{ "id": "lanoxin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-19", "status": "published_traceable_archive" }, "names": { "brand": "Lanoxin", "generic": "地高辛", "aliases": [ "LANOXIN", "digoxin" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国当前 LANOXIN 地高辛片公开标签（2024-12 修订；DailyMed SPL v12 于 2025-01-09 发布）", "dosageFormClass": "口服片：62.5 mcg、125 mcg、250 mcg（当前美国片剂标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1954（当前美国片剂标签所列 Initial U.S. Approval）", "archiveSponsorText": "Advanz Pharma (US) Corp. / DailyMed（NLM）当前片剂公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "LANOXIN injection", "LANOXIN oral solution", "digoxin injection", "digoxin oral solution", "LANOXIN pediatric injection" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lanoxin-62-5mcg-bottle-ndc-59212-240-55", "marketCode": "US", "labelVersion": { "zh": "处方信息 2024-12 修订；DailyMed SPL v12 于 2025-01-09 发布", "en": "Prescribing information revised Dec 2024; DailyMed SPL v12 published 9 Jan 2025" }, "dosageForm": { "zh": "地高辛口服片", "en": "digoxin oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 59212-240-55", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 62.5 mcg；100 片瓶装", "en": "62.5 mcg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=62-5mcgbottle.jpg&setid=d91e3646-4c63-4512-ab22-db39c085c4dc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地高辛", "en": "digoxin" }, "value": 62.5, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "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": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃橙色", "en": "peach/orange" }, "shape": { "zh": "5 mm 圆片", "en": "5 mm round tablet" }, "imprint": "LANOXIN / U3A", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lanoxin-125mcg-bottle-ndc-59212-242-55", "marketCode": "US", "labelVersion": { "zh": "处方信息 2024-12 修订；DailyMed SPL v12 于 2025-01-09 发布", "en": "Prescribing information revised Dec 2024; DailyMed SPL v12 published 9 Jan 2025" }, "dosageForm": { "zh": "地高辛口服片", "en": "digoxin oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 59212-242-55", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 125 mcg；100 片瓶装", "en": "125 mcg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=125mcgbottle.jpg&setid=d91e3646-4c63-4512-ab22-db39c085c4dc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地高辛", "en": "digoxin" }, "value": 125, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "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": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "6 mm 圆片", "en": "6 mm round tablet" }, "imprint": "LANOXIN / Y3B", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lanoxin-125mcg-unit-dose-ndc-59212-242-56", "marketCode": "US", "labelVersion": { "zh": "处方信息 2024-12 修订；DailyMed SPL v12 于 2025-01-09 发布", "en": "Prescribing information revised Dec 2024; DailyMed SPL v12 published 9 Jan 2025" }, "dosageForm": { "zh": "地高辛口服片", "en": "digoxin oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 59212-242-56", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 125 mcg；院内单位剂量装（10 板×10 片）", "en": "125 mcg per tablet; institutional unit-dose pack (10 blisters × 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cn-120891-01-lanoxin-125-mcg-tablet-100s-v1thumb.jpg&setid=d91e3646-4c63-4512-ab22-db39c085c4dc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地高辛", "en": "digoxin" }, "value": 125, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister", "typeLabel": { "zh": "院内单位剂量装（10 板×10 片）", "en": "institutional unit-dose pack (10 blisters × 10 tablets)" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/单位剂量盒", "en": "tablets per unit-dose carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/单位剂量盒", "en": "tablets per unit-dose carton" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "6 mm 圆片", "en": "6 mm round tablet" }, "imprint": "LANOXIN / Y3B", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lanoxin-250mcg-bottle-ndc-59212-249-55", "marketCode": "US", "labelVersion": { "zh": "处方信息 2024-12 修订；DailyMed SPL v12 于 2025-01-09 发布", "en": "Prescribing information revised Dec 2024; DailyMed SPL v12 published 9 Jan 2025" }, "dosageForm": { "zh": "地高辛口服片", "en": "digoxin oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 59212-249-55", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 250 mcg；100 片瓶装", "en": "250 mcg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=250mcgbottle.jpg&setid=d91e3646-4c63-4512-ab22-db39c085c4dc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地高辛", "en": "digoxin" }, "value": 250, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "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": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "7 mm 圆片", "en": "7 mm round tablet" }, "imprint": "LANOXIN / X3A", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lanoxin-125mcg-bottle-ndc-59212-242-55", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=125mcgbottle.jpg&setid=d91e3646-4c63-4512-ab22-db39c085c4dc&type=img", "alt": "LANOXIN 地高辛当前美国 DailyMed 标签中的 125 mcg、NDC 59212-242-55、100 片瓶装包装面板", "archiveMarket": "美国", "labelVersion": "处方信息 2024-12 修订；DailyMed SPL v12 于 2025-01-09 发布", "presentation": "LANOXIN 地高辛片 125 mcg，NDC 59212-242-55，100 片瓶装", "notice": "此图只对应美国当前片剂标签中的 125 mcg 瓶装。它不代表 62.5 mcg、250 mcg、院内单位剂量装、LANOXIN 注射剂、generic 地高辛口服液或其他市场；不用于鉴定真伪，也不生成个人片数、分片、血药浓度或转换方案。", "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LANOXIN 说明书放大阅读：mcg 与 mg 相差一千倍，剂型也必须分开", "en": "LANOXIN label reading: mcg and mg differ by a thousand-fold, and dosage form must remain separate" }, "summary": { "zh": "本模块只帮助核对片剂商品名、每片 mcg、NDC、刻痕与包装；不生成片数、分片、血药浓度目标、漏用、转换或停药。", "en": "This module only helps check the tablet brand, mcg per tablet, NDC, score and pack; it does not generate tablet counts, splitting, serum targets, missed-use, conversion or stopping." }, "checks": [ { "zh": "1 mg = 1000 mcg。62.5/125/250 mcg 分别只等于 0.0625/0.125/0.25 mg；“125 mg”不是“125 mcg”，而是后一数值的一千倍。这个关系用于防止单位误读，不是个人剂量换算器。", "en": "1 mg = 1000 mcg. The 62.5/125/250 mcg labels equal 0.0625/0.125/0.25 mg respectively; 125 mg is not 125 mcg but a thousand-fold larger. This relationship prevents unit misreading; it is not a personal dose converter." }, { "zh": "125 mcg 同时有 100 片瓶装和院内单位剂量装，必须继续核对 NDC 与包装。包装不同不自动改变每片标示量，也不能据此判断个人应拿几片。", "en": "The 125 mcg tablet appears in both a 100-tablet bottle and an institutional unit-dose pack, so NDC and pack still matter. A different pack does not automatically change the amount per tablet or determine an individual's tablet count." }, { "zh": "62.5 mcg 无刻痕；125 mcg 与 250 mcg 标签列有刻痕。刻痕是准确 presentation 的外观线索，不代表网页可以决定任何人能否分片或怎样分。", "en": "The 62.5 mcg tablet is unscored; the 125 mcg and 250 mcg tablets are labelled as scored. A score is an appearance clue for an exact presentation, not permission for a webpage to decide whether or how someone splits a tablet." }, { "zh": "LANOXIN 注射剂是另一 NDA、SPL、途径与浓度表达；generic 地高辛口服液也不是本页片剂。相同品牌或通用名不支持按 mcg、mL 或途径自行换算。", "en": "LANOXIN injection has a different NDA, SPL, route and concentration expression; generic digoxin oral solution is also not this tablet record. A shared brand or generic name does not support self-conversion by mcg, mL or route." }, { "zh": "恶心呕吐、持续腹泻、明显乏力或意识改变、视物异常、心悸/晕厥或疑似误用时，应及时联系当地医生、药师、毒物咨询或紧急医疗支持；不要依据网页自行补服、停用或改量。", "en": "With nausea/vomiting, persistent diarrhoea, marked weakness or confusion, visual disturbance, palpitations/fainting or suspected misuse, promptly contact local clinicians, pharmacists, poison-control or emergency support; do not self-make-up, stop or change an amount from this page." } ], "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "地高辛怎样起作用：标签描述对 Na+/K+-ATPase 的抑制及其心脏效应", "en": "How digoxin works: the label describes Na+/K+-ATPase inhibition and cardiac effects" }, "summary": { "zh": "当前片剂标签描述地高辛抑制 Na+/K+-ATPase，并由此影响细胞内离子与心肌收缩。