SUCCINYLCHOLINE CHLORIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)

Available from:

Renaissance Lakewood LLC

Administration route:

PARENTERAL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION
RENAISSANCE LAKEWOOD LLC
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SUCCINYLCHOLINE CHLORIDE INJECTION USP, 20 MG/ML
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 Duchenne’s 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).
PRIMARY