제일제약부피바카인염산염헤비주사0.5% 효능·효과
제일제약부피바카인염산염헤비주사0.5% 복용법 (용법·용량)
○ 성인
2. 경막외마취
○ 성인
2. 경막외마취
3. 선골마취 : 15-20㎖(75-100㎎)
○ 성인
제일제약부피바카인염산염헤비주사0.5% 부작용·주의사항
전체 7개 항목 펼치기/접기
1. 경고
2. 다음 환자에는 투여하지 말 것.
3. 이상반응
매우 흔하게
(>1/10)
일반적 : 구역
순환계 : 저혈압, 서맥
흔하게
(>1/100)
신경계 : 요추천자 후 두통
위장계 : 구토
비뇨기계 : 요정체, 요실금
흔하지않게
(1/100-1/1000)
신경계 : 지각이상, 부전마비, 감각이상
근골격계 : 근무력, 등통증
드물게
(<1/1000)
순환계 : 심정지
일반적 : 알러지반응, 아나필락시스성 쇼크
CNS: 우발적 전척추차단, 하반신불수, 마비, 신경장애, 지주
막염
기도: 호흡억제
4. 일반적 주의
5. 상호작용
6. 임부와 수유부에 대한 투여
7. 적용상의 주의
제일제약부피바카인염산염헤비주사0.5% 성분·함량
1mL 기준
| 성분 | 영문 | 분량 |
|---|---|---|
| 부피바카인염산염일수화물 | Bupivacaine Hydrochloride Hydrate | 5.28 밀리그램 |
📍 제일제약부피바카인염산염헤비주사0.5% 살 수 있는 내 주변 약국
전문의약품은 의사 처방전이 있어야 약국에서 받을 수 있습니다. 재고는 약국에 전화로 확인하세요.
🗺️ 지도에서 찾기🌐 해외(미국) 정보 — 부피바카인염산염일수화물
미국 FDA·NLM 자료 · 2026-10-02 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)
Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection is recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see Dosage and Administration (2.2) , Contraindications (4) , Warnings and Precautions (5.1 , 5.5 , 5.7 , 5.9 )]. Bupivacaine hydrochloride injection contains bupivacaine, an amide local anesthetic is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. ( 1 , 2.2 ) Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use. ( 1 , 2.2 , 4 , 5.1 , 5.5 , 5.7 , 5.9 )
⚠️ 박스 경고(가장 강한 경고)
영어 원문 (미국 FDA 라벨)
WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE IN OBSTETRICAL ANESTHESIA There have been reports of cardiac arrest with difficult resuscitation or death during use of bupivacaine hydrochloride for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% (7.5 mg/mL) concentration of bupivacaine hydrochloride is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary [ see Warnings and Precautions (5.1) ]. WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE IN OBSTETRICAL ANESTHESIA See full prescribing information for complete boxed warning. There have been reports of cardiac arrest with difficult resuscitation or death during use of bupivacaine hydrochloride for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following …
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
Bupivacaine hydrochloride is contraindicated in: • obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. • intravenous regional anesthesia (Bier Block) [see Warnings and Precautions (5.7) ]. • patients with a known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of bupivacaine hydrochloride. • Obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. ( 4 ) • Intravenous regional anesthesia (Bier Block). ( 4 ) • Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of bupivacaine. ( 4 )
주요 경고·주의
영어 원문 (미국 FDA 라벨)
• Dose-Related Toxicity : Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after injection of bupivacaine hydrochloride. ( 5.2 ) • Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use. See full prescribing information for more detail on managing these risks. ( 5.3 ) • Chondrolysis with Intra-Articular Infusion : Intra-articular infusions of local anesthetics including bupivacaine hydrochloride following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. ( 5.5 ) • Risk of Cardiac Arrest with Intravenous Regional Anesthesia Use (Bier Block) : There have been reports of cardiac arrest and death during the use of bupivacaine for intravenous regional anesthesia (Bier Block). ( 5.7 ) • Risk of Systemic Toxicities with Unintended Intravascular or Intrathecal Injection : Unintended intravascular or intrathecal injection may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Aspirate for blood or cerebrospinal fluid (where applicable) prior to each dose. ( 5.9 ) 5.1 Risk of Cardiac Arrest with Use of Bupivacaine Hydrochloride injection in Obstetrical Anesthesia There have been reports of cardiac arrest with difficult resuscitation or death during use of bupivacaine hydrochloride for epidural …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
8.1 Pregnancy Risk Summary Bupivacaine hydrochloride is contraindicated for obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death [see Contraindications (4) , Warnings and Precautions (5.1) ]. There are no available data on use of bupivacaine hydrochloride in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal studies, embryo-fetal lethality was noted when bupivacaine was administered subcutaneously to pregnant rabbits during organogenesis at clinically relevant doses. Decreased pup survival was observed in a rat pre- and post-natal developmental study (dosing from implantation through …
미국 제품명 Sensorcaine, Marcaine
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 16,879건 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 ineffective3,364
- 2 적응증 외 사용off label use1,159
- 3 통증pain1,099
- 4 ANAESTHETIC COMPLICATION835
- 5 저혈압hypotension818
- 6 MATERNAL EXPOSURE DURING PREGNANCY625
- 7 감각저하hypoaesthesia622
- 8 오심nausea602
- 9 EXPOSURE DURING PREGNANCY458
- 10 구토vomiting438
- 11 호흡 곤란dyspnoea404
- 12 어지러움dizziness392
미국 리콜 기록
FDA 리콜(회수) 기록 25건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.
- 2026.04.22 · 2등급 · Huons Co., Ltd. Lack of Assurance of Sterility
- 2023.01.25 · 2등급 · Fresenius Kabi USA, LLC Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
- 2023.01.25 · 2등급 · Fresenius Kabi USA, LLC Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
- 2023.01.25 · 2등급 · Fresenius Kabi USA, LLC Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
- 2022.08.24 · 3등급(경미) · HERON THERAPEUTICS, INC. Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
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.
허가 정보
- 품목기준코드
- 201106875
- 허가 구분
- 신고 · 완제의약품
- 상태
- 정상
- 저장 방법
- 밀봉용기, 실온(1∼30℃)보관
- 사용 기간
- 제조일로부터 36 개월
- 포장 단위
- 1앰플(4mL) × 자사포장단위
- ATC 코드
- N01BB01
- 표준코드
- 8806505012904, 8806505012911
- 최근 변경
- 2023.08.22
허가 변경 이력
- · 사용상주의사항변경(부작용포함), 2023-08-22
원문: 식약처 의약품안전나라