block of the myoneural junction (Phase
I block) may change to a block with characteristics superficially resembling
a non-depolarizing block (Phase II block). Prolonged respiratory muscle paralysis
or weakness may be observed in patients manifesting this transition to Phase
II block. The transition from Phase I to Phase II block has been reported
in 7 of 7 patients studied under halothane anesthesia after an accumulated
dose of 2 to 4 mg/kg succinylcholine (administered in repeated, divided doses).
The onset of Phase II block coincided with the onset of tachyphylaxis and
prolongation of spontaneous recovery. In another study, using balanced anesthesia
(N2O/O2/narcotic-thiopental) and succinylcholine infusion,
the transition was less abrupt, with great individual variability in the dose
of succinylcholine required to produce Phase II block. Of 32 patients studied,
24 developed Phase II block. Tachyphylaxis was not associated with the transition
to Phase II block, and 50% of the patients who developed Phase II block experienced
prolonged recovery.
When Phase II block is suspected
in cases of prolonged neuromuscular blockade, positive diagnosis should be
made by peripheral nerve stimulation, prior to administration of any anticholinesterase
drug. Reversal of Phase II block is a medical decision which must be made
upon the basis of the individual, clinical pharmacology and the experience
and judgment of the physician. The presence of Phase II block is indicated
by fade of responses to successive stimuli (preferably "train of four"). The
use of an anticholinesterase drug to reverse Phase II block should be accompanied
by appropriate doses of an anticholinergic drug to prevent disturbances of
cardiac rhythm. After adequate reversal of Phase II block with an anticholinesterase
agent, the patient should be continually observed for at least 1 hour for
signs of return of muscle relaxation. Reversal should not be attempted unless:
(1) a peripheral nerve stimulator is used to determine the presence of Phase
II block (since anticholinesterase agents will potentiate succinylcholine-induced
Phase I block), and (2) spontaneous recovery of muscle twitch has been observed
for at least 20 minutes and has reached a plateau with further recovery proceeding
slowly; this delay is to ensure complete hydrolysis of succinylcholine by
plasma cholinesterase prior to administration of the anticholinesterase agent.
Should the type of block be misdiagnosed, depolarization of the type initially
induced by succinylcholine (i.e., Phase I block) will be prolonged by an anticholinesterase
agent.
Succinylcholine should be employed with caution
in patients with fractures or muscle spasm because the initial muscle fasciculations
may cause additional trauma.
Succinylcholine may cause
a transient increase in intracranial pressure; however, adequate anesthetic
induction prior to administration of succinylcholine will minimize this effect.
Succinylcholine may increase intragastric pressure, which could result in
regurgitation and possible aspiration of stomach contents.
Neuromuscular blockade may be prolonged in patients with hypokalemia or hypocalcemia.
Reduced Plasma Cholinesterase Activity: Succinylcholine
should be used carefully in patients with reduced plasma cholinesterase (pseudocholinesterase)
activity. The likelihood of prolonged neuromuscular block following administration
of succinylcholine must be considered in such patients (see DOSAGE and ADMINISTRATION).
Plasma cholinesterase activity may be diminished in the presence of genetic
abnormalities of plasma cholinesterase (e.g., patients heterozygous or homozygous
for atypical plasma cholinesterase gene), pregnancy, severe liver or kidney
disease, malignant tumors, infections, burns, anemia, decompensated heart
disease, peptic ulcer, or myxedema. Plasma cholinesterase activity may also
be diminished by chronic administration of oral contraceptives, glucocorticoids,
or certain monoamine oxidase inhibitors and by irreversible inhibitors of
plasma cholinesterase (e.g., organophosphate insecticides, echothiophate,
and certain antineoplastic drugs).
