{ "id": "azor", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "AZOR", "generic": "氨氯地平/奥美沙坦酯片", "aliases": [ "Azor", "amlodipine olmesartan", "amlodipine and olmesartan medoxomil", "amlodipine/olmesartan", "氨氯地平奥美沙坦", "氨氯地平奥美沙坦酯片", "氨氯地平/奥美沙坦酯", "NDA 022100", "0713-0870-30", "0713-0871-30", "0713-0872-30", "0713-0873-30", "AZOR C73", "AZOR C74", "AZOR C75", "AZOR C77" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 AZOR 标签（2023-07-12 更新）列示氨氯地平/奥美沙坦酯薄膜衣口服片、四个规格及四个准确 30 片瓶装面板；FDA Orange Book 2026-08-28 数据将 NDA 022100 四个规格均列为处方 RLD，10/40 mg 同时列为 RS。页面不由此推定实时库存、购买资格、其他市场包装或可替代性。", "dosageFormClass": "氨氯地平/奥美沙坦酯固定两成分薄膜衣口服片：5/20、10/20、5/40、10/40 mg；每组两个数字属于同一片内两种成分", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2007", "archiveSponsorText": "Cosette Pharmaceuticals, Inc.（FDA 当前申请与 DailyMed 标签记录）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NORVASC", "amlodipine tablet", "BENICAR", "olmesartan medoxomil tablet", "BENICAR HCT", "TRIBENZOR", "LOTREL", "EXFORGE", "CADUET" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-azor-amlodipine-olmesartan-tablet-5-20mg-30-bottle-ndc-0713087030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "AZOR 氨氯地平/奥美沙坦酯薄膜衣口服片", "en": "AZOR amlodipine/olmesartan medoxomil film-coated oral tablet" }, "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 0713-0870-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 5 mg＋奥美沙坦酯 20 mg；30 片瓶装", "en": "Amlodipine 5 mg plus olmesartan medoxomil 20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=azor-07.jpg&setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用另一种降压药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another blood-pressure medicine or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、无刻痕薄膜衣片，约 6 mm；无刻痕不表示可自行掰开或磨碎", "en": "round, unscored film-coated tablet, approximately 6 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "C73", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 5/20 mg、NDC 0713-0870-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "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-azor-amlodipine-olmesartan-tablet-10-20mg-30-bottle-ndc-0713087130", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "AZOR 氨氯地平/奥美沙坦酯薄膜衣口服片", "en": "AZOR amlodipine/olmesartan medoxomil film-coated oral tablet" }, "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 0713-0871-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 10 mg＋奥美沙坦酯 20 mg；30 片瓶装", "en": "Amlodipine 10 mg plus olmesartan medoxomil 20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=azor-08.jpg&setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用另一种降压药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another blood-pressure medicine or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "灰橙色", "en": "grayish orange" }, "shape": { "zh": "圆形、无刻痕薄膜衣片，约 8 mm；无刻痕不表示可自行掰开或磨碎", "en": "round, unscored film-coated tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "C74", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 10/20 mg、NDC 0713-0871-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "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-azor-amlodipine-olmesartan-tablet-5-40mg-30-bottle-ndc-0713087230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "AZOR 氨氯地平/奥美沙坦酯薄膜衣口服片", "en": "AZOR amlodipine/olmesartan medoxomil film-coated oral tablet" }, "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 0713-0872-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 5 mg＋奥美沙坦酯 40 mg；30 片瓶装", "en": "Amlodipine 5 mg plus olmesartan medoxomil 40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=azor-09.jpg&setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用另一种降压药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another blood-pressure medicine or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "乳白色", "en": "cream" }, "shape": { "zh": "圆形、无刻痕薄膜衣片，约 8 mm；无刻痕不表示可自行掰开或磨碎", "en": "round, unscored film-coated tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "C75", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 5/40 mg、NDC 