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verified 29 Aug 2026)" }, "dosageForm": { "zh": "CREXONT 卡比多巴/左旋多巴缓释口服胶囊", "en": "CREXONT carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-969-23", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 70 mg＋左旋多巴 280 mg；120 粒瓶装纸盒", "en": "Carbidopa 70 mg plus levodopa 280 mg per capsule; carton containing a 120-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 70, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量或换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose or conversion" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 280, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量或与其他制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation" } } ], "concentration": null, "container": { "typeCode": "bottle_in_carton", "typeLabel": { "zh": "纸盒内瓶装", "en": "bottle in carton" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊体、紫色胶囊帽", "en": "white body and purple cap" }, "shape": { "zh": "两节缓释胶囊；不能由外形推定可分半、咀嚼或压碎", "en": "two-piece extended-release capsule; form does not imply permission to halve, chew or crush" }, "imprint": "IPX203 / 280", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 70/280 mg、NDC 64896-969-23、120 粒包装美国公开标签结构化文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-crexont-carbidopa-87-5mg-levodopa-350mg-120-capsule-carton-ndc-6489697016", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-05-29 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CREXONT 卡比多巴/左旋多巴缓释口服胶囊", "en": "CREXONT carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-970-16", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 87.5 mg＋左旋多巴 350 mg；120 粒瓶装纸盒", "en": "Carbidopa 87.5 mg plus levodopa 350 mg per capsule; carton containing a 120-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=crexont-carbidopa-and-levodopa-extended-release-ca-6.jpg&setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 87.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量或换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose or conversion" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 350, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量或与其他制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation" } } ], "concentration": null, "container": { "typeCode": "bottle_in_carton", "typeLabel": { "zh": "纸盒内瓶装", "en": "bottle in carton" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊体、中橙色胶囊帽", "en": "white body and medium-orange cap" }, "shape": { "zh": "两节缓释胶囊；不能由外形推定可分半、咀嚼或压碎", "en": "two-piece extended-release capsule; form does not imply permission to halve, chew or crush" }, "imprint": "IPX203 / 350", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 87.5/350 mg、NDC 64896-970-16、120 粒包装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-crexont-carbidopa-87-5mg-levodopa-350mg-120-capsule-carton-ndc-6489697023", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-05-29 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CREXONT 卡比多巴/左旋多巴缓释口服胶囊", "en": "CREXONT carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-970-23", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 87.5 mg＋左旋多巴 350 mg；120 粒瓶装纸盒", "en": "Carbidopa 87.5 mg plus levodopa 350 mg per capsule; carton containing a 120-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 87.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量或换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose or conversion" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 350, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量或与其他制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation" } } ], "concentration": null, "container": { "typeCode": "bottle_in_carton", "typeLabel": { "zh": "纸盒内瓶装", "en": "bottle in carton" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊体、中橙色胶囊帽", "en": "white body and medium-orange cap" }, "shape": { "zh": "两节缓释胶囊；不能由外形推定可分半、咀嚼或压碎", "en": "two-piece extended-release capsule; form