{ "id": "aldactone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "Aldactone", "generic": "螺内酯", "aliases": [ "ALDACTONE", "spironolactone", "spironolactone tablets", "螺内酯片", "NDA 012151", "0025-1001-31", "0025-1041-31", "0025-1031-31" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国当前 ALDACTONE 螺内酯公开标签（DailyMed SPL v25，2025-12-01 发布）", "dosageFormClass": "口服薄膜衣片：25 mg、50 mg、100 mg（当前美国标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1960（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Pfizer Laboratories Div Pfizer Inc / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ALDACTAZIDE", "spironolactone hydrochlorothiazide" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-aldactone-tablet-25mg-ndc-0025-1001-31", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25，2025-12-01 发布", "en": "DailyMed SPL v25, published 1 Dec 2025" }, "dosageForm": { "zh": "ALDACTONE 螺内酯口服薄膜衣片", "en": "ALDACTONE spironolactone film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0025-1001-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 25 mg；100 片瓶装", "en": "25 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc&type=img&name=aldactone-05.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "螺内酯", "en": "spironolactone" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、利尿或补钾方案", "en": "labelled amount per tablet; not an individual's tablet count, diuretic or potassium plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-aldactone-tablet-50mg-ndc-0025-1041-31", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25，2025-12-01 发布", "en": "DailyMed SPL v25, published 1 Dec 2025" }, "dosageForm": { "zh": "ALDACTONE 螺内酯口服薄膜衣片", "en": "ALDACTONE spironolactone film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0025-1041-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 50 mg；100 片瓶装", "en": "50 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc&type=img&name=aldactone-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "螺内酯", "en": "spironolactone" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、利尿或补钾方案", "en": "labelled amount per tablet; not an individual's tablet count, diuretic or potassium plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-aldactone-tablet-100mg-ndc-0025-1031-31", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25，2025-12-01 发布", "en": "DailyMed SPL v25, published 1 Dec 2025" }, "dosageForm": { "zh": "ALDACTONE 螺内酯口服薄膜衣片", "en": "ALDACTONE spironolactone film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0025-1031-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mg；100 片瓶装", "en": "100 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc&type=img&name=aldactone-07.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "螺内酯", "en": "spironolactone" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、利尿或补钾方案", "en": "labelled amount per tablet; not an individual's tablet count, diuretic or potassium plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-aldactone-tablet-25mg-ndc-0025-1001-31", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc&type=img&name=aldactone-05.jpg", "alt": "ALDACTONE 螺内酯在美国 DailyMed Pfizer 当前公开标签中的 25 mg、NDC 0025-1001-31、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v25（2025-12-01 发布）", "presentation": "ALDACTONE 螺内酯：每片 25 mg，NDC 0025-1001-31，100 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 ALDACTONE、螺内酯 25 mg、NDC 0025-1001-31 与 100 片瓶装。它只帮助核对品牌、通用名、每片标示量、口服片、包装数量与来源；不用于鉴定真伪，也不证明 50 mg、100 mg、ALDACTAZIDE、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的片数、利尿、补钾、联用、开始、停用或换药方案。", "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ALDACTONE 说明书放大阅读：25、50、100 mg 先是每片身份，不是利尿或补钾方案", "en": "ALDACTONE label reading: 25, 50 and 100 mg identify each tablet; they are not a diuretic or potassium plan" }, "summary": { "zh": "本模块以美国 DailyMed 当前公开标签为阅读入口，帮助核对 ALDACTONE、螺内酯、每片 25/50/100 mg、口服薄膜衣片和准确瓶装。