{ "id": "lopressor", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "LOPRESSOR", "generic": "酒石酸美托洛尔", "aliases": [ "LOPRESSOR", "Lopressor", "倍他乐克", "倍他乐克平片", "美托洛尔普通片", "酒石酸美托洛尔", "metoprolol tartrate", "immediate-release metoprolol", "NDA 218698", "30698-460-03", "30698-460-01", "30698-460-10", "arrowhead E", "metoprolol immediate release" ], "marketBrandNames": [ { "name": "倍他乐克®平片", "market": { "zh": "中国大陆（企业公开产品列表）", "en": "Mainland China (company public product list)" }, "evidenceStatus": "publication_status_unresolved", "note": { "zh": "阿斯利康中国列表对应酒石酸美托洛尔片 25、50、100 mg；这只是名称与规格检索线索，不能与美国 LOPRESSOR 酒石酸美托洛尔 12.5 mg 按片数或 mg 自行换算。", "en": "AstraZeneca China's list maps the name to metoprolol tartrate tablets 25, 50 and 100 mg. This is a name-and-strength lookup cue only and cannot be self-converted by tablet count or milligrams with U.S. LOPRESSOR metoprolol tartrate 12.5 mg." }, "source": { "id": "src_74aa269ebb2ff692", "label": "阿斯利康中国：倍他乐克®平片（酒石酸美托洛尔片）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®平片", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_74aa269ebb2ff692", "label": "阿斯利康中国：倍他乐克®平片（酒石酸美托洛尔片）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 12.5 mg 片：NDA 218698、三个 NDC 瓶装与 2026-01-26 更新的 DailyMed 标签；美国历史 50 mg／100 mg 片：NDA 017963 的 2023 标签档案；中国大陆倍他乐克®平片：阿斯利康中国公开产品列表只提供 25、50、100 mg 名称与规格线索。三条资料按市场、NDA、规格和日期分开，不推定实时供应、价格、真伪或可替代性。", "dosageFormClass": "当前美国 NDA 218698 为酒石酸美托洛尔 12.5 mg 无刻痕薄膜衣普通片，分别为 30、60、1000 片瓶装；不得与历史 50/100 mg 片、LOPRESSOR 口服液、LOPRESSOR HCT、注射剂或 TOPROL-XL 缓释片合并换算。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2025-08-28（当前 12.5 mg 片 NDA 218698 批准函）；历史 LOPRESSOR 片另见 NDA 017963", "archiveSponsorText": "XTM Consulting LLC（NDA 218698 批准函申请方）；Validus Pharmaceuticals LLC（当前 DailyMed 标签分销方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "LOPRESSOR metoprolol tartrate tablets", "酒石酸美托洛尔片", "倍他乐克", "倍他乐克平片" ], "excludedProductCues": [ "TOPROL-XL", "metoprolol succinate", "extended-release metoprolol", "琥珀酸美托洛尔缓释片", "倍他乐克缓释片", "LOPRESSOR oral solution", "metoprolol injection", "LOPRESSOR HCT" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lopressor-metoprolol-tartrate-tablet-12-5mg-30bottle-ndc-30698-460-03", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国标签（SPL v3；2026-01-26 更新）", "en": "U.S. DailyMed label (SPL v3; updated 26 Jan 2026)" }, "dosageForm": { "zh": "LOPRESSOR 酒石酸美托洛尔 12.5 mg 薄膜衣口服片", "en": "LOPRESSOR metoprolol tartrate 12.5 mg film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-460-03", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片酒石酸美托洛尔 12.5 mg；30 片瓶装", "en": "Metoprolol tartrate 12.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=metoprolol-tartrate-30-tablets.jpg&setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "酒石酸美托洛尔", "en": "metoprolol tartrate" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或普通片／缓释片换算指令", "en": "labelled amount per tablet; not an individual tablet count, frequency or standard/extended-release conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listing_not_live_stock", "marketingStartDate": "2025-08-11", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "5 mm 圆形、双凸、薄膜衣片", "en": "5 mm round, biconvex, film-coated tablet" }, "imprint": { "zh": "一面为箭头形标记与 E，另一面无文字", "en": "arrowhead mark and E on one side; plain on the other" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lopressor-metoprolol-tartrate-tablet-12-5mg-60bottle-ndc-30698-460-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国标签（SPL v3；2026-01-26 