제일엠지주 효능·효과
제일엠지주 복용법 (용법·용량)
제일엠지주 부작용·주의사항
전체 8개 항목 펼치기/접기
1. 경고
2. 다음 환자에는 투여하지 말 것.
3. 다음 환자에는 신중히 투여할 것.
4. 이상반응
5. 상호작용
6. 임부 및 수유부에 대한 투여
7. 고령자에 대한 투여
8. 적용상의 주의
제일엠지주 성분·함량
1밀리리터 중 기준
| 성분 | 영문 | 분량 |
|---|---|---|
| 황산마그네슘수화물 | Magnesium Sulfate Hydrate | 0.1 그램 |
🌐 해외(미국) 정보 — 황산마그네슘수화물
미국 FDA·NLM 자료 · 2026-10-01 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)
Magnesium Sulfate in 5% Dextrose Injection is indicated for: • Prevention of eclampsia in patients with preeclampsia • Treatment of seizures and prevention of recurrent seizures in patients with eclampsia Magnesium Sulfate in 5% Dextrose Injection is indicated for ( 1 ): • Prevention of eclampsia in patients with preeclampsia ( 1 ) • Treatment of seizures and prevention of recurrent seizures in patients with eclampsia ( 1 )
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients: • with heart block or myocardial damage • in diabetic coma • with myasthenia gravis [see Warnings and Precautions (5.6) ] • Heart block or myocardial damage ( 4 ) • Diabetic coma ( 4 ) • Myasthenia gravis ( 4 , 5.6 )
주요 경고·주의
영어 원문 (미국 FDA 라벨)
• Fetal-neonatal toxicity with prolonged use : Administration beyond 5 to 7 days is not recommended and can lead to hypocalcemia and bone abnormalities ( 2.2 , 5.1 ) • Risk of magnesium toxicity : Monitor magnesium concentrations and clinical signs of magnesium toxicity including respiratory depression, an injectable calcium salt should be immediately available to counteract hazards, for significant toxicity stop Magnesium Sulfate in 5% Dextrose Injection ( 5.2 ) • Risk of elevated blood glucose: Solutions containing dextrose should be used with caution in patients with known prediabetes or diabetes mellitus ( 5.3 ) • Co-administration with unapproved tocolytics : Do not use concomitantly with beta adrenergic agents such as terbutaline and calcium channel blockers such as nifedipine ( 5.4 ) • Aluminum toxicity : Aluminum may reach toxic concentrations with prolonged parenteral administration in patients with renal impairment ( 5.5 ) • Exacerbation of Myasthenia Gravis : Use is contraindicated because use in patients with underlying myasthenia gravis can precipitate a myasthenic crisis ( 5.6 ) 5.1 Fetal-Neonatal Toxicity with Prolonged Use Continuous administration of magnesium sulfate beyond 5 to 7 days in pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. Neonates of women receiving Magnesium Sulfate in 5% Dextrose Injection …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
8.1 Pregnancy Risk Summary Magnesium Sulfate in 5% Dextrose Injection is indicated in pregnant women for the prevention of eclampsia in women with preeclampsia and the treatment of seizures and prevention of recurrent seizures in women with eclampsia. Fetal, neonatal, and maternal risks are discussed throughout the labeling. Clinical Considerations Labor or Delivery: Magnesium Sulfate in 5% Dextrose Injection is not approved for the treatment of pre-term labor. Administration of Magnesium Sulfate in 5% Dextrose Injection to pregnant women longer than 5 to 7 days may lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia [see …
미국 제품명 Epsom Salt, Rapidol Sal Inglesa, MAGNESIA SULPHURICA, Sal Inglesa EPSOM SALT, Theraworx Relief, Theraworx Relief for Foot Cramps Roll On
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 19,664건 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 구토vomiting3,033
- 2 오심nausea2,476
- 3 약효 없음drug ineffective1,770
- 4 두통headache960
- 5 복통abdominal pain919
- 6 적응증 외 사용off label use908
- 7 통증pain865
- 8 설사diarrhoea864
- 9 발열pyrexia838
- 10 MATERNAL EXPOSURE DURING PREGNANCY770
- 11 호흡 곤란dyspnoea704
- 12 FOETAL EXPOSURE DURING PREGNANCY690
미국 리콜 기록
FDA 리콜(회수) 기록 4건 중 최근 4건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.
- 2026.04.08 · 1등급(심각) · Amneal Pharmaceuticals, LLC Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
- 2016.02.24 · 1등급(심각) · Hospira Inc. Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
- 2015.05.20 · 1등급(심각) · Hospira Inc. Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.
- 2012.06.27 · 3등급(경미) · Hospira, Inc. Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
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
- 201605919
- 허가 구분
- 신고 · 완제의약품
- 상태
- 취하 (2026.03.27)
- 위탁 제조
- 대한뉴팜(주)
- 저장 방법
- 밀봉용기, 실온(1~30℃)보관
- 사용 기간
- 제조일로부터 36 개월
- 포장 단위
- 5mL/앰플 x 25앰플
- ATC 코드
- A12CC02
- 표준코드
- 8806454047507, 8806454047514, 8806454047521
- 최근 변경
- 2021.10.12
허가 변경 이력
- · 용법·용량, 2021-10-12
- · 효능·효과, 2021-09-30
- · 사용상주의사항변경(부작용포함), 2020-02-21
원문: 식약처 의약품안전나라