{ "id": "dilantin-phenytoin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-05", "status": "published_traceable_archive" }, "names": { "brand": "DILANTIN", "generic": "苯妥英钠缓释胶囊", "aliases": [ "Dilantin", "phenytoin", "phenytoin sodium extended capsules", "苯妥英", "苯妥英钠", "苯妥英钠缓释胶囊", "NDC 58151-118-01", "NDC 58151-110-01", "084349", "DILANTIN", "phenytoin sodium", "extended phenytoin sodium capsules", "58151-118-01", "58151-110-01" ], "marketBrandNames": [ { "name": "DILANTIN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "当前品牌标签；不证明实时库存、价格或个人适用。", "en": "Current brand label; not proof of live stock, price or individual suitability." }, "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "本页只建立美国 DILANTIN 苯妥英钠缓释胶囊当前品牌标签档案：30 mg 与 100 mg 每粒含量及两个 100 粒瓶装。该记录不外推中国大陆或其他市场的批准、商品名、参比身份、供应、价格、购买资格或个人适用性。", "dosageFormClass": "本档案只对应 DILANTIN 缓释苯妥英钠胶囊。口服混悬液、咀嚼片、速释胶囊、磷苯妥英注射剂以及其他厂牌不是同一个准确产品；剂型或品牌变化需要专业监测，不能只按共同成分或总毫克数自行替换。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1953（标签所示苯妥英美国初始批准年份）", "archiveSponsorText": "Viatris Specialty LLC" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "DILANTIN", "DILANTIN extended phenytoin sodium capsules", "苯妥英钠缓释胶囊" ], "excludedProductCues": [ "DILANTIN-125", "DILANTIN INFATABS", "phenytoin oral suspension", "phenytoin prompt capsules", "fosphenytoin", "CEREBYX", "generic phenytoin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-dilantin-phenytoin-extended-capsule-30mg-100-bottle-ndc-5815111801", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2023-08 修订）", "en": "Current U.S. DailyMed brand label (revised August 2023)" }, "dosageForm": { "zh": "DILANTIN 苯妥英钠缓释胶囊", "en": "DILANTIN extended phenytoin sodium capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-118-01", "pouchCode": null, "applicationNumber": "ANDA 084349（legacy RLD record）", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含苯妥英钠 30 mg；100 粒瓶装", "en": "Phenytoin sodium 30 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯妥英钠", "en": "phenytoin sodium" }, "value": 30, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频次、疗程或换药换算值", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or switching conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-05", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明囊体、淡粉色囊帽", "en": "white opaque body with pale-pink cap" }, "shape": { "zh": "4号硬胶囊", "en": "size 4 hard capsule" }, "imprint": "VLE / DILANTIN 30 mg", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-dilantin-phenytoin-extended-capsule-100mg-100-bottle-ndc-5815111001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2023-08 修订）", "en": "Current U.S. DailyMed brand label (revised August 2023)" }, "dosageForm": { "zh": "DILANTIN 苯妥英钠缓释胶囊", "en": "DILANTIN extended phenytoin sodium capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-110-01", "pouchCode": null, "applicationNumber": "ANDA 084349（legacy RLD record）", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含苯妥英钠 100 mg；100 粒瓶装", "en": "Phenytoin sodium 100 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯妥英钠", "en": "phenytoin sodium" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频次、疗程或换药换算值", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or switching conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-05", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明囊体、中橙色囊帽", "en": "white opaque body with medium-orange cap" }, "shape": { "zh": "3号硬胶囊", "en": "size 3 hard capsule" }, "imprint": "VLE / DILANTIN / 100 mg", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-dilantin-phenytoin-extended-capsule-100mg-100-bottle-ndc-5815111001", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593&type=img", "alt": "DILANTIN 100 mg、NDC 58151-110-01、100 粒瓶装的 DailyMed 官方包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed；2023-08 修订", "presentation": "白色不透明囊体、中橙色囊帽，VLE / DILANTIN / 100 mg；每粒 100 mg，100 粒瓶装。", "notice": "只对应所引美国当前准确包装。外观、颜色和刻印仅用于辅助定位，不用于鉴定真伪、证明实时库存或生成个人剂量。", "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DILANTIN 说明书放大阅读：每粒含量、不能突然停药、血药浓度与多药核对", "en": "DILANTIN enlarged label: per-capsule amount, no abrupt withdrawal, levels and polypharmacy review" }, "summary": { "zh": "包装上的 30 mg 或 100 mg 是每粒含量，100 Capsules 是瓶内粒数。