{ "id": "biaxin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "BIAXIN", "generic": "克拉霉素", "aliases": [ "Biaxin Filmtab", "BIAXIN XL", "Biaxin Granules", "clarithromycin", "clarithromycin tablets", "clarithromycin extended-release tablets", "clarithromycin for oral suspension", "克拉霉素", "克拉霉素片", "克拉霉素缓释片", "克拉霉素口服混悬剂", "clarithromycin extended release", "NDA 050662", "NDA 050698", "NDA 050775", "54868-3820-0", "54868-2338-2", "54868-4191-0", "54868-4919-0", "54868-3384-0", "KT", "KL", "KJ" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国：FDA Orange Book 2026-08-26 数据将 BIAXIN 250/500 mg 普通片、BIAXIN 125/250 mg/5 mL 混悬剂与 BIAXIN XL 500 mg 缓释片五个历史产品行列为 RLD，Product Type 均为 Discontinued、RS 均为 No。本页的 2012 DailyMed 页面明确是再包装历史标签；2026 年克拉霉素普通片标签只用于现行成分级安全对照，不证明 BIAXIN 品牌当前供应。", "dosageFormClass": "克拉霉素口服产品历史档案：BIAXIN 250/500 mg 普通片、BIAXIN XL 500 mg 缓释片、BIAXIN 复溶后 125/250 mg/5 mL 混悬剂；相同成分不表示普通片、缓释片和液体可按 mg 自行互换", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1991", "archiveSponsorText": "AbbVie Inc.（FDA Orange Book 当前申请主体）；历史 DailyMed 标签由 Physicians Total Care, Inc. 再包装发布" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "azithromycin", "ZITHROMAX", "erythromycin", "KLACID", "clarithromycin injection", "克拉霉素注射剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-historical-repackaged-biaxin-clarithromycin-250mg-20-tablet-bottle-ndc-54868-3820-0", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史再包装公开标签（2012-02-22 更新）；FDA Orange Book 当前状态另行核对", "en": "Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately" }, "dosageForm": { "zh": "BIAXIN 克拉霉素普通薄膜衣片", "en": "BIAXIN clarithromycin immediate-release film-coated tablet" }, "route": { "zh": "口服（历史准确产品身份字段）", "en": "oral (historical exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-3820-0", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片克拉霉素 250 mg；20 片瓶装", "en": "Clarithromycin 250 mg per tablet; 20 tablets in a bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克拉霉素", "en": "clarithromycin" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或与另一剂型的换算式", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion from another form" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "a bottle" }, "fill": null, "countPerPackage": 20, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_repackaged_label_not_current_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、约 15 mm、无刻痕", "en": "oval, approximately 15 mm, unscored" }, "imprint": "KT", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN 克拉霉素 250 mg、NDC 54868-3820-0、20 片瓶装历史再包装标签文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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-historical-repackaged-biaxin-clarithromycin-500mg-14-tablet-bottle-ndc-54868-2338-2", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史再包装公开标签（2012-02-22 更新）；FDA Orange Book 当前状态另行核对", "en": "Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately" }, "dosageForm": { "zh": "BIAXIN 克拉霉素普通薄膜衣片", "en": "BIAXIN clarithromycin immediate-release film-coated tablet" }, "route": { "zh": "口服（历史准确产品身份字段）", "en": "oral (historical exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-2338-2", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片克拉霉素 500 mg；14 片瓶装", "en": "Clarithromycin 500 mg per tablet; 14 tablets in a bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克拉霉素", "en": "clarithromycin" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或与另一剂型的换算式", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion from another form" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "a