SUCCINYLCHOLINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Succinylcholine Chloride (UNII: I9L0DDD30I) (Succinylcholine - UNII:J2R869A8YF)

Available from:

Dr.Reddy's Laboratories Inc.,

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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)] Risk Summary Available data from published literature from case reports and case

Product summary:

Succinylcholine chloride injection, USP is supplied as a clear, colorless solution in the following concentrations and packages: Refrigeration of undiluted succinylcholine chloride injection will assure full potency until expiration date. Store in refrigerator 2°C to 8°C (36°F to 46°F). The multiple-dose vials are stable for up to 14 days at room temperature without significant loss of potency. Rx Only Distributor: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 Made in India Revised: 11/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUCCINYLCHOLINE- SUCCINYLCHOLINE INJECTION, SOLUTION
DR.REDDY'S LABORATORIES INC.,
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUCCINYLCHOLINE
CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
SUCCINYLCHOLINE CHLORIDE INJECTION.
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)
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
Contraindications (4) 11/2022
Warnings and Precautions, Malignant Hyperthermia (5.5) 11/2022
INDICATIONS AND USAGE
Succinylcholine chloride 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
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