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WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS 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 Warnings and Precautions (5.1 )] . When a healthy appearing pediatric patient develops cardiac arrest within minutes after administration of Succinylcholine Chloride Injection, 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 Warnings and Precautions (5.1) ] . Reserve the use of Succinylcholine Chloride Injection 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 Warnings and Precautions (5.1) ] .

Succinylcholine Chloride Injection 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 ) Individualize dosage after careful assessment of the patient. ( 2.1 ) Accidental administration of neuromuscular blocking agents may be fatal. Store with the prefilled syringe and cap intact, and in a manner that minimizes the possibility of selecting the wrong product. ( 2.1 ) See full prescribing information for dosage recommendations, preparation instructions, and administration information. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 )

NDC No. Container Size (mL) mg/mL mg (total) mOsmol/mL (calc.) Single-dose 0641-6234-10 Prefilled single-dose Syringe 5 20 100 0.338 Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in the following concentration and package: NDC 0641-6234-10,  5 mL single-dose prefilled syringes packaged in a carton of 10. Refrigeration of the undiluted Succinylcholine Chloride Injection will assure full potency until expiration date. All units carry a date of expiration. Discard unused portion. Store in refrigerator 2° C to 8°C (36° C to 46 °F).The single-dose syringes are stable for up to 14 days at room temperature without significant loss of potency. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 462-923-02

Succinylcholine Chloride Injection is contraindicated: in patients with skeletal muscle myopathies [see Warnings and Precautions (5.1 )] in patients with known hypersensitivity to succinylcholine. Severe anaphylactic reactions to succinylcholine have been reported [see Warnings and Precautions (5. 2) ] after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see Warnings and Precautions (5.4 )] in patients with known or suspected genetic susceptibility to malignant hyperthermia [see Warnings and Precautions (5.5) , Clinical Pharmacology (12.5)]

Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use.  Succinylcholine Chloride Injection contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated as Ethanaminium, 2,2’-[(1,4-dioxo-1,4-butanediyl) bis(oxy)]bis[ N, N, N -trimethyl-, dichloride, dihydrate, it’s molecular formula is  C 14 H 30 Cl 2 N 2 O 4 • 2H 2 O and its molecular weight is 397.34. It has the following structural formula: Structural Formula Succinylcholine is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. The drug is incompatible with alkaline solutions but relatively stable in acid solutions. Solutions of the drug lose potency unless refrigerated. Succinylcholine Chloride Injection, USP 100 mg/5 mL (20 mg/mL) is intended for single-dose administration and contains no preservatives. Unused solution should be discarded. Product not requiring dilution (single-dose prefilled syringe) contains sodium chloride to render isotonic. Each milliliter contains 20 mg succinylcholine chloride USP equivalent to 21.99 mg succinylcholine chloride dihydrate, and 4.5 mg of sodium chloride as an isotonicity agent. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH of the solution is 3.6 (3.0 to 4.5).

Drugs that May Enhance the Neuromuscular Blocking Action of Succinylcholine : promazine, oxytocin, aprotinin, certain non‑penicillin antibiotics, quinidine, β‑adrenergic blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, isoflurane, desflurane, metoclopramide, terbutaline, and drugs that reduce plasma cholinesterase activity. ( 7.1 )

Safety and effectiveness of succinylcholine chloride have been established in pediatric patient age groups, neonate to adolescent. Because of a risk of ventricular dysrhythmias, cardiac arrest, and death from hyperkalemic rhabdomyolysis in pediatric patients, reserve the use of Succinylcholine Chloride Injection 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 Warnings and Precautions (5.1 )] . Intravenous bolus administration of Succinylcholine Chloride Injection in pediatric patients (including infants) may result in profound bradycardia or, rarely, asystole. The incidence and severity of bradycardia is higher in pediatric patients than adults [see Warnings and Precautions (5.6) ] . The effective dose of Succinylcholine Chloride Injection in pediatric patients may be higher than that predicted by body weight dosing alone [see Dosage and Administration (2.3) ] .