机制用于理解为何单位、肾功能、相互作用、心率/节律和监测都需要专业复核；不预测个人效果或给药量。", "en": "The current tablet label describes digoxin inhibition of Na+/K+-ATPase and resulting effects on intracellular ions and myocardial contraction. This helps explain why units, kidney function, interactions, rate/rhythm and monitoring need professional review; it does not predict an individual's effect or amount." }, "checks": [ { "zh": "机制不能从症状或手表读数判断某个人是否需要地高辛，也不能解释一次血药浓度是否应调整；诊断、监测时点与结果必须由专业人员结合准确产品和临床背景判断。", "en": "Mechanism cannot determine from symptoms or a watch reading whether someone needs digoxin or whether one serum result warrants a change. Diagnosis, sampling time and interpretation need professionals with the exact product and clinical context." }, { "zh": "作用于心率/传导并不使 LANOXIN 与其他心律、心衰或血压产品可自行叠加、轮换、替代或按 mg 换算；完整药单、肾功能和电解质背景都要核对。", "en": "Effects on rate/conduction do not make LANOXIN self-combinable, alternatable, substitutable or milligram-convertible with another rhythm, heart-failure or blood-pressure product. The complete medicine list, kidney function and electrolyte context all need review." }, { "zh": "机制不能处理疑似中毒、明显心悸、晕厥、意识改变或严重胃肠道/视觉症状；出现急性严重担忧时应优先使用当地紧急医疗支持。", "en": "Mechanism cannot manage suspected toxicity, marked palpitations, fainting, confusion or severe gastrointestinal/visual symptoms; prioritise local urgent medical support for an acute serious concern." } ], "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 当前美国片剂标签（Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Lanoxin", "generic": "地高辛", "dosageFormClass": "口服片：62.5 mcg、125 mcg、250 mcg（当前美国片剂标签所列）" }, "labelSource": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "productRoutes": [ { "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "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": "2026-09-05", "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": "2026-09-05", "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 LANOXIN（digoxin）当前美国片剂标签列出 62.5 mcg、125 mcg 与 250 mcg。页面始终保留 mcg，并把 125 mcg 的瓶装与院内单位剂量装分开；它不把 mcg 静默改成同数字 mg，也不生成个人片数、血药浓度目标、漏用、加减量、分片、注射—口服转换或停药方案。", "history": "当前片剂标签列示美国初始批准年份为 1954，NDA 020405。LANOXIN 注射剂现属 NDA 009330 和独立标签；generic digoxin oral solution 也不是本品牌片剂 presentation，因此均不并入本页当前四个包装。", "sourceDocuments": [ { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } ], "applicationNumber": "NDA 020405", "approvalTimeline": [ { "date": "1954", "title": { "zh": "标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the label" }, "detail": { "zh": "当前 LANOXIN 片剂标签列示 Initial U.S. Approval: 1954；该年份不自动说明其他市场状态。", "en": "The current LANOXIN tablet label lists Initial U.S. Approval: 1954; that year does not establish status in another market." }, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed: current LANOXIN tablet public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, { "date": "2024-12-05", "title": { "zh": "当前处方信息更新/修订", "en": "Current prescribing-information update/revision" }, "detail": { "zh": "DailyMed 页面将 Drug Label Information Updated 标为 2024-12-05，正文列示 Revised 12/2024。", "en": "DailyMed lists Drug Label Information Updated as 5 Dec 2024 and the prescribing information as Revised 12/2024." }, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed: current LANOXIN tablet public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, { "date": "2025-01-09", "title": { "zh": "DailyMed SPL v12 公开", "en": "DailyMed SPL v12 published" }, "detail": { "zh": "DailyMed 当前版本列表将 v12 标为 current，并列示 2025-01-09 Published；该日期与正文修订月分开。", "en": "DailyMed marks v12 as current and lists Published 9 Jan 2025; this remains separate from the prescribing-information revision month." }, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed: current LANOXIN tablet public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } } ], "marketStatus": [ { "market": { "zh": "美国片剂", "en": "United States tablets" }, "status": { "zh": "已链接 NDA 020405 当前公开标签", "en": "Current NDA 020405 public label linked" }, "detail": { "zh": "四个 presentation 仅对应 Advanz 当前片剂标签中的有效包装。", "en": "The four presentations correspond only to active packs in the current Advanz tablet label." } }, { "market": { "zh": "LANOXIN 注射剂、generic 地高辛口服液及其他市场", "en": "LANOXIN injection, generic digoxin oral solution and other markets" }, "status": { "zh": "明确分开或待建立", "en": "Explicitly separate or not established" }, "detail": { "zh": "不同 NDA、SPL、剂型、途径或品牌状态不得并入本片剂档案。", "en": "A different NDA, SPL, form, route or brand status is not merged into this tablet dossier." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "125 mcg 是不是 125 mg？", "en": "Is 125 mcg the same as 125 mg?" }, "answer": { "zh": "不是。1 mg = 1000 mcg，因此 125 mcg = 0.125 mg。