{ "id": "celexa", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "CELEXA", "generic": "西酞普兰", "aliases": [ "Celexa", "citalopram", "citalopram hydrobromide", "西酞普兰", "氢溴酸西酞普兰", "西酞普兰片", "NDA 020822", "0456-4010-01", "0456-4020-01", "0456-4020-63", "0456-4040-01", "0456-4040-63", "FP 10 mg", "F P 20 mg", "F P 40 mg" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DailyMed 当前 CELEXA 西酞普兰口服片标签（SPL v40；2023-10-09 生效；NDA 020822）", "dosageFormClass": "西酞普兰口服薄膜衣片：每片 10 mg、20 mg 或 40 mg；分别记录三种 100 片瓶装和两种 100 片单位剂量纸盒身份", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998", "archiveSponsorText": "Allergan, Inc.（DailyMed 标签 packager；包装面板列 AbbVie）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "LEXAPRO", "escitalopram", "艾司西酞普兰", "citalopram oral solution", "西酞普兰口服液", "generic citalopram" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-celexa-citalopram-10mg-100-bottle-ndc-0456401001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v40；2023-10-09 生效）", "en": "Current U.S. DailyMed public label (SPL v40; 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100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=celexa-03.jpg&setid=4259d9b1-de34-43a4-85a8-41dd214e9177&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西酞普兰（以氢溴酸西酞普兰提供）", "en": "citalopram (supplied as citalopram hydrobromide)" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、掰片或停换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting or stopping/switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形薄膜衣片；有刻痕，但刻痕只作外观核对，不是自行掰片许可", "en": "oval film-coated tablet; 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scored, but the score is an appearance clue and not permission to self-split" }, "imprint": "F | P / 20 mg", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 20 mg、NDC 0456-4020-63、100 片单位剂量纸盒（10 包×10 片）当前美国标签身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-celexa-citalopram-40mg-100-bottle-ndc-0456404001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v40；2023-10-09 生效）", "en": "Current U.S. DailyMed public label (SPL v40; 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scored, but the score is an appearance clue and not permission to self-split" }, "imprint": "F | P / 40 mg", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 40 mg、NDC 0456-4040-01、100 片瓶装当前美国标签身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-celexa-citalopram-40mg-100-unit-dose-carton-ndc-0456404063", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v40；2023-10-09 生效）", "en": "Current U.S. DailyMed public label (SPL v40; effective 9 Oct 2023)" }, "dosageForm": { "zh": "CELEXA 西酞普兰口服薄膜衣片", "en": "CELEXA citalopram oral film-coated tablet" }, "route": { "zh": "口服（准确片剂产品身份字段）", "en": "oral (exact tablet-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-4040-63; inner blister NDC 0456-4040-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于西酞普兰 40 mg；100 片单位剂量纸盒（10 包×10 片）", "en": "Equivalent to citalopram 40 mg per tablet; 100-tablet unit-dose carton (10 packs × 10 tablets)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西酞普兰（以氢溴酸西酞普兰提供）", "en": "citalopram (supplied as citalopram hydrobromide)" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、掰片或停换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting or stopping/switching instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单位剂量纸盒", "en": "unit-dose carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 10, "unit": { "zh": "片/内层泡罩", "en": "tablets per inner blister" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/单位剂量纸盒", "en": "tablets per unit-dose carton" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片；有刻痕，但刻痕只作外观核对，不是自行掰片许可", "en": "oval film-coated tablet; scored, but the score