Succinylcholine Chloride Prescribing Information
- Acute rhabdomyolysis with hyperkalemia followed by ventricular dysrhythmias, cardiac arrest, and death has occurred after the administration of succinylcholine to apparently healthy pediatric patients who were subsequently found to have undiagnosed skeletal muscle myopathy, most frequently Duchenne muscular dystrophy[see.]5.1 Ventricular Dysrhythmias, Cardiac Arrest, and Death From Hyperkalemic Rhabdomyolysis in Pediatric PatientsThere have been reports of ventricular dysrhythmias, cardiac arrest, and death secondary to acute rhabdomyolysis with hyperkalemia in apparently healthy pediatric patients who received succinylcholine. Many of these pediatric patients were subsequently found to have a skeletal muscle myopathy such as Duchenne muscular dystrophy whose clinical signs were not obvious.The syndrome often presented as sudden cardiac arrest within minutes after the administration of succinylcholine. These pediatric patients were usually, but not exclusively, males, and most frequently 8 years of age or younger. There have also been reports in adolescents. There may be no signs or symptoms to alert the practitioner to which patients are at risk. A careful history and physical may identify developmental delays suggestive of a myopathy. A preoperative creatine kinase could identify some but not all patients at risk.When a healthy-appearing pediatric patient develops cardiac arrest within minutes after administration of succinylcholine chloride, not felt to be due to inadequate ventilation, oxygenation or anesthetic overdose, immediate treatment for hyperkalemia should be instituted. Due to the abrupt onset of this syndrome, routine resuscitative measures are likely to be unsuccessful. Careful monitoring of the electrocardiogram may alert the practitioner to peaked T-waves (an early sign). Administration of intravenous calcium, bicarbonate, and glucose with insulin, with hyperventilation have resulted in successful resuscitation in some of the reported cases. Extraordinary and prolonged resuscitative efforts have been effective in some cases. In addition, in the presence of signs of malignant hyperthermia, appropriate treatment should be initiated concurrently[see Warnings and Precautions (5.5)].Because it is difficult to identify which patients are at risk, reserve the use of succinylcholine chloride in pediatric patients 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.
- When a healthy appearing pediatric patient develops cardiac arrest within minutes after administration of succinylcholine chloride, not felt to be due to inadequate ventilation, oxygenation or anesthetic overdose, immediate treatment for hyperkalemia should be instituted. In the presence of signs of malignant hyperthermia, appropriate treatment should be instituted concurrently[see.]5.1 Ventricular Dysrhythmias, Cardiac Arrest, and Death From Hyperkalemic Rhabdomyolysis in Pediatric PatientsThere have been reports of ventricular dysrhythmias, cardiac arrest, and death secondary to acute rhabdomyolysis with hyperkalemia in apparently healthy pediatric patients who received succinylcholine. Many of these pediatric patients were subsequently found to have a skeletal muscle myopathy such as Duchenne muscular dystrophy whose clinical signs were not obvious.The syndrome often presented as sudden cardiac arrest within minutes after the administration of succinylcholine. These pediatric patients were usually, but not exclusively, males, and most frequently 8 years of age or younger. There have also been reports in adolescents. There may be no signs or symptoms to alert the practitioner to which patients are at risk. A careful history and physical may identify developmental delays suggestive of a myopathy. A preoperative creatine kinase could identify some but not all patients at risk.When a healthy-appearing pediatric patient develops cardiac arrest within minutes after administration of succinylcholine chloride, not felt to be due to inadequate ventilation, oxygenation or anesthetic overdose, immediate treatment for hyperkalemia should be instituted. Due to the abrupt onset of this syndrome, routine resuscitative measures are likely to be unsuccessful. Careful monitoring of the electrocardiogram may alert the practitioner to peaked T-waves (an early sign). Administration of intravenous calcium, bicarbonate, and glucose with insulin, with hyperventilation have resulted in successful resuscitation in some of the reported cases. Extraordinary and prolonged resuscitative efforts have been effective in some cases. In addition, in the presence of signs of malignant hyperthermia, appropriate treatment should be initiated concurrently[see Warnings and Precautions (5.5)].Because it is difficult to identify which patients are at risk, reserve the use of succinylcholine chloride in pediatric patients 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.
