Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)
Eugia US LLC
INTRAVENOUS
PRESCRIPTION DRUG
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 chloride. Severe anaphylactic reactions to succinylcholine chloride 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
Succinylcholine chloride injection, USP is supplied as a clear, colorless solution in the following concentrations and packages: 200 mg per 10 mL (20 mg/mL) 10 mL Multiple-Dose Vials in a Carton of 25 NDC 55150-315-25 Refrigeration of undiluted succinylcholine chloride injection, USP 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. The vial stopper is not made with natural rubber latex. This product’s labeling may have been updated. For the most recent Prescribing Information, please visit eugiaus.com. For Medical Information about succinylcholine chloride injection, USP, please visit eugiaus.com or call 1-888-238-7880. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India
Abbreviated New Drug Application
SUCCINYLCHOLINE CHLORIDE - SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION EUGIA US LLC ---------- 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 blocking age Perskaitykite visą dokumentą