0713-0872-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "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-azor-amlodipine-olmesartan-tablet-10-40mg-30-bottle-ndc-0713087330", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "AZOR 氨氯地平/奥美沙坦酯薄膜衣口服片", "en": "AZOR amlodipine/olmesartan medoxomil film-coated oral tablet" }, "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 0713-0873-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 10 mg＋奥美沙坦酯 40 mg；30 片瓶装", "en": "Amlodipine 10 mg plus olmesartan medoxomil 40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=azor-0a.jpg&setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用另一种降压药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another blood-pressure medicine or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕红色", "en": "brownish red" }, "shape": { "zh": "圆形、无刻痕薄膜衣片，约 8 mm；无刻痕不表示可自行掰开或磨碎", "en": "round, unscored film-coated tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "C77", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 10/40 mg、NDC 0713-0873-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "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-azor-amlodipine-olmesartan-tablet-5-20mg-30-bottle-ndc-0713087030", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=azor-07.jpg&setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "alt": { "zh": "DailyMed 当前 AZOR 5/20 mg、NDC 0713-0870-30、30 片瓶装标签面板", "en": "Current DailyMed AZOR 5/20 mg, NDC 0713-0870-30, 30-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（2023-07-12 更新）", "presentation": "AZOR 氨氯地平 5 mg/奥美沙坦酯 20 mg 每片，NDC 0713-0870-30，30 片瓶装。", "notice": "此图只对应当前标签中的 AZOR 5/20 mg、NDC 0713-0870-30、30 片瓶装面板；不能代表另三个规格、其他市场或仿制药，不用于鉴定真伪，也不证明实时库存、个人片数或可替代性。", "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 5/20 mg、NDC 0713-0870-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "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": "AZOR 说明书放大阅读：一片已有两种降压成分，先核对氨氯地平和奥美沙坦是否重复", "en": "AZOR label reading: one tablet already contains two blood-pressure ingredients; first check duplicate amlodipine and olmesartan" }, "summary": { "zh": "AZOR 每片固定含氨氯地平和奥美沙坦酯。例如 10/40 mg 表示同一片内分别含 10 mg 与 40 mg；不能理解成两片、半片或可与单方产品直接相加换算。", "en": "Each AZOR tablet contains fixed amounts of amlodipine and olmesartan medoxomil. For example, 10/40 mg means 10 mg and 40 mg of the two ingredients in one tablet; it is not a two-tablet cue, a half-tablet cue or a sum that can be directly converted with single-ingredient products." }, "checks": [ { "zh": "逐盒看有效成分。NORVASC 是单方氨氯地平，BENICAR 是单方奥美沙坦酯；LOTREL、EXFORGE、CADUET、BENICAR HCT 和 TRIBENZOR 可能与 AZOR 共享一种成分。若同时出现在药单，不要自行删掉或加上任何一盒，应由药师或开方团队结合完整处方判断。", "en": "Read the active ingredients on every pack. NORVASC is amlodipine alone and BENICAR is olmesartan medoxomil alone; LOTREL, EXFORGE, CADUET, BENICAR HCT and TRIBENZOR may share an ingredient with AZOR. If they appear together, do not add or remove a pack yourself; a pharmacist or prescriber must review the complete prescriptions." }, { "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." }, { "zh": "严重、持续的慢性腹泻并伴明显体重下降，可能与标签所述类乳糜泻性肠病有关，即使已使用数月或数年也应尽快联系医疗团队；若出现脱水、晕厥、意识异常或无法进水，使用当地急救服务。", "en": "Severe, persistent chronic diarrhoea with substantial weight loss may relate to the labelled sprue-like enteropathy, even after months or years of use, and warrants prompt contact with the care team. Use local emergency services for dehydration, fainting, altered consciousness or inability to take fluids." }, { "zh": "老人或体弱者若明显头晕、晕厥、跌倒、尿量减少或持续呕吐腹泻，应及时联系医疗团队；严重或突然时使用当地急救服务。应结合血压、肾功能、肝功能、电解质与完整药单复核，网页不按年龄生成方案。", "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. Review blood pressure, kidney and liver function, electrolytes and the full medicine list; the site does not generate a regimen from age." }, { "zh": "标签注明：糖尿病患者合用阿利吉仑属于禁忌边界。其他肾素-血管紧张素系统药物、NSAID（如布洛芬或萘普生）、锂盐、含钾补充剂或代盐，以及胆汁酸螯合剂考来维仑都需要按准确产品和完整药单核对；网页不安排个人间隔或停换药。", "en": "The label contraindicates aliskiren coadministration in patients with diabetes. Other renin-angiotensin-system medicines, NSAIDs such as ibuprofen or naproxen, lithium, potassium supplements or salt substitutes, and the bile-acid sequestrant colesevelam require exact-product and full-list review. The site does not arrange an individual's interval, stopping or switching." }, { "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": "四种片剂均为薄膜衣、圆形、无刻痕。