不能据此推导个人粒数、频次、疗程或换药换算。突然停用抗癫痫药可能诱发癫痫持续状态，应按专业安排调整。", "en": "The 30 mg or 100 mg figure is the amount per capsule and 100 Capsules is the bottle count. Pack numbers do not determine an individual's capsule count, frequency, course or switching conversion. Abrupt antiepileptic withdrawal may precipitate status epilepticus; changes require professional planning." }, "checks": [ { "zh": "不要突然停用、漏服后自行加倍、轮换不同厂牌或把缓释胶囊换成其他剂型；品牌或剂型变化可能改变吸收，需要按专业安排监测苯妥英浓度和临床反应。", "en": "Do not abruptly stop, double after a missed dose, rotate brands or replace extended capsules with another form. Brand or dosage-form changes may alter absorption and require professionally planned phenytoin-level and clinical monitoring." }, { "zh": "眼震、走路不稳、说话含糊、嗜睡、意识变化等可能提示神经系统毒性；不要用网页自行调量，应及时联系医疗专业人员。", "en": "Nystagmus, unsteady walking, slurred speech, drowsiness or mental-status change may signal neurologic toxicity. Do not self-adjust from a webpage; contact a healthcare professional promptly." }, { "zh": "严重皮疹、水疱、口腔黏膜损害、面唇舌喉肿胀、发热伴皮疹或淋巴结肿大，可能涉及严重皮肤反应、DRESS 或血管性水肿，需要紧急医疗评估。", "en": "Severe rash, blistering, mucosal injury, swelling of the face/lips/tongue/throat, or fever with rash or lymph-node enlargement may involve severe skin reactions, DRESS or angioedema and needs urgent medical assessment." }, { "zh": "苯妥英相互作用很多；处方药、非处方药、中草药、补充剂、酒精使用情况和营养支持都应一次性交给医生或药师核对，不能只靠错开时间。", "en": "Phenytoin has many interactions. Prescriptions, OTC medicines, herbs, supplements, alcohol use and nutrition support should be reviewed together by a doctor or pharmacist; simply spacing doses is insufficient." }, { "zh": "老人清除率可能降低；肝肾功能异常或低白蛋白时，总浓度可能误导，需要专业人员判断是否监测游离苯妥英。不要按年龄自行减粒。", "en": "Clearance may decrease in older adults. With renal/hepatic impairment or hypoalbuminemia, total concentration can mislead and a professional may consider unbound phenytoin. Do not self-reduce by age." }, { "zh": "CYP2C9 等遗传因素只是严重皮肤反应和代谢风险评估的一部分；说明书并不支持人人做全基因筛查，也不能凭网页基因结果自行决定剂量。", "en": "Genetic factors such as CYP2C9 are only part of severe-skin-reaction and metabolism assessment. The label does not support whole-genome screening for everyone, and webpage genetic results must not determine self-dosing." } ], "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用与浓度阅读：稳定钠通道不等于可以自行试量", "en": "Mechanism and concentration: sodium-channel stabilization does not justify self-titration" }, "summary": { "zh": "苯妥英通过影响电压依赖性钠通道、限制神经元重复放电而发挥抗癫痫作用。其代谢可在治疗范围内逐渐饱和，因此剂量与血药浓度不是简单线性关系；包装含量、体重或一次浓度都不能单独生成个人方案。", "en": "Phenytoin limits repetitive neuronal firing through effects on voltage-dependent sodium channels. Metabolism can become saturated within the therapeutic range, so dose and blood concentration are not simply linear; pack strength, body weight or one level cannot independently generate a personal regimen." }, "checks": [ { "zh": "小幅剂量变化也可能造成不成比例的浓度变化；不要把 30 mg 与 100 mg 当成可随意拼接的积木。", "en": "A small dose change may cause a disproportionate concentration change; do not treat 30 mg and 100 mg strengths as freely interchangeable building blocks." }, { "zh": "开始、停用或调整相互作用药物后，苯妥英浓度和临床反应可能变化；应由专业人员确定复核时点。", "en": "Starting, stopping or changing an interacting medicine can alter phenytoin levels and response; a professional should set review timing." }, { "zh": "控制发作与避免毒性需要结合处方、发作记录、症状、实验室结果和具体制剂；机制科普不能替代复诊。", "en": "Balancing seizure control and toxicity requires the prescription, seizure record, symptoms, laboratory results and exact formulation; mechanism education cannot replace follow-up." } ], "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DILANTIN", "generic": "苯妥英钠缓释胶囊", "dosageFormClass": "本档案只对应 DILANTIN 缓释苯妥英钠胶囊。口服混悬液、咀嚼片、速释胶囊、磷苯妥英注射剂以及其他厂牌不是同一个准确产品；剂型或品牌变化需要专业监测，不能只按共同成分或总毫克数自行替换。" }, "labelSource": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "productRoutes": [ { "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-05", "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": "2026-09-05", "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": "DILANTIN 是苯妥英钠缓释胶囊的美国品牌档案。