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:

Zydus Pharmaceuticals USA Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Succinylcholine chloride injection 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 known or suspected genetic susceptibility to malignant hyperthermia [see Warnings and Precautions (5.5), Clinical Pharmacology (12.5)] Risk Summary Available data from published literature from case reports and case series over

Product summary:

Succinylcholine chloride injection, USP is supplied as a clear, colorless solution in the following concentrations and packages: Refrigeration of undiluted succinylcholine chloride injection will assure full potency until expiration date. Store in refrigerator 2 °C to 8 °C (36 °F to 46 °F). The multiple-dose vials are stable for up to 14 days at room temperature without significant loss of potency. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please address medical inquiries to, [e-mail] or Tel.: [phone].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUCCINYLCHOLINE CHLORIDE - SUCCINYLCHOLINE CHLORIDE INJECTION,
SOLUTION
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUCCINYLCHOLINE
CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
SUCCINYLCHOLINE CHLORIDE INJECTION.
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
Contraindications (4)
11/2022
Warnings and Precautions, Malignant Hyperthermia (5.5) 11/2022
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)
Accidental administration of neuromuscular blocking agents may be
f