{ "id": "cardura-doxazosin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "CARDURA", "generic": "多沙唑嗪普通片", "aliases": [ "Cardura", "doxazosin", "doxazosin mesylate", "多沙唑嗪", "甲磺酸多沙唑嗪", "可多华", "doxazosin tablets", "甲磺酸多沙唑嗪片", "CARDURA", "NDA 019668", "58151-074-01", "58151-075-01", "58151-076-01", "58151-077-01", "CN1 VLE", "CN2 VLE", "CN4 VLE", "CN8 VLE" ], "marketBrandNames": [ { "name": "CARDURA", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 019668；当前品牌标签列 1、2、4、8 mg 普通片。监管标签不等于实时供应。", "en": "NDA 019668; the current brand label lists 1, 2, 4 and 8 mg immediate-release tablets. A regulatory label is not live supply." }, "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 当前品牌标签列 CARDURA 1、2、4、8 mg 普通片四个 100 片瓶装，均归入 NDA 019668。网页核对的是当前标签与包装身份，不证明当地实时库存、购买资格、个人适用性或其他国家包装。", "dosageFormClass": "多沙唑嗪普通口服片。CARDURA XL 是 4 mg、8 mg 缓释片，使用不同 NDA、缓释结构、包装与说明书；即使成分和 mg 相同，也不能自行一比一替换、掰碎或拼接。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1990（美国初始批准年份）", "archiveSponsorText": "Viatris Specialty LLC（当前美国品牌标签分销方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "CARDURA", "Cardura doxazosin", "多沙唑嗪片", "甲磺酸多沙唑嗪片", "可多华" ], "excludedProductCues": [ "CARDURA XL", "doxazosin extended release", "多沙唑嗪缓释片", "FLOMAX", "tamsulosin", "坦索罗辛", "MINIPRESS", "prazosin", "HYTRIN", "terazosin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cardura-doxazosin-1mg-100-tablet-bottle-ndc-5815107401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（患者信息修订 2023-10；当前 SPL 2026-07-16 发布）", "en": "Current U.S. DailyMed brand label (patient information revised Oct 2023; current SPL published 16 Jul 2026)" }, "dosageForm": { "zh": "CARDURA 多沙唑嗪普通口服片", "en": "CARDURA doxazosin immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-074-01", "pouchCode": null, "applicationNumber": "NDA 019668", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多沙唑嗪 1 mg；100 片瓶装", "en": "Doxazosin 1 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多沙唑嗪（以游离碱计）", "en": "doxazosin (as free base)" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加量步骤或与 CARDURA XL 的换算值", "en": "labelled amount per tablet; not an individual's tablet count, titration step or a conversion to CARDURA XL" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "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": "圆形、无刻痕，约 7 mm", "en": "round and unscored, approximately 7 mm" }, "imprint": "CN1 / VLE", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cardura-doxazosin-2mg-100-tablet-bottle-ndc-5815107501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（患者信息修订 2023-10；当前 SPL 2026-07-16 发布）", "en": "Current U.S. DailyMed brand label (patient information revised Oct 2023; current SPL published 16 Jul 2026)" }, "dosageForm": { "zh": "CARDURA 多沙唑嗪普通口服片", "en": "CARDURA doxazosin immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-075-01", "pouchCode": null, "applicationNumber": "NDA 019668", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多沙唑嗪 2 mg；100 片瓶装", "en": "Doxazosin 2 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-05.jpg&setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多沙唑嗪（以游离碱计）", "en": "doxazosin (as free base)" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加量步骤或与 CARDURA XL 的换算值", "en": "labelled amount per tablet; not an individual's tablet count, titration step or a conversion to CARDURA XL" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "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": "长圆形、有刻痕，约 9 mm", "en": "oblong and scored, approximately 9 mm" }, "imprint": "CN2 / VLE", "scoreStatus": "scored_not_personal_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cardura-doxazosin-4mg-100-tablet-bottle-ndc-5815107601", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（患者信息修订 