更新）", "en": "U.S. DailyMed label (SPL v3; updated 26 Jan 2026)" }, "dosageForm": { "zh": "LOPRESSOR 酒石酸美托洛尔 12.5 mg 薄膜衣口服片", "en": "LOPRESSOR metoprolol tartrate 12.5 mg film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-460-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片酒石酸美托洛尔 12.5 mg；60 片瓶装", "en": "Metoprolol tartrate 12.5 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=metoprolol-tartrate-60-tablets.jpg&setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "酒石酸美托洛尔", "en": "metoprolol tartrate" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或普通片／缓释片换算指令", "en": "labelled amount per tablet; not an individual tablet count, frequency or standard/extended-release conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listing_not_live_stock", "marketingStartDate": "2026-01-25", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "5 mm 圆形、双凸、薄膜衣片", "en": "5 mm round, biconvex, film-coated tablet" }, "imprint": { "zh": "一面为箭头形标记与 E，另一面无文字", "en": "arrowhead mark and E on one side; plain on the other" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lopressor-metoprolol-tartrate-tablet-12-5mg-1000bottle-ndc-30698-460-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国标签（SPL v3；2026-01-26 更新）", "en": "U.S. DailyMed label (SPL v3; updated 26 Jan 2026)" }, "dosageForm": { "zh": "LOPRESSOR 酒石酸美托洛尔 12.5 mg 薄膜衣口服片", "en": "LOPRESSOR metoprolol tartrate 12.5 mg film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-460-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片酒石酸美托洛尔 12.5 mg；1000 片瓶装", "en": "Metoprolol tartrate 12.5 mg per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=metoprolol-tartrate-1000-tablets.jpg&setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "酒石酸美托洛尔", "en": "metoprolol tartrate" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或普通片／缓释片换算指令", "en": "labelled amount per tablet; not an individual tablet count, frequency or standard/extended-release conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listing_not_live_stock", "marketingStartDate": "2025-08-11", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "5 mm 圆形、双凸、薄膜衣片", "en": "5 mm round, biconvex, film-coated tablet" }, "imprint": { "zh": "一面为箭头形标记与 E，另一面无文字", "en": "arrowhead mark and E on one side; plain on the other" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lopressor-metoprolol-tartrate-tablet-12-5mg-30bottle-ndc-30698-460-03", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=metoprolol-tartrate-30-tablets.jpg&setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f&type=img", "alt": "LOPRESSOR 酒石酸美托洛尔 12.5 mg、NDC 30698-460-03、30 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v3（2026-01-26 更新）", "presentation": "LOPRESSOR 酒石酸美托洛尔 12.5 mg；NDC 30698-460-03；30 片瓶装。", "notice": "此图只对应当前美国标签中的一个准确瓶装面板。另有 60 片和 1000 片瓶装，均须按各自 NDC 核对；它不用于鉴定真伪，也不能证明实时库存、购买资格、历史 50/100 mg 产品或其他市场产品身份。", "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LOPRESSOR 说明书放大阅读：先分清当前 12.5 mg 普通片、历史片剂和缓释片", "en": "Enlarged LOPRESSOR label: separate the current 12.5 mg standard tablet, historical tablets and extended release" }, "summary": { "zh": "这一阅读模块围绕当前 NDA 218698 的 12.5 mg 无刻痕普通片，不把旧 50/100 mg 标签、口服液、复方、注射剂或缓释片的文字搬到当前产品。", "en": "This reading module is limited to the current NDA 218698 12.5 mg unscored standard tablet. It does not transfer wording from historical 50/100 mg tablets, oral solution, combination, injection or extended-release products." }, "checks": [ { "zh": "12.5 mg 是每片标签标示量，30、60 或 1000 是每瓶片数；这些数字都不是某个人一天吃几片、是否掰开或怎样换成另一种美托洛尔的答案。", "en": "The 12.5 mg figure is the labelled amount per tablet, while 30, 60 or 1,000 is the bottle count. None answers an individual's daily tablet count, splitting question or conversion to another metoprolol product." }, { "zh": "标签将该片描述为无刻痕。