{ "id": "cytomel-liothyronine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-06", "status": "published_traceable_archive" }, "names": { "brand": "CYTOMEL", "generic": "碘塞罗宁钠", "aliases": [ "Cytomel", "liothyronine", "liothyronine sodium", "T3", "L-triiodothyronine", "碘塞罗宁", "碘塞罗宁钠", "碘塞罗宁钠片", "三碘甲状腺原氨酸" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国：CYTOMEL 碘塞罗宁钠片 NDA 010379、5/25/50 mcg 三种当前品牌包装、现行电子说明书与 Orange Book RLD/RS 身份。该美国证据不外推中国大陆、欧盟、日本或其他市场的批准、商品名、包装、供应、原研/仿制关系或可替代性。", "dosageFormClass": "口服普通片 5、25、50 mcg；mcg 是微克，1 mg 等于 1000 mcg。网页不把微克与毫克、碘塞罗宁与左甲状腺素，或不同甲状腺制剂做个人换算。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1956（美国初始批准）", "archiveSponsorText": "Pfizer Laboratories Div Pfizer Inc（当前美国品牌标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "CYTOMEL", "liothyronine", "liothyronine sodium", "碘塞罗宁", "碘塞罗宁钠" ], "excludedProductCues": [ "levothyroxine", "SYNTHROID", "EUTHYROX", "thyroid desiccated", "Armour Thyroid", "methimazole", "TAPAZOLE" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cytomel-liothyronine-5mcg-100-tablet-bottle-ndc-6079311501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v15；2026-05-18 生效；处方信息 2025-04 修订）", "en": "Current U.S. DailyMed brand label (SPL v15; effective 18 May 2026; prescribing information revised Apr 2025)" }, "dosageForm": { "zh": "CYTOMEL 碘塞罗宁钠口服片", "en": "CYTOMEL liothyronine sodium oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 60793-115-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于碘塞罗宁 5 mcg（微克）；100 片瓶装", "en": "Equivalent to liothyronine 5 mcg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cytomel-03.jpg&setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "碘塞罗宁（以碘塞罗宁钠提供）", "en": "liothyronine (supplied as liothyronine sodium)" }, "value": 5, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换算或补服指令", "en": "labelled amount per tablet; not an individual tablet count, frequency, conversion or missed-use 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": "2026-09-06", "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": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形、约 6 mm、无刻痕", "en": "round, approximately 6 mm, unscored" }, "imprint": "KPI;115", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cytomel-liothyronine-25mcg-100-tablet-bottle-ndc-6079311601", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v15；2026-05-18 生效；处方信息 2025-04 修订）", "en": "Current U.S. DailyMed brand label (SPL v15; effective 18 May 2026; prescribing information revised Apr 2025)" }, "dosageForm": { "zh": "CYTOMEL 碘塞罗宁钠口服片", "en": "CYTOMEL liothyronine sodium oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 60793-116-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于碘塞罗宁 25 mcg（微克）；100 片瓶装", "en": "Equivalent to liothyronine 25 mcg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cytomel-04.jpg&setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "碘塞罗宁（以碘塞罗宁钠提供）", "en": "liothyronine (supplied as liothyronine sodium)" }, "value": 25, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换算或补服指令", "en": "labelled amount per tablet; not an individual tablet count, frequency, conversion or missed-use 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": "2026-09-06", "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": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形、约 7 mm、有刻痕", "en": "round, approximately 7 mm, scored" }, "imprint": "KPI;116", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cytomel-liothyronine-50mcg-100-tablet-bottle-ndc-6079311701", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v15；2026-05-18 生效；处方信息 2025-04 修订）", "en": "Current U.S. DailyMed brand label (SPL v15; effective 18 May 2026; prescribing information revised Apr 2025)" }, "dosageForm": { "zh": "CYTOMEL 碘塞罗宁钠口服片", "en": "CYTOMEL