염화석사메토늄
Suxamethonium Chloride
원료 코드 M082422 국내 제품 2개 (단일제 2 · 복합제 0)
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이 성분만 든 제품 (단일제 2)
🌐 해외(미국) 정보 — 염화석사메토늄
미국 FDA·NLM 자료 · 2026-10-04 기준이 성분은 한국어 번역이 없습니다(검수 전 자동 번역 게시는 멈춰 두었습니다). 아래는 미국 FDA 원문입니다 — 원문 라벨(DailyMed).
미국에서 쓰이는 곳(적응증)
영어 원문 (미국 FDA 라벨)
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 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)
⚠️ 박스 경고(가장 강한 경고)
영어 원문 (미국 FDA 라벨)
WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS 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 [see Warnings and Precautions (5.1)] . When a healthy appearing pediatric patient develops cardiac arrest within minutes after administration of succinylcholine chloride injection, 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 [see Warnings and Precautions (5.1)] . Reserve the use of succinylcholine chloride injection 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)] . 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 …
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
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)] Skeletal muscle myopathies (4) Known hypersensitivity to succinylcholine (4) After the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury (4) Known or suspected genetic susceptibility to malignant hyperthermia (4)
주요 경고·주의
영어 원문 (미국 FDA 라벨)
Anaphylaxis : Severe anaphylactic reactions to neuromuscular blocking agents, including succinylcholine, have been reported. Some cases have been life-threatening and fatal. Take necessary precautions, such as the immediate availability of appropriate emergency treatment. (5.2) Risk of Death due to Medication Errors : Unintended administration of succinylcholine chloride injection may result in paralysis, respiratory arrest and death. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. (5.3) Hyperkalemia : succinylcholine chloride injection may induce serious cardiac arrhythmias or cardiac arrest due to hyperkalemia. (5.4) Malignant Hyperthermia : Malignant hyperthermia may occur, especially in individuals with known or suspected susceptibility based on genetic factors or family history. Discontinue triggering agents, administer intravenous dantrolene sodium, and apply supportive therapies. (5.5) Bradycardia : Intravenous bolus administration may result in profound bradycardia or, rarely, asystole. The incidence is higher following a second dose of succinylcholine. Pretreatment with anticholinergic agents (e.g., atropine) may reduce the occurrence of bradyarrhythmias. (5.6) 5.1 Ventricular Dysrhythmias, Cardiac Arrest, and Death From Hyperkalemic Rhabdomyolysis in Pediatric Patients There have been reports of ventricular dysrhythmias, cardiac arrest, and death …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
8.1 Pregnancy 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 estimated background risk of major birth defects and miscarriage for the indicated …
미국 제품명 Anectine
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 3,845건 가운데 많이 적힌 증상입니다. 보고 수는 약 때문이라는 증거가 아니며, 많이 쓰는 약일수록 많아집니다. 증상 이름의 한국어는 AI 번역(참고용)이라 영어 원어를 함께 적었습니다.
- 1 약효 없음drug ineffective443
- 2 저혈압hypotension310
- 3 HYPERTHERMIA MALIGNANT288
- 4 CARDIAC ARREST261
- 5 약물 상호작용drug interaction225
- 6 ANAPHYLACTIC SHOCK220
- 7 ANAPHYLACTIC REACTION184
- 8 통증pain139
- 9 신부전renal failure137
- 10 MATERNAL EXPOSURE DURING PREGNANCY132
- 11 RHABDOMYOLYSIS131
- 12 BRADYCARDIA127
미국 리콜 기록
FDA 리콜(회수) 기록 5건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.
- 2025.10.15 · 2등급 · Dr. Reddy's Laboratories, Inc. Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
- 2025.09.17 · 2등급 · Zydus Pharmaceuticals (USA) Inc Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
- 2017.08.09 · 2등급 · Hospira a Pfizer Company Lack of Sterility Assurance
- 2016.05.11 · 3등급(경미) · Hospira Inc. Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
- 2013.05.15 · 2등급 · Hospira Inc. Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
출처: 미국 FDA openFDA(라벨·FAERS·리콜), 미국 국립의학도서관 RxNorm · DailyMed 원문 라벨. 한국어는 오픈드럭 서버 AI(gemma)가 자동 번역한 참고용(사람 검수 전)으로 오역이 있을 수 있으니 반드시 원문을 확인하세요.
