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90-tablet bottle (U.S. label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-420mg.jpg&setid=3e180dc7-c871-4efc-8755-cae882976c8d", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸地尔硫卓", "en": "diltiazem hydrochloride" }, "value": 420, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "420 mg 每片标签标示量；不是个人片数、频率或换算指令", "en": "420 mg labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-cardizem-la-diltiazem-hydrochloride-er-tablet-120mg-90-bottle-ndc-0187-2045-90", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-120mg.jpg&setid=3e180dc7-c871-4efc-8755-cae882976c8d", "alt": "CARDIZEM LA 盐酸地尔硫卓 120 mg 在美国 DailyMed 当前公开标签中的 90 片瓶装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（2025-11-11 更新）", "presentation": "CARDIZEM LA（盐酸地尔硫卓）缓释片 120 mg、90 片瓶装（NDC 0187-2045-90；DailyMed 当前标签所列）。", "notice": "此图只对应美国 DailyMed 当前标签中 CARDIZEM LA、盐酸地尔硫卓、缓释片、120 mg、NDC 0187-2045-90、90 片瓶装主展示面，只帮助核对品牌、通用名、标示强度、缓释片、包装数量与来源；不用于鉴定真伪，也不证明 180–420 mg、其他包装、其他市场标签、原研身份、目标市场批准或可售资格。", "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CARDIZEM LA 说明书放大阅读：缓释片的 mg 先用于认清这一盒药", "en": "CARDIZEM LA label reading: mg on an extended-release tablet identifies this exact product first" }, "summary": { "zh": "本模块以 DailyMed 当前美国公开标签为阅读入口，帮助核对 CARDIZEM LA、盐酸地尔硫卓、缓释口服片、每片标示量、特定 NDC 与瓶装。它不提供任何人的片数、服用时间、漏用处理、分片、停用、从其他地尔硫卓产品转换或联用答案。", "en": "This module uses the current U.S. DailyMed public label to check CARDIZEM LA, diltiazem hydrochloride, extended-release oral tablets, labelled per-tablet amount, a specific NDC and bottle. It does not provide anyone's tablet count, timing, missed-use handling, splitting, stopping, conversion from another diltiazem product or co-use answer." }, "checks": [ { "zh": "120、180、240、300、360、420 mg 是这份美国标签中区分缓释片的每片标示量；不是网页可转成“每天几颗”、几种规格相加、对半、补用或相互换算的公式。", "en": "120, 180, 240, 300, 360 and 420 mg distinguish extended-release tablets in this U.S. label; they are not a webpage formula for ‘how many each day’, adding strengths, halving, make-up use or conversion." }, { "zh": "该标签明确该缓释片应整片吞服，不应咀嚼或研碎。这个产品特异的文字不自动适用于其他地尔硫卓剂型、其他缓释片、胶囊或其他市场产品；任何吞咽困难、分片或换剂型问题都应由药师或开方团队按实际产品核对。", "en": "The label states that this extended-release tablet is swallowed whole and not chewed or crushed. That product-specific wording does not automatically apply to another diltiazem form, extended-release tablet, capsule or another-market product; swallowing difficulty, splitting or form-change questions need pharmacist or prescriber review for the actual product." }, { "zh": "标签中的“转为 CARDIZEM LA”文字是处方资料，不能被当成自助换算器。共同写有地尔硫卓、相近 mg 数、同为心脏或血压药，均不证明可以自行替换、叠加、轮换或调整。", "en": "The label's ‘switching to CARDIZEM LA’ wording is prescribing information, not a self-service conversion calculator. A shared diltiazem name, similar mg number, or heart/blood-pressure context does not prove products can be self-substituted, combined, alternated or adjusted." }, { "zh": "标签提示与可能影响心脏传导或收缩的药物、β 受体阻断剂、地高辛及多种代谢相关药物有关的核对线索。