{ "id": "lotrel", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "LOTREL", "generic": "氨氯地平/盐酸贝那普利胶囊", "aliases": [ "Lotrel", "amlodipine benazepril", "amlodipine and benazepril hydrochloride", "amlodipine/benazepril", "氨氯地平贝那普利", "氨氯地平贝那普利胶囊", "氨氯地平/贝那普利", "NDA 020364", "0078-0405-05", "0078-0406-05", "0078-0364-05", "0078-0379-05", "Lotrel 2260", "Lotrel 2265", "Lotrel 0364", "Lotrel 0379" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前公开 LOTREL 标签（2023-08 修订）列示氨氯地平/盐酸贝那普利口服胶囊、四个规格及四个 100 粒瓶装面板；FDA Orange Book 与 Drugs@FDA 2026-08-28 数据将 NDA 020364 的六个历史规格均列为 RLD、RS 为 No、Marketing Status 为 Discontinued。公开标签用于阅读，不证明当前供应、库存、购买资格或可替代性。", "dosageFormClass": "氨氯地平/盐酸贝那普利固定两成分口服胶囊：当前公开标签列示 5/10、5/20、10/20、10/40 mg；每组两个数字属于同一粒胶囊内两种成分", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995", "archiveSponsorText": "Sandoz Inc.（FDA 当前申请记录）；DailyMed（NLM）当前公开品牌标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NORVASC", "amlodipine tablet", "LOTENSIN", "benazepril tablet", "ZESTRIL", "VASOTEC", "ALTACE", "CAPOTEN", "ENTRESTO", "EXFORGE", "CADUET" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lotrel-amlodipine-benazepril-capsule-5-10mg-100-bottle-ndc-0078040505", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-08 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (revised Aug 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "LOTREL 氨氯地平/盐酸贝那普利口服胶囊", "en": "LOTREL amlodipine/benazepril hydrochloride oral capsule" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0405-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒氨氯地平 5 mg＋贝那普利 10 mg；100 粒瓶装", "en": "Amlodipine 5 mg plus benazepril 10 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotrel-03.jpg&setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人粒数或换算指令", "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or conversion instruction" } }, { "ingredient": { "zh": "贝那普利", "en": "benazepril" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是加用 ACE 抑制剂或换算指令", "en": "labelled amount of the second ingredient per capsule; not an instruction to add an ACE inhibitor or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅棕色胶囊，两条白色环带", "en": "light-brown capsule with two white bands" }, "shape": { "zh": "胶囊，两条白色环带；胶囊外形不代表可自行打开、分装或减半", "en": "capsule with two white bands; capsule form does not establish permission to open, divide or halve it" }, "imprint": "Lotrel; code 2260", "scoreStatus": "capsule_no_split_cue", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 5/10 mg、NDC 0078-0405-05、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lotrel-amlodipine-benazepril-capsule-5-20mg-100-bottle-ndc-0078040605", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-08 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (revised Aug 2023; 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not an instruction to add an ACE inhibitor or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色胶囊，两条白色环带", "en": "pink capsule with two white bands" }, "shape": { "zh": "胶囊，两条白色环带；胶囊外形不代表可自行打开、分装或减半", "en": "capsule with two white bands; capsule form does not establish permission to open, divide or halve it" }, "imprint": "Lotrel; code 2265", "scoreStatus": "capsule_no_split_cue", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 5/20 mg、NDC 0078-0406-05、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lotrel-amlodipine-benazepril-capsule-10-20mg-100-bottle-ndc-0078036405", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-08 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (revised Aug 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "LOTREL 氨氯地平/盐酸贝那普利口服胶囊", "en": "LOTREL amlodipine/benazepril hydrochloride oral capsule" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0364-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒氨氯地平 10 mg＋贝那普利 20 mg；100 粒瓶装", "en": "Amlodipine 10 mg plus benazepril 20 