SUCCINYLCHOLINE CHLORIDE injection, solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Camber Pharmaceuticals, Inc.

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in the following concentration and package: 200 mg/10 mL (20 mg/mL) 10 mL Multiple-dose Fliptop Vial:           NDC 31722-981-10 25 Vials in a Carton:                               NDC 31722-981-31 Refrigeration of undiluted Succinylcholine Chloride Injection, USP 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. For more information, call 1-866-495-1995. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854 Manufactured by: Aspiro Pharma Limited Survey No. 321, Biotech Park, Phase – III               Karkapatla Village, Markook (Mandal) Siddipet, Telangana-502281, India. Revised: 01/2023

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
CAMBER PHARMACEUTICALS, 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 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