它不决定个人的片数、血钾监测、饮食、补充剂、利尿安排或与其他心血管产品的联合方案。", "en": "This module uses the current U.S. DailyMed public label to check ALDACTONE, spironolactone, 25/50/100 mg per tablet, film-coated oral tablets and the exact bottle. It does not decide an individual's tablet count, potassium monitoring, diet, supplements, diuretic plan or combination with another cardiovascular product." }, "checks": [ { "zh": "先把 ALDACTONE、螺内酯、每片 25、50 或 100 mg、口服片、实际 NDC 和目标市场一起核对。毫克数是这一准确片剂的标示量，不是网页可换算成个人片数、隔天使用或由一盒替换另一盒的规则。", "en": "Check ALDACTONE, spironolactone, 25, 50 or 100 mg per tablet, oral-tablet form, actual NDC and target market together. Milligrams are the labelled amount in an exact tablet, not a web rule for personal tablet count, alternate-day use or replacing one pack with another." }, { "zh": "标签对高钾血症、肾功能恶化、低血压和电解质异常列有警示，也提示钾补充剂、高钾食物和盐替代品需要核对。它们不是网站可以据此给个人作出“该补/不该补、该吃/不该吃”结论的依据；请把药盒、补充剂、非处方药和完整药单交给药师或医生。", "en": "The label includes warnings about hyperkalaemia, worsening renal function, hypotension and electrolyte abnormalities, and flags potassium supplements, high-potassium foods and salt substitutes for review. These do not let a website decide whether an individual should use or avoid a product; take the packs, supplements, OTC products and complete medicine list to a pharmacist or clinician." }, { "zh": "“利尿剂”“醛固酮拮抗剂”或“保钾”都是类别线索，不表示可以把 ALDACTONE 与其他利尿剂、降压药、心衰药、补钾产品或草本自行叠加、轮换或替换。每个产品的强度、剂型、目标市场标签、既往反应和检查结果都需一起复核。", "en": "“Diuretic”, “aldosterone antagonist” and “potassium-sparing” are class clues; they do not permit self-combining, alternating or replacing ALDACTONE with another diuretic, blood-pressure medicine, heart-failure medicine, potassium product or herb. Strength, dosage form, target-market label, prior reactions and test results all need review together." }, { "zh": "标签把其他升高血钾的药物或产品、NSAIDs（常见于止痛退热药）、锂盐列为需要专业核对的联用线索。NSAIDs 可能减弱利尿、排钠或降压作用；利尿剂也可能降低锂清除并增加锂毒性风险。看到这些名称时应核对完整药单、肾功能及相关检查，而不是自行错开时间、停药或加减量。", "en": "The label identifies other potassium-raising products, NSAIDs (common in pain or fever medicines) and lithium as co-medication clues requiring professional review. NSAIDs may reduce diuretic, natriuretic or antihypertensive effects, while diuretics may reduce lithium clearance and increase lithium-toxicity risk. When these names appear, the complete medicine list, kidney function and relevant tests need review rather than self-separating timing, stopping or changing an amount." }, { "zh": "当前美国标签列示的辅料包括硫酸钙、玉米淀粉、香料、羟丙甲纤维素、氧化铁、硬脂酸镁、聚乙二醇、聚维酮和二氧化钛。辅料表只对应这一准确美国标签，可用于向药师询问过敏或耐受问题；不能据此断言另一厂牌更差、疗效不同或可以自行替换。", "en": "The current U.S. label lists inactive ingredients including calcium sulfate, corn starch, flavour, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, povidone and titanium dioxide. This excipient list applies only to the exact U.S. label and can frame allergy or tolerability questions for a pharmacist; it does not prove another manufacturer is inferior, has different efficacy or can be self-substituted." }, { "zh": "出现晕厥、明显心悸或无力、呼吸困难、严重呕吐腹泻、意识变化或其他急性严重不适时，应优先使用当地紧急医疗支持；不要等待网页检索，也不要靠另一盒药自行抵消或调整。", "en": "With fainting, marked palpitations or weakness, breathing difficulty, severe vomiting or diarrhoea, altered consciousness or another acute severe problem, prioritise local emergency medical support; do not wait for a website search or self-counteract or adjust with another pack." } ], "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；Warnings and Patient Counseling）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "螺内酯怎样起作用：它阻断醛固酮的作用路径", "en": "How spironolactone works: it blocks an aldosterone pathway" }, "summary": { "zh": "美国 ALDACTONE 标签将螺内酯描述为醛固酮拮抗剂，并说明其在远端肾小管拮抗醛固酮。