독사조신메실산염

Doxazosin Mesylate

원료 코드 M252421 국내 제품 10개 (단일제 10 · 복합제 0) DUR 성분 D000088

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이 성분만 든 제품 (단일제 10)

광고

🌐 해외(미국) 정보 — 독사조신메실산염

미국 FDA·NLM 자료 · 2026-10-02 기준

이 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)

Doxazosin tablets are an alpha 1 adrenergic antagonist indicated for: Signs and symptoms of Benign Prostatic Hyperplasia (BPH) Treatment of HypertensionTreatment of Hypertension 1.1 Benign Prostatic Hyperplasia (BPH) Doxazosin tablets are indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension Doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is …

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

The use of doxazosin tablets is contraindicated in patients with a hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of its components. Hypersensitivity to doxazosin, other quinazolines, or any other ingredient in doxazosin tablets. ( 4 )

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Postural hypotension with or without syncope may occur. ( 5.1 ) Risk of Intraoperative Floppy Iris Syndrome during cataract surgery. ( 5.2 ) Screen for the presence of prostate cancer prior to treatment for BPH and at regular intervals afterwards. ( 5.3 ) 5.1 Postural Hypotension Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of doxazosin tablets. However, infrequently, symptomatic postural hypotension has also been reported later than a few hours after dosing. As with other alpha-blockers, there is a potential for syncope, especially after the initial dose or after an increase in dosage strength. Advise patient how to avoid symptoms resulting from postural hypotension and what measures to take should they develop. Concomitant administration of doxazosin tablets with a PDE-5 inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. 5.2 Cataract Surgery Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with alpha 1 blockers. This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. The patient’s surgeon should be prepared for …

임신·특수 환자

영어 원문 (미국 FDA 라벨)

Hepatic Impairment: Monitor for hypotension. ( 8.6 , 12.3 ) 8.1 Pregnancy Risk Summary The limited available data with doxazosin tablets in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. However, untreated hypertension during pregnancy can result in increased maternal risks [ see Clinical Considerations ]. In animal reproduction studies, no adverse developmental effects were observed when doxazosin was orally administered to pregnant rabbits and rats during the period of organogenesis at doses of up to 41 and 20 mg/kg, respectively (exposures in rabbits and rats were 10 and 4 times, respectively, the human AUC exposures with a 12 …

미국 제품명 Cardura XL

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 35,890건 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. 1 호흡 곤란dyspnoea1,985
  2. 2 어지러움dizziness1,737
  3. 3 피로fatigue1,723
  4. 4 설사diarrhoea1,681
  5. 5 약효 없음drug ineffective1,606
  6. 6 오심nausea1,480
  7. 7 저혈압hypotension1,309
  8. 8 쇠약asthenia1,268
  9. 9 급성 신장 손상acute kidney injury1,258
  10. 10 두통headache1,251
  11. 11 고혈압hypertension1,153
  12. 12 약물 상호작용drug interaction1,124

미국 리콜 기록

FDA 리콜(회수) 기록 8건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.

  • 2026.02.18 · 3등급(경미) · Unichem Pharmaceuticals USA Inc. Tablets/Capsules Imprinted with Wrong ID
  • 2025.01.22 · 2등급 · Viatris Inc Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
  • 2025.01.22 · 2등급 · Viatris Inc Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
  • 2023.05.03 · 2등급 · Northwind Pharmaceuticals LLC CGMP Deviations
  • 2023.03.08 · 2등급 · Accord Healthcare, Inc. CGMP Deviations: recalling drug products following an FDA inspection.

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 취소·취하된 제품 1개 한올독사조신메실산염정2밀리그램 한올바이오파마(주)· 혈압강하제· 2002년 허가 유효기간만료