bottle" }, "fill": null, "countPerPackage": 14, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_repackaged_label_not_current_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 14, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、约 18 mm、无刻痕", "en": "oval, approximately 18 mm, unscored" }, "imprint": "KL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN 克拉霉素 500 mg、NDC 54868-2338-2、14 片瓶装历史再包装标签文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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-historical-repackaged-biaxin-xl-clarithromycin-500mg-20-tablet-bottle-ndc-54868-4191-0", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史再包装公开标签（2012-02-22 更新）；FDA Orange Book 当前状态另行核对", "en": "Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately" }, "dosageForm": { "zh": "BIAXIN XL 克拉霉素缓释薄膜衣片", "en": "BIAXIN XL clarithromycin extended-release film-coated tablet" }, "route": { "zh": "口服（历史准确产品身份字段）", "en": "oral (historical exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-4191-0", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片克拉霉素 500 mg；20 片瓶装", "en": "Clarithromycin 500 mg per tablet; 20 tablets in a bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克拉霉素", "en": "clarithromycin" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或与另一剂型的换算式", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion from another form" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "a bottle" }, "fill": null, "countPerPackage": 20, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_repackaged_label_not_current_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、约 19 mm、无刻痕", "en": "oval, approximately 19 mm, unscored" }, "imprint": "KJ", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN XL 克拉霉素 500 mg、NDC 54868-4191-0、20 片瓶装历史再包装标签文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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-historical-repackaged-biaxin-clarithromycin-125mg-per-5ml-100ml-bottle-ndc-54868-4919-0", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史再包装公开标签（2012-02-22 更新）；FDA Orange Book 当前状态另行核对", "en": "Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately" }, "dosageForm": { "zh": "BIAXIN 克拉霉素口服混悬剂颗粒（复溶后）", "en": "BIAXIN clarithromycin granules for oral suspension (after constitution)" }, "route": { "zh": "口服（历史准确产品身份字段）", "en": "oral (historical exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-4919-0", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL_after_reconstitution", "primaryDisplay": { "zh": "复溶后每 5 mL 含克拉霉素 125 mg；总量 100 mL 瓶装", "en": "Clarithromycin 125 mg per 5 mL after constitution; 100 mL bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克拉霉素", "en": "clarithromycin" }, "value": 125, "unit": "mg", "basisCode": "per_5_mL_after_reconstitution", "basisLabel": { "zh": "复溶后每 5 mL 标签标示量；不是整瓶总量、个人毫升数或家庭量具换算", "en": "labelled amount per 5 mL after constitution; not the bottle total, an individual's millilitres or a household-measure conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 mL 瓶装", "en": "100 mL bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "mL/瓶（复溶后总量）", "en": "mL per bottle after constitution" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_repackaged_label_not_current_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "mL/瓶（复溶后总量）", "en": "mL per bottle after constitution" } }, "physicalClues": { "color": null, "shape": null, "imprint": null, "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN 克拉霉素 125 mg/5 mL、NDC 54868-4919-0、复溶后 100 mL 