{ "id": "toprol-xl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "Toprol-XL", "generic": "琥珀酸美托洛尔", "aliases": [ "倍他乐克", "倍他乐克缓释片", "metoprolol succinate", "metoprolol extended release", "metoprolol succinate extended release", "琥珀酸美托洛尔缓释片" ], "marketBrandNames": [ { "name": "倍他乐克®缓释片", "market": { "zh": "中国大陆（阿斯利康中国公开产品列表）", "en": "Mainland China (AstraZeneca China public product list)" }, "evidenceStatus": "publication_status_unresolved", "note": { "zh": "阿斯利康中国产品列表将倍他乐克®缓释片对应为琥珀酸美托洛尔缓释片，并列出 47.5 mg 与 95 mg。这里仅建立中国药盒名称检索入口；本档案主体仍是美国 TOPROL-XL 25/50/100/200 mg，跨市场规格与包装不能合并或换算。", "en": "AstraZeneca China's product list maps Betaloc ZOK® to metoprolol succinate extended-release tablets and lists 47.5 mg and 95 mg. This is only a China pack-name search route; the dossier remains the U.S. TOPROL-XL 25/50/100/200 mg product, and cross-market strengths and packages must not be merged or converted." }, "source": { "id": "src_74aa269ebb2ff692", "label": "阿斯利康中国：倍他乐克®缓释片（琥珀酸美托洛尔缓释片）产品列表", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/cvm.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": { "value": "倍他乐克®缓释片", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_74aa269ebb2ff692", "label": "阿斯利康中国：倍他乐克®缓释片（琥珀酸美托洛尔缓释片）产品列表", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/cvm.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国当前公开监管标签；中国大陆商品名仅作一手来源约束的检索线索", "dosageFormClass": "口服缓释片（25、50、100、200 mg；DailyMed 2026 标签所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1992（美国标签所列初始批准年份）", "archiveSponsorText": "DailyMed 公开监管标签档案；中国大陆名称线索来自阿斯利康中国公开产品列表" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "metoprolol tartrate", "metoprolol immediate release", "immediate release metoprolol", "lopressor", "metoprolol injection", "酒石酸美托洛尔", "美托洛尔普通片", "美托洛尔注射液", "倍他乐克平片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-toprol-xl-er-tablet-25mg-ndc-70842-110-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v7，2026-03-03 更新；2026-03-06 发布", "en": "DailyMed SPL v7, updated 3 Mar 2026 and published 6 Mar 2026" }, "dosageForm": { "zh": "TOPROL-XL 琥珀酸美托洛尔缓释口服片", "en": "TOPROL-XL metoprolol succinate extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 70842-110-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 25 mg；100 片瓶装（缓释片）", "en": "25 mg per tablet; 100-tablet bottle (extended-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a&name=toprol-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "琥珀酸美托洛尔", "en": "metoprolol succinate" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、分片或转换规则", "en": "labelled strength per tablet; not an individual tablet-count, splitting or conversion rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、双凸薄膜衣片", "en": "oval biconvex film-coated tablet" }, "imprint": "A/β", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔 25 mg、100 片瓶装（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-toprol-xl-er-tablet-50mg-ndc-70842-111-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v7，2026-03-03 更新；2026-03-06 发布", "en": "DailyMed SPL v7, updated 3 Mar 2026 and published 6 Mar 2026" }, "dosageForm": { "zh": "TOPROL-XL 琥珀酸美托洛尔缓释口服片", "en": "TOPROL-XL metoprolol succinate extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 70842-111-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 50 mg；100 片瓶装（缓释片）", "en": "50 mg per tablet; 100-tablet bottle (extended-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a&name=toprol-05.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "琥珀酸美托洛尔", "en": "metoprolol succinate" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、分片或转换规则", "en": "labelled strength per tablet; not an individual tablet-count, splitting or conversion rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸薄膜衣片", "en": "round biconvex film-coated tablet" }, "imprint": "A/mo", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔 50 mg、100 片瓶装（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-toprol-xl-er-tablet-100mg-ndc-70842-112-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v7，2026-03-03 更新；2026-03-06 发布", "en": "DailyMed SPL v7, updated 3 Mar 2026 and published 6 Mar 2026" }, "dosageForm": { "zh": "TOPROL-XL 琥珀酸美托洛尔缓释口服片", "en": "TOPROL-XL metoprolol succinate extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 70842-112-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mg；100 片瓶装（缓释片）", "en": "100 mg per tablet; 100-tablet bottle (extended-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a&name=toprol-04.