{ "id": "vimpat-lacosamide", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "VIMPAT", "generic": "拉考沙胺片／口服液", "aliases": [ "Vimpat", "lacosamide", "lacosamide tablets", "lacosamide oral solution", "拉考沙胺", "拉考沙胺片", "拉考沙胺口服液", "维派特", "NDA 022253", "NDA 022255", "VIMPAT", "0131-2477-60", "0131-2478-60", "0131-2479-60", "0131-2480-60", "0131-5410-72" ], "marketBrandNames": [ { "name": "VIMPAT", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "当前品牌标签；本页只展示口服片和口服液。监管记录不证明实时供应或个人适用。", "en": "Current brand label; this page displays only oral tablets and oral solution. A regulatory record does not prove live supply or individual suitability." }, "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经系统", "sourceArchiveMarket": "美国 DailyMed 当前 VIMPAT 品牌标签把薄膜衣口服片、口服液和静脉注射剂列在同一 SPL 中。本档案面向普通读者只展示 50、100、150、200 mg 四种口服片单位剂量纸盒，以及 10 mg/mL、200 mL 口服液准确面板；注射剂明确排除。美国 CV 管制分类、公开标签和 NDC 不等于其他市场法律状态、实时库存、购买资格或个人适用性。", "dosageFormClass": "VIMPAT 拉考沙胺薄膜衣口服片（每片 50、100、150、200 mg）与口服液（10 mg/mL，200 mL/瓶）。片剂必须整片吞服、不得切开；口服液须用合适量具，不能用家用茶匙。注射剂不是本口服档案同一展示产品。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2008-10-28（FDA 原始批准函）", "archiveSponsorText": "UCB, Inc.（当前美国品牌标签包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "VIMPAT lacosamide", "VIMPAT tablets", "VIMPAT oral solution", "拉考沙胺片", "拉考沙胺口服液" ], "excludedProductCues": [ "VIMPAT injection", "lacosamide injection", "generic lacosamide", "KEPPRA", "levetiracetam", "LAMICTAL", "lamotrigine", "TEGRETOL", "carbamazepine" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-vimpat-lacosamide-tablet-50mg-60-unit-dose-carton-ndc-0131247760", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-05 修订；SPL v63）", "en": "Current U.S. DailyMed brand label (revised May 2026; SPL v63)" }, "dosageForm": { "zh": "VIMPAT 拉考沙胺薄膜衣口服片", "en": "VIMPAT lacosamide film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0131-2477-60", "pouchCode": null, "applicationNumber": "NDA 022253", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片拉考沙胺 50 mg；60 片单位剂量纸盒（6 板，每板 10 片）", "en": "Lacosamide 50 mg per tablet; 60-tablet unit-dose carton (6 cards of 10)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vimpat-05.jpg&setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉考沙胺", "en": "lacosamide" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单位剂量纸盒", "en": "unit-dose carton" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "SP / 50", "scoreStatus": "unscored_do_not_cut", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vimpat-lacosamide-tablet-100mg-60-unit-dose-carton-ndc-0131247860", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-05 修订；SPL v63）", "en": "Current U.S. DailyMed brand label (revised May 2026; SPL v63)" }, "dosageForm": { "zh": "VIMPAT 拉考沙胺薄膜衣口服片", "en": "VIMPAT lacosamide film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0131-2478-60", "pouchCode": null, "applicationNumber": "NDA 022253", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片拉考沙胺 100 mg；60 片单位剂量纸盒（6 板，每板 10 片）", "en": "Lacosamide 100 mg per tablet; 60-tablet unit-dose carton (6 cards of 10)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vimpat-06.jpg&setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉考沙胺", "en": "lacosamide" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单位剂量纸盒", "en": "unit-dose carton" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "深黄色", "en": "dark yellow" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "SP / 100", "scoreStatus": "unscored_do_not_cut", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vimpat-lacosamide-tablet-150mg-60-unit-dose-carton-ndc-0131247960", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-05 修订；SPL v63）", "en": "Current U.S. DailyMed brand label (revised May 2026; SPL v63)" }, "dosageForm": { "zh": "VIMPAT 拉考沙胺薄膜衣口服片", "en": "VIMPAT lacosamide film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0131-2479-60", "pouchCode": null, "applicationNumber": "NDA 022253", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片拉考沙胺 150 mg；60 片单位剂量纸盒（6 板，每板 10 片）", "en": "Lacosamide 150 mg per tablet; 60-tablet unit-dose carton (6 cards of 