{ "id": "lotensin-benazepril", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "LOTENSIN", "generic": "盐酸贝那普利普通片", "aliases": [ "Lotensin", "benazepril", "benazepril hydrochloride", "贝那普利", "盐酸贝那普利", "洛汀新", "benazepril tablets", "盐酸贝那普利片", "LOTENSIN", "NDA 019851", "30698-448-01", "30698-449-01", "30698-450-01", "LOTENSIN 10", "LOTENSIN 20", "LOTENSIN 40" ], "marketBrandNames": [ { "name": "LOTENSIN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 019851；当前品牌标签列 10、20、40 mg 普通片。监管标签不等于实时供应。", "en": "NDA 019851; the current brand label lists 10, 20 and 40 mg immediate-release tablets. A regulatory label is not live supply." }, "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 当前 LOTENSIN 品牌标签列 10、20、40 mg 普通片三个 100 片瓶装，均归入 NDA 019851。历史审批文件还出现 5 mg，但当前品牌标签的剂型强度和包装面板未列 5 mg；网页不把历史规格改写为当前品牌包装或实时供应。", "dosageFormClass": "盐酸贝那普利普通口服片。LOTENSIN HCT 另含氢氯噻嗪，LOTREL 另含氨氯地平；共同品牌或成分词根不建立一比一替换、叠加或 mg 换算。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1991（美国初始批准年份）", "archiveSponsorText": "Validus Pharmaceuticals LLC（当前美国品牌标签包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "LOTENSIN", "Lotensin benazepril", "盐酸贝那普利片", "贝那普利片", "洛汀新" ], "excludedProductCues": [ "LOTENSIN HCT", "benazepril hydrochloride hydrochlorothiazide", "贝那普利氢氯噻嗪", "LOTREL", "amlodipine benazepril", "氨氯地平贝那普利" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lotensin-benazepril-10mg-100-tablet-bottle-ndc-3069844801", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v10；2025-09-30 更新，2025-10-02 发布）", "en": "Current U.S. DailyMed brand label (SPL v10; updated 30 Sep and published 2 Oct 2025)" }, "dosageForm": { "zh": "LOTENSIN 盐酸贝那普利普通口服片", "en": "LOTENSIN benazepril hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-448-01", "pouchCode": null, "applicationNumber": "NDA 019851", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸贝那普利 10 mg；100 片瓶装", "en": "Benazepril hydrochloride 10 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotensin-02.jpg&setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸贝那普利", "en": "benazepril hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数，也不是与 LOTENSIN HCT、LOTREL 或其他 ACE 抑制剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count or a conversion to LOTENSIN HCT, LOTREL or another ACE inhibitor" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深黄色", "en": "dark yellow" }, "shape": { "zh": "圆形、约 8 mm；当前标签正文列为无刻痕", "en": "round, approximately 8 mm; current label text lists no score" }, "imprint": "LOTENSIN / 10", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lotensin-benazepril-20mg-100-tablet-bottle-ndc-3069844901", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v10；2025-09-30 更新，2025-10-02 发布）", "en": "Current U.S. DailyMed brand label (SPL v10; updated 30 Sep and published 2 Oct 2025)" }, "dosageForm": { "zh": "LOTENSIN 盐酸贝那普利普通口服片", "en": "LOTENSIN benazepril hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-449-01", "pouchCode": null, "applicationNumber": "NDA 019851", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸贝那普利 20 mg；100 片瓶装", "en": "Benazepril hydrochloride 20 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotensin-03.jpg&setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸贝那普利", "en": "benazepril hydrochloride" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数，也不是与 