SUCCINYLCHOLINE CHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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.

Product summary:

SUCCINYLCHOLINE CHLORIDE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1353-1 SUCCINYLCHOLINE CHLORIDE INJECTION, USP 200mg (20mg/mL) 10mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms QUELICIN™ (Succinylcholine Chloride Injection, USP) is supplied as a clear, colorless solution in the following concentrations and packages: 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. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1246-2.0 Revised: 6/2018

Authorization status:

New Drug Application

Summary of Product characteristics

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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SUCCINYLCHOLINE CHLORIDE INJECTION, USP 200MG (20MG/ML) 10ML VIAL
BOXED WARNING
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: P