{ "id": "flomax", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "FLOMAX", "generic": "坦索罗辛", "aliases": [ "Flomax", "tamsulosin", "tamsulosin hydrochloride", "tamsulosin hydrochloride capsules", "坦索罗辛", "盐酸坦索罗辛", "盐酸坦索罗辛胶囊", "NDA 020579", "0024-5837-01", "NDC 0024-5837-01", "BI 58", "Flomax 0 4 mg BI 58" ], "marketBrandNames": [ { "name": "FLOMAX", "market": { "zh": "美国历史品牌档案", "en": "U.S. historical brand archive" }, "evidenceStatus": "dated_brand_pack_marketing_ended", "note": { "zh": "NDA 020579；0.4 mg、NDC 0024-5837-01、100 粒瓶装；公开营销记录于 2025-10-31 结束。", "en": "NDA 020579; 0.4 mg, NDC 0024-5837-01, 100-capsule bottle; the public marketing record ended 31 Oct 2025." }, "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国官方资料将 FLOMAX 与 NDA 020579、坦索罗辛盐酸盐 0.4 mg 胶囊、NDC 0024-5837-01 和 100 粒瓶装相连。该品牌 NDC 的公开营销终止日期为 2025-10-31，因此本页保存的是有日期的品牌身份档案，不代表当前库存、可购买性、真伪或其他市场状态。", "dosageFormClass": "坦索罗辛盐酸盐普通口服硬胶囊 0.4 mg；0.4 mg 是每粒标签标示量，100 是所示品牌瓶内粒数。胶囊不得压碎、咀嚼或打开；这些字段不能变成个人服用、恢复、加量、停用或替换方案。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997-04-15（美国 NDA 020579 原始批准日期）", "archiveSponsorText": "Boehringer Ingelheim Pharmaceuticals（美国 NDA 020579 品牌标签）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "FLOMAX", "FLOMAX tamsulosin hydrochloride", "tamsulosin hydrochloride capsules", "盐酸坦索罗辛胶囊" ], "excludedProductCues": [ "UROXATRAL", "alfuzosin", "RAPAFLO", "silodosin", "HYTRIN", "terazosin", "CARDURA", "doxazosin", "MINIPRESS", "prazosin", "CIALIS", "tadalafil" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-flomax-tamsulosin-hydrochloride-0-4mg-100-capsule-bottle-ndc-0024583701", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国品牌标签（SPL v10；2025-01-02 生效）", "en": "U.S. DailyMed brand label (SPL v10; effective 2 Jan 2025)" }, "dosageForm": { "zh": "FLOMAX 坦索罗辛盐酸盐 0.4 mg 口服硬胶囊", "en": "FLOMAX tamsulosin hydrochloride 0.4 mg oral hard capsule" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-5837-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒坦索罗辛盐酸盐 0.4 mg；100 粒瓶装", "en": "Tamsulosin hydrochloride 0.4 mg per capsule; 100-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "坦索罗辛盐酸盐", "en": "tamsulosin hydrochloride" }, "value": 0.4, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人服用、恢复或加量指令", "en": "labelled amount per capsule; not an individual dosing, restart or escalation instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "dated_brand_record_marketing_ended_not_live_stock", "marketingStartDate": null, "marketingEndDate": "2025-10-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "橄榄绿色不透明胶囊帽、橙色不透明胶囊体", "en": "olive-green opaque cap and orange opaque body" }, "shape": { "zh": "19 mm 硬胶囊；无刻痕；胶囊不得压碎、咀嚼或打开", "en": "19 mm hard capsule; unscored; capsule must not be crushed, chewed or opened" }, "imprint": "Flomax; 0; 4; mg; BI; 58", "scoreStatus": "unscored_do_not_crush_chew_or_open", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "品牌文字身份完整，官方包装图片直链不可用", "en": "Brand text identity is complete; the official package-image endpoint was unusable" }, "summary": { "zh": "DailyMed 品牌标签列出 FLOMAX、NDA 020579、NDC 0024-5837-01、每粒 0.4 mg、100 粒瓶装、胶囊颜色、19 mm 尺寸及 BI 58 印记；但复核时官方包装图片直链未返回可用图像内容。