{ "id": "rapaflo-silodosin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "RAPAFLO", "generic": "西洛多辛胶囊", "aliases": [ "Rapaflo", "silodosin", "西洛多辛", "西洛多辛胶囊", "优利福", "WATSON 151", "WATSON 152", "RAPAFLO", "silodosin capsules", "NDA 022206", "0023-6142-30", "0023-6142-90", "0023-6147-30" ], "marketBrandNames": [ { "name": "RAPAFLO", "market": { "zh": "美国（历史）", "en": "United States (historical)" }, "evidenceStatus": "historical_public_record", "note": { "zh": "NDA 022206；4 mg／8 mg 历史 RLD 当前均列 DISCN，不代表当前品牌供应。", "en": "NDA 022206; the historical 4 mg and 8 mg RLD rows are currently DISCN and do not establish current brand supply." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据入口：RAPAFLO／silodosin NDA 022206 两个历史 RLD 规格均列 DISCN", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "FDA Orange Book 当前把 RAPAFLO 西洛多辛 4 mg 与 8 mg 胶囊、NDA 022206 列为历史 RLD，两个规格均为 DISCN。DailyMed 历史原品牌标签保留 8 mg 的 30／90 粒瓶装与 4 mg 的 30 粒瓶装；最后两个在册品牌 NDC 的营销记录已于 2026-03-31 结束。历史标签、历史包装图、当前通用药、实时库存和其他市场供应不得混写。", "dosageFormClass": "西洛多辛 4 mg／8 mg 口服硬明胶胶囊（历史 RAPAFLO 原品牌）。RAPAFLO、FLOMAX、UROXATRAL、CARDURA／CARDURA XL、HYTRIN、MINIPRESS 及含度他雄胺复方是不同准确产品；共同用途或 α 阻滞机制不建立 mg 换算、开胶囊、叠加、轮换或替换规则。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2008-10-08（FDA NDA 022206 批准日期）", "archiveSponsorText": "AbbVie Inc.（FDA 当前 NDA 申请持有人）；历史标签列 Allergan／Kissei" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "RAPAFLO", "Rapaflo silodosin", "silodosin capsules", "西洛多辛胶囊" ], "excludedProductCues": [ "RAPAMUNE", "sirolimus", "西罗莫司", "FLOMAX", "tamsulosin", "坦索罗辛", "UROXATRAL", "alfuzosin", "CARDURA", "doxazosin", "HYTRIN", "terazosin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-rapaflo-silodosin-8mg-30-capsule-bottle-ndc-0023614230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史原品牌标签（2020-12 修订；该 NDC 营销结束 2026-03-31）", "en": "Historical U.S. originator-brand DailyMed label (revised Dec 2020; marketing for this NDC ended 2026-03-31)" }, "dosageForm": { "zh": "RAPAFLO 西洛多辛口服硬明胶胶囊（历史原品牌）", "en": "RAPAFLO silodosin oral hard-gelatin capsule (historical originator brand)" }, "route": { "zh": "口服（历史品牌产品身份字段）", "en": "oral (historical brand product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0023-6142-30", "pouchCode": null, "applicationNumber": "NDA 022206", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒西洛多辛 8 mg；30 粒防儿童开启瓶装；历史 RLD、当前 DISCN", "en": "8 mg silodosin per capsule; 30-capsule child-resistant bottle; historical RLD, currently DISCN" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rapaflo-07.jpg&archiveid=889761", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西洛多辛", "en": "silodosin" }, "value": 8, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "历史品牌每粒标示量；不是个人粒数、频率或与另一种 α 阻滞剂的换算值", "en": "historical brand amount per capsule; not an individual's capsule count, frequency or conversion to another alpha blocker" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": "2026-03-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明", "en": "white opaque" }, "shape": { "zh": "硬明胶胶囊；约 19 mm", "en": "hard-gelatin capsule; approximately 19 mm" }, "imprint": "WATSON 152 / 8 mg", "scoreStatus": "not_applicable_capsule_do_not_infer_opening_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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-rapaflo-silodosin-8mg-90-capsule-bottle-ndc-0023614290", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史原品牌标签（2020-12 修订；该 NDC 营销结束 2022-12-31）", "en": "Historical U.S. originator-brand DailyMed label (revised Dec 2020; marketing for this NDC ended 2022-12-31)" }, "dosageForm": { "zh": "RAPAFLO 西洛多辛口服硬明胶胶囊（历史原品牌）", "en": "RAPAFLO silodosin