Patients homozygous
for atypical plasma cholinesterase gene (1 in 2500 patients) are extremely
sensitive to the neuromuscular blocking effect of succinylcholine. In these
patients, a 5 to 10 mg test dose of succinylcholine may be administered to
evaluate sensitivity to succinylcholine, or neuromuscular blockade may be
produced by the cautious administration of a 1 mg/mL solution of succinylcholine
by slow intravenous infusion. Apnea or prolonged muscle paralysis should be
treated with controlled respiration.
Drug Interactions:
Drugs which may enhance the neuromuscular blocking action
of succinylcholine include: promazine, oxytocin, aprotinin, certain non-penicillin
antibiotics, quinidine, ß-adrenergic blockers, procainamide, lidocaine,
trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, diethylether,
isoflurane, desflurane, metoclopramide and terbutaline. The neuromuscular
blocking effect of succinylcholine 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).
If other neuromuscular blocking agents are to be used during the same procedure,
the possibility of a synergistic or antagonistic effect should be considered.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
There have been no long-term studies performed in animals
to evaluate carcinogenic potential.
Pregnancy:
Teratogenic Effects: Pregnancy
Category C.
Animal reproduction studies have not been
conducted with succinylcholine chloride. It is also not known whether succinylcholine
can cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity. Succinylcholine should be given to a pregnant woman only if clearlyneeded.
Nonteratogenic Effects: Plasma cholinesterase levels are decreased by approximately 24%
during pregnancy and for several days postpartum. Therefore, a higher proportion
of patients may be expected to show increased sensitivity (prolonged apnea)
to succinylcholine when pregnant than when nonpregnant.
Labor and Delivery:
Succinylcholine is commonly used to provide muscle relaxation
during delivery by caesarean section. While small amounts of succinylcholine
are known to cross the placental barrier, under normal conditions the quantity
of drug that enters fetal circulation after a single dose of 1 mg/kg to the
mother should not endanger the fetus. However, since the amount of drug that
crosses the placental barrier is dependent on the concentration gradient between
the maternal and fetal circulations, residual neuromuscular blockade (apnea
and flaccidity) may occur in the newborn after repeated high doses to, or
in the presence of atypical plasma cholinesterase in, the mother.
Nursing Mothers:
It is not known whether succinylcholine is excreted in human
milk. Because many drugs are excreted in human milk, caution should be exercised
following succinylcholine administration to a nursing woman.
Pediatric Use:
Safety and effectiveness of succinylcholine chloride have
been established in pediatric patient age groups, neonate to adolescent. There
are rare reports of ventricular dysrhythmias and cardiac arrest secondary
to acute rhabdomyolysis with hyperkalemia in apparently healthy pediatric
patients who receive succinylcholine (see BOX WARNING). Many of these pediatric
patients were subsequently found to have a skeletal muscle myopathy such as
Duchennes muscular dystrophy whose clinical signs were not obvious.
The syndrome often presents as sudden cardiac arrest within minutes after
the administration of succinylcholine. These pediatric patients are usually,
but not exclusively, males, and most frequently 8 years of age or younger.
There have also been reports in adolescents. There may be no signs or symptoms
to alert the practitioner to which patients are at risk. A careful history
and physical may identify developmental delays suggestive of a myopathy. A
preoperative creatine kinase could identify some but not all patients at risk.
Due to the abrupt onset of this syndrome, routine resuscitative measures are
likely to be unsuccessful. Careful monitoring of the electrocardiogram may
alert the practitioner to peaked T-waves (an early sign). Administration of
intravenous calcium, bicarbonate, and glucose with insulin, with hyperventilation
have resulted in successful resuscitation in some of the reported cases. Extraordinary
and prolonged resuscitative efforts have been effective in some cases. In
addition, in the presence of signs of malignant hyperthermia, appropriate
treatment should be initiated concurrently (see WARNINGS). Since it is difficult
to identify which patients are at risk, it is recommended that the use of
succinylcholine in pediatric patients should be reserved for emergency intubation
or instances where immediate securing of the airway is necessary, e.g., laryngospasm,
difficult airway, full stomach, or for intramuscular use when a suitable vein
is inaccessible.