历史再包装标签文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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-historical-repackaged-biaxin-clarithromycin-250mg-per-5ml-100ml-bottle-ndc-54868-3384-0", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史再包装公开标签（2012-02-22 更新）；FDA Orange Book 当前状态另行核对", "en": "Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately" }, "dosageForm": { "zh": "BIAXIN 克拉霉素口服混悬剂颗粒（复溶后）", "en": "BIAXIN clarithromycin granules for oral suspension (after constitution)" }, "route": { "zh": "口服（历史准确产品身份字段）", "en": "oral (historical exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-3384-0", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL_after_reconstitution", "primaryDisplay": { "zh": "复溶后每 5 mL 含克拉霉素 250 mg；总量 100 mL 瓶装", "en": "Clarithromycin 250 mg per 5 mL after constitution; 100 mL bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克拉霉素", "en": "clarithromycin" }, "value": 250, "unit": "mg", "basisCode": "per_5_mL_after_reconstitution", "basisLabel": { "zh": "复溶后每 5 mL 标签标示量；不是整瓶总量、个人毫升数或家庭量具换算", "en": "labelled amount per 5 mL after constitution; not the bottle total, an individual's millilitres or a household-measure conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 mL 瓶装", "en": "100 mL bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "mL/瓶（复溶后总量）", "en": "mL per bottle after constitution" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_repackaged_label_not_current_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "mL/瓶（复溶后总量）", "en": "mL per bottle after constitution" } }, "physicalClues": { "color": null, "shape": null, "imprint": null, "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN 克拉霉素 250 mg/5 mL、NDC 54868-3384-0、复溶后 100 mL 历史再包装标签文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "未找到可与原品牌单一规格和包装一一对应的当前官方图片", "en": "No current official image was found that maps one-to-one to a single original-brand strength and pack" }, "summary": { "zh": "DailyMed 可检索页面明确标为 Physicians Total Care 再包装历史标签；为避免把再包装图、通用药图或另一个剂型图片当成 BIAXIN 原品牌外观，本页只展示五个经核对的文字身份卡，不展示包装图片。", "en": "The searchable DailyMed page is explicitly a historical Physicians Total Care repackaged label. To avoid presenting a repackaged, generic or different-form image as original-brand BIAXIN appearance, the dossier shows five reviewed text identity cards and no package image." }, "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN／BIAXIN XL 克拉霉素普通片、缓释片与混悬剂历史再包装公开标签（2012-02-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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": "BIAXIN 说明书放大阅读：先分清普通片、缓释片和每 5 mL 混悬剂", "en": "BIAXIN label reading: first separate immediate-release tablets, extended-release tablets and suspension per 5 mL" }, "summary": { "zh": "同一个“克拉霉素”名称下曾有普通片、BIAXIN XL 缓释片和复溶后混悬剂三种不同口服呈现。普通片 500 mg 与缓释片 500 mg 不能只按数字自行替换；本页把每片 mg、复溶后 mg/5 mL、缓释结构、历史状态和高风险相互作用分开读，也不计算任何人的片数、毫升数、频率或疗程。", "en": "The same clarithromycin name historically covered immediate-release tablets, BIAXIN XL extended-release tablets and suspension after constitution. A 500 mg immediate-release tablet and a 500 mg extended-release tablet are not self-interchangeable from the number alone. This page separates mg per tablet, mg per 5 mL after constitution, extended-release design, historical status and higher-risk interactions; it calculates no individual's tablet count, millilitres, frequency or course." }, "checks": [ { "zh": "BIAXIN 500 mg 普通片和 BIAXIN XL 500 mg 缓释片虽然每片数字相同，却不是同一种释放产品。