Succinylcholine Chloride

SUCCINYLCHOLINE CHLORIDE — succinylcholine chloride injection, solution
Gland Pharma Limited

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, 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 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)].

1 Succinylcholine Chloride 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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Information

• Succinylcholine chloride injection is for intravenous or intramuscular use only.
• Succinylcholine chloride injection 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 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 CO2 . 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 supplied in multiple-dose vials does not require dilution before use [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 cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product [see Warnings and Precautions (5.3)].

2.2 Dosage Recommendations for Intravenous Use in Adults


For Short Surgical Procedures
The average dose required to produce neuromuscular blockade and to facilitate tracheal intubation is 0.6 mg/kg succinylcholine chloride injection given intravenously. The optimum intravenous dose of succinylcholine chloride injection 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 injection may be used to determine the sensitivity of the patient and the individual recovery time [see Warnings and Precautions (5.9)].

For Long Surgical Procedures
Continuous Intravenous Infusion
The dosage of succinylcholine chloride injection administered by continuous intravenous infusion depends upon the duration of the surgical procedure and the need for muscle relaxation.
Diluted succinylcholine chloride injection 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 injection and, hence, of relaxation. This diluted succinylcholine chloride injection 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 injection 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 Patients

For emergency tracheal intubation or in instances where immediate securing of the airway is necessary, the intravenous dose of succinylcholine chloride injection 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 injection 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 Patients

If a suitable vein is inaccessible, succinylcholine chloride injection 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.

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