liothyronine sodium oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 60793-117-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于碘塞罗宁 50 mcg（微克）；100 片瓶装", "en": "Equivalent to liothyronine 50 mcg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cytomel-05.jpg&setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "碘塞罗宁（以碘塞罗宁钠提供）", "en": "liothyronine (supplied as liothyronine sodium)" }, "value": 50, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换算或补服指令", "en": "labelled amount per tablet; not an individual tablet count, frequency, conversion or missed-use 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": "2026-09-06", "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": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形、约 8 mm、有刻痕", "en": "round, approximately 8 mm, scored" }, "imprint": "KPI;117", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-cytomel-liothyronine-25mcg-100-tablet-bottle-ndc-6079311601", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cytomel-04.jpg&setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "alt": "CYTOMEL 碘塞罗宁钠 25 mcg、NDC 60793-116-01、100 片当前美国瓶装标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签 SPL v15（2026-05-18 生效）", "presentation": "CYTOMEL 每片相当于碘塞罗宁 25 mcg，白色至类白色圆片，KPI/116 刻字，有刻痕，100 片瓶装。", "notice": "此图只对应一个准确美国品牌包装，用于核对品牌、通用名、每片微克含量、NDC 与瓶装数量；不用于鉴定真伪，不证明实时库存、另一规格、其他市场、购买资格、个人片数或可替代性。", "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CYTOMEL 说明书放大阅读：先看 mcg，再看心脏、骨骼、血糖与药物相互作用", "en": "CYTOMEL enlarged label: start with mcg, then review cardiac, bone, glucose and interaction risks" }, "summary": { "zh": "当前标签把微克规格、老年心血管风险、过量导致的甲亢表现、骨密度、糖尿病控制、抗凝药和多类相互作用列为重点。网页帮助把药盒和问题带给专业人员，不计算个人剂量、片数、分片、换药或监测方案。", "en": "The current label prioritises microgram strengths, cardiovascular risk in older adults, hyperthyroid effects of overtreatment, bone density, diabetes control, anticoagulants and multiple interactions. The page helps bring the pack and questions to a professional; it does not calculate an individual dose, tablet count, split, switch or monitoring plan." }, "checks": [ { "zh": "5、25、50 mcg 是每片碘塞罗宁当量。mcg 是微克，mg 是毫克，1 mg 等于 1000 mcg；包装数字不能脱离单位相加，也不能把 25 mcg 错读成 25 mg 或据此推算片数。", "en": "The 5, 25 and 50 mcg figures are liothyronine equivalents per tablet. Mcg means micrograms, mg means milligrams, and 1 mg equals 1,000 mcg. Never detach a pack number from its unit, read 25 mcg as 25 mg or use it to calculate a tablet count." }, { "zh": "25 mcg 与 50 mcg 片有刻痕，5 mcg 片无刻痕；本站不把刻痕当作自行掰片许可。能否分片、如何取得准确小剂量、分片后的均一性和储存须针对实际产品与处方让药师确认。", "en": "The 25 and 50 mcg tablets are scored; the 5 mcg tablet is unscored. This site does not treat a score as permission to self-split. Ask a pharmacist about the exact product, prescription, dose accuracy, uniformity and storage before splitting." }, { "zh": "甲状腺激素过量可能增加心率并诱发心绞痛或心律失常；老人和有心血管疾病者风险更高，标签特别提到心房颤动。出现胸痛、明显心悸、晕厥、呼吸困难或急性意识异常应及时寻求当地医疗帮助，严重情况使用急救；不要自行停换或补服。", "en": "Thyroid-hormone overtreatment may increase heart rate and precipitate angina or arrhythmias. Risk is higher in older adults and people with cardiovascular disease, and the label specifically notes atrial fibrillation. Chest pain, marked palpitations, fainting, breathing difficulty or acute confusion requires prompt local care and emergency help when severe; do not self-stop, switch or catch up." }, { "zh": "CYTOMEL 有黑框警示：不能用于肥胖治疗或减肥。超出生理需要的剂量可能造成严重甚至危及生命的毒性；不要与减肥药、兴奋剂或其他甲状腺激素自行组合。", "en": "CYTOMEL carries a boxed warning: it is not for treatment of obesity or for weight loss. Doses beyond physiologic requirements can cause serious or life-threatening toxicity; do not self-combine it with weight-loss drugs, stimulants or other thyroid hormones." }, { "zh": "标签提示口服抗凝药（包括华法林类监测场景）、地高辛类、糖尿病药、三环类抗抑郁药、胆汁酸结合剂／离子交换树脂、利福平、苯巴比妥、胺碘酮等相互作用。