{ "id": "amiodarone-cordarone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-26", "status": "published_traceable_archive" }, "names": { "brand": "CORDARONE", "generic": "胺碘酮", "aliases": [ "Cordarone", "胺碘酮", "盐酸胺碘酮", "amiodarone", "amiodarone hydrochloride", "CORDARONE" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 2018-10 患者用药指南与 FDA 2016 补充批准记录。均为有日期的公开历史资料；不代表中国大陆、欧盟、日本或其他市场的现行标签、供应或可替代性。", "dosageFormClass": "盐酸胺碘酮口服片：200 mg（美国历史公开资料所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1985（美国初始批准；仅定位美国历史资料）", "archiveSponsorText": "Wyeth Pharmaceuticals LLC（2018 DailyMed 文件所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cordarone-amiodarone-hydrochloride-tablet-200mg-historical-source-text", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史患者用药指南（2018-10 修订）", "en": "U.S. DailyMed historical Medication Guide (revised Oct 2018)" }, "dosageForm": { "zh": "CORDARONE 盐酸胺碘酮口服片（美国历史文件）", "en": "CORDARONE amiodarone hydrochloride oral tablet (historical U.S. document)" }, "route": { "zh": "口服（历史文件产品身份字段）", "en": "oral (historical-document product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "Historical U.S. document — no exact package panel established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸胺碘酮 200 mg（美国历史文件的文字身份；未建立包装面板）", "en": "Amiodarone hydrochloride 200 mg per tablet (historical U.S. document text identity; no exact package panel established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸胺碘酮（每片）", "en": "amiodarone hydrochloride (per tablet)" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史文件标示量；不是个人片数、频率、分片或换药指令", "en": "Labelled amount per tablet in the historical document; not an individual's tablet count, frequency, splitting or switching instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_label_record_only", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_2501cc572e4e60db", "label": "DailyMed（NLM）：CORDARONE 胺碘酮美国患者用药指南（Wyeth/Pfizer；2018-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验有日期的历史美国文件，但未保留可一一对应的官方原品牌包装图，故不展示包装图片", "en": "Dated U.S. historical documents were reviewed, but no one-to-one official original-brand package image was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 CORDARONE、胺碘酮、口服片、200 mg、2018 年美国患者用药指南以及 FDA 历史批准资料。此次未保留可同时对应这一历史品牌、单一规格、单一包装和可公开展示的官方图片；为避免把零售图、再包装图、版本不明图、其他市场图片或另一种胺碘酮产品误作准确 CORDARONE 外观，页面不展示包装图片，只保留有日期的一手文件供放大阅读。", "en": "This dossier retains CORDARONE, amiodarone, oral tablets, 200 mg, the 2018 U.S. Medication Guide and FDA historical approval material. No official image was retained that can be matched at once to this dated brand, one strength and one package and safely displayed; to avoid treating a retail image, repackaged image, version-uncertain image, another-market image or another amiodarone product as the exact CORDARONE appearance, the page withholds package imagery and retains dated primary documents for enlarged reading." }, "source": { "id": "src_2501cc572e4e60db", "label": "DailyMed（NLM）：CORDARONE 胺碘酮美国患者用药指南（Wyeth/Pfizer；2018-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CORDARONE 说明书放大阅读：先把 200 mg 看成历史口服片身份，而不是个人片数", "en": "CORDARONE label reading: read 200 mg as a dated oral-tablet identity, not a personal tablet count" }, "summary": { "zh": "本模块使用美国 DailyMed 2018 年 CORDARONE 患者用药指南，帮助读者把品牌、胺碘酮、口服片、200 mg、文件日期和美国市场资料放在一起阅读。