Label: 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

If you are a consumer or patient please visit this version.

  • 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).

  • Primary package for Succinylcholine

    Carton Image

  • INGREDIENTS AND APPEARANCE
    SUCCINYLCHOLINE CHLORIDE 
    succinylcholine chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49396-0152
    Route of AdministrationPARENTERAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF) SUCCINYLCHOLINE CHLORIDE200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49396-0152-26 in 1 BOX10/01/2018
    125 in 1 CARTON
    110 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21023110/01/2018
    Labeler - Renaissance Lakewood LLC (077744035)
    Registrant - Renaissance Lakewood LLC (077744035)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renaissance Lakewood LLC077744035manufacture(49396-0152) , analysis(49396-0152)