{
  "id": "topamax-topiramate",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-09-04",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "TOPAMAX",
    "generic": "托吡酯片／可撒服胶囊",
    "aliases": [
      "TOPAMAX",
      "Topamax",
      "topiramate",
      "topiramate tablets",
      "topiramate sprinkle capsules",
      "托吡酯",
      "托吡酯片",
      "托吡酯可撒服胶囊",
      "妥泰",
      "NDA 020505",
      "NDA 020844",
      "50458-639-65",
      "50458-640-65",
      "50458-641-65",
      "50458-642-65",
      "50458-645-65",
      "50458-647-65"
    ],
    "marketBrandNames": [
      {
        "name": "TOPAMAX",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "evidenceStatus": "current_regulatory_record",
        "note": {
          "zh": "当前品牌标签；本页展示普通片与可撒服胶囊。监管记录不证明实时供应或个人适用。",
          "en": "Current brand label; this page displays conventional tablets and sprinkle capsules. A regulatory record does not prove live supply or individual suitability."
        },
        "source": {
          "id": "src_e3e6c3d2c730579e",
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          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593",
          "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 TOPAMAX 品牌标签包含 25、50、100、200 mg 四种包衣口服片和 15、25 mg 两种可撒服胶囊。本档案逐个绑定美国 NDC 与准确包装面板；美国品牌标签、NDA 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": "TOPAMAX 托吡酯包衣口服片（每片 25、50、100、200 mg）与可撒服胶囊（每粒 15、25 mg）。普通片须整片吞服且不能咀嚼；可撒服胶囊可整粒吞服，或把全部内容物撒在一茶匙软食上立即吞下，不能咀嚼，也不能留到以后。",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "1996-12-24（FDA 审评记录）",
    "archiveSponsorText": "Janssen Pharmaceuticals, Inc.（当前美国品牌标签包装方）"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [
      "TOPAMAX topiramate",
      "TOPAMAX tablets",
      "TOPAMAX Sprinkle Capsules",
      "托吡酯片",
      "托吡酯可撒服胶囊"
    ],
    "excludedProductCues": [
      "generic topiramate",
      "TROKENDI XR",
      "QUDEXY XR",
      "EPRONTIA",
      "phentermine/topiramate",
      "VIMPAT",
      "DEPAKOTE",
      "KEPPRA"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
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        "en": "Current U.S. DailyMed brand label (revised March 2026; SPL v30)"
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      "dosageForm": {
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        "en": "TOPAMAX topiramate coated oral tablet"
      },
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        "zh": "口服",
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      "pouchCode": null,
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      "primaryDisplay": {
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      },
      "physicalClues": {
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          "zh": "乳白色",
          "en": "cream"
        },
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          "zh": "圆形包衣片，约 6 mm，无刻痕",
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        },
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      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
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      "id": "us-topamax-topiramate-tablet-50mg-60-bottle-ndc-5045864065",
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        "en": "Current U.S. DailyMed brand label (revised March 2026; SPL v30)"
      },
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        "zh": "TOPAMAX 托吡酯包衣口服片",
        "en": "TOPAMAX topiramate coated oral tablet"
      },
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            "zh": "每片标签标示量；不是个人片数、频次、疗程、分片或停药指令",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, splitting or stopping instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "含干燥剂瓶装",
          "en": "bottle with desiccant"
        },
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      },
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      },
      "physicalClues": {
        "color": {
          "zh": "浅黄色",
          "en": "light yellow"
        },
        "shape": {
          "zh": "圆形包衣片，约 8 mm，无刻痕",
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      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
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      "id": "us-topamax-topiramate-tablet-100mg-60-bottle-ndc-5045864165",
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      },
      "physicalClues": {
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          "zh": "黄色",
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        },
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        "unit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "白色与透明胶囊，内含白色至类白色小球",
          "en": "white and clear capsule containing white to off-white spheres"
        },
        "shape": {
          "zh": "胶囊，约 18 mm，无刻痕",
