{ "id": "carafate-sucralfate", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "CARAFATE", "generic": "硫糖铝", "aliases": [ "Carafate", "sucralfate", "硫糖铝", "硫糖铝片", "硫糖铝口服混悬液", "NDA 018333", "NDA 019183" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国：CARAFATE 1 g 片剂 NDA 018333 在 Orange Book 列为处方 RLD/RS，DailyMed 有当前公开标签；1 g/10 mL 口服混悬液属于 NDA 019183，Orange Book 当前列为 DISCN，虽仍有 2023 年公开标签档案，也不能写成实时库存。", "dosageFormClass": "片剂按每片 1 g 标示；混悬液按每 10 mL 含 1 g 标示。1 g 等于 1000 mg 只是单位换算，不是个人片数、毫升数、频次或疗程。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1981（美国片剂标签营销起始日期）", "archiveSponsorText": "AbbVie, Inc. / Allergan, Inc.（DailyMed 当前美国标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "CARAFATE", "Carafate sucralfate", "硫糖铝" ], "excludedProductCues": [ "aluminum hydroxide", "氢氧化铝", "omeprazole", "famotidine", "bismuth", "铋剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-carafate-1g-tablet-58914-171-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 SPL；处方信息修订 2024-05", "en": "Current DailyMed SPL; prescribing information revised May 2024" }, "dosageForm": { "zh": "CARAFATE 硫糖铝 1 g 口服片", "en": "CARAFATE sucralfate 1 g oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDA 018333 / NDC 58914-171-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硫糖铝 1 g；100 片瓶装", "en": "Sucralfate 1 g per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=carafate-tablets-02.jpg&setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硫糖铝", "en": "sucralfate" }, "value": 1, "unit": "g", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数或频次", "en": "labelled amount per tablet; not an individual's tablet count or frequency" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_public_label_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "浅粉色", "en": "light pink" }, "shape": { "zh": "长椭圆形、有刻痕；刻痕不是自行掰片许可", "en": "oblong and scored; the score is not permission to self-split" }, "imprint": "CARAFATE / 1712", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-carafate-1g-per-10ml-suspension-nda-019183", "marketCode": "US", "labelVersion": { "zh": "DailyMed 2023-06-08 有日期标签；Orange Book 当前 DISCN", "en": "Dated DailyMed label of 8 Jun 2023; currently DISCN in Orange Book" }, "dosageForm": { "zh": "CARAFATE 硫糖铝 1 g/10 mL 口服混悬液（历史身份）", "en": "CARAFATE sucralfate 1 g/10 mL oral suspension (historical identity)" }, "route": { "zh": "仅口服", "en": "oral only" }, "routeCodes": [ "oral" ], "productCode": "NDA 019183 / NDC 58914-170", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_10_ml", "primaryDisplay": { "zh": "每 10 mL 含硫糖铝 1 g；不是个人毫升数", "en": "Sucralfate 1 g per 10 mL; not an individual's millilitres" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=carafate-oral-suspension-02.jpg&setid=0fb67b1c-b4c0-46f2-8a81-df1510e006aa", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硫糖铝", "en": "sucralfate" }, "value": 1, "unit": "g", "basisCode": "per_10_ml", "basisLabel": { "zh": "每 10 mL 标签浓度；不是个人用量", "en": "labelled concentration per 10 mL; not an individual's amount" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_orange_book_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_1187e6edc0397419", "label": "DailyMed（NLM）：CARAFATE 1 g/10 mL 口服混悬液美国公开标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fb67b1c-b4c0-46f2-8a81-df1510e006aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-carafate-1g-tablet-58914-171-10", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=carafate-tablets-02.jpg&setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "alt": "美国当前 CARAFATE 硫糖铝片每片 1 g、NDC 58914-171-10、100 片瓶装的 DailyMed 官方标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前 SPL；处方信息修订 2024-05", "presentation": "CARAFATE 硫糖铝片：每片 1 g，NDC 58914-171-10，100 片瓶装。", "notice": "此图只对应所引 DailyMed 当前标签中的美国 1 g 片剂、NDC 58914-171-10、100 片瓶装；不代表口服混悬液、中国大陆或其他市场包装、实时库存及个人适用性，不用于鉴定真伪，也不生成个人片数、频次或与其他药物的间隔方案。", "source": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CARAFATE 说明书放大阅读：先核对吞咽、肾功能与完整药单", "en": "CARAFATE enlarged label: first check swallowing, kidney function and the complete medicine list" }, "summary": { "zh": "硫糖铝虽主要在胃肠道局部作用，但会结合某些合并用药并降低其吸收；肾功能不全或透析人群还需关注铝蓄积。