该换算只用于防止单位误读，不决定任何人的片数或用量。", "en": "No. 1 mg = 1000 mcg, so 125 mcg = 0.125 mg. This equivalence only prevents unit misreading and does not determine anyone's tablet count or amount." } }, { "question": { "zh": "药单里同时有地高辛和胺碘酮，可以按原来的方法继续吃吗？", "en": "If digoxin and amiodarone are both on the medicine list, can the previous routine simply continue?" }, "answer": { "zh": "网页不能确认。当前官方标签同时提示地高辛浓度升高及心率／传导方面的联用风险线索；应尽快由开方团队或药师核对两盒实际药、完整药单、肾功能、电解质、心率／心电及既有监测结果。不要自行停用、错开、掰片、补服或调整任何一种药。", "en": "A webpage cannot confirm that. Current official labels flag both increased digoxin concentration and rate/conduction concerns with this combination. Promptly have the prescribing team or pharmacist review both actual packs, the complete medicine list, kidney function, electrolytes, heart-rate/ECG information and existing monitoring results. Do not self-stop, separate, split, catch up or adjust either medicine." } }, { "question": { "zh": "老人一直吃同样的地高辛，为什么还要看肾功能和新加的药？", "en": "Why should an older adult on the same digoxin routine still review kidney function and newly added medicines?" }, "answer": { "zh": "当前 LANOXIN 标签说明高龄、低体重、肾功能受损和电解质异常会增加地高辛毒性风险；地高辛主要经肾脏排泄，联用药也可能改变其浓度或心率／传导效应。是否需要改变方案必须由专业人员结合准确产品、检查与监测判断，网页不能给出减量或停药结论。", "en": "The current LANOXIN label identifies advanced age, low body weight, impaired renal function and electrolyte abnormalities as toxicity risk factors. Digoxin is mainly excreted by the kidneys, and co-medications may alter its concentration or rate/conduction effects. Any change requires professional interpretation of the exact product, tests and monitoring; this page provides no reduction or stopping decision." } }, { "question": { "zh": "服地高辛时出现恶心、视物异常、明显乏力、心悸或晕厥怎么办？", "en": "What should someone do if nausea, visual changes, marked weakness, palpitations or fainting occurs while taking digoxin?" }, "answer": { "zh": "这些可能是需要及时评估的警讯，但网页不能判断原因。应立即联系负责团队；若症状严重、出现晕厥、明显意识改变、胸部严重不适或其他急性危险表现，应使用当地紧急医疗渠道。不要等待网页答复，也不要自行补服、停用或换药。", "en": "These can be warning signs requiring prompt assessment, but a webpage cannot determine the cause. Contact the responsible team immediately; severe symptoms, fainting, marked altered awareness, serious chest discomfort or another acute danger sign requires local emergency care. Do not wait for a web answer or self-catch-up, stop or switch." } } ], "relatedMedicineChecks": [ { "target": { "id": "amiodarone-cordarone", "brand": "CORDARONE", "generic": "胺碘酮", "canonicalUrls": { "zh": "https://origindrug.com/drugs/amiodarone-cordarone/", "en": "https://origindrug.com/en/drugs/amiodarone-cordarone/" } }, "title": { "zh": "与 CORDARONE／胺碘酮同在药单上时：地高辛浓度与心率／传导都要专业核对", "en": "When CORDARONE / amiodarone is on the same list: digoxin concentration and rate/conduction need professional review" }, "summary": { "zh": "当前美国 LANOXIN 片剂标签说明：地高辛的中毒浓度只略高于治疗浓度，选择方案时要考虑年龄、体重、肾功能和联用药；其相互作用表还列出胺碘酮会升高地高辛血清浓度。当前胺碘酮通用名标签同时把地高辛列为可增强心动过缓、窦性停搏和房室传导阻滞风险线索的负性变时药。本卡只要求尽快把两种实际药盒、完整药单、近期肾功能／电解质、心率或心电记录及既有地高辛监测结果交给开方团队或药师核对；它不判断能否同用，不提供浓度目标、减量比例、给药间隔、停药或换药方案，也不建议自行错开、掰片、漏服补用或调整任何一种药。CORDARONE 页面属于历史品牌档案；当前通用名标签不证明该品牌当前供应。", "en": "The current U.S. LANOXIN tablet label says toxic digoxin concentrations are only slightly higher than therapeutic concentrations, and that age, body weight, renal function and concomitant medicines matter when a regimen is selected; its interaction table also lists increased serum digoxin concentration with amiodarone. A current U.S. generic amiodarone label separately lists digoxin as a negative chronotrope that can add to bradycardia, sinus arrest and AV block. This card only calls for prompt review of both actual packs, the complete medicine list, recent kidney-function/electrolyte information, heart-rate or ECG records and any existing digoxin-monitoring results by the prescribing team or pharmacist. It does not decide co-use or provide a concentration target, reduction percentage, timing interval, stop or switch plan, and does not advise self-separation, tablet splitting, catch-up use or adjustment of either medicine. The CORDARONE page is a historical brand archive; a current generic label does not establish current brand supply." }, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（胺碘酮相互作用、治疗窗与老人／肾功能核对）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lanoxin/", "en": "https://origindrug.com/en/drugs/lanoxin/" }, "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." ] }