10)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vimpat-07.jpg&setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉考沙胺", "en": "lacosamide" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单位剂量纸盒", "en": "unit-dose carton" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "鲑红色", "en": "salmon" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "SP / 150", "scoreStatus": "unscored_do_not_cut", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vimpat-lacosamide-tablet-200mg-60-unit-dose-carton-ndc-0131248060", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-05 修订；SPL v63）", "en": "Current U.S. DailyMed brand label (revised May 2026; SPL v63)" }, "dosageForm": { "zh": "VIMPAT 拉考沙胺薄膜衣口服片", "en": "VIMPAT lacosamide film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0131-2480-60", "pouchCode": null, "applicationNumber": "NDA 022253", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片拉考沙胺 200 mg；60 片单位剂量纸盒（6 板，每板 10 片）", "en": "Lacosamide 200 mg per tablet; 60-tablet unit-dose carton (6 cards of 10)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vimpat-08.jpg&setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉考沙胺", "en": "lacosamide" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单位剂量纸盒", "en": "unit-dose carton" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "SP / 200", "scoreStatus": "unscored_do_not_cut", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vimpat-lacosamide-oral-solution-10mg-per-ml-200ml-glass-bottle-ndc-0131541072", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-05 修订；SPL v63）", "en": "Current U.S. DailyMed brand label (revised May 2026; SPL v63)" }, "dosageForm": { "zh": "VIMPAT 拉考沙胺口服液", "en": "VIMPAT lacosamide oral solution" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0131-5410-72", "pouchCode": null, "applicationNumber": "NDA 022255", "presentationRole": null, "primaryStrengthBasisCode": "per_mL", "primaryDisplay": { "zh": "每 1 mL 含拉考沙胺 10 mg；200 mL 玻璃瓶", "en": "Lacosamide 10 mg per mL; 200 mL glass bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vimpat-10.jpg&setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉考沙胺", "en": "lacosamide" }, "value": 10, "unit": "mg/mL", "basisCode": "per_mL", "basisLabel": { "zh": "每毫升标签标示浓度；不是个人应量取的毫升数", "en": "labelled concentration per mL; not the number of mL an individual should measure" } } ], "concentration": null, "container": { "typeCode": "glass_bottle", "typeLabel": { "zh": "玻璃瓶", "en": "glass bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/盒", "en": "bottle per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "unit": { "zh": "mL/瓶", "en": "mL per bottle" } }, "physicalClues": { "color": { "zh": "无色至黄色或黄棕色液体", "en": "colourless to yellow or yellow-brown liquid" }, "shape": { "zh": "草莓味口服液；玻璃瓶", "en": "strawberry-flavoured oral solution in a glass bottle" }, "imprint": "NDC 0131-5410-72", "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-vimpat-lacosamide-tablet-100mg-60-unit-dose-carton-ndc-0131247860", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vimpat-06.jpg&setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "alt": "VIMPAT 拉考沙胺 100 mg、NDC 0131-2478-60、60 片单位剂量纸盒的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（2026-05 修订；SPL v63）", "presentation": "VIMPAT 拉考沙胺：每片 100 mg，NDC 0131-2478-60，60 片单位剂量纸盒（6 板，每板 10 片）；深黄色椭圆片，SP / 100。", "notice": "此图只对应所引美国 100 mg 单位剂量纸盒，不代表其他规格、60 片瓶装、14 片起始包装、口服液、注射剂、其他市场或实时库存，不用于鉴定真伪，也不授权切片、加减量、换药或停药。", "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VIMPAT 说明书放大阅读：分清每片 mg、每毫升浓度、跌倒、心脏传导与停药风险", "en": "VIMPAT enlarged label: mg per tablet, concentration per mL, falls, cardiac conduction and withdrawal" }, "summary": { "zh": "口服片的 50、100、150、200 mg 是每片含量，60 Tablets（60 片）是整盒片数；口服液 10 mg/mL 是每毫升浓度，200 mL 是整瓶体积。这些包装数字都不是个人用量。