On this page
Succinylcholine Chloride
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Succinylcholine Chloride | 20 mg/mL | 2598128 | View |
| Succinylcholine Chloride Dihydrate | 20 mg/mL | 1594589 | — |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Depolarizing Neuromuscular Blocker [EPC] | EPC | 4 members — no class page |
| Neuromuscular Depolarizing Blockade [PE] | PE | 4 members — no class page |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 211589-001 | SUCCINYLCHOLINE CHLORIDE | INJECTABLE | SUCCINYLCHOLINE CHLORIDE | Prescription | AP |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 5 | Labeling | Approved | October 2, 2023 | Standard |
| Supplement | 1 | Labeling | Approved | December 3, 2021 | Standard |
| Original application | 1 | Approved | January 15, 2020 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251218). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingBoxed 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 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)]. 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 INJECTION, 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 SUCCINYLCHOLINE CHLORIDE INJECTION 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 Changes
openFDA Drug LabelingRecent Major Changes Boxed Warning 08/2021 Dosaage and Administration (2.1) 08/2021 Warnings and Precautions (5.1, 5.2, 5.4, 5.9, 5.10, 5.12, 5.13, 55.14) 08/2021
Indications and Usage
openFDA Drug Labeling1 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 INDICATIONS AND USAGE 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 ( 1 )
Dosage and Administration
openFDA Drug Labeling2 DOSAGE AND ADMINISTRATION 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 succinylcholine chloride injection 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 succinylcholine chloride injection dosage recommendations, preparation instructions, and administration information. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) 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 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 supplied in single-dose prefilled syringes 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 prefilled syringe and cap 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 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 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 …
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution as follows: • 100 mg/5 mL (20 mg/mL) in a single-dose, prefilled syringe contains: 20 mg of succinylcholine chloride anhydrous, equivalent to 21.99 mg of succinylcholine chloride dihydrate, USP. • 200 mg/10 mL (20 mg/mL) in a single-dose prefilled syringe contains: 20 mg of succinylcholine chloride anhydrous, equivalent to 21.99 mg of succinylcholine chloride dihydrate, USP. Injection :100 mg/5 mL (20 mg/mL) and 200 mg/10 mL (20 mg/mL) in Single-dose, pre-filled syringe ( 3 )
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS 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 )] • Skeletal muscle myopathies ( 4 ) • Known hypersensitivity to succinylcholine ( 4 ) • After the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury ( 4 ) • Known or suspected genetic susceptibility to malignant hyperthermia ( 4 )
Warnings and Cautions
openFDA Drug Labeling5 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 ) Risk of Death due to Medication Errors : Unintended administration of succinylcholine chloride 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 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 ) 5.1 Ventricular Dysrhythmias, Cardiac Arrest, and Death From Hyperkalemic Rhabdomyolysis in Pediatric Patients There have been reports of ventricular dysrhythmias, cardiac arrest, and death secondary to acute rhabdomyolysis with hyperkalemia in apparently healthy pediatric patients who received succinylcholine. Many of these pediatric patients were subsequently found to have a skeletal muscle myopathy such as Duchenne muscular dystrophy whose clinical signs were not obvious. The syndrome often presented as sudden cardiac arrest within minutes after the administration of succinylcholine. These pediatric patients were usually, but not exclusively, males, and most frequently 8 years of age or younger. There have also been reports in adolescents. There may be no signs or symptoms to alert the practitioner to which patients are at risk. A careful history and physical may identify developmental delays suggestive of a myopathy. A preoperative creatine kinase could identify some but not all patients at risk. 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. Due to the abrupt onset of this syndrome, routine resuscitative measures are likely to be unsuccessful. Careful monitoring of the electrocardiogram may alert the practitioner to peaked T-waves (an early sign). Administration of intravenous calcium, bicarbonate, and glucose with insulin, with hyperventilation have resulted in successful resuscitation in some of the reported cases. Extraordinary and prolonged resuscitative efforts have been effective in some cases. In addition, in the presence of signs of malignant hyperthermia, appropriate treatment should be initiated concurrently [see Warnings and Precautions ( 5.5 )]. Because it is difficult to identify which patients are at risk, 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. 5.2 Anaphylaxis Severe anaphylactic reactions to neuromuscular blocking agents, including succinylcholine, have been reported. These reactions have, in some cases, been life-threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken. Allergic cross-reactivity between neuromuscular blocking agents, bo …
Warnings