网页不自动生成错开时间表。", "en": "Although sucralfate acts mainly in the gut, it can bind some co-medications and reduce absorption; aluminum accumulation also matters in renal impairment or dialysis. The site does not generate a personal separation schedule." }, "checks": [ { "zh": "1 g 片剂与 1 g/10 mL 混悬液的计量基础不同；标签明确指出两种剂型的等效性未被证明，不能自行用 10 mL 换一片。", "en": "The 1 g tablet and 1 g/10 mL suspension use different quantity bases; the label says equivalence has not been demonstrated, so 10 mL must not be self-exchanged for one tablet." }, { "zh": "吞咽困难、气管切开、既往误吸、近期或长期插管，或咳嗽/咽反射受影响的人，片剂存在误吸与呼吸并发症风险，应先由专业人员核对剂型。", "en": "With dysphagia, tracheostomy, prior aspiration, intubation, or impaired cough/gag reflex, tablet aspiration and respiratory complications require professional dosage-form review." }, { "zh": "慢性肾功能不全或透析会降低所吸收铝的排出；同时使用含铝制酸剂可能增加总铝负担。", "en": "Chronic renal failure or dialysis reduces excretion of absorbed aluminum, and aluminum-containing antacids may increase total burden." }, { "zh": "标签列出的相互作用对象包括地高辛、氟喹诺酮类、左甲状腺素、苯妥英、四环素、茶碱和华法林等。不要只凭网页自行安排间隔；请让药师核对完整药单。", "en": "The label lists interaction concerns including digoxin, fluoroquinolones, levothyroxine, phenytoin, tetracycline, theophylline and warfarin. Do not create a separation schedule from the site alone; have a pharmacist review the complete list." } ], "source": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "硫糖铝怎样起作用：主要形成覆盖溃疡部位的局部屏障", "en": "How sucralfate works: mainly by forming a local barrier over the ulcer site" }, "summary": { "zh": "标签说明其全身吸收很少，并可在溃疡处形成黏附复合物，帮助抵御酸、胃蛋白酶和胆盐。它不是简单的“强力中和胃酸”，也不能据此自行与抑酸药叠加或替换。", "en": "The label says systemic absorption is minimal and describes an ulcer-adherent complex that helps protect against acid, pepsin and bile salts. This does not justify self-adding or replacing acid-suppressing medicines." }, "checks": [ { "zh": "黑便、呕血、吞咽困难、持续呕吐或明显乏力需要及时医疗评估，不能只靠“形成保护膜”的解释自行处理。", "en": "Black stools, vomiting blood, dysphagia, persistent vomiting or marked fatigue requires timely clinical assessment, not self-treatment from a barrier explanation." }, { "zh": "局部作用不等于没有相互作用；硫糖铝可在胃肠道结合其他药物，因此必须核对完整药单。", "en": "Local action does not mean no interactions; sucralfate can bind other medicines in the gastrointestinal tract, so the complete medicine list must be reviewed." }, { "zh": "同样用于胃部不适的质子泵抑制剂、H2 受体阻滞剂、制酸剂和铋剂具有不同成分与作用路径，不能按症状或品牌自行叠加、轮换或替代。", "en": "Proton-pump inhibitors, H2 blockers, antacids and bismuth products used for stomach concerns have different ingredients and pathways and must not be self-combined, alternated or substituted from symptoms or brands." } ], "source": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CARAFATE", "generic": "硫糖铝", "dosageFormClass": "片剂按每片 1 g 标示；混悬液按每 10 mL 含 1 g 标示。1 g 等于 1000 mg 只是单位换算，不是个人片数、毫升数、频次或疗程。" }, "labelSource": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "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": "2026-08-31", "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_1187e6edc0397419", "label": "DailyMed（NLM）：CARAFATE 1 g/10 mL 口服混悬液美国公开标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fb67b1c-b4c0-46f2-8a81-df1510e006aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "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": "2026-08-31", "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：CARAFATE／sucralfate NDA 018333 片剂与 NDA 019183 混悬液产品身份", "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": "2026-08-31", "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": "CARAFATE 是硫糖铝品牌档案。