尤其是老人或多药并用时，请把全部实际药盒、处方标签、非处方药和补充剂一起交给药师或开方团队；不要自行停、加、错开或改用任何一种药。", "en": "The label flags review cues with medicines that may affect cardiac conduction or contractility, beta-blockers, digitalis and multiple metabolism-related products. Especially for older people or people using several medicines, take all actual packs, prescription labels, OTC products and supplements together to a pharmacist or prescriber; do not self-stop, add, time-separate or change any medicine." } ], "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "地尔硫卓怎样起作用：钙通道阻滞解释机制，不替代个人方案", "en": "How diltiazem works: calcium-channel blockade explains a mechanism, not an individual plan" }, "summary": { "zh": "当前美国标签将 CARDIZEM LA 归为非二氢吡啶类钙通道阻滞剂。它帮助理解药物类别与为何心率、传导和完整药单需要一起核对，但不预测个人血压、心率、适用性、剂量或联合用药方案。", "en": "The current U.S. label classifies CARDIZEM LA as a nondihydropyridine calcium-channel blocker. This helps explain the class and why heart rate, conduction and the complete medicine list need review, but does not predict individual blood pressure, heart rate, suitability, dose or a combination plan." }, "checks": [ { "zh": "“钙通道阻滞剂”是药物类别与作用路径线索，不是“凡是降压或心脏药都能一起吃”的结论。药物类别、剂型、既往反应、心率与传导相关情况、肾肝功能和完整药单都需要专业人员逐项判断。", "en": "‘Calcium-channel blocker’ is a class and pathway clue, not a conclusion that every blood-pressure or heart medicine can be used together. Drug class, dosage form, prior reactions, heart-rate/conduction context, kidney/liver function and the complete medicine list need item-by-item professional review." }, { "zh": "与 β 受体阻断剂、地高辛或另一种心率相关药物有共同的“心脏”用途或机制线索，不建立同日叠加、轮换、替代或按 mg 换算的关系。", "en": "A shared heart-related use or mechanism cue with a beta-blocker, digoxin or another heart-rate-related medicine does not establish same-day combination, alternation, substitution or milligram conversion." }, { "zh": "机制阅读不能替代症状判断。若有昏厥、胸部不适、明显心悸、呼吸困难、严重头晕或其他急性问题，应使用当地紧急和医疗渠道，不应依据网页自行调整。", "en": "Mechanism reading cannot replace symptom assessment. With fainting, chest discomfort, pronounced palpitations, breathing difficulty, severe dizziness or another acute concern, use local urgent and medical care pathways rather than self-adjusting from a webpage." } ], "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；Clinical Pharmacology；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CARDIZEM LA", "generic": "盐酸地尔硫卓", "dosageFormClass": "盐酸地尔硫卓缓释口服片：120 mg、180 mg、240 mg、300 mg、360 mg、420 mg 每片（该美国公开标签所列）" }, "labelSource": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "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": "2026-08-23", "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": "2026-08-23", "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": "美国 DailyMed 当前 CARDIZEM LA 标签列出盐酸地尔硫卓缓释口服片及 120 mg 至 420 mg 的每片标示量。本页把品牌、通用名、缓释片、每片标示量、特定 NDC、瓶装面板与原始标签放在一起，帮助先核对身份；不把 mg、90 片瓶装或说明书中的转换文字变成个人片数、分片、停用、换药或联用方案。", "history": "DailyMed 当前美国公开标签列示 Initial U.S. Approval: 1982、NDA 021392 与 2025-11 更新。这里的历史和标签节点仅用于定位这一美国品牌缓释片档案；它不证明任何市场的原研/仿制关系、库存、当前可得性、个人适用性或可自行换药。", "sourceDocuments": [ { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "NDA 021392（DailyMed 当前美国公开标签所列；本档案不据此推定其他市场状态）", "approvalTimeline": [ { "date": "1982", "title": { "zh": "美国公开标签所列初始批准年份", "en": "Initial U.S. approval year listed in the public label" }, "detail": { "zh": "DailyMed 的 CARDIZEM LA 当前美国公开标签列示 Initial U.S. Approval: 1982。该年份只定位这份美国标签的历史信息；不建立中国大陆或其他市场的批准、供应、可售资格、原研/仿制关系、可替代性或个人适用性。", "en": "The current U.S. DailyMed public label for CARDIZEM LA lists Initial U.S. Approval: 1982. This year only locates this U.S. label history; it does not establish approval, supply, sale eligibility, originator/generic relationship, interchangeability or individual suitability in Mainland China or another market." }, "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2025-11-11", "title": { "zh": "DailyMed 当前美国公开标签更新", "en": "Current U.S. DailyMed public label updated" }, "detail": { "zh": "本档案以 DailyMed 当前公开标签核对 CARDIZEM LA、盐酸地尔硫卓缓释片、120–420 mg 每片标示量、各 90 片瓶装 NDC 与 120 mg 瓶装面板。