2023-10；当前 SPL 2026-07-16 发布）", "en": "Current U.S. DailyMed brand label (patient information revised Oct 2023; current SPL published 16 Jul 2026)" }, "dosageForm": { "zh": "CARDURA 多沙唑嗪普通口服片", "en": "CARDURA doxazosin immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-076-01", "pouchCode": null, "applicationNumber": "NDA 019668", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多沙唑嗪 4 mg；100 片瓶装", "en": "Doxazosin 4 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-06.jpg&setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多沙唑嗪（以游离碱计）", "en": "doxazosin (as free base)" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加量步骤或与 CARDURA XL 的换算值", "en": "labelled amount per tablet; not an individual's tablet count, titration step or a conversion to CARDURA XL" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "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": "菱形、有刻痕，约 12 mm", "en": "rhombus-shaped and scored, approximately 12 mm" }, "imprint": "CN4 / VLE", "scoreStatus": "scored_not_personal_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cardura-doxazosin-8mg-100-tablet-bottle-ndc-5815107701", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（患者信息修订 2023-10；当前 SPL 2026-07-16 发布）", "en": "Current U.S. DailyMed brand label (patient information revised Oct 2023; current SPL published 16 Jul 2026)" }, "dosageForm": { "zh": "CARDURA 多沙唑嗪普通口服片", "en": "CARDURA doxazosin immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-077-01", "pouchCode": null, "applicationNumber": "NDA 019668", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多沙唑嗪 8 mg；100 片瓶装", "en": "Doxazosin 8 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-07.jpg&setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多沙唑嗪（以游离碱计）", "en": "doxazosin (as free base)" }, "value": 8, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加量步骤或与 CARDURA XL 的换算值", "en": "labelled amount per tablet; not an individual's tablet count, titration step or a conversion to CARDURA XL" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "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": "胶囊形、有刻痕，约 12 mm", "en": "capsule-shaped and scored, approximately 12 mm" }, "imprint": "CN8 / VLE", "scoreStatus": "scored_not_personal_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-cardura-doxazosin-1mg-100-tablet-bottle-ndc-5815107401", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "alt": "CARDURA 多沙唑嗪 1 mg、NDC 58151-074-01、100 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（2026-07-16 发布）", "presentation": "1 mg：白色圆形、约 7 mm、无刻痕，CN1 / VLE；NDC 58151-074-01，100 片瓶装。另有 2、4、8 mg 当前准确包装，必须按 NDC 分开核对。", "notice": "此图只对应美国 NDC 58151-074-01 的 1 mg、100 片瓶装，不代表 CARDURA XL、其他国家包装、仿制品或实时库存，也不用于鉴定真伪。", "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CARDURA 说明书放大阅读：分清每片 mg、整瓶片数、普通片与 CARDURA XL", "en": "CARDURA enlarged label: separate per-tablet mg, bottle count, immediate-release tablets and CARDURA XL" }, "summary": { "zh": "1、2、4、8 mg 是每片多沙唑嗪标示量；100 Tablets 是整瓶片数。CARDURA XL 的 4/8 mg 是另一缓释产品，不能因为同成分同数字就自行替换。", "en": "The 1, 2, 4 and 8 mg figures are labelled doxazosin per tablet; 100 Tablets is the bottle count. CARDURA XL 4/8 mg is a separate extended-release product and cannot be self-substituted because ingredient and number match." }, "checks": [ { "zh": "标签警示站立性低血压、头晕和晕厥，特别是在开始、增加规格或中断后恢复时。老人、已有跌倒或同时使用其他降压药者应优先带完整药单核对；网页不生成恢复或加量方案。", "en": "The label warns about postural hypotension, dizziness and syncope, particularly when starting, increasing a strength or resuming after interruption. Older adults, people with falls or another blood-pressure medicine require priority full-list review; the site generates no restart or titration plan." }, { "zh": "CIALIS、VIAGRA 等 PDE-5 抑制剂与 CARDURA 同用可叠加降压并引起症状性低血压；强 CYP3A 抑制剂也可能增加暴露。