药单同时出现时要让药师逐项核对并结合化验监测，不能根据网页自行错开、加减或停药。", "en": "The label describes interactions involving oral anticoagulants, including warfarin-type monitoring situations, digitalis glycosides, diabetes therapy, tricyclic antidepressants, bile-acid sequestrants/ion-exchange resins, rifampin, phenobarbital, amiodarone and others. Ask a pharmacist to review the complete list and relevant monitoring; do not self-separate, increase, reduce or stop medicines from the page." } ], "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "碘塞罗宁怎样起作用：T3 进入细胞核并调控基因转录与蛋白合成", "en": "How liothyronine works: T3 enters the cell nucleus and regulates gene transcription and protein synthesis" }, "summary": { "zh": "标签说明，T3 与 T4 进入细胞核，结合与 DNA 相连的甲状腺激素受体蛋白，形成的核受体复合物调控基因转录、信使 RNA 与细胞质蛋白合成。甲状腺激素的生理作用主要由 T3 产生，但机制不能替代诊断、化验解释或个人用药决定。", "en": "The label says T3 and T4 enter the cell nucleus and bind thyroid-receptor proteins attached to DNA. The nuclear-receptor complex regulates gene transcription, messenger RNA and cytoplasmic protein synthesis. Physiologic thyroid-hormone actions are produced predominantly by T3, but mechanism cannot replace diagnosis, laboratory interpretation or an individual treatment decision." }, "checks": [ { "zh": "碘塞罗宁是 T3，左甲状腺素是 T4；共同属于甲状腺激素不表示它们是同一种药，也不能按 5、25、50、75 或 100 这些数字自行换算、叠加、轮换或替代。", "en": "Liothyronine is T3 and levothyroxine is T4. Belonging to the thyroid-hormone family does not make them one medicine or allow self-conversion, combination, alternation or substitution using figures such as 5, 25, 50, 75 or 100." }, { "zh": "药效起始较快、另一种甲状腺制剂的残余效应可持续，并不构成自行切换的时间表。SYNTHROID、EUTHYROX、CYTOMEL、甲状腺片或其他产品同时出现在药单时，应先核对准确成分、单位、处方和化验计划。", "en": "A relatively rapid onset and residual effects of another thyroid preparation do not create a self-switch timetable. If SYNTHROID, EUTHYROX, CYTOMEL, desiccated thyroid or another product appears on the list, first review the exact ingredient, unit, prescription and laboratory plan." }, { "zh": "当前标签没有把全基因组筛查写成所有人使用 CYTOMEL 前的常规要求。心血管情况、年龄、妊娠、糖尿病、肾上腺功能、药物相互作用、症状和实验室结果需要结合具体问题解释，不能用基因检测替代。", "en": "The current label does not make whole-genome screening a routine prerequisite for everyone before CYTOMEL. Cardiovascular status, age, pregnancy, diabetes, adrenal function, interactions, symptoms and laboratory results require interpretation for the actual question and cannot be replaced by genomic testing." } ], "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CYTOMEL", "generic": "碘塞罗宁钠", "dosageFormClass": "口服普通片 5、25、50 mcg；mcg 是微克，1 mg 等于 1000 mcg。网页不把微克与毫克、碘塞罗宁与左甲状腺素，或不同甲状腺制剂做个人换算。" }, "labelSource": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "productRoutes": [ { "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "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": "2026-09-06", "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_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：CYTOMEL NDA 010379、5/25/50 mcg 与 RLD/RS 身份", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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": "2026-09-06", "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": "CYTOMEL 是碘塞罗宁钠（T3）口服片。瓶身的 5、25、50 mcg 表示每片微克含量，不是毫克，也不是每天片数；5 mcg 不是 5 mg。老人和有心血管疾病的人需要特别留意心率、心绞痛和心律失常风险。它不能与 SYNTHROID／EUTHYROX 等左甲状腺素产品或其他甲状腺制剂按数字自行换算、叠加、轮换或停换。", "history": "CYTOMEL 在美国的初始批准可追溯至 1956 年。FDA 2019 年批准函记录 NDA 010379/S-057 对供应信息等标签内容的修订；DailyMed 当前记录为 SPL v15，生效日 2026-05-18，处方信息修订于 2025-04。本页把初始批准、当前标签、准确包装和实时供应严格分开。", "sourceDocuments": [ { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_9bafbf295435e70d", "label": "FDA：CYTOMEL NDA 010379/S-057 补充申请批准函（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/010379Orig1s057ltr.