无刻痕不等于网页可以直接给出“绝对不能掰”或“可以对半”的结论；应依据准确药盒、处方与药师/开方团队确认。", "en": "The label describes this tablet as unscored. That alone does not let a webpage declare that splitting is always prohibited or acceptable; use the exact pack, prescription and pharmacist/prescriber review." }, { "zh": "突然停用可能加重心肌缺血。不要因为心率、血压、头晕或一次漏用而自行停药、补服、减量、隔天用或与缓释片交替。", "en": "Abrupt cessation may worsen myocardial ischaemia. Do not self-stop, make up, reduce, alternate days or rotate with an extended-release tablet because of a pulse, blood-pressure value, dizziness or one missed use." }, { "zh": "心率过慢、低血压、晕厥、跌倒、呼吸困难、心衰加重或胸痛需要及时联系当地医疗团队；急重症状使用当地急救渠道。", "en": "Bradycardia, hypotension, syncope, a fall, breathing difficulty, worsening heart failure or chest pain needs timely local clinical review; use local emergency pathways for severe symptoms." }, { "zh": "糖尿病患者、禁食或呕吐者要注意：标签提示 β 阻滞剂可能掩盖心动过速等低血糖警示。不要只依赖心率判断是否低血糖。", "en": "For diabetes, fasting or vomiting, the label warns that beta blockers may mask signs of hypoglycaemia such as tachycardia. Do not rely on pulse alone to judge hypoglycaemia." }, { "zh": "手术或牙科操作前，应告知团队正在使用 LOPRESSOR；不要据网页自行提前停用。", "en": "Tell the surgical or dental team about LOPRESSOR. Do not stop it in advance based on a webpage." } ], "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "酒石酸美托洛尔怎样起作用：以 β1 受体阻断为主，但选择性不是绝对", "en": "How metoprolol tartrate works: mainly beta-1 blockade, but selectivity is not absolute" }, "summary": { "zh": "标签把美托洛尔描述为以 β1 肾上腺素能受体为主的阻断剂，可减慢窦性心率并影响房室结传导；较高暴露下也可能影响 β2 受体。这解释了心率、血压、呼吸和联用核对的重要性，但不能产生个人处方。", "en": "The label describes metoprolol as a predominantly beta-1 adrenergic blocker that slows sinus rate and affects AV-nodal conduction; at higher exposure it may also affect beta-2 receptors. This explains why pulse, blood pressure, breathing and co-medications matter, but it cannot generate an individual prescription." }, "checks": [ { "zh": "普通片与缓释片的释放方式不同；相同活性成分词根或相近 mg 不建立自行换算、叠加或轮换关系。", "en": "Standard and extended-release tablets have different release designs. A shared active-ingredient root or similar milligrams creates no self-conversion, combination or rotation rule." }, { "zh": "不同 NDA、剂型、规格、辅料与市场标签都属于产品身份；作用机理相似不能证明原研关系、真伪、可售资格或个人适用性。", "en": "Different NDAs, dosage forms, strengths, excipients and market labels are product-identity fields. Similar mechanisms cannot prove originator status, authenticity, sale eligibility or individual suitability." }, { "zh": "心率、血压、糖代谢、呼吸系统情况和其他减慢心率药物都会改变专业人员需要核对的风险；机理说明不能决定个人是否开始、继续、减量或停用。", "en": "Pulse, blood pressure, glucose regulation, respiratory status and other heart-rate-slowing medicines all affect the risks a professional needs to review; a mechanism explanation cannot decide whether an individual should start, continue, reduce or stop treatment." } ], "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LOPRESSOR", "generic": "酒石酸美托洛尔", "dosageFormClass": "当前美国 NDA 218698 为酒石酸美托洛尔 12.5 mg 无刻痕薄膜衣普通片，分别为 30、60、1000 片瓶装；不得与历史 50/100 mg 片、LOPRESSOR 口服液、LOPRESSOR HCT、注射剂或 TOPROL-XL 缓释片合并换算。" }, "labelSource": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "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_2f9e041472de1f78", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国电子说明书 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "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_1003d2645bc095e8", "label": "FDA：LOPRESSOR 酒石酸美托洛尔 50 mg／100 mg 片 NDA 017963 标签档案（2023；历史产品）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017693s076lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "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": "当前美国 LOPRESSOR 12.5 mg 片属于 NDA 218698，与历史 50/100 mg LOPRESSOR 片、口服液、复方 LOPRESSOR HCT，以及 TOPROL-XL 缓释片不是同一个产品身份。