{ "id": "feldene-piroxicam", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-13", "status": "published_traceable_archive" }, "names": { "brand": "FELDENE", "generic": "吡罗昔康（piroxicam）口服胶囊", "aliases": [ "FELDENE", "Feldene", "piroxicam", "吡罗昔康", "吡罗昔康胶囊", "piroxicam capsules", "NDA 018147" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "本页建立的是美国 FELDENE NDA 018147 的有日期公开档案：FDA 2021-04 品牌处方信息列出 10 mg 和 20 mg 口服胶囊，DailyMed 公开患者用药指南于 2025-01 修订。两项来源不能证明今天的库存、购买渠道、真伪，也不能推定中国大陆、欧盟、日本或其他市场的批准、供应或可替代关系。", "dosageFormClass": "口服胶囊。FDA 有日期文件列出 10 mg 与 20 mg 两种标签强度；不同药品、不同 NSAID 或不同市场包装不能只按 mg 数自行替换、叠加或选择片数。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1982（FDA 2021 标签所列美国初始批准年份）", "archiveSponsorText": "Pfizer（所审阅美国品牌历史标签及患者用药指南来源）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "FELDENE", "piroxicam capsules", "吡罗昔康胶囊" ], "excludedProductCues": [ "piroxicam gel", "piroxicam injection", "generic piroxicam product", "other NSAID" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "无经逐项核实的准确 FELDENE 包装图，页面不以相似药盒代替", "en": "No exact FELDENE package image was individually verified; look-alike packs are not substituted" }, "summary": { "zh": "本页审阅的 FDA 品牌标签和 DailyMed 患者用药指南用于药品身份与安全阅读，不提供一张可核验为准确市场包装的公开图。因此页面保留剂型与来源文字，不展示零售图、相似胶囊或截图来暗示准确包装、供应或真伪。", "en": "The reviewed FDA brand label and DailyMed Medication Guide support identity and safety reading, not an exact publicly verifiable market-pack image. The page therefore retains dosage-form and source text and withholds retail images, look-alike capsules and screenshots that could imply an exact package, availability or authenticity." }, "source": { "id": "src_c1e4431b9d9cd597", "label": "FDA：FELDENE（吡罗昔康）10 mg／20 mg 口服胶囊美国处方信息（NDA 018147；2021-04 修订；有日期历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "FELDENE 说明书放大阅读：先排除重复 NSAID，再识别出血、心血管和严重皮肤警讯", "en": "FELDENE enlarged label: first exclude duplicate NSAIDs, then recognise bleeding, cardiovascular and serious skin warnings" }, "summary": { "zh": "黑便、呕血、胸痛、气短、单侧无力或言语不清、脸或喉咙肿胀、明显少尿、快速水肿、起疱或皮肤脱落不是继续依赖网页试用的情形，应及时使用当地医疗支持。网页不提供个人剂量、频率、疗程、补服或换药方案。", "en": "Black stools, vomiting blood, chest pain, shortness of breath, one-sided weakness or speech difficulty, face or throat swelling, markedly reduced urine, rapid swelling, blistering or skin peeling are not situations for continued self-trial from a webpage and require timely local medical support. The site provides no individual dose, frequency, course, catch-up or switching plan." }, "checks": [ { "zh": "不要只按“止痛”用途把 FELDENE 与布洛芬、萘普生、双氯芬酸、塞来昔布、依托考昔或阿司匹林等 NSAID 自行叠加、轮换或换算。共同类别反而提示先核对重复成分与风险。", "en": "Do not self-combine, alternate or convert FELDENE with ibuprofen, naproxen, diclofenac, celecoxib, etoricoxib or aspirin merely because they are used for pain. The shared NSAID class instead signals a need to check duplication and risk first." }, { "zh": "既往溃疡或消化道出血、抗凝或影响止血的药、SSRI/SNRI、ACEI/ARB、利尿剂、锂、甲氨蝶呤及其他 NSAID 同在药单时，需要结合完整清单和准确产品核对；网页不生成错开或停药指令。", "en": "Prior ulcer or gastrointestinal bleeding, medicines affecting haemostasis, SSRI/SNRI medicines, ACE inhibitors/ARBs, diuretics, lithium, methotrexate and other NSAIDs on the same list require review against the complete list and exact product; the site does not generate spacing or stopping instructions." }, { "zh": "FDA 用药指南提示 NSAID 可能出现严重心血管和胃肠道不良反应。老人、心血管病、肾病、心衰、脱水或多药同用者不应把“常见止痛药”理解为可以自行加用。", "en": "The FDA Medication Guide warns that NSAIDs can cause serious cardiovascular and gastrointestinal adverse reactions. Older adults and people with cardiovascular disease, kidney disease, heart failure, dehydration or multiple medicines must not interpret a common pain medicine as permission to self-add it." }, { "zh": "药名匹配不能确认胶囊强度、具体包装、真伪或个人适用性。请同时核对实际药盒、来源日期、处方和完整药单。", "en": "A name match cannot confirm capsule strength, an exact pack, authenticity or individual suitability. Check the actual pack, source date, prescription and complete medicine list together." } ], "source": { "id": "src_701889096e111b05", "label": "DailyMed（NLM）：FELDENE（吡罗昔康）FDA 批准 NSAID 患者用药指南（Pfizer；2025-01 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=dedef9e5-23de-49ff-895a-30906b5c7da3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "吡罗昔康怎样起作用：NSAID 与前列腺素路径的风险阅读", "en": "How piroxicam works: NSAID and prostaglandin-pathway risk reading" }, "summary": { "zh": "FDA 标签将吡罗昔康归为 NSAID。对普通阅读者，更重要的是共同机制不等于共同用法：前列腺素路径与疼痛、炎症以及胃肠道、肾脏、血小板和妊娠相关生理有关，不能从机制页面推出个人该吃多少或是否应替换另一种药。", "en": "The FDA label classifies piroxicam as an NSAID. For ordinary readers, the key point is that a shared mechanism does not create a shared regimen: prostaglandin pathways relate to pain and inflammation as well as gastrointestinal, kidney, platelet and pregnancy-related physiology, and a mechanism page cannot determine an individual amount or whether another medicine should be replaced." }, "checks": [ { "zh": "NSAID 这一类别不能用来推导个人的剂量、频率、疗程、补服或换药。", "en": "The NSAID class cannot determine an individual's dose, frequency, course, catch-up or switching plan." }, { "zh": "同属 NSAID 不代表可以同时服用；应先找出药单中的重复止痛、感冒和阿司匹林产品。", "en": "Being in the same NSAID class does not permit co-use; first identify duplicate pain, cold and aspirin products on the medicine list." }, { "zh": "出现警讯时，机制解释不替代当地医疗支持。", "en": "When warning signs occur, a mechanism explanation does not replace local medical support." } ], "source": { "id": "src_c1e4431b9d9cd597", "label": "FDA：FELDENE（吡罗昔康）10 mg／20 mg 口服胶囊美国处方信息（NDA 018147；2021-04 修订；有日期历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "FELDENE", "generic": "吡罗昔康（piroxicam）口服胶囊", "dosageFormClass": "口服胶囊。FDA 有日期文件列出 10 mg 与 20 mg 两种标签强度；不同药品、不同 NSAID 或不同市场包装不能只按 mg 数自行替换、叠加或选择片数。" }, "labelSource": { "id": "src_c1e4431b9d9cd597", "label": "FDA：FELDENE（吡罗昔康）10 mg／20 mg 口服胶囊美国处方信息（NDA 018147；2021-04 修订；有日期历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "productRoutes": [ { "source": { "id": "src_c1e4431b9d9cd597", "label": "FDA：FELDENE（吡罗昔康）10 mg／20 mg 口服胶囊美国处方信息（NDA 018147；2021-04 修订；有日期历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "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": "2026-09-13", "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": "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": "2026-09-13", "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": "FELDENE 是吡罗昔康口服 NSAID 的美国品牌历史档案。它不是“与其他止痛药都能搭配”的通用选项：先核对是否已经使用布洛芬、萘普生、双氯芬酸、塞来昔布、依托考昔或阿司匹林等 NSAID；老人、既往消化道出血、心脑血管病、肾病、心衰、脱水或多药同用者更应带完整药单请药师或医生核对。", "history": "FDA 有日期处方信息列出美国初始批准年份为 1982，并显示 2021-04 修订。DailyMed 的 FDA 批准 NSAID 患者用药指南标示 Pfizer、2025-01 修订。两个文件的日期和主体分别保留，不把历史品牌标签表述为全球或任何地区的实时售卖信息。", "sourceDocuments": [ { "id": "src_c1e4431b9d9cd597", "label": "FDA：FELDENE（吡罗昔康）10 mg／20 mg 口服胶囊美国处方信息（NDA 018147；2021-04 修订；有日期历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_701889096e111b05", "label": "DailyMed（NLM）：FELDENE（吡罗昔康）FDA 批准 NSAID 患者用药指南（Pfizer；2025-01 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=dedef9e5-23de-49ff-895a-30906b5c7da3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA：FELDENE／吡罗昔康 NDA 018147 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "FELDENE NDA 018147", "approvalTimeline": [ { "date": "1982", "title": { "zh": "美国标签所列初始批准年份", "en": "Initial U.S. approval year listed in the label" }, "detail": { "zh": "FDA 有日期处方信息列示 Initial U.S. Approval: 1982；该年份只定位美国品牌历史。", "en": "The dated FDA prescribing information lists Initial U.S. Approval: 1982; this only locates U.S. brand history." }, "source": { "id": "src_c1e4431b9d9cd597", "label": "FDA：FELDENE（吡罗昔康）10 mg／20 mg 口服胶囊美国处方信息（NDA 018147；2021-04 修订；有日期历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "2021-04", "title": { "zh": "FDA 有日期品牌处方信息修订", "en": "Dated FDA brand prescribing-information revision" }, "detail": { "zh": "所审阅 PDF 的文件名和标签正文标识 2021-04 修订。", "en": "The reviewed PDF filename and label text identify an April 2021 revision." }, "source": { "id": "src_c1e4431b9d9cd597", "label": "FDA：FELDENE（吡罗昔康）10 mg／20 mg 口服胶囊美国处方信息（NDA 018147；2021-04 修订；有日期历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "2025-01", "title": { "zh": "DailyMed 患者用药指南修订", "en": "DailyMed Medication Guide revision" }, "detail": { "zh": "所审阅的 FDA 批准 NSAID 患者用药指南标示 Pfizer、2025-01 修订。", "en": "The reviewed FDA-approved NSAID Medication Guide identifies Pfizer and a January 2025 revision." }, "source": { "id": "src_701889096e111b05", "label": "DailyMed（NLM）：FELDENE（吡罗昔康）FDA 批准 NSAID 患者用药指南（Pfizer；2025-01 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=dedef9e5-23de-49ff-895a-30906b5c7da3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "有日期品牌标签与患者用药指南已链接", "en": "Dated brand label and Medication Guide linked" }, "detail": { "zh": "文件可定位历史监管信息，不建立当前库存、购买、真伪或个人适用性结论。", "en": "The documents locate historical regulatory information and do not establish current stock, purchase, authenticity or individual suitability." } }, { "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": "待逐项建立当地现行记录", "en": "Current local record not yet established" }, "detail": { "zh": "不从美国 NDA、英文品牌或美国标签推定当地批准、商品名、供应、原研/仿制关系或可替代性。", "en": "No local approval, brand, supply, originator/generic relationship or interchangeability is inferred from a U.S. NDA, English brand or U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "FELDENE 能和布洛芬或萘普生一起用吗？", "en": "Can FELDENE be used with ibuprofen or naproxen?" }, "answer": { "zh": "不要仅因都用于疼痛就自行叠加。它们同属 NSAID，可能增加风险；带上全部处方药、非处方药和保健品请药师或临床医生核对。", "en": "Do not self-combine them merely because all are used for pain. They are NSAIDs and may increase risk; have all prescriptions, OTC products and supplements reviewed by a pharmacist or clinician." } }, { "question": { "zh": "10 mg 和 20 mg 能按数字自行换算吗？", "en": "Can 10 mg and 20 mg be self-converted from the numbers?" }, "answer": { "zh": "不能。标签强度是准确产品身份字段，不是个人片数、频率、补服或疗程指令。", "en": "No. Label strength is an exact-product identity field, not an individual tablet count, frequency, catch-up or course instruction." } }, { "question": { "zh": "网页没有药盒图片，怎样核对？", "en": "How can I check a product when the page has no pack image?" }, "answer": { "zh": "本页不使用未经逐项核验的相似图。请用实际药盒、通用名、剂型、来源日期、处方和当地官方查询入口进行核对；对真伪或用药存疑时请联系当地正规药师或医疗团队。", "en": "This page does not use unverified look-alike images. Check the actual pack, generic name, dosage form, source date, prescription and local official lookup route; for authenticity or medicine-use concerns, contact a local licensed pharmacist or care team." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/feldene-piroxicam/", "en": "https://origindrug.com/en/drugs/feldene-piroxicam/" }, "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." ] }