does not imply permission to halve, chew or crush" }, "imprint": "IPX203 / 350", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 87.5/350 mg、NDC 64896-970-23、120 粒包装美国公开标签结构化文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-crexont-carbidopa-35mg-levodopa-140mg-120-capsule-carton-ndc-6489696716", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=crexont-carbidopa-and-levodopa-extended-release-ca-3.jpg&setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "alt": "DailyMed 当前 CREXONT 35/140 mg、NDC 64896-967-16、120 粒纸盒标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（SPL v19，2026-05-29 更新）", "presentation": "CREXONT 每粒卡比多巴 35 mg / 左旋多巴 140 mg，NDC 64896-967-16，120 粒瓶装纸盒。", "notice": "此图只对应 CREXONT 35/140 mg、NDC 64896-967-16、120 粒纸盒；不能代表其他规格、-23 NDC、RYTARY、SINEMET、STALEVO、其他市场或仿制药，不用于鉴定真伪，也不证明实时库存或可替代性。", "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 35/140 mg、NDC 64896-967-16、120 粒包装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": { "status": "partial_exact_visual_coverage", "title": { "zh": "八个包装身份中只有四个有精确官方展示面板", "en": "Only four of eight package identities have exact official display panels" }, "summary": { "zh": "当前 SPL 为四个 -16 NDC 提供一一对应的 120 粒纸盒面板；四个 -23 NDC 只有结构化文字身份。网页不把相同规格的 -16 图片借给 -23 包装。", "en": "The current SPL provides exact 120-capsule carton panels for the four -16 NDCs. The four -23 NDCs have structured text identity only. The site does not lend an image from a same-strength -16 pack to a -23 pack." }, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v19，2026-05-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CREXONT 说明书放大阅读：缓释胶囊、苹果酱给药与换算边界", "en": "CREXONT label reading: extended release, applesauce administration and conversion boundaries" }, "summary": { "zh": "每组双数字是同一粒胶囊内卡比多巴与左旋多巴的标签量，不是两粒药。打开胶囊撒在苹果酱上只适用于标签所写的吞咽困难场景，而且必须使用全部内容物；任何从 SINEMET、RYTARY 或其他产品的转换都由开方团队管理。", "en": "Each paired strength states carbidopa and levodopa in one capsule, not two medicines. Opening onto applesauce is limited to the labelled swallowing-difficulty method and requires the entire contents. Any transition from SINEMET, RYTARY or another product is prescriber-managed." }, "checks": [ { "zh": "整粒吞咽；不要咀嚼、分开、压碎。吞咽困难时，标签允许打开一整粒，把全部内容物撒在 1–2 汤匙苹果酱上立即吞下且不咀嚼；不能保存或只取一部分。不要与酒精同服。", "en": "Swallow whole; do not chew, divide or crush. For swallowing difficulty, the label allows opening one complete capsule, sprinkling all contents on 1–2 tablespoons of applesauce and swallowing immediately without chewing. Do not store or take only part. Do not take with alcohol." }, { "zh": "即释卡比多巴/左旋多巴不能按 1:1 自行替换。标签含专业转换表，也提到从 RYTARY 转换时按左旋多巴成分约 1:1 的临床起始信息，但这不是消费者换算规则。不要抄表、自算胶囊数、混用旧药或隔天轮换。", "en": "Immediate-release carbidopa/levodopa is not self-substitutable 1:1. The label contains professional conversion tables and clinician-facing information describing an approximately 1:1 levodopa-component transition from RYTARY, but this is not a consumer conversion rule. Do not copy tables, calculate capsules, combine old supplies or alternate products by day." }, { "zh": "与其他左旋多巴产品联用未被研究；停用 COMT 抑制剂也可能改变治疗需要。不要自行增减、叠加、停换药或快速停用。快速减量或停药后出现高热、明显僵硬、意识改变或自主神经不稳时，立即使用当地急救服务。", "en": "Use with other levodopa products has not been studied, and stopping a COMT inhibitor may alter treatment needs. Do not self-add, reduce, combine, switch or rapidly stop. Use local emergency services for high fever, marked rigidity, altered consciousness or autonomic instability after a rapid reduction or withdrawal." }, { "zh": "突然入睡、明显嗜睡、头晕、幻觉、精神症状、异常冲动或新的不自主动作需尽快联系治疗团队；驾驶或操作机器前尤其要按专业意见评估。家属或照护者可能更早观察到变化。", "en": "Sudden sleep, marked somnolence, dizziness, hallucinations, psychotic symptoms, intense urges or new involuntary movements require prompt contact with the treating team. Professional assessment is especially important before driving or operating machinery. Family or carers may notice changes earlier." }, { "zh": "2026 年标签加入维生素 B6 缺乏与相关癫痫发作警示。