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "琥珀酸美托洛尔", "en": "metoprolol succinate" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、分片或转换规则", "en": "labelled strength per tablet; not an individual tablet-count, splitting or conversion rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸薄膜衣片", "en": "round biconvex film-coated tablet" }, "imprint": "A/ms", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔 100 mg、100 片瓶装（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-toprol-xl-er-tablet-200mg-ndc-70842-113-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v7，2026-03-03 更新；2026-03-06 发布", "en": "DailyMed SPL v7, updated 3 Mar 2026 and published 6 Mar 2026" }, "dosageForm": { "zh": "TOPROL-XL 琥珀酸美托洛尔缓释口服片", "en": "TOPROL-XL metoprolol succinate extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 70842-113-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mg；100 片瓶装（缓释片）", "en": "200 mg per tablet; 100-tablet bottle (extended-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a&name=toprol-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "琥珀酸美托洛尔", "en": "metoprolol succinate" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、分片或转换规则", "en": "labelled strength per tablet; not an individual tablet-count, splitting or conversion rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、双凸薄膜衣片", "en": "oval biconvex film-coated tablet" }, "imprint": "A/mY", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔 200 mg、100 片瓶装（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-toprol-xl-er-tablet-25mg-ndc-70842-110-02", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a&name=toprol-06.jpg", "alt": "TOPROL-XL 琥珀酸美托洛尔在美国 DailyMed 当前公开标签中的 25 mg、NDC 70842-110-02、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 2026-03 更新", "presentation": "TOPROL-XL 琥珀酸美托洛尔：每片 25 mg，NDC 70842-110-02，100 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 TOPROL-XL、琥珀酸美托洛尔 25 mg、NDC 70842-110-02 和 100 片瓶装。它仅帮助核对品牌、通用名、每片标示量、缓释片、包装数量、刻痕和来源；不用于鉴定真伪，也不证明 50 mg、100 mg、200 mg、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的分片、联用、开始、停用或换药方案。", "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔当前美国公开标签（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TOPROL-XL 说明书放大阅读：美托洛尔名称相近，释放方式不能省略", "en": "TOPROL-XL label reading: a similar metoprolol name does not erase release form" }, "summary": { "zh": "本模块以 DailyMed 2026 美国公开标签为阅读入口，帮助区分 TOPROL-XL、琥珀酸美托洛尔、口服缓释片、25/50/100/200 mg 与准确瓶装；它不决定个人该服多少、是否转换或与其他心血管药合用。", "en": "This module uses the 2026 U.S. DailyMed public label as a reading entry point. It separates TOPROL-XL, metoprolol succinate, extended-release oral tablets, 25/50/100/200 mg and exact bottles; it does not decide an individual's amount, switch or combination with another cardiovascular medicine." }, "checks": [ { "zh": "先同时核对 TOPROL-XL、琥珀酸美托洛尔、缓释片、每片标示强度和目标市场。包装上都出现“美托洛尔”或数字相近，不能证明可按片数自行换算、替代或交替使用。", "en": "Check TOPROL-XL, metoprolol succinate, extended-release tablet, stated strength per tablet and target market together. A shared “metoprolol” name or similar number does not prove products can be self-converted, substituted or alternated by tablet count." }, { "zh": "“缓释”描述制剂在给药间隔内的释放设计，不是“效果更强”或“可随意掰碎”的通用结论。是否可分割、吞服方式或能否改用另一种剂型，只能按该准确产品的现行标签和药师意见确认。", "en": "“Extended release” describes a formulation's release design across the dosing interval; it is not a universal claim of being “stronger” or freely crushable. Splitting, swallowing method or changing to another form can only be confirmed from the current label for that exact product and a pharmacist." }, { "zh": "该标签列有与可乐定、地高辛或某些钙通道阻滞剂等联用时需额外核对的情形，并提示不应自行突然停用。若心率、头晕、胸部不适或用药清单有变化，应带实际包装请医生或药师核对，而不是按网页自行加减或停药。", "en": "The label identifies situations needing extra review with clonidine, digoxin or some calcium-channel blockers, and warns against self-directed abrupt discontinuation. With heart-rate changes, dizziness, chest discomfort or a changed medicine list, bring the actual pack to a clinician or pharmacist rather than self-adjusting or stopping from a webpage." } ], "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔当前美国公开标签（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "琥珀酸美托洛尔怎样起作用：它主要阻断心脏的 β1 肾上腺素能受体", "en": "How metoprolol succinate works: it mainly blocks cardiac beta1 adrenergic receptors" }, "summary": { "zh": "FDA 公开标签将美托洛尔描述为 β1 选择性（心脏选择性）肾上腺素能受体阻断剂；该选择性并非绝对。