这个机制帮助阅读药物类别和标签警示；不预测个人体液变化、血压、血钾、适用性、片数或任何联用方案。", "en": "The U.S. ALDACTONE label describes spironolactone as an aldosterone antagonist acting at the distal renal tubule. This mechanism helps read the drug class and label warnings; it does not predict an individual's fluid change, blood pressure, potassium, suitability, tablet count or any combination plan." }, "checks": [ { "zh": "“阻断醛固酮”解释的是一个生理作用路径，不是从网页判断水肿、血压、乏力、心悸或化验异常原因的工具。需要治疗或调整时，应由专业人员结合准确诊断、检查和完整药单判断。", "en": "“Blocking aldosterone” explains one physiologic pathway; it is not a website tool for determining the cause of oedema, blood pressure, fatigue, palpitations or an abnormal test. Need for treatment or adjustment requires a professional with the exact diagnosis, tests and complete medicine list." }, { "zh": "机制与“保钾”名称都不能替代对肾功能、电解质、其他心血管药、止痛药、补充剂或盐替代品的个体化核对。不要从机制词自行添加、去掉或补用任何药物或补充剂。", "en": "Neither the mechanism nor the phrase “potassium-sparing” replaces individual review of kidney function, electrolytes, other cardiovascular medicines, pain medicines, supplements or salt substitutes. Do not self-add, remove or make up any medicine or supplement from a mechanism word." }, { "zh": "与其他影响体液、血压或肾脏相关路径的产品同用时，不能仅凭“类别不同”或“机制不同”判断一定能联用。带上完整药单与实际包装让药师或医生核对，才是下一步。", "en": "When another product affects fluid balance, blood pressure or kidney-related pathways, neither a different class nor a different mechanism proves it can be combined. Bringing the complete medicine list and actual packs to a pharmacist or clinician is the next step." } ], "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Aldactone", "generic": "螺内酯", "dosageFormClass": "口服薄膜衣片：25 mg、50 mg、100 mg（当前美国标签所列）" }, "labelSource": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "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_102d35b70ca3a4e3", "label": "DailyMed（NLM）：ALDACTONE 当前美国电子说明书 PDF（可放大阅读）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=0fed2822-3a03-4b64-9857-c682fcd462bc", "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." } } ], "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": "2026-08-20", "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": "美国 DailyMed 的 ALDACTONE 公开标签将其列为螺内酯口服薄膜衣片，并列示 25 mg、50 mg、100 mg 三种片剂。此页帮助核对品牌、通用名、每片强度、瓶装、标签版本和来源；不把标签文字转换为个人片数、利尿、补钾、联用、停用或换药方案。", "history": "本页对应 Pfizer Laboratories Div Pfizer Inc 在美国 DailyMed 当前标签体系中的 ALDACTONE。高龄、心力衰竭、肾脏问题、肝病、水肿或多药并用时，更不能只凭“利尿”“保钾”或相同毫克数自行增减、合并或替换；需由药师或医生结合准确产品和完整药单核对。", "sourceDocuments": [ { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_102d35b70ca3a4e3", "label": "DailyMed（NLM）：ALDACTONE 当前美国电子说明书 PDF（可放大阅读）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=0fed2822-3a03-4b64-9857-c682fcd462bc", "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_23e9da0a651a03b6", "label": "FDA：ALDACTONE（螺内酯）片 NDA 012151/S-080 补充批准函（2025-11-19）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/012151Orig1s080ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 012151", "approvalTimeline": [ { "date": "1960", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 ALDACTONE 标签列示 Initial U.S. Approval: 1960；该年份不自动说明其他市场的产品状态。", "en": "The current ALDACTONE label lists Initial U.S. Approval: 1960; it does not establish product status in another market." }, "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-11-19", "title": { "zh": "NDA 012151 S-080 补充批准", "en": "NDA 012151 S-080 supplemental approval" }, "detail": { "zh": "FDA 公开批准函记录 ALDACTONE（螺内酯）片剂的 NDA 012151/S-080 于 2025-11-19 获批。