경보메로페넴주500mg 효능·효과
1. 유효균종
2. 적응증
경보메로페넴주500mg 복용법 (용법·용량)
1. 성인
2. 소아
<용액의 조제=""></용액의>
경보메로페넴주500mg 부작용·주의사항
전체 12개 항목 펼치기/접기
1. 다음 환자에는 투여하지 말 것.
2. 다음 환자에는 신중히 투여할 것.
3. 이상반응
4. 일반적 주의
5. 약물 상호작용
6. 임부에 대한 투여
7. 수유부에 대한 투여
8. 미숙아, 신생아에 대한 투여
9. 고령자에 대한 투여
10. 임상검사치에 대한 영향
11. 적용상의 주의
12. 기타
경보메로페넴주500mg 성분·함량
1바이알 중 기준
| 성분 | 영문 | 분량 |
|---|---|---|
| 메로페넴건조탄산나트륨 | Meropenem Dried Sodium Carbonate | 500 밀리그램 |
병용금기 — 함께 쓰면 안 되는 성분 (1)
이 약의 성분과 같이 처방·복용하면 안 되는 성분입니다(식약처 DUR 병용금기). 해당 성분이 든 약을 먹고 있다면 의사·약사에게 알리세요.
| 상대 성분 | 이유 |
|---|---|
| 발프로산 | 간질발작 재발 |
🌐 해외(미국) 정보 — 메로페넴건조탄산나트륨
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)
A. Intravenous or Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis. Acute …
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
Systemic fungal infections.
주요 경고·주의
영어 원문 (미국 FDA 라벨)
Serious Neurologic Adverse Reactions with Epidural Administration Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. In patients on corticosteroid therapy subject to any unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Immunosuppression and Increased Risk of Infection Corticosteroids, including dexamethasone sodium phosphate injection, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infection Corticosteroid-associated …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
Usage in Pregnancy Since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Average and large doses of cortisone or hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except …
미국 제품명 Dexamethasone Sodium Phosphate, Prednisolone Sodium Phosphate, Orapred ODT
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 18,205건 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 적응증 외 사용off label use1,436
- 2 오심nausea1,148
- 3 발열pyrexia1,008
- 4 피로fatigue933
- 5 구토vomiting926
- 6 설사diarrhoea909
- 7 약효 없음drug ineffective891
- 8 호흡 곤란dyspnoea811
- 9 폐렴pneumonia746
- 10 빈혈anaemia720
- 11 통증pain708
- 12 두통headache613
미국 리콜 기록
FDA 리콜(회수) 기록 6건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.
- 2026.03.25 · 2등급 · SOMERSET THERAPEUTICS LLC Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
- 2025.12.10 · 2등급 · Blossom Pharmaceuticals cGMP deviations
- 2024.06.26 · 2등급 · Eugia US LLC Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
- 2019.04.17 · 1등급(심각) · Aurobindo Pharma USA Inc. Presence of Particulate Matter: One vial was found to contain a hair.
- 2017.11.29 · 3등급(경미) · West-Ward Pharmaceuticals Corp. Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
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
- 201100658
- 허가 구분
- 신고 · 완제의약품
- 상태
- 취하 (2024.07.08)
- 위탁 제조
- 대한뉴팜(주)
- 저장 방법
- 밀봉용기, 실온보관(1~30℃)
- 사용 기간
- 제조일로부터 36 개월
- 포장 단위
- 자사포장단위
- ATC 코드
- J01DH02
- 표준코드
- 8806650014709
- 최근 변경
- 2024.03.04
허가 변경 이력
- · 사용상주의사항변경(부작용포함), 2024-03-04
- · 사용상주의사항변경(부작용포함), 2019-06-07
원문: 식약처 의약품안전나라
