네오티가손캡슐10mg 효능·효과
광고
네오티가손캡슐10mg 복용법 (용법·용량)
○ 표준 용법·용량
○ 성인
○ 소아
○ 병용치료
네오티가손캡슐10mg 부작용·주의사항
전체 11개 항목 펼치기/접기
1. 경고
2. 다음 환자에는 투여하지 말 것.
3. 다음 환자에는 신중히 투여할 것.
4. 이상반응
이상반응의 종류
이상반응 발현증례수 및 빈도수
유
무
불명
합계
(n=41)
(n=550)
(n=13)
(n=604)
n (%)
n (%)
n (%)
n (%)
피부 및 부속기계
증례수
12
(29.3 )
85
(15.5 )
1
(7.7 )
98
(16.23)
입술건조
건수
4
(9.8 )
26
(4.7 )
0
(0.0 )
30
(4.97)
피부건조
건수
1
(2.4 )
4
(0.7 )
0
(0.0 )
5
(0.83)
점막건조
건수
0
(0.0 )
4
(0.7 )
0
(0.0 )
4
(0.66)
인설(피부박화,피부박리 포함)
건수
11
(26.8 )
46
(8.4 )
0
(0.0 )
57
(9.44)
균열(구각균열 포함)
건수
1
(2.4 )
8
(1.5 )
1
(7.7 )
10
(1.66)
지루
건수
0
(0.0 )
1
(0.2 )
0
(0.0 )
1
(0.17)
가려움
건수
0
(0.0 )
6
(1.1 )
0
(0.0 )
6
(0.99)
탈모증
건수
0
(0.0 )
2
(0.4 )
0
(0.0 )
2
(0.33)
홍반
건수
0
(0.00)
3
(0.55)
0
(0.00)
3
(0.50)
조갑주위염
건수
1
(2.44)
0
(0.00)
0
(0.00)
1
(0.17)
화폐상 습진
건수
0
(0.00)
1
(0.18)
0
(0.00)
1
(0.17)
홍반성 모낭성 발진
건수
0
(0.00)
1
(0.18)
0
(0.00)
1
(0.17)
안면 피부염
건수
0
(0.00)
1
(0.18)
0
(0.00)
1
(0.17)
손/발바닥수포
건수
0
(0.00)
1
(0.18)
0
(0.00)
1
(0.17)
안면 색소 침착
건수
0
(0.00)
1
(0.18)
0
(0.00)
1
(0.17)
비타민A과다증
건수
0
(0.00)
1
(0.18)
0
(0.00)
1
(0.17)
근골격계이상
증례수
0
(0.00)
1
(0.18)
0
(0.00)
1
(0.17)
골의 통증
건수
0
(0.00)
1
(0.18)
0
(0.00)
1
(0.17)
중추신경계
증례수
0
(0.00)
3
(0.55)
0
(0.00)
3
(0.50)
두통
건수
0
(0.00)
3
(0.55)
0
(0.00)
3
(0.50)
시각이상
증례수
0
(0.00)
2
(0.36)
0
(0.00)
2
(0.33)
결막염
건수
0
(0.00)
1
(0.18)
0
(0.00)
1
(0.17)
안구건조
건수
0
(0.00)
1
(0.18)
0
(0.00)
1
(0.17)
위장관계
증례수
15
(36.59)
107
(19.45)
1
(7.69)
123
(20.36)
구순염
건수
13
(31.71)
87
(15.82)
1
(7.69)
101
(16.72)
구갈(구강건조)
건수
5
(12.20)
33
(6.00)
0
(0.00)
38
(6.29)
설사
건수
0
(0.00)
1
(0.18)
0
(0.00)
1
(0.17)
속쓰림
건수
1
(2.44)
1
(0.18)
0
(0.00)
2
(0.33)
구역
건수
0
(0.00)
2
(0.36)
0
(0.00)
2
(0.33)
위장관장애(복통 포함)
건수
1
(2.44)
4
(0.73)
0
(0.00)
5
(0.83)
간 및 담도계
증례수
1
(2.44)
2
(0.36)
0
(0.00)
3
(0.50)
간효소치
(ALT/AST)증가
건수
1
(2.44)
2
(0.36)
0
(0.00)
3
(0.50)
대사 및 영양이상
증례수
0
(0.00)
4
(0.73)
0
(0.00)
4
(0.66)
과중성지방혈증
건수
0
(0.00)
2
(0.36)
0
(0.00)
2
(0.33)
과콜레스테롤혈증
건수
0
(0.00)
3
(0.55)
0
(0.00)
3
(0.50)
전신이상
증례수
0
(0.00)
3
(0.55)
0
(0.00)
3
(0.50)
안면부종
건수
0
(0.00)
1
(0.18)
0
(0.00)
1
(0.17)
피로
건수
0
(0.00)
1
(0.18)
0
(0.00)
1
(0.17)
흉부불편감
건수
0
(0.00)
1
(0.18)
0
(0.00)
1
(0.17)
합계
증례수
22
(53.66)
155
(28.18)
2
(15.38)
179
(29.64)
건수
39
(95.12)
250
(45.45)
2
(15.38)
291
(48.18)
이상반응의 종류
