덱사메타손팔미테이트
Dexamethasone Palmitate
원료 코드 M258481 국내 제품 2개 (단일제 2 · 복합제 0) DUR 성분 D000199
🌐 미국 FDA 자료(영문 라벨·부작용 보고·리콜)가 있습니다. 한국어는 AI 번역 참고용이니 원문을 함께 확인하세요. 해외 정보 보기
⚠️ DUR 안전사용 기준
- 🤰 임부금기 2등급 "동물실험에서 기형발생 작용 보고. 태아의 성장지체, 언청이의 위험 등의 증가, 뇌성장 및 발달에 영향 가능성. 신생아에 부신부전증 유발 가능성."(정제/캡슐/용액주사제/유화주사제/용액용분말주사제/서방성현탁액용분말주사제/용액용동결건조분말주사제/현탁액용동결건조분말주사제/서방성현탁액용동결건조분말주사제/리포좀화현탁액용동결건조분말주사제/현탁액주사제/서방성현탁액성주사제/이식물)
- 🤰 임부금기 2등급 (일반액상분무제/정량액상분무제/일반분말분무제/정량분말분무제)
이 성분만 든 제품 (단일제 2)
병용금기 성분 (3)
아래 성분이 든 약과 함께 쓰면 안 됩니다 (식약처 DUR).
| 상대 성분 | 이유 |
|---|---|
| 다클라타스비르 | 다클라타스비르에 대한 바이러스 반응의 소실을 유발 가능 |
| 스파플록사신 | 1. 아킬레스건 파열 및 손상<특히 노인> 2. 심혈관계 부작용 증가 |
| 아수나프레비르 | 아수나프레비르에 대한 바이러스 반응의 소실을 유발 가능 |
🌐 해외(미국) 정보 — 덱사메타손팔미테이트
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)
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 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 308,305건 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 use23,656
- 2 피로fatigue17,772
- 3 설사diarrhoea17,598
- 4 오심nausea14,726
- 5 PLASMA CELL MYELOMA14,363
- 6 폐렴pneumonia14,123
- 7 사망death13,769
- 8 약효 없음drug ineffective13,719
- 9 호중구 감소증neutropenia11,946
- 10 발열pyrexia11,612
- 11 THROMBOCYTOPENIA10,930
- 12 호흡 곤란dyspnoea10,728
미국 리콜 기록
FDA 리콜(회수) 기록 9건 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.
- 2025.09.17 · 2등급 · Sandoz Inc Temperature Abuse
- 2024.06.26 · 2등급 · Eugia US LLC Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
- 2022.06.15 · 2등급 · Mckesson Medical-Surgical Inc. Corporate Office cGMP deviations: Temperature abuse
- 2022.06.15 · 2등급 · Mckesson Medical-Surgical Inc. Corporate Office cGMP deviations: Temperature abuse
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.
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