{ "id": "minipress-prazosin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "MINIPRESS", "generic": "盐酸哌唑嗪胶囊", "aliases": [ "Minipress", "prazosin", "prazosin hydrochloride", "prazosin capsules", "哌唑嗪", "盐酸哌唑嗪", "盐酸哌唑嗪胶囊", "MINIPRESS", "NDA 017442", "66993-431-85", "66993-432-85", "66993-433-85", "Pfizer 431 Minipress", "Pfizer 437 Minipress", "Pfizer 438 Minipress" ], "marketBrandNames": [ { "name": "MINIPRESS", "market": { "zh": "美国历史品牌档案", "en": "U.S. historical brand archive" }, "evidenceStatus": "historical_brand_pack_marketing_ended", "note": { "zh": "NDA 017442；品牌标签列 1、2、5 mg，各 250 粒瓶装；所示 NDC 在 2024 年结束营销。", "en": "NDA 017442; the brand label lists 1, 2 and 5 mg in 250-capsule bottles; the displayed NDC marketing records ended in 2024." }, "source": { "id": "src_294971ca52388f2e", "label": "DailyMed（NLM）：Pfizer MINIPRESS 1／2／5 mg 胶囊品牌标签档案（所列瓶装 NDC 已于 2024 年结束营销）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=36c4da56-502e-4da1-acf7-8e81ee453dcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 的 Pfizer MINIPRESS 品牌标签列出 1、2、5 mg、各 250 粒瓶装，但三个所示品牌 NDC 的营销记录均已在 2024 年结束。Prasco 当前授权仿制药标签另列同一 NDA 017442 下 1、2、5 mg、各 90 粒瓶装，三项均无营销终止日期。品牌历史身份、授权仿制药、包装面板、胶囊印记、实时库存与个人适用性必须分开理解。", "dosageFormClass": "哌唑嗪盐酸盐普通口服胶囊；1、2、5 mg 是每粒以哌唑嗪计的含量，90 或 250 是对应瓶内粒数。当前授权仿制药胶囊仍带 Pfizer／Minipress 印记，但 Prasco 瓶标不是当前 MINIPRESS 品牌瓶装；印记、品牌和包装不能只看一个字段下结论。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1976-06-23（美国 NDA 017442 批准日期）", "archiveSponsorText": "Pfizer（MINIPRESS NDA 与历史品牌）；Prasco Laboratories（当前美国授权仿制药标签）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "MINIPRESS", "MINIPRESS prazosin", "prazosin hydrochloride capsules", "盐酸哌唑嗪胶囊" ], "excludedProductCues": [ "HYTRIN", "terazosin", "RAPAFLO", "silodosin", "UROXATRAL", "alfuzosin", "CARDURA", "doxazosin", "FLOMAX", "tamsulosin", "CATAPRES", "clonidine" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-prasco-authorized-generic-prazosin-1mg-90-capsule-bottle-ndc-6699343185", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国授权仿制药标签（2026-03-06 更新；2026-03-09 发布）", "en": "Current U.S. authorised-generic DailyMed label (updated 6 Mar 2026; published 9 Mar 2026)" }, "dosageForm": { "zh": "Prasco 哌唑嗪盐酸盐普通口服硬胶囊（NDA 授权仿制药）", "en": "Prasco prazosin hydrochloride immediate-release oral hard capsule (NDA authorised generic)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 66993-431-85", "pouchCode": null, "applicationNumber": "NDA 017442", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒以哌唑嗪计 1 mg；90 粒瓶装；当前授权仿制药", "en": "Prazosin 1 mg per capsule; 90-capsule bottle; current authorised generic" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prazosin-02.jpg&setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "哌唑嗪（以盐酸盐形式）", "en": "prazosin (as hydrochloride)" }, "value": 1, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、使用频率、起始量或同类药换算值", "en": "labelled amount per capsule; not an individual's capsule count, frequency, starting amount or alpha-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_authorized_generic_regulatory_listing_not_live_stock", "marketingStartDate": "2021-08-25", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "无刻痕硬胶囊，18 mm", "en": "unscored hard capsule, 18 mm" }, "imprint": { "zh": "Pfizer; 431; Minipress", "en": "Pfizer; 