抑郁、意识混乱、口角炎、舌炎、皮炎、贫血、神经病变或癫痫发作需要医疗评估；抽搐、意识丧失或持续发作时立即急救。不要依据网页自行验血、补充大剂量 B6 或停换药。", "en": "The 2026 label added vitamin B6 deficiency and associated seizure warnings. Depression, confusion, cheilosis, glossitis, dermatitis, anaemia, neuropathy or seizures needs clinical assessment; use emergency care for convulsions, loss of consciousness or ongoing seizures. Do not arrange tests, take high-dose B6 or stop/switch treatment from the site." }, { "zh": "非选择性 MAO 抑制剂及停药不足两周属于禁忌边界；铁盐或含铁复合维生素可能降低生物利用度，多巴胺 D2 拮抗剂（包括甲氧氯普胺）可能降低疗效。请把处方药、非处方药、补充剂和酒精放在同一张清单交给药师核对。", "en": "Nonselective MAO inhibitors, including use within the previous two weeks, form a contraindication boundary. Iron salts or iron-containing multivitamins may reduce bioavailability, and dopamine D2 antagonists including metoclopramide may reduce effectiveness. Put prescriptions, non-prescription medicines, supplements and alcohol on one list for pharmacist review." }, { "zh": "高脂高热量餐可能使左旋多巴峰值延迟约两小时，高蛋白餐可能降低吸收。不要自行通过跳餐、极端改变蛋白质、错开时间或改胶囊数来补偿，让治疗团队结合日常饮食与症状记录评估。", "en": "A high-fat, high-calorie meal may delay the levodopa peak by about two hours, and a high-protein meal may reduce absorption. Do not compensate by skipping meals, radically changing protein, rescheduling or changing capsule count; have the treating team review the usual diet and symptom record." }, { "zh": "标签还涉及心血管事件、既往消化性溃疡出血、青光眼眼压与妊娠动物数据。胸痛、严重气促、昏厥、呕血或黑便、急性视力变化等严重表现应使用当地紧急医疗渠道。", "en": "The label also addresses cardiovascular events, upper gastrointestinal bleeding with prior peptic ulcer, intraocular pressure in glaucoma and pregnancy animal data. Use local urgent or emergency care for chest pain, severe breathlessness, fainting, vomiting blood or black stools, acute visual change or another serious presentation." } ], "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v19，2026-05-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分与特定缓释设计：共同成分不等于同一产品", "en": "Two ingredients and a specific extended-release design: shared ingredients do not make the same product" }, "summary": { "zh": "左旋多巴进入脑内并转化为多巴胺；卡比多巴主要减少外周左旋多巴分解。CREXONT 采用自己的即释/缓释颗粒设计以形成特定释放曲线。这个机制解释双成分与缓释身份，但不能证明与 RYTARY 或其他制剂等效，也不能生成个人转换或胶囊数。", "en": "Levodopa reaches the brain and is converted to dopamine; carbidopa mainly reduces peripheral levodopa breakdown. CREXONT uses its own immediate- and extended-release components to create a specific release profile. This explains its two ingredients and extended-release identity but cannot establish equivalence with RYTARY or another formulation or generate an individual conversion or capsule count." }, "checks": [ { "zh": "CREXONT、RYTARY、SINEMET、Sinemet CR 和 STALEVO 的释放结构或成分组合不同，共享卡比多巴/左旋多巴不能使每粒/片 mg 自动等效。", "en": "CREXONT, RYTARY, SINEMET, Sinemet CR and STALEVO differ in release design or ingredient combination. Shared carbidopa/levodopa does not make per-capsule or per-tablet milligrams automatically equivalent." }, { "zh": "苹果酱方式保留的是整粒内容物，不是把颗粒碾碎；咀嚼、压碎、只取部分或保存混合物越过标签边界。", "en": "The applesauce method preserves the entire capsule contents; it does not permit grinding pellets. Chewing, crushing, taking part or storing the mixture crosses the label boundary." }, { "zh": "机理不能判断个人何时换制剂、如何处理漏服、需要什么监测或是否适合某一规格；这些必须结合准确药盒、症状记录与完整药单由治疗团队评估。", "en": "Mechanism cannot decide when an individual should change formulation, respond to missed use, receive monitoring or use a strength. The treating team must review the exact pack, symptom record and complete medicine list." } ], "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v19，2026-05-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CREXONT", "generic": "卡比多巴/左旋多巴缓释胶囊", "dosageFormClass": "卡比多巴/左旋多巴固定两成分缓释口服胶囊：35/140、52.5/210、70/280、87.5/350 mg；每组数字属于同一粒胶囊内两种成分；CREXONT 与 RYTARY、SINEMET、STALEVO 等是不同产品，不能把标签数字当成个人换算表" }, "labelSource": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v19，2026-05-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v19，2026-05-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "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." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：CREXONT，NDA 217186，四个规格均为处方 RLD；87.5/350 mg 同时为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "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." } }, { "source": { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：CREXONT NDA 217186 申请、标签与补充申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2026-crexont-carbidopa-levodopa-vitamin-b6-seizure-safety-communication", "issuedAt": "2026-03-20", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：CREXONT 等含卡比多巴/左旋多巴产品的维生素 B6 缺乏与癫痫发作警告", "en": "FDA Drug Safety Communication: vitamin B6 deficiency and seizures warning for CREXONT and other carbidopa/levodopa products" }, "summary": { "zh": "FDA 于 2026-03-20 发布安全通讯，要求所有含卡比多巴/左旋多巴产品加入维生素 B6 缺乏及相关癫痫发作警告；CREXONT 当前标签已纳入这项警示。该通讯不能判断个人是否缺乏、是否需要检测或补充，也不支持自行停药、换成 RYTARY／SINEMET／STALEVO、改变胶囊数或调整时间。癫痫发作、意识丧失或持续抽搐时立即使用当地急救服务；其他疑似表现请让开方团队结合准确产品和完整药单评估。", "en": "On 20 Mar 2026, FDA issued a Drug Safety Communication requiring every carbidopa/levodopa product to add a warning about vitamin B6 deficiency and associated seizures; the current CREXONT label includes this warning. It cannot determine an individual's deficiency, testing or supplementation need and does not support self-stopping, switching to RYTARY, SINEMET or STALEVO, changing capsule count or altering timing. Use local emergency services for a seizure, loss of consciousness or ongoing convulsions; have the prescribing team assess other suspected symptoms using the exact product and complete medicine list." }, "source": { "id": "src_8e24316f2d733113", "label": "FDA：2026-03-20 含卡比多巴/左旋多巴产品维生素 B6 缺乏与癫痫发作药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-warning-about-vitamin-b6-deficiency-and-associated-seizures-drug-products-containing", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "CREXONT 是卡比多巴/左旋多巴缓释胶囊，但不是 RYTARY、SINEMET 或 STALEVO 的另一种包装。现行标签明确：即释卡比多巴/左旋多巴不能按 1:1 自行替换为 CREXONT；与其他左旋多巴产品的联用也未被研究。吞咽困难时可把一整粒的全部内容物撒在 1–2 汤匙苹果酱上立即吞下且不咀嚼；不能只取一部分、保存、压碎或饮酒同服。网页不提供个人转换表、胶囊数、间隔、漏服或停药方案。", "history": "FDA 于 2024-08-07 批准 CREXONT（IPX203）NDA 217186 的四个缓释胶囊规格。2026 年 S-008 补充申请更新吞咽困难者的苹果酱给药文字，S-011 及 FDA 类别安全通讯加入维生素 B6 缺乏与相关癫痫发作警示。当前 DailyMed SPL v19 于 2026-05-29 更新。标签所列 Initial U.S. Approval: 1975 指卡比多巴/左旋多巴组合历史，不是 CREXONT 品牌在 1975 年获批。", "sourceDocuments": [ { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v19，2026-05-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：CREXONT，NDA 217186，四个规格均为处方 RLD；87.5/350 mg 同时为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：CREXONT NDA 217186 申请、标签与补充申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_86201a2d9211e9a1", "label": "FDA：CREXONT NDA 217186 原始批准记录（四个规格；2024-08-07）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/217186Orig1s000Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_584d8b322b235466", "label": "FDA：CREXONT NDA 217186/S-008 吞咽困难者苹果酱给药标签补充批准函（2026）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217186Orig1s008ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_2cf7a7a8ce9a5b6c", "label": "FDA：CREXONT NDA 217186/S-011 维生素 B6 缺乏与相关癫痫发作标签补充批准函（2026）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217186Orig1s011ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_8e24316f2d733113", "label": "FDA：2026-03-20 含卡比多巴/左旋多巴产品维生素 B6 缺乏与癫痫发作药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-warning-about-vitamin-b6-deficiency-and-associated-seizures-drug-products-containing", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } ], "applicationNumber": "FDA NDA 217186（CREXONT / carbidopa and levodopa extended-release capsules）", "approvalTimeline": [ { "date": "2024-08-07", "title": { "zh": "CREXONT 四个缓释胶囊规格获批", "en": "Four CREXONT extended-release capsule strengths approved" }, "detail": { "zh": "FDA 原始批准记录确认 NDA 217186 的 35/140、52.5/210、70/280 与 87.5/350 mg 四规格；当前 Orange Book 均列处方 RLD。", "en": "The FDA