Clinical studies of succinylcholine chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Carcinogenesis There have been no long-term studies performed in animals to evaluate carcinogenic potential of succinylcholine. Mutagenesis Adequate studies have not been completed to evaluate the genotoxic potential of succinylcholine. Impairment of Fertility There are no studies to evaluate the potential impact of succinylcholine on fertility.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Ventricular Dysrhythmias, Cardiac Arrest, and Death from Hyperkalemic Rhabdomyolysis in Pediatric Patients [see Warnings and Precautions (5.1) ] Anaphylaxis [see Warnings and Precautions (5.2) ] Hyperkalemia [see Warnings and Precautions (5.4) ] Malignant Hyperthermia [see Warnings and Precautions (5.5) ] Bradycardia [see Warnings and Precautions (5.6 )] Increase in Intraocular Pressure [see  Warnings and Precautions (5.7 )] Prolonged Neuromuscular Block due to Phase II Block and Tachyphylaxis [see Warnings and Precautions (5.8 )] The following adverse reactions associated with the use of succinylcholine were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular disorders : Cardiac arrest, arrhythmias, bradycardia, tachycardia, hypertension, hypotension Electrolyte disorders : Hyperkalemia Eye disorders : Increased intraocular pressure Gastrointestinal disorders : Excessive salivation Immune system disorders : Hypersensitivity reactions including anaphylaxis (in some cases life-threatening and fatal) Musculoskeletal disorders : Malignant hyperthermia, rhabdomyolysis with possible myoglobinuric acute renal failure, muscle fasciculation, jaw rigidity, postoperative muscle pain Respiratory disorders : Prolonged respiratory depression or apnea Skin disorders : Rash

Overdosage with Succinylcholine Chloride Injection may result in neuromuscular block beyond the time needed for surgery and anesthesia. This may be manifested by skeletal muscle weakness, decreased respiratory reserve, low tidal volume, or apnea. The primary treatment is maintenance of a patent airway and respiratory support until recovery of normal respiration is assured. Depending on the dose and duration of Succinylcholine Chloride Injection administration, the characteristic depolarizing neuromuscular block (Phase I) may change to a block with characteristics superficially resembling a non-depolarizing block (Phase II) [see Warnings and Precautions (5.8) ] .

Risk Summary Available data from published literature from case reports and case series over several 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 (see Clinical Considerations). Animal reproduction studies have not been conducted with succinylcholine chloride. 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. Clinical Considerations Maternal Adverse Reactions 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. Fetal/Neonatal Adverse Reactions Apnea and flaccidity may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase, in the mother. Labor or Delivery 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.

Succinylcholine Chloride Injection is for intravenous or intramuscular use only. Succinylcholine Chloride Injection must be administered under supervision of experienced clinicians who are familiar with its actions and with appropriate neuromuscular monitoring techniques. Succinylcholine Chloride Injection 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 CO 2 . The clinician must be prepared to assist or control respiration. The dosage of Succinylcholine Chloride Injection 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 Injection before unconsciousness has been induced [see Warnings and Precautions (5.14 )] . The occurrence of bradyarrhythmias with administration of Succinylcholine Chloride Injection 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 Injection by infusion [see Dosage and Administration (2.2 ), Warnings and Precautions (5.8 )] . Visually inspect Succinylcholine Chloride Injection 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 Injection must be diluted for continuous intravenous infusion [see  Dosage and Administration (2.5) ] . Risk of Medication Errors Accidental administration of neuromuscular blocking agents may be fatal. Store Succinylcholine Chloride Injection with the prefilled syringe and cap intact, and in a manner that minimizes the possibility of selecting the wrong product [see Warnings and Precautions (5.3) ] .

Succinylcholine Chloride Injection, USP, is a clear, colorless solution available as follows: 100 mg per 5 mL (20 mg/mL) in a single-dose, prefilled syringe

Succinylcholine is a depolarizing neuromuscular blocker. As does acetylcholine, it combines with the cholinergic receptors of the motor end plate to produce depolarization. This depolarization may be observed as fasciculations. Subsequent neuromuscular transmission is inhibited so long as adequate concentration of succinylcholine remains at the receptor site. Onset of flaccid paralysis is rapid (less than one minute after intravenous administration), and with single administration lasts approximately 4 to 6 minutes. The paralysis following administration of succinylcholine is progressive, with differing sensitivities of different muscles. This initially involves consecutively the levator muscles of the face, muscles of the glottis and finally the intercostals and the diaphragm and all other skeletal muscles.

