Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)
Amneal Pharmaceuticals LLC
INTRAMUSCULAR
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. 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
Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in 10 mL multiple-dose vials. Each mL contains succinylcholine chloride, USP 20 mg. It is available as follows: 200 mg/10 mL (20 mg/mL) 10 mL Multiple-dose Fliptop Vial: NDC 70121-1581-1 25 Vials in a Carton: NDC 70121-1581-5 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, go to www.amneal.com or call toll-free 1-877-835-5472. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 12-2022-06
Abbreviated New Drug Application
SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION AMNEAL PHARMACEUTICALS 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, 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 (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 fatal. Store succinylcholine Pročitajte cijeli dokument