openFDA Drug LabelingWARNINGS Succinylcholine should be used 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 carbon dioxide. the clinician must be prepared to assist or control respiration. To avoid distress to the patient, succinylcholine should not be administered before unconsciousness has been induced. In emergency situations, however, it may be necessary to administer succinylcholine before unconsciousness is induced. Succinylcholine is metabolized by plasma cholinesterase and should be used with caution, if at all, in patients known to be or suspected of being homozygous for the atypical plasma cholinesterase gene. Anaphylaxis Severe anaphylactic reactions to neuromuscular blocking agents, including succinylcholine, have been reported. These reactions have, in some cases, been life-threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken. Precautions should also be taken in those individuals who have had previous anaphylactic reactions to other neuromuscular blocking agents since cross-reactivity between neuromuscular blocking agents, both depolarizing and non-depolarizing, has been reported in this class of drugs. Risk of Death due to Medication Errors Administration of succinylcholine chloride injection results in paralysis, which may lead to respiratory arrest and death; this progression may be more likely to occur in a patient for whom it is not intended. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. If another healthcare provider is administering the product, ensure that the intended dose is clearly labeled and communicated. Hyperkalemia: (SEE BOX WARNING) Succinylcholine should be administered with GREAT CAUTION to patients suffering from electrolyte abnormalities and those who may have massive digitalis toxicity, because in these circumstances succinylcholine may induce serious cardiac arrhythmias or cardiac arrest due to hyperkalemia. GREAT CAUTION should be observed if succinylcholine is administered to patients during the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury (see CONTRAINDICATIONS ). The risk of hyperkalemia in these patients increases over time and usually peaks at 7 to 10 days after the injury. The risk is dependent on the extent and location of the injury. The precise time of onset and the duration of the risk period are undetermined. Patients with chronic abdominal infection, subarachnoid hemorrhage, or conditions causing degeneration of central and peripheral nervous systems should receive succinylcholine with GREAT CAUTION because of the potential for developing severe hyperkalemia. Malignant Hyperthermia: Succinylcholine administration has been associated with acute onset of malignant hyperthermia, a potentially fatal hypermetabolic state of skeletal muscle. The risk of developing malignant hyperthermia following succinylcholine administration increases with the concomitant administration of volatile anesthetics. Malignant hyperthermia frequently presents as intractable spasm of the jaw muscles (masseter spasm) which may progress to generalized rigidity, increased oxygen demand, tachycardia, tachypnea and profound hyperpyrexia. Successful outcome depends on recognition of early signs, such as jaw muscle spasm, acidosis, or generalized rigidity to initial administration of succinylcholine for tracheal intubation, or failure of tachycardia to respond to deepening anesthesia. Skin mottling, rising temperature and coagulopathies may occur later in the course of the hy …
Adverse Reactions
openFDA Drug Labeling6 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 Steriscience at 1-888-278-1784 or www.steri-science.com or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
openFDA Drug Labeling7 Drug Interactions 7.1 Drugs that May Affect the Neuromuscular Blocking Action of Succinylcholine Chloride injection Drugs that may enhance the neuromuscular blocking action of succinylcholine include: promazine, oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, isoflurane, desflurane, metoclopramide, and terbutaline. The neuromuscular blocking effect of succinylcholine may be enhanced by drugs that reduce plasma cholinesterase activity (e.g., chronically administered oral contraceptives, glucocorticoids, or certain monoamine oxidase inhibitors) or by drugs that irreversibly inhibit plasma cholinesterase [see Warnings and Precautions ( 5.9)]. If other neuromuscular blocking agents are to be used during the same procedure, consider the possibility of a synergistic or antagonistic effect. 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) See 17 for PATIENT COUNSELING INFORMATION. Revised: 01/2023
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Available data from published literature from case reports and case series over 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% to 4% and 15% to 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. 8.2 Lactation 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, USP and any potential adverse effects on the breastfed infant from SUCCINYLCHOLINE CHLORIDE INJECTION, USP or from the underlying maternal condition. 8.4 Pediatric Use 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, USP 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, USP 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, USP in pediatric patients may be higher than that predicted by body weight dosing alone [see Dosage and Administration (2.3) ] . 8.5 Geriatric Use Clinical studies of SUCCINYLCHOLINE CHLORIDE INJECTION, USP did not include sufficient numbers of subjects aged 65 years 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.
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action Succinylcholine chloride 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 chloride 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 chloride 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.