本站因此仅展示文字身份，不以占位图、搜索图或再包装图代替，也不用于真伪、供应或购买判断。", "en": "The DailyMed brand label lists FLOMAX, NDA 020579, NDC 0024-5837-01, 0.4 mg per capsule, a 100-capsule bottle, capsule colours, 19 mm size and the BI 58 imprint; however, its official package-image endpoint returned no usable image content during review. The site therefore shows text identity only and does not substitute a placeholder, search image or repackaged image, or use it for authenticity, supply or purchase decisions." }, "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "FLOMAX 说明书放大阅读：0.4 mg、完整吞服、头晕跌倒与手术告知", "en": "Enlarged FLOMAX label: 0.4 mg, intact swallowing, dizziness/falls and surgical disclosure" }, "summary": { "zh": "本模块帮助识别每粒含量、胶囊完整性、体位性低血压、相互作用与眼科手术告知。标签中的用法与中断后恢复段落不转写为个人方案。", "en": "This module identifies per-capsule strength, capsule integrity, orthostatic hypotension, interactions and eye-surgery disclosure. Label dosing and restart paragraphs are not converted into an individual plan." }, "checks": [ { "zh": "标签将 FLOMAX 用于良性前列腺增生相关症状，并明确它不用于治疗高血压。排尿症状、头晕或“α 阻滞剂”字样都不能支持自行换药或叠加。", "en": "The label uses FLOMAX for signs and symptoms of benign prostatic hyperplasia and states that it is not indicated for hypertension. Urinary symptoms, dizziness or the words alpha blocker do not support self-switching or combining medicines." }, { "zh": "胶囊应保持完整，不得压碎、咀嚼或打开。0.4 mg 是每粒标签量，不是根据网页自行决定的起始、恢复、加量、漏服补服或停药规则。", "en": "The capsule should remain intact and must not be crushed, chewed or opened. The 0.4 mg figure is a labelled amount per capsule, not a website-derived rule for starting, restarting, increasing, replacing missed doses or stopping." }, { "zh": "起立时头晕、低血压或晕厥可能导致跌倒。老人、夜间起身者和同时使用其他影响血压药物者，应把准确药盒、症状和完整药单交给医生或药师核对。", "en": "Dizziness on standing, hypotension or syncope may lead to falls. Older adults, people rising at night and those using other blood-pressure-affecting medicines should have the exact pack, symptoms and complete medicine list reviewed by a clinician or pharmacist." }, { "zh": "白内障或青光眼手术前，应告知眼科团队现在或过去使用过坦索罗辛；标签同时说明，术前停用的获益尚未确立，不能据网页自行停药。", "en": "Before cataract or glaucoma surgery, tell the eye-care team about current or past tamsulosin use. The label also says the benefit of stopping before surgery has not been established, so do not stop it from a web page." }, { "zh": "晕厥、跌倒受伤或严重虚弱需要及时医疗评估；持续数小时的疼痛性勃起是急症信号，应立即使用当地急救渠道。", "en": "Syncope, an injurious fall or severe weakness needs timely medical assessment. A painful erection lasting hours is an emergency signal requiring immediate local emergency care." } ], "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "坦索罗辛怎样起作用：松弛前列腺与膀胱颈平滑肌，不等于缩小前列腺或治疗高血压", "en": "How tamsulosin works: relaxing prostate and bladder-neck smooth muscle does not shrink the prostate or treat hypertension" }, "summary": { "zh": "标签将坦索罗辛描述为 α1 肾上腺素能受体阻断剂，其作用可松弛前列腺和膀胱颈平滑肌、改善尿流。机理也解释体位性低血压边界，但不能选择个人剂量、联用或替代药。", "en": "The label describes tamsulosin as an alpha-1 adrenergic receptor blocker that can relax smooth muscle in the prostate and bladder neck and improve urine flow. The mechanism also helps explain orthostatic-hypotension boundaries but cannot select an individual dose, combination or substitute." }, "checks": [ { "zh": "FLOMAX、UROXATRAL、RAPAFLO、HYTRIN、CARDURA 和 MINIPRESS 是不同成分或产品。