Depending on the dose and duration of succinylcholine administration, the characteristic depolarizing neuromuscular block (Phase I block) may change to a block with characteristics superficially resembling a non-depolarizing block (Phase II block). This may be associated with prolonged respiratory muscle paralysis or weakness in patients who manifest the transition to Phase II block. Tachyphylaxis occurs with repeated administration [see Warnings and Precautions (5.8 )] . The transition from Phase I to Phase II block has been reported in 7 of 7 patients studied under halothane anesthesia after an accumulated dose of 2 to 4 mg/kg succinylcholine (administered in repeated, divided doses). The onset of Phase II block coincided with the onset of tachyphylaxis and prolongation of spontaneous recovery. In another study, using balanced anesthesia (N 2 O/O 2 /narcotic‑thiopental) and succinylcholine infusion, the transition was less abrupt, with great individual variability in the dose of succinylcholine required to produce Phase II block. Of 32 patients studied, 24 developed Phase II block. Tachyphylaxis was not associated with the transition to Phase II block, and 50% of the patients who developed Phase II block experienced prolonged recovery [see Warnings and Precautions (5.8) ]. Succinylcholine has no direct effect on the myocardium. Succinylcholine stimulates both autonomic ganglia and muscarinic receptors which may cause changes in cardiac rhythm, including cardiac arrest. Changes in rhythm, including cardiac arrest, may also result from vagal stimulation, which may occur during surgical procedures, or from hyperkalemia, particularly in pediatric patients [see Warnings and Precautions ( 5.1 , 5.4 , 5.6 ), Use in Specific Populations (8.4 )] . These effects are enhanced by halogenated anesthetics. Succinylcholine causes an increase in intraocular pressure immediately after its injection and during the fasciculation phase, which may persist after onset of complete paralysis [see  Warnings and Precautions (5.7) ] . Succinylcholine may cause increases in intracranial pressure immediately after its injection and during the fasciculation phase [see Warnings and Precautions (5.11 )]. As with other neuromuscular blocking agents, the potential for releasing histamine is present following succinylcholine administration. Signs and symptoms of histamine-mediated release such as flushing, hypotension and bronchoconstriction are, however, uncommon with normal clinical usage. Succinylcholine has no effect on consciousness, pain threshold or cerebration. [see Warnings and Precautions (5.14) ]. Succinylcholine has no direct action on the uterus or other smooth muscle structures.

Elimination Succinylcholine levels were reported to be below the detection limit of 2 µg/mL after 2.5 minutes of an intravenous bolus dose of 1 or 2 mg/kg in 14 anesthetized patients. Metabolism Succinylcholine is rapidly hydrolyzed by plasma cholinesterase to succinylmonocholine (which possesses clinically insignificant depolarizing muscle relaxant properties) and then more slowly to succinic acid and choline. Excretion About 10% of the drug is excreted unchanged in the urine. Specific Populations Pediatric Patients Due to the relatively large volume of distribution in the pediatric patient versus the adult patient, the effective dose of Succinylcholine Chloride Injection in pediatric patients may be higher than that predicted by body weight dosing alone [see Dosage and Administration (2.3 )] .

Contraindications (4) 11/2022 Warnings and Precautions (5.5) 11/2022

Anaphylaxis : Severe anaphylactic reactions to neuromuscular blocking agents, including succinylcholine, have been reported. Some cases have been life‑threatening and fatal. Take necessary precautions, such as the immediate availability of appropriate emergency treatment. ( 5.2 ) Risk of Death due to Medication Errors : Unintended administration of Succinylcholine Chloride Injection may result in paralysis, respiratory arrest and death. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. ( 5.3 ) Hyperkalemia : Succinylcholine Chloride Injection may induce serious cardiac arrhythmias or cardiac arrest due to hyperkalemia. ( 5.4 ) Malignant Hyperthermia : Malignant hyperthermia may occur, especially in individuals with known or suspected susceptibility based on genetic factors or family history. Discontinue triggering agents, administer intravenous dantrolene sodium, and apply supportive therapies. ( 5.5 ) Bradycardia : Intravenous bolus administration may result in profound bradycardia or, rarely, asystole. The incidence is higher following a second dose of succinylcholine. Pretreatment with anticholinergic agents (e.g., atropine) may reduce the occurrence of bradyarrhythmias. ( 5.6 )

NDC 0641- 6234 -01           Rx only  Succinylcholine Chloride Injection, USP 100 mg per 5 mL (20 mg/mL) WARNING: Paralyzing Agent For Intravenous or Intramuscular Administration Store in refrigerator. Preservative-Free  5 mL Single-Dose Prefilled Syringe - Discard Unused Portion.

Risk Summary There are no data on the presence of succinylcholine or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.  The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Succinylcholine Chloride Injection and any potential adverse effects on the breastfed infant from Succinylcholine Chloride Injection or from the underlying maternal condition.

WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS 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 Warnings and Precautions (5.1 )] . When a healthy appearing pediatric patient develops cardiac arrest within minutes after administration of Succinylcholine Chloride Injection, 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 Warnings and Precautions (5.1) ] . Reserve the use of Succinylcholine Chloride Injection 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 Warnings and Precautions (5.1) ] .

Succinylcholine Chloride Injection 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 ) Individualize dosage after careful assessment of the patient. ( 2.1 ) Accidental administration of neuromuscular blocking agents may be fatal. Store with the prefilled syringe and cap intact, and in a manner that minimizes the possibility of selecting the wrong product. ( 2.1 ) See full prescribing information for dosage recommendations, preparation instructions, and administration information. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 )

NDC No. Container Size (mL) mg/mL mg (total) mOsmol/mL (calc.) Single-dose 0641-6234-10 Prefilled single-dose Syringe 5 20 100 0.338 Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in the following concentration and package: NDC 0641-6234-10,  5 mL single-dose prefilled syringes packaged in a carton of 10. Refrigeration of the undiluted Succinylcholine Chloride Injection will assure full potency until expiration date. All units carry a date of expiration. Discard unused portion. Store in refrigerator 2° C to 8°C (36° C to 46 °F).The single-dose syringes are stable for up to 14 days at room temperature without significant loss of potency. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 462-923-02

Succinylcholine Chloride Injection is contraindicated: in patients with skeletal muscle myopathies [see Warnings and Precautions (5.1 )] in patients with known hypersensitivity to succinylcholine. Severe anaphylactic reactions to succinylcholine have been reported [see Warnings and Precautions (5. 2) ] after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see Warnings and Precautions (5.4 )] in patients with known or suspected genetic susceptibility to malignant hyperthermia [see Warnings and Precautions (5.5) , Clinical Pharmacology (12.5)]

Drugs that May Enhance the Neuromuscular Blocking Action of Succinylcholine : promazine, oxytocin, aprotinin, certain non‑penicillin antibiotics, quinidine, β‑adrenergic blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, isoflurane, desflurane, metoclopramide, terbutaline, and drugs that reduce plasma cholinesterase activity. ( 7.1 )

Safety and effectiveness of succinylcholine chloride have been established in pediatric patient age groups, neonate to adolescent. Because of a risk of ventricular dysrhythmias, cardiac arrest, and death from hyperkalemic rhabdomyolysis in pediatric patients, reserve the use of Succinylcholine Chloride Injection 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 Warnings and Precautions (5.1 )] . Intravenous bolus administration of Succinylcholine Chloride Injection in pediatric patients (including infants) may result in profound bradycardia or, rarely, asystole. The incidence and severity of bradycardia is higher in pediatric patients than adults [see Warnings and Precautions (5.6) ] . The effective dose of Succinylcholine Chloride Injection in pediatric patients may be higher than that predicted by body weight dosing alone [see Dosage and Administration (2.3) ] .

Clinical studies of succinylcholine chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Carcinogenesis There have been no long-term studies performed in animals to evaluate carcinogenic potential of succinylcholine. Mutagenesis Adequate studies have not been completed to evaluate the genotoxic potential of succinylcholine. Impairment of Fertility There are no studies to evaluate the potential impact of succinylcholine on fertility.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Ventricular Dysrhythmias, Cardiac Arrest, and Death from Hyperkalemic Rhabdomyolysis in Pediatric Patients [see Warnings and Precautions (5.1) ] Anaphylaxis [see Warnings and Precautions (5.2) ] Hyperkalemia [see Warnings and Precautions (5.4) ] Malignant Hyperthermia [see Warnings and Precautions (5.5) ] Bradycardia [see Warnings and Precautions (5.6 )] Increase in Intraocular Pressure [see  Warnings and Precautions (5.7 )] Prolonged Neuromuscular Block due to Phase II Block and Tachyphylaxis [see Warnings and Precautions (5.8 )] The following adverse reactions associated with the use of succinylcholine were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular disorders : Cardiac arrest, arrhythmias, bradycardia, tachycardia, hypertension, hypotension Electrolyte disorders : Hyperkalemia Eye disorders : Increased intraocular pressure Gastrointestinal disorders : Excessive salivation Immune system disorders : Hypersensitivity reactions including anaphylaxis (in some cases life-threatening and fatal) Musculoskeletal disorders : Malignant hyperthermia, rhabdomyolysis with possible myoglobinuric acute renal failure, muscle fasciculation, jaw rigidity, postoperative muscle pain Respiratory disorders : Prolonged respiratory depression or apnea Skin disorders : Rash

