{ "id": "imdur-isosorbide-mononitrate", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "IMDUR", "generic": "单硝酸异山梨酯", "aliases": [ "Imdur", "isosorbide mononitrate", "isosorbide mononitrate extended release", "单硝酸异山梨酯", "单硝酸异山梨酯缓释片", "依姆多", "NDA 020225", "PL 46500/0002" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 FDA Orange Book：IMDUR 30 mg、60 mg、120 mg 均为 NDA 020225 历史 RLD、当前 DISCN，且并非因安全性或有效性撤回；英国 eMC：Imdur 60 mg 缓释片保留当前产品资料。英国产品说明不能自动替代美国历史标签或其他市场包装。", "dosageFormClass": "缓释口服片。英国准确 60 mg Durules 产品资料说明不得咀嚼或压碎、整片吞服，并另列该准确片可分割；这不能泛化为美国历史 30/60/120 mg 或其他厂牌均可掰片。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1987（英国首次授权）；1993（美国 30/60 mg）", "archiveSponsorText": "美国历史 NDA：Schering-Plough；英国当前产品资料：TopRidge Pharma" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "IMDUR", "Imdur isosorbide mononitrate", "单硝酸异山梨酯缓释片", "依姆多" ], "excludedProductCues": [ "MONOKET", "isosorbide mononitrate immediate release", "nitroglycerin", "glyceryl trinitrate", "硝酸甘油", "isosorbide dinitrate", "二硝酸异山梨酯" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-imdur-isosorbide-mononitrate-30mg-er-nda-020225-product-001", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（1993-08-12）", "en": "Historical product identity in the current FDA Orange Book dataset (1993-08-12)" }, "dosageForm": { "zh": "IMDUR 单硝酸异山梨酯 30 mg 口服缓释片（美国历史 RLD）", "en": "IMDUR isosorbide mononitrate 30 mg oral extended-release tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020225 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片单硝酸异山梨酯 30 mg；历史 RLD 当前 DISCN", "en": "Isosorbide mononitrate 30 mg per tablet; historical RLD currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "单硝酸异山梨酯", "en": "isosorbide mononitrate" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或分片许可", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or splitting permission" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：IMDUR／isosorbide mononitrate NDA 020225 的 30/60/120 mg 历史缓释片 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "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": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-imdur-isosorbide-mononitrate-60mg-er-nda-020225-product-002", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（1993-08-12）", "en": "Historical product identity in the current FDA Orange Book dataset (1993-08-12)" }, "dosageForm": { "zh": "IMDUR 单硝酸异山梨酯 60 mg 口服缓释片（美国历史 RLD）", "en": "IMDUR isosorbide mononitrate 60 mg oral extended-release tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020225 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片单硝酸异山梨酯 60 mg；历史 RLD 当前 DISCN", "en": "Isosorbide mononitrate 60 mg per tablet; historical RLD currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "单硝酸异山梨酯", "en": "isosorbide mononitrate" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或分片许可", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or splitting permission" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：IMDUR／isosorbide mononitrate NDA 020225 的 30/60/120 mg 历史缓释片 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "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": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-imdur-isosorbide-mononitrate-120mg-er-nda-020225-product-003", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（1995-03-30）", "en": "Historical product identity in the current FDA Orange Book dataset (1995-03-30)" }, "dosageForm": { "zh": "IMDUR 单硝酸异山梨酯 120 mg 口服缓释片（美国历史 RLD）", "en": "IMDUR isosorbide mononitrate 120 mg oral extended-release tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020225 / Product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片单硝酸异山梨酯 120 mg；历史 RLD 当前 DISCN", "en": "Isosorbide mononitrate 120 mg per tablet; historical RLD currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "单硝酸异山梨酯", "en": "isosorbide mononitrate" }, "value": 120, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或分片许可", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or splitting permission" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：IMDUR／isosorbide mononitrate NDA 020225 的 30/60/120 mg 历史缓释片 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "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": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "gb-imdur-isosorbide-mononitrate-60mg-durules-pl-46500-0002", "marketCode": "GB", "labelVersion": { "zh": "英国当前 