它不为任何人计算剂量，不给出开始、停止、漏服补用、分片、错开时间或与其他心律药同用的决定。", "en": "This module uses the 2018 U.S. DailyMed CORDARONE Medication Guide to read the brand, amiodarone, oral tablet, 200 mg, document date and U.S. record together. It does not calculate a dose or decide starting, stopping, missed-use handling, splitting, timing separation or co-use with another rhythm medicine for anyone." }, "checks": [ { "zh": "200 mg 是该美国历史文件中口服片的标示强度；它不是“每天几片”、两片能否相加、能否对半、漏服后如何补用或与另一种胺碘酮产品换算的公式。", "en": "200 mg is the labelled strength of the oral tablet in this dated U.S. document; it is not a formula for ‘how many per day’, adding tablets, halving, missed-use handling or converting to another amiodarone product." }, { "zh": "该患者用药指南把肺部、肝脏和心律相关严重问题列为需要专业监测的内容，并提示药物可能在停用后数月仍留在体内。这些信息说明为什么不能依据网页自行突然停药、恢复旧方案或改变时间表。", "en": "The Medication Guide identifies serious lung, liver and rhythm-related concerns requiring professional monitoring and notes that the medicine may remain in the body for months after stopping. This explains why a webpage cannot support suddenly stopping, restarting an old plan or changing a schedule." }, { "zh": "文件还要求把全部处方药、非处方药、维生素和草本补充剂告知专业人员。看到两个产品都与心律、心脏或血压有关，并不建立同日叠加、隔天轮换、替代或安全间隔的结论。", "en": "The document also asks people to disclose all prescription medicines, OTC products, vitamins and herbal supplements. Two products both relating to rhythm, heart or blood pressure do not establish same-day co-use, alternate-day use, substitution or a safe interval." }, { "zh": "本页所列文件已过其修订日期；若手上药盒来自中国大陆或其他市场，或药袋、说明书与本页不同，应带准确药盒与现行处方标签向发药药师或开方团队核对，而不是以历史美国资料替代。", "en": "The documents listed here are dated. If the pack is from mainland China or another market, or its dispensing label or leaflet differs from this page, take the exact pack and current prescription label to the dispensing pharmacist or prescribing team rather than substituting a dated U.S. document." } ], "source": { "id": "src_2501cc572e4e60db", "label": "DailyMed（NLM）：CORDARONE 胺碘酮美国患者用药指南（Wyeth/Pfizer；2018-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "胺碘酮怎样起作用：药理分类帮助理解，不能用来安排个人心律用药", "en": "How amiodarone works: pharmacology helps explain a class, not arrange an individual rhythm-medicine plan" }, "summary": { "zh": "FDA 的历史 CORDARONE 资料将其描述为以 III 类作用为主的抗心律失常药，并说明它可延长心肌细胞动作电位与不应期。这里解释的是公开资料中的药理路径，不预测个人心律、是否适用、剂量、监测、联用或换药方案。", "en": "Historical FDA CORDARONE material describes it as an antiarrhythmic with predominantly Class III effects and explains that it can prolong myocardial action-potential duration and refractoriness. This is a public pharmacology pathway, not a prediction of an individual's rhythm, suitability, dose, monitoring, co-use or switching plan." }, "checks": [ { "zh": "“III 类抗心律失常药”是帮助理解文件的类别词，不是“心律不齐就能吃”或“同类药可以互换”的结论。病因、心电图、其他药物、肝肺甲状腺相关情况和准确标签都必须由专业人员共同评估。", "en": "‘Class III antiarrhythmic’ is a category term for reading the document, not a conclusion that it is suitable for an arrhythmia or interchangeable with another class member. Cause, ECG findings, other medicines, lung/liver/thyroid context and the exact label require professional assessment together." }, { "zh": "即使两个药都影响心律、心率或传导，也不能从机制文字推导出同服、隔天轮换、谁先停或按 mg 换算。请把所有实际药盒、药袋标签、非处方药和补充剂一起带去核对。", "en": "Even if two medicines affect rhythm, heart rate or conduction, mechanism text cannot determine co-use, alternate-day use, which one to stop first or milligram conversion. Take all actual packs, dispensing labels, OTC products and supplements together for review." }, { "zh": "出现昏厥、胸部不适、明显心悸、呼吸困难、严重头晕或其他急性担忧时，应使用当地紧急和医疗渠道；不要等待本页或根据机制说明自行改变药物。", "en": "With fainting, chest discomfort, marked palpitations, breathing difficulty, severe dizziness or another acute concern, use local urgent and medical care pathways rather than waiting for this page or self-changing a medicine from a mechanism explanation." } ], "source": { "id": "src_ee829b42b80b1fae", "label": "FDA：CORDARONE（胺碘酮）美国历史处方信息（2004-10；药理机制）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018972s030_Cordarone_prntlbl.