SUCCINYLCHOLINE CHLORIDE injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

HF Acquisition Co LLC, DBA HealthFirst

Indgivelsesvej:

INTRAMUSCULAR

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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SUCCINYLCHOLINE CHLORIDE INJECTION, USP 200MG/10ML (20MG/ML) 10ML
VIAL
SPL UNCLASSIFIED
A short-acting depolarizing skeletal muscle relaxant.
BOXED 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 ...
SPL UNCLASSIFIED
THIS DRUG SHOULD BE USED ONLY BY INDIVIDUALS FAMILIAR WITH ITS
ACTIONS,
CHARACTERISTICS AND HAZARDS.
DESCRIPTION
Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic
solution to be used as
ultra short-acting, depolarizing, skeletal muscle relaxant. See HOW
SUPPLIED for
summary of content and characteristics of the solutions. The solutions
are for
intramuscular or intravenous use.
Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4
and its
molecular weight is 361.31.
It has the following structural formula:
Succinylcholine is a diquaternary base consisting of the dichloride
salt of the dicholine
ester of succinic acid. It is a white, odorless, slightly bitter
powder, very soluble in water.
The drug is incompatible with alkaline solutions but relatively stable
in acid solutions.
Solutions of the drug lose potency unless refrigerated.
Solution intended for multiple-dose administration contains 0.18%
methylparaben and
0.02% propylparaben as preservatives (List No. 6629). Product not
requiring dilution
(multiple-dose fliptop vial) contains sodium chloride to render
isotonic.
May contain sodium hydroxide and/or hydrochloric acid for pH
adjustment. pH is 3.6
(3.0 to 4.5). See table in HOW SUPPLIED for characteristics.
Sodium Chloride, USP, chemically designated NaCl, is a white
crystalline compound freely
soluble in water.
CLINICAL PHARMACOLOGY
Succinylcholine is a depolarizing skeletal muscle relaxant. As does
acetylcholine, it
combines with the cholinergic receptors of the motor end plate to
produce
d