LOTENSIN HCT、LOTREL 或其他 ACE 抑制剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count or a conversion to LOTENSIN HCT, LOTREL or another ACE inhibitor" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、约 8 mm；当前标签正文列为无刻痕", "en": "round, approximately 8 mm; current label text lists no score" }, "imprint": "LOTENSIN / 20", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lotensin-benazepril-40mg-100-tablet-bottle-ndc-3069845001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v10；2025-09-30 更新，2025-10-02 发布）", "en": "Current U.S. DailyMed brand label (SPL v10; updated 30 Sep and published 2 Oct 2025)" }, "dosageForm": { "zh": "LOTENSIN 盐酸贝那普利普通口服片", "en": "LOTENSIN benazepril hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-450-01", "pouchCode": null, "applicationNumber": "NDA 019851", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸贝那普利 40 mg；100 片瓶装", "en": "Benazepril hydrochloride 40 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotensin-04.jpg&setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸贝那普利", "en": "benazepril hydrochloride" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数，也不是与 LOTENSIN HCT、LOTREL 或其他 ACE 抑制剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count or a conversion to LOTENSIN HCT, LOTREL or another ACE inhibitor" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深玫瑰红色", "en": "dark rose" }, "shape": { "zh": "圆形、约 8 mm；当前标签正文列为无刻痕", "en": "round, approximately 8 mm; current label text lists no score" }, "imprint": "LOTENSIN / 40", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lotensin-benazepril-10mg-100-tablet-bottle-ndc-3069844801", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotensin-02.jpg&setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "alt": "LOTENSIN 盐酸贝那普利 10 mg、NDC 30698-448-01、100 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（2025-10-02 发布）", "presentation": "10 mg：深黄色圆形、约 8 mm、LOTENSIN / 10；NDC 30698-448-01，100 片瓶装。另有 20、40 mg 当前准确包装，必须按 NDC 分开核对。", "notice": "此图只对应美国 NDC 30698-448-01 的 10 mg、100 片瓶装，不代表 LOTENSIN HCT、LOTREL、历史 5 mg、其他市场包装或实时库存，也不用于鉴定真伪。", "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LOTENSIN 说明书放大阅读：分清每片 mg、整瓶片数、单方与两个复方", "en": "LOTENSIN enlarged label: separate per-tablet mg, bottle count, single ingredient and two combinations" }, "summary": { "zh": "10、20、40 mg 是每片盐酸贝那普利标示量；100 Tablets 是整瓶片数。LOTENSIN HCT 另含氢氯噻嗪，LOTREL 另含氨氯地平，不能从共同词根或总毫克数自行拼接、叠加或替换。", "en": "The 10, 20 and 40 mg figures are labelled benazepril hydrochloride per tablet; 100 Tablets is the bottle count. LOTENSIN HCT also contains hydrochlorothiazide and LOTREL also contains amlodipine, so shared name stems or total milligrams do not permit self-assembly, combination or substitution." }, "checks": [ { "zh": "标签有胎儿毒性黑框警示。若已怀孕、可能怀孕或计划怀孕，应立即联系开方团队；网页不生成继续、暂停或替代方案。", "en": "The label carries a boxed warning for fetal toxicity. Contact the prescriber promptly for pregnancy, possible pregnancy or pregnancy planning; the site generates no continuation, stopping or substitution plan." }, { "zh": "面、唇、舌或喉咙肿胀，尤其伴呼吸或吞咽困难，属于需要紧急处理的血管性水肿信号；不要等待网页判断。", "en": "Swelling of the face, lips, tongue or throat—especially with breathing or swallowing difficulty—is an emergency angioedema signal. Do not wait for a website assessment." }, { "zh": "ENTRESTO 