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100, 500 and 1000 Tablets are bottle counts. The current label describes these tablets as unscored, so arithmetic or appearance cannot create permission to split. The site also does not turn professional dose-adjustment text into an individual's frequency, tablet count, titration or missed-dose plan." }, "checks": [ { "zh": "头晕、站起时眼前发黑、明显乏力、心悸或晕厥可能伴随血压过低；老人、跌倒风险高或同时使用其他降压药者应及时核对完整药单。严重晕厥、受伤或意识异常应使用当地急救。", "en": "Dizziness, darkening vision on standing, marked weakness, palpitations or syncope may accompany low blood pressure. Older adults, people at higher fall risk or those using other antihypertensives require timely review of the complete medicine list. Severe syncope, injury or altered awareness needs local emergency care." }, { "zh": "肼屈嗪可引起心肌刺激、心动过速和心绞痛；说明书指出其与心肌缺血有关并曾被牵涉于心肌梗死。新发或加重胸痛、明显气促、冷汗或放射痛不能等待网页，应立即使用当地急救渠道。", "en": "Hydralazine can cause myocardial stimulation, tachycardia and angina; the label links it to myocardial ischaemia and notes implication in myocardial infarction. New or worsening chest pain, marked breathlessness, cold sweat or radiating pain must not wait for a webpage and requires local emergency care." }, { "zh": "长期治疗可能出现类似系统性红斑狼疮的表现，包括肾小球肾炎。关节痛、发热、胸痛、明显不适、皮疹或尿液/肾脏异常应联系治疗团队；说明书所述定期全血细胞计数和抗核抗体检查由负责团队安排，网页不自行开检查。", "en": "Longer treatment can cause a syndrome resembling systemic lupus erythematosus, including glomerulonephritis. Joint pain, fever, chest pain, marked malaise, rash or urinary/kidney changes need treating-team review. Periodic complete blood count and antinuclear antibody testing described by the label belongs to the responsible team; the site does not order tests." }, { "zh": "麻木、刺痛或灼痛可能提示周围神经炎；标签还列出血红蛋白和红细胞减少、白细胞减少、粒细胞缺乏或紫癜等血液异常。出现进行性神经症状、发热咽痛、异常出血或瘀斑应及时就医。", "en": "Numbness, tingling or burning can suggest peripheral neuritis. The label also lists reduced haemoglobin/red cells, leucopenia, agranulocytosis or purpura. Progressive neurological symptoms, fever/sore throat, unusual bleeding or bruising needs prompt medical review." }, { "zh": "应把全部降压药、利尿剂、β 受体阻滞剂、硝酸酯、BIDIL、PDE-5 抑制剂以及单胺氧化酶抑制剂等完整药单交给医生或药师核对。不要自行叠加、错开、停掉一盒或按一次血压读数改变用法。", "en": "Give the doctor or pharmacist the complete list, including other antihypertensives, diuretics, beta blockers, nitrates, BIDIL, PDE-5 inhibitors and monoamine oxidase inhibitors. Do not self-combine, space, remove a pack or change use from one blood-pressure reading." } ], "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "肼屈嗪怎样影响血压：直接放松血管平滑肌，但身体会出现反射性反应", "en": "How hydralazine affects blood pressure: direct vascular smooth-muscle relaxation with reflex responses" }, "summary": { "zh": "当前标签说明肼屈嗪直接作用于血管平滑肌，使外周血管舒张并降低外周阻力；同时可能增加心率、心输出量、肾素和醛固酮。完整分子机制并未因此被简化成一个开关，也不能从机制预测个人血压、脉搏、疗效或风险。", "en": "The current label says hydralazine acts directly on vascular smooth muscle, producing peripheral vasodilation and reduced peripheral resistance. Heart rate, cardiac output, renin and aldosterone may also increase. This does not reduce the full molecular mechanism to one switch or predict an individual's pressure, pulse, benefit or risk." }, "checks": [ { "zh": "“扩张血管”不代表可与硝酸异山梨酯、BIDIL、硝酸甘油、钙通道阻滞剂或其他降压药按 mg 自行拼接；共同降压用途可能叠加低血压、心率和跌倒风险。", "en": "Vasodilation does not permit self-assembling hydralazine with isosorbide dinitrate, BIDIL, nitroglycerin, a calcium-channel blocker or another antihypertensive by milligrams. A shared blood-pressure role may add hypotension, heart-rate and fall risks." }, { "zh": "肼屈嗪存在乙酰化多态性，慢乙酰化者可能有较高药物水平；这解释部分个体差异，但不是网页默认推荐全基因组筛查、基因分型或自行调药的理由。", "en": "Hydralazine has polymorphic acetylation, and slow acetylators may have higher drug levels. This explains some variability but is not a default reason for the site to recommend whole-genome screening, genotype testing or self-adjustment." }, { "zh": "同样的每片 mg 在疾病、年龄、肝肾状况、血压、脉搏和并用药不同的人身上意义不同。