is an appearance clue and not permission to self-split" }, "imprint": "F | P / 40 mg", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 40 mg、NDC 0456-4040-63、100 片单位剂量纸盒（10 包×10 片）当前美国标签身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-celexa-citalopram-20mg-100-bottle-ndc-0456402001", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=celexa-03.jpg&setid=4259d9b1-de34-43a4-85a8-41dd214e9177&type=img", "alt": "CELEXA 西酞普兰 20 mg、NDC 0456-4020-01、100 片瓶装在美国 DailyMed 当前标签中的主展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v40（2023-10-09 生效）", "presentation": "CELEXA 20 mg、NDC 0456-4020-01、100 片瓶装主展示面", "notice": "此图只对应当前美国标签中的 20 mg、100 片瓶装面板，用于核对品牌、通用名、每片标示量、NDC 与包装数量；不用于鉴定真伪，也不证明另一规格、剂型、市场、库存、购买资格或可替代性。", "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CELEXA 说明书放大阅读：先分清每片 mg、刻痕、老年与 CYP2C19 边界", "en": "CELEXA label reading: separate mg per tablet, score marks, older-age and CYP2C19 boundaries" }, "summary": { "zh": "当前美国标签分别列出 10、20、40 mg 片，并包含 Medication Guide、黑框警示、QT 延长、血清素综合征、出血、低钠和停药反应等内容。本模块帮助普通读者把准确产品与需要专业复核的问题带回药师或开方团队；不提供个人片数、加减量、掰片、停药或换药方案。", "en": "The current U.S. label separately lists 10, 20 and 40 mg tablets and includes a Medication Guide, boxed warning, QT prolongation, serotonin syndrome, bleeding, hyponatraemia and discontinuation information. This module helps ordinary readers take the exact product and review questions to a pharmacist or prescriber; it gives no personal tablet count, dose change, splitting, stopping or switching plan." }, "checks": [ { "zh": "10、20、40 mg 是每片所含西酞普兰的标签标示量，不是一次吃几片或一天吃几次。20 mg 与 40 mg 片有刻痕、10 mg 片无刻痕；刻痕是产品外观线索，不等于任何人都可以自行掰半，也不能据此用多片小规格替代大规格。", "en": "10, 20 and 40 mg are the labelled citalopram amounts per tablet, not tablets per dose or doses per day. The 20 and 40 mg tablets are scored and the 10 mg tablet is unscored. A score is a product-appearance clue, not permission for anyone to self-split or replace a larger strength with several smaller tablets." }, { "zh": "标签单独提示 60 岁以上、肝功能受损、CYP2C19 慢代谢者或使用西咪替丁/其他 CYP2C19 抑制剂的人需要更严格的专业剂量边界。标签提到 CYP2C19 不等于所有人都需要做全基因筛查；网页也不根据基因结果、年龄或药名替个人选剂量。", "en": "The label sets a stricter professional dosing boundary for people over 60, hepatic impairment, CYP2C19 poor metabolisers or use of cimetidine/another CYP2C19 inhibitor. Mention of CYP2C19 does not mean everyone needs whole-genome screening, and the site does not select an individual's dose from genes, age or a medicine name." }, { "zh": "心律问题、低钾或低镁、利尿药、晕厥/心悸，或药单里还有延长 QT 的药时，应优先让专业人员核对。老年人、使用利尿药或容量不足者还更容易出现低钠；新出现明显乏力、头痛、混乱、步态不稳、跌倒、抽搐或意识变化需要及时医疗评估。", "en": "A heart-rhythm condition, low potassium or magnesium, a diuretic, fainting/palpitations or another QT-prolonging medicine on the list requires priority professional review. Older adults, people taking diuretics or those who are volume depleted also have greater hyponatraemia risk. New marked weakness, headache, confusion, unsteady gait, falls, seizures or altered awareness needs timely medical assessment." }, { "zh": "MAOI、匹莫齐特、其他影响血清素的药、阿司匹林/NSAID、抗血小板药、华法林或其他抗凝药都属于完整药单核对重点。发热伴激越、震颤、肌肉僵硬、腹泻或意识变化，严重出血，呼吸困难，昏厥，或自伤/自杀想法需要立即使用当地急救或危机支持。", "en": "MAOIs, pimozide, other serotonergic medicines, aspirin/NSAIDs, antiplatelets, warfarin and other anticoagulants are priority full-list checks. Fever with agitation, tremor, muscle rigidity, diarrhoea or altered awareness, severe bleeding, breathing difficulty, fainting, or thoughts of self-harm/suicide requires immediate local emergency or crisis support." }, { "zh": "不要因感觉好转、不舒服、漏服或担心副作用就自行骤停、轮换 CELEXA 与 LEXAPRO、ZOLOFT、PROZAC、PAXIL 等同类药，或把两种药叠加。