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotrel-05.jpg&setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人粒数或换算指令", "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or conversion instruction" } }, { "ingredient": { "zh": "贝那普利", "en": "benazepril" }, "value": 20, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是加用 ACE 抑制剂或换算指令", "en": "labelled amount of the second ingredient per capsule; not an instruction to add an ACE inhibitor or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "紫色至紫晶色胶囊，两条白色环带", "en": "purple to amethyst capsule with two white bands" }, "shape": { "zh": "胶囊，两条白色环带；胶囊外形不代表可自行打开、分装或减半", "en": "capsule with two white bands; capsule form does not establish permission to open, divide or halve it" }, "imprint": "Lotrel; code 0364", "scoreStatus": "capsule_no_split_cue", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 10/20 mg、NDC 0078-0364-05、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lotrel-amlodipine-benazepril-capsule-10-40mg-100-bottle-ndc-0078037905", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-08 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (revised Aug 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "LOTREL 氨氯地平/盐酸贝那普利口服胶囊", "en": "LOTREL amlodipine/benazepril hydrochloride oral capsule" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0379-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒氨氯地平 10 mg＋贝那普利 40 mg；100 粒瓶装", "en": "Amlodipine 10 mg plus benazepril 40 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotrel-06.jpg&setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人粒数或换算指令", "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or conversion instruction" } }, { "ingredient": { "zh": "贝那普利", "en": "benazepril" }, "value": 40, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是加用 ACE 抑制剂或换算指令", "en": "labelled amount of the second ingredient per capsule; not an instruction to add an ACE inhibitor or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "深蓝色胶囊，两条白色环带", "en": "dark-blue capsule with two white bands" }, "shape": { "zh": "胶囊，两条白色环带；胶囊外形不代表可自行打开、分装或减半", "en": "capsule with two white bands; capsule form does not establish permission to open, divide or halve it" }, "imprint": "Lotrel; code 0379", "scoreStatus": "capsule_no_split_cue", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 10/40 mg、NDC 0078-0379-05、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lotrel-amlodipine-benazepril-capsule-5-10mg-100-bottle-ndc-0078040505", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotrel-03.jpg&setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "alt": { "zh": "DailyMed LOTREL 5/10 mg、NDC 0078-0405-05、100 粒瓶装公开标签面板", "en": "DailyMed LOTREL 5/10 mg, NDC 0078-0405-05, 100-capsule bottle public-label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 美国公开品牌标签（2023-08 修订）", "presentation": "LOTREL 氨氯地平 5 mg/贝那普利 10 mg 每粒，NDC 0078-0405-05，100 粒瓶装。", "notice": "此图只对应公开标签中的 LOTREL 5/10 mg、NDC 0078-0405-05、100 粒瓶装面板；不能代表另三个面板、已停止销售的其他历史规格、其他市场或仿制药，不用于鉴定真伪，也不证明当前库存、个人粒数或可替代性。", "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 5/10 mg、NDC 0078-0405-05、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LOTREL 说明书放大阅读：一粒已有两种降压成分，先排查氨氯地平与 ACE 抑制剂重复", "en": "LOTREL label reading: one capsule already contains two blood-pressure ingredients; check duplicate amlodipine and ACE inhibitors first" }, "summary": { "zh": "LOTREL 每粒固定含氨氯地平和贝那普利。例如 10/20 mg 表示同一粒内分别含 10 mg 与 20 mg；不能把它理解为半粒、两粒、可打开分装或能与其他产品直接相加换算。", "en": "Each LOTREL capsule contains fixed amounts of amlodipine and benazepril. For example, 10/20 mg means 10 mg and 20 mg of the two ingredients in one capsule; it is not a half-capsule cue, a two-capsule cue, permission to open and divide it, or a sum that can be directly converted across products." }, "checks": [ { "zh": "逐盒核对有效成分。NORVASC 是单方氨氯地平；LOTENSIN 是单方贝那普利；ZESTRIL、VASOTEC、ALTACE、CAPOTEN 也是 ACE 抑制剂。