SUCCINYLCHOLINE CHLORIDE
Details
- Status
- Prescription
- First Approved
- 1972-09-20
- Routes
- INJECTION, INTRAMUSCULAR, INTRAVENOUS
- Dosage Forms
- INJECTABLE, SOLUTION
Companies
SUCCINYLCHOLINE CHLORIDE Approval History
What SUCCINYLCHOLINE CHLORIDE Treats
29 FDA approvalsOriginally approved for its first indication in 1972 . Covers 29 distinct patient populations.
- Other (29)
Other
(29 approvals)- • Approved indication (Sep 1972)
- • Approved indication (May 2018)Letter
- • Approved indication (Jun 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Aug 2019)
- • Approved indication (Oct 2019)
- • Approved indication (Jan 2020)
- • Approved indication (May 2020)
- • Approved indication (May 2020)
- • Approved indication (May 2020)
- • Approved indication (May 2020)
- • Approved indication (Jun 2020)
- • Approved indication (Jun 2020)
- • Approved indication (Jun 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Nov 2020)
- • Approved indication (Nov 2020)
- • Approved indication (Dec 2020)
- • Approved indication (Mar 2021)
- • Approved indication (Aug 2021)Label Letter
- • Approved indication (Oct 2021)
- • Approved indication (Feb 2022)
- • Approved indication (Feb 2023)
- • Approved indication (Oct 2023)
- • Approved indication (Jan 2024)Letter
- • Approved indication (Jul 2024)
- • Approved indication (Sep 2024)
- • Approved indication (Feb 2025)
- • Approved indication (Feb 2025)
SUCCINYLCHOLINE CHLORIDE Boxed Warning
BOXED WARNING 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 heal...
BOXED WARNING 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 )] . 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 ) When a healthy-appearing pediatric patient develops cardiac arrest soon after administration of succinylcholine chloride, 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 ) Reserve use of s
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SUCCINYLCHOLINE CHLORIDE FDA Label Details
ProIndications & Usage
FDA Label (PDF)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 is a depolarizing neuromuscular blocker 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.
BOXED WARNING 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 apparen...
SUCCINYLCHOLINE CHLORIDE Patents & Exclusivity
Patents (1 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.