不要自己错开、减半或停掉其中一盒。", "en": "PDE-5 inhibitors such as CIALIS or VIAGRA can add to blood-pressure lowering and cause symptomatic hypotension with CARDURA; strong CYP3A inhibitors may also increase exposure. Do not self-separate, halve or stop a pack." }, { "zh": "准备白内障手术时，应主动告知眼科团队现在或过去使用过 CARDURA/其他 α1 阻滞剂。标签并不支持患者为此自行停药。", "en": "Before cataract surgery, tell the eye team about current or previous CARDURA/other alpha-1 blocker use. The label does not support self-stopping for this reason." }, { "zh": "2、4、8 mg 片有刻痕，但刻痕只是准确产品的外观线索，不是网页允许个人分片、改变剂量或替代另一规格的指令。", "en": "The 2, 4 and 8 mg tablets are scored, but the score is an appearance clue for the exact product—not website permission to split, change an amount or replace another strength." } ], "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "多沙唑嗪怎样起作用：阻断 α1 肾上腺素能受体，影响前列腺/膀胱颈平滑肌张力与外周血管阻力", "en": "How doxazosin works: alpha-1 adrenergic blockade affects prostate/bladder-neck smooth-muscle tone and systemic vascular resistance" }, "summary": { "zh": "当前标签说明，阻断前列腺基质、包膜与膀胱颈的 α1 受体可降低尿道阻力；在高血压场景，选择性 α1 阻断降低全身血管阻力。一个机制可关联两类标签用途，但不能根据症状、血压或前列腺大小自行选择规格或与其他 α 阻滞剂叠加。", "en": "The current label explains that alpha-1 blockade in prostatic stroma, capsule and bladder neck can reduce urethral resistance, while selective alpha-1 blockade in hypertension reduces systemic vascular resistance. One mechanism can relate to two labelled settings, but symptoms, blood pressure or prostate size do not permit self-selection of strength or combination with another alpha blocker." }, "checks": [ { "zh": "CARDURA、FLOMAX、MINIPRESS 与 HYTRIN 不是同一种药；共同的 α 阻滞相关机制不建立 mg 换算、轮换或叠加规则。", "en": "CARDURA, FLOMAX, MINIPRESS and HYTRIN are not one medicine. A related alpha-blocker mechanism does not establish milligram conversion, alternation or combination." }, { "zh": "CARDURA 普通片与 CARDURA XL 缓释片的释放结构、NDA 和准确包装不同。XL 标签还说明可能排出看似药片的空壳；这不能套用到普通片，也不能自行压碎缓释片。", "en": "CARDURA immediate-release and CARDURA XL have different release structures, NDAs and exact packs. The XL label also explains that an empty shell may appear in stool; this does not apply to immediate-release tablets or permit crushing the extended-release tablet." }, { "zh": "作用机理不能替代完整药单与个体评估。老人出现站立不稳、晕厥、跌倒，或同用降压药、PDE-5 抑制剂时，应及时核对而不是自行停换。", "en": "Mechanism does not replace complete-list and individual review. Unsteadiness on standing, syncope or a fall in an older adult, or co-use with blood-pressure or PDE-5 medicines, requires timely review rather than self-stopping or switching." } ], "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CARDURA", "generic": "多沙唑嗪普通片", "dosageFormClass": "多沙唑嗪普通口服片。CARDURA XL 是 4 mg、8 mg 缓释片，使用不同 NDA、缓释结构、包装与说明书；即使成分和 mg 相同，也不能自行一比一替换、掰碎或拼接。" }, "labelSource": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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_c95032586bca0c04", "label": "DailyMed（NLM）：CARDURA XL 多沙唑嗪缓释片当前美国品牌标签（仅用于剂型边界）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=355bcdce-0481-48ba-8ebd-2009106aaf77", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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": "2026-09-02", "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": "CARDURA 是多沙唑嗪普通片品牌档案，标签涉及良性前列腺增生症状与高血压。1/2/4/8 mg 是每片含量，100 Tablets 是整瓶片数，不是个人片数。老人或多药使用者尤其要核对站立性低血压、晕厥、跌倒、PDE-5 抑制剂、其他降压药、强 CYP3A 抑制剂和白内障手术信息；网页不替个人决定规格、次数或换药。", "history": "CARDURA 的美国初始批准年份为 1990。FDA 2009 年补充批准函确认 NDA 019668 下 1、2、4、8 mg 片；当前 DailyMed 品牌标签的患者信息修订于 2023-10，当前 SPL 于 2026-07-16 发布，并展示四个 Viatris 100 片瓶装。