431; Minipress" }, "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prasco-authorized-generic-prazosin-2mg-90-capsule-bottle-ndc-6699343285", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国授权仿制药标签（2026-03-06 更新；2026-03-09 发布）", "en": "Current U.S. authorised-generic DailyMed label (updated 6 Mar 2026; published 9 Mar 2026)" }, "dosageForm": { "zh": "Prasco 哌唑嗪盐酸盐普通口服硬胶囊（NDA 授权仿制药）", "en": "Prasco prazosin hydrochloride immediate-release oral hard capsule (NDA authorised generic)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 66993-432-85", "pouchCode": null, "applicationNumber": "NDA 017442", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒以哌唑嗪计 2 mg；90 粒瓶装；当前授权仿制药", "en": "Prazosin 2 mg per capsule; 90-capsule bottle; current authorised generic" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prazosin-03.jpg&setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "哌唑嗪（以盐酸盐形式）", "en": "prazosin (as hydrochloride)" }, "value": 2, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、使用频率、起始量或同类药换算值", "en": "labelled amount per capsule; not an individual's capsule count, frequency, starting amount or alpha-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_authorized_generic_regulatory_listing_not_live_stock", "marketingStartDate": "2022-03-11", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色与白色", "en": "pink and white" }, "shape": { "zh": "无刻痕硬胶囊，18 mm", "en": "unscored hard capsule, 18 mm" }, "imprint": { "zh": "Pfizer; 437; Minipress", "en": "Pfizer; 437; Minipress" }, "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prasco-authorized-generic-prazosin-5mg-90-capsule-bottle-ndc-6699343385", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国授权仿制药标签（2026-03-06 更新；2026-03-09 发布）", "en": "Current U.S. authorised-generic DailyMed label (updated 6 Mar 2026; published 9 Mar 2026)" }, "dosageForm": { "zh": "Prasco 哌唑嗪盐酸盐普通口服硬胶囊（NDA 授权仿制药）", "en": "Prasco prazosin hydrochloride immediate-release oral hard capsule (NDA authorised generic)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 66993-433-85", "pouchCode": null, "applicationNumber": "NDA 017442", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒以哌唑嗪计 5 mg；90 粒瓶装；当前授权仿制药", "en": "Prazosin 5 mg per capsule; 90-capsule bottle; current authorised generic" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prazosin-04.jpg&setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "哌唑嗪（以盐酸盐形式）", "en": "prazosin (as hydrochloride)" }, "value": 5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、使用频率、起始量或同类药换算值", "en": "labelled amount per capsule; not an individual's capsule count, frequency, starting amount or alpha-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_authorized_generic_regulatory_listing_not_live_stock", "marketingStartDate": "2022-03-11", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色与白色", "en": "blue and white" }, "shape": { "zh": "无刻痕硬胶囊，22 mm", "en": "unscored hard capsule, 22 mm" }, "imprint": { "zh": "Pfizer; 438; Minipress", "en": "Pfizer; 438; Minipress" }, "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-prasco-authorized-generic-prazosin-1mg-90-capsule-bottle-ndc-6699343185", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prazosin-02.jpg&setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d&type=img", "alt": "Prasco 哌唑嗪盐酸盐 1 mg、NDC 66993-431-85、90 粒瓶装当前美国授权仿制药 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国授权仿制药标签（2026-03-06 更新；2026-03-09 发布）", "presentation": "当前授权仿制药准确包装：1 mg 白色胶囊，印有 Pfizer／431／Minipress；NDC 66993-431-85，90 粒瓶装。