老人或同时使用多种心率、血压药物者，应重点核对心率过慢、低血压、头晕跌倒、呼吸困难、低血糖症状被掩盖和突然停药风险；网页不提供个人片数、频率、减量、停用或普通片／缓释片转换方案。", "history": "FDA 于 2025-08-28 批准 NDA 218698 的 LOPRESSOR 酒石酸美托洛尔 12.5 mg 片，用于血流动力学稳定的成人心肌梗死患者相关标签用途。DailyMed 当前记录列出 NDC 30698-460-03、-01、-10 和三个瓶装，并在标签抬头保留“Initial U.S. Approval: 1992”；另有 FDA 资料显示历史 LOPRESSOR 50/100 mg 片归于 NDA 017963。本站同时展示这些字段，但不把标签抬头年份误写成当前 NDA 218698 的批准日期。", "sourceDocuments": [ { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_2f9e041472de1f78", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国电子说明书 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_cbf19b6cb915e288", "label": "FDA：LOPRESSOR 酒石酸美托洛尔 12.5 mg 片 NDA 218698 批准函（2025-08-28）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218698Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_1003d2645bc095e8", "label": "FDA：LOPRESSOR 酒石酸美托洛尔 50 mg／100 mg 片 NDA 017963 标签档案（2023；历史产品）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017693s076lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_74aa269ebb2ff692", "label": "阿斯利康中国：倍他乐克®平片（酒石酸美托洛尔片）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" } ], "applicationNumber": "NDA 218698（当前 12.5 mg 片）；NDA 017963（历史 50/100 mg 片档案）", "approvalTimeline": [ { "date": "1978-08-07", "title": { "zh": "历史 LOPRESSOR 片 NDA 017963 获批", "en": "Legacy LOPRESSOR tablet NDA 017963 approved" }, "detail": { "zh": "FDA 公开审评资料将历史 LOPRESSOR 片与该日期和 NDA 017963 相连；本页以 2023 标签档案保留 50/100 mg 历史，不把它当成当前 12.5 mg 包装。", "en": "FDA public review material links legacy LOPRESSOR tablets to this date and NDA 017963. This page preserves the 50/100 mg history through the 2023 label archive without treating it as the current 12.5 mg pack." }, "source": { "id": "src_1003d2645bc095e8", "label": "FDA：LOPRESSOR 酒石酸美托洛尔 50 mg／100 mg 片 NDA 017963 标签档案（2023；历史产品）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017693s076lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-08-28", "title": { "zh": "当前 12.5 mg LOPRESSOR 片 NDA 218698 获批", "en": "Current 12.5 mg LOPRESSOR tablet NDA 218698 approved" }, "detail": { "zh": "FDA 批准函确认这是 505(b)(2) 申请，批准用途限于函件和标签所述的血流动力学稳定成人心肌梗死情形。", "en": "The FDA approval letter confirms a 505(b)(2) application, with the approved use limited to the haemodynamically stable adult myocardial-infarction setting described in the letter and label." }, "source": { "id": "src_cbf19b6cb915e288", "label": "FDA：LOPRESSOR 酒石酸美托洛尔 12.5 mg 片 NDA 218698 批准函（2025-08-28）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218698Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2026-01-26", "title": { "zh": "DailyMed 当前标签更新", "en": "Current DailyMed label updated" }, "detail": { "zh": "当前标签列出 12.5 mg、三个 NDC 瓶装、外观、辅料和安全章节。", "en": "The current label lists 12.5 mg, three NDC bottle presentations, appearance, excipients and safety sections." }, "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国当前 12.5 mg 片", "en": "Current U.S. 12.5 mg tablet" }, "status": { "zh": "NDA 218698；三个公开标签瓶装", "en": "NDA 218698; three public-label bottle presentations" }, "detail": { "zh": "NDC 