Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in 10 mL multiple-dose vials. Each mL contains succinylcholine chloride, USP 20 mg.
It is available as follows:
200 mg/10 mL (20 mg/mL)
10 mL Multiple-dose Fliptop Vial: NDC 70121-1581-1
25 Vials in a Carton: NDC 70121-1581-5
Summary of content and characteristics of the solutions:
Container
Size (mL)
mg/mL
mg (total)
mOsmol/mL
Multiple-dose Fliptop Vial
10 mL
20 mg/mL
200 mg
0.338
Refrigeration of the undiluted agent will assure full potency until expiration date. All units carry a date of expiration.
Store in refrigerator at 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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BOXED WARNING (What is this?)
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).
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SPL UNCLASSIFIED SECTION
This drug should be used only by individuals familiar with its actions, characteristics and hazards.
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DESCRIPTION
Succinylcholine chloride injection, USP is a sterile, nonpyrogenic solution to be used as an ultra short-acting, depolarizing, skeletal muscle relaxant, see HOW SUPPLIED for summary of content and characteristics of the solutions. The solutions are for intramuscular or intravenous use.
Succinylcholine Chloride is chemically designated as Ethanaminium, 2,2’-[(1,4-dioxo-1,4-butanediyl) bis(oxy)] bis [N, N, N-trimethyl-, dichloride, dihydrate, its molecular formula is C14H30Cl2N2O4.2H2O and its molecular weight is 397.34.
It has the following structural formula:
1
Succinylcholine is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. Succinylcholine chloride, USP is a white, odorless, crystalline powder. It is freely soluble in water, slightly soluble in alcohol and practically insoluble in ether. The drug is incompatible with alkaline solutions but relatively stable in acid solutions. Solutions of the drug lose potency unless refrigerated.
Solution intended for multiple-dose administration contains methylparaben, 0.18% and propylparaben, 0.02% as preservatives. Product not requiring dilution (multiple-dose fliptop vial) contains 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 section for characteristics.
Sodium Chloride, USP, chemically designated NaCl, is a white crystalline compound freely soluble in water.