2 mg 与 5 mg 有各自颜色、印记和 NDC。", "notice": "图片只对应 Prasco 当前授权仿制药瓶标。胶囊上的 Pfizer／Minipress 印记不能把它变成当前品牌瓶装；图像不用于鉴定真伪，也不能证明实时库存或其他市场供应。", "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "哌唑嗪说明书放大阅读：每粒 mg、瓶内粒数、首次使用、晕厥与同类重复", "en": "Enlarged prazosin label: per-capsule mg, bottle count, starting risk, syncope and duplicate alpha blockers" }, "summary": { "zh": "1、2、5 mg 是每粒哌唑嗪量，90 是当前授权仿制药瓶内粒数，250 是历史品牌瓶装数量。标签重点警示首次使用、快速增加或加入其他降压药时的体位性低血压和晕厥；网页不把剂量段落转成个人方案。", "en": "The 1, 2 and 5 mg figures are amounts of prazosin per capsule; 90 is the current authorised-generic bottle count and 250 is the historical brand bottle count. The label prominently warns about postural hypotension and syncope when starting, increasing rapidly or adding another antihypertensive; the site does not turn dosing text into an individual plan." }, "checks": [ { "zh": "老人、独居者、有跌倒史、夜间起身或同时使用其他降压药者，应把准确药盒、血压、头晕或晕厥情况和完整药单交给医生或药师核对，不能根据网页自己从 1 mg 换到 2 mg 或 5 mg。", "en": "Older adults, people living alone, those with falls or night-time rising, and people using another antihypertensive should have the exact pack, blood pressure, dizziness or syncope and full medicine list reviewed; do not use the page to move from 1 mg to 2 mg or 5 mg." }, { "zh": "标签说明同时加入利尿剂、β 阻滞剂或其他降压药可能增加低血压影响。错开服用时间不等于风险消失，网页也不能代替开方团队调整。", "en": "The label explains that adding a diuretic, beta blocker or another antihypertensive may increase hypotensive effects. Self-spacing does not prove that risk has disappeared and cannot replace prescriber review." }, { "zh": "同类 α 阻滞剂以及 PDE-5 抑制剂可能共同影响血压。MINIPRESS、HYTRIN、CARDURA、FLOMAX、RAPAFLO、UROXATRAL、CIALIS 或 VIAGRA 出现在同一药单时，要核对而不是自行轮换或叠加。", "en": "Related alpha blockers and PDE-5 inhibitors may have combined blood-pressure effects. If MINIPRESS, HYTRIN, CARDURA, FLOMAX, RAPAFLO, UROXATRAL, CIALIS or VIAGRA appear on one list, seek review rather than self-alternating or combining them." }, { "zh": "晕厥、跌倒受伤或严重虚弱需要及时医疗评估；持续超过 4 小时的勃起是 FDA 标签明确的急症信号，应立即使用当地急救渠道。", "en": "Syncope, an injurious fall or severe weakness needs timely medical assessment. An erection lasting more than four hours is an FDA-labelled emergency signal requiring immediate local emergency care." } ], "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "哌唑嗪怎样起作用：阻断 α1 受体可降低血管阻力，也带来起立性低血压边界", "en": "How prazosin works: alpha-1 blockade can lower vascular resistance and creates an orthostatic-hypotension boundary" }, "summary": { "zh": "官方标签将哌唑嗪描述为 α1 肾上腺素能受体阻断剂，其血压作用与降低外周血管阻力有关。机理能解释为什么同用其他降压药时需谨慎，但不能决定某个人该用哪一粒、何时开始或能否改成另一种 α 阻滞剂。", "en": "The official label describes prazosin as an alpha-1 adrenergic blocker whose blood-pressure effect is associated with reduced peripheral vascular resistance. Mechanism helps explain caution with other blood-pressure medicines but cannot select an individual's capsule, starting time or switch to another alpha blocker." }, "checks": [ { "zh": "MINIPRESS、HYTRIN、CARDURA、FLOMAX、RAPAFLO 和 UROXATRAL 是不同成分或产品。