As in adults, the incidence of bradycardia
in pediatric patients is higher following the second dose of succinylcholine.
The incidence and severity of bradycardia is higher in pediatric patients
than adults. Pre-treatment with anticholinergic agents, e.g., atropine, may
reduce the occurrence of bradyarrhythmias.
Geriatric Use:
Clinical studies of Quelicin did not include sufficient numbers
of subjects aged 65 and over to determine whether they respond differently
from younger subjects. Other reported clinical experience has not identified
differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing range, reflecting the greater frequency
of decreased hepatic, renal, or cardiac function, and of concomitant disease
or other drug therapy.
ADVERSE REACTIONS
Adverse reactions to succinylcholine consist primarily of
an extension of its pharmacological actions. Succinylcholine causes profound
muscle relaxation resulting in respiratory depression to the point of apnea;
this effect may be prolonged. Hypersensitivity reactions, including anaphylaxis,
may occur in rare instances. The following additional adverse reactions have
been reported: cardiac arrest, malignant hyperthermia, arrhythmias, bradycardia,
tachycardia, hypertension, hypotension, hyperkalemia, prolonged respiratory
depression or apnea, increased intraocular pressure, muscle fasciculation,
jaw rigidity, postoperative muscle pain, rhabdomyolysis with possible myoglobinuric
acute renal failure, excessive salivation, and rash.
OVERDOSAGE
Overdosage with succinylcholine may result in neuromuscular
block beyond the time needed for surgery and anesthesia. This may be manifested
by skeletal muscle weakness, decreased respiratory reserve, low tidal volume,
or apnea. The primary treatment is maintenance of a patent airway and respiratory
support until recovery of normal respiration is assured. Depending on the
dose and duration of succinylcholine administration, the characteristic depolarizing
neuromuscular block (Phase I) may change to a block with characteristics superficially
resembling a non-depolarizing block (Phase II) (see PRECAUTIONS).
DOSAGE AND ADMINISTRATION
The dosage of succinylcholine should be individualized and
should always be determined by the clinician after careful assessment of the
patient (see WARNINGS).
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.
Adults:
For Short Surgical
Procedures: The average dose required to produce neuromuscular blockade
and to facilitate tracheal intubation is 0.6 mg/kg Quelicin (succinylcholine
chloride) Injection given intravenously. The optimum dose will vary among
individuals and may be from 0.3 to 1.1 mg/kg for adults. Following administration
of doses in this range, neuromuscular blockade develops in about 1 minute;
maximum blockade may persist for about 2 minutes, after which recovery takes
place within 4 to 6 minutes. However, very large doses may result in more
prolonged blockade. A 5 to 10 mg test dose may be used to determine the
sensitivity of the patient and the individual recovery time (see PRECAUTIONS).
For Long Surgical Procedures: The dose of succinylcholine
administered by infusion depends upon the duration of the surgical procedure
and the need for muscle relaxation. The average rate for an adult ranges between
2.5 and 4.3 mg per minute.
Solutions containing from
1 to 2 mg per mL succinylcholine have commonly been used for continuous infusion.
The more dilute solution (1 mg per mL) is probably preferable from the standpoint
of ease of control of the rate of administration of the drug and, hence, of
relaxation. This intravenous solution containing 1 mg per mL may be administered
at a rate of 0.5 mg (0.5 mL) to 10 mg (10 mL) per minute to obtain the required
amount of relaxation. The amount required per minute will depend upon the
individual response as well as the degree of relaxation required. Avoid overburdening
the circulation with a large volume of fluid. It is recommended that neuromuscular
function be carefully monitored with a peripheral nerve stimulator when using
succinylcholine by infusion in order to avoid overdose, detect development
of Phase II block, follow its rate of recovery, and assess the effects of
reversing agents (see PRECAUTIONS).