이상반응 발현증례수 및 빈도수
1-14일
15-30일
31-60일
61-90일
91-120일
121일 이상
합계
(n=72)
(n=124)
(n=165)
(n=103)
(n=49)
(n=91)
(n=604)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
피부 및
부속기계
증례수
5
(6.94)
16
(12.90)
19
(11.52)
21
(20.39)
14
(28.57)
23
(25.27)
98
(16.23)
입술건조
건수
2
(2.78)
5
(4.03)
4
(2.42)
6
(5.83)
6
(12.24)
7
(7.69)
30
(4.97)
피부건조
건수
0
(0.00)
0
(0.00)
1
(0.61)
0
(0.00)
0
(0.00)
4
(4.40)
5
(0.83)
점막건조
건수
2
(2.78)
1
(0.81)
0
(0.00)
0
(0.00)
0
(0.00)
1
(1.10)
4
(0.66)
인설(피부박화,피부박리 포함)
건수
1
(1.39)
10
(8.06)
11
(6.67)
15
(14.56)
8
(16.33)
12
(13.19)
57
(9.44)
균열(구각균열 포함)
건수
1
(1.39)
1
(0.81)
3
(1.82)
3
(2.91)
2
(4.08)
0
(0.00)
10
(1.66)
지루
건수
1
(1.39)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
1
(0.17)
가려움
건수
0
(0.00)
3
(2.42)
1
(0.61)
0
(0.00)
0
(0.00)
2
(2.20)
6
(0.99)
탈모증
건수
0
(0.00)
0
(0.00)
0
(0.00)
1
(0.97)
1
(2.04)
0
(0.00)
2
(0.33)
홍반
건수
0
(0.00)
1
(0.81)
1
(0.61)
1
(0.97)
0
(0.00)
0
(0.00)
3
(0.50)
조갑주위염
건수
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
1
(1.10)
1
(0.17)
화폐상 습진
건수
0
(0.00)
1
(0.81)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
1
(0.17)
홍반성 모낭성 발진
건수
0
(0.00)
1
(0.81)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
1
(0.17)
안면 피부염
건수
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
1
(2.04)
0
(0.00)
1
(0.17)
손/발바닥수포
건수
0
(0.00)
0
(0.00)
0
(0.00)
1
(0.97)
0
(0.00)
0
(0.00)
1
(0.17)
안면 색소 침착
건수
0
(0.00)
1
(0.81)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
1
(0.17)
비타민A과다증
건수
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
1
(1.10)
1
(0.17)
근골격계이상
증례수
0
(0.00)
1
(0.81)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
1
(0.17)
골의 통증
건수
0
(0.00)
1
(0.81)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
1
(0.17)
중추신경계
증례수
0
(0.00)
1
(0.81)
1
(0.61)
0
(0.00)
0
(0.00)
1
(1.10)
3
(0.50)
두통
건수
0
(0.00)
1
(0.81)
1
(0.61)
0
(0.00)
0
(0.00)
1
(1.10)
3
(0.50)
시각이상
증례수
1
(1.39)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
1
(1.10)
2
(0.33)
결막염
건수
1
(1.39)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
1
(0.17)
안구건조
건수
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
1
(1.10)
1
(0.17)
위장관계
증례수
11
(15.28)
18
(14.52)
28
(16.97)
24
(23.30)
14
(28.57)
28
(30.77)
123
(20.36)
구순염
건수
8
(11.11)
16
(12.90)
21
(12.73)
16
(15.53)