历史标签要求 BIAXIN XL 随餐并整片吞服，不得咀嚼、掰开或压碎；不能因都是 500 mg 就自行互换、叠加或轮换。", "en": "BIAXIN 500 mg immediate-release tablets and BIAXIN XL 500 mg extended-release tablets have the same number per tablet but are not the same release product. The historical label says BIAXIN XL is taken with food and swallowed whole, not chewed, broken or crushed. A shared 500 mg number does not permit self-switching, combining or alternating." }, { "zh": "混悬剂的 125 mg/5 mL 或 250 mg/5 mL 是复溶后每 5 mL 的浓度，不是整瓶总量，也不是用家用汤匙估算的个人用量。历史标签还要求每次使用前充分摇匀、不要冷藏，并在复溶后 14 天内使用；实际产品和当地现行说明必须另行核对。", "en": "Suspension 125 mg/5 mL or 250 mg/5 mL is the concentration per 5 mL after constitution, not the bottle total or an individual amount to estimate with a household spoon. The historical label also says to shake well before each use, not refrigerate and use within 14 days after mixing; the actual product and current local instructions still require separate review." }, { "zh": "当前美国克拉霉素普通片标签与历史 BIAXIN 标签都显示重要相互作用边界，包括辛伐他汀或洛伐他汀、秋水仙碱、华法林、部分心律药、钙通道阻滞剂、卡马西平及多种 CYP3A 相关药物。网页不凭药名自动判断能否同服；请把所有处方药、非处方药、保健品和实际药盒交给药师核对。", "en": "The current U.S. generic clarithromycin tablet label and historical BIAXIN label both describe important interaction boundaries involving medicines such as simvastatin or lovastatin, colchicine, warfarin, certain rhythm medicines, calcium-channel blockers, carbamazepine and other CYP3A-related products. The site does not decide co-use from names alone; give a pharmacist every prescription, OTC product, supplement and actual pack." }, { "zh": "FDA 2018 年药物安全通讯提醒：对心脏病患者开具克拉霉素时需谨慎权衡长期风险。该通讯不表示每个人都会发生问题，也不能据此自行停抗菌药或心脏药；胸痛、明显呼吸困难、单侧无力或言语不清等急症表现应立即使用当地急救服务。", "en": "FDA's 2018 Drug Safety Communication advises caution and benefit-risk review before prescribing clarithromycin to patients with heart disease. It does not mean every person will have a problem and does not support self-stopping an antibacterial or heart medicine. Chest pain, marked breathing difficulty, one-sided weakness or slurred speech requires immediate local emergency care." }, { "zh": "克拉霉素属于抗菌药，不治疗普通病毒性感冒。不要拿剩药、与家人共用、因症状相似自行改成阿奇霉素、阿莫西林或其他抗菌药，也不要自行拼接疗程。", "en": "Clarithromycin is an antibacterial and does not treat an ordinary viral cold. Do not use leftovers, share with family, switch to azithromycin, amoxicillin or another antibacterial because symptoms look similar, or assemble a course yourself." }, { "zh": "严重或带血腹泻、明显腹痛伴发热或脱水、黄疸或深色尿、心悸或晕厥、严重皮疹或呼吸困难需要及时医疗评估；呼吸困难、晕厥、严重过敏或其他危急表现应立即使用当地急救服务。", "en": "Severe or bloody diarrhoea, marked abdominal pain with fever or dehydration, jaundice or dark urine, palpitations or fainting, severe rash or breathing difficulty needs prompt medical assessment. Trouble breathing, fainting, severe allergy or another emergency requires immediate local emergency care." } ], "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN／BIAXIN XL 克拉霉素普通片、缓释片与混悬剂历史再包装公开标签（2012-02-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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": "克拉霉素怎样起作用：抑制细菌蛋白质合成，但机制不能代替病原与相互作用核对", "en": "How clarithromycin works: inhibiting bacterial protein synthesis does not replace organism or interaction review" }, "summary": { "zh": "克拉霉素是大环内酯类抗菌药，通过与细菌核糖体 50S 亚基结合抑制蛋白质合成。