{ "id": "augmentin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Augmentin", "generic": "阿莫西林/克拉维酸钾", "aliases": [ "奥格门汀", "amoxicillin clavulanate", "amoxicillin/clavulanate potassium" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 FDA 2026 公开标签档案", "dosageFormClass": "口服片剂、口服混悬液及咀嚼片（FDA 2026 公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1984（FDA 2026 公开标签所列美国初始批准）", "archiveSponsorText": "FDA 美国公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-augmentin-tablet-250mg-125mg-ndc-81964-018-30", "marketCode": "US", "labelVersion": { "zh": "FDA 美国处方信息（2026；仅为所引标签展示面，不代表供应）", "en": "FDA U.S. prescribing information (2026; cited label panel only, not availability)" }, "dosageForm": { "zh": "AUGMENTIN 阿莫西林/克拉维酸钾口服薄膜衣片", "en": "AUGMENTIN amoxicillin/clavulanate potassium film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-018-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 250 mg / 125 mg；30 片瓶装（美国 FDA 2026 标签文字）", "en": "250 mg / 125 mg per tablet; 30-tablet bottle (FDA U.S. 2026 label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或可自行换算的数量", "en": "labelled amount per tablet; not an individual's tablet count or self-conversion" } }, { "ingredient": { "zh": "克拉维酸", "en": "clavulanic acid" }, "value": 125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；必须与阿莫西林成分一同核对", "en": "labelled amount per tablet; check together with the amoxicillin component" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "AUGMENTIN / 250/125", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1cf9523d380cb101", "label": "FDA：AUGMENTIN 2026 美国处方信息（精确片剂强度、NDC 与包装数量）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-augmentin-tablet-500mg-125mg-ndc-81964-006-14", "marketCode": "US", "labelVersion": { "zh": "FDA 美国处方信息（2026；仅为所引标签展示面，不代表供应）", "en": "FDA U.S. prescribing information (2026; cited label panel only, not availability)" }, "dosageForm": { "zh": "AUGMENTIN 阿莫西林/克拉维酸钾口服薄膜衣片", "en": "AUGMENTIN amoxicillin/clavulanate potassium film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-006-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 500 mg / 125 mg；20 片瓶装（美国 FDA 2026 标签文字）", "en": "500 mg / 125 mg per tablet; 20-tablet bottle (FDA U.S. 2026 label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或可自行换算的数量", "en": "labelled amount per tablet; not an individual's tablet count or self-conversion" } }, { "ingredient": { "zh": "克拉维酸", "en": "clavulanic acid" }, "value": 125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；必须与阿莫西林成分一同核对", "en": "labelled amount per tablet; check together with the amoxicillin component" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 20, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 20, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "AUGMENTIN / 500/125", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1cf9523d380cb101", "label": "FDA：AUGMENTIN 2026 美国处方信息（精确片剂强度、NDC 与包装数量）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-augmentin-tablet-875mg-125mg-ndc-81964-021-14", "marketCode": "US", "labelVersion": { "zh": "FDA 美国处方信息（2026；仅为所引标签展示面，不代表供应）", "en": "FDA U.S. prescribing information (2026; cited label panel only, not availability)" }, "dosageForm": { "zh": "AUGMENTIN 阿莫西林/克拉维酸钾口服薄膜衣片", "en": "AUGMENTIN amoxicillin/clavulanate potassium film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-021-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 875 mg / 125 mg；20 片瓶装（美国 FDA 2026 标签文字）", "en": "875 mg / 125 mg per tablet; 20-tablet bottle (FDA U.S. 2026 label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 875, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或可自行换算的数量", "en": "labelled amount per tablet; not an individual's tablet count or self-conversion" } }, { "ingredient": { "zh": "克拉维酸", "en": "clavulanic acid" }, "value": 125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；必须与阿莫西林成分一同核对", "en": "labelled amount per tablet; check together with the amoxicillin component" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 20, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 20, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped film-coated tablet" }, "imprint": "AUGMENTIN 875", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1cf9523d380cb101", "label": "FDA：AUGMENTIN 2026 美国处方信息（精确片剂强度、NDC 与包装数量）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "未建立准确原品牌包装对应关系，故不展示包装图片", "en": "No exact original-brand package correspondence was established, so no package visual is shown" }, "summary": { "zh": "此次核验的 DailyMed AUGMENTIN 图像来自 Dr. Reddy’s Laboratories 的 2016 公开标签，覆盖片剂、口服混悬液粉末和咀嚼片等多种不同产品呈现；图片本身未被确认可一一对应本档案的准确原品牌、当前强度、剂型和包装。