网页只帮助识别准确产品与说明书边界，不计算个人目标血压、等效剂量或递增速度。", "en": "The same per-tablet milligram figure has different context across disease, age, liver/kidney status, pressure, pulse and co-medication. The site identifies the exact product and label boundary and does not calculate an individual target pressure, equivalent dose or titration speed." } ], "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "APRESOLINE / hydralazine", "generic": "盐酸肼屈嗪普通片", "dosageFormClass": "盐酸肼屈嗪普通口服片；不并入本页口服片身份的产品包括 20 mg/mL 注射剂、BIDIL 硝酸异山梨酯/盐酸肼屈嗪固定复方及其他降压药。APRESOLINE 历史原研与当前通用药也必须分开；共同成分、用途或 mg 数字不建立换算、片数、频次、递增、分片或替换结论。" }, "labelSource": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_58616678e6f146bc", "label": "FDA Drugs@FDA：APRESOLINE／hydralazine hydrochloride NDA 008303 的 1953 年初始批准、四个口服片历史 RLD 与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=008303", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_57c7bee7f33ae3fb", "label": "FDA：APRESOLINE（hydralazine hydrochloride）NDA 008303 历史口服片标签（1996 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/008303s068lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "APRESOLINE 是盐酸肼屈嗪普通片的美国历史原研/RLD；本页可见包装是当前通用药，不是原品牌。10/25/50/100 mg 是每片含量，100/500/1000 Tablets 是整瓶片数。说明书重点涉及血压过低、眩晕/晕厥与跌倒、心跳加快和心绞痛/胸痛、狼疮样综合征、麻木刺痛及血细胞变化。网页不生成个人频次、片数、递增计划或停换药指令。", "history": "FDA 记录 APRESOLINE 于 1953 年在美国初始批准。当前四个口服历史 RLD 规格均为 DISCN，且不是因安全性或有效性撤回。DailyMed 当前页面则展示 ANDA 200770 的十二个通用药瓶装身份。APRESOLINE 20 mg/mL 注射剂与口服片是不同剂型，BIDIL 还含硝酸异山梨酯，均不得借共同成分混入本页口服片身份。", "sourceDocuments": [ { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_58616678e6f146bc", "label": "FDA Drugs@FDA：APRESOLINE／hydralazine hydrochloride NDA 008303 的 1953 年初始批准、四个口服片历史 RLD 与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=008303", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_57c7bee7f33ae3fb", "label": "FDA：APRESOLINE（hydralazine hydrochloride）NDA 008303 历史口服片标签（1996 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/008303s068lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "APRESOLINE NDA 008303（历史原研/RLD）；hydralazine hydrochloride ANDA 200770（当前通用药标签）", "approvalTimeline": [ { "date": "1953-01-15", "title": { "zh": "APRESOLINE 在美国初始批准", "en": "Initial U.S. approval of APRESOLINE" }, "detail": { "zh": "FDA Drugs@FDA 将 NDA 008303 记录为 1953 年初始批准的优先审评新分子实体。", "en": "FDA Drugs@FDA records NDA 008303 as a priority-reviewed new molecular entity initially approved in 1953." }, "source": { "id": "src_58616678e6f146bc", "label": "FDA Drugs@FDA：APRESOLINE／hydralazine hydrochloride NDA 008303 的 1953 年初始批准、四个口服片历史 RLD 与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=008303", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "1996", "title": { "zh": "FDA 历史口服片标签版本", "en": "Historical FDA oral-tablet label version" }, "detail": { "zh": "FDA 公开保存 NDA 008303 的 1996 年 APRESOLINE 口服片标签；它用于历史追溯，不冒充当前品牌供应。", "en": "FDA publicly preserves a 1996 APRESOLINE oral-tablet label under NDA 008303. It supports history and is not presented as current brand supply." }, "source": { "id": "src_57c7bee7f33ae3fb", "label": "FDA：APRESOLINE（hydralazine hydrochloride）NDA 008303 历史口服片标签（1996 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/008303s068lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-09-02", "title": { "zh": "当前原研状态与通用药包装核验", "en": "Current originator status and generic-pack verification" }, "detail": { "zh": "四个 APRESOLINE 口服 RLD 规格均为 DISCN 且非因安全性或有效性撤回；ANDA 200770 当前标签列出十二个通用药瓶装 NDC。", "en": "All four APRESOLINE oral RLD strengths are DISCN and not withdrawn for safety or