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": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：CYTOMEL NDA 010379、5/25/50 mcg 与 RLD/RS 身份", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "NDA 010379", "approvalTimeline": [ { "date": "1956-05-08", "title": { "zh": "CYTOMEL 在美国初始批准", "en": "Initial U.S. approval of CYTOMEL" }, "detail": { "zh": "DailyMed 三种当前产品表均列出 NDA 010379 与 1956-05-08 的营销起始日期；Orange Book 将 CYTOMEL 连接到同一 NDA。", "en": "All three current DailyMed product tables list NDA 010379 and a marketing start date of 8 May 1956; the Orange Book connects CYTOMEL to the same NDA." }, "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, { "date": "2019-08-08", "title": { "zh": "FDA 批准 S-057 标签补充申请", "en": "FDA approved the S-057 labelling supplement" }, "detail": { "zh": "批准函说明修订供应信息以解决处方信息与 DailyMed 的差异，并作其他编辑调整。", "en": "The approval letter describes revisions to How Supplied to resolve discrepancies between prescribing information and DailyMed, plus other editorial changes." }, "source": { "id": "src_9bafbf295435e70d", "label": "FDA：CYTOMEL NDA 010379/S-057 补充申请批准函（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/010379Orig1s057ltr.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": "2026-09-06", "reviewedAt": "2026-09-06" } }, { "date": "2026-05-18", "title": { "zh": "DailyMed 当前 SPL v15 生效", "en": "Current DailyMed SPL v15 became effective" }, "detail": { "zh": "当前记录保留 5、25、50 mcg 三个品牌瓶装及 2025-04 修订的处方信息。", "en": "The current record retains three brand bottles at 5, 25 and 50 mcg and prescribing information revised Apr 2025." }, "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前品牌标签存在；NDA/RLD 身份已核验", "en": "Current brand label present; NDA/RLD identity verified" }, "detail": { "zh": "三种 NDC 和包装图来自同一当前 DailyMed 标签；市场可获得性与库存仍须向持证渠道实时核实。", "en": "All three NDCs and package panels come from one current DailyMed label. Market availability and stock still require real-time confirmation from an authorised channel." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "准确市场产品记录待逐项建立", "en": "Exact market-product records not yet established" }, "detail": { "zh": "不从美国 CYTOMEL 名称、NDA、NDC 或外观推定当地批准、商品名、包装、供应、原研/仿制关系或可替代性。", "en": "No local approval, trade name, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. CYTOMEL name, NDA, NDC or appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "25 mcg 是不是 25 mg？", "en": "Is 25 mcg the same as 25 mg?" }, "answer": { "zh": "不是。25 mcg 是 25 微克，等于 0.025 mg；单位相差 1000 倍。看到药盒数字时必须把数字与 mcg／μg／mg 一起读，不要据此自己算片数。", "en": "No. 25 mcg is 25 micrograms, equal to 0.025 mg; the units differ by a factor of 1,000. Read the number together with mcg/μg/mg and do not calculate your own tablet count." } }, { "question": { "zh": "有刻痕的 25 或 50 mcg 片能自己掰半吗？", "en": "Can a scored 25 or 50 mcg tablet be self-split?" }, "answer": { "zh": "刻痕先是产品外观和结构信息，不是网页给出的分片许可。是否可以分、如何保证所需剂量与储存，应让药师根据准确产品、处方和实际情况确认。", "en": "A score is first a product appearance and structure feature, not online permission to split. Ask a pharmacist whether the exact product can be divided and how dose accuracy and storage would be managed." } }, { "question": { "zh": "CYTOMEL 和 SYNTHROID／EUTHYROX 能自己换算或一起吃吗？", "en": "Can CYTOMEL be self-converted or combined with SYNTHROID/EUTHYROX?" }, "answer": { "zh": "不能。CYTOMEL 是 T3，SYNTHROID／EUTHYROX 是 T4 产品；剂型、药代、单位、相互作用和监测都不同。换药或合用只能由了解病史、完整药单和化验结果的专业人员决定。", "en": "No. CYTOMEL is T3, while SYNTHROID/EUTHYROX are T4 products. Formulation, pharmacokinetics, units, interactions and monitoring differ. A professional with the history, complete list and laboratory results must decide any switch or combination." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "medicine-list-review-for-older-adults" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/cytomel-liothyronine/", "en": "https://origindrug.com/en/drugs/cytomel-liothyronine/" }, "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." ] }