- Reserve the use of succinylcholine chloride in pediatric patients 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.]5.1 Ventricular Dysrhythmias, Cardiac Arrest, and Death From Hyperkalemic Rhabdomyolysis in Pediatric PatientsThere have been reports of ventricular dysrhythmias, cardiac arrest, and death secondary to acute rhabdomyolysis with hyperkalemia in apparently healthy pediatric patients who received succinylcholine. Many of these pediatric patients were subsequently found to have a skeletal muscle myopathy such as Duchenne muscular dystrophy whose clinical signs were not obvious.The syndrome often presented as sudden cardiac arrest within minutes after the administration of succinylcholine. These pediatric patients were usually, but not exclusively, males, and most frequently 8 years of age or younger. There have also been reports in adolescents. There may be no signs or symptoms to alert the practitioner to which patients are at risk. A careful history and physical may identify developmental delays suggestive of a myopathy. A preoperative creatine kinase could identify some but not all patients at risk.When a healthy-appearing pediatric patient develops cardiac arrest within minutes after administration of succinylcholine chloride, not felt to be due to inadequate ventilation, oxygenation or anesthetic overdose, immediate treatment for hyperkalemia should be instituted. Due to the abrupt onset of this syndrome, routine resuscitative measures are likely to be unsuccessful. Careful monitoring of the electrocardiogram may alert the practitioner to peaked T-waves (an early sign). Administration of intravenous calcium, bicarbonate, and glucose with insulin, with hyperventilation have resulted in successful resuscitation in some of the reported cases. Extraordinary and prolonged resuscitative efforts have been effective in some cases. In addition, in the presence of signs of malignant hyperthermia, appropriate treatment should be initiated concurrently[see Warnings and Precautions (5.5)].Because it is difficult to identify which patients are at risk, reserve the use of succinylcholine chloride in pediatric patients 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.
| Boxed Warning | 08/2021 |
Dosage and Administration (2.1 Important Dosage and Administration Information
Risk of Medication Errors Accidental administration of neuromuscular blocking agents may be fatal. Store succinylcholine chloride with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product [see Warnings and Precautions (5.3)] . | 08/2021 |
Warnings and Precautions (5.1 Ventricular Dysrhythmias, Cardiac Arrest, and Death From Hyperkalemic Rhabdomyolysis in Pediatric Patients There have been reports of ventricular dysrhythmias, cardiac arrest, and death secondary to acute rhabdomyolysis with hyperkalemia in apparently healthy pediatric patients who received succinylcholine. Many of these pediatric patients were subsequently found to have a skeletal muscle myopathy such as Duchenne muscular dystrophy whose clinical signs were not obvious. The syndrome often presented as sudden cardiac arrest within minutes after the administration of succinylcholine. These pediatric patients were usually, but not exclusively, males, and most frequently 8 years of age or younger. There have also been reports in adolescents. There may be no signs or symptoms to alert the practitioner to which patients are at risk. A careful history and physical may identify developmental delays suggestive of a myopathy. A preoperative creatine kinase could identify some but not all patients at risk. When a healthy-appearing pediatric patient develops cardiac arrest within minutes after administration of succinylcholine chloride, not felt to be due to inadequate ventilation, oxygenation or anesthetic overdose, immediate treatment for hyperkalemia should be instituted. Due to the abrupt onset of this syndrome, routine resuscitative measures are likely to be unsuccessful. Careful monitoring of the electrocardiogram may alert the practitioner to peaked T-waves (an early sign). Administration of intravenous calcium, bicarbonate, and glucose with insulin, with hyperventilation have resulted in successful resuscitation in some of the reported cases. Extraordinary and prolonged resuscitative efforts have been effective in some cases. In addition, in the presence of signs of malignant hyperthermia, appropriate treatment should be initiated concurrently [see Warnings and Precautions (5.5)] .Because it is difficult to identify which patients are at risk, reserve the use of succinylcholine chloride in pediatric patients 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. 5.2 AnaphylaxisSevere anaphylactic reactions to neuromuscular blocking agents, including succinylcholine, have been reported. These reactions have, in some cases, been life-threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken. Allergic cross-reactivity between neuromuscular blocking agents, both depolarizing and non-depolarizing, has been reported in this class of drugs. Therefore, assess patients for previous anaphylactic reactions to other neuromuscular blocking agents before administering succinylcholine chloride. 5.4 HyperkalemiaSuccinylcholine chloride may induce serious cardiac arrhythmias or cardiac arrest due to hyperkalemia in patients with electrolyte abnormalities and those who may have digitalis toxicity. Succinylcholine chloride is contraindicated after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury [see Contraindications (4)] . 