无刻痕不等于可自行掰开、磨碎或按颜色换药；应按准确处方和药师或开方团队意见核对。", "en": "All four tablets are round, film-coated and unscored. An unscored tablet does not permit self-splitting, crushing or colour-based switching; check the exact prescription with a pharmacist or prescriber." } ], "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 氨氯地平/奥美沙坦酯当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "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，奥美沙坦阻断血管紧张素 II 的 AT1 受体作用", "en": "How the two ingredients work together: amlodipine supports arterial relaxation and olmesartan blocks angiotensin II activity at the AT1 receptor" }, "summary": { "zh": "当前标签说明：氨氯地平是二氢吡啶类钙通道阻滞剂，减少钙离子进入血管平滑肌并产生外周动脉舒张；奥美沙坦酯转化为奥美沙坦，选择性阻断血管紧张素 II 与 AT1 受体结合。两条路径放在同一片中，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 reduces calcium influx into vascular smooth muscle and produces peripheral arterial vasodilation. Olmesartan medoxomil is converted to olmesartan, which selectively blocks angiotensin II binding to the AT1 receptor. Combining both pathways in one tablet 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；奥美沙坦成分可能影响肾功能和电解质。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 olmesartan may affect kidney function and electrolytes. 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、分片、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, splitting, make-up use or alternation plan." }, { "zh": "当前标签指出，≥75 岁人群的氨氯地平初始量考虑与 AZOR 最低规格之间存在边界；这不是网页给老人停用或改量的指令，而是提醒带准确药盒、监测结果和完整药单让开方团队复核。", "en": "The current label identifies a boundary between amlodipine initiation considerations in people aged 75 years or older and AZOR's lowest strength. This is not a website instruction to stop or change an amount; it prompts review of the exact pack, monitoring results and complete medicine list by the prescribing team." } ], "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 氨氯地平/奥美沙坦酯当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "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": "AZOR", "generic": "氨氯地平/奥美沙坦酯片", "dosageFormClass": "氨氯地平/奥美沙坦酯固定两成分薄膜衣口服片：5/20、10/20、5/40、10/40 mg；每组两个数字属于同一片内两种成分" }, "labelSource": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 氨氯地平/奥美沙坦酯当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "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_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 氨氯地平/奥美沙坦酯当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "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 Orange Book 当前数据：AZOR，NDA 022100，四个口服片规格均列为处方 RLD；10/40 mg 同时列为 RS", "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_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：AZOR NDA 022100 原始批准与申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "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": "AZOR 一片同时含氨氯地平和奥美沙坦酯。药盒上的 5/20、10/20、5/40 或 10/40 不是半片、两片或加减法，而是同一片内两种成分各有多少毫克。若药单还有 NORVASC、BENICAR，或 LOTREL、EXFORGE、CADUET、BENICAR HCT、TRIBENZOR 等可能共享成分的产品，应带所有药盒和处方让药师或开方团队逐项核对，不要自行叠加、停药、轮换或按毫克换算。", "history": "FDA 公开审评资料与 Orange Book 记录 AZOR NDA 022100 于 2007-09-26 获批，四个规格均为处方 RLD；当前数据将 10/40 mg 同时列为 RS。DailyMed 当前标签页面于 2023-07-12 更新，四个 NDC 的 30 片瓶装营销起始日期列为 2022-09-01，未列营销结束日期；这仍不是实时库存证明。", "sourceDocuments": [ { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 氨氯地平/奥美沙坦酯当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "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 Orange Book 当前数据：AZOR，NDA 022100，四个口服片规格均列为处方 RLD；10/40 mg 同时列为 RS", "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_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：AZOR NDA 022100 原始批准与申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "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_e6e3de41afca3ccd", "label": "FDA：AZOR NDA 022100 