oral hard-gelatin capsule (historical originator brand)" }, "route": { "zh": "口服（历史品牌产品身份字段）", "en": "oral (historical brand product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0023-6142-90", "pouchCode": null, "applicationNumber": "NDA 022206", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒西洛多辛 8 mg；90 粒防儿童开启瓶装；历史 RLD、当前 DISCN", "en": "8 mg silodosin per capsule; 90-capsule child-resistant bottle; historical RLD, currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西洛多辛", "en": "silodosin" }, "value": 8, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "历史品牌每粒标示量；不是个人粒数、频率或与另一种 α 阻滞剂的换算值", "en": "historical brand amount per capsule; not an individual's capsule count, frequency or conversion to another alpha blocker" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": "2022-12-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明", "en": "white opaque" }, "shape": { "zh": "硬明胶胶囊；约 19 mm", "en": "hard-gelatin capsule; approximately 19 mm" }, "imprint": "WATSON 152 / 8 mg", "scoreStatus": "not_applicable_capsule_do_not_infer_opening_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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-rapaflo-silodosin-4mg-30-capsule-bottle-ndc-0023614730", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史原品牌标签（2020-12 修订；该 NDC 营销结束 2026-03-31）", "en": "Historical U.S. originator-brand DailyMed label (revised Dec 2020; marketing for this NDC ended 2026-03-31)" }, "dosageForm": { "zh": "RAPAFLO 西洛多辛口服硬明胶胶囊（历史原品牌）", "en": "RAPAFLO silodosin oral hard-gelatin capsule (historical originator brand)" }, "route": { "zh": "口服（历史品牌产品身份字段）", "en": "oral (historical brand product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0023-6147-30", "pouchCode": null, "applicationNumber": "NDA 022206", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒西洛多辛 4 mg；30 粒防儿童开启瓶装；历史 RLD、当前 DISCN", "en": "4 mg silodosin per capsule; 30-capsule child-resistant bottle; historical RLD, currently DISCN" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rapaflo-08.jpg&archiveid=889761", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西洛多辛", "en": "silodosin" }, "value": 4, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "历史品牌每粒标示量；不是个人粒数、频率或与另一种 α 阻滞剂的换算值", "en": "historical brand amount per capsule; not an individual's capsule count, frequency or conversion to another alpha blocker" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": "2026-03-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明", "en": "white opaque" }, "shape": { "zh": "硬明胶胶囊；约 16 mm", "en": "hard-gelatin capsule; approximately 16 mm" }, "imprint": "WATSON 151 / 4 mg", "scoreStatus": "not_applicable_capsule_do_not_infer_opening_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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-rapaflo-silodosin-8mg-30-capsule-bottle-ndc-0023614230", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rapaflo-07.jpg&archiveid=889761", "alt": "RAPAFLO 西洛多辛 8 mg、NDC 0023-6142-30、30 粒瓶装的 DailyMed 历史原品牌标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 美国历史原品牌标签（2020-12 修订；该 NDC 营销结束 2026-03-31）", "presentation": "8 mg：白色不透明硬明胶胶囊，约 19 mm，绿色刻印 WATSON 152 / 8 mg；NDC 0023-6142-30，30 粒防儿童开启瓶装。另有 4 mg、30 粒的历史准确包装面板。", "notice": "此图只对应美国历史 NDC 0023-6142-30；该 NDC 营销记录已于 2026-03-31 结束。它不代表当前品牌库存、通用药或其他市场包装，也不用于鉴定真伪。", "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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": "RAPAFLO 说明书放大阅读：分清每粒 4／8 mg、整瓶粒数与历史品牌状态", "en": "RAPAFLO enlarged label: separate 4/8 mg per capsule, bottle count and historical-brand status" }, "summary": { "zh": "4 mg 或 8 mg 是每粒西洛多辛含量；30／90 Capsules 是历史品牌整瓶粒数。