HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use QUELICIN™ safely and effectively. See full prescribing information for QUELICIN™.
QUELICIN™ (succinylcholine chloride) injection, for intravenous or intramuscular use
Initial U.S. Approval: 1952 WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS
See full prescribing information for complete boxed warning.- •
- Acute rhabdomyolysis with hyperkalemia followed by ventricular dysrhythmias, cardiac arrest, and death has occurred after use in apparently healthy pediatric patients who were subsequently found to have undiagnosed skeletal muscle myopathy. (5.1)
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- When a healthy-appearing pediatric patient develops cardiac arrest soon after administration of QUELICIN, not felt to be due to other causes, immediate treatment for hyperkalemia should be instituted. In the presence of signs of malignant hyperthermia, appropriate treatment should be instituted concurrently. (5.1)
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- Reserve use of QUELICIN in pediatric patients for emergency intubation or instances where immediate securing of the airway is necessary, or for intramuscular use when a suitable vein is inaccessible. (5.1)
RECENT MAJOR CHANGESContraindications (4) | 11/2022 | Warnings and Precautions, Malignant Hyperthermia (5.5) | 11/2022 |
INDICATIONS AND USAGEQUELICIN is a depolarizing neuromuscular blocker indicated in adults and pediatric patients: - •
- as an adjunct to general anesthesia (1)
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- to facilitate tracheal intubation (1)
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- to provide skeletal muscle relaxation during surgery or mechanical ventilation. (1)
DOSAGE AND ADMINISTRATION- •
- For intravenous or intramuscular use only. (2.1)
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- Individualize dosage after careful assessment of the patient. (2.1)
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- Accidental administration of neuromuscular blocking agents may be fatal. Store QUELICIN with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product. (2.1)
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- See full prescribing information for QUELICIN dosage recommendations, preparation instructions, and administration information. (2.2, 2.3, 2.4, 2.5, 2.6)
DOSAGE FORMS AND STRENGTHSInjection: - •
- 1,000 mg/10 mL (100 mg/mL) in single-dose fliptop vials (3)
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- 200 mg/10 mL (20 mg/mL) in multiple-dose fliptop vials (3)
CONTRAINDICATIONS- •
- Skeletal muscle myopathies (4)
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- Known hypersensitivity to succinylcholine (4)
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- After the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury (4)
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- Known or suspected genetic susceptibility to malignant hyperthermia (4)
WARNINGS AND PRECAUTIONS- •
- 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)
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- Risk of Death due to Medication Errors: Unintended administration of QUELICIN 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)
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- Hyperkalemia: QUELICIN may induce serious cardiac arrhythmias or cardiac arrest due to hyperkalemia. (5.4)
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- 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)
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- 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)
ADVERSE REACTIONSAdverse 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 Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSDrugs 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) Revised: 11/2022 |