标签要求停药过程由专业人员逐步安排；网页不会生成个人减量表。", "en": "Do not abruptly self-stop, rotate CELEXA with LEXAPRO, ZOLOFT, PROZAC, PAXIL or another related medicine, or combine them because you feel better, unwell, missed a dose or fear a side effect. The label places discontinuation under gradual professional management; the site does not generate an individual taper." } ], "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "西酞普兰怎样起作用：抑制血清素再摄取，不等于可以和其他 SSRI 自行替换", "en": "How citalopram works: serotonin-reuptake inhibition does not make SSRIs self-interchangeable" }, "summary": { "zh": "当前标签把西酞普兰描述为选择性血清素再摄取抑制剂（SSRI），通过增强中枢血清素活动来理解其药理作用。西酞普兰是外消旋混合物，其中 S-对映体与主要再摄取抑制作用相关；这只能解释药理关系，不能据此把 CELEXA 与只含艾司西酞普兰的 LEXAPRO 按毫克换算、同服或替换。", "en": "The current label describes citalopram as a selective serotonin reuptake inhibitor (SSRI), with its pharmacology understood through enhanced central serotonergic activity. Citalopram is a racemic mixture and the S-enantiomer is associated with most reuptake inhibition. This explains a pharmacologic relationship only; it does not permit milligram conversion, co-use or substitution between CELEXA and LEXAPRO, which contains escitalopram." }, "checks": [ { "zh": "作用机制不是个人疗效预测器。症状、既往反应、其他疾病、心电图、电解质、肝功能、年龄和完整药单都会影响专业判断；网页不会根据一个机制词替个人选药。", "en": "A mechanism is not an individual outcome predictor. Symptoms, previous response, other conditions, ECG, electrolytes, liver function, age and the complete medicine list can affect professional judgement. The site does not select a medicine from a mechanism term." }, { "zh": "同属 SSRI 或商品名相近，不表示可以轮换、叠加、共用剩药或按 mg 一比一换算。药盒上的品牌、通用名、每片强度、剂型、目标市场与处方必须一起核对。", "en": "A shared SSRI class or similar brand wording does not permit rotation, combination, sharing leftovers or one-for-one milligram conversion. Check the brand, generic name, strength per tablet, dosage form, target market and prescription together." }, { "zh": "全基因筛查不是本页给出的普遍前置要求。若开方团队认为 CYP2C19、心电图、电解质或其他检测会改变个人决策，应由其结合准确药品和临床情况解释检测范围与结果。", "en": "Whole-genome screening is not a universal prerequisite stated by this page. If the treating team believes CYP2C19, ECG, electrolytes or another test may change an individual decision, that team should explain the scope and result in the context of the exact medicine and clinical situation." } ], "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CELEXA", "generic": "西酞普兰", "dosageFormClass": "西酞普兰口服薄膜衣片：每片 10 mg、20 mg 或 40 mg；分别记录三种 100 片瓶装和两种 100 片单位剂量纸盒身份" }, "labelSource": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "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": "2026-08-30", "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": "2026-08-30", "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": "CELEXA 是西酞普兰口服薄膜衣片的美国品牌档案。当前标签列出 10、20、40 mg 三种每片强度、五种外层包装身份和完整 Medication Guide。本页优先解释每片 mg、刻痕、老年与 CYP2C19 边界、QT/低钠、同类药与多药联用；不会把标签数字变成个人片数，也不会指导自行掰片、换药或停药。", "history": "DailyMed 当前标签列出 CELEXA 的美国初始批准年份为 1998，SPL v40 于 2023-10-09 生效。本档案只记录当前美国口服片；口服液、通用药、LEXAPRO／艾司西酞普兰及其他市场产品必须分别核对。", "sourceDocuments": [ { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_7a71411a51d03fce", "label": "FDA Drugs@FDA：CELEXA（citalopram）NDA 020822 申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020822", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 020822（CELEXA / citalopram oral tablets）", "approvalTimeline": [ { "date": "1998-01-01", "title": { "zh": "美国初始批准年份", "en": "Initial U.S. approval year" }, "detail": { "zh": "DailyMed 当前标签列出 Initial U.S. Approval: 1998。这里只记录年份，不推定首批包装、其他市场状态或当前供应。", "en": "The current DailyMed label states Initial U.S. Approval: 1998. This records the year only and does not infer the first pack, another market's status or current supply." }, "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2023-10-09", "title": { "zh": "当前 DailyMed SPL v40 生效", "en": "Current DailyMed SPL v40 became effective" }, "detail": { "zh": "当前标签有效日期为 2023-10-09，并附 FDA 批准的 Medication Guide。