为避免将历史或多呈现标签图误读为准确原品牌外观，本档案不展示该图片，只保留 FDA 和公开标签作为文字核验入口。", "en": "The reviewed DailyMed AUGMENTIN image comes from a 2016 public label for Dr. Reddy’s Laboratories that covers tablets, powder for oral suspension and chewable tablets across multiple presentations. The image itself was not confirmed as a one-to-one match for this dossier’s exact original-brand, current strength, form and package. To avoid treating a historical or multi-presentation label image as exact original-brand appearance, this dossier withholds the image and retains the FDA and public labels as text-verification entries." }, "source": { "id": "src_cb4896c41b116878", "label": "DailyMed（NLM）：AUGMENTIN 2016 公开标签（Dr. Reddy’s Laboratories）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=174cc098-fe49-4f1a-87e2-601c7573f0db&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AUGMENTIN 说明书放大阅读：两个数字对应两个成分，不能只看阿莫西林", "en": "AUGMENTIN label reading: two numbers describe two ingredients, not amoxicillin alone" }, "summary": { "zh": "本模块以 DailyMed 公开标签为阅读入口，说明 AUGMENTIN 的阿莫西林/克拉维酸钾复方标示、片剂、口服混悬液和咀嚼片之间需要怎样先核对身份；它不生成个人片数、毫升数、疗程或抗菌药选择方案。", "en": "This module uses a DailyMed public label as a reading entry point. It explains how to first identify the amoxicillin/clavulanate potassium combination, tablets, oral suspension and chewable tablets; it does not generate an individual tablet count, millilitre amount, course or antibacterial-medicine choice." }, "checks": [ { "zh": "250 mg/125 mg、500 mg/125 mg、875 mg/125 mg 分别同时标示阿莫西林与克拉维酸的量；“总毫克数”或其中一个数字都不能单独代表完整产品。先核对两个成分、剂型和目标市场。", "en": "250 mg/125 mg, 500 mg/125 mg and 875 mg/125 mg each state amounts for both amoxicillin and clavulanate. A total milligram number or either number alone does not identify the complete product. First check both ingredients, dosage form and target market." }, { "zh": "该公开标签明确指出：两片 250 mg/125 mg 片剂不能替代一片 500 mg/125 mg 片剂，因为克拉维酸部分不同。这是产品身份与标签阅读提示，不是自行调整服用数量的公式。", "en": "This public label explicitly states that two 250 mg/125 mg tablets should not be substituted for one 500 mg/125 mg tablet because the clavulanate component differs. This is a product-identity and label-reading point, not a formula for self-adjusting the number of tablets." }, { "zh": "口服混悬液以“每 5 mL 含两种成分”的方式标示；不同浓度、量取工具、复溶与保存要求都必须跟随这一瓶实际产品的现行标签和处方。不能把片剂数字直接换算成儿童或成人的毫升数。", "en": "Oral suspension is labelled as two ingredients per 5 mL. Different concentrations, measuring devices, reconstitution and storage requirements must follow the current label and prescription for the actual bottle. Tablet numbers cannot be directly converted into a child’s or adult’s millilitre amount." }, { "zh": "某些包装的刻痕、咀嚼片或混悬液外观是识别线索，不是对任意掰开、研碎、替换或合用的许可。出现过敏史、胃肠不适、正在服用多种药物或需要调整时，请带实际包装与完整药单联系医生或药师。", "en": "A score mark, chewable tablet or suspension appearance can be an identification clue, not permission to split, crush, substitute or combine products. With allergy history, gastrointestinal symptoms, multiple medicines or a need to adjust treatment, take the actual pack and complete medicine list to a clinician or pharmacist." } ], "source": { "id": "src_cb4896c41b116878", "label": "DailyMed（NLM）：AUGMENTIN 公开标签", "url": "https://www.dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=174cc098-fe49-4f1a-87e2-601c7573f0db&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿莫西林/克拉维酸怎样起作用：一个作用于细菌细胞壁，另一个可抑制部分 β-内酰胺酶", "en": "How amoxicillin/clavulanate works: one acts at the bacterial cell wall and the other may inhibit some beta-lactamases" }, "summary": { "zh": "FDA 标签说明，阿莫西林与细菌细胞壁中的青霉素结合蛋白结合并抑制细胞壁合成；克拉维酸是与青霉素结构相关的 β-内酰胺，可使某些 β-内酰胺酶失活。