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 undetermined.Patients with chronic abdominal infection, subarachnoid hemorrhage, or conditions causing degeneration of central and peripheral nervous systems are at an increased risk of developing severe hyperkalemia after succinylcholine chloride administration. Consider avoiding use of succinylcholine chloride in these patients or verify the patient’s baseline potassium levels are within the normal range prior to succinylcholine chloride administration. 5.9 Risk of Prolonged Neuromuscular Block in Patients with Reduced Plasma Cholinesterase ActivitySuccinylcholine chloride is not recommended in patients with known reduced plasma cholinesterase (pseudocholinesterase) activity due to the likelihood of prolonged neuromuscular block following administration of succinylcholine chloride in such patients. Plasma cholinesterase activity may be diminished in the presence of genetic abnormalities of plasma cholinesterase (e.g., patients heterozygous or homozygous for atypical plasma cholinesterase gene), pregnancy, severe liver or kidney disease, malignant tumors, infections, burns, anemia, decompensated heart disease, peptic ulcer, or myxedema. Plasma cholinesterase activity may also be diminished by chronic administration of oral contraceptives, glucocorticoids, or certain monoamine oxidase inhibitors and by irreversible inhibitors of plasma cholinesterase (e.g., organophosphate insecticides, echothiophate, and certain antineoplastic drugs) [see Drug Interactions (7.1)] .Patients homozygous for atypical plasma cholinesterase gene (1 in 2,500 patients) are extremely sensitive to the neuromuscular blocking effect of succinylcholine. If succinylcholine chloride is administered to a patient homozygous for atypical plasma cholinesterase, resulting apnea or prolonged muscle paralysis should be treated with controlled respiration. 5.10 Risk of Additional Trauma in Patients With Fractures or Muscle SpasmsSuccinylcholine chloride should be employed with caution in patients with fractures or muscle spasm because the initial muscle fasciculations may cause additional trauma. Monitor neuromuscular transmission and the development of fasciculations throughout the use of neuromuscular blocking agents. 5.12 Risk of Aspiration due to Increase in Intragastric PressureSuccinylcholine may increase intragastric pressure, which could result in regurgitation and possible aspiration of stomach contents. Evaluate patients at risk for aspiration and regurgitation. Monitor patients during induction of anesthesia and neuromuscular blockade for clinical signs of vomiting and/or aspiration. 5.13 Prolonged Neuromuscular Block in Patients with Hypokalemia or HypocalcemiaNeuromuscular blockade may be prolonged in patients with hypokalemia (e.g., after severe vomiting, diarrhea, digitalisation and diuretic therapy) or hypocalcemia (e.g., after massive transfusions). Correct severe electrolyte disturbances when possible. In order to help preclude possible prolongation of neuromuscular block, monitor neuromuscular transmission throughout the use of succinylcholine chloride. 5.14 Risks due to Inadequate AnesthesiaNeuromuscular blockade in the conscious patient can lead to distress. Use succinylcholine chloride in the presence of appropriate sedation or general anesthesia. Monitor patients to ensure that the level of anesthesia is adequate. In emergency situations, however, it may be necessary to administer succinylcholine chloride before unconsciousness is induced. | 08/2021 |
Succinylcholine chloride is indicated in adults and pediatric patients:
- as an adjunct to general anesthesia
- to facilitate tracheal intubation
- to provide skeletal muscle relaxation during surgery or mechanical ventilation.
- For intravenous or intramuscular use only. ()
2.1 Important Dosage and Administration Information- Succinylcholine chloride is for intravenous or intramuscular use only.
- Succinylcholine chloride must be titrated to effect by or under supervision of experienced clinicians who are familiar with its actions and with appropriate neuromuscular monitoring techniques.
- Succinylcholine chloride should be administered only by those skilled in the management of artificial respiration and only when facilities are instantly available for tracheal intubation and for providing adequate ventilation of the patient, including the administration of oxygen under positive pressure and the elimination of CO2. The clinician must be prepared to assist or control respiration.
- The dosage of succinylcholine chloride should be individualized and should always be determined by the clinician after careful assessment of the patient.
- To avoid distress to the patient, do not administer succinylcholine chloride before unconsciousness has been induced[see Warnings and Precautions (5.14)].
- The occurrence of bradyarrhythmias with administration of succinylcholine chloride may be reduced by pretreatment with anticholinergics (e.g., atropine)[see Warnings and Precautions (5.6)].
- Monitor neuromuscular function with a peripheral nerve stimulator when using succinylcholine chloride by infusion[see Dosage and Administration (2.2), Warnings and Precautions (5.8)].
- Visually inspect succinylcholine chloride for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer solutions that are not clear and colorless.