30698-460-03（30 片）、-01（60 片）、-10（1000 片）；目录字段不等于实时库存。", "en": "NDC 30698-460-03 (30), -01 (60) and -10 (1,000 tablets); directory fields are not live stock." } }, { "market": { "zh": "美国历史 50/100 mg 片", "en": "Legacy U.S. 50/100 mg tablets" }, "status": { "zh": "NDA 017963 历史标签另存", "en": "NDA 017963 retained as a separate historical label" }, "detail": { "zh": "不得将旧适应症、刻痕、外观、剂量文字或包装迁移到当前 12.5 mg 产品。", "en": "Do not transfer legacy indications, scoring, appearance, dosage wording or packs to the current 12.5 mg product." } }, { "market": { "zh": "中国大陆倍他乐克®平片", "en": "Mainland China Betaloc standard tablets" }, "status": { "zh": "企业产品列表名称与规格线索", "en": "Company product-list name and strength cues" }, "detail": { "zh": "25、50、100 mg；当前批准文号、完整说明书与包装仍须按中国监管来源逐项核验。", "en": "25, 50 and 100 mg; current approval numbers, full labels and packs still require item-by-item Chinese regulatory verification." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签为什么写 1992，FDA 批准函却是 2025？", "en": "Why does the label say 1992 while the FDA approval letter is dated 2025?" }, "answer": { "zh": "两者不是同一个字段。当前标签抬头保留 Initial U.S. Approval: 1992，但当前 12.5 mg 片的申请号是 NDA 218698，批准函日期为 2025-08-28；更早的 LOPRESSOR 片还有 NDA 017963 历史。核对产品应优先使用准确 NDA、剂型、强度、NDC 和标签版本，不能只看一个年份。", "en": "They are not the same field. The current label heading retains Initial U.S. Approval: 1992, while the current 12.5 mg tablet is NDA 218698 with an approval letter dated 28 Aug 2025; earlier LOPRESSOR tablets also have an NDA 017963 history. Product identity requires the exact NDA, dosage form, strength, NDC and label version, not one year alone." } }, { "question": { "zh": "12.5 mg 无刻痕片能不能掰半？", "en": "Can the 12.5 mg unscored tablet be split?" }, "answer": { "zh": "网页不能从“无刻痕”单独推导出个人操作结论。请带实际药盒和处方询问药师或开方团队；不要用旧 50/100 mg 片、缓释片或另一厂家产品的做法替代。", "en": "A webpage cannot derive an individual handling instruction from the word unscored alone. Ask a pharmacist or prescriber with the actual pack and prescription; do not substitute instructions from legacy 50/100 mg tablets, extended-release tablets or another manufacturer." } }, { "question": { "zh": "LOPRESSOR 与 TOPROL-XL 都是美托洛尔，可以自行换吗？", "en": "LOPRESSOR and TOPROL-XL are both metoprolol. Can they be self-switched?" }, "answer": { "zh": "不能。盐型、普通/缓释设计、每单位含量、适应症、包装、标签和处方都要分别核对；相近 mg 不形成自行换算、叠加或轮换关系。", "en": "No. Salt, standard/extended-release design, amount per unit, indication, pack, label and prescription all require separate checking; similar milligrams create no self-conversion, combination or rotation rule." } } ], "relatedMedicineChecks": [ { "target": { "id": "toprol-xl", "brand": "Toprol-XL", "generic": "琥珀酸美托洛尔", "canonicalUrls": { "zh": "https://origindrug.com/drugs/toprol-xl/", "en": "https://origindrug.com/en/drugs/toprol-xl/" } }, "title": { "zh": "与 TOPROL-XL／琥珀酸美托洛尔缓释片同在药单上时", "en": "When TOPROL-XL / metoprolol succinate extended release is on the same list" }, "summary": { "zh": "LOPRESSOR 是酒石酸美托洛尔普通片，TOPROL-XL 是琥珀酸美托洛尔缓释片；共同出现“美托洛尔”只触发完整药单核对。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": "LOPRESSOR is a standard metoprolol tartrate tablet, while TOPROL-XL is an extended-release metoprolol succinate tablet; they must be reviewed as distinct standard and extended-release tablets. A shared metoprolol name triggers a complete medicine-list review; this card does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lopressor/", "en": "https://origindrug.com/en/drugs/lopressor/" }, "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." ] }