作用类别相关不建立 mg 换算、轮换、同服或替换规则。", "en": "FLOMAX, UROXATRAL, RAPAFLO, HYTRIN, CARDURA and MINIPRESS are different ingredients or products. Related pharmacology creates no milligram conversion, alternation, combination or substitution rule." }, { "zh": "它不缩小前列腺，也不用于高血压。作用机理不能代替症状评估、血压、跌倒史、手术计划和完整药单。", "en": "It does not shrink the prostate and is not indicated for hypertension. Mechanism cannot replace assessment of symptoms, blood pressure, falls, surgical plans and the complete medicine list." }, { "zh": "相同通用名也可能有不同厂家、辅料、包装、市场与标签日期；作用机理相同不能证明实物真伪、当前供应或可自行替代。", "en": "The same generic name can still have different manufacturers, excipients, packs, markets and label dates. A shared mechanism cannot prove authenticity, current supply or self-substitutability." } ], "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "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": "FLOMAX", "generic": "坦索罗辛", "dosageFormClass": "坦索罗辛盐酸盐普通口服硬胶囊 0.4 mg；0.4 mg 是每粒标签标示量，100 是所示品牌瓶内粒数。胶囊不得压碎、咀嚼或打开；这些字段不能变成个人服用、恢复、加量、停用或替换方案。" }, "labelSource": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "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_8c888fa3209fadb7", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐品牌电子说明书 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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": "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." } } ], "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": "FLOMAX 是坦索罗辛盐酸盐的美国品牌历史档案，用于良性前列腺增生相关症状的标签阅读，不是降压药。老人、夜间起身者、有头晕、晕厥或跌倒史者，应特别核对体位性低血压、其他 α 阻滞剂、PDE5 抑制剂和强 CYP3A4 抑制剂；网页不提供个人起始、恢复、停药、加量或换药方案。", "history": "FDA 原始批准资料记录 FLOMAX NDA 020579 于 1997-04-15 获批。2014-09-29 的补充批准函记录 S-029 标签更新。DailyMed SPL v10 于 2025-01-02 生效，保留 0.4 mg、100 粒品牌瓶装及 BI 58 胶囊线索；该 NDC 的营销记录于 2025-10-31 结束。", "sourceDocuments": [ { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_8c888fa3209fadb7", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐品牌电子说明书 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_fcbe041e382b3a8a", "label": "FDA：FLOMAX（NDA 020579）1997 年原始批准资料包", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020579ap.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_ea3f4b403da307a4", "label": "FDA：FLOMAX NDA 020579/S-029 补充批准函（2014-09-29）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020579Orig1s029ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 020579", "approvalTimeline": [ { "date": "1997-04-15", "title": { "zh": "FDA 批准 FLOMAX NDA", "en": "FDA approval of the FLOMAX NDA" }, "detail": { "zh": "FDA 原始批准资料包记录 NDA 020579 的批准。", "en": "The FDA original approval package records approval of NDA 020579." }, "source": { "id": "src_fcbe041e382b3a8a", "label": "FDA：FLOMAX（NDA 020579）1997 年原始批准资料包", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020579ap.