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100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucotrol-xl-06.jpg&setid=eed99b60-d043-4249-9b2a-f05e46fb588d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列吡嗪", "en": "glipizide" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加减量或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸、无刻痕缓释片", "en": "round, biconvex, unscored extended-release tablet" }, "imprint": "GXL 10", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-glucotrol-xl-glipizide-er-10mg-500-bottle-ndc-0049017808", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国现行公开标签（SPL v28，2026-07-21 生效）", "en": "Current U.S. DailyMed public label (SPL v28, effective 21 Jul 2026)" }, "dosageForm": { "zh": "GLUCOTROL XL 格列吡嗪缓释口服片", "en": "GLUCOTROL XL glipizide extended-release oral tablet" }, "route": { "zh": "口服（必须保持渗透泵缓释片完整）", "en": "oral (the osmotic extended-release tablet must remain intact)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0049-0178-08", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片格列吡嗪 10 mg；500 片瓶装", "en": "Glipizide 10 mg per tablet; 500-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列吡嗪", "en": "glipizide" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加减量或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸、无刻痕缓释片", "en": "round, biconvex, unscored extended-release tablet" }, "imprint": "GXL 10", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-glucotrol-xl-glipizide-er-5mg-100-bottle-ndc-0049017402", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucotrol-xl-05.jpg&setid=eed99b60-d043-4249-9b2a-f05e46fb588d&type=img", "alt": { "zh": "DailyMed 官方 GLUCOTROL XL 5 mg、100 片瓶装标签面板", "en": "Official DailyMed GLUCOTROL XL 5 mg 100-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 美国现行公开标签（SPL v28，2026-07-21 生效）", "presentation": "GLUCOTROL XL 格列吡嗪缓释片：每片 5 mg，NDC 0049-0174-02，100 片瓶装标签面板。", "notice": "此图只对应美国 DailyMed 当前标签中的 GLUCOTROL XL、格列吡嗪缓释片 5 mg、NDC 0049-0174-02 与 100 片瓶装。它只帮助核对品牌、通用名、每片标示量、缓释剂型、包装数量与来源；不用于鉴定真伪，也不证明 2.5 mg、10 mg、500 片瓶装、普通格列吡嗪片、其他市场、当前库存、可替代性或任何个人的片数、加减量、联用、停用或换药方案。", "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "GLUCOTROL XL 说明书放大阅读：不能掰碎，看到空壳通常不是漏吸收", "en": "GLUCOTROL XL label reading: do not split or crush; an empty shell usually does not mean failed absorption" }, "summary": { "zh": "GLUCOTROL XL 的药物装在不可溶解的外壳内，通过小孔缓慢释放。官方患者说明明确要求整片吞服，不得掰开、压碎、溶解、咀嚼或切半；释药后的空壳可能随大便排出。", "en": "GLUCOTROL XL contains medicine in a non-dissolvable shell that releases it slowly through a small opening. The official patient information says to swallow it whole and not break, crush, dissolve, chew or cut it in half; the empty shell may pass in stool after release." }, "checks": [ { "zh": "2.5、5、10 mg 是每片标签量，不是一次吃几片。即使标签中的研究记录某些多片组合具有生物等效性，也不能据此自行拼片、加减量、换成普通格列吡嗪或把别人的方案照搬。", "en": "2.5, 5 and 10 mg are labelled amounts per tablet, not tablets per dose. Even though the label records bioequivalence for certain multiple-tablet combinations in studies, that does not permit self-assembling tablets, changing amounts, switching to immediate-release glipizide or copying another person's regimen." }, { "zh": "整片吞服，不要掰、切、压碎、溶解或咀嚼。破坏渗透泵结构可能让过多药物一次释放；有吞咽困难时应带准确药盒询问药师或开方团队，不要自行改剂型。", "en": "Swallow whole; do not break, cut, crush, dissolve or chew. Damaging the osmotic system can release too much medicine at once. If swallowing is difficult, take the exact pack to a pharmacist or prescriber rather than changing the dosage form yourself." }, { "zh": "排便中看到像完整药片的东西，可能是已经释药的不可溶外壳。不要因为看到外壳就补吃一片或重复服用；若血糖异常、外壳频繁出现且有疑问或同时存在持续腹泻/肠道狭窄史，应联系专业人员。", "en": "Something resembling a whole tablet in stool may be the non-dissolvable shell after drug release. Do not take an extra tablet or repeat a dose because you see it. Contact a professional for abnormal glucose, persistent concern, continuing diarrhoea or a history of intestinal narrowing." }, { "zh": "低血糖可很严重；老人、肾肝功能异常、营养不足、进食减少、剧烈或长时间运动、饮酒，以及与其他降糖药同用时风险可能更高。