{ "id": "lithobid-lithium-carbonate", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-13", "status": "published_traceable_archive" }, "names": { "brand": "LITHOBID", "generic": "碳酸锂（lithium carbonate）300 mg 缓释口服片", "aliases": [ "Lithobid", "lithium carbonate", "lithium carbonate extended release", "碳酸锂", "碳酸锂缓释片", "锂盐", "LITHOBID", "62559-280-01", "LITHOBID 300" ], "marketBrandNames": [ { "name": "LITHOBID", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "dated_regulatory_record", "note": { "zh": "NDA 018027 的 300 mg 缓释口服片；当前阅读文件为 2022-10-28 有效的美国公开标签。", "en": "300 mg extended-release oral tablet under NDA 018027; the reading document is the U.S. public label effective 28 Oct 2022." }, "source": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "本页建立的是美国 LITHOBID NDA 018027 的 300 mg 缓释口服片档案。DailyMed 所审阅标签有效版本为 2022-10-28，并列示 NDC 62559-280-01、100 片/瓶。FDA Orange Book 数据文件把该产品列为 RLD/RS。上述资料不证明今天的库存、购买渠道、真伪，亦不推定中国大陆、欧盟、日本或其他市场的批准、商品名、包装、供应或可替代性。", "dosageFormClass": "碳酸锂薄膜衣缓释口服片。300 mg 是每片标示量；缓释片、普通口服锂盐片、柠檬酸锂口服液、其他市场产品和其他锂盐不是可按名称或 mg 自行换算、叠加、轮换或替代的同一产品。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国历史批准早于 1982 年（FDA Orange Book 记录）", "archiveSponsorText": "ANI Pharmaceuticals, Inc.（所审阅美国公开标签主体及 FDA Orange Book 条目申请主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "LITHOBID", "Lithobid", "lithium carbonate extended-release tablets", "碳酸锂缓释片" ], "excludedProductCues": [ "lithium citrate oral solution", "lithium citrate syrup", "lithium carbonate immediate release", "Lithonate", "lithium injection", "氯化锂", "other lithium salt" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lithobid-lithium-carbonate-300mg-ndc-62559-280-01", "marketCode": "US", "labelVersion": { "zh": "美国公开标签有效版本：2022-10-28", "en": "U.S. public-label effective version: 2022-10-28" }, "dosageForm": { "zh": "LITHOBID 碳酸锂 300 mg 薄膜衣缓释口服片", "en": "LITHOBID lithium carbonate 300 mg film-coated extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-280-01 / NDA 018027", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片碳酸锂 300 mg；不是个人片数、频率或调整方案", "en": "300 mg lithium carbonate per tablet; not an individual's tablet count, schedule or adjustment plan" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "碳酸锂", "en": "lithium carbonate" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用指令", "en": "labelled amount per tablet; not an individual-use instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-13", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "dated_public_label_not_live_supply_confirmation", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "保留准确产品身份，不以相似锂盐药盒或药片代替外观图", "en": "Exact product identity retained; no look-alike lithium-salt pack or tablet image substituted" }, "summary": { "zh": "公开标签可核对 NDC、剂型、每片标示量、100 片/瓶和片剂刻印线索，但本次未保留一张能与该版本、该 NDC 和公开一手来源逐一对应的可展示包装主图。为避免把普通片、柠檬酸锂口服液、其他市场或来源不明图片误当作 LITHOBID，本页不展示药盒或药片外观图。", "en": "The public label supports checking the NDC, dosage form, per-tablet amount, 100-tablet bottle and imprint clues, but no displayable principal pack image was retained one-to-one for this version, NDC and a primary public source. To avoid presenting an immediate-release tablet, lithium citrate liquid, another-market product or source-uncertain image as LITHOBID, this page withholds pack and tablet imagery." }, "source": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LITHOBID 说明书放大阅读：先分清缓释片、每片 300 mg 与监测边界", "en": "LITHOBID enlarged label: first separate extended release, 300 mg per tablet and monitoring boundaries" }, "summary": { "zh": "这份美国标签对应碳酸锂 300 mg 缓释片；300 mg 是每片标示量，100 片是包装数量，两者都不是个人该吃几片或多久吃一次的答案。锂中毒风险与血锂浓度密切相关；请用准确药盒、处方和完整药单向负责团队核对，而不是按网站、相似药名或旧药自行调整。", "en": "This U.S. label is for a 300 mg extended-release lithium carbonate tablet; 300 mg is the amount per tablet and 100 tablets is the package count. Neither tells an individual how many tablets or when to take them. Lithium-toxicity risk is closely related to serum lithium concentration; use the exact pack, prescription and complete medicine list with the responsible team, not a website, similar name or leftover medicine, for any adjustment." }, "checks": [ { "zh": "缓释片不是普通碳酸锂片，也不是柠檬酸锂口服液。