它还涉及 CYP3A 和转运体相互作用，因此“同类抗菌药”或“同样 500 mg”都不能用作自行替换依据。", "en": "Clarithromycin is a macrolide antibacterial that binds to the bacterial 50S ribosomal subunit and inhibits protein synthesis. It also involves CYP3A and transporter interactions, so a shared antibacterial class or the same 500 mg number cannot justify self-substitution." }, "checks": [ { "zh": "药物作用于细菌蛋白质合成，不等于仅凭咳嗽、发热、咽痛或痰色就能判断病因、敏感性或是否需要抗菌药。", "en": "Acting on bacterial protein synthesis does not allow cough, fever, sore throat or sputum colour alone to identify the cause, susceptibility or need for an antibacterial." }, { "zh": "普通片和缓释片的释放速度不同；mg 数字只描述每片标示量，不描述吸收曲线、个人频次或可互换性。", "en": "Immediate- and extended-release tablets have different release profiles. The mg number describes labelled amount per tablet, not the absorption curve, individual frequency or interchangeability." }, { "zh": "CYP3A／P-gp 相互作用会使某些合用药的暴露量改变；年龄、肾肝功能、心律风险和完整药单都可能改变专业判断，网页不会生成一张人人适用的“可同服”清单。", "en": "CYP3A/P-gp interactions can change exposure to some co-medications. Age, kidney and liver function, rhythm risk and the complete medicine list can change professional judgement, so the site does not generate a universal co-use list." } ], "source": { "id": "src_62627375eee202d9", "label": "DailyMed（NLM）：克拉霉素 500 mg 普通薄膜衣片当前美国公开标签（2026-03-05 发布；非 BIAXIN 品牌身份）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa69ea92-0b41-43fb-918f-ed80e0dedf04", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "BIAXIN", "generic": "克拉霉素", "dosageFormClass": "克拉霉素口服产品历史档案：BIAXIN 250/500 mg 普通片、BIAXIN XL 500 mg 缓释片、BIAXIN 复溶后 125/250 mg/5 mL 混悬剂；相同成分不表示普通片、缓释片和液体可按 mg 自行互换" }, "labelSource": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN／BIAXIN XL 克拉霉素普通片、缓释片与混悬剂历史再包装公开标签（2012-02-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN／BIAXIN XL 克拉霉素普通片、缓释片与混悬剂历史再包装公开标签（2012-02-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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_62627375eee202d9", "label": "DailyMed（NLM）：当前美国克拉霉素标签中的冠心病患者长期全因死亡风险警示（用于承接 FDA 2018-02-22 安全通讯的现行标签证据）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa69ea92-0b41-43fb-918f-ed80e0dedf04", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：BIAXIN／BIAXIN XL 的五个历史 RLD 产品行均列为 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." } } ], "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": [ { "id": "fda-2018-clarithromycin-biaxin-heart-disease-long-term-risk-communication", "issuedAt": "2018-02-22", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：心脏病患者使用克拉霉素（BIAXIN）的潜在长期风险", "en": "FDA Drug Safety Communication: potential long-term risk with clarithromycin (BIAXIN) in patients with heart disease" }, "summary": { "zh": "FDA 于 2018-02-22 发布安全通讯，建议在心脏病患者中开具克拉霉素（BIAXIN）前谨慎权衡获益和风险，原因是长期随访资料提示治疗结束多年后可能增加心脏问题或死亡风险。该公告是美国、特定日期、特定人群背景的监管沟通；它不表示每位使用者都会发生问题，也不能据此自行停用抗菌药、心脏药或改用另一种抗菌药。胸痛、明显呼吸困难、单侧无力或言语不清等急症表现需要立即使用当地急救服务；非急症的联用与替代问题应连同实际药盒和完整药单由开方团队或药师核对。", "en": "On 22 Feb 2018, FDA issued a Drug Safety Communication advising careful benefit-risk review before prescribing clarithromycin (BIAXIN) to patients with heart disease because long-term follow-up data suggested a potential increase in heart problems or death years after treatment. This is a dated U.S. regulatory communication for a named population context. It does not mean every user will have a problem and does not support self-stopping an antibacterial or heart medicine or switching to another antibacterial. Chest pain, marked breathing difficulty, one-sided weakness or slurred speech requires immediate local emergency care; non-emergency co-use or substitution questions require the actual pack and complete medicine list to be reviewed by the prescribing team or pharmacist." }, "source": { "id": "src_62627375eee202d9", "label": "DailyMed（NLM）：当前美国克拉霉素标签中的冠心病患者长期全因死亡风险警示（用于承接 FDA 2018-02-22 安全通讯的现行标签证据）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa69ea92-0b41-43fb-918f-ed80e0dedf04", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "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": "BIAXIN 是克拉霉素的美国历史品牌档案，曾包含普通片、缓释片和复溶后混悬剂。