베실산아트라쿠륨
Atracurium Besylate
원료 코드 M200668 국내 제품 1개 (단일제 1 · 복합제 0) DUR 성분 D001432
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이 성분만 든 제품 (단일제 1)
🌐 해외(미국) 정보 — 베실산아트라쿠륨
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)
Atracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
Atracurium besylate is contraindicated in patients known to have a hypersensitivity to it. Use of atracurium besylate from multiple dose vials containing benzyl alcohol as a preservative is contraindicated in patients with a known hypersensitivity to benzyl alcohol.
주요 경고·주의
영어 원문 (미국 FDA 라벨)
SUPPORT. EQUIPMENT AND PERSONNEL MUST BE IMMEDIATELY AVAILABLE FOR ENDOTRACHEAL INTUBATION AND SUPPORT OF VENTILATION, INCLUDING ADMINISTRATION OF POSITIVE PRESSURE OXYGEN. ADEQUACY OF RESPIRATION MUST BE ASSURED THROUGH ASSISTED OR CONTROLLED VENTILATION. ANTICHOLINESTERASE REVERSAL AGENTS SHOULD BE IMMEDIATELY AVAILABLE. DO NOT GIVE ATRACURIUM BESYLATE BY INTRAMUSCULAR ADMINISTRATION. Atracurium has no known effect on consciousness, pain threshold, or cerebration. It should be used only with adequate anesthesia. Atracurium besylate injection, which has an acid pH, should not be mixed with alkaline solutions (e.g., barbiturate solutions) in the same syringe or administered simultaneously during intravenous infusion through the same needle. Depending on the resultant pH of such mixtures, atracurium may be inactivated and a free acid may be precipitated. Atracurium besylate injection 10 mL multiple dose vials contain benzyl alcohol. In neonates, benzyl alcohol has been associated with an increased incidence of neurological and other complications which are sometimes fatal. Atracurium besylate 5 mL single use vials do not contain benzyl alcohol (see PRECAUTIONS, Pediatric Use ). Anaphylaxis Severe anaphylactic reactions to neuromuscular blocking agents, including atracurium besylate, have been reported. These reactions have in some cases been life-threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
Pregnancy Teratogenic Effects: Pregnancy Category C Atracurium besylate has been shown to be potentially teratogenic in rabbits when given in doses up to approximately one-half the human dose. There are no adequate and well-controlled studies in pregnant women. Atracurium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Atracurium besylate was administered subcutaneously on days 6 through 18 of gestation to non-ventilated Dutch rabbits. Treatment groups were given either 0.15 mg/kg once daily or 0.10 mg/kg twice daily. Lethal respiratory distress occurred in two 0.15 mg/kg animals and in one 0.10 mg/kg animal, with transient …
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 703건 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 저혈압hypotension74
- 2 ANAPHYLACTIC REACTION66
- 3 ANAPHYLACTIC SHOCK66
- 4 BRADYCARDIA40
- 5 BRONCHOSPASM35
- 6 약물 상호작용drug interaction35
- 7 CARDIAC ARREST33
- 8 THROMBOCYTOPENIA30
- 9 약효 없음drug ineffective26
- 10 산소포화도 감소oxygen saturation decreased26
- 11 증상 악화condition aggravated22
- 12 RESPIRATORY FAILURE22
미국 리콜 기록
FDA 리콜 기록이 없습니다.
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.