Description
openFDA Drug Labeling11 DESCRIPTION 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: 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 (in anhydrous form) equivalent to 21.99 mg succinylcholine chloride USP (in dihydrate form) and 4.7 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), with an osmolarity of 0.338 mOsm/mL (calc.). Figure
Overdosage
openFDA Drug Labeling10 OVERDOSAGE Overdosage with SUCCINYLCHOLINE CHLORIDE INJECTION, USP 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, USP 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) ] .
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING Succinylcholine Chloride Injection, USP is a clear, colorless solution and is supplied as follows: NDC Succinylcholine Chloride Injection, USP (20 mg per mL) Package Factor 71288- 719 -92 200 mg per 10 mL in a Multi-Dose Fliptop Vial 25 vials per carton Refrigeration of undiluted Succinylcholine Chloride Injection, USP will assure full potency until expiration date. Store refrigerated 2° to 8° (36° to 46°F). The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. This product’s labeling may have been updated. For the most recent Prescribing Information, please visit www.meithealpharma.com. For Medical Information about Succinylcholine Chloride Injection, USP, please visit www.meithealpharma.com or call 1-844-824-8426. PREMIERProRx ® Mfd. for Meitheal Pharmaceuticals 8700 W Bryn Mawr, Ste 600S Chicago, IL 60631 (USA) ©2025 Meitheal Pharmaceuticals Inc. Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. No. 16 Xuefu Road, Nanjing High & New Technology Development Zone Nanjing, China 210061 PREMIERProRx ® is a registered trademark of Premier Healthcare Alliance, L.P., used under license. April 2025 8H4AA19-00
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: SUCCINYLCHOLINE CHLORIDE DIHYDRATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class II | September 17, 2025 | Zydus Pharmaceuticals (USA) Inc | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity. | Ongoing |
Shortages
Source: FDA Drug Shortages| Status | Availability | Company | Presentation | Updated |
|---|---|---|---|---|
| To Be Discontinued | Fresenius Kabi USA, LLC | Succinylcholine Chloride, Injection, 20 mg/1 mL (NDC 63323-943-10) | July 23, 2026 |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 69918-700-10 | 69918-700 | Amring Pharmaceuticals Inc. | 10 VIAL, MULTI-DOSE in 1 CARTON (69918-700-10) / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-01) | April 10, 2019 |
| 69918-700-25 | 69918-700 | Amring Pharmaceuticals Inc. | 25 VIAL, MULTI-DOSE in 1 CARTON (69918-700-25) / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-01) | April 10, 2019 |
| 71839-121-25 | 71839-121 | BE Pharmaceuticals Inc. | 25 VIAL, MULTI-DOSE in 1 CARTON (71839-121-25) / 10 mL in 1 VIAL, MULTI-DOSE (71839-121-01) | February 7, 2022 |
| 43066-127-05 | 43066-127 | Baxter Healthcare Corporation | 5 CARTON in 1 CARTON (43066-127-05) / 1 SYRINGE, PLASTIC in 1 CARTON (43066-127-01) / 5 mL in 1 SYRINGE, PLASTIC | September 24, 2024 |
| 43066-129-05 | 43066-129 | Baxter Healthcare Corporation | 5 CARTON in 1 CARTON (43066-129-05) / 1 SYRINGE, PLASTIC in 1 CARTON (43066-129-01) / 10 mL in 1 SYRINGE, PLASTIC | September 24, 2024 |
| 31722-981-31 | 31722-981 | Camber Pharmaceuticals, Inc. | 25 VIAL, MULTI-DOSE in 1 CARTON (31722-981-31) / 10 mL in 1 VIAL, MULTI-DOSE (31722-981-10) | May 4, 2020 |
