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다우노루비신염산염

Daunorubicin Hydrochloride

원료 코드 M222833 국내 제품 4개 (단일제 3 · 복합제 1) DUR 성분 D000198

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⚠️ DUR 안전사용 기준

  • 🤰 임부금기 2등급 (용액주사제/유화주사제/용액용분말주사제/서방성현탁액용분말주사제/용액용동결건조분말주사제/현탁액용동결건조분말주사제/서방성현탁액용동결건조분말주사제/리포좀화현탁액용동결건조분말주사제/현탁액주사제/서방성현탁액성주사제)

이 성분만 든 제품 (단일제 3)

다우노신주20밀리그램(다우노루비신염산염) 한국유나이티드제약(주)· 주로 악성종양에 작용하는 것· 2024년 허가 전문 주사용다우노마이신20밀리그램(다우노루비신염산염) 동아에스티(주)· 주로 악성종양에 작용하는 것· 20(역가)밀리그램· 2013년 허가 전문 다우노신주(다우노루비신염산염) 한국유나이티드제약(주)· 주로 악성종양에 작용하는 것· 21.4밀리그램· 1998년 허가 전문

광고

다른 성분과 섞인 제품 (복합제 1)

목록 펼치기 빅시오스리포좀주 (주)한독· 항악성종양제· 2022년 허가 전문

🌐 해외(미국) 정보 — 다우노루비신염산염

미국 FDA·NLM 자료 · 2026-10-03 기준

이 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)

Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

Daunorubicin Hydrochloride Injection must be given into a rapidly flowing intravenous infusion. It must never be given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration. Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m 2 in adults, 300 mg/m 2 in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age. Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage. It is recommended that daunorubicin hydrochloride be administered only by physicians who are experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection. Dosage should be reduced in patients with impaired hepatic or renal function.

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Daunorubicin hydrochloride injection is contraindicated in patients who have shown a hypersensitivity to it.

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Bone Marrow Daunorubicin hydrochloride is a potent bone marrow suppressant. Suppression will occur in all patients given a therapeutic dose of this drug. Therapy with daunorubicin hydrochloride should not be started in patients with pre-existing drug-induced bone marrow suppression unless the benefit from such treatment warrants the risk. Persistent, severe myelosuppression may result in superinfection or hemorrhage. Cardiac Effects Special attention must be given to the potential cardiac toxicity of daunorubicin hydrochloride, particularly in infants and children. Pre-existing heart disease and previous therapy with doxorubicin are co-factors of increased risk of daunorubicin-induced cardiac toxicity and the benefit-to-risk ratio of daunorubicin hydrochloride therapy in such patients should be weighed before starting daunorubicin hydrochloride. In adults, at total cumulative doses less than 550 mg/m 2 , acute congestive heart failure is seldom encountered. However, rare instances of pericarditis-myocarditis, not dose-related, have been reported. In adults, at cumulative doses exceeding 550 mg/m 2 , there is an increased incidence of drug-induced congestive heart failure. Based on prior clinical experience with doxorubicin, this limit appears lower, namely 400 mg/m 2 , in patients who received radiation therapy that encompassed the heart. In infants and children, there appears to be a greater susceptibility to anthracycline-induced cardiotoxicity compared to that in adults, …

임신·특수 환자

영어 원문 (미국 FDA 라벨)

Pregnancy Daunorubicin hydrochloride may cause fetal harm when administered to a pregnant woman. An increased incidence of fetal abnormalities (parieto-occipital cranioschisis, umbilical hernias, or rachischisis) and abortions was reported in rabbits at doses of 0.05 mg/kg/day or approximately 1/100th of the highest recommended human dose on a body surface area basis. Rats showed an increased incidence of esophageal, cardiovascular and urogenital abnormalities as well as rib fusions at doses of 4 mg/kg/day or approximately 1/2 the human dose on a body surface area basis. Decreases in fetal birth weight and post-delivery growth rate were observed in mice. There are no adequate and …

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 3,895건 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. 1 발열성 호중구 감소증febrile neutropenia688
  2. 2 발열pyrexia313
  3. 3 ACUTE MYELOID LEUKAEMIA312
  4. 4 사망death281
  5. 5 MYELOSUPPRESSION225
  6. 6 적응증 외 사용off label use224
  7. 7 폐렴pneumonia219
  8. 8 ACUTE MYELOID LEUKAEMIA RECURRENT211
  9. 9 치료제 효과 불완전therapeutic product effect incomplete200
  10. 10 패혈증sepsis194
  11. 11 BACTERIAL INFECTION168
  12. 12 발진rash155

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.