标签还说明 TOPROL-XL 的缓释设计由多个控释小丸构成，旨在于给药间隔内持续释放。这解释的是作用与剂型设计，不是个人的加减量、停药或与其他心血管药合用方案。", "en": "The FDA public label describes metoprolol as a beta1-selective (cardioselective) adrenergic-receptor blocker; this selectivity is not absolute. It also explains that TOPROL-XL uses multiple controlled-release pellets designed to release metoprolol continuously across the dosing interval. This describes mechanism and formulation design, not an individual's dose change, stopping or combination plan." }, "checks": [ { "zh": "“主要作用于 β1”不代表对每个人都只影响心脏，也不能用作自行判断合并肺部疾病、低心率、头晕或其他药物能否同用的依据。应让医生或药师结合完整情况复核。", "en": "“Mainly beta1” does not mean the effect is confined to the heart in every person, and it cannot decide by itself whether coexisting lung disease, a low heart rate, dizziness or another medicine is compatible. Have a clinician or pharmacist review the full situation." }, { "zh": "缓释机制不等于不能分割。该 FDA 标签对准确的 TOPROL-XL 说明为可沿刻痕分开、但整片或半片均不应压碎或咀嚼；其他美托洛尔产品或市场标签可能不同，不能把这条规则外推。", "en": "An extended-release mechanism does not automatically mean a tablet cannot be divided. The FDA label for this exact TOPROL-XL product says scored tablets may be divided but whole or half tablets must not be crushed or chewed; other metoprolol products or market labels can differ, so do not generalize this rule." }, { "zh": "共同机制也不能决定与可乐定、地高辛、钙通道阻滞剂等如何合用或何时停药。出现心率异常、头晕、胸部不适，或药物清单变化时，带上实际包装请开方团队或药师核对。", "en": "A shared mechanism also cannot decide how to combine with clonidine, digoxin, calcium-channel blockers or when to interrupt treatment. With an abnormal heart rate, dizziness, chest discomfort or a changed medicine list, take the actual pack to the prescribing team or pharmacist for review." } ], "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔当前美国公开标签（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Toprol-XL", "generic": "琥珀酸美托洛尔", "dosageFormClass": "口服缓释片（25、50、100、200 mg；DailyMed 2026 标签所列）" }, "labelSource": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔当前美国公开标签（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔当前美国公开标签（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "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": "2026-08-20", "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": "DailyMed 的 TOPROL-XL（metoprolol succinate）2026 美国公开标签将其列为口服缓释片，列示 25、50、100、200 mg 规格、四个 100 片瓶装 NDC，以及美国初始批准年份为 1992。本页用于放大阅读准确产品身份；不构成个人开始、停用、换药、分片或剂量建议。", "history": "“美托洛尔”不是完整产品身份。缓释制剂与其他盐型、释放方式、规格和目标市场的产品须逐项核对；不要依据名称相近自行把缓释片换成另一种美托洛尔产品。", "sourceDocuments": [ { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔当前美国公开标签（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 019962", "approvalTimeline": [ { "date": "1992", "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: 1992。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: 1992. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed: TOPROL-XL current public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-03", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-03 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 2026-03 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_e4a96f0457fcd5f8", "label": "DailyMed: TOPROL-XL current public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "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": "lopressor", "brand": "LOPRESSOR", "generic": "酒石酸美托洛尔", "canonicalUrls": { "zh": "https://origindrug.com/drugs/lopressor/", "en": "https://origindrug.com/en/drugs/lopressor/" } }, "title": { "zh": "与 LOPRESSOR／酒石酸美托洛尔同在药单上时：先区分缓释片与普通片", "en": "When LOPRESSOR / metoprolol tartrate is on the same list: first separate extended-release and standard tablets" }, "summary": { "zh": "TOPROL-XL 的美国公开标签将其标为琥珀酸美托洛尔缓释片；LOPRESSOR 是酒石酸美托洛尔普通口服片。共同出现“美托洛尔”或相近 mg 数字，只提示把两种实际药盒和完整药单交给药师或开方团队核对；本卡片不判断能否同用，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The U.S. public label identifies TOPROL-XL as an extended-release metoprolol succinate tablet, while LOPRESSOR is a standard metoprolol tartrate oral tablet. A shared ‘metoprolol’ name or similar mg number only signals that both actual packs and the complete medicine list need pharmacist or prescriber review; this card does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔当前美国公开标签（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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/toprol-xl/", "en": "https://origindrug.com/en/drugs/toprol-xl/" }, "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." ] }