意识不清、抽搐或无法安全吞咽属于急症，应立即使用当地急救服务，不要强行喂食。", "en": "Hypoglycaemia can be severe. Risk may be higher in older adults, kidney or liver impairment, malnutrition, reduced food intake, severe or prolonged exercise, alcohol use and with other glucose-lowering medicines. Confusion, seizure or inability to swallow safely is an emergency: use local emergency services and do not force food or drink." }, { "zh": "咪康唑、氟康唑、考来维仑、β 受体阻滞剂、其他降糖药及所有处方药、非处方药、草药和补充剂都应放入完整药单核对。网页不从两个药名自动决定能否同服、需要间隔多久或怎样调整。", "en": "Miconazole, fluconazole, colesevelam, beta-blockers, other diabetes medicines and every prescription, OTC, herbal and supplement product belong on the complete list for review. The site does not decide co-use, spacing or adjustment from two medicine names." } ], "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "格列吡嗪怎样起作用：促进仍有功能的胰岛 β 细胞释放胰岛素", "en": "How glipizide works: stimulating insulin release from functioning pancreatic beta cells" }, "summary": { "zh": "格列吡嗪属于磺脲类，主要通过促进仍有功能的胰岛 β 细胞释放胰岛素来降低血糖。GLUCOTROL XL 的渗透泵结构改变释放过程，不表示可以跳过进食、血糖监测或个体化评估，也不证明比其他降糖药更适合某个人。", "en": "Glipizide is a sulfonylurea that lowers glucose mainly by stimulating insulin release from functioning pancreatic beta cells. GLUCOTROL XL's osmotic system changes drug release; it does not remove the need for food, glucose monitoring or individual assessment and does not prove superiority for a person over another diabetes medicine." }, "checks": [ { "zh": "它不是胰岛素，也不用于 1 型糖尿病或糖尿病酮症酸中毒。疾病名称、一次血糖或家人的经验不能决定个人是否适合。", "en": "It is not insulin and is not for type 1 diabetes or diabetic ketoacidosis. A diagnosis label, one glucose reading or another person's experience cannot determine individual suitability." }, { "zh": "缓释结构和普通格列吡嗪的释放方式不同；不要按相同毫克数自行互换，也不要与格列齐特、格列美脲或其他磺脲类轮换或叠加。", "en": "Extended-release and immediate-release glipizide have different release patterns. Do not self-exchange them by matching milligrams, or rotate or combine them with gliclazide, glimepiride or another sulfonylurea." }, { "zh": "网页解释机制和标签，不替个人设定血糖目标、片数、服用时刻、漏服补服、停药或联合方案。请结合准确处方、进食情况、肾肝功能、低血糖史与完整药单由专业人员判断。", "en": "The site explains mechanism and label identity. It does not set an individual's glucose target, tablet count, timing, missed-use action, stopping or combination plan. Professional review requires the exact prescription, food intake, kidney and liver function, hypoglycaemia history and complete medicine list." } ], "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "GLUCOTROL XL", "generic": "格列吡嗪缓释片", "dosageFormClass": "24 小时渗透泵缓释口服片：每片 2.5、5 或 10 mg；不是普通格列吡嗪片，也不是格列齐特缓释片" }, "labelSource": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：GLUCOTROL XL，NDA 020329；5 mg、10 mg 为处方 RLD，2.5 mg 为已停止销售 RLD", "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": [], "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": "GLUCOTROL XL 是格列吡嗪缓释片，用于成年 2 型糖尿病患者配合饮食与运动改善血糖控制。药物装在不可溶解的渗透泵外壳中缓慢释放：必须整片吞服，不能掰、切、压碎、溶解或咀嚼；排便时偶尔看到像药片的空壳，通常不表示药没有吸收。网页只帮助辨认产品、读懂说明书和低血糖风险，不给个人剂量或换药方案。", "history": "FDA 于 1994 年批准 5 mg、10 mg GLUCOTROL XL，并于 1999 年批准 2.5 mg。当前官方数据仍把三个强度与 NDA 020329、RLD 身份相连；DailyMed 现行标签为 SPL v28、2026-07-21 生效。产品身份、标签日期与市场供应状态必须分别阅读。", "sourceDocuments": [ { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：GLUCOTROL XL，NDA 020329；5 mg、10 mg 为处方 RLD，2.5 mg 为已停止销售 RLD", "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_ba0d4d24a4153f88", "label": "FDA：GLUCOTROL XL NDA 020329/S-035 补充批准信（2021-05-21）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020329Orig1s035ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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 020329（GLUCOTROL XL / glipizide extended-release tablets）", "approvalTimeline": [ { "date": "1994-04-26", "title": { "zh": "FDA 批准 5 mg 与 10 mg", "en": "FDA approved 5 mg and 10 mg" }, "detail": { "zh": "Orange Book 当前数据把两个强度与 NDA 020329 及 RLD 身份相连。", "en": "Current Orange Book data link both strengths to NDA 020329 and RLD identity." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：GLUCOTROL XL，NDA 020329；5 mg、10 mg 为处方 RLD，2.5 mg 为已停止销售 RLD", "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": "1999-08-10", "title": { "zh": "FDA 批准 2.5 mg", "en": "FDA approved 2.5 mg" }, "detail": { "zh": "当前 Orange Book 将该强度列为已停止销售的 RLD；DailyMed 标签仍保留其历史包装记录。", "en": "The current Orange Book lists this strength as a discontinued RLD; DailyMed retains its historical package record." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：GLUCOTROL XL，NDA 020329；5 mg、10 mg 为处方 RLD，2.5 mg 为已停止销售 RLD", "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": "2021-05-21", "title": { "zh": "FDA 批准 S-035 标签补充申请", "en": "FDA approved S-035 labelling supplement" }, "detail": { "zh": "批准信是有日期的监管节点；本页现行用药信息以更新后的 DailyMed 标签为准。", "en": "The approval letter is a dated regulatory node; current use information on this page follows the later DailyMed label." }, "source": { "id": "src_ba0d4d24a4153f88", "label": "FDA：GLUCOTROL XL NDA 020329/S-035 补充批准信（2021-05-21）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020329Orig1s035ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-07-21", "title": { "zh": "DailyMed 当前标签生效日期", "en": "Current DailyMed label effective date" }, "detail": { "zh": "SPL v28 是本页核验的现行公开标签节点；标签日期不等于任何具体药店库存。", "en": "SPL v28 is the current public-label node reviewed here; a label date is not proof of stock at a particular pharmacy." }, "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "5 mg、10 mg 有现行公开品牌标签；2.5 mg 的 NDC 记录显示 2023 年营销结束", "en": "5 mg and 10 mg have a current public brand label; the 2.5 mg NDC record shows marketing ended in 2023" }, "detail": { "zh": "现行标签与 Orange Book 身份用于核实产品，不表示任何具体渠道有库存，也不是个人购买或用药建议。", "en": "The current label and Orange Book identity verify the product; they do not establish stock at a particular channel or provide individual purchasing or use advice." } }, { "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": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、通用名或毫克数推定当地商品名、批准、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. brand, generic name or milligram amount." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "为什么大便里会看到像药片的东西？", "en": "Why might something resembling a tablet appear in stool?" }, "answer": { "zh": "GLUCOTROL XL 使用不可溶解的渗透泵外壳缓慢释放药物。药物释放后，空壳可能随大便排出，这是官方患者说明列出的现象。不要因此补吃；如血糖异常、持续担忧或伴肠道症状，请联系专业人员。", "en": "GLUCOTROL XL uses a non-dissolvable osmotic shell to release medicine slowly. The empty shell may pass in stool after release, as described in the official patient information. Do not take an extra tablet because of it; contact a professional for abnormal glucose, persistent concern or accompanying bowel symptoms." } }, { "question": { "zh": "5 mg 可以掰一半当 2.5 mg 吗？", "en": "Can a 5 mg tablet be split to make 2.5 mg?" }, "answer": { "zh": "不能自行这样做。片剂无刻痕，官方说明要求整片吞服，不得掰开、压碎、溶解、咀嚼或切半，因为这会破坏缓释结构。需要调整时应核对准确处方和可用产品。", "en": "Do not do this yourself. The tablet is unscored, and official information says to swallow it whole without breaking, crushing, dissolving, chewing or cutting it in half because this damages extended release. Any adjustment requires review of the exact prescription and available product." } }, { "question": { "zh": "和格列齐特缓释片、格列美脲是一种药吗？", "en": "Is it the same medicine as modified-release gliclazide or glimepiride?" }, "answer": { "zh": "不是。它们可能都属于磺脲类，但有效成分、产品身份、释放方式、强度与说明书不同，不能按毫克数自行替换、轮换或叠加。", "en": "No. They may all be sulfonylureas, but active ingredient, product identity, release pattern, strength and label differ. Do not self-substitute, rotate or combine them by milligram numbers." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/glucotrol-xl/", "en": "https://origindrug.com/en/drugs/glucotrol-xl/" }, "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." ] }