FDA 当前把两个品牌规格列为 DISCN；标签内容可用于安全阅读，但不能证明当前品牌有货，也不能据此计算个人粒数。", "en": "Four or eight milligrams is the silodosin amount per capsule; 30/90 Capsules is the historical-brand bottle count. FDA currently lists both brand strengths as DISCN. The label remains useful for safety reading but does not establish current brand stock or calculate an individual's capsule count." }, "checks": [ { "zh": "标签提示开始使用时可能出现站立性低血压、头晕或晕厥。老人、低血压、有跌倒史或同时使用降压药者，应优先把血压情况、完整药单与准确药盒交给医生或药师核对；不要自行错开或停掉一盒。", "en": "The label warns that postural hypotension, dizziness or syncope can occur when starting treatment. Older adults, people with low blood pressure or falls, and those using antihypertensives should prioritise review of blood pressure, the complete medicine list and exact packs with a clinician or pharmacist; do not self-separate or stop a pack." }, { "zh": "肾功能会影响暴露；历史标签把严重肾功能损害列为禁忌，并为中度肾功能损害列出不同规格路径。网页不根据化验值替个人选择 4 mg、8 mg、粒数或时间，必须由负责团队结合当前产品与处方判断。", "en": "Kidney function affects exposure. The historical label contraindicates severe renal impairment and specifies a different strength pathway for moderate impairment. The site does not select 4 mg, 8 mg, capsule count or timing from a laboratory value; the responsible team must assess the current product and prescription." }, { "zh": "强 CYP3A4 抑制剂（标签举例包括酮康唑、伊曲康唑、克拉霉素、利托那韦）属于禁忌联用；强 P-gp 抑制剂如环孢素不建议同用。维拉帕米、红霉素等中度 CYP3A4 抑制剂也需要谨慎核对。不要自行错开时间、减半或临时停药。", "en": "Strong CYP3A4 inhibitors (including ketoconazole, itraconazole, clarithromycin and ritonavir in the label) are contraindicated, and strong P-gp inhibitors such as ciclosporin are not recommended. Moderate CYP3A4 inhibitors such as verapamil or erythromycin also require careful review. Do not self-space, halve or temporarily stop medicines." }, { "zh": "标签说明不应与其他 α 阻滞剂联用，并提示 PDE-5 抑制剂及其他降压药可能增加站立性反应。相似用途或共同机制不等于可以按 mg 自行换算、叠加、轮换或替换。", "en": "The label says not to combine with other alpha blockers and notes that PDE-5 inhibitors and antihypertensives may increase orthostatic effects. Similar use or mechanism does not permit self-conversion, combination, alternation or substitution by milligrams." }, { "zh": "白内障或其他眼科手术前，即使已经停用，也应主动告诉眼科团队曾使用 RAPAFLO／其他 α1 阻滞剂。标签并不支持患者为手术自行停药。", "en": "Before cataract or another eye procedure, tell the eye team about current or previous RAPAFLO/other alpha-1 blocker use, even after stopping. The label does not support self-stopping for surgery." }, { "zh": "出现晕厥、跌倒受伤、持续疼痛勃起或其他急性严重不适时，应优先联系当地紧急医疗服务；不要等待网页判断或用另一种药自行抵消。", "en": "For fainting, a fall with injury, a persistent painful erection or another acute severe problem, prioritise local emergency medical services; do not wait for a webpage decision or self-counteract with another medicine." } ], "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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": "西洛多辛怎样起作用：选择性阻断下尿路突触后 α1 肾上腺素能受体", "en": "How silodosin works: selective blockade of post-synaptic alpha-1 adrenoceptors in the lower urinary tract" }, "summary": { "zh": "历史标签说明，西洛多辛阻断前列腺、膀胱底/膀胱颈、前列腺包膜与前列腺尿道的突触后 α1 受体，使这些组织的平滑肌松弛，从而改善尿流并减轻良性前列腺增生相关症状；体外研究显示其对 α1A 亚型具有高亲和力。机制不能诊断病因、排除前列腺癌或决定个人用药。", "en": "The historical label explains that silodosin blocks post-synaptic alpha-1 receptors in the prostate, bladder base/neck, prostatic capsule and prostatic urethra, relaxing smooth muscle in these tissues to improve urine flow and reduce BPH-related symptoms. In-vitro work showed high affinity for the alpha-1A subtype. Mechanism cannot diagnose the cause, exclude prostate cancer or determine individual treatment." }, "checks": [ { "zh": "RAPAFLO、RAPAMUNE 与名称相似却是完全不同的药：RAPAFLO 是西洛多辛，RAPAMUNE 是西罗莫司。