eMC SmPC（2026-08-31 核验）", "en": "Current UK eMC SmPC (checked 31 Aug 2026)" }, "dosageForm": { "zh": "Imdur 单硝酸异山梨酯 60 mg 缓释薄膜衣片（Durules）", "en": "Imdur isosorbide mononitrate 60 mg extended-release film-coated tablet (Durules)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "PL 46500/0002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片单硝酸异山梨酯 60 mg；英国准确产品可分割但不得咀嚼或压碎", "en": "Isosorbide mononitrate 60 mg per tablet; this exact UK product is divisible but must not be chewed or crushed" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "单硝酸异山梨酯", "en": "isosorbide mononitrate" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片英国产品标示量；可分割声明只限该准确产品，不是个人方案", "en": "amount per UK product tablet; divisibility applies only to this exact product and is not an individual plan" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_public_product_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "没有取得与四个产品身份一一对应的官方包装主图", "en": "No official principal pack image was obtained one-to-one for all four product identities" }, "summary": { "zh": "本页只展示官方文字身份，不以零售图、当前通用药、MONOKET 普通片、硝酸甘油或其他市场相似药片替代 IMDUR 包装。颜色、刻印、刻痕和能否分片必须按手中准确产品说明书核对。", "en": "Only official text identities are shown. Retail images, current generics, MONOKET immediate-release tablets, nitroglycerin and look-alike tablets from another market are not substituted for IMDUR packs. Colour, imprint, score and divisibility require the exact product label." }, "source": { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "IMDUR 说明书放大阅读：缓释预防药不是急性胸痛急救药", "en": "IMDUR enlarged label: a preventive extended-release medicine is not acute chest-pain rescue" }, "summary": { "zh": "IMDUR 用于预防心绞痛，英国资料明确不用于缓解急性发作。急性胸痛应按既有急救计划和当地紧急医疗流程处理；网页不生成急救步骤或个人剂量。", "en": "IMDUR is used to prevent angina, and the UK information states it is not for relief of an acute attack. Acute chest pain requires the existing emergency plan and local urgent-care pathway; the site does not generate rescue steps or an individual dose." }, "checks": [ { "zh": "不要把 IMDUR 缓释片、MONOKET 普通片和舌下/颊用硝酸甘油按成分家族或毫克数自行换算、交替或替代。", "en": "Do not self-convert, alternate or substitute IMDUR extended-release tablets, MONOKET immediate-release tablets and sublingual/buccal nitroglycerin from a nitrate family or milligram figures." }, { "zh": "西地那非、他达拉非、伐地那非等 PDE-5 抑制剂与有机硝酸酯可能造成危险性低血压；不要自行错开时间来规避禁忌，应立即向开方团队核对完整药单。", "en": "PDE-5 inhibitors such as sildenafil, tadalafil or vardenafil with an organic nitrate may cause dangerous hypotension. Do not invent a separation interval to bypass the contraindication; promptly review the complete list with the prescriber." }, { "zh": "头晕、低血压或晕厥风险与降压药、利尿剂、其他血管扩张药和酒精同在药单时更需核对。老年人起身不稳或跌倒应及时评估。", "en": "Dizziness, hypotension or syncope requires priority review with antihypertensives, diuretics, other vasodilators or alcohol. Unsteadiness on standing or a fall in an older person needs timely assessment." }, { "zh": "英国准确 60 mg 产品说明可分割，但仍明确不得咀嚼或压碎；这不是所有 IMDUR、通用缓释片或其他市场产品的通用许可。", "en": "The exact UK 60 mg product is described as divisible but must not be chewed or crushed. This is not universal permission for every IMDUR, generic extended-release or other-market product." } ], "source": { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "单硝酸异山梨酯怎样起作用：有机硝酸酯使血管平滑肌松弛", "en": "How isosorbide mononitrate works: an organic nitrate relaxes vascular smooth muscle" }, "summary": { "zh": "血管扩张可降低心脏负荷并帮助预防心绞痛，但也解释了头痛、头晕和低血压风险。缓释结构延长释放，不会把它变成急性发作时立即起效的急救药。", "en": "Vasodilation can reduce cardiac workload and help prevent angina, while also explaining headache, dizziness and hypotension. Extended release prolongs delivery and does not turn it into immediate rescue for an acute attack." }, "checks": [ { "zh": "缓释不是“药效更强”，而是释放过程不同；不能用普通片数量拼成缓释效果。", "en": "Extended release does not mean stronger; it means a different release process. Immediate-release tablet counts cannot be assembled to recreate it." }, { "zh": "同为硝酸酯不等于同一产品；给药途径、释放方式和临床情境必须一起核对。", "en": "Sharing a nitrate class does not make products identical; route, release design and clinical context must be checked together." }, { "zh": "头痛或头晕不能作为自行加量、减量、停药或换药依据。", "en": "Headache or dizziness is not a basis for self-increasing, reducing, stopping or switching treatment." } ], "source": { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "IMDUR", "generic": "单硝酸异山梨酯", "dosageFormClass": "缓释口服片。