SUCCINYLCHOLINE CHLORIDE- succinylcholine chloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Micro Labs Limited

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 injection 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 Precau

Product summary:

Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution. It is available as follows:            Refrigeration of undiluted succinylcholine chloride injection will assure full potency until expiration date. Store in refrigerator 2° to 8°C (36° to 46°F). The multiple-dose vials are stable for up to 14 days at room temperature without significant loss of potency. This product’s labeling may have been updated. For the most recent Prescribing Information, please visit www.microlabs.com. Manufactured by: Micro Labs Limited Bangalore - 560099, INDIA. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Rev. 11/2022 For Medical Information about succinylcholine chloride injection, USP, please visit www.microlabs.com or call 1-855-839-8195.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUCCINYLCHOLINE CHLORIDE - SUCCINYLCHOLINE CHLORIDE INJECTION
MICRO LABS LIMITED
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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 INJECTION, 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 INJECTION 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 injection 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 bl