SUCCINYLCHOLINE CHLORIDE injection

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

即購入

ダウンロード 製品の特徴 (SPC)
25-05-2020

有効成分:

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

から入手可能:

Indoco Remedies Limited

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

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.

製品概要:

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. 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 by: INDOCO REMEDIES LIMITED L32, 33 & 34, Verna industrial area, Verna, Goa-403 722, India Revised: 05/2020

認証ステータス:

Abbreviated New Drug Application

製品の特徴

                                SUCCINYLCHOLINE CHLORIDE - SUCCINYLCHOLINE CHLORIDE INJECTION
INDOCO REMEDIES LIMITED
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SUCCINYLCHOLINE CHLORIDE INJECTION, USP
A short-acting depolarizing skeletal muscle relaxant.
WARNING
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
inaccessible (see _PRECAUTIONS: 
                                
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