患者指南要求片剂整片吞服、不得切开；口服液使用药用滴管或量杯，不能使用家用茶匙。", "en": "For tablets, 50, 100, 150 and 200 mg are amounts per tablet and 60 Tablets is the carton count. For oral solution, 10 mg/mL is the concentration per mL and 200 mL is the bottle volume. None is an individual amount. The Medication Guide says to swallow tablets whole without cutting and to use a medicine dropper or cup, not a household teaspoon, for the solution." }, "checks": [ { "zh": "眩晕、复视、嗜睡、协调和平衡问题会增加跌倒风险；老人或同时使用其他镇静/抗癫痫药时，应把真实药盒、步态变化、跌倒史和完整药单一起交给医生或药师核对。", "en": "Dizziness, double vision, somnolence, coordination and balance problems can increase fall risk. Older adults or people using another sedating or antiseizure medicine should have the real packs, gait changes, fall history and full medicine list reviewed together." }, { "zh": "VIMPAT 可影响 PR 间期并与房室传导阻滞、心动过缓、室性心律失常和晕厥相关。已有心脏病、传导问题，或 β 受体阻滞剂、钙通道阻滞剂、钾通道阻滞剂、钠通道阻滞剂及其他影响传导药物同在药单时，说明书提出心电图和密切监测边界；网页不替代这些检查。", "en": "VIMPAT can affect the PR interval and is associated with AV block, bradycardia, ventricular arrhythmia and syncope. With heart or conduction disease, or beta blockers, calcium-channel blockers, potassium-channel blockers, sodium-channel blockers or other conduction-affecting medicines, the label sets ECG and monitoring boundaries that the site cannot replace." }, { "zh": "不要突然停药或自行快速减量；抗癫痫药突然停用可能增加发作，患者指南警示可能出现持续状态。网页不提供减量表，也不能把 VIMPAT 与 KEPPRA、LAMICTAL、TEGRETOL 等按 mg 一比一换算、轮换或叠加。", "en": "Do not abruptly stop or rapidly self-reduce. Sudden antiseizure-medicine withdrawal can increase seizures, and the Medication Guide warns of status epilepticus. The site provides no taper and cannot convert, rotate or combine VIMPAT one-for-one by milligrams with KEPPRA, LAMICTAL, TEGRETOL or another product." }, { "zh": "情绪、行为或自伤想法突然出现或恶化，应及时联系专业人员；严重皮疹、发热、淋巴结肿大、黄疸、深色尿或多器官过敏线索也需要紧急核对，不能只在网页上观察。", "en": "New or worsening mood, behaviour or self-harm thoughts require prompt professional contact. Serious rash, fever, swollen glands, jaundice, dark urine or multi-organ hypersensitivity clues also require urgent review, not web-only observation." }, { "zh": "口服液按 10 mg/mL 标示，必须用药用量具；不要用家用茶匙，不要凭瓶体积倒取，也不要把毫克数直接当毫升数。个人毫升数只能来自准确处方和专业核对。", "en": "The solution is labelled 10 mg/mL and requires a medicine measuring device. Do not use a household teaspoon, pour by bottle volume or treat milligrams as millilitres. An individual's mL amount must come from the exact prescription and professional review." } ], "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：钠通道慢失活线索不能生成换药或联合方案", "en": "Mechanism reading: a slow sodium-channel inactivation clue cannot generate switching or combination plans" }, "summary": { "zh": "当前标签说明 VIMPAT 发挥抗癫痫作用的精确机制尚未完全阐明；体外研究提示拉考沙胺可能选择性增强电压门控钠通道的慢失活，使过度兴奋神经元膜稳定。这个线索不能决定个人剂量、证明与另一种钠通道药同服安全，也不能生成同类药换算表。", "en": "The current label states that the precise mechanism by which VIMPAT exerts antiseizure effects remains incompletely explained. In vitro evidence suggests lacosamide may selectively enhance slow inactivation of voltage-gated sodium channels, stabilising hyperexcitable neuronal membranes. This clue cannot select a dose, prove safe co-use with another sodium-channel medicine or create a class conversion table." }, "checks": [ { "zh": "卡马西平、拉莫三嗪等也可能涉及钠通道，但不同药物的分子、适应症、剂型、药代和相互作用不同；共同机制词不等于可以自行替代或叠加。", "en": "Carbamazepine, lamotrigine and others may also involve sodium channels, but their molecules, indications, forms, pharmacokinetics and interactions differ. A shared mechanism term does not permit self-substitution or combination." }, { "zh": "心脏也依赖离子通道传导，所以神经系统的钠通道机制不能脱离心电图、心脏病史和影响传导药物单独解读。", "en": "The heart also relies on ion-channel conduction, so a neurological sodium-channel mechanism cannot be read apart from ECG, cardiac history and conduction-affecting medicines." }, { "zh": "是否需要基因检测、是否适合老人或能否从另一种抗癫痫药转换，不由机制段落回答；必须回到诊断、准确药盒、处方、肝肾功能、心脏情况与专业评估。", "en": "Mechanism does not decide genetic testing, older-adult suitability or switching from another antiseizure medicine. Those questions require diagnosis, exact packs, prescription, liver/kidney function, cardiac status and professional assessment." } ], "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VIMPAT", "generic": "拉考沙胺片／口服液", "dosageFormClass": "VIMPAT 拉考沙胺薄膜衣口服片（每片 50、100、150、200 mg）与口服液（10 mg/mL，200 mL/瓶）。片剂必须整片吞服、不得切开；口服液须用合适量具，不能用家用茶匙。注射剂不是本口服档案同一展示产品。" }, "labelSource": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "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": "2026-09-04", "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": "2026-09-04", "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": "VIMPAT 是拉考沙胺口服片和口服液的美国品牌档案。