Overdosage with Succinylcholine Chloride Injection may result in neuromuscular block beyond the time needed for surgery and anesthesia. This may be manifested by skeletal muscle weakness, decreased respiratory reserve, low tidal volume, or apnea. The primary treatment is maintenance of a patent airway and respiratory support until recovery of normal respiration is assured. Depending on the dose and duration of Succinylcholine Chloride Injection administration, the characteristic depolarizing neuromuscular block (Phase I) may change to a block with characteristics superficially resembling a non-depolarizing block (Phase II) [see Warnings and Precautions (5.8) ] .

Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use.  Succinylcholine Chloride Injection contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated as Ethanaminium, 2,2’-[(1,4-dioxo-1,4-butanediyl) bis(oxy)]bis[ N, N, N -trimethyl-, dichloride, dihydrate, it’s molecular formula is  C 14 H 30 Cl 2 N 2 O 4 • 2H 2 O and its molecular weight is 397.34. It has the following structural formula: Structural Formula Succinylcholine is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. The drug is incompatible with alkaline solutions but relatively stable in acid solutions. Solutions of the drug lose potency unless refrigerated. Succinylcholine Chloride Injection, USP 100 mg/5 mL (20 mg/mL) is intended for single-dose administration and contains no preservatives. Unused solution should be discarded. Product not requiring dilution (single-dose prefilled syringe) contains sodium chloride to render isotonic. Each milliliter contains 20 mg succinylcholine chloride USP equivalent to 21.99 mg succinylcholine chloride dihydrate, and 4.5 mg of sodium chloride as an isotonicity agent. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH of the solution is 3.6 (3.0 to 4.5).

Risk Summary Available data from published literature from case reports and case series over several 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 (see Clinical Considerations). Animal reproduction studies have not been conducted with succinylcholine chloride. 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. Clinical Considerations Maternal Adverse Reactions 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. Fetal/Neonatal Adverse Reactions Apnea and flaccidity may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase, in the mother. Labor or Delivery 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.

Succinylcholine Chloride Injection is for intravenous or intramuscular use only. Succinylcholine Chloride Injection must be administered under supervision of experienced clinicians who are familiar with its actions and with appropriate neuromuscular monitoring techniques. Succinylcholine Chloride Injection 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 CO 2 . The clinician must be prepared to assist or control respiration. The dosage of Succinylcholine Chloride Injection 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 Injection before unconsciousness has been induced [see Warnings and Precautions (5.14 )] . The occurrence of bradyarrhythmias with administration of Succinylcholine Chloride Injection 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 Injection by infusion [see Dosage and Administration (2.2 ), Warnings and Precautions (5.8 )] . Visually inspect Succinylcholine Chloride Injection 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 Injection must be diluted for continuous intravenous infusion [see  Dosage and Administration (2.5) ] . Risk of Medication Errors Accidental administration of neuromuscular blocking agents may be fatal. Store Succinylcholine Chloride Injection with the prefilled syringe and cap intact, and in a manner that minimizes the possibility of selecting the wrong product [see Warnings and Precautions (5.3) ] .

Succinylcholine Chloride Injection, USP, is a clear, colorless solution available as follows: 100 mg per 5 mL (20 mg/mL) in a single-dose, prefilled syringe

Succinylcholine is a depolarizing neuromuscular blocker. As does acetylcholine, it combines with the cholinergic receptors of the motor end plate to produce depolarization. This depolarization may be observed as fasciculations. Subsequent neuromuscular transmission is inhibited so long as adequate concentration of succinylcholine remains at the receptor site. Onset of flaccid paralysis is rapid (less than one minute after intravenous administration), and with single administration lasts approximately 4 to 6 minutes. The paralysis following administration of succinylcholine is progressive, with differing sensitivities of different muscles. This initially involves consecutively the levator muscles of the face, muscles of the glottis and finally the intercostals and the diaphragm and all other skeletal muscles.

