베사노이드연질캡슐10mg 효능·효과
광고
베사노이드연질캡슐10mg 복용법 (용법·용량)
베사노이드연질캡슐10mg 부작용·주의사항
전체 7개 항목 펼치기/접기
1. 다음 환자에는 투여하지 말 것.
2. 이상반응
3. 일반적 주의
4. 상호작용
5. 임부 및 수유부에 대한 투여
6. 과량투여시 처치
7. 적용상의 주의
베사노이드연질캡슐10mg 성분·함량
1캅셀 (내용량 164mg) 중/1캅셀 (내용량 164mg) 중-공연질캅셀: 1캅셀당 기준
| 성분 | 영문 | 분량 |
|---|---|---|
| 트레티노인 | Tretinoin | 10.00 밀리그램 |
베사노이드연질캡슐10mg 낱알 모양 (식별 표시)
- 모양
- 타원형 · 연질캡슐제, 액상
- 색
- 주황 / 갈색
- 표시(앞/뒤)
- 10mg / -
- 크기
- 9.7 × 6.4 mm, 두께 6.4mm
병용금기 — 함께 쓰면 안 되는 성분 (9)
이 약의 성분과 같이 처방·복용하면 안 되는 성분입니다(식약처 DUR 병용금기). 해당 성분이 든 약을 먹고 있다면 의사·약사에게 알리세요.
📍 베사노이드연질캡슐10mg 살 수 있는 내 주변 약국
전문의약품은 의사 처방전이 있어야 약국에서 받을 수 있습니다. 재고는 약국에 전화로 확인하세요.
🗺️ 지도에서 찾기🌐 해외(미국) 정보 — 트레티노인
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).
Retinoid [EPC]
미국에서 쓰이는 곳(적응증)
영어 원문 (미국 FDA 라벨)
Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. Tretinoin capsules are a retinoid indicated for induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL), characterized by presence of t(15;17) translocation or presence of PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.
⚠️ 박스 경고(가장 강한 경고)
영어 원문 (미국 FDA 라벨)
WARNING: EMBRYO-FETAL TOXICITY and DIFFERENTIATION SYNDROME • Tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules. Advise females of reproductive potential to use two effective methods of contraception during treatment with tretinoin capsules and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with tretinoin capsules and for 1 week after the last dose [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)] . • Differentiation Syndrome, which can be life-threatening or fatal, occurred in about 26% of patients with APL who received tretinoin capsules. At first signs or symptoms of this syndrome, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms. Consider withholding tretinoin capsules for moderate and severe Differentiation Syndrome until resolution [see Warnings and Precautions (5.2)] . WARNING: EMBRYO-FETAL TOXICITY and DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. • Embryo-Fetal Toxicity: tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a …
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
Tretinoin capsules are contraindicated in patients with a known hypersensitivity to tretinoin capsules, any of its components, or other retinoids. Reactions have included rash, pruritus, face edema, and dyspnea [see Adverse Reactions ( 6.1 )]. Hypersensitivity to tretinoin capsules, any of its components, or other retinoids
주요 경고·주의
영어 원문 (미국 FDA 라벨)
• Patients Without t(15;17) Translocation or PML/RARα Fusion: Tretinoin capsules may be initiated based on morphological diagnosis of APL. Confirm diagnosis by detection of the t(15;17) translocation or PML/RARα fusion. ( 5.3 ) • Leukocytosis: Consider administering cytoreductive chemotherapy (including an anthracycline if not contraindicated or hydroxyurea) with tretinoin capsules in the setting of leukocytosis, as clinically indicated. ( 5.4 ) • Intracranial Hypertension: Tretinoin capsules have been associated with benign intracranial hypertension, especially in pediatric patients. Consider interruption, dose reduction, or discontinuation of tretinoin capsules as appropriate. ( 5.5 ) • Lipid Abnormalities: Patients experienced hypercholesterolemia and/or hypertriglyceridemia, which may be reversible upon completion of treatment. Monitor fasting triglycerides and cholesterol at baseline and periodically during treatment. ( 5.6 ) • Hepatotoxicity: Monitor liver function test results at baseline and during treatment as clinically indicated. ( 5.7 ) • Thromboembolic Events: Venous and arterial events have been reported; these events may occur during the first month of treatment with tretinoin capsules. ( 5.8 , 7.4 ) 5.1 Embryo-Fetal Toxicity Tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Tretinoin capsules are a retinoid and there is an increased risk of major congenital malformations, spontaneous abortions and …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
8.1 Pregnancy Risk Summary Based on findings in animals and its mechanism of action [see Clinical Pharmacology ( 12.1 )], tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Tretinoin capsules are a retinoid and there is an increased risk of major congenital malformations, spontaneous abortions and premature births following exposure to retinoids during pregnancy in humans. Tretinoin was teratogenic and embryotoxic in mice, rats, hamsters, rabbits and pigtail monkeys at doses less than the human dose on a mg/m 2 basis (see Data) . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects …
미국 제품명 Retin-A MICRO, Altreno
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 8,792건 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 약효 없음drug ineffective984
- 2 적응증 외 사용off label use973
- 3 통증pain598
- 4 미승인 적응증 사용product use in unapproved indication540
- 5 구토vomiting498
- 6 발진rash477
- 7 오심nausea453
- 8 두통headache434
- 9 설사diarrhoea414
- 10 홍반erythema412
- 11 감각이상paraesthesia409
- 12 증상 악화condition aggravated401
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.
허가 정보
- 품목기준코드
- 199504168
- 허가 구분
- 신고 · 완제의약품
- 상태
- 정상
- 위탁 제조
- Catalent Germany Eberbach GmbH, CENEXI
- 저장 방법
- 차광, 밀폐용기, 상온보관
- 사용 기간
- 제조일로부터 36 개월
- 포장 단위
- 100 캅셀
- ATC 코드
- L01XF01
- 보험 코드
- 055500060
- 표준코드
- 8800555000607, 8800555000614, 8800573000108, 8800573000115, 8806450002708, 8806450002715 외 2개
- 최근 변경
- 2023.07.13
허가 변경 이력
- · 사용상주의사항변경(부작용포함), 2023-07-13
- · 사용상의 주의사항, 2022-07-26
- · 사용상주의사항변경(부작용포함), 2019-01-07
- · 제품명칭변경, 2014-05-29
- · 효능효과변경, 2008-02-02
- · 용법용량변경, 2008-02-02
- · 사용상주의사항변경(부작용포함), 2008-02-02
- · 사용상주의사항변경(부작용포함), 2003-05-21
- · 사용상주의사항변경(부작용포함), 2000-07-27
원문: 식약처 의약품안전나라