CARDURA XL 另属 NDA 021269，不能合并为同一剂型。", "sourceDocuments": [ { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_c95032586bca0c04", "label": "DailyMed（NLM）：CARDURA XL 多沙唑嗪缓释片当前美国品牌标签（仅用于剂型边界）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=355bcdce-0481-48ba-8ebd-2009106aaf77", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_c14c1243de3a5757", "label": "FDA：CARDURA 多沙唑嗪片 NDA 019668/S-021 补充批准函（1、2、4、8 mg）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019668s021ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "NDA 019668", "approvalTimeline": [ { "date": "1990", "title": { "zh": "CARDURA 美国初始批准", "en": "Initial U.S. approval of CARDURA" }, "detail": { "zh": "当前 DailyMed 标签列示的初始批准年份。", "en": "Initial approval year stated by the current DailyMed label." }, "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2009-07-08", "title": { "zh": "FDA 批准补充标签", "en": "FDA approved a supplemental label" }, "detail": { "zh": "补充批准函确认 1、2、4、8 mg 片，并增加 PDE-5 抑制剂相关低血压信息。", "en": "The supplement letter confirms 1, 2, 4 and 8 mg tablets and adds hypotension information for PDE-5 inhibitors." }, "source": { "id": "src_c14c1243de3a5757", "label": "FDA：CARDURA 多沙唑嗪片 NDA 019668/S-021 补充批准函（1、2、4、8 mg）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019668s021ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-07-16", "title": { "zh": "当前 DailyMed SPL 发布", "en": "Current DailyMed SPL published" }, "detail": { "zh": "当前四个 Viatris 品牌瓶装与 2023-10 患者信息可公开阅读。", "en": "The current four Viatris brand bottles and Oct 2023 patient information are publicly readable." }, "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "NDA 019668；1、2、4、8 mg 普通片，四个 100 片瓶装。", "en": "NDA 019668; 1, 2, 4 and 8 mg immediate-release tablets in four 100-tablet bottles." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地商品名、包装或供应", "en": "Local brand, pack and supply are not established by this dossier" }, "detail": { "zh": "“可多华”等名称须与当地药监记录、说明书和手中药盒逐项核对。", "en": "Names such as 可多华 require item-by-item checking against the local regulator, leaflet and pack in hand." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "CARDURA 4 mg 能直接换成 CARDURA XL 4 mg 吗？", "en": "Can CARDURA 4 mg be directly replaced by CARDURA XL 4 mg?" }, "answer": { "zh": "不能从共同成分和相同数字作这种结论。它们属于不同 NDA、释放结构和说明书；请让开方团队按准确产品、用途、血压和完整药单判断，不要自行一比一替换。", "en": "No conclusion can be drawn from a shared ingredient and matching number. They have different NDAs, release structures and labels; the prescriber must review the exact products, purpose, blood pressure and full medicine list. Do not self-substitute one-for-one." } }, { "question": { "zh": "药片有刻痕，是不是都可以吃半片？", "en": "Does a score mean every tablet can be taken as a half?" }, "answer": { "zh": "不是。刻痕可帮助识别准确产品，但能否分片还取决于处方、产品说明书、分割均匀性和个人方案。1 mg 当前片无刻痕；任何规格都不要仅凭刻痕自行减半。", "en": "No. A score can help identify an exact product, but splitting still depends on the prescription, product label, dose uniformity and individual plan. The current 1 mg tablet is unscored; do not self-halve any strength from the score alone." } }, { "question": { "zh": "同时有 FLOMAX、CARDURA、CIALIS 或其他降压药怎么办？", "en": "What if FLOMAX, CARDURA, CIALIS or another blood-pressure medicine are on the same list?" }, "answer": { "zh": "不要自行删掉或错开任何一盒。共同用途、α 阻滞或降压作用可能增加头晕、站立性低血压、晕厥与跌倒风险，也可能是专业人员有意安排；只有准确药盒、处方、血压和完整药单能判断。", "en": "Do not remove or separate a pack yourself. Shared uses, alpha blockade or blood-pressure effects may increase dizziness, orthostatic hypotension, syncope and falls, or may be intentionally prescribed. Only exact packs, prescriptions, blood pressure and the complete list can establish this." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/cardura-doxazosin/", "en": "https://origindrug.com/en/drugs/cardura-doxazosin/" }, "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." ] }