Label: SUCCINYLCHOLINE CHLORIDE- succinylcholine chloride injection

  • NDC Code(s): 49396-0152-2
  • Packager: Renaissance Lakewood LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 13, 2018

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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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  • Primary package for Succinylcholine
  • INGREDIENTS AND APPEARANCE
    SUCCINYLCHOLINE CHLORIDE 
    succinylcholine chloride injection
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49396-0152
    Route of Administration PARENTERAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF) SUCCINYLCHOLINE CHLORIDE 200 mg  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49396-0152-2 6 in 1 BOX 10/01/2018
    1 25 in 1 CARTON
    1 10 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA210231 10/01/2018
    Labeler - Renaissance Lakewood LLC (077744035)
    Registrant - Renaissance Lakewood LLC (077744035)
    Establishment
    Name Address ID/FEI Business Operations
    Renaissance Lakewood LLC 077744035 manufacture(49396-0152) , analysis(49396-0152)
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