若与 LOTREL 同时出现在药单，不要自行加上、删掉或轮换任何一盒，应让药师或开方团队结合完整处方判断。", "en": "Check the active ingredients on every pack. NORVASC is amlodipine alone, LOTENSIN is benazepril alone, and ZESTRIL, VASOTEC, ALTACE and CAPOTEN are also ACE inhibitors. If they appear with LOTREL, do not add, remove or alternate any pack yourself; a pharmacist or prescriber must review the complete prescriptions." }, { "zh": "ENTRESTO 含沙库巴曲/缬沙坦。当前 LOTREL 标签把与奈普利酶抑制剂合用列为禁忌，并规定 ACE 抑制剂切换前后 36 小时边界；网页不据此安排个人停药或换药，应立即联系开方团队或药师核对。", "en": "ENTRESTO contains sacubitril/valsartan. The current LOTREL label contraindicates coadministration with a neprilysin inhibitor and states a 36-hour boundary around switching an ACE inhibitor. The site does not use this to arrange an individual's stopping or switching; contact the prescriber or pharmacist promptly for review." }, { "zh": "面部、眼睑、嘴唇、舌头或咽喉肿胀，吞咽或呼吸困难，可能是血管性水肿；应立即使用当地急救服务，不要等待网页判断。", "en": "Swelling of the face, eyelids, lips, tongue or throat, or difficulty swallowing or breathing, may be angioedema and requires local emergency services immediately. Do not wait for a website assessment." }, { "zh": "老人或体弱者若出现明显头晕、晕厥、跌倒、尿量减少、持续呕吐或腹泻，应及时联系医疗团队；严重、突然或伴意识异常时使用当地急救服务。应结合血压、肾功能、肝功能、钾和完整药单复核，网页不按年龄自动给方案。", "en": "Older or frail adults with marked dizziness, fainting, a fall, reduced urine or persistent vomiting or diarrhoea should contact the care team promptly; use local emergency services for severe or sudden symptoms or altered consciousness. Review blood pressure, kidney and liver function, potassium and the full medicine list; the site does not generate a regimen from age." }, { "zh": "不要自行使用含钾补充剂或含钾代盐。布洛芬或萘普生等 NSAID、锂盐、其他肾素-血管紧张素系统药物、阿利吉仑，以及其他降压药都需要按完整药单复核；糖尿病患者合用阿利吉仑属于标签禁忌边界。", "en": "Do not use potassium supplements or potassium-containing salt substitutes without professional review. NSAIDs such as ibuprofen or naproxen, lithium, other renin-angiotensin-system medicines, aliskiren and other blood-pressure medicines require full-list review; aliskiren coadministration in diabetes is a labelled contraindication boundary." }, { "zh": "当前标签把与氨氯地平合用时辛伐他汀每日上限写为 20 mg。网页不据此改变个人剂量；若药单有辛伐他汀，应让药师或开方团队核对准确产品与处方。", "en": "The current label limits simvastatin to 20 mg daily when used with amlodipine. The site does not change an individual's dose from this statement; if simvastatin is on the medicine list, have the exact product and prescription reviewed by a pharmacist or prescriber." }, { "zh": "标签有胎儿毒性黑框警示。已经怀孕、可能怀孕或计划怀孕者应立即联系开方团队核对，不要等待网页判断，也不要自行安排停换药。", "en": "The label carries a boxed warning for fetal toxicity. Anyone who is pregnant, may be pregnant or plans pregnancy should contact the prescribing team promptly; do not wait for a website decision or arrange stopping or switching independently." } ], "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 氨氯地平/盐酸贝那普利当前美国公开标签（2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样协同：氨氯地平帮助血管舒张，贝那普利减少血管紧张素 II 形成", "en": "How the two ingredients work together: amlodipine supports arterial relaxation and benazepril reduces angiotensin II formation" }, "summary": { "zh": "当前标签说明：氨氯地平是二氢吡啶类钙通道阻滞剂，抑制钙离子跨膜进入血管平滑肌并产生外周动脉舒张；贝那普利转化为贝那普利拉，抑制血管紧张素转换酶，减少血管紧张素 II 和醛固酮相关作用。两条路径放在同一粒胶囊中，不表示网页能按血压数字拆分或重组个人方案。", "en": "The current label explains that amlodipine is a dihydropyridine calcium-channel blocker that inhibits transmembrane calcium influx into vascular smooth muscle and produces peripheral arterial vasodilation. Benazepril is converted to benazeprilat, which inhibits angiotensin-converting enzyme and reduces angiotensin II- and aldosterone-related effects. Combining both paths in one capsule does not let the site split or rebuild an individual's regimen from a blood-pressure number." }, "checks": [ { "zh": "氨氯地平成分可能与水肿、头晕或低血压有关；贝那普利成分可能影响钾和肾功能。