英国准确 60 mg Durules 产品资料说明不得咀嚼或压碎、整片吞服，并另列该准确片可分割；这不能泛化为美国历史 30/60/120 mg 或其他厂牌均可掰片。" }, "labelSource": { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "英国电子药品目录 eMC", "en": "UK electronic medicines compendium (emc)" }, "market": { "zh": "英国", "en": "United Kingdom" }, "recordType": { "zh": "公开药品说明书或患者说明书", "en": "Public product information or patient leaflet" }, "reviewedAt": "2026-08-31", "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_10e511bf83430e3b", "label": "FDA Orange Book：IMDUR／isosorbide mononitrate NDA 020225 的 30/60/120 mg 历史缓释片 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "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": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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": "英国电子药品目录 eMC", "en": "UK electronic medicines compendium (emc)" }, "market": { "zh": "英国", "en": "United Kingdom" }, "recordType": { "zh": "公开药品说明书或患者说明书", "en": "Public product information or patient leaflet" }, "reviewedAt": "2026-08-31", "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": "IMDUR 是单硝酸异山梨酯缓释品牌档案，用于预防心绞痛，不是急性胸痛时的急救药。胸痛突然发作、加重或伴呼吸困难、出汗、晕厥时，应使用当地紧急医疗流程；不要等待缓释片起效，也不要自行加量。", "history": "英国产品资料记录 1987-07-21 首次授权。美国 NDA 020225 的 30 mg 与 60 mg 于 1993-08-12 批准，120 mg 于 1995-03-30 批准；三个品牌行当前均为 DISCN。", "sourceDocuments": [ { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：IMDUR／isosorbide mononitrate NDA 020225 的 30/60/120 mg 历史缓释片 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "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": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "美国历史 NDA 020225；英国 PL 46500/0002", "approvalTimeline": [ { "date": "1987-07-21", "title": { "zh": "英国 Imdur 60 mg 首次授权", "en": "First UK authorisation of Imdur 60 mg" }, "detail": { "zh": "当前 SmPC 保留品牌、60 mg 缓释片与授权编号。", "en": "The current SmPC retains the brand, 60 mg extended-release tablet and authorisation number." }, "source": { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "1993-08-12", "title": { "zh": "美国 30 mg 与 60 mg 历史 RLD 批准", "en": "Historical U.S. approval of 30 mg and 60 mg RLD products" }, "detail": { "zh": "两项均属 NDA 020225，当前 DISCN。", "en": "Both are under NDA 020225 and currently DISCN." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：IMDUR／isosorbide mononitrate NDA 020225 的 30/60/120 mg 历史缓释片 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "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": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1995-03-30", "title": { "zh": "美国 120 mg 历史 RLD 批准", "en": "Historical U.S. approval of the 120 mg RLD product" }, "detail": { "zh": "当前同样列为 DISCN。", "en": "It is likewise currently listed DISCN." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：IMDUR／isosorbide mononitrate NDA 020225 的 30/60/120 mg 历史缓释片 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "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": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "三个历史 RLD 均为 DISCN", "en": "All three historical RLD products are DISCN" }, "detail": { "zh": "并非因安全性或有效性撤回；不代表当前品牌供应。", "en": "Not withdrawn for safety or effectiveness reasons; does not establish current brand supply." } }, { "market": { "zh": "英国", "en": "United Kingdom" }, "status": { "zh": "60 mg 当前产品资料可读", "en": "Current 60 mg product information readable" }, "detail": { "zh": "PL 46500/0002；实际供应仍须当地核对。", "en": "PL 46500/0002; actual supply still requires local checking." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "胸痛时可以多吃一片 IMDUR 吗？", "en": "Can I take an extra IMDUR tablet during chest pain?" }, "answer": { "zh": "不要根据网页这样做。IMDUR 是预防用缓释药，不是急性发作急救药；突然或加重胸痛应按既有急救计划和当地紧急医疗流程处理。", "en": "Do not do this from a website. IMDUR is a preventive extended-release medicine, not acute rescue; sudden or worsening chest pain requires the existing emergency plan and local urgent-care pathway." } }, { "question": { "zh": "60 mg 有刻痕就都能掰半吗？", "en": "Does a score mean every 60 mg tablet can be halved?" }, "answer": { "zh": "不能泛化。英国准确 Imdur 60 mg 资料允许分割但不得咀嚼或压碎；其他厂牌和市场必须查手中准确说明书。", "en": "Do not generalise. The exact UK Imdur 60 mg information permits division but not chewing or crushing; every other manufacturer and market requires its exact label." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/imdur-isosorbide-mononitrate/", "en": "https://origindrug.com/en/drugs/imdur-isosorbide-mononitrate/" }, "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." ] }