| 73043-021-01 | 73043-021 | Devatis, Inc. | 25 VIAL, MULTI-DOSE in 1 CARTON (73043-021-01) / 10 mL in 1 VIAL, MULTI-DOSE | September 15, 2024 |
| 55150-315-25 | 55150-315 | Eugia US LLC | 25 VIAL, MULTI-DOSE in 1 CARTON (55150-315-25) / 10 mL in 1 VIAL, MULTI-DOSE (55150-315-01) | October 16, 2023 |
| 65219-274-05 | 65219-274 | Fresenius Kabi USA LLC | 10 SYRINGE, PLASTIC in 1 CARTON (65219-274-05) / 5 mL in 1 SYRINGE, PLASTIC (65219-274-01) | June 19, 2025 |
| 65219-276-10 | 65219-276 | Fresenius Kabi USA LLC | 10 SYRINGE, PLASTIC in 1 CARTON (65219-276-10) / 10 mL in 1 SYRINGE, PLASTIC (65219-276-01) | June 19, 2025 |
| 63323-943-10 | 63323-943 | Fresenius Kabi USA, LLC | 25 VIAL, MULTI-DOSE in 1 CARTON (63323-943-10) / 10 mL in 1 VIAL, MULTI-DOSE (63323-943-21) | January 25, 2021 |
| 68083-450-25 | 68083-450 | Gland Pharma Limited | 25 VIAL, MULTI-DOSE in 1 CARTON (68083-450-25) / 10 mL in 1 VIAL, MULTI-DOSE (68083-450-01) | June 16, 2020 |
| 51662-1525-1 | 51662-1525 | HF Acquisition Co LLC, DBA HealthFirst | 10 mL in 1 VIAL, MULTI-DOSE (51662-1525-1) | January 21, 2021 |
| 0404-9983-20 | 0404-9983 | Henry Schein, Inc. | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9983-20) / 10 mL in 1 VIAL, MULTI-DOSE | July 22, 2022 |
| 0143-9338-25 | 0143-9338 | Hikma Pharmaceuticals USA Inc. | 25 VIAL in 1 CARTON (0143-9338-25) / 10 mL in 1 VIAL | April 26, 2021 |
| 70756-613-10 | 70756-613 | Lifestar Pharma LLC | 10 VIAL, MULTI-DOSE in 1 CARTON (70756-613-10) / 10 mL in 1 VIAL, MULTI-DOSE (70756-613-80) | February 2, 2023 |
| 70756-613-25 | 70756-613 | Lifestar Pharma LLC | 25 VIAL, MULTI-DOSE in 1 CARTON (70756-613-25) / 10 mL in 1 VIAL, MULTI-DOSE (70756-613-80) | February 2, 2023 |
| 71872-7166-1 | 71872-7166 | Medical Purchasing Solutions, LLC | 1 VIAL, MULTI-DOSE in 1 BAG (71872-7166-1) / 10 mL in 1 VIAL, MULTI-DOSE | May 13, 2019 |
| 71872-7167-1 | 71872-7167 | Medical Purchasing Solutions, LLC | 1 VIAL, MULTI-DOSE in 1 BAG (71872-7167-1) / 1 mL in 1 VIAL, MULTI-DOSE | June 19, 2019 |
| 71872-7221-1 | 71872-7221 | Medical Purchasing Solutions, LLC | 1 VIAL in 1 BAG (71872-7221-1) / 10 mL in 1 VIAL | September 1, 2020 |
| 71872-7272-1 | 71872-7272 | Medical Purchasing Solutions, LLC | 1 VIAL, MULTI-DOSE in 1 BAG (71872-7272-1) / 10 mL in 1 VIAL, MULTI-DOSE | November 30, 2021 |
| 71288-719-11 | 71288-719 | Meitheal Pharmaceuticals Inc. | 25 VIAL, MULTI-DOSE in 1 CARTON (71288-719-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-719-10) | October 19, 2021 |
| 71288-719-92 | 71288-719 | Meitheal Pharmaceuticals Inc. | 25 VIAL, MULTI-DOSE in 1 CARTON (71288-719-92) / 10 mL in 1 VIAL, MULTI-DOSE (71288-719-91) | October 19, 2021 |
| 69918-700-12 | 69918-700 | Nordic Pharma, Inc. | 10 VIAL, MULTI-DOSE in 1 CARTON (69918-700-12) / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-05) | May 20, 2024 |
| 69918-700-29 | 69918-700 | Nordic Pharma, Inc. | 25 VIAL, MULTI-DOSE in 1 CARTON (69918-700-29) / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-05) | May 20, 2024 |
| 66794-232-42 | 66794-232 | Piramal Critical Care Inc | 25 VIAL, MULTI-DOSE in 1 CARTON (66794-232-42) / 10 mL in 1 VIAL, MULTI-DOSE (66794-232-02) | January 20, 2021 |
| 84549-301-25 | 84549-301 | ProPharma Distribution | 10 mL in 1 VIAL (84549-301-25) | August 27, 2025 |
| 70518-4409-0 | 70518-4409 | REMEDYREPACK INC. | 10 VIAL in 1 CARTON (70518-4409-0) / 10 mL in 1 VIAL (70518-4409-1) | July 29, 2025 |