50、100、150、200 mg 是每片含量；10 mg/mL 是口服液每毫升浓度，都不是应该吃几片或量几毫升。老人和多药使用者要优先核对眩晕、复视、步态不稳与跌倒、心脏传导与晕厥、肝肾功能、其他抗癫痫药，以及突然停药导致癫痫加重的风险；网页不生成个人剂量或换停方案。", "history": "FDA 于 2008-10-28 批准 VIMPAT 拉考沙胺片 NDA 022253 与注射剂 NDA 022254。当前 DailyMed SPL v63 于 2026-05 修订，另列口服液 NDA 022255，并保留四种口服片、口服液、患者用药指南、心脏传导和停药风险等阅读内容。", "sourceDocuments": [ { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_bb5da2169ce36a52", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺 FDA 批准患者用药指南", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "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": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_bd801b1c55217038", "label": "FDA：VIMPAT 拉考沙胺片 NDA 022253 与注射剂 NDA 022254 原始批准函（2008-10-28）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022253s000%2C%20022254s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_67351f803004edec", "label": "FDA：VIMPAT NDA 022253／022254 原始跨学科总结审评（2008）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022253s000_022254s000_SumR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 022253 / NDA 022255", "approvalTimeline": [ { "date": "2008-10-28", "title": { "zh": "VIMPAT 拉考沙胺片美国初始批准", "en": "Initial U.S. approval of VIMPAT lacosamide tablets" }, "detail": { "zh": "FDA 原始批准函列出 NDA 022253 的 50、100、150、200 mg 口服片。", "en": "The FDA original approval letter lists 50, 100, 150 and 200 mg oral tablets under NDA 022253." }, "source": { "id": "src_bd801b1c55217038", "label": "FDA：VIMPAT 拉考沙胺片 NDA 022253 与注射剂 NDA 022254 原始批准函（2008-10-28）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022253s000%2C%20022254s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2026-05-12", "title": { "zh": "当前品牌说明书生效日期", "en": "Current brand-label effective date" }, "detail": { "zh": "DailyMed SPL v63 汇总口服片、口服液与注射剂，并更新患者指南及安全阅读内容。", "en": "DailyMed SPL v63 covers tablets, oral solution and injection with the current Medication Guide and safety reading." }, "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "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": "本页展示 NDA 022253 四种口服片单位剂量纸盒及 NDA 022255 口服液，均为美国 CV；不代表实时供应。", "en": "This page displays four NDA 022253 unit-dose tablet cartons and the NDA 022255 oral solution, all U.S. Schedule V; not evidence of live supply." } }, { "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": "当地商品名、批准、参比、管制分类、包装和供应尚未逐市场确认", "en": "Local brand, approval, reference, controlled-drug class, pack and supply are not yet established market by market" }, "detail": { "zh": "不从美国 VIMPAT 商品名、NDA、NDC、CV 或包装外观推定其他市场状态。", "en": "No other-market status is inferred from the U.S. VIMPAT name, NDA, NDC, Schedule V class or package appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "50、100、150、200 mg 是应该吃几片吗？", "en": "Do 50, 100, 150 and 200 mg tell me how many tablets to take?" }, "answer": { "zh": "不是。这些数字是每片含量；60 Tablets 是单位剂量纸盒中的总片数。个人片数和时间只看准确处方并由负责治疗的专业人员确认。", "en": "No. These are amounts per tablet; 60 Tablets is the carton count. Individual tablet count and timing come only from the exact prescription and treating professional." } }, { "question": { "zh": "片剂能切半吗？", "en": "Can the tablet be cut in half?" }, "answer": { "zh": "当前患者指南明确要求整片吞服、不得切开。不要用数学把较大规格切成较小规格，也不要据此改变剂量。", "en": "The current Medication Guide says to swallow the tablet whole and not cut it. Do not use arithmetic to turn a larger strength into a smaller one or change a dose." } }, { "question": { "zh": "10 mg/mL 等于每次喝 10 mL 吗？", "en": "Does 10 mg/mL mean taking 10 mL each time?" }, "answer": { "zh": "不是。10 mg/mL 表示每 1 mL 的浓度；个人应量取多少毫升必须按处方换算，并用药用量具核对，不能使用家用茶匙。", "en": "No. It is the concentration in each 1 mL. The prescribed number of mL must be calculated from the actual prescription and checked with a medicine measuring device, never a household teaspoon." } } ], "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/vimpat-lacosamide/", "en": "https://origindrug.com/en/drugs/vimpat-lacosamide/" }, "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." ] }