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CORDARONE", "generic": "胺碘酮", "dosageFormClass": "盐酸胺碘酮口服片：200 mg（美国历史公开资料所列）" }, "labelSource": { "id": "src_2501cc572e4e60db", "label": "DailyMed（NLM）：CORDARONE 胺碘酮美国患者用药指南（Wyeth/Pfizer；2018-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "productRoutes": [ { "source": { "id": "src_2501cc572e4e60db", "label": "DailyMed（NLM）：CORDARONE 胺碘酮美国患者用药指南（Wyeth/Pfizer；2018-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "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": "2026-08-26", "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_15c3689b51c7b02f", "label": "FDA：CORDARONE 胺碘酮 200 mg 补充批准函（NDA 018972/S-051；2016-04）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018972Orig1s051ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "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": "2026-08-26", "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_9659163bae20721f", "label": "FDA：Cordarone／amiodarone HCl 孤儿药指定与营销批准记录", "url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=77293", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "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": "2026-08-26", "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": "2026-08-26", "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": "本页将 CORDARONE、胺碘酮、口服片、200 mg 与美国有日期的公开文件放在一起，帮助先识别手中资料所对应的历史产品记录。它不把历史资料当作任何市场的当前说明书，也不把 mg、刻痕、同类心律药或网页文字转写为个人的片数、漏服补用、分片、联用、停用或换药方案。", "history": "FDA 的公开孤儿药记录列示 Cordarone（amiodarone HCl）于 1995 年获得所述美国营销批准；DailyMed 的 CORDARONE 患者用药指南修订于 2018 年。两者只能定位历史美国文件。实际药盒、批准状态、持有人、包装、规格与现行用法必须在使用地按当前官方记录另行核对。", "sourceDocuments": [ { "id": "src_2501cc572e4e60db", "label": "DailyMed（NLM）：CORDARONE 胺碘酮美国患者用药指南（Wyeth/Pfizer；2018-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, { "id": "src_15c3689b51c7b02f", "label": "FDA：CORDARONE 胺碘酮 200 mg 补充批准函（NDA 018972/S-051；2016-04）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018972Orig1s051ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, { "id": "src_9659163bae20721f", "label": "FDA：Cordarone／amiodarone HCl 孤儿药指定与营销批准记录", "url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=77293", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } ], "applicationNumber": "NDA 018972（CORDARONE 胺碘酮 200 mg；FDA 有日期历史批准记录）", "approvalTimeline": [ { "date": "1985", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1985。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1985. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_2501cc572e4e60db", "label": "DailyMed: CORDARONE amiodarone U.S. Medication Guide (revised 2018-10)", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, { "date": "2018-10 dated DailyMed Medication Guide", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2018-10 dated DailyMed Medication Guide 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2018-10 dated DailyMed Medication Guide FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_2501cc572e4e60db", "label": "DailyMed: CORDARONE amiodarone U.S. Medication Guide (revised 2018-10)", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [ { "target": { "id": "coumadin", "brand": "Coumadin", "generic": "华法林钠", "canonicalUrls": { "zh": "https://origindrug.com/drugs/coumadin/", "en": "https://origindrug.com/en/drugs/coumadin/" } }, "title": { "zh": "与 COUMADIN／华法林同在药单上时：这是需要专业监测的高风险核对项", "en": "When COUMADIN / warfarin is on the same list: this is a high-risk professional-monitoring check" }, "summary": { "zh": "当前美国胺碘酮通用名标签明确列出与华法林的相互作用，并提示胺碘酮停用后相互作用仍可能持续数周至数月。