Intermittent intravenous
injections of succinylcholine may also be used to provide muscle relaxation
for long procedures. An intravenous injection of 0.3 to 1.1 mg/kg may be given
initially, followed, at appropriate intervals, by further injections of 0.04
to 0.07 mg/kg to maintain the degree of relaxation required.
Pediatrics: For emergency tracheal intubation or
in instances where immediate securing of the airway is necessary, the intravenous
dose of succinylcholine is 2 mg/kg for infants and small pediatric patients;
for older pediatric patients and adolescents the dose is 1 mg/kg (see BOX
WARNING and PRECAUTIONS: Pediatric Use). It is currently known that the effective
dose of succinylcholine in pediatric patients may be higher than that predicted
by body weight dosing alone. For example, the usual adult IV dose of 0.6 mg/kg
is comparable to a dose of 2-3 mg/kg in neonates and infants to 6 months and
1-2 mg/kg in infants up to 2 years of age. This is thought to be due to the
relatively large volume of distribution in the pediatric patient versus the
adult patient.
Rarely, I.V. bolus administration of
succinylcholine in infants and pediatric patients may result in malignant
ventricular arrythmias and cardiac arrest secondary to acute rhabdomyolysis
with hyperkalemia. In such situations, an underlying myopathy should be suspected.
Intravenous bolus administration of succinylcholine in infants or pediatric
patients may result in profound bradycardia or, rarely, asystole. As in adults,
the incidence of bradycardia in pediatric patients is higher following a second
dose of succinylcholine. Whereas bradycardia is common in pediatric patients
after an initial dose of 1.5 mg/kg, bradycardia is seen in adults only after
repeated exposure. The occurrence of bradyarrhythmias may be reduced by pretreatment
with atropine (see PRECAUTIONS: Pediatric Use).
Intramuscular Use: If necessary, succinylcholine
may be given intramuscularly to infants, older pediatric patients or adults
when a suitable vein is inaccessible. A dose of up to 3 to 4 mg/kg may be
given, but not more than 150 mg total dose should be administered by this
route. The onset of effect of succinylcholine given intramuscularly is usually
observed in about 2 to 3 minutes.
Compatibility
and Admixtures: Succinylcholine is acidic (pH 3.5) and should not
be mixed with alkaline solutions having a pH greater than 8.5 (e.g., barbiturate
solutions). Admixtures containing 1 to 2 mg/mL may be prepared by adding 1
g Quelicin to 1000 or 500 mL sterile solution, such as 5% Dextrose Injection,
USP or 0.9% Sodium Chloride Injection, USP. Admixtures of Quelicin must be
used within 24 hours after preparation. Aseptic techniques should be used
to prepare the diluted product. Admixtures of Quelicin should be prepared
for single patient use only. The unused portion of diluted Quelicin should
be discarded.
To prevent needle-stick injuries, needles
should not be recapped, purposely bent, or broken by hand.
HOW SUPPLIED
Quelicin® (Succinylcholine Chloride Injection,
USP) is supplied as a clear, colorless solution in the following concentrations
and packages:
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List No.
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Container
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Size
(mL)
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mg/mL
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mg (total)
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mOsmol/mL
(calc.)
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Single-dose
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8065
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Abboject Unit of Use Syringe
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5
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20
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100
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0.328
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6970
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Fliptop Vial
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10 in 20
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100
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1000
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0.830
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Multiple-dose
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6629
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Fliptop Vial
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10
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20
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200
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0.338
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Refrigeration of the undiluted agent will assure full potency
until expiration date. All units carry a date of expiration.
Store in refrigerator 2° to 8°C (36° to 46°F). The multi-dose vials are stable for up to 14 days at room temperature
without significant loss of potency.
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©Hospira 2004
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EN-0122
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Printed in USA
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HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
| Quelicin (Succinylcholine Chloride) |
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| Quelicin (Succinylcholine Chloride) |
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| Quelicin (Succinylcholine Chloride) |
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Revised: 07/2006HOSPIRA, INC.