共同成分或“锂”字不能建立按 mg 自行换算、替换、叠加或轮换。", "en": "An extended-release tablet is not an immediate-release lithium carbonate tablet or a lithium citrate oral liquid. A shared ingredient or the word “lithium” does not establish self-conversion, substitution, combination or alternation by milligrams." }, { "zh": "利尿剂、ACEI/ARB、NSAID 止痛药、脱水、腹泻、呕吐、发热、进食饮水明显变化或肾功能变化都可能使专业人员优先复核锂相关风险；网页不生成暂停、补服、错开时间或加减量指令。", "en": "Diuretics, ACE inhibitors/ARBs, NSAID pain medicines, dehydration, diarrhoea, vomiting, fever, marked food/fluid changes or kidney-function changes can make lithium-related risk a priority for professional review; the site generates no pause, catch-up, spacing or dose-change instruction." }, { "zh": "明显手抖或动作不稳、说话含糊、严重嗜睡或混乱、持续呕吐腹泻、昏厥、异常心跳、呼吸困难或无法保持安全，应立即使用当地急救或医疗支持，并带上全部药盒；不要等待网页判断。", "en": "Marked tremor or unsteadiness, slurred speech, severe drowsiness or confusion, persistent vomiting/diarrhoea, fainting, abnormal heartbeat, breathing difficulty or inability to remain safe requires local emergency or medical support immediately with every medicine pack; do not wait for a website assessment." }, { "zh": "药片颜色、刻印、刻痕或“100 片”只能帮助核对准确产品身份。刻痕本身不表示可以自行掰开、减量或改变产品。", "en": "Tablet colour, imprint, a score line or “100 tablets” can only help check exact product identity. A score line itself does not permit self-splitting, reducing or changing the product." } ], "source": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "碳酸锂怎样起作用：机制阅读不能替代血锂、肾功能和完整药单核对", "en": "How lithium carbonate works: mechanism reading does not replace lithium level, kidney function or full-list review" }, "summary": { "zh": "锂的临床作用涉及多条细胞信号路径，但机制解释不能代替血锂监测，也不能仅凭情绪、睡眠、一次化验或“以前吃过”决定继续、停用、换药或与另一种精神科药同服。对普通读者而言，先分清准确剂型和同时使用的药物，比用机制猜个人方案更安全。", "en": "Lithium's clinical effects involve several cellular-signalling pathways, but a mechanism explanation does not replace serum-lithium monitoring and cannot use mood, sleep, one test result or prior use alone to decide continuation, stopping, switching or co-use with another psychiatric medicine. For ordinary readers, first separating the exact dosage form and every co-medication is safer than guessing an individual plan from mechanism." }, "checks": [ { "zh": "“同属情绪稳定剂”不等于同一种药。碳酸锂、丙戊酸盐、拉莫三嗪、抗精神病药和抗抑郁药不能从共同用途、名称或 mg 自行互换、叠加或轮换。", "en": "Being called a mood stabiliser does not make medicines the same. Lithium carbonate, valproate, lamotrigine, antipsychotics and antidepressants cannot be self-converted, combined or alternated from a shared use, name or milligram figure." }, { "zh": "是否需要药物基因检测不是网页的默认结论；锂相关安全通常还涉及血锂、肾功能、甲状腺、钙水平、心脏风险、年龄、妊娠可能性和完整药单等具体临床信息，应由负责团队解释。", "en": "Whether pharmacogenetic testing is needed is not the site's default conclusion. Lithium-related safety can also involve serum lithium, kidney function, thyroid, calcium, cardiac risk, age, pregnancy potential and the complete medicine list; the responsible team should interpret these clinical details." }, { "zh": "机制相近、情绪症状相似或曾经使用过锂盐，都不能代替当前准确产品、监测结果和专业评估；网页不根据这些线索生成继续、停用或换药结论。", "en": "A similar mechanism, similar mood symptoms or prior lithium use cannot replace the current exact product, monitoring results and professional assessment; the site does not generate a continuation, stopping or switching conclusion from these clues." } ], "source": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LITHOBID", "generic": "碳酸锂（lithium carbonate）300 mg 缓释口服片", "dosageFormClass": "碳酸锂薄膜衣缓释口服片。300 mg 是每片标示量；缓释片、普通口服锂盐片、柠檬酸锂口服液、其他市场产品和其他锂盐不是可按名称或 mg 自行换算、叠加、轮换或替代的同一产品。" }, "labelSource": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "productRoutes": [ { "source": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "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": "2026-09-13", "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 数据文件：LITHOBID（碳酸锂）NDA 018027、300 mg 缓释口服片 RLD/RS 产品条目", "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." } } ], "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": "2026-09-13", "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": "LITHOBID 是碳酸锂 300 mg 缓释口服片的美国品牌档案。标签将锂中毒与血锂浓度密切相关，并强调开始治疗前应具备及时准确的血锂检测条件。