12
(24.49)
28
(30.77)
101
(16.72)
구갈(구강건조)
건수
2
(2.78)
7
(5.65)
10
(6.06)
8
(7.77)
3
(6.12)
8
(8.79)
38
(6.29)
설사
건수
0
(0.00)
0
(0.00)
0
(0.00)
1
(0.97)
0
(0.00)
0
(0.00)
1
(0.17)
속쓰림
건수
0
(0.00)
0
(0.00)
1
(0.61)
1
(0.97)
0
(0.00)
0
(0.00)
2
(0.33)
구역
건수
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
2
(2.20)
2
(0.33)
위장관장애(복통 포함)
건수
2
(2.78)
0
(0.00)
1
(0.61)
1
(0.97)
1
(2.04)
0
(0.00)
5
(0.83)
간 및 담도계
증례수
1
(1.39)
0
(0.00)
1
(0.61)
0
(0.00)
1
(2.04)
0
(0.00)
3
(0.50)
간효소치(ALT/AST)증가
건수
1
(1.39)
0
(0.00)
1
(0.61)
0
(0.00)
1
(2.04)
0
(0.00)
3
(0.50)
대사 및
영양이상
증례수
1
(1.39)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
3
(3.30)
4
(0.66)
과중성지방혈증
건수
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
2
(2.20)
2
(0.33)
과콜레스테롤혈증
건수
1
(1.39)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
2
(2.20)
3
(0.50)
전신이상
증례수
0
(0.00)
2
(1.61)
1
(0.61)
0
(0.00)
0
(0.00)
0
(0.00)
3
(0.50)
안면부종
건수
0
(0.00)
1
(0.81)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
1
(0.17)
피로
건수
0
(0.00)
0
(0.00)
1
(0.61)
0
(0.00)
0
(0.00)
0
(0.00)
1
(0.17)
흉부불편감
건수
0
(0.00)
1
(0.81)
0
(0.00)
0
(0.00)
0
(0.00)
0
(0.00)
1
(0.17)
합계
증례수
14
(19.44)
29
(23.39)
38
(23.03)
35
(33.98)
23
(46.94)
40
(43.96)
179
(29.64)
건수
22
(30.56)
51
(41.13)
57
(34.55)
54
(52.43)
35
(71.43)
72
(79.12)
291
(48.18)
5. 일반적 주의
6. 상호작용
7. 임부 및 수유부에 대한 투여
8. 소아에 대한 투여
9. 고령자에 대한 투여
10. 과량투여시의 처치
11. 보관 및 취급상의 주의사항
네오티가손캡슐10mg 성분·함량
1캡슐(130mg) 중 기준
| 성분 | 영문 | 분량 |
|---|---|---|
| 분무건조아시트레틴25% | Spray Dried Acitretin 25% | 40.0 밀리그램 |
네오티가손캡슐10mg 낱알 모양 (식별 표시)
- 모양
- 장방형 · 경질캡슐제, 산제
- 색
- 갈색 / 노랑
- 표시(앞/뒤)
- 10 / -
- 크기
- 14 × 4.8 mm, 두께 5mm
병용금기 — 함께 쓰면 안 되는 성분 (10)
이 약의 성분과 같이 처방·복용하면 안 되는 성분입니다(식약처 DUR 병용금기). 해당 성분이 든 약을 먹고 있다면 의사·약사에게 알리세요.
📍 네오티가손캡슐10mg 살 수 있는 내 주변 약국
전문의약품은 의사 처방전이 있어야 약국에서 받을 수 있습니다. 재고는 약국에 전화로 확인하세요.
🗺️ 지도에서 찾기🌐 해외(미국) 정보 — 분무건조아시트레틴25%
미국 FDA·NLM 자료 · 2026-10-06 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)
Acitretin Capsules, USP are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules, USP should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules, USP should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — Acitretin Capsules, USP can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.