          "en": "capsule, about 18 mm, unscored"
        },
        "imprint": "TOP / 15 mg",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e3e6c3d2c730579e",
        "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593",
        "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-topamax-topiramate-sprinkle-capsule-25mg-60-bottle-ndc-5045864565",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国品牌标签（2026-03 修订；SPL v30）",
        "en": "Current U.S. DailyMed brand label (revised March 2026; SPL v30)"
      },
      "dosageForm": {
        "zh": "TOPAMAX 托吡酯可撒服胶囊",
        "en": "TOPAMAX topiramate sprinkle capsule"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 50458-645-65",
      "pouchCode": null,
      "applicationNumber": "NDA 020844",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_capsule",
      "primaryDisplay": {
        "zh": "每粒托吡酯 25 mg；60 粒瓶装",
        "en": "Topiramate 25 mg per capsule; 60-capsule bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=topamax-09.jpg&setid=21628112-0c47-11df-95b3-498d55d89593",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "托吡酯",
            "en": "topiramate"
          },
          "value": 25,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒标签标示量；不是个人粒数、频次、疗程或停药指令",
            "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or stopping instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 60,
        "countUnit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-04",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 60,
        "unit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "白色与透明胶囊，内含白色至类白色小球",
          "en": "white and clear capsule containing white to off-white spheres"
        },
        "shape": {
          "zh": "胶囊，约 19 mm，无刻痕",
          "en": "capsule, about 19 mm, unscored"
        },
        "imprint": "TOP / 25 mg",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e3e6c3d2c730579e",
        "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593",
        "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-topamax-topiramate-tablet-100mg-60-bottle-ndc-5045864165",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=topamax-06.jpg&setid=21628112-0c47-11df-95b3-498d55d89593",
    "alt": "TOPAMAX 托吡酯 100 mg、NDC 50458-641-65、60 片瓶装的 DailyMed 官方标签面板",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed 当前美国品牌标签（2026-03 修订；SPL v30）",
    "presentation": "TOPAMAX 托吡酯：每片 100 mg，NDC 50458-641-65，60 片瓶装；黄色圆形无刻痕包衣片，OMN / 100。",
    "notice": "此图只对应所引美国 100 mg、60 片瓶装面板，不代表其他规格、可撒服胶囊、通用药、缓释制剂、口服液、复方、其他市场或实时库存，不用于鉴定真伪，也不授权分片、加减量、换药或停药。",
    "source": {
      "id": "src_e3e6c3d2c730579e",
      "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593",
      "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": "TOPAMAX 说明书放大阅读：分清每片/每粒 mg、普通片与可撒服胶囊、眼部与代谢风险",
      "en": "TOPAMAX enlarged label: mg per tablet/capsule, conventional versus sprinkle forms, eye and metabolic risks"
    },
    "summary": {
      "zh": "25、50、100、200 mg 是每片普通片的托吡酯含量；15、25 mg 是每粒可撒服胶囊的含量；60 Tablets/Capsules 是整瓶数量。这些数字都不是个人用量。普通片须整片吞服、不能咀嚼；可撒服胶囊可整粒吞服，也可打开后把全部小球撒在一茶匙软食上立即吞下，不能咀嚼；混合物不能留到以后。",
      "en": "The 25, 50, 100 and 200 mg figures are topiramate amounts per conventional tablet; 15 and 25 mg are amounts per sprinkle capsule; 60 Tablets/Capsules is the bottle count. None is an individual amount. Tablets are swallowed whole and not chewed. Sprinkle capsules may be swallowed whole or opened so all pellets are placed on one teaspoon of soft food, swallowed immediately, not chewed and not stored."
    },
    "checks": [
      {
        "zh": "新发视力下降、视物异常或眼痛可能提示需要立即处理的眼部问题；说明书警示继发性闭角型青光眼若不治疗可造成永久视力丧失。不要等待网页判断，也不要自行决定停药速度，立即联系医疗专业人员。",
        "en": "New reduced vision, visual disturbance or eye pain may signal an urgent eye problem. The label warns that untreated secondary angle-closure glaucoma can cause permanent visual loss. Do not wait for a website judgment or choose a stopping speed yourself; seek prompt professional care."
      },
      {
        "zh": "托吡酯可降低血清碳酸氢盐并引起代谢性酸中毒；肾病、严重呼吸问题、腹泻、酮症饮食或其他导致酸中毒的药物会叠加风险。说明书建议基线和定期测量碳酸氢盐，网页不能代替化验或据此给出加减量。",
        "en": "Topiramate can lower serum bicarbonate and cause metabolic acidosis. Kidney disease, severe respiratory disorders, diarrhoea, a ketogenic diet or other acidosis-producing medicines can add risk. The label recommends baseline and periodic bicarbonate measurement; the site cannot replace tests or adjust a dose from them."
      },
      {
        "zh": "思维、注意、记忆、语言、反应速度、嗜睡、眩晕和协调问题会影响驾驶并增加老人跌倒风险；请把实际变化、跌倒史、肾功能、完整药单和准确药盒一起交给医生或药师核对。",
        "en": "Changes in thinking, attention, memory, speech, reaction speed, sleepiness, dizziness or coordination may affect driving and increase fall risk in older adults. Have the actual changes, fall history, kidney function, complete medicine list and exact pack reviewed together."
