아미트리프틸린염산염
Amitriptyline Hydrochloride
원료 코드 M223101 국내 제품 5개 (단일제 5 · 복합제 0) DUR 성분 D000809
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이 성분만 든 제품 (단일제 5)
에나폰정5밀리그램(아미트리프틸린염산염) 환인제약(주)· 정신신경용제· 5.00밀리그램· 2013년 허가 전문
명인아미트리프틸린염산염정10밀리그램 명인제약(주)· 정신신경용제· 10밀리그램· 1985년 허가 전문
에트라빌10밀리그램정(아미트리프틸린염산염) 동화약품(주)· 정신신경용제· 10.0밀리그램· 1975년 허가 전문
에트라빌25밀리그램정(아미트리프틸린염산염) 동화약품(주)· 정신신경용제· 25.0밀리그램· 1975년 허가 전문 에나폰정10밀리그램(아미트리프틸린염산염) 환인제약(주)· 정신신경용제· 10.00밀리그램· 1970년 허가 전문광고
병용금기 성분 (6)
아래 성분이 든 약과 함께 쓰면 안 됩니다 (식약처 DUR).
🌐 해외(미국) 정보 — 아미트리프틸린염산염
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).
미국에서 쓰이는 곳(적응증)
영어 원문 (미국 FDA 라벨)
For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
⚠️ 박스 경고(가장 강한 경고)
영어 원문 (미국 FDA 라벨)
Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of amitriptyline hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Amitriptyline hydrochloride tablets are not approved for use in pediatric patients [see WARNINGS: Clinical Worsening and Suicide Risk , PRECAUTIONS: Information for Patients and PRECAUTIONS: Pediatric Use ].
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
Amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. Amitriptyline hydrochloride should not be given with cisapride due to the potential for increased QT interval and increased risk for arrhythmia. This drug is not recommended for use during the acute recovery phase following myocardial infarction.
주요 경고·주의
영어 원문 (미국 FDA 라벨)
Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
Usage in Pregnancy Teratogenic effects were not observed in mice, rats, or rabbits when amitriptyline was given orally at doses of 2 to 40 mg/kg/day (up to 13 times the maximum recommended human dose Based on a maximum recommended amitriptyline dose of 150 mg/day or 3 mg/kg/day for a 50 kg patient. ). Studies in the literature have shown amitriptyline to be teratogenic in mice and hamsters when given by various routes of administration at doses of 28 to 100 mg/kg/day (9 to 33 times the maximum recommended human dose), producing multiple malformations. Another study in the rat reported that an oral dose of 25 mg/kg/day (8 times the maximum recommended human dose) produced delays in …
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 17,466건 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 통증pain1,657
- 2 오심nausea1,535
- 3 두통headache1,476
- 4 피로fatigue1,449
- 5 호흡 곤란dyspnoea1,441
- 6 어지러움dizziness1,224
- 7 설사diarrhoea1,184
- 8 권태감malaise1,100
- 9 구토vomiting1,063
- 10 낙상fall1,053
- 11 적응증 외 사용off label use1,051
- 12 관절통arthralgia995
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FDA 리콜(회수) 기록 1건 중 최근 1건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.
- 2017.07.12 · 3등급(경미) · Sandoz Incorporated Cross Contamination With Other Product: Imipramine
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.
