SUCCINYLCHOLINE CHLORIDE injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

STI Pharma LLC

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 personal or familial history of malignant hyperthermia [see Warnings and Precautions (5.5)] Risk Summary  Available data from published literature from case

leaflet_short:

Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in the following concentration and package: 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. Manufactured in India for: STI Pharma LLC Newtown, PA 18940 1.888.301.9680 Revised: 09/2021

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION
STI PHARMA LLC
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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 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
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
INDICATIONS AND USAGE (1)
Succinylcholine Chloride Injection, is a depolarizing neuromuscular
blocker indicated in adults and pediatric
patients: (1)
as an adjunct to general anesthesia (1)
to facilitate tracheal intubation (1)
to provide skeletal muscle relaxation during surgery or mechanical
ventilation. (1)
(1)
DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION (2)
For intravenous or intramuscular use only. (2.1)
Individuali