⚠️ 박스 경고(가장 강한 경고)
영어 원문 (미국 FDA 라벨)
WARNINGS: Pregnancy Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. Acitretin also must not be used by females who may not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation of treatment. Acitretin is a metabolite of etretinate (TEGISON), and major human fetal abnormalities have been reported with the administration of acitretin and etretinate. Potentially, any fetus exposed can be affected. Clinical evidence has shown that concurrent ingestion of acitretin and ethanol has been associated with the formation of etretinate, which has a significantly longer elimination half-life than acitretin. Because the longer elimination half-life of etretinate would increase the duration of teratogenic potential for female patients, ethanol must not be ingested by female patients of childbearing potential either during treatment with acitretin or for 2 months after cessation of therapy. This allows for elimination of acitretin, thus removing the substrate for transesterification to etretinate. The mechanism of the metabolic process for conversion of acitretin to etretinate has not been fully defined. It is not known whether substances other than ethanol are associated with transesterification. Acitretin has been shown to be embryotoxic and/or teratogenic in rabbits, mice, and rats at oral doses of 0.6, 3, and …
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
Pregnancy: S ee boxed CONTRAINDICATIONS AND WARNINGS . Acitretin is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed WARNINGS: Hepatotoxicity , WARNINGS: Lipids and Possible Cardiovascular Effects , and PRECAUTIONS ). An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with acitretin is also contraindicated (see PRECAUTIONS: Drug Interactions ). Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see WARNINGS: Pseudotumor Cerebri ). Acitretin is contraindicated in cases of hypersensitivity (e.g., angioedema, urticaria) to the preparation (acitretin or excipients) or to other retinoids .
주요 경고·주의
영어 원문 (미국 FDA 라벨)
( See also boxed CONTRAINDICATIONS AND WARNINGS .) Hepatotoxicity: Of the 525 subjects treated in US clinical trials, 2 had clinical jaundice with elevated serum bilirubin and transaminases considered related to treatment with acitretin. Liver function test results in these subjects returned to normal after acitretin was discontinued. Two of the 1,289 subjects treated in European clinical trials developed biopsy-confirmed toxic hepatitis. A second biopsy in one of these subjects revealed nodule formation suggestive of cirrhosis. One subject in a Canadian clinical trial of 63 subjects developed a 3-fold increase of transaminases. A liver biopsy of this subject showed mild lobular disarray, multifocal hepatocyte loss, and mild triaditis of the portal tracts compatible with acute reversible hepatic injury. The subject’s transaminase levels returned to normal 2 months after acitretin was discontinued. The potential of therapy with acitretin to induce hepatotoxicity was prospectively evaluated using liver biopsies in an open-label trial of 128 subjects. Pretreatment and posttreatment biopsies were available for 87 subjects. A comparison of liver biopsy findings before and after therapy revealed 49 (58%) subjects showed no change, 21 (25%) improved, and 14 (17%) subjects had a worsening of their liver biopsy status. For 6 subjects, the classification changed from class 0 (no pathology) to class I (normal fatty infiltration; nuclear variability and portal inflammation; both mild); …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
Pregnancy:
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 4,849건 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 건선psoriasis1,184
- 2 약효 없음drug ineffective1,170
- 3 통증pain490
- 4 피로fatigue483
- 5 적응증 외 사용off label use476
- 6 오심nausea441
- 7 소양증pruritus441
- 8 두통headache372
- 9 SKIN EXFOLIATION372
- 10 폐렴pneumonia357
- 11 발열pyrexia347
- 12 권태감malaise345
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
- 200806769
- 허가 구분
- 신고 · 완제의약품
- 상태
- 정상
- 위탁 제조
- Cenexi
- 저장 방법
- 기밀용기, 습기를 피하여 25℃ 이하 보관
- 사용 기간
- 제조일로부터 36 개월
- 포장 단위
- 100캡슐(10캡슐/PTP X 10)
- ATC 코드
- D05BB02
- 보험 코드
- 643304780
- 표준코드
- 8806433047801, 8806433047818
- 최근 변경
- 2020.04.27
허가 변경 이력
- · 사용상주의사항변경(부작용포함), 2020-04-27
- · 사용상주의사항변경(부작용포함), 2019-06-13
- · 사용상주의사항변경(부작용포함), 2019-04-28
- · 사용상주의사항변경(부작용포함), 2015-12-30
- · 사용상주의사항변경(부작용포함), 2014-01-30
- · 용법용량변경, 2014-01-30
- · 효능효과변경, 2014-01-30
- · 성상변경, 2012-07-03
- · 성상변경, 2009-04-09
- · 사용상주의사항변경(부작용포함), 2008-06-20
원문: 식약처 의약품안전나라