它不建立实际在售、库存、购买、个人片数、频率、分片、调量或换药方案。", "en": "This dossier uses the current DailyMed public label to check CARDIZEM LA, diltiazem hydrochloride extended-release tablets, labelled 120–420 mg per tablet, the NDCs for 90-tablet bottles and a 120 mg bottle panel. It does not establish actual marketing, stock, purchase, individual tablet count, frequency, splitting, adjustment or switching." }, "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签、六个 90 片瓶装身份与一个准确瓶装面板", "en": "Current public label, six 90-tablet bottle identities and one exact bottle panel linked" }, "detail": { "zh": "本页分别记录 CARDIZEM LA 缓释片 120、180、240、300、360、420 mg 的特定 90 片瓶装 NDC，并展示 120 mg、NDC 0187-2045-90 的标签面板。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、频率、停用、换药或可替代性。", "en": "This page records specific 90-tablet bottle NDCs for CARDIZEM LA extended-release tablets at 120, 180, 240, 300, 360 and 420 mg and displays the 120 mg, NDC 0187-2045-90 label panel. It does not authenticate a product or establish actual marketing, stock, purchase, individual tablet count, frequency, stopping, switching or interchangeability." } }, { "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": "不从美国标签、SPL、NDA、NDC、英文商品名、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, SPL, NDA, NDC, English brand, package image or label holder; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "120、180、240、300、360、420 mg 能否按毫克数、瓶装数量或“同为地尔硫卓”自行互换？", "en": "Can 120, 180, 240, 300, 360 and 420 mg be self-exchanged by milligram number, bottle quantity or shared diltiazem name?" }, "answer": { "zh": "不能。它们是这份美国标签中分别列出的准确缓释片身份。网页不把产品数字变成个人片数、分片、咀嚼/研碎、补用、同日叠加、隔天轮换、替代或调整规则；请带着实际药盒、现行处方和完整药单交给药师或开方团队核对。", "en": "No. They are distinct extended-release tablet identities listed in this U.S. label. This page does not turn product numbers into individual tablet count, splitting, chewing/crushing, make-up use, same-day combination, alternate-day use, substitution or adjustment rules; take the actual pack, current prescription and complete medicine list to a pharmacist or prescribing team for review." } }, { "question": { "zh": "为什么本页强调“整片吞服”，却不告诉我是否能掰开或怎样换成另一种地尔硫卓？", "en": "Why does this page emphasise ‘swallow whole’ but not say whether I can split it or change to another diltiazem product?" }, "answer": { "zh": "当前标签对这一准确缓释片写有整片吞服、不可咀嚼或研碎的文字；但分片、吞咽困难、漏用、换剂型和转换涉及实际产品与个人处方。网页不应把标签中的处方转换资料变成自助操作；请由药师或开方团队按实际包装和完整药单确认。", "en": "The current label states that this exact extended-release tablet is swallowed whole and not chewed or crushed; however, splitting, swallowing difficulty, missed use, dosage-form changes and conversion involve the actual product and individual prescription. A webpage should not turn prescribing conversion text into self-service instructions; have a pharmacist or prescribing team confirm from the actual pack and complete medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/cardizem-la/", "en": "https://origindrug.com/en/drugs/cardizem-la/" }, "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." ] }