共同的 α 阻滞机制不建立 mg 换算、同服、轮换或替换规则。", "en": "MINIPRESS, HYTRIN, CARDURA, FLOMAX, RAPAFLO and UROXATRAL are different ingredients or products. Related alpha blockade creates no milligram conversion, combination, alternation or substitution rule." }, { "zh": "当前 Prasco 授权仿制药与历史 Pfizer 品牌瓶装同属 NDA 017442，但瓶标、包装数量和市场时间不同；相同申请号不表示包装完全相同或实时有货。", "en": "The current Prasco authorised generic and historical Pfizer brand bottles share NDA 017442, but their labels, counts and market dates differ. A shared application number does not make the packs identical or establish live stock." }, { "zh": "作用机理不能替代血压、跌倒史、肝肾情况、完整药单和专业评估，也不能依据一次头晕或夜尿自行判断继续、停用或换药。", "en": "Mechanism does not replace blood pressure, fall history, liver/kidney status, the full medicine list and professional assessment, or decide continuation, stopping or switching from one episode of dizziness or nocturia." } ], "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MINIPRESS", "generic": "盐酸哌唑嗪胶囊", "dosageFormClass": "哌唑嗪盐酸盐普通口服胶囊；1、2、5 mg 是每粒以哌唑嗪计的含量，90 或 250 是对应瓶内粒数。当前授权仿制药胶囊仍带 Pfizer／Minipress 印记，但 Prasco 瓶标不是当前 MINIPRESS 品牌瓶装；印记、品牌和包装不能只看一个字段下结论。" }, "labelSource": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_725211c55a3e8271", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐当前美国授权仿制药电子说明书 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_294971ca52388f2e", "label": "DailyMed（NLM）：Pfizer MINIPRESS 1／2／5 mg 胶囊品牌标签档案（所列瓶装 NDC 已于 2024 年结束营销）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=36c4da56-502e-4da1-acf7-8e81ee453dcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "MINIPRESS 是哌唑嗪的美国品牌历史档案。普通人最容易误读的是：1、2、5 mg 是每粒含量，90 或 250 是一瓶的粒数；当前 Prasco 授权仿制药胶囊虽保留 Pfizer／Minipress 印记，瓶标却是通用名产品。老人、多药使用者和有头晕、起立不稳或跌倒史的人，应重点核对突然降压、晕厥、其他降压药与 PDE-5 抑制剂；网页不提供个人起始、恢复、加量、停药或换药方案。", "history": "FDA 资料显示 MINIPRESS 胶囊 NDA 017442 于 1976-06-23 批准。2015 年补充批准加入持续勃起相关紧急警示。DailyMed 保留 Pfizer 品牌标签，但三个 250 粒品牌瓶装记录在 2024 年结束营销；当前 Prasco 授权仿制药则分别建立三个 90 粒瓶装身份。", "sourceDocuments": [ { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_725211c55a3e8271", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐当前美国授权仿制药电子说明书 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_294971ca52388f2e", "label": "DailyMed（NLM）：Pfizer MINIPRESS 1／2／5 mg 胶囊品牌标签档案（所列瓶装 NDC 已于 2024 年结束营销）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=36c4da56-502e-4da1-acf7-8e81ee453dcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_af227bae6b44bd12", "label": "FDA：MINIPRESS 哌唑嗪盐酸盐 1／2／5 mg 胶囊补充批准函（2015-02-27）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017442Orig1s043ltr.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": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 017442", "approvalTimeline": [ { "date": "1976-06-23", "title": { "zh": "MINIPRESS 胶囊 NDA 获 FDA 批准", "en": "FDA approval of the MINIPRESS capsule NDA" }, "detail": { "zh": "NDA 017442；1、2、5 mg 产品历史均早于 1982 年。", "en": "NDA 017442; the 1, 2 and 5 mg product histories all predate 1982." }, "source": { "id": "src_af227bae6b44bd12", "label": "FDA：MINIPRESS 哌唑嗪盐酸盐 1／2／5 mg 胶囊补充批准函（2015-02-27）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017442Orig1s043ltr.