| 82449-232-02 | 82449-232 | STERISCIENCE SPECIALTIES PRIVATE LIMITED | 10 SYRINGE in 1 PACKAGE (82449-232-02) / 5 mL in 1 SYRINGE (82449-232-01) | September 30, 2024 |
| 70069-301-10 | 70069-301 | Somerset Therapeutics, LLC | 10 VIAL in 1 CARTON (70069-301-10) / 10 mL in 1 VIAL (70069-301-01) | December 16, 2020 |
| 70069-301-25 | 70069-301 | Somerset Therapeutics, LLC | 25 VIAL in 1 CARTON (70069-301-25) / 10 mL in 1 VIAL (70069-301-01) | January 15, 2020 |
| 70069-783-10 | 70069-783 | Somerset Therapeutics, LLC | 10 VIAL in 1 CARTON (70069-783-10) / 10 mL in 1 VIAL | May 30, 2023 |
| 70069-783-25 | 70069-783 | Somerset Therapeutics, LLC | 25 VIAL in 1 CARTON (70069-783-25) / 10 mL in 1 VIAL | May 30, 2023 |
| 70771-1352-7 | 70771-1352 | Zydus Lifesciences Limited | 25 VIAL, MULTI-DOSE in 1 TRAY (70771-1352-7) / 10 mL in 1 VIAL, MULTI-DOSE (70771-1352-1) | May 10, 2018 |
| 70710-1377-2 | 70710-1377 | Zydus Pharmaceuticals USA Inc. | 25 VIAL, MULTI-DOSE in 1 TRAY (70710-1377-2) / 10 mL in 1 VIAL, MULTI-DOSE (70710-1377-1) | May 10, 2018 |
| 69918-700 | 69918-700 | Amring Pharmaceuticals Inc. | — | April 10, 2019 |
| 71839-121 | 71839-121 | BE Pharmaceuticals Inc. | — | February 7, 2022 |
| 43066-127 | 43066-127 | Baxter Healthcare Corporation | — | September 24, 2024 |
| 43066-129 | 43066-129 | Baxter Healthcare Corporation | — | September 24, 2024 |
| 31722-981 | 31722-981 | Camber Pharmaceuticals, Inc. | — | May 4, 2020 |
| 73043-021 | 73043-021 | Devatis, Inc. | — | September 15, 2024 |
| 55150-315 | 55150-315 | Eugia US LLC | — | October 16, 2023 |
| 65219-274 | 65219-274 | Fresenius Kabi USA LLC | — | June 19, 2025 |
| 65219-276 | 65219-276 | Fresenius Kabi USA LLC | — | June 19, 2025 |
| 63323-943 | 63323-943 | Fresenius Kabi USA, LLC | — | January 25, 2021 |
| 68083-450 | 68083-450 | Gland Pharma Limited | — | June 16, 2020 |
| 51662-1525 | 51662-1525 | HF Acquisition Co LLC, DBA HealthFirst | — | January 21, 2021 |
| 0404-9983 | 0404-9983 | Henry Schein, Inc. | — | July 22, 2022 |
| 0143-9338 | 0143-9338 | Hikma Pharmaceuticals USA Inc. | — | April 26, 2021 |
| 70756-613 | 70756-613 | Lifestar Pharma LLC | — | February 2, 2023 |
| 71872-7166 | 71872-7166 | Medical Purchasing Solutions, LLC | — | November 20, 2018 |
| 71872-7167 | 71872-7167 | Medical Purchasing Solutions, LLC | — | April 10, 2019 |
| 71872-7221 | 71872-7221 | Medical Purchasing Solutions, LLC | — | January 15, 2020 |
| 71872-7272 | 71872-7272 | Medical Purchasing Solutions, LLC | — | May 4, 2020 |
| 71288-719 | 71288-719 | Meitheal Pharmaceuticals Inc. | — | October 19, 2021 |
| 66794-232 | 66794-232 | Piramal Critical Care Inc | — | January 20, 2021 |
| 84549-301 | 84549-301 | ProPharma Distribution | — | January 15, 2020 |
| 70518-4409 | 70518-4409 | REMEDYREPACK INC. | — | July 29, 2025 |
| 82449-232 | 82449-232 | STERISCIENCE SPECIALTIES PRIVATE LIMITED | — | September 30, 2024 |
| 70069-301 | 70069-301 | Somerset Therapeutics, LLC | — | January 15, 2020 |
| 70069-783 | 70069-783 | Somerset Therapeutics, LLC | — | May 30, 2023 |
| 70771-1352 | 70771-1352 | Zydus Lifesciences Limited | — | May 10, 2018 |
| 70710-1377 | 70710-1377 | Zydus Pharmaceuticals USA Inc. | — | May 10, 2018 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
| Enforcement | FDA | Recall records |
| Drug Shortages | FDA | Supply availability |
Generated September 25, 2026 · 14 sections on this page.