拍照或文字只出现 RAP 开头时必须继续核对完整商品名、通用名、规格和包装代码，不能自动命中。", "en": "RAPAFLO and RAPAMUNE have similar names but are entirely different medicines: RAPAFLO is silodosin and RAPAMUNE is sirolimus. A photo or text showing only a RAP prefix requires the full brand, generic, strength and package code; it must not auto-match." }, { "zh": "RAPAFLO、FLOMAX、UROXATRAL、CARDURA／CARDURA XL、HYTRIN 与 MINIPRESS 不是同一种药；共同 α 阻滞机制不建立 mg 换算、交替、叠加或替换规则。", "en": "RAPAFLO, FLOMAX, UROXATRAL, CARDURA/CARDURA XL, HYTRIN and MINIPRESS are not one medicine. A related alpha-blocking mechanism creates no milligram conversion, alternation, combination or substitution rule." }, { "zh": "“改善尿流”不是自行诊断良性前列腺增生的依据。排尿困难、尿潴留、血尿、发热、疼痛或症状变化需要及时专业评估；不要只按年龄或他人经验开始或更换药物。", "en": "“Improves urine flow” does not support self-diagnosis of benign prostatic hyperplasia. Difficulty urinating, retention, blood in urine, fever, pain or changing symptoms require timely professional assessment; do not start or switch from age or another person's experience." } ], "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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": "RAPAFLO", "generic": "西洛多辛胶囊", "dosageFormClass": "西洛多辛 4 mg／8 mg 口服硬明胶胶囊（历史 RAPAFLO 原品牌）。RAPAFLO、FLOMAX、UROXATRAL、CARDURA／CARDURA XL、HYTRIN、MINIPRESS 及含度他雄胺复方是不同准确产品；共同用途或 α 阻滞机制不建立 mg 换算、开胶囊、叠加、轮换或替换规则。" }, "labelSource": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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_5271f325803f94d1", "label": "DailyMed（NLM）：RAPAFLO 美国历史电子说明书 PDF（可放大阅读；不代表当前品牌供应）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "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_10e511bf83430e3b", "label": "FDA Orange Book 当前数据入口：RAPAFLO／silodosin NDA 022206 两个历史 RLD 规格均列 DISCN", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "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": "RAPAFLO 是西洛多辛 4 mg／8 mg 胶囊的美国历史原品牌档案，当前 FDA 条目均为 DISCN。4 mg 或 8 mg 是每粒含量，30／90 Capsules 是整瓶粒数，不是个人每天粒数。老人或同时使用多种药物者尤其要核对肾功能、站立性低血压/晕厥/跌倒、其他 α 阻滞剂、降压药、PDE-5 抑制剂、强 CYP3A4/P-gp 抑制剂及白内障手术信息；网页不替个人决定规格、粒数、时间或换药。", "history": "FDA 于 2008-10-08 批准 RAPAFLO NDA 022206 的 4 mg 与 8 mg 胶囊。历史标签列产品由 Allergan 分销、Kissei 授权，并保留三个品牌瓶装身份；90 粒 8 mg 包装营销记录于 2022-12-31 结束，30 粒 4 mg 与 8 mg 包装于 2026-03-31 结束。FDA 当前 Orange Book 将两个规格均列为 DISCN，因此所有包装图只能作为历史核对资料。", "sourceDocuments": [ { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_5271f325803f94d1", "label": "DailyMed（NLM）：RAPAFLO 美国历史电子说明书 PDF（可放大阅读；不代表当前品牌供应）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_f80d2de2f47f6b1e", "label": "FDA：RAPAFLO（silodosin）胶囊 NDA 022206 原始批准函（4 mg／8 mg；2008-10-08）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022206s000_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据入口：RAPAFLO／silodosin NDA 022206 两个历史 RLD 规格均列 DISCN", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "NDA 022206", "approvalTimeline": [ { "date": "2008-10-08", "title": { "zh": "FDA 批准 RAPAFLO", "en": "FDA approved RAPAFLO" }, "detail": { "zh": "原始批准函确认 4 mg 与 8 mg 西洛多辛胶囊及良性前列腺增生相关标签用途。", "en": "The original approval letter confirms 4 mg and 8 mg silodosin capsules and the BPH-related labelled use." }, "source": { "id": "src_f80d2de2f47f6b1e", "label": "FDA：RAPAFLO（silodosin）胶囊 NDA 022206 原始批准函（4 mg／8 mg；2008-10-08）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022206s000_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2022-12-31", "title": { "zh": "8 mg、90 粒历史包装营销记录结束", "en": "Marketing record ended for the historical 8 mg, 90-capsule pack" }, "detail": { "zh": "NDC 0023-6142-90 此后仅作历史产品身份核对。", "en": "NDC 0023-6142-90 is used only as a historical product identity after this date." }, "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-03-31", "title": { "zh": "最后两个在册原品牌 NDC 营销记录结束", "en": "Marketing records ended for the last two listed originator-brand NDCs" }, "detail": { "zh": "NDC 0023-6142-30 与 0023-6147-30 的包装图此后只作历史核对；当前 Orange Book 两规格均为 DISCN。", "en": "Package panels for NDC 0023-6142-30 and 0023-6147-30 are historical references after this date; both strengths are currently DISCN in the Orange Book." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据入口：RAPAFLO／silodosin NDA 022206 两个历史 RLD 规格均列 DISCN", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史 RLD，4 mg／8 mg 当前均为 DISCN", "en": "Historical RLD; both 4 mg and 8 mg currently DISCN" }, "detail": { "zh": "原品牌包装图与电子说明书保留为历史资料，不证明当前品牌有货。", "en": "Originator-brand package panels and the electronic label are retained as historical material and do not establish current brand stock." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "现行监管记录待逐市场建立", "en": "Current regulatory records require market-by-market review" }, "detail": { "zh": "“优利福”等名称必须与当地药监记录、现行说明书和手中药盒逐项核对；不从美国历史品牌推定当地批准或供应。", "en": "Names such as 优利福 require item-by-item checking against the local regulator, current leaflet and pack in hand; U.S. historical-brand status does not establish local approval or supply." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "4 mg 和 8 mg 是每天吃几粒吗？", "en": "Do 4 mg and 8 mg tell me how many capsules to take each day?" }, "answer": { "zh": "不是。它们是每粒西洛多辛的历史品牌标示量；30／90 是整瓶粒数。个人规格、粒数、时间与适用性必须结合当前实际产品、处方、肾功能和完整药单由负责团队判断，网页不代算。", "en": "No. They are historical-brand amounts of silodosin per capsule; 30/90 is the bottle count. The responsible team must assess the current exact product, prescription, kidney function and full medicine list to determine strength, capsule count, timing and suitability; the site does not calculate them." } }, { "question": { "zh": "胶囊能打开、倒一半或和食物混合吗？", "en": "Can the capsule be opened, half emptied or mixed with food?" }, "answer": { "zh": "不要从“胶囊”外形自行推断。历史标签包含特定吞咽困难说明，但不能跨厂家、跨市场或脱离处方套用，更不允许目测倒一半来减量。请让药师按手中准确产品的现行说明书核对。", "en": "Do not infer this from the capsule shape. The historical label contains a specific swallowing-difficulty route, but it cannot be transferred across manufacturers or markets or used outside the prescription, and it never permits visually emptying half for dose reduction. Ask a pharmacist to check the current label for the exact product in hand." } }, { "question": { "zh": "能换成 FLOMAX、UROXATRAL 或 CARDURA 吗？", "en": "Can it be switched to FLOMAX, UROXATRAL or CARDURA?" }, "answer": { "zh": "不能从相似用途或共同 α 阻滞机制这样判断。它们的成分、剂型、规格、NDA 与说明书不同，不能按 mg 自行一比一换算、叠加或轮换。", "en": "That conclusion cannot be drawn from a similar use or related alpha-blocking mechanism. Their ingredients, dosage forms, strengths, NDAs and labels differ; do not self-convert, combine or alternate them milligram for milligram." } }, { "question": { "zh": "包装图还能用于判断现在买到的是原品牌吗？", "en": "Can the package panel identify an originator-brand pack available now?" }, "answer": { "zh": "不能。本页两张图来自历史 DailyMed 原品牌标签，相关 NDC 营销记录已结束，FDA 当前把 4 mg／8 mg RAPAFLO 均列为 DISCN。当前药盒必须按完整文字、厂家、NDC/批准信息和目标市场官方记录另行核对。", "en": "No. The two panels come from a historical DailyMed originator-brand label, the related NDC marketing records have ended, and FDA currently lists both RAPAFLO strengths as DISCN. A current pack requires separate review of all text, manufacturer, NDC or approval information and the target market's official record." } } ], "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/rapaflo-silodosin/", "en": "https://origindrug.com/en/drugs/rapaflo-silodosin/" }, "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." ] }