30 mg 或 100 mg 是每粒含量，100 Capsules 是整瓶粒数，都不是个人应该吃几粒。苯妥英代谢具有饱和、非线性特征，小幅剂量或相互作用变化也可能带来明显血药浓度变化；不要自行加减、突然停用、换厂牌或换剂型。老人、多药合用者，以及肝肾功能或白蛋白异常者尤其需要把实际药盒、完整药单和监测结果一起交给医生或药师核对。", "history": "DILANTIN 标签标注苯妥英于 1953 年在美国初始获批。FDA 2007 年审评资料确认 100 mg 缓释胶囊的参比制剂历史；当前 DailyMed 品牌标签于 2023 年 8 月修订，列出 30 mg 和 100 mg 缓释胶囊及精确包装。", "sourceDocuments": [ { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, { "id": "src_fb1b5582e14ba71e", "label": "FDA：DILANTIN 2021 年批准标签，记录苯妥英美国初始批准年份 1953", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/084349s087lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "approved_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, { "id": "src_2abd274b26c87f1f", "label": "FDA：DILANTIN 100 mg 缓释胶囊参比制剂（RLD）生物等效性审评资料（2007）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/084349Orig1s045BIOEQ_REV.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } ], "applicationNumber": "ANDA 084349（legacy RLD record）", "approvalTimeline": [ { "date": "1953", "title": { "zh": "苯妥英美国初始批准年份", "en": "Initial U.S. approval year for phenytoin" }, "detail": { "zh": "FDA 批准标签列出 Initial U.S. Approval: 1953。", "en": "The FDA-approved label states Initial U.S. Approval: 1953." }, "source": { "id": "src_fb1b5582e14ba71e", "label": "FDA：DILANTIN 2021 年批准标签，记录苯妥英美国初始批准年份 1953", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/084349s087lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "approved_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, { "date": "2007-05-17", "title": { "zh": "FDA 参比制剂审评记录", "en": "FDA reference-listed-drug review" }, "detail": { "zh": "FDA 审评资料将 DILANTIN 100 mg 缓释胶囊列为 Orange Book RLD，并保留历史申请编号口径。", "en": "FDA review material identifies DILANTIN 100 mg extended capsules as the Orange Book RLD and preserves the legacy application-number terminology." }, "source": { "id": "src_2abd274b26c87f1f", "label": "FDA：DILANTIN 100 mg 缓释胶囊参比制剂（RLD）生物等效性审评资料（2007）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/084349Orig1s045BIOEQ_REV.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, { "date": "2023-08", "title": { "zh": "当前 DailyMed 标签修订", "en": "Current DailyMed label revision" }, "detail": { "zh": "标签列出 30 mg 与 100 mg 缓释胶囊、精确 NDC 和包装面板。", "en": "The label lists 30 mg and 100 mg extended capsules, exact NDCs and package panels." }, "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "展示两个准确 100 粒瓶装；不证明实时供应。", "en": "Two exact 100-capsule bottles are displayed; not proof of live supply." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "当地批准、商品名、参比、包装和供应尚未逐市场确认", "en": "Local approval, brand, reference, pack and supply not yet established market by market" }, "detail": { "zh": "不从美国标签或历史 RLD 记录推定其他市场状态。", "en": "No other-market status is inferred from the U.S. label or legacy RLD record." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "100 mg 是每次吃一粒吗？", "en": "Does 100 mg mean one capsule each time?" }, "answer": { "zh": "不是。100 mg 只说明每粒含量；个人粒数、频次和疗程必须以准确处方、具体剂型和专业监测为准。", "en": "No. 100 mg is only the amount per capsule; capsule count, frequency and course require the exact prescription, formulation and professional monitoring." } }, { "question": { "zh": "同是苯妥英，能直接换厂牌或剂型吗？", "en": "Can phenytoin brands or dosage forms be switched directly?" }, "answer": { "zh": "不能自行换。吸收和释放可能不同，说明书要求品牌或剂型变化时谨慎并监测血药浓度；请带两盒实物或官方说明书复核。", "en": "Do not self-switch. Absorption and release may differ; the label calls for caution and level monitoring with brand or dosage-form changes. Bring both packs or official labels for review." } }, { "question": { "zh": "老人是不是减半吃就更安全？", "en": "Is half the dose automatically safer for an older adult?" }, "answer": { "zh": "不是。老人清除率可能降低，但具体调整需要结合制剂、处方、发作情况、相互作用、肝肾功能、白蛋白和浓度监测，不能自行掰分或减粒。", "en": "No. Clearance may decrease with age, but changes require formulation, prescription, seizure status, interactions, liver/kidney function, albumin and level monitoring; do not split or reduce capsules yourself." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/dilantin-phenytoin/", "en": "https://origindrug.com/en/drugs/dilantin-phenytoin/" }, "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." ] }