देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)
Sandoz Inc
SUCCINYLCHOLINE CHLORIDE
SUCCINYLCHOLINE CHLORIDE 20 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
ANECTINE is indicated in adults and pediatric patients: ANECTINE is contraindicated in patients with: hyperkalemia, which may result in cardiac arrest [see Warnings and Precautions (5.4)] Risk Summary Available data from published literature from case reports and case series over decades of use with succinylcholine during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Succinylcholine is used commonly during delivery by caesarean section to provide muscle relaxation. If succinylcholine is used during labor and delivery, there is a risk for prolonged apnea in some pregnant women (see Clinical Considerations). Animal reproduction studies have not been conducted with succinylcholine chloride. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Maternal Adverse Reactions Plasma cholinesterase levels are decreased by approximately 24% during pregnancy and for several days postpartum which can prolong the effect of ANECTINE. Therefore, some pregnant or newly postpartum patients may experience prolonged apnea following administration of ANECTINE. Fetal/Neonatal Adverse Reactions Apnea and flaccidity may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase in the mother. Labor or Delivery Succinylcholine is commonly used to provide muscle relaxation during delivery by caesarean section. Succinylcholine is known to cross the placental barrier in an amount that is dependent on the concentration gradient between the maternal and fetal circulation. Risk Summary There are no data on the presence of succinylcholine or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ANECTINE and any potential adverse effects on the breastfed infant from ANECTINE or from the underlying maternal condition. Safety and effectiveness of succinylcholine chloride have been established in pediatric patients age groups, neonate to adolescent. Since there is a risk of ventricular dysrhythmias, cardiac arrest, and death from hyperkalemic rhabdomyolysis in pediatric patients, reserve the use of ANECTINE in pediatric patients for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible [see Warnings and Precautions (5.1)] . Intravenous bolus administration of ANECTINE in infants or pediatric patients may result in profound bradycardia or, rarely, asystole. The incidence and severity of bradycardia is higher in pediatric patients than adults [see Warnings and Precautions (5.6)] . The effective dose of ANECTINE in pediatric patients may be higher than that predicted by body weight dosing alone [see Dosage and Administration (2.3)] . Clinical studies of succinylcholine chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
ANECTINE (Succinylcholine Chloride Injection, USP) is supplied as a clear, colorless solution in multiple-dose vials. 200 mg/10 mL (20 mg/mL) Store in refrigerator at 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. Distributed by Sandoz Inc., Princeton, NJ 08540
New Drug Application
ANECTINE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION SANDOZ INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ANECTINE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ANECTINE. ANECTINE (SUCCINYLCHOLINE CHLORIDE) INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR USE INITIAL U.S. APPROVAL: 1952 WARNING: RISK OF VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • RECENT MAJOR CHANGES INDICATIONS AND USAGE ANECTINE is a depolarizing neuromuscular blocker indicated in adults and pediatric patients: • • • DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS Injection: 200 mg/ 10 mL (20 mg/mL) in multiple-dose vials (3) CONTRAINDICATIONS • • • • ® ACUTE RHABDOMYOLYSIS WITH HYPERKALEMIA FOLLOWED BY VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH HAS OCCURRED AFTER THE ADMINISTRATION OF SUCCINYLCHOLINE TO APPARENTLY HEALTHY PEDIATRIC PATIENTS WHO WERE SUBSEQUENTLY FOUND TO HAVE UNDIAGNOSED SKELETAL MUSCLE MYOPATHY, MOST FREQUENTLY DUCHENNE MUSCULAR DYSTROPHY. (5.1). WHEN A HEALTHY APPEARING PEDIATRIC PATIENT DEVELOPS CARDIAC ARREST WITHIN MINUTES AFTER ADMINISTRATION OF ANECTINE NOT FELT TO BE DUE TO INADEQUATE VENTILATION, OXYGENATION, OR ANESTHETIC OVERDOSE, 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 ANECTINE IN PEDIATRIC PATIENTS SHOULD BE FOR EMERGENCY INTUBATION OR INSTANCES WHERE IMMEDIATE SECURING OF THE AIRWAY IS NECESSARY, E.G., LARYNGOSPASM, DIFFICULT AIRWAY, FULL STOMACH, OR FOR INTRAMUSCULAR USE WHEN A SUITABLE VEIN IS INACCESSIBLE (5.1). Contraindications (4) 11/2023 Warnings and Precautions (5.5) 11/2023 as an adjunct to general anesthesia (1) to facilitate tracheal intubation (1) to provide skeletal muscle relaxation during s पूरा दस्तावेज़ पढ़ें