该监管节点不建立个人适用性、联用、调整或其他市场状态。", "en": "The FDA public approval letter records approval of NDA 012151/S-080 for ALDACTONE (spironolactone) tablets on 19 Nov 2025. This regulatory node does not establish individual suitability, combination, adjustment or another-market status." }, "source": { "id": "src_23e9da0a651a03b6", "label": "FDA：ALDACTONE（螺内酯）片 NDA 012151/S-080 补充批准函（2025-11-19）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/012151Orig1s080ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-12-01", "title": { "zh": "DailyMed 公开当前 SPL v25", "en": "Current SPL v25 published on DailyMed" }, "detail": { "zh": "DailyMed 将当前 ALDACTONE SPL v25 的 Published Date 列为 2025-12-01。该公开日期、标签图片和 NDC 仅用于记录身份，不能说明个人使用、库存、可得性或替代关系。", "en": "DailyMed lists 1 Dec 2025 as the Published Date for the current ALDACTONE SPL v25. The public date, label image and NDC record identity only; they do not establish individual use, stock, availability or interchangeability." }, "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前标签与 3 个精确瓶装展示面", "en": "Current label and three exact bottle panels linked" }, "detail": { "zh": "本页分别记录 25 mg、50 mg、100 mg 的特定 NDC 与 100 片瓶装展示面；不据此建立实际在售、库存、个人用量、补钾、联用、换药或其他规格状态。", "en": "This page records the specified NDC and 100-tablet bottle panel separately for 25 mg, 50 mg and 100 mg; it does not establish actual marketing, stock, individual use, potassium management, combination, switching or another-presentation status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签推定当地商品名、批准、包装、供应、原研关系或可替代性。", "en": "No local trade name, approval, packaging, supply, originator relationship or interchangeability is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "25、50、100 mg 能否只按毫克数自行换成片数或另一盒？", "en": "Can 25, 50 and 100 mg be self-converted into tablet counts or another bottle?" }, "answer": { "zh": "不能。它们是当前标签分别列出的准确片剂身份。网页不把包装数字变成个人片数、隔天使用、补钾、联用、替代或调整规则；请携带实际药盒与完整药单咨询药师或医生。", "en": "No. They are distinct tablet identities listed in the current label. This page does not turn package numbers into an individual's tablet count, alternate-day use, potassium plan, combination, substitution or adjustment rule; take the actual pack and complete medicine list to a pharmacist or clinician." } }, { "question": { "zh": "“保钾”是否说明可以自行添加或去掉补钾产品、盐替代品或其他药？", "en": "Does “potassium-sparing” mean a person can self-add or remove potassium products, salt substitutes or another medicine?" }, "answer": { "zh": "不能。这是机制和类别线索，不是个体化联用结论。肾功能、电解质、既往反应、其他药物和准确标签都需要由专业人员一起核对。", "en": "No. It is a mechanism and class clue, not an individual combination conclusion. Kidney function, electrolytes, prior reactions, other medicines and the exact label all require joint professional review." } } ], "relatedMedicineChecks": [ { "target": { "id": "klor-con", "brand": "KLOR-CON", "generic": "氯化钾", "canonicalUrls": { "zh": "https://origindrug.com/drugs/klor-con/", "en": "https://origindrug.com/en/drugs/klor-con/" } }, "title": { "zh": "与 KLOR-CON／氯化钾同在药单上时：先核对血钾、肾功能与完整药单", "en": "When KLOR-CON / potassium chloride is on the same list: review potassium, kidney function and the complete medicine list first" }, "summary": { "zh": "ALDACTONE 的美国公开标签提示，与补钾产品或其他可升高血钾的药物同用可能导致高钾血症，肾功能受损时风险更高。本卡片只提示把 ALDACTONE、KLOR-CON、其他处方药、非处方药、补充剂、盐替代品及相关检查交给药师或开方团队核对；它不判断能否同用，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The U.S. public ALDACTONE label says co-use with potassium supplementation or other medicines that can increase potassium may lead to hyperkalaemia, with greater risk in renal impairment. This card only signals that ALDACTONE, KLOR-CON, other prescription medicines, OTC products, supplements, salt substitutes and relevant tests need review by a pharmacist or prescribing team; it does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；Drug Interactions）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/aldactone/", "en": "https://origindrug.com/en/drugs/aldactone/" }, "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." ] }