不能只看“降压”两个字而忽略症状、化验和完整药单。", "en": "Amlodipine may be associated with oedema, dizziness or hypotension, while benazepril may affect potassium and kidney function. The words 'blood pressure' must not replace symptoms, laboratory review and the complete medicine list." }, { "zh": "四组双数字是四种完整标签产品身份。不同 mg 组合、颜色、印字和 NDC 不能由网页转换成个人加量、减量、打开胶囊、补服或交替使用。", "en": "The four paired strengths are four complete labelled product identities. Different milligram pairs, colours, imprints and NDCs cannot be converted by the site into an individual increase, decrease, capsule opening, make-up use or alternation plan." }, { "zh": "老人、体弱者或存在肾功能、肝功能、水分不足等情况时，更需要专业人员结合实际药盒与监测结果复核；公开标签仍可阅读不等于该品牌当前可得。", "en": "Older or frail adults and people with kidney or liver impairment or volume depletion particularly need professional review using the actual packs and monitoring results. A publicly readable label does not mean that the brand is currently available." } ], "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 氨氯地平/盐酸贝那普利当前美国公开标签（2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LOTREL", "generic": "氨氯地平/盐酸贝那普利胶囊", "dosageFormClass": "氨氯地平/盐酸贝那普利固定两成分口服胶囊：当前公开标签列示 5/10、5/20、10/20、10/40 mg；每组两个数字属于同一粒胶囊内两种成分" }, "labelSource": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 氨氯地平/盐酸贝那普利当前美国公开标签（2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 氨氯地平/盐酸贝那普利当前美国公开标签（2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA/openFDA Orange Book 当前数据：LOTREL，NDA 020364，六个历史 RLD 规格均列为 Discontinued", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_64c97139855a59cd", "label": "FDA/openFDA Drugs@FDA 当前数据：LOTREL NDA 020364 原始批准、申请持有人与六个已停止销售产品记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020364", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "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": "LOTREL 一粒同时含氨氯地平和贝那普利。药盒上的 5/10、5/20、10/20 或 10/40 不是分粒、半粒或两粒的算式，而是同一粒胶囊内两种成分各有多少毫克。若药单还有 NORVASC 或其他氨氯地平，以及 ZESTRIL、VASOTEC、ALTACE、CAPOTEN 等 ACE 抑制剂，或出现 ENTRESTO，应带所有药盒让药师或开方团队核对成分重复与特殊切换边界，不要自行加药、停药、打开胶囊或轮换。FDA 当前记录将 LOTREL 六个历史 RLD 规格均列为已停止销售。", "history": "FDA Drugs@FDA 当前数据记录 LOTREL NDA 020364 于 1995-03-03 获原始批准，属于新复方；2020-02-10 有 S-066 补充批准信。DailyMed 当前公开品牌标签为 2023-08 修订。FDA Orange Book 与 Drugs@FDA 2026-08-28 数据将 2.5/10、5/10、5/20、10/20、10/40、5/40 mg 六个历史规格均列为 RLD、RS 为 No、Marketing Status 为 Discontinued；当前公开标签只列示其中四个规格与四个 100 粒瓶装面板。", "sourceDocuments": [ { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 氨氯地平/盐酸贝那普利当前美国公开标签（2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA/openFDA Orange Book 当前数据：LOTREL，NDA 020364，六个历史 RLD 规格均列为 Discontinued", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_64c97139855a59cd", "label": "FDA/openFDA Drugs@FDA 当前数据：LOTREL NDA 020364 原始批准、申请持有人与六个已停止销售产品记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020364", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_ff49e4565bc0f1d2", "label": "FDA：LOTREL NDA 020364/S-066 补充批准信（2020-02-10）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020364Orig1s066ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 020364（LOTREL / amlodipine and benazepril hydrochloride oral capsules）", "approvalTimeline": [ { "date": "1995-03-03", "title": { "zh": "LOTREL 原始批准", "en": "Original LOTREL approval" }, "detail": { "zh": "Drugs@FDA 当前数据记录 NDA 020364 原始批准，审评分类为新复方。", "en": "Current Drugs@FDA data record the original approval of NDA 020364 as a new combination." }, "source": { "id": "src_64c97139855a59cd", "label": "FDA/openFDA Drugs@FDA 当前数据：LOTREL NDA 020364 原始批准、申请持有人与六个已停止销售产品记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020364", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2020-02-10", "title": { "zh": "S-066 补充批准", "en": "S-066 supplemental approval" }, "detail": { "zh": "FDA 公开补充批准信记录标签更新节点；它不证明当前市场供应。", "en": "The FDA public supplemental approval letter records a labelling milestone; it does not establish current market supply." }, "source": { "id": "src_ff49e4565bc0f1d2", "label": "FDA：LOTREL NDA 020364/S-066 