original approval record confirms NDA 217186 strengths 35/140, 52.5/210, 70/280 and 87.5/350 mg; current Orange Book data list all four as prescription RLD products." }, "source": { "id": "src_86201a2d9211e9a1", "label": "FDA：CREXONT NDA 217186 原始批准记录（四个规格；2024-08-07）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/217186Orig1s000Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-03-20", "title": { "zh": "FDA 发布维生素 B6 缺乏与癫痫发作安全通讯", "en": "FDA issued vitamin B6 deficiency and seizure safety communication" }, "detail": { "zh": "通讯覆盖含卡比多巴/左旋多巴产品，不判断个人是否缺乏、是否需补充或是否应停药。", "en": "The communication covers carbidopa/levodopa products and does not determine individual deficiency, supplementation or stopping." }, "source": { "id": "src_8e24316f2d733113", "label": "FDA：2026-03-20 含卡比多巴/左旋多巴产品维生素 B6 缺乏与癫痫发作药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-warning-about-vitamin-b6-deficiency-and-associated-seizures-drug-products-containing", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "date": "2026-05-29", "title": { "zh": "当前 DailyMed 页面更新", "en": "Current DailyMed page updated" }, "detail": { "zh": "SPL v19 列四规格、八个结构化包装 NDC、四个精确纸盒面板、苹果酱规则及 B6 安全信息。", "en": "SPL v19 lists four strengths, eight structured package NDCs, four exact carton panels, the applesauce method and B6 safety information." }, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v19，2026-05-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-29", "title": { "zh": "Orange Book 身份核验", "en": "Orange Book identity reviewed" }, "detail": { "zh": "四规格均为处方 RLD，87.5/350 mg 同时为 RS。", "en": "All four strengths are prescription RLD products; 87.5/350 mg is also the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：CREXONT，NDA 217186，四个规格均为处方 RLD；87.5/350 mg 同时为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "四个处方 RLD；87.5/350 mg 同时为 RS；当前 SPL 列八个包装 NDC", "en": "Four prescription RLD products; 87.5/350 mg is also RS; current SPL lists eight package NDCs" }, "detail": { "zh": "四个 -16 NDC 有精确纸盒面板；四个 -23 NDC 保持文字身份。监管记录不等于库存、购买资格或个人可替换性。", "en": "Four -16 NDCs have exact carton panels; four -23 NDCs retain text identity. Regulatory records do not establish stock, purchasing eligibility or individual interchangeability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、共同成分、颜色或双数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients, colours or paired numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "CREXONT 胶囊能打开只吃一半吗？", "en": "Can a CREXONT capsule be opened and half taken?" }, "answer": { "zh": "不能。吞咽困难时可打开，但必须把一整粒的全部内容物撒在 1–2 汤匙苹果酱上立即吞下且不咀嚼；不能分半、估算颗粒、压碎或保存。", "en": "No. For swallowing difficulty it may be opened only when all contents of one complete capsule are sprinkled on 1–2 tablespoons of applesauce and swallowed immediately without chewing. Do not halve, estimate pellets, crush or store." } }, { "question": { "zh": "CREXONT、RYTARY 和 SINEMET 能按左旋多巴毫克直接换吗？", "en": "Can CREXONT, RYTARY and SINEMET be switched directly by levodopa milligrams?" }, "answer": { "zh": "不能自行换算。标签中的转换信息是专业人员管理治疗的起点，不是消费者计算器；请携带所有药盒、实际处方和症状记录由开方团队核对。", "en": "Do not self-convert. Label transition information is a clinician-managed starting point, not a consumer calculator. Take every pack, the actual prescription and symptom record to the prescribing team." } }, { "question": { "zh": "为什么八个 NDC 只有四张图？", "en": "Why do eight NDCs have only four images?" }, "answer": { "zh": "当前 SPL 只为四个 -16 NDC 提供精确纸盒面板；四个 -23 NDC 只有结构化文字身份。网页不重复借用可能造成误认的图片。", "en": "The current SPL provides exact carton panels only for the four -16 NDCs. The four -23 NDCs have structured text identity only, so the site does not reuse potentially misleading images." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity", "family-medicine-list-for-pharmacist" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/crexont/", "en": "https://origindrug.com/en/drugs/crexont/" }, "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." ] }