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": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2015-02-27", "title": { "zh": "FDA 批准持续勃起警示更新", "en": "FDA approved the priapism warning update" }, "detail": { "zh": "补充批准函覆盖 1、2、5 mg 胶囊并加入超过 4 小时需立即求助的急症文字。", "en": "The supplement covered the 1, 2 and 5 mg capsules and added emergency wording for an erection lasting over four hours." }, "source": { "id": "src_af227bae6b44bd12", "label": "FDA：MINIPRESS 哌唑嗪盐酸盐 1／2／5 mg 胶囊补充批准函（2015-02-27）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017442Orig1s043ltr.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": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2026-03-09", "title": { "zh": "当前 Prasco 授权仿制药 SPL v6 发布", "en": "Current Prasco authorised-generic SPL v6 published" }, "detail": { "zh": "三个 90 粒瓶装均在册且无营销终止日期。", "en": "All three 90-capsule bottles are listed without a marketing-end date." }, "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国 MINIPRESS 品牌包装", "en": "U.S. MINIPRESS brand packs" }, "status": { "zh": "三个所示品牌瓶装 NDC 已结束营销", "en": "The three displayed brand-bottle NDC marketing records have ended" }, "detail": { "zh": "1、2、5 mg，各 250 粒；结束日期分别为 2024-04-30、2024-05-31、2024-05-31。", "en": "1, 2 and 5 mg, each in 250-capsule bottles; end dates were 30 Apr 2024, 31 May 2024 and 31 May 2024." } }, { "market": { "zh": "美国 Prasco 授权仿制药", "en": "U.S. Prasco authorised generic" }, "status": { "zh": "当前公开标签在册", "en": "Current public-label listing" }, "detail": { "zh": "1、2、5 mg，各 90 粒瓶装；不等于实时库存或当前品牌瓶装。", "en": "1, 2 and 5 mg in 90-capsule bottles; this does not establish live stock or a current brand bottle." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "为什么通用名瓶子里的胶囊还写着 Minipress？", "en": "Why does a generic-name bottle contain capsules marked Minipress?" }, "answer": { "zh": "当前官方记录把 Prasco 产品标为 NDA 授权仿制药，并列出胶囊上的 Pfizer／431、437 或 438／Minipress 印记。应同时读瓶标主体、NDC、强度、粒数和标签日期，不能只凭胶囊一个词判断品牌或真伪。", "en": "The current official record classifies the Prasco products as NDA authorised generics and lists Pfizer/431, 437 or 438/Minipress capsule imprints. Read the bottle entity, NDC, strength, count and label date together; one word on a capsule cannot determine brand status or authenticity." } }, { "question": { "zh": "1 mg、2 mg、5 mg 能按倍数自行换吗？", "en": "Can 1 mg, 2 mg and 5 mg be swapped by arithmetic?" }, "answer": { "zh": "不能。数字表示每粒含量，不是自行拼粒、减量、起始、恢复或轮换方案。哌唑嗪有明显的首次使用与体位性低血压风险，必须让开方团队结合血压、症状和完整药单判断。", "en": "No. The figures are amounts per capsule, not a self-designed capsule combination, reduction, start, restart or rotation plan. Prazosin has important starting and postural-hypotension risks requiring prescriber review with blood pressure, symptoms and the full medicine list." } }, { "question": { "zh": "能和 HYTRIN、FLOMAX 或降压药一起吃吗？", "en": "Can it be taken with HYTRIN, FLOMAX or another blood-pressure medicine?" }, "answer": { "zh": "网页不能作出这个决定。相同或相关作用可能增加降压、头晕、晕厥和跌倒风险；把每个实际包装、使用时间和完整药单交给医生或药师核对，不要自行错开、叠加或换用。", "en": "A website cannot make that decision. Related effects may increase hypotension, dizziness, syncope and falls; give the exact packs, timing and full medicine list to a clinician or pharmacist rather than self-spacing, combining or switching." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/minipress-prazosin/", "en": "https://origindrug.com/en/drugs/minipress-prazosin/" }, "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." ] }