SUCCINYLCHOLINE CHLORIDE injection, solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)

Disponible des:

Somerset Therapeutics, LLC

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 personal or familial history of malignant hyperthermia [see Warnings and Precautions (5.5)] Risk Summary Available data from published literature from case reports and case series over decades of use with s

Resumen del producto:

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.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
SOMERSET THERAPEUTICS, LLC
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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 injection is a depolarizing neuromuscular
blocker indicated in adults and pediatric
patients: (1)
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 neuromuscul