含沙库巴曲/缬沙坦，标签规定与贝那普利等 ACE 抑制剂转换有 36 小时边界；不要自行安排错开、停药或换药。", "en": "ENTRESTO contains sacubitril/valsartan, and the label specifies a 36-hour boundary when switching to or from an ACE inhibitor such as benazepril. Do not self-schedule spacing, stopping or switching." }, { "zh": "补钾、含钾代盐、保钾利尿药、另一种 ACEI/ARB、NSAID、锂或利尿剂同处药单时，应优先核对肾功能、血钾、低血压与完整药单；老人脱水、站立不稳或跌倒更应及时核对。", "en": "Potassium supplements or salt substitutes, a potassium-sparing diuretic, another ACE inhibitor/ARB, NSAID, lithium or a diuretic on the same list requires priority review of kidney function, potassium, hypotension and the complete medicine list. Dehydration, unsteadiness or a fall in an older adult needs timely review." } ], "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "贝那普利怎样起作用：抑制 ACE，减少血管紧张素 II，并影响缓激肽通路", "en": "How benazepril works: ACE inhibition reduces angiotensin II and affects the bradykinin pathway" }, "summary": { "zh": "贝那普利在体内转为活性代谢物贝那普利拉，抑制 ACE 后减少血管紧张素 II 形成并降低醛固酮相关作用。ACE 也参与缓激肽分解，这有助于理解为何咳嗽和血管性水肿需要被认真识别；机制不能替个人决定药物或剂量。", "en": "Benazepril is converted to the active metabolite benazeprilat. ACE inhibition reduces formation of angiotensin II and related aldosterone effects. ACE also participates in bradykinin breakdown, which helps explain why cough and angioedema require attention; mechanism cannot choose a medicine or dose for an individual." }, "checks": [ { "zh": "LOTENSIN、ZESTRIL、VASOTEC、ALTACE、CAPOTEN 和 COVERSYL 不是同一种药；共同 ACE 抑制机制不建立 mg 换算、轮换或叠加规则。", "en": "LOTENSIN, ZESTRIL, VASOTEC, ALTACE, CAPOTEN and COVERSYL are not one medicine. A shared ACE-inhibitor mechanism does not establish milligram conversion, alternation or combination." }, { "zh": "与 ARB、阿利吉仑或另一种肾素-血管紧张素系统药物共同出现，可能增加低血压、高钾和肾功能受损风险；共同机制不是更强或更适合的证明。", "en": "Co-listing an ARB, aliskiren or another renin-angiotensin-system medicine may increase hypotension, hyperkalaemia and kidney-impairment risk. A shared mechanism is not proof of greater benefit or suitability." }, { "zh": "干咳可以与 ACE 抑制剂有关，但老人呼吸困难、喉头紧、面唇舌肿胀不能简单当作普通咳嗽，应按紧急信号处理。", "en": "A dry cough can be associated with ACE inhibitors, but breathing difficulty, throat tightness or face/lip/tongue swelling in an older adult must not be dismissed as an ordinary cough and requires emergency action." } ], "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LOTENSIN", "generic": "盐酸贝那普利普通片", "dosageFormClass": "盐酸贝那普利普通口服片。LOTENSIN HCT 另含氢氯噻嗪，LOTREL 另含氨氯地平；共同品牌或成分词根不建立一比一替换、叠加或 mg 换算。" }, "labelSource": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "LOTENSIN 是盐酸贝那普利单方普通片品牌档案。10/20/40 mg 是每片含量，100 Tablets 是整瓶片数，不是个人片数。老人或多药使用者应优先核对站立性低血压/跌倒、肾功能、血钾、补钾与含钾代盐、利尿剂、NSAID 止痛药、锂、其他 ACEI/ARB 和 ENTRESTO；网页不替个人决定规格、次数、停药或换药。", "history": "LOTENSIN 的美国初始批准年份为 1991。FDA 2012 年补充批准函同时列出 LOTENSIN 单方与 LOTENSIN HCT 复方并分别绑定 NDA，说明共同品牌词根不能合并产品。当前 DailyMed SPL v10 于 2025-10-02 发布，列示三个 Validus 100 片瓶装。", "sourceDocuments": [ { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_bf47012f7d7dd413", "label": "FDA：LOTENSIN 贝那普利 NDA 019851/S-043 与 LOTENSIN HCT 分剂型补充批准函（2012）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851s043%2C020033s045ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "NDA 019851", "approvalTimeline": [ { "date": "1991", "title": { "zh": "LOTENSIN 美国初始批准", "en": "Initial U.S. approval of LOTENSIN" }, "detail": { "zh": "当前 