Depending on the dose and duration of succinylcholine administration, the characteristic depolarizing neuromuscular block (Phase I block) may change to a block with characteristics superficially resembling a non-depolarizing block (Phase II block). This may be associated with prolonged respiratory muscle paralysis or weakness in patients who manifest the transition to Phase II block. Tachyphylaxis occurs with repeated administration [see Warnings and Precautions (5.8 )] . The transition from Phase I to Phase II block has been reported in 7 of 7 patients studied under halothane anesthesia after an accumulated dose of 2 to 4 mg/kg succinylcholine (administered in repeated, divided doses). The onset of Phase II block coincided with the onset of tachyphylaxis and prolongation of spontaneous recovery. In another study, using balanced anesthesia (N 2 O/O 2 /narcotic‑thiopental) and succinylcholine infusion, the transition was less abrupt, with great individual variability in the dose of succinylcholine required to produce Phase II block. Of 32 patients studied, 24 developed Phase II block. Tachyphylaxis was not associated with the transition to Phase II block, and 50% of the patients who developed Phase II block experienced prolonged recovery [see Warnings and Precautions (5.8) ]. Succinylcholine has no direct effect on the myocardium. Succinylcholine stimulates both autonomic ganglia and muscarinic receptors which may cause changes in cardiac rhythm, including cardiac arrest. Changes in rhythm, including cardiac arrest, may also result from vagal stimulation, which may occur during surgical procedures, or from hyperkalemia, particularly in pediatric patients [see Warnings and Precautions ( 5.1 , 5.4 , 5.6 ), Use in Specific Populations (8.4 )] . These effects are enhanced by halogenated anesthetics. Succinylcholine causes an increase in intraocular pressure immediately after its injection and during the fasciculation phase, which may persist after onset of complete paralysis [see  Warnings and Precautions (5.7) ] . Succinylcholine may cause increases in intracranial pressure immediately after its injection and during the fasciculation phase [see Warnings and Precautions (5.11 )]. As with other neuromuscular blocking agents, the potential for releasing histamine is present following succinylcholine administration. Signs and symptoms of histamine-mediated release such as flushing, hypotension and bronchoconstriction are, however, uncommon with normal clinical usage. Succinylcholine has no effect on consciousness, pain threshold or cerebration. [see Warnings and Precautions (5.14) ]. Succinylcholine has no direct action on the uterus or other smooth muscle structures.

Elimination Succinylcholine levels were reported to be below the detection limit of 2 µg/mL after 2.5 minutes of an intravenous bolus dose of 1 or 2 mg/kg in 14 anesthetized patients. Metabolism Succinylcholine is rapidly hydrolyzed by plasma cholinesterase to succinylmonocholine (which possesses clinically insignificant depolarizing muscle relaxant properties) and then more slowly to succinic acid and choline. Excretion About 10% of the drug is excreted unchanged in the urine. Specific Populations Pediatric Patients Due to the relatively large volume of distribution in the pediatric patient versus the adult patient, the effective dose of Succinylcholine Chloride Injection in pediatric patients may be higher than that predicted by body weight dosing alone [see Dosage and Administration (2.3 )] .

Contraindications (4) 11/2022 Warnings and Precautions (5.5) 11/2022

Anaphylaxis : Severe anaphylactic reactions to neuromuscular blocking agents, including succinylcholine, have been reported. Some cases have been life‑threatening and fatal. Take necessary precautions, such as the immediate availability of appropriate emergency treatment. ( 5.2 ) Risk of Death due to Medication Errors : Unintended administration of Succinylcholine Chloride Injection may result in paralysis, respiratory arrest and death. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. ( 5.3 ) Hyperkalemia : Succinylcholine Chloride Injection may induce serious cardiac arrhythmias or cardiac arrest due to hyperkalemia. ( 5.4 ) Malignant Hyperthermia : Malignant hyperthermia may occur, especially in individuals with known or suspected susceptibility based on genetic factors or family history. Discontinue triggering agents, administer intravenous dantrolene sodium, and apply supportive therapies. ( 5.5 ) Bradycardia : Intravenous bolus administration may result in profound bradycardia or, rarely, asystole. The incidence is higher following a second dose of succinylcholine. Pretreatment with anticholinergic agents (e.g., atropine) may reduce the occurrence of bradyarrhythmias. ( 5.6 )

NDC 0641- 6234 -01           Rx only  Succinylcholine Chloride Injection, USP 100 mg per 5 mL (20 mg/mL) WARNING: Paralyzing Agent For Intravenous or Intramuscular Administration Store in refrigerator. Preservative-Free  5 mL Single-Dose Prefilled Syringe - Discard Unused Portion.

Risk Summary There are no data on the presence of succinylcholine or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.  The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Succinylcholine Chloride Injection and any potential adverse effects on the breastfed infant from Succinylcholine Chloride Injection or from the underlying maternal condition.