老人、脱水或进食饮水异常者、肾脏或心脏问题者，以及同时使用利尿剂、ACEI/ARB、NSAID 止痛药或其他可能影响锂水平药物者，应优先让药师或开方团队核对完整药单、实际药盒、近期状况和监测安排。网页不决定个人片数、频率、补服、减停或换药。", "history": "FDA Orange Book 中的 LITHOBID NDA 018027 产品条目使用“Approved Prior to Jan 1, 1982”字段，并为 300 mg 缓释口服片列示 RLD/RS。DailyMed 公开标签标示 ANI Pharmaceuticals、2022-10-28 有效版本。本页保留美国产品和文件日期，不把它写成任何其他市场的现行说明书或供应证明。", "sourceDocuments": [ { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：LITHOBID（碳酸锂）NDA 018027、300 mg 缓释口服片 RLD/RS 产品条目", "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" } ], "applicationNumber": "NDA 018027；DailyMed SETID f7f5b69a-c2a1-4586-a189-1475d41387c0", "approvalTimeline": [ { "date": "1981-12-31", "title": { "zh": "历史批准时间仅记录为“1982 年前”", "en": "Historical approval is recorded only as “prior to 1982”" }, "detail": { "zh": "FDA Orange Book 的 NDA 018027 产品条目使用“Approved Prior to Jan 1, 1982”字段；本站不从该字段虚构具体批准日。", "en": "The FDA Orange Book entry under NDA 018027 uses “Approved Prior to Jan 1, 1982”; the site does not invent a specific approval date from that field." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：LITHOBID（碳酸锂）NDA 018027、300 mg 缓释口服片 RLD/RS 产品条目", "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" } }, { "date": "2022-10-28", "title": { "zh": "美国公开标签有效版本", "en": "U.S. public-label effective version" }, "detail": { "zh": "DailyMed 标签标示 ANI Pharmaceuticals，覆盖 LITHOBID 300 mg 缓释口服片；它是有日期文件，不是实时供应证明。", "en": "The DailyMed label identifies ANI Pharmaceuticals and covers LITHOBID 300 mg extended-release oral tablets; it is a dated document, not live-supply evidence." }, "source": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "有日期公开标签与 Orange Book 产品记录", "en": "Dated public label and Orange Book product record" }, "detail": { "zh": "可用于核对美国品牌、剂型、每片标示量、NDC 和 RLD/RS 产品字段；不确认今天库存、可购买性、真伪或个人适用。", "en": "They support checking the U.S. brand, form, per-tablet amount, NDC and RLD/RS product fields; they do not establish today's stock, purchase availability, authenticity or individual suitability." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "当地品牌、批准、包装与供应待逐项核验", "en": "Local brand, approval, pack and supply require item-by-item verification" }, "detail": { "zh": "不从美国 LITHOBID 标签外推中国大陆、欧盟、日本或其他市场状态。", "en": "No status for Mainland China, the EU, Japan or another market is inferred from the U.S. LITHOBID label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "300 mg 是我一次该吃几片吗？", "en": "Does 300 mg tell me how many tablets to take at once?" }, "answer": { "zh": "不是。300 mg 是这一个准确产品的每片标示量。个人片数、频次、任何补服或调整都必须由负责团队结合处方、血锂监测、肾功能和完整药单决定。", "en": "No. 300 mg is the labelled amount per tablet for this exact product. Individual tablet count, schedule, any catch-up and any adjustment must be decided by the responsible team using the prescription, serum-lithium monitoring, kidney function and the complete medicine list." } }, { "question": { "zh": "缓释碳酸锂能和普通片或柠檬酸锂口服液按 mg 互换吗？", "en": "Can extended-release lithium carbonate be exchanged with an immediate-release tablet or lithium citrate liquid by milligrams?" }, "answer": { "zh": "不能自行这样做。它们的剂型、释放特征和产品身份不同；请让药师或开方团队核对准确药盒和处方。", "en": "Do not do this yourself. Their dosage forms, release characteristics and product identities differ; have the exact pack and prescription checked by a pharmacist or prescribing team." } }, { "question": { "zh": "老人出现手抖、走路不稳、混乱或持续呕吐腹泻怎么办？", "en": "What if an older adult develops tremor, unsteadiness, confusion or persistent vomiting/diarrhoea?" }, "answer": { "zh": "不要用网页自行决定停药、补服或减量。及时联系当地医疗服务；如有严重意识变化、昏厥、异常心跳、呼吸困难或无法保持安全，应立即使用当地急救服务，并带上全部药盒。", "en": "Do not use a webpage to decide stopping, catch-up or reduction. Contact local medical services promptly; severe altered awareness, fainting, abnormal heartbeat, breathing difficulty or inability to remain safe requires local emergency services immediately with every medicine pack." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "interactions-are-not-a-home-scheduling-problem", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lithobid-lithium-carbonate/", "en": "https://origindrug.com/en/drugs/lithobid-lithium-carbonate/" }, "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." ] }