SUCCINYLCHOLINE CHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Succinylcholine Chloride is supplied in the following dosage forms. NDC 51662-1525-1 SUCCINYLCHOLINE CHLORIDE INJECTION, USP 200mg/10mL (20mg/mL) 10mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 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

Summary of Product characteristics

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
BOXED WARNING
DES CRIPTION
Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic
solution to be used as an 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 C14H30Cl2N2O4.2H2O and its
molecular weight is 397.34.
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 or almost white, odorless, crystalline
powder, freely 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. 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
depolarization. This depolarization may be
observed as fasciculations. Subsequent neuromuscular transmission is
inhibited so long as adequate
concentration of succinylcholine remains at the receptor site. Onset
of flaccid paralysis is rapid (less
than one minute after intravenous administration), and with single
administration lasts approximately 4 to
6 minutes.
Succinylcholine is