本卡片只提示尽快把两种实际药盒、当前说明书、监测记录和完整药单交给开方团队、药师或抗凝管理团队核对；它不判断能否同用，不提供 INR 目标、剂量、给药间隔或停换药方案，也不建议自行停用、错开时间、替换或调整任何一种药。CORDARONE 本页是历史品牌档案，所引当前通用名标签不能证明该品牌当前供应或市场状态。", "en": "A current U.S. generic amiodarone label identifies an interaction with warfarin and notes that interactions can persist for weeks to months after amiodarone is stopped. This card only signals that both actual packs, current labels, monitoring records and the complete medicine list need prompt review by the prescribing team, pharmacist or anticoagulation service; it does not decide co-use, provide an INR target, dose, timing interval or stop/switch plan, or advise self-stopping, time-separation, replacement or adjustment of either medicine. This CORDARONE page is a historical brand archive; the cited current generic label does not establish current brand supply or market status." }, "source": { "id": "src_115d36855c37f0e1", "label": "DailyMed（NLM）：胺碘酮当前美国通用名标签（华法林相互作用；仅作成分层核对，不代表 CORDARONE 当前市场状态）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=28cd0224-3569-4308-bd40-480bc4230503&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "lanoxin", "brand": "Lanoxin", "generic": "地高辛", "canonicalUrls": { "zh": "https://origindrug.com/drugs/lanoxin/", "en": "https://origindrug.com/en/drugs/lanoxin/" } }, "title": { "zh": "与 LANOXIN／地高辛同在药单上时：地高辛浓度与心率／传导都要专业核对", "en": "When LANOXIN / digoxin is on the same list: digoxin concentration and rate/conduction need professional review" }, "summary": { "zh": "当前美国胺碘酮通用名标签说明胺碘酮可升高地高辛浓度，并把地高辛列为可能增强心动过缓、窦性停搏和房室传导阻滞风险线索的负性变时药；当前 LANOXIN 片剂标签还说明地高辛的中毒浓度只略高于治疗浓度，年龄、体重、肾功能和联用药都需要纳入专业判断。本卡只要求尽快把两种实际药盒、完整药单、近期肾功能／电解质、心率或心电记录及既有地高辛监测结果交给开方团队或药师核对；它不判断能否同用，不提供浓度目标、减量比例、给药间隔、停药或换药方案，也不建议自行错开、掰片、漏服补用或调整任何一种药。CORDARONE 页面属于历史品牌档案；当前通用名标签不证明该品牌当前供应。", "en": "A current U.S. generic amiodarone label says amiodarone can increase digoxin concentration and lists digoxin as a negative chronotrope that can add to bradycardia, sinus arrest and AV block. The current U.S. LANOXIN tablet label also says toxic digoxin concentrations are only slightly higher than therapeutic concentrations, and that age, body weight, renal function and concomitant medicines matter in professional decisions. This card only calls for prompt review of both actual packs, the complete medicine list, recent kidney-function/electrolyte information, heart-rate or ECG records and any existing digoxin-monitoring results by the prescribing team or pharmacist. It does not decide co-use or provide a concentration target, reduction percentage, timing interval, stop or switch plan, and does not advise self-separation, tablet splitting, catch-up use or adjustment of either medicine. The CORDARONE page is a historical brand archive; a current generic label does not establish current brand supply." }, "source": { "id": "src_115d36855c37f0e1", "label": "DailyMed（NLM）：胺碘酮当前美国通用名标签（地高辛浓度与心率／传导相互作用；不代表 CORDARONE 当前供应）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=28cd0224-3569-4308-bd40-480bc4230503&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/amiodarone-cordarone/", "en": "https://origindrug.com/en/drugs/amiodarone-cordarone/" }, "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." ] }