      },
      {
        "zh": "与丙戊酸（如 DEPAKOTE）同用可关联高氨血症/脑病和低体温；与其他碳酸酐酶抑制剂、导致酸中毒的药物或酮症饮食同在时还要核对肾结石风险。不能靠错开时间自行解决，也不能按共同抗癫痫用途或 mg 一比一换药。",
        "en": "Concomitant valproate (such as DEPAKOTE) is associated with hyperammonaemia/encephalopathy and hypothermia. Other carbonic-anhydrase inhibitors, acidosis-producing medicines or a ketogenic diet also require kidney-stone risk review. Self-separating times does not solve these issues, and a shared antiseizure use or milligram figure does not permit one-for-one switching."
      },
      {
        "zh": "不要突然停药或自行快速减量；突然停用抗癫痫药可能增加发作，包括持续状态。可撒服胶囊与普通片也不能凭相同 mg 自行互换，个人改变必须由负责治疗的专业人员决定。",
        "en": "Do not abruptly stop or rapidly self-reduce. Sudden antiseizure-medicine withdrawal can increase seizures, including status epilepticus. Sprinkle capsules and tablets also must not be self-interchanged from matching milligrams; individual changes require the treating professional."
      },
      {
        "zh": "妊娠或可能怀孕时，胎儿风险与激素避孕效果变化需要尽早专业讨论；严重皮疹、水疱脱皮、面舌喉肿胀、吞咽或呼吸困难属于需要迅速处理的警讯。",
        "en": "Pregnancy or possible pregnancy requires early professional discussion of fetal risk and possible changes in hormonal-contraceptive effectiveness. Severe rash, blistering or peeling, face/tongue/throat swelling, or trouble swallowing or breathing are warning signs needing prompt care."
      }
    ],
    "source": {
      "id": "src_e3e6c3d2c730579e",
      "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593",
      "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：四条实验线索不能生成个人选药、换药或联合方案",
      "en": "Mechanism reading: four experimental clues cannot generate personal selection, switching or combination plans"
    },
    "summary": {
      "zh": "当前标签说明 TOPAMAX 抗癫痫和预防偏头痛作用的精确机制尚不清楚。临床前研究提示四条可能线索：阻断电压依赖性钠通道、增强部分 GABA-A 受体活动、拮抗 AMPA/海人酸型谷氨酸受体，以及抑制碳酸酐酶 II 与 IV。这些线索不能单独决定个人剂量、证明联合安全或把另一种药按 mg 换算过来。",
      "en": "The current label states that the precise mechanisms of TOPAMAX for antiseizure and migraine-prevention effects are unknown. Preclinical evidence suggests four possible contributors: blocking voltage-dependent sodium channels, augmenting activity at some GABA-A receptors, antagonising AMPA/kainate glutamate receptors, and inhibiting carbonic anhydrase II and IV. These clues cannot independently select an individual dose, prove combination safety or convert another medicine by milligrams."
    },
    "checks": [
      {
        "zh": "拉莫三嗪、卡马西平、拉考沙胺等也可能涉及钠通道，但分子、剂型、适应症、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": "Lamotrigine, carbamazepine and lacosamide may also involve sodium channels, but molecules, forms, indications, pharmacokinetics and interactions differ. A shared mechanism term does not permit self-substitution or combination."
      },
      {
        "zh": "碳酸酐酶抑制线索能帮助理解酸中毒与结石风险，却不能让读者根据喝水量、化验或症状自行改药。",
        "en": "The carbonic-anhydrase clue helps explain acidosis and stone risk, but it does not let a reader change medicine from fluid intake, tests or symptoms."
      },
      {
        "zh": "是否适合老人、是否需要基因检测、能否从另一种抗癫痫药转换，都必须回到诊断、实际处方、肾功能、妊娠情况、完整药单与专业评估。",
        "en": "Older-adult suitability, genetic testing and switching from another antiseizure medicine require diagnosis, the actual prescription, kidney function, pregnancy context, complete medicine list and professional assessment."