- Succinylcholine chloride supplied in multiple-dose vials does not require dilution before use[see Dosage and Administration (2.5)].
Risk of Medication ErrorsAccidental administration of neuromuscular blocking agents may be fatal. Store succinylcholine chloride with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product
[see Warnings and Precautions (5.3)]. - Individualize dosage after careful assessment of the patient. ()
2.1 Important Dosage and Administration Information- Succinylcholine chloride is for intravenous or intramuscular use only.
- Succinylcholine chloride must be titrated to effect by or under supervision of experienced clinicians who are familiar with its actions and with appropriate neuromuscular monitoring techniques.
- Succinylcholine chloride should be administered only by those skilled in the management of artificial respiration and only when facilities are instantly available for tracheal intubation and for providing adequate ventilation of the patient, including the administration of oxygen under positive pressure and the elimination of CO2. The clinician must be prepared to assist or control respiration.
- The dosage of succinylcholine chloride should be individualized and should always be determined by the clinician after careful assessment of the patient.
- To avoid distress to the patient, do not administer succinylcholine chloride before unconsciousness has been induced[see Warnings and Precautions (5.14)].
- The occurrence of bradyarrhythmias with administration of succinylcholine chloride may be reduced by pretreatment with anticholinergics (e.g., atropine)[see Warnings and Precautions (5.6)].
- Monitor neuromuscular function with a peripheral nerve stimulator when using succinylcholine chloride by infusion[see Dosage and Administration (2.2), Warnings and Precautions (5.8)].
- Visually inspect succinylcholine chloride for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer solutions that are not clear and colorless.
- Succinylcholine chloride supplied in multiple-dose vials does not require dilution before use[see Dosage and Administration (2.5)].
Risk of Medication ErrorsAccidental administration of neuromuscular blocking agents may be fatal. Store succinylcholine chloride with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product
[see Warnings and Precautions (5.3)]. - Accidental administration of neuromuscular blocking agents may be fatal. Store succinylcholine chloride with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product. ()
2.1 Important Dosage and Administration Information- Succinylcholine chloride is for intravenous or intramuscular use only.
- Succinylcholine chloride must be titrated to effect by or under supervision of experienced clinicians who are familiar with its actions and with appropriate neuromuscular monitoring techniques.
- Succinylcholine chloride should be administered only by those skilled in the management of artificial respiration and only when facilities are instantly available for tracheal intubation and for providing adequate ventilation of the patient, including the administration of oxygen under positive pressure and the elimination of CO2. The clinician must be prepared to assist or control respiration.
- The dosage of succinylcholine chloride should be individualized and should always be determined by the clinician after careful assessment of the patient.
- To avoid distress to the patient, do not administer succinylcholine chloride before unconsciousness has been induced[see Warnings and Precautions (5.14)].
- The occurrence of bradyarrhythmias with administration of succinylcholine chloride may be reduced by pretreatment with anticholinergics (e.g., atropine)[see Warnings and Precautions (5.6)].
- Monitor neuromuscular function with a peripheral nerve stimulator when using succinylcholine chloride by infusion[see Dosage and Administration (2.2), Warnings and Precautions (5.8)].
- Visually inspect succinylcholine chloride for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer solutions that are not clear and colorless.
- Succinylcholine chloride supplied in multiple-dose vials does not require dilution before use[see Dosage and Administration (2.5)].