effectiveness. The current ANDA 200770 label lists twelve generic bottle NDCs." }, "source": { "id": "src_58616678e6f146bc", "label": "FDA Drugs@FDA：APRESOLINE／hydralazine hydrochloride NDA 008303 的 1953 年初始批准、四个口服片历史 RLD 与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=008303", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 APRESOLINE 口服片", "en": "United States — APRESOLINE oral tablets" }, "status": { "zh": "历史原研/RLD，已停市", "en": "Historical originator/RLD; discontinued" }, "detail": { "zh": "NDA 008303；10、25、50、100 mg 当前均为 DISCN，且并非因安全性或有效性撤回。", "en": "NDA 008303; the 10, 25, 50 and 100 mg rows are DISCN and not withdrawn for safety or effectiveness." } }, { "market": { "zh": "美国当前通用药", "en": "United States — current generic" }, "status": { "zh": "当前公开通用药标签", "en": "Current public generic label" }, "detail": { "zh": "ANDA 200770；10、25、50、100 mg，各有 100、500、1000 片瓶装。", "en": "ANDA 200770; 10, 25, 50 and 100 mg, each in 100-, 500- and 1000-tablet bottles." } }, { "market": { "zh": "注射剂与 BIDIL", "en": "Injection and BIDIL" }, "status": { "zh": "不同剂型或固定复方", "en": "Separate dosage form or fixed combination" }, "detail": { "zh": "APRESOLINE 20 mg/mL 注射剂不是口服片；BIDIL 另含硝酸异山梨酯，不能按共同肼屈嗪成分并入本档案包装。", "en": "APRESOLINE 20 mg/mL injection is not an oral tablet. BIDIL additionally contains isosorbide dinitrate and cannot be merged into these packs from a shared hydralazine ingredient." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地品牌、规格、包装或供应", "en": "Local brand, strength, pack and supply are not established" }, "detail": { "zh": "必须按当地药监记录、现行说明书和手中药盒逐项核对。", "en": "Check the local regulator, current label and pack in hand item by item." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "照片里的是 APRESOLINE 原研药瓶吗？", "en": "Is the pictured bottle the original APRESOLINE product?" }, "answer": { "zh": "不是。图片是 Strides ANDA 200770 当前通用药包装面板；APRESOLINE 只作为历史原研/RLD 身份展示，本页没有把通用药图片冒充原品牌。", "en": "No. The image is a current Strides generic package panel under ANDA 200770. APRESOLINE is shown only as the historical originator/RLD identity, and no generic image is presented as the original brand." } }, { "question": { "zh": "1000 Tablets 是一次要吃 1000 片吗？", "en": "Does 1000 Tablets mean taking 1000 tablets at once?" }, "answer": { "zh": "不是。1000 Tablets 是整瓶片数；10/25/50/100 mg 才是每片标签含量。网页不根据瓶数或 mg 生成个人片数、频次或递增方案。", "en": "No. 1000 Tablets is the bottle count; 10/25/50/100 mg is the labelled amount per tablet. The site does not use a bottle count or milligrams to generate an individual tablet count, frequency or titration plan." } }, { "question": { "zh": "100 mg 可以掰成两片 50 mg 吗？", "en": "Can a 100 mg tablet be split into two 50 mg halves?" }, "answer": { "zh": "不能由算术自行决定。当前标签描述这些片剂无刻痕，100 mg 与 50 mg 还是不同准确产品；分片必须核对具体处方、厂家现行标签和药师意见。", "en": "Not from arithmetic alone. The current label describes these tablets as unscored, and 100 mg and 50 mg remain separate exact products. Splitting requires the exact prescription, current manufacturer label and pharmacist review." } }, { "question": { "zh": "APRESOLINE、BIDIL 和 ISORDIL 是同一种药吗？", "en": "Are APRESOLINE, BIDIL and ISORDIL the same medicine?" }, "answer": { "zh": "不是。APRESOLINE 是肼屈嗪历史品牌；BIDIL 是硝酸异山梨酯/盐酸肼屈嗪固定复方；ISORDIL 是硝酸异山梨酯产品。共同心血管用途不建立替换或叠加许可。", "en": "No. APRESOLINE is the historical hydralazine brand; BIDIL is a fixed isosorbide dinitrate/hydralazine hydrochloride combination; ISORDIL is an isosorbide dinitrate product. A shared cardiovascular role does not permit substitution or combination." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/apresoline-hydralazine/", "en": "https://origindrug.com/en/drugs/apresoline-hydralazine/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }