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tablet/capsule shape not applicable" }, "imprint": "N/A", "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-neurontin-gabapentin-capsule-100mg-100-bottle-ndc-5815128101", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-07.jpg&setid=97935fd9-1d4a-43b6-a5d9-de994591187b&type=img", "alt": "NEURONTIN 加巴喷丁 100 mg、NDC 58151-281-01、100 粒瓶装在美国 DailyMed 当前公开标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（页面 2026-05-12 更新；处方信息 2025-04 修订）", "presentation": "NEURONTIN 加巴喷丁口服胶囊：每粒 100 mg，NDC 58151-281-01，100 粒瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 NEURONTIN、加巴喷丁 100 mg、NDC 58151-281-01 与 100 粒瓶装。它只帮助核对品牌、通用名、每粒标示量、胶囊、包装数量、外观线索与来源；不用于鉴定真伪，也不证明 300/400 mg 胶囊、600/800 mg 刻痕片、250 mg/5 mL 口服溶液、其他包装、其他市场、原研身份、当前可得性、可替代性或任何个人的粒数、片数、毫升数、分割、调量、联用、停用或换药方案。", "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "NEURONTIN 说明书放大阅读：胶囊、刻痕片与口服液的数字不能互相代算", "en": "NEURONTIN label reading: capsule, scored-tablet and oral-solution numbers cannot be converted by guesswork" }, "summary": { "zh": "本模块以 DailyMed 的 NEURONTIN 美国公开标签为阅读入口，核对加巴喷丁、准确剂型、mg 或 mg/5 mL、包装和目标市场。它不提供个人片数、毫升数、加减量、换剂型、联用或停药方案。", "en": "This module uses the DailyMed NEURONTIN U.S. public label to check gabapentin, exact dosage form, mg or mg/5 mL, package and target market. It does not provide an individual's tablet count, millilitre amount, escalation, reduction, form switch, combination or stopping plan." }, "checks": [ { "zh": "先分清胶囊、600／800 mg 刻痕片和 250 mg/5 mL 口服溶液。mg 表示一个确定单位中的标示量，mg/5 mL 表示液体浓度；它们不是网页可以替任何人推导“该吃几粒／几毫升”的答案。", "en": "First distinguish capsules, 600/800 mg scored tablets and 250 mg/5 mL oral solution. mg is the stated amount in a defined unit, while mg/5 mL is a liquid concentration; neither lets a webpage derive how many units or millilitres any person should use." }, { "zh": "标签写明胶囊应整粒随水吞服。仅对该准确品牌的 600／800 mg 刻痕片说明了可能分半时余半片的标签处置；这不授权把胶囊打开、把任何片剂掰半、研碎，或把其他规格、市场与剂型按经验替代。", "en": "The label states that capsules should be swallowed whole with water. It separately addresses a remaining half only when this exact brand's 600/800 mg scored tablet is divided; that does not authorise opening capsules, splitting or crushing any tablet, or experience-based substitution across strengths, markets or forms." }, { "zh": "标签提示减量、停用或改用另一种药物应逐渐完成，且不应突然或快速停用。它不是让读者自行安排速度或时点的指令；对漏用、转换、嗜睡、头晕、跌倒或其他不适，应联系负责团队或药师核对。", "en": "The label says dose reduction, discontinuation or substitution with another medicine should be gradual and not abrupt or rapid. It is not an instruction for readers to choose a speed or timing; for a missed use, transition, sleepiness, dizziness, a fall or another concern, contact the responsible team or pharmacist for review." }, { "zh": "标签指出肾功能与老年人的用药资料需要格外谨慎核对，并提示与中枢抑制药（尤其阿片类）合用时存在呼吸抑制和镇静风险。它解释为何完整药单和肾功能相关资料必须由专业人员审阅，不构成任何个人调整或组合规则。", "en": "The label calls for particular care with renal-function information and older adults, and warns of respiratory-depression and sedation risk with CNS depressants, especially opioids. This explains why the complete medicine list and renal-function information need professional review; it does not create an individual adjustment or combination rule." } ], "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "加巴喷丁怎样起作用：标签明确写明其镇痛与抗癫痫作用的精确机制尚未确定", "en": "How gabapentin works: the label says its precise analgesic and antiepileptic mechanisms are not established" }, "summary": { "zh": "NEURONTIN 标签写明加巴喷丁的精确镇痛和抗癫痫机制尚未确定；体外研究显示它可高亲和力结合电压激活钙通道的 α2δ 亚基，但该结合与治疗效应的关系仍未知。这里保留不确定性，不把机制词变成个人疗效、剂量、联用或转换结论。", "en": "The NEURONTIN label says gabapentin's precise analgesic and antiepileptic mechanisms are unknown. In-vitro studies show high-affinity binding to the alpha-2-delta subunit of voltage-activated calcium channels, while the relationship to therapeutic effect remains unknown. This preserves uncertainty rather than turning mechanism terms into conclusions about individual response, dose, combination or switching." }, "checks": [ { "zh": "“α2δ 亚基”是标签中的实验和药理线索，不是任何疼痛、发作、头晕、睡眠改变或其他不适原因的诊断工具，也不能据此决定是否开始、增加、叠加或改用药物。", "en": "“Alpha-2-delta subunit” is an experimental and pharmacologic clue in a label, not a diagnostic tool for pain, a seizure, dizziness, sleep change or another concern, and it cannot decide whether to start, increase, combine or switch a medicine." }, { "zh": "与其他神经系统用药或镇痛药名称、用途或机制看似相关，不表示可以自行叠加、轮换、按 mg 换算或用余药续用。准确剂型、肾功能、完整药单和当前标签必须由专业人员一起评估。", "en": "A seeming relationship in name, use or mechanism with another nervous-system or pain medicine does not permit self-combination, alternation, milligram conversion or using leftovers. Exact dosage form, renal function, the complete medicine list and current label need professional review together." }, { "zh": "明显嗜睡、呼吸变慢或困难、面部／口唇／咽喉肿胀、持续或反复发作、意识改变或其他急性问题，应优先使用当地紧急医疗和既有照护渠道；机制页面不能替代现场评估。", "en": "With marked sleepiness, slowed or difficult breathing, face/lip/throat swelling, persistent or repeated seizures, altered consciousness or another acute concern, prioritise local emergency care and established care pathways; a mechanism page cannot replace in-person assessment." } ], "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Neurontin", "generic": "加巴喷丁", "dosageFormClass": "NEURONTIN 加巴喷丁：100 / 300 / 400 mg 口服胶囊、600 / 800 mg 薄膜衣刻痕片、250 mg/5 mL 口服溶液（美国公开标签所列；本页分别建立五种 100 单位瓶装与一瓶 470 mL 口服液身份，不将不同剂型、包装或其他市场合并）" }, "labelSource": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "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": "2026-08-23", "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": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2019-gabapentinoid-serious-breathing-gabapentin", "issuedAt": "2019-12-19", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：包括 Neurontin（gabapentin）在内的加巴喷丁类药物严重呼吸问题风险沟通", "en": "FDA Drug Safety Communication: serious breathing-problem warning for gabapentinoids including Neurontin (gabapentin)" }, "summary": { "zh": "FDA 于 2019-12-19 发布药物安全通讯，明确列出 Neurontin（gabapentin），并说明在存在呼吸风险因素时使用加巴喷丁类药物可能出现严重呼吸困难；公告所列背景包括与阿片类镇痛药或其他中枢神经系统抑制药同用、降低肺功能的疾病及高龄。FDA 要求在美国加巴喷丁类药物处方信息中增加呼吸抑制风险警语。该记录是美国、特定日期的类别监管沟通，不表示手中任何 Neurontin 包装、其他剂型或市场、任何联用，或任何个人已发生问题，也不支持自行停药、减量、加量、换药或把 Neurontin 与其他镇静性药物自行叠加／拆分。出现呼吸困难、反应异常、难以唤醒或其他紧急症状时应立即使用当地急救服务；非紧急的联用或风险问题应连同实际包装和完整药单由开方团队或药师核对。", "en": "On 2019-12-19, FDA issued a Drug Safety Communication that explicitly lists Neurontin (gabapentin) and says serious breathing difficulties may occur with gabapentinoids in people with respiratory risk factors. The communication names use with opioid pain medicines or other central-nervous-system depressants, conditions that reduce lung function, and older age as context; FDA required respiratory-depression warnings in U.S. gabapentinoid prescribing information. This is a dated U.S. class regulatory communication. It does not mean that any Neurontin pack, another dosage form or market, any combination, or any individual has a problem, and it does not support self-stopping, reducing, increasing, switching, or independently adding/splitting Neurontin with another sedating medicine. Trouble breathing, unusual unresponsiveness, inability to wake, or another emergency requires local emergency services; non-emergency combination or risk questions need the actual pack and complete medicine list reviewed by a pharmacist or prescribing team." }, "source": { "id": "src_d155de4d5f6093e9", "label": "FDA：2019-12-19 加巴喷丁／普瑞巴林（含 Neurontin、Lyrica）严重呼吸问题药物安全通讯", "url": "https://www.fda.gov/safety/medical-product-safety-information/neurontin-gralise-horizant-gabapentin-and-lyrica-lyrica-cr-pregabalin-drug-safety-communication", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前美国公开标签列有 NEURONTIN（gabapentin）的三种胶囊、两种刻痕片和一种口服溶液。本页分别建立准确包装的品牌、通用名、单位标示量、NDC、外观线索和一手来源核对卡；不把包装数字变成个人粒数、片数、毫升数、分割、转换、减停、联用、转换或购买结论。", "history": "本页只建立 DailyMed 当前美国公开标签所列的 NEURONTIN 100 mg 胶囊（NDC 58151-281-01）、300 mg 胶囊（58151-282-01）、400 mg 胶囊（58151-283-01）、600 mg 刻痕片（58151-284-01）、800 mg 刻痕片（58151-285-01）各 100 单位瓶装，以及 250 mg/5 mL 口服溶液（58151-290-35；470 mL 瓶装）身份。胶囊、刻痕片和液体浓度不能按同一通用名、相近 mg 或包装数字凭经验互换；实际计划需由开方团队按现行标签和个人资料核对。", "sourceDocuments": [ { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "NDA 020235 / 020882 / 021129（当前 DailyMed NEURONTIN 标签所列）", "approvalTimeline": [ { "date": "1993", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1993。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1993. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed: NEURONTIN current U.S. label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2026-05-12", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-05-12 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-05-12 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed: NEURONTIN current U.S. label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/neurontin/", "en": "https://origindrug.com/en/drugs/neurontin/" }, "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." ] }