日期定位文件版本，不是任何人的开始、停药或换药日期。", "en": "The current label has an effective date of 9 Oct 2023 and includes the FDA-approved Medication Guide. The date identifies the file version, not anyone's start, stopping or switching date." }, "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前品牌片剂标签、Medication Guide、五个外层包装身份和三个官方瓶装面板", "en": "Current brand-tablet label, Medication Guide, five outer-pack identities and three official bottle panels linked" }, "detail": { "zh": "本页记录 10、20、40 mg 的每片标示量、NDC、颜色、刻字、刻痕和包装数量。标签存在不等于任何地点有库存、可购买、适合个人或可以自行换规格。", "en": "The dossier records the per-tablet amount, NDC, colour, imprint, score and pack count for 10, 20 and 40 mg. A label does not establish local stock, purchase availability, individual suitability or self-switching between strengths." } }, { "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": "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、NDA、通用名、包装面板或共同药理类别推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. brand, NDA, generic name, package panel or shared pharmacologic class." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "CELEXA 20 mg 有刻痕，可以自己掰半当 10 mg 吗？", "en": "CELEXA 20 mg is scored. Can I split it myself to make 10 mg?" }, "answer": { "zh": "不要仅凭刻痕自行决定。刻痕是准确片剂的外观身份之一，不会自动证明掰后剂量、稳定性、个人处方和停换药过程都合适；请让药师或开方团队核对准确药盒、处方与目的。", "en": "Do not decide from the score alone. It is an appearance feature of the exact tablet and does not automatically establish post-split amount, stability, prescription suitability or a stopping/switching process. Ask a pharmacist or prescriber to check the exact pack, prescription and purpose." } }, { "question": { "zh": "CELEXA 与 LEXAPRO 名字和机制接近，可以按毫克换吗？", "en": "CELEXA and LEXAPRO have related names and mechanisms. Can their milligrams be converted?" }, "answer": { "zh": "不能从名字、机制或毫克数自行换算。CELEXA 是西酞普兰，LEXAPRO 是艾司西酞普兰；产品、标签、强度体系和个人边界不同，停换药必须由负责治疗的专业人员安排。", "en": "Not from names, mechanism or milligram figures. CELEXA is citalopram and LEXAPRO is escitalopram. Their products, labels, strength systems and individual boundaries differ, and the treating professional must arrange any stopping or switching." } }, { "question": { "zh": "说明书写 CYP2C19，是不是每个人都要做全基因筛查？", "en": "The label mentions CYP2C19. Does everyone need whole-genome screening?" }, "answer": { "zh": "当前标签没有把全基因筛查写成所有人的普遍前置要求。它指出 CYP2C19 慢代谢状态及某些抑制剂会影响专业剂量边界；是否需要何种检测，应由开方团队结合准确药品、年龄、肝功能、同服药和其他临床资料解释。", "en": "The current label does not state whole-genome screening as a universal prerequisite. It identifies CYP2C19 poor-metaboliser status and certain inhibitors as professional dosing boundaries. The prescribing team should explain whether any testing is needed using the exact medicine, age, liver function, co-medications and other clinical information." } }, { "question": { "zh": "老人服用后出现混乱、走路不稳或跌倒怎么办？", "en": "What if an older adult develops confusion, unsteady walking or a fall?" }, "answer": { "zh": "应及时联系当地医疗服务并携带全部药盒和完整药单。标签提示老年人、利尿药使用者或容量不足者低钠风险更高；网页不能判断具体原因，也不要自行骤停或补服。若伴抽搐、昏厥、严重心悸、意识变化或自伤想法，应立即使用当地急救或危机支持。", "en": "Contact local medical services promptly and take every pack and the complete medicine list. The label notes greater hyponatraemia risk in older adults, diuretic users or volume depletion. The site cannot diagnose the cause, and the medicine should not be abruptly self-stopped or made up. Seizure, fainting, severe palpitations, altered awareness or self-harm thoughts requires immediate local emergency or crisis support." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "family-medicine-list-for-pharmacist", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/celexa/", "en": "https://origindrug.com/en/drugs/celexa/" }, "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." ] }