原始申请行政审评资料（2007）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022100s000_AdminCorres_P1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 022100（AZOR / amlodipine and olmesartan medoxomil oral tablets）", "approvalTimeline": [ { "date": "2007-09-26", "title": { "zh": "AZOR 原始批准", "en": "Original AZOR approval" }, "detail": { "zh": "FDA 公开审评资料与 Orange Book 当前记录 NDA 022100 的四个固定复方规格获批。", "en": "FDA public review material and current Orange Book data record approval of the four fixed-combination strengths under NDA 022100." }, "source": { "id": "src_e6e3de41afca3ccd", "label": "FDA：AZOR NDA 022100 原始申请行政审评资料（2007）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022100s000_AdminCorres_P1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2022-09-01", "title": { "zh": "当前四个 NDC 标签营销起始日期", "en": "Current label marketing-start date for four NDCs" }, "detail": { "zh": "DailyMed 当前页面对四个 30 片瓶装 NDC 均列 2022-09-01 为营销起始日期且未列结束日期；这不是实时库存证明。", "en": "The current DailyMed page lists 1 Sep 2022 as the marketing-start date for all four 30-tablet bottle NDCs and no end date; this is not real-time stock evidence." }, "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 氨氯地平/奥美沙坦酯当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "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": "2023-07-12", "title": { "zh": "当前公开标签页面更新", "en": "Current public label page updated" }, "detail": { "zh": "DailyMed 当前页面列示四个规格、四个准确 30 片瓶装面板、外观和放大安全信息。", "en": "The current DailyMed page lists four strengths, four exact 30-tablet bottle panels, appearance and enlarged safety information." }, "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 氨氯地平/奥美沙坦酯当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "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 Orange Book 身份核验", "en": "Current Orange Book identity reviewed" }, "detail": { "zh": "当前数据将四个规格均列为处方 RLD，并将 10/40 mg 列为 RS。", "en": "Current data list all four strengths as prescription RLD products and 10/40 mg as the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：AZOR，NDA 022100，四个口服片规格均列为处方 RLD；10/40 mg 同时列为 RS", "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": "四个处方 RLD 规格；10/40 mg 同时为 RS；四个当前标签 NDC 无营销结束日期", "en": "Four prescription RLD strengths; 10/40 mg also RS; four current-label NDCs have no marketing end date" }, "detail": { "zh": "这些官方记录支持核对产品身份，不证明药房实时库存、购买资格或可替代性。", "en": "These official records support product-identity review; they do not establish real-time 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 U.S. brand, shared ingredients or milligram numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "10/40 mg 是不是要吃两片，或把一片掰半？", "en": "Does 10/40 mg mean two tablets or half a tablet?" }, "answer": { "zh": "都不是。它表示同一片内有氨氯地平 10 mg 和奥美沙坦酯 40 mg。网页不会把双数字转换为分片、磨碎或个人片数。", "en": "Neither. It means one tablet contains amlodipine 10 mg and olmesartan medoxomil 40 mg. The site does not convert the paired numbers into splitting, crushing or an individual tablet count." } }, { "question": { "zh": "已经吃 AZOR，还能再吃 NORVASC 或 BENICAR 吗？", "en": "Can NORVASC or BENICAR be taken in addition to AZOR?" }, "answer": { "zh": "网页不能替个人决定。AZOR 已含氨氯地平和奥美沙坦酯，另一个同成分产品可能是重复，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. AZOR already contains amlodipine and olmesartan medoxomil, so another same-ingredient 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": "长期腹泻只是胃肠不适，可以先等等吗？", "en": "Is persistent diarrhoea just a stomach problem that can wait?" }, "answer": { "zh": "标签记录奥美沙坦相关类乳糜泻性肠病可能在开始使用数月到数年后出现，并可伴严重慢性腹泻和明显体重下降。应尽快联系医疗团队核对；出现脱水、晕厥、意识异常或无法进水时使用当地急救服务。网页不作个人诊断。", "en": "The label records that olmesartan-associated sprue-like enteropathy may occur months to years after initiation and may involve severe chronic diarrhoea and substantial weight loss. Contact the care team promptly; use local emergency services for dehydration, fainting, altered consciousness or inability to take fluids. The site does not diagnose an individual." } } ], "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/azor/", "en": "https://origindrug.com/en/drugs/azor/" }, "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." ] }