1 Indications and Usage 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.

Succinylcholine chloride injection is a depolarizing neuromuscular blocker indicated in adults and pediatric patients: • as an adjunct to general anesthesia ( 1) • to facilitate tracheal intubation ( 1) • to provide skeletal muscle relaxation during surgery or mechanical ventilation.

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6 Adverse Reactions 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 Adverse reactions reported with succinylcholine are cardiac arrest, malignant hyperthermia, arrhythmias, bradycardia, tachycardia, hypertension, hypotension, hyperkalemia, prolonged respiratory depression or apnea.

( 6) To report SUSPECTED ADVERSE REACTIONS, contact Aspiro Pharma Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .