SUCCINYLCHOLINE injection, solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Medical Purchasing Solutions, LLC

administration_route:

INTRAVENOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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.

leaflet_short:

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.   Rx Only Distributor: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 Made in India Issued: 0220 To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy's Laboratories Inc., at 1- 888-375-3784, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

authorization_status:

Abbreviated New Drug Application

SPC

SUCCINYLCHOLINE- SUCCINYLCHOLINE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
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SUCCINYLCHOLINE CHLORIDE INJECTION, USP
A SHORT-ACTING DEPOLARIZING SKELETAL MUSCLE RELAXANT.
BOXED WARNING
WARNING
RIS K 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 inaccessible (see
PRECAU