包装上的 500 mg 可能指普通片每片，也可能指 BIAXIN XL 每片；125 或 250 mg/5 mL 则是复溶后每 5 mL 的浓度。三类产品不能只按数字自行替换。克拉霉素与多种药物存在重要相互作用；老年人、多药联用者及心脏病、肾肝问题人群尤其应把全部药盒交给药师或开方团队逐项核对。", "history": "FDA Orange Book 记录 BIAXIN 普通片于 1991-10-31 获批，口服混悬剂于 1993-12-23 获批，BIAXIN XL 缓释片于 2000-03-03 获批。当前 Orange Book 将本页五个 RLD 产品行列为 Discontinued；2012 DailyMed 页面为再包装历史标签。FDA 2018 年另发布心脏病患者长期风险药物安全通讯。", "sourceDocuments": [ { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN／BIAXIN XL 克拉霉素普通片、缓释片与混悬剂历史再包装公开标签（2012-02-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_62627375eee202d9", "label": "DailyMed（NLM）：克拉霉素 500 mg 普通薄膜衣片当前美国公开标签（2026-03-05 发布；非 BIAXIN 品牌身份）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa69ea92-0b41-43fb-918f-ed80e0dedf04", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：BIAXIN／BIAXIN XL 的五个历史 RLD 产品行均列为 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_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口：BIAXIN NDA 050662／050698 与 BIAXIN XL NDA 050775", "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" }, { "id": "src_62627375eee202d9", "label": "DailyMed（NLM）：当前美国克拉霉素标签中的冠心病患者长期全因死亡风险警示（用于承接 FDA 2018-02-22 安全通讯的现行标签证据）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa69ea92-0b41-43fb-918f-ed80e0dedf04", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_99b7228016fe2074", "label": "FDA：BIAXIN／BIAXIN XL／BIAXIN Granules 2013 年相互作用、警告与上市后不良反应标签补充批准函", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052%2Cs053%2C050698Orig1s031%2Cs032%2C050775Orig1s020%2Cs021ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 050662（BIAXIN 普通片）／050698（混悬剂）／050775（BIAXIN XL 缓释片）", "approvalTimeline": [ { "date": "1991-10-31", "title": { "zh": "BIAXIN 250/500 mg 普通片获批", "en": "BIAXIN 250/500 mg immediate-release tablets approved" }, "detail": { "zh": "FDA Orange Book 将 NDA 050662 的 250 mg 与 500 mg 产品行列为历史 RLD；当前 Product Type 为 Discontinued、RS 为 No。", "en": "FDA Orange Book lists the NDA 050662 250 mg and 500 mg product rows as historical RLD products; current Product Type is Discontinued and RS is No." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：BIAXIN／BIAXIN XL 的五个历史 RLD 产品行均列为 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" } }, { "date": "1993-12-23", "title": { "zh": "BIAXIN 125/250 mg/5 mL 混悬剂产品获批", "en": "BIAXIN 125/250 mg per 5 mL suspension products approved" }, "detail": { "zh": "FDA Orange Book 将 NDA 050698 的 125 mg/5 mL 与 250 mg/5 mL 产品行列为历史 RLD；本档案不纳入非 RLD 的 187 mg/5 mL 历史行。", "en": "FDA Orange Book lists the NDA 050698 125 mg/5 mL and 250 mg/5 mL rows as historical RLD products. This dossier does not include the non-RLD historical 187 mg/5 mL row." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：BIAXIN／BIAXIN XL 的五个历史 RLD 产品行均列为 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" } }, { "date": "2000-03-03", "title": { "zh": "BIAXIN XL 500 mg 缓释片获批", "en": "BIAXIN XL 500 mg extended-release tablet approved" }, "detail": { "zh": "FDA Orange Book 将 NDA 050775 的 500 mg 缓释片列为历史 RLD；当前 Product Type 为 Discontinued、RS 为 No。", "en": "FDA Orange Book lists the NDA 050775 500 mg extended-release tablet as a historical RLD; current Product Type is Discontinued and RS is No." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：BIAXIN／BIAXIN XL 的五个历史 RLD 产品行均列为 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" } }, { "date": "2018-02-22", "title": { "zh": "FDA 发布心脏病患者长期风险安全通讯", "en": "FDA issued long-term-risk safety communication for patients with heart disease" }, "detail": { "zh": "FDA 建议在心脏病患者中开具克拉霉素前谨慎权衡获益与风险；公告不支持个人自行停药或换药。", "en": "FDA advised careful benefit-risk review before prescribing clarithromycin to patients with heart disease; the communication does not support self-stopping or switching." }, "source": { "id": "src_62627375eee202d9", "label": "DailyMed（NLM）：当前美国克拉霉素标签中的冠心病患者长期全因死亡风险警示（用于承接 FDA 2018-02-22 安全通讯的现行标签证据）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa69ea92-0b41-43fb-918f-ed80e0dedf04", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-03-05", "title": { "zh": "当前美国通用名克拉霉素普通片标签发布", "en": "Current U.S. generic clarithromycin immediate-release tablet label published" }, "detail": { "zh": "该标签用于核对当前成分级警示与相互作用，不把通用名产品包装或在售状态推回历史 BIAXIN 品牌。", "en": "This label supports current ingredient-level warning and interaction review; it does not transfer a generic product pack or availability status to historical BIAXIN." }, "source": { "id": "src_62627375eee202d9", "label": "DailyMed（NLM）：克拉霉素 500 mg 普通薄膜衣片当前美国公开标签（2026-03-05 发布；非 BIAXIN 品牌身份）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa69ea92-0b41-43fb-918f-ed80e0dedf04", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "五个历史 RLD 产品行当前均列为 Discontinued；RS 均为 No", "en": "All five historical RLD product rows are currently Discontinued; RS is No for each" }, "detail": { "zh": "历史标签可用于阅读普通片、缓释片和混悬剂边界，但不证明当前 BIAXIN 品牌库存、可购买性或可自行换成通用名产品。", "en": "The historical label supports reading boundaries among immediate-release tablets, extended-release tablets and suspension, but does not establish current BIAXIN stock, purchasing availability or self-substitution with a generic product." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行品牌与产品记录", "en": "Current brand and product records not yet established" }, "detail": { "zh": "不从美国 BIAXIN 品牌、NDA、共同通用名或历史再包装标签推定当地商品名、批准、规格、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, strength, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. BIAXIN brand, NDA, shared generic name or historical repackaged label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "BIAXIN 500 mg 和 BIAXIN XL 500 mg 是一回事吗？", "en": "Are BIAXIN 500 mg and BIAXIN XL 500 mg the same?" }, "answer": { "zh": "不是。一个是普通片，一个是缓释片；相同的每片 500 mg 不代表释放方式、用法或可互换性相同。历史标签还要求 XL 整片吞服、不得掰开或压碎。", "en": "No. One is immediate release and one is extended release. The same 500 mg per tablet does not make release, administration or interchangeability the same. The historical label also says XL is swallowed whole and not broken or crushed." } }, { "question": { "zh": "125 mg/5 mL 是否表示每次喝 5 mL？", "en": "Does 125 mg/5 mL mean 5 mL each time?" }, "answer": { "zh": "不是。它只是复溶后每 5 mL 的浓度表示，不是任何人的单次毫升数。个人用量必须来自准确处方，并结合年龄、体重、感染、肾肝功能、剂型和完整药单由专业人员确认。", "en": "No. It only states concentration per 5 mL after constitution, not an individual's millilitres per use. An exact prescription and professional review of age, weight, infection, kidney and liver function, dosage form and full medicine list are required." } }, { "question": { "zh": "正在吃他汀或秋水仙碱，可以自己加克拉霉素吗？", "en": "Can clarithromycin be self-added while taking a statin or colchicine?" }, "answer": { "zh": "不要。克拉霉素与部分他汀、秋水仙碱及多种其他药有重要相互作用和禁忌边界；把准确药盒、全部药名、剂型、规格和器官功能相关信息交给药师或开方团队核对。", "en": "No. Clarithromycin has important interaction and contraindication boundaries with some statins, colchicine and many other medicines. Give the exact packs, all medicine names, forms, strengths and organ-function information to a pharmacist or prescribing team." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "family-medicine-list-for-pharmacist", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/biaxin/", "en": "https://origindrug.com/en/drugs/biaxin/" }, "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." ] }