Risk of Medication ErrorsAccidental administration of neuromuscular blocking agents may be fatal. Store succinylcholine chloride with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product
[see Warnings and Precautions (5.3)]. - See full prescribing information for succinylcholine chloride dosage recommendations, preparation instructions, and administration information. (,
2.2 Dosage Recommendations for Intravenous Use in AdultsFor Short Surgical Procedures
The average dose required to produce neuromuscular blockade and to facilitate tracheal intubation is 0.6 mg/kg succinylcholine chloride given intravenously. The optimum intravenous dose of succinylcholine chloride will vary among patients and may be from 0.3 mg/kg to 1.1 mg/kg for adults. Following intravenous administration of doses in this range, neuromuscular blockade develops in about 1 minute; maximum blockade may persist for about 2 minutes, after which recovery takes place within 4 to 6 minutes. A 5 to 10 mg intravenous test dose of succinylcholine chloride may be used to determine the sensitivity of the patient and the individual recovery time[see Warnings and Precautions (5.9)].For Long Surgical ProceduresContinuous Intravenous Infusion
The dosage of succinylcholine chloride administered by continuous intravenous infusion depends upon the duration of the surgical procedure and the need for muscle relaxation.Diluted succinylcholine chloride solutions containing from 1 mg/mL to 2 mg/mL succinylcholine have commonly been used for continuous intravenous infusion
[see Dosage and Administration (2.5)]. The more dilute solution (1 mg/mL) is probably preferable from the standpoint of ease of control of the rate of administration of succinylcholine chloride and, hence, of relaxation. This diluted succinylcholine chloride solution containing 1 mg/mL succinylcholine may be administered intravenously at a rate of 0.5 mg (0.5 mL) per minute to 10 mg (10 mL) per minute to obtain the required amount of relaxation. The amount required per minute will depend upon the individual response as well as the degree of relaxation required. The average rate of continuous intravenous infusion for an adult ranges between 2.5 mg per minute and 4.3 mg per minute.Monitor neuromuscular function with a peripheral nerve stimulator when using succinylcholine chloride by infusion in order to avoid overdose, detect development of Phase II block, follow its rate of recovery, and assess the effects of reversing agents
[see Warnings and Precautions (5.8)].Intermittent Intravenous Injection
Intermittent intravenous injections of succinylcholine chloride may also be used to provide muscle relaxation for long procedures. An intravenous injection of 0.3 mg/kg to 1.1 mg/kg may be given initially, followed, at appropriate intervals, by further intravenous injections of 0.04 mg/kg to 0.07 mg/kg to maintain the degree of relaxation required.,2.3 Dosage Recommendations for Intravenous Use in Pediatric PatientsFor emergency tracheal intubation or in instances where immediate securing of the airway is necessary, the intravenous dose of succinylcholine chloride is 2 mg/kg for infants and other small pediatric patients; for older pediatric patients and adolescents the intravenous dose is 1 mg/kg
[see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].The effective dose of succinylcholine chloride in pediatric patients may be higher than that predicted by body weight dosing alone. For example, the usual adult intravenous dose of 0.6 mg/kg is comparable to a dose of 2 mg/kg to 3 mg/kg in neonates and infants up to 6 months of age and 1 mg/kg to 2 mg/kg in infants up to 2 years of age[see Clinical Pharmacology (12.3)].,2.4 Dosage Recommendations for Intramuscular Use in Adults and Pediatric PatientsIf a suitable vein is inaccessible, succinylcholine chloride may be administered intramuscularly at a dose of up to 3 mg/kg to 4 mg/kg to infants, older pediatric patients, or adults. The total dose administered by the intramuscular route should not exceed 150 mg. The onset of effect of succinylcholine given intramuscularly is usually observed in about 2 to 3 minutes.
,2.5 Preparation of Succinylcholine Chloride Injection, SolutionSuccinylcholine chloride supplied in multiple-dose vials does not require dilution before use.
Succinylcholine chloride may be diluted to 1 mg/mL or 2 mg/mL in a solution such as:
- 5% Dextrose Injection, USP, or
- 0.9% Sodium Chloride Injection, USP
Prepare the diluted succinylcholine chloride solution for single patient use only. Store the diluted succinylcholine chloride solution in a refrigerator [2 °C to 8 °C (36 °F to 46 °F)] and use within 24 hours after preparation. Visually inspect the diluted succinylcholine chloride solution for particulate matter and discoloration prior to administration. Do not administer solutions that are not clear and colorless. Discard any unused portion of the diluted succinylcholine chloride solution.
)2.6 Drug IncompatibilitySuccinylcholine chloride is acidic (pH is between 3.0 and 4.5) and may not be compatible with alkaline solutions having a pH greater than 8.5 (e.g., barbiturate solutions). Therefore, do not mix succinylcholine chloride with alkaline solutions.
Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution as follows:
- 200 mg/10 mL (20 mg/mL) in multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP).
Available data from published literature from case reports and case series over decades of use with
succinylcholine during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Succinylcholine is used commonly during delivery by caesarean section to provide muscle relaxation. If succinylcholine is used during labor and delivery, there is a risk for prolonged apnea in some pregnant women
Plasma cholinesterase levels are decreased by approximately 24% during pregnancy and for several days postpartum which can prolong the effect of succinylcholine. Therefore, some pregnant patients may experience prolonged apnea.
Apnea and flaccidity may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase in, the mother.
Succinylcholine is commonly used to provide muscle relaxation during delivery by caesarean section. Succinylcholine is known to cross the placental barrier in an amount that is dependent on the concentration gradient between the maternal and fetal circulation.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.