클로니딘염산염
Clonidine Hydrochloride
원료 코드 M223200 국내 제품 1개 (단일제 1 · 복합제 0) DUR 성분 D000055
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이 성분만 든 제품 (단일제 1)
병용금기 성분 (1)
아래 성분이 든 약과 함께 쓰면 안 됩니다 (식약처 DUR).
| 상대 성분 | 이유 |
|---|---|
| 세리티닙 | - 심장 박동수와 혈압을 정기적으로 모니터링할 것 |
🌐 해외(미국) 정보 — 클로니딘염산염
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).
미국에서 쓰이는 곳(적응증)
영어 원문 (미국 FDA 라벨)
Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
Clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS ).
주요 경고·주의
영어 원문 (미국 FDA 라벨)
Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
Pregnancy Teratogenic Effects Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as 1/3 the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in …
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 57,116건 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 ineffective4,430
- 2 피로fatigue3,518
- 3 통증pain3,514
- 4 오심nausea3,475
- 5 두통headache3,431
- 6 적응증 외 사용off label use3,431
- 7 고혈압hypertension3,273
- 8 호흡 곤란dyspnoea2,748
- 9 설사diarrhoea2,666
- 10 구토vomiting2,468
- 11 어지러움dizziness2,292
- 12 만성 신장병chronic kidney disease2,238
미국 리콜 기록
FDA 리콜(회수) 기록 11건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.
- 2026.04.15 · 2등급 · Teva Pharmaceuticals USA, Inc CGMP Deviations: use of an unapproved raw material
- 2026.04.15 · 2등급 · Teva Pharmaceuticals USA, Inc CGMP Deviations: use of an unapproved raw material
- 2026.04.15 · 2등급 · Teva Pharmaceuticals USA, Inc CGMP Deviations: use of an unapproved raw material
- 2022.09.28 · 3등급(경미) · UNICHEM PHARMACEUTICALS USA INC Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
- 2022.06.29 · 2등급 · Mayne Pharma Inc Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
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.