시타라빈
Cytarabine
원료 코드 M040334 국내 제품 5개 (단일제 4 · 복합제 1) DUR 성분 D000449
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⚠️ DUR 안전사용 기준
- 🤰 임부금기 2등급 동물실험에서 기형발생 작용 보고.(용액주사제/유화주사제/용액용분말주사제/서방성현탁액용분말주사제/용액용동결건조분말주사제/현탁액용동결건조분말주사제/서방성현탁액용동결건조분말주사제/리포좀화현탁액용동결건조분말주사제/현탁액주사제/서방성현탁액성주사제)
이 성분만 든 제품 (단일제 4)
광고
다른 성분과 섞인 제품 (복합제 1)
🌐 해외(미국) 정보 — 시타라빈
미국 FDA·NLM 자료 · 2026-10-03 기준이 성분은 한국어 번역이 없습니다(검수 전 자동 번역 게시는 멈춰 두었습니다). 아래는 미국 FDA 원문입니다 — 원문 라벨(DailyMed).
Nucleoside Metabolic Inhibitor [EPC]
미국에서 쓰이는 곳(적응증)
영어 원문 (미국 FDA 라벨)
Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.
⚠️ 박스 경고(가장 강한 경고)
영어 원문 (미국 FDA 라벨)
Only physicians experienced in cancer chemotherapy should use Cytarabine Injection. For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The main toxic effect of cytarabine injection is bone marrow suppression with leukopenia, thrombocytopenia and anemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration, and hepatic dysfunction. The physician must judge possible benefit to the patient against known toxic effects of this drug in considering the advisability of therapy with Cytarabine Injection. Before making this judgement or beginning treatment, the physician should be familiar with the following text.
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
Cytarabine Injection is contraindicated in those patients who are hypersensitive to the drug.
주요 경고·주의
영어 원문 (미국 FDA 라벨)
(See boxed WARNING ) Cytarabine is a potent bone marrow suppressant. Therapy should be started cautiously in patients with pre-existing drug-induced bone marrow suppression. Patients receiving this drug must be under close medical supervision and, during induction therapy, should have leucocyte and platelet counts performed daily. Bone marrow examinations should be performed frequently after blasts have disappeared from the peripheral blood. Facilities should be available for management of complications, possibly fatal, of bone marrow suppression (infection resulting from granulocytopenia and other impaired body defenses, and hemorrhage secondary to thrombocytopenia). One case of anaphylaxis that resulted in acute cardiopulmonary arrest and required resuscitation has been reported. This occurred immediately after the intravenous administration of cytarabine injection. Severe and at times fatal CNS, GI and pulmonary toxicity (different from that seen with conventional therapy regimens of cytarabine injection) has been reported following some experimental dose schedules for cytarabine injection. These reactions include reversible corneal toxicity, and hemorrhagic conjunctivitis, which may be prevented or diminished by prophylaxis with a local corticosteroid eye drop; cerebral and cerebellar dysfunction, including personality changes, somnolence and coma, usually reversible; severe gastrointestinal ulceration, including pneumatosis cystoides intestinalis leading to peritonitis; …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
6. Pregnancy See WARNINGS .
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 61,947건 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 발열성 호중구 감소증febrile neutropenia8,130
- 2 적응증 외 사용off label use5,221
- 3 발열pyrexia4,380
- 4 호중구 감소증neutropenia3,748
- 5 약효 없음drug ineffective3,222
- 6 패혈증sepsis3,082
- 7 THROMBOCYTOPENIA3,017
- 8 DISEASE PROGRESSION2,852
- 9 폐렴pneumonia2,492
- 10 MYELOSUPPRESSION2,322
- 11 사망death2,246
- 12 PANCYTOPENIA2,189
미국 리콜 기록
FDA 리콜(회수) 기록 1건 중 최근 1건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.
- 2012.09.26 · 2등급 · Hospira Inc. The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
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.