SUCCINYLCHOLINE CHLORIDE injection

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Nexus Pharmaceuticals Inc

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Succinylcholine is contraindicated in persons with known or suspected genetic susceptibility to malignant hyperthermia [see WARNINGS, CLINICAL PHARMACOLOGY ], skeletal muscle myopathies and known hypersensitivity to the drug. It is also contraindicated in patients after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, because succinylcholine administered to such individuals may result in severe hyperkalemia which may result in cardiac arrest (see WARNINGS ). 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 not known.

Resumen del producto:

Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in the following concentration and package: Refrigeration of the undiluted agent will assure full potency until expiration date. All units carry a date of expiration. The container closure is not made with natural rubber latex. Store in refrigerator 2° to 8°C (36° to 46°F). The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency. Manufactured in Germany for: Nexus Pharmaceuticals, Inc. Lincolnshire, IL 60069 USA NEXUS PHARMACEUTICALS SCCPI01DER03 Revised 04/2023

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION
NEXUS PHARMACEUTICALS INC
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SUCCINYLCHOLINE CHLORIDE INJECTION, USP
An ultra-short-acting depolarizing skeletal muscle relaxant.
WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH
FROM HYPERKALEMIC RHABDOMYOLYSIS
There have been rare reports of acute rhabdomyolysis with hyperkalemia
followed
by ventricular dysrhythmias, cardiac arrest and death after the
administration of
succinylcholine to apparently healthy pediatric patients who were
subsequently
found to have undiagnosed skeletal muscle myopathy, most frequently
Duchenne's
muscular dystrophy.
This syndrome often presents as peaked T-waves and sudden cardiac
arrest within
minutes after the administration of the drug in healthy appearing
pediatric patients
(usually, but not exclusively, males, and most frequently 8 years of
age or
younger). There have also been reports in adolescents.
Therefore, when a healthy appearing infant or child develops cardiac
arrest soon
after administration of succinylcholine, not felt to be due to
inadequate ventilation,
oxygenation or anesthetic overdose, immediate treatment for
hyperkalemia should
be instituted. This should include administration of intravenous
calcium,
bicarbonate, and glucose with insulin, with hyperventilation. Due to
the abrupt
onset of this syndrome, routine resuscitative measures are likely to
be
unsuccessful. However, extraordinary and prolonged resuscitative
efforts have
resulted in successful resuscitation in some reported cases. In
addition, in the
presence of signs of malignant hyperthermia, appropriate treatment
should be
instituted concurrently.
Since there may be no signs or symptoms to alert the practitioner to
which
patients are at risk, it is recommended that the use of
succinylcholine in pediatric
patients should be reserved 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
inac