它主要在胃肠道局部形成保护性屏障，但仍可能影响其他药物吸收；吞咽困难、肾功能不全、透析或同时服用多种药的人，应把完整药单和实际药盒交给药师逐项核对。", "history": "美国片剂标签记录营销起始日期为 1981-10-30。口服混悬液 1993-12-16 起有标签记录，但当前 Orange Book 为 DISCN。本页把当前片剂与历史混悬液拆开，不把公开旧标签等同于当前供应。", "sourceDocuments": [ { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_1187e6edc0397419", "label": "DailyMed（NLM）：CARAFATE 1 g/10 mL 口服混悬液美国公开标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fb67b1c-b4c0-46f2-8a81-df1510e006aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CARAFATE／sucralfate NDA 018333 片剂与 NDA 019183 混悬液产品身份", "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" } ], "applicationNumber": "NDA 018333（片剂）/ NDA 019183（混悬液）", "approvalTimeline": [ { "date": "1981-10-30", "title": { "zh": "美国 CARAFATE 片剂标签营销起始记录", "en": "U.S. CARAFATE tablet label marketing-start record" }, "detail": { "zh": "DailyMed 当前结构化标签把 NDA 018333、NDC 58914-171-10 与该日期关联；这是监管与标签身份，不是全球供应证明。", "en": "The current structured DailyMed label links NDA 018333 and NDC 58914-171-10 to this date; this is regulatory and label identity, not proof of global supply." }, "source": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "1993-12-16", "title": { "zh": "美国 CARAFATE 口服混悬液标签营销起始记录", "en": "U.S. CARAFATE oral-suspension label marketing-start record" }, "detail": { "zh": "DailyMed 标签档案记录 NDA 019183 的 1 g/10 mL 产品；Orange Book 当前 DISCN 状态优先用于解释现行监管目录。", "en": "The DailyMed label archive records the 1 g/10 mL product under NDA 019183; the current Orange Book DISCN status governs interpretation of the current approval catalogue." }, "source": { "id": "src_1187e6edc0397419", "label": "DailyMed（NLM）：CARAFATE 1 g/10 mL 口服混悬液美国公开标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fb67b1c-b4c0-46f2-8a81-df1510e006aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "2024-05", "title": { "zh": "片剂处方信息修订", "en": "Tablet prescribing information revised" }, "detail": { "zh": "现行片剂标签覆盖产品外观、吞咽误吸、肾功能与合并用药吸收等重点。", "en": "The current tablet label covers product appearance, aspiration with swallowing impairment, renal considerations and co-medication absorption." }, "source": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } } ], "marketStatus": [ { "market": { "zh": "美国片剂", "en": "U.S. tablet" }, "status": { "zh": "当前公开标签；Orange Book RLD/RS", "en": "Current public label; Orange Book RLD/RS" }, "detail": { "zh": "1 g 每片，NDC 58914-171-10。", "en": "1 g per tablet, NDC 58914-171-10." } }, { "market": { "zh": "美国混悬液", "en": "U.S. suspension" }, "status": { "zh": "有日期标签档案；Orange Book DISCN", "en": "Dated label archive; Orange Book DISCN" }, "detail": { "zh": "1 g/10 mL 是浓度，不代表当前库存。", "en": "1 g/10 mL is a concentration and does not establish current stock." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "1 g 是不是就是一次吃一片？", "en": "Does 1 g mean one tablet each time?" }, "answer": { "zh": "不是。1 g 是每片标签含量；混悬液的 1 g/10 mL 是浓度。个人片数、毫升数和频次必须以准确处方与现行标签核对。", "en": "No. One gram is the labelled amount per tablet, while 1 g/10 mL is a concentration. Individual tablet count, millilitres and frequency require the exact prescription and current label." } }, { "question": { "zh": "药太多，网页能自动告诉我怎么错开吗？", "en": "Can the site automatically tell me how to separate many medicines?" }, "answer": { "zh": "不能。请带完整药单、药盒和处方让药师制定可执行的时间表。", "en": "No. Take the complete list, packs and prescription to a pharmacist for an actionable schedule." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/carafate-sucralfate/", "en": "https://origindrug.com/en/drugs/carafate-sucralfate/" }, "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." ] }