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2014-09-29", "title": { "zh": "FDA 批准 S-029 标签补充", "en": "FDA approval of the S-029 labelling supplement" }, "detail": { "zh": "补充批准函记录相应标签更新。", "en": "The supplement approval letter records the corresponding label update." }, "source": { "id": "src_ea3f4b403da307a4", "label": "FDA：FLOMAX NDA 020579/S-029 补充批准函（2014-09-29）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020579Orig1s029ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-01-02", "title": { "zh": "DailyMed SPL v10 生效", "en": "DailyMed SPL v10 became effective" }, "detail": { "zh": "该版本保留 0.4 mg 品牌胶囊、100 粒瓶装和外观文字线索。", "en": "This version preserves the 0.4 mg brand capsule, 100-capsule bottle and textual appearance clues." }, "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-10-31", "title": { "zh": "所示品牌 NDC 营销记录结束", "en": "Marketing record ended for the displayed brand NDC" }, "detail": { "zh": "这是监管目录字段，不等于全球停售，也不证明任何渠道库存。", "en": "This is a regulatory-listing field, not proof of global discontinuation or any channel's stock." }, "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国 FLOMAX 品牌包装", "en": "U.S. FLOMAX brand pack" }, "status": { "zh": "所示 NDC 营销记录已结束", "en": "Marketing record ended for the displayed NDC" }, "detail": { "zh": "0.4 mg、NDC 0024-5837-01、100 粒瓶装；结束日期 2025-10-31。", "en": "0.4 mg, NDC 0024-5837-01, 100-capsule bottle; end date 31 Oct 2025." } }, { "market": { "zh": "其他厂家与市场", "en": "Other manufacturers and markets" }, "status": { "zh": "本档案未逐项建立", "en": "Not individually established in this dossier" }, "detail": { "zh": "不得由该美国品牌记录推定中国大陆、欧盟、日本或其他市场的批准、供应、价格、真伪或可替代性。", "en": "This U.S. brand record cannot establish approval, supply, price, authenticity or substitutability in Mainland China, the EU, Japan or another market." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "FLOMAX 是降压药吗？", "en": "Is FLOMAX a blood-pressure medicine?" }, "answer": { "zh": "不是。美国品牌标签明确它不用于治疗高血压。它仍可能引起体位性低血压、头晕或晕厥，所以完整药单和跌倒风险需要专业核对。", "en": "No. The U.S. brand label explicitly states it is not indicated for hypertension. It can still cause orthostatic hypotension, dizziness or syncope, so the full medicine list and fall risk need professional review." } }, { "question": { "zh": "0.4 mg 胶囊可以打开或压碎吗？", "en": "Can the 0.4 mg capsule be opened or crushed?" }, "answer": { "zh": "标签明确胶囊不得压碎、咀嚼或打开。吞咽困难或剂型疑问应联系开方医生或药师，不自行处理胶囊。", "en": "The label explicitly says the capsule must not be crushed, chewed or opened. Ask the prescriber or pharmacist about swallowing or dosage-form concerns rather than altering the capsule." } }, { "question": { "zh": "停了几天能按原来方式恢复吗？", "en": "Can it be restarted the same way after several missed days?" }, "answer": { "zh": "网页不提供恢复方案。标签有专门的中断后恢复段落，而低血压、晕厥、合并用药和个人情况会影响判断；应联系开方团队。", "en": "This page does not provide a restart plan. The label has a specific restart paragraph, and hypotension, syncope, co-medications and individual factors affect the decision; contact the prescribing team." } }, { "question": { "zh": "品牌营销记录结束是否等于坦索罗辛买不到？", "en": "Does the ended brand marketing record mean tamsulosin is unavailable?" }, "answer": { "zh": "不能这样推断。该日期只约束所示美国品牌 NDC；它既不证明全球停售，也不代表其他厂家、市场或渠道的实时库存。", "en": "No. The date applies only to the displayed U.S. brand NDC; it proves neither global discontinuation nor live stock for other manufacturers, markets or channels." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/flomax/", "en": "https://origindrug.com/en/drugs/flomax/" }, "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." ] }