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:

Amring Pharmaceuticals Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Succinylcholine chloride is indicated in adults and pediatric patients: - as an adjunct to general anesthesia - to facilitate tracheal intubation - to provide skeletal muscle relaxation during surgery or mechanical ventilation. Succinylcholine chloride is contraindicated: - in patients with skeletal muscle myopathies [see Warnings and Precautions (5.1)] - in patients with known hypersensitivity to succinylcholine. Severe anaphylactic reactions to succinylcholine have been reported [see Warnings and Precautions (5.2)] - after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see Warnings and Precautions (5.4)] - in patients with personal or familial history of malignant hyperthermia [see Warnings and Precautions (5.5)] Risk Summary Available data from published literature from case reports and case series over decades of use with succinylcholine during pregnancy h

Product summary:

Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in the following concentrations and packages: NDC No. Container Size (mL) mg/mL mg (total) mOsmol/mL (calc.) Multiple-dose 69918-700-01 NDC No. Carton Size (mL) mg/mL mg (total) mOsmol/mL (calc.) Multiple-dose 69918-700-10 69918-700-25 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
AMRING PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUCCINYLCHOLINE
CHLORIDE INJECTION, SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION.
SUCCINYLCHOLINE CHLORIDE INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR
USE
INITIAL U.S. APPROVAL: 1952
WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM
HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ACUTE RHABDOMYOLYSIS WITH HYPERKALEMIA FOLLOWED BY VENTRICULAR
DYSRHYTHMIAS,
CARDIAC ARREST, AND DEATH HAS OCCURRED AFTER USE IN APPARENTLY HEALTHY
PEDIATRIC
PATIENTS WHO WERE SUBSEQUENTLY FOUND TO HAVE UNDIAGNOSED SKELETAL
MUSCLE
MYOPATHY. (5.1)
WHEN A HEALTHY-APPEARING PEDIATRIC PATIENT DEVELOPS CARDIAC ARREST
SOON AFTER
ADMINISTRATION OF SUCCINYLCHOLINE CHLORIDE, NOT FELT TO BE DUE TO
OTHER CAUSES,
IMMEDIATE TREATMENT FOR HYPERKALEMIA SHOULD BE INSTITUTED. IN THE
PRESENCE OF
SIGNS OF MALIGNANT HYPERTHERMIA, APPROPRIATE TREATMENT SHOULD BE
INSTITUTED
CONCURRENTLY. (5.1)
RESERVE USE OF SUCCINYLCHOLINE CHLORIDE IN PEDIATRIC PATIENTS FOR
EMERGENCY
INTUBATION OR INSTANCES WHERE IMMEDIATE SECURING OF THE AIRWAY IS
NECESSARY, OR FOR
INTRAMUSCULAR USE WHEN A SUITABLE VEIN IS INACCESSIBLE. (5.1)
RECENT MAJOR CHANGES
Boxed Warning
08/2021
Dosage and Administration (2.1)
08/2021
Warnings and Precautions (5.1, 5.2, 5.4, 5.9, 5.10, 5.12, 5.13, 5.14)
08/2021
INDICATIONS AND USAGE
Succinylcholine chloride is a depolarizing neuromuscular blocker
indicated in adults and pediatric patients:
as an adjunct to general anesthesia (1)
to facilitate tracheal intubation (1)
to provide skeletal muscle relaxation during surgery or mechanical
ventilation. (1)
DOSAGE AND ADMINISTRATION
For intravenous or intramuscular use only. (2.1)
Individualize dosage after careful assessment of the patient. (2.1)
Acci