这解释为什么它是两种成分的复方抗菌药，不诊断感染、不决定个人片数、毫升数、疗程或是否需要抗菌药。", "en": "The FDA label explains that amoxicillin binds penicillin-binding proteins in the bacterial cell wall and inhibits cell-wall synthesis; clavulanic acid is a beta-lactam related in structure to penicillin that may inactivate some beta-lactamase enzymes. This explains why it is a two-ingredient antibacterial combination; it does not diagnose infection or decide an individual's tablet count, millilitre amount, course or need for an antibacterial." }, "checks": [ { "zh": "“含阿莫西林”或“可抑制部分 β-内酰胺酶”都不能判断发热、咳嗽、咽痛、腹泻或其他症状一定由细菌引起，更不能据此自行开始、续用或把家中剩药给其他人。是否需要抗菌药必须结合诊断、检查和准确产品的现行标签。", "en": "Neither “contains amoxicillin” nor “may inhibit some beta-lactamases” can show that fever, cough, sore throat, diarrhoea or another symptom is definitely bacterial, or justify self-starting, continuing or sharing leftovers. Whether an antibacterial is needed requires diagnosis, testing and the current label for the exact product." }, { "zh": "双成分机制不让 AUGMENTIN 与阿莫西林单药、其他青霉素类、头孢类或其他抗菌药可自行叠加、替换或按一个数字换算。两个成分、剂型、强度、过敏史和完整药单必须一起交由专业人员核对。", "en": "A two-ingredient mechanism does not make AUGMENTIN self-combinable, substitutable or convertible by one number with amoxicillin alone, another penicillin, cephalosporin or another antibacterial. Both ingredients, dosage form, strength, allergy history and the complete medicine list need professional review together." }, { "zh": "机制不能把 250 mg/125 mg、500 mg/125 mg、875 mg/125 mg、咀嚼片或混悬液变成自行增减、掰分或转换的方案。尤其涉及皮疹、呼吸不适、严重腹泻或其他新症状时，应及时使用当地医疗支持，而不是从机制页面推断下一步。", "en": "Mechanism cannot turn 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg, chewable tablets or suspension into a self-made increase, reduction, splitting or conversion plan. Especially with rash, breathing trouble, severe diarrhoea or another new symptom, use timely local medical support rather than infer the next step from a mechanism page." } ], "source": { "id": "src_1cf9523d380cb101", "label": "FDA：AUGMENTIN 2026 美国处方信息（微生物学）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Augmentin", "generic": "阿莫西林/克拉维酸钾", "dosageFormClass": "口服片剂、口服混悬液及咀嚼片（FDA 2026 公开标签所列）" }, "labelSource": { "id": "src_cb4896c41b116878", "label": "DailyMed（NLM）：AUGMENTIN 公开标签", "url": "https://www.dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=174cc098-fe49-4f1a-87e2-601c7573f0db&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_cb4896c41b116878", "label": "DailyMed（NLM）：AUGMENTIN 公开标签", "url": "https://www.dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=174cc098-fe49-4f1a-87e2-601c7573f0db&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_1cf9523d380cb101", "label": "FDA：AUGMENTIN 2026 美国处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 AUGMENTIN（amoxicillin/clavulanate potassium）公开标签将其列为阿莫西林与克拉维酸钾的口服复方制剂，并列示片剂、口服混悬液和咀嚼片。该页面用于阅读具体产品、剂型和两个成分的标示方式；不据此推定中国大陆或其他市场的当前批准、规格、持有人、原研关系、供应或可售资格。", "history": "复方包装上的两个数字分别对应两种成分的标示量；相同的“阿莫西林 mg”不自动代表克拉维酸部分、剂型或产品可以换算。抗菌药是否适用、具体剂型、实际用量和疗程必须由诊断、处方与目标市场的现行标签共同核对。", "sourceDocuments": [ { "id": "src_1cf9523d380cb101", "label": "FDA：AUGMENTIN 2026 美国处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_cb4896c41b116878", "label": "DailyMed（NLM）：AUGMENTIN 公开标签", "url": "https://www.dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=174cc098-fe49-4f1a-87e2-601c7573f0db&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 050564 / 050575 / 050597 / 050720 / 050725 / 050726", "approvalTimeline": [ { "date": "1984", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1984。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1984. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_1cf9523d380cb101", "label": "FDA: AUGMENTIN prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_1cf9523d380cb101", "label": "FDA: AUGMENTIN prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/augmentin/", "en": "https://origindrug.com/en/drugs/augmentin/" }, "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." ] }