SUCCINYLCHOLINE CHLORIDE injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Medical Purchasing Solutions, LLC

Verabreichungsweg:

INTRAMUSCULAR

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 personal or familial history of malignant hyperthermia, 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.

Produktbesonderheiten:

Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in the following concentrations and packages: Refrigeration of the undiluted agent will assure full potency until expiration date. All units carry a date of expiration. 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. Revised: 12/2018 Manufactured by: Renaissance Pharmaceuticals Inc. Lakewood, NJ 08701 Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312 141092

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
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SUCCINYLCHOLINE CHLORIDE INJECTION, USP
A short-acting depolarizing skeletal muscle relaxant.
Fliptop Vial
Rx only
WARNING RISK OF CARDIAC ARREST 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