      }
    ],
    "source": {
      "id": "src_e3e6c3d2c730579e",
      "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593",
      "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": "TOPAMAX",
      "generic": "托吡酯片／可撒服胶囊",
      "dosageFormClass": "TOPAMAX 托吡酯包衣口服片（每片 25、50、100、200 mg）与可撒服胶囊（每粒 15、25 mg）。普通片须整片吞服且不能咀嚼；可撒服胶囊可整粒吞服，或把全部内容物撒在一茶匙软食上立即吞下，不能咀嚼，也不能留到以后。"
    },
    "labelSource": {
      "id": "src_e3e6c3d2c730579e",
      "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593",
      "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_e3e6c3d2c730579e",
          "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593",
          "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": "TOPAMAX 是托吡酯普通片和可撒服胶囊的美国品牌档案。25、50、100、200 mg 是每片含量，15、25 mg 是每粒含量，60 Tablets/Capsules 是整瓶数量，都不是应该吃几片或几粒。老人和多药使用者要优先核对思维与反应变慢、眩晕和跌倒、新发视力问题或眼痛、碳酸氢盐与代谢性酸中毒、肾结石、丙戊酸等相互作用，以及突然停药导致发作加重的风险；网页不生成个人剂量或换停方案。",
    "history": "TOPAMAX 托吡酯片 NDA 020505 于 1996-12-24 获批。当前 DailyMed SPL v30 于 2026-03 修订，包含四种口服片、两种可撒服胶囊、患者用药指南、包装面板以及眼部、代谢、认知、妊娠、过敏和停药风险。",
    "sourceDocuments": [
      {
        "id": "src_e3e6c3d2c730579e",
        "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593",
        "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_79ee9db25ef88656",
        "label": "DailyMed（NLM）：TOPAMAX 托吡酯 FDA 批准患者用药指南",
        "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=21628112-0c47-11df-95b3-498d55d89593",
        "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_e7a7dd0d4191dbe9",
        "label": "FDA：TOPAMAX 托吡酯 NDA 020505 审评记录，记载 1996-12-24 批准",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax_clinphrmr.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"
      },
      {
        "id": "src_d68e97cb1529e5ef",
        "label": "FDA：TOPAMAX 托吡酯片 NDA 020505 与可撒服胶囊 NDA 020844 补充批准函（2012）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020505Orig1s050%2C020844Orig1s041ltr.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"
      }
    ],
    "applicationNumber": "NDA 020505 / NDA 020844",
    "approvalTimeline": [
      {
        "date": "1996-12-24",
        "title": {
          "zh": "TOPAMAX 托吡酯片美国初始批准",
          "en": "Initial U.S. approval of TOPAMAX topiramate tablets"
        },
        "detail": {
          "zh": "FDA 审评记录明确记载 NDA 020505 于该日获批。",
          "en": "The FDA review record states that NDA 020505 was approved on this date."
        },
        "source": {
          "id": "src_e7a7dd0d4191dbe9",
          "label": "FDA：TOPAMAX 托吡酯 NDA 020505 审评记录，记载 1996-12-24 批准",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax_clinphrmr.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"
        }
      },
      {
        "date": "2026-03-12",
        "title": {
          "zh": "当前品牌说明书生效日期",
          "en": "Current brand-label effective date"
        },
        "detail": {
          "zh": "DailyMed SPL v30 汇总口服片与可撒服胶囊，并更新禁忌、严重过敏/皮肤反应及安全阅读内容。",
          "en": "DailyMed SPL v30 covers tablets and sprinkle capsules and updates contraindication, severe hypersensitivity/skin-reaction and safety reading."
        },
        "source": {
          "id": "src_e3e6c3d2c730579e",
          "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593",
          "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 020505 四种普通片和 NDA 020844 两种可撒服胶囊；不代表实时供应。",
          "en": "This page displays four NDA 020505 tablets and two NDA 020844 sprinkle capsules; 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、包装和供应尚未逐市场确认",
          "en": "Local brand, approval, reference, pack and supply are not yet established market by market"
        },
        "detail": {
          "zh": "不从美国 TOPAMAX 商品名、NDA、NDC 或包装外观推定其他市场状态。",
          "en": "No other-market status is inferred from the U.S. TOPAMAX name, NDA, NDC or package appearance."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "25、50、100、200 mg 是应该吃几片吗？",
          "en": "Do 25, 50, 100 and 200 mg tell me how many tablets to take?"
        },
        "answer": {
          "zh": "不是。这些是每片含量；60 Tablets 是瓶中总片数。个人片数、时间和逐步调整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 bottle count. Individual tablet count, timing and titration come only from the exact prescription and treating professional."
        }
      },
      {
        "question": {
          "zh": "普通片能掰开或咀嚼吗？",
          "en": "Can the conventional tablet be split or chewed?"
        },
        "answer": {
          "zh": "当前片剂为无刻痕包衣片，患者指南要求整片吞服并明确不能咀嚼。网页不把数学上的一半当作可分片许可。",
          "en": "The current tablets are unscored coated tablets, and the Medication Guide says to swallow them whole and not chew. The site does not treat arithmetic half as permission to split."
        }
      },
      {
        "question": {
          "zh": "可撒服胶囊可以怎样阅读？",
          "en": "How should the sprinkle-capsule instructions be read?"
        },
        "answer": {
          "zh": "它是不同剂型。说明书允许整粒吞服，或打开后把全部小球撒在一茶匙软食上立即吞下；不能咀嚼，也不能把混合物留到以后。具体是否适合个人仍以处方和专业确认准。",
          "en": "It is a different dosage form. The label permits swallowing it whole or opening it and placing all pellets on one teaspoon of soft food for immediate swallowing. Do not chew or store the mixture. Individual suitability still depends on the prescription and professional confirmation."
        }
      }
    ],
    "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/topamax-topiramate/",
    "en": "https://origindrug.com/en/drugs/topamax-topiramate/"
  },
  "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."
  ]
}