DailyMed 标签列示的初始批准年份。", "en": "Initial approval year stated by the current DailyMed label." }, "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2012-01-30", "title": { "zh": "FDA 批准胎儿毒性等标签补充", "en": "FDA approved a fetal-toxicity and related labelling supplement" }, "detail": { "zh": "补充批准函分别列出 LOTENSIN NDA 019851 与 LOTENSIN HCT NDA 020033，并更新胎儿毒性警示。", "en": "The supplement letter separately lists LOTENSIN NDA 019851 and LOTENSIN HCT NDA 020033 and updates fetal-toxicity labelling." }, "source": { "id": "src_bf47012f7d7dd413", "label": "FDA：LOTENSIN 贝那普利 NDA 019851/S-043 与 LOTENSIN HCT 分剂型补充批准函（2012）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851s043%2C020033s045ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2025-10-02", "title": { "zh": "当前 DailyMed SPL 发布", "en": "Current DailyMed SPL published" }, "detail": { "zh": "当前三个 Validus 品牌瓶装与说明书可公开阅读。", "en": "The current three Validus brand bottles and label are publicly readable." }, "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "NDA 019851；10、20、40 mg 普通片，三个 100 片瓶装。", "en": "NDA 019851; 10, 20 and 40 mg immediate-release tablets in three 100-tablet bottles." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地商品名、包装或供应", "en": "Local brand, pack and supply are not established by this dossier" }, "detail": { "zh": "“洛汀新”等名称须与当地药监记录、说明书和手中药盒逐项核对。", "en": "Names such as 洛汀新 require item-by-item checking against the local regulator, leaflet and pack in hand." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "LOTENSIN、LOTENSIN HCT 和 LOTREL 是一回事吗？", "en": "Are LOTENSIN, LOTENSIN HCT and LOTREL the same product?" }, "answer": { "zh": "不是。LOTENSIN 是贝那普利单方，LOTENSIN HCT 再加氢氯噻嗪，LOTREL 再加氨氯地平；共同成分可能造成重复，不能按品牌词根自行叠加或换算。", "en": "No. LOTENSIN is benazepril alone, LOTENSIN HCT adds hydrochlorothiazide, and LOTREL adds amlodipine. A shared ingredient may create duplication and does not permit self-combination or conversion from brand stems." } }, { "question": { "zh": "标签有历史 5 mg，为什么当前包装只有 10、20、40 mg？", "en": "Why do historical records mention 5 mg while current packs show 10, 20 and 40 mg?" }, "answer": { "zh": "历史审批记录与当前公开标签是不同时间证据。当前标签的剂型强度和三个包装面板只列 10、20、40 mg；网页不把历史 5 mg 改写成当前品牌供应。", "en": "Historical approval records and a current public label are different time-bounded evidence. The current dosage-form section and three pack panels list only 10, 20 and 40 mg; the site does not rewrite historical 5 mg as current brand supply." } }, { "question": { "zh": "同时有 ENTRESTO、补钾、布洛芬或另一种降压药怎么办？", "en": "What if ENTRESTO, potassium, ibuprofen or another blood-pressure medicine is on the same list?" }, "answer": { "zh": "不要自行删药、补药或安排错开。ENTRESTO 与 ACE 抑制剂有 36 小时标签边界；补钾、NSAID、其他 RAS 药物和利尿剂还涉及血钾、肾功能和低血压。请用准确药盒、处方、化验和完整药单让开方团队或药师核对。", "en": "Do not self-remove, add or schedule spacing. ENTRESTO and ACE inhibitors have a 36-hour label boundary; potassium, NSAIDs, other RAS medicines and diuretics also involve potassium, kidney function and hypotension. Have the prescriber or pharmacist review exact packs, prescriptions, laboratory results and the complete medicine list." } } ], "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/lotensin-benazepril/", "en": "https://origindrug.com/en/drugs/lotensin-benazepril/" }, "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." ] }