补充批准信（2020-02-10）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020364Orig1s066ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2023-08-01", "title": { "zh": "当前公开品牌标签修订", "en": "Current public brand label revised" }, "detail": { "zh": "DailyMed 当前页面列示四个规格、四个准确 100 粒瓶装面板及放大安全信息。", "en": "The current DailyMed page lists four strengths, four exact 100-capsule bottle panels and enlarged safety information." }, "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 氨氯地平/盐酸贝那普利当前美国公开标签（2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-28", "title": { "zh": "当前 FDA 数据状态核验", "en": "Current FDA data status reviewed" }, "detail": { "zh": "Orange Book 与 Drugs@FDA 数据将 NDA 020364 六个历史规格均列为 RLD、RS 为 No、Discontinued。", "en": "Orange Book and Drugs@FDA data list all six historical NDA 020364 strengths as RLD products, RS No and Discontinued." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA/openFDA Orange Book 当前数据：LOTREL，NDA 020364，六个历史 RLD 规格均列为 Discontinued", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "六个历史 RLD 规格当前均列为 Discontinued；四个有日期品牌标签面板可公开阅读", "en": "All six historical RLD strengths are currently listed as Discontinued; four dated brand-label panels remain publicly readable" }, "detail": { "zh": "公开标签用于核对成分、规格、包装、外观和安全信息，不证明药房库存、购买资格或可替代性。", "en": "The public label supports review of ingredients, strengths, packs, appearance and safety information; it does not establish pharmacy stock, purchasing eligibility or interchangeability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国历史品牌、共同成分或 mg 数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the historical U.S. brand, shared ingredients or milligram numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "10/20 mg 是不是把胶囊减半或吃两粒？", "en": "Does 10/20 mg mean half a capsule or two capsules?" }, "answer": { "zh": "都不是。它表示同一粒胶囊内有氨氯地平 10 mg 和贝那普利 20 mg。网页不会把双数字转换为打开胶囊、分装、减半或个人粒数。", "en": "Neither. It means one capsule contains amlodipine 10 mg and benazepril 20 mg. The site does not convert the paired numbers into opening, dividing, halving or an individual capsule count." } }, { "question": { "zh": "胶囊可以打开，倒出一半就等于减量吗？", "en": "Can the capsule be opened and half the contents used to reduce the amount?" }, "answer": { "zh": "不能从胶囊外形或毫克数字得出这个结论。当前公开标签建立的是完整胶囊产品身份，并没有让网页据此提供打开、分装或减半方案；应按准确药瓶、处方和药师或开方团队意见核对。", "en": "That conclusion cannot be drawn from capsule form or milligram numbers. The current public label establishes an intact capsule product identity and does not allow the site to provide an opening, dividing or halving plan. Check the exact bottle, prescription and pharmacist or prescriber advice." } }, { "question": { "zh": "已经吃 LOTREL，还能再吃 NORVASC 或其他 ACE 抑制剂吗？", "en": "Can NORVASC or another ACE inhibitor be taken in addition to LOTREL?" }, "answer": { "zh": "网页不能替个人决定。LOTREL 已含氨氯地平和 ACE 抑制剂贝那普利，另一个同成分或同类产品可能是重复，也可能是专业人员有意安排；只有准确处方、实际药盒和完整药单才能判断。不要自行加上或停掉任何一盒。", "en": "The site cannot decide for an individual. LOTREL already contains amlodipine and the ACE inhibitor benazepril; another same-ingredient or same-class product may be duplicative or intentionally prescribed. Only exact prescriptions, packs and the complete medicine list can establish that. Do not add or stop a pack yourself." } }, { "question": { "zh": "为什么标签还能打开，FDA 却写着 Discontinued？", "en": "Why is the label still readable when FDA data say Discontinued?" }, "answer": { "zh": "公开标签是监管与安全信息档案，不等于实时供应清单。当前 FDA 数据对六个历史 RLD 产品的市场状态为 Discontinued，因此页面不会把可阅读标签写成当前有货。", "en": "A public label is a regulatory and safety-information record, not a live supply list. Current FDA data list all six historical RLD products as Discontinued, so this page does not present a readable label as current availability." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lotrel/", "en": "https://origindrug.com/en/drugs/lotrel/" }, "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." ] }