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effective 30 Apr 2026)" }, "dosageForm": { "zh": "盐酸可乐定普通口服片", "en": "clonidine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52817-182-00", "pouchCode": null, "applicationNumber": "ANDA 070923", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸可乐定 0.3 mg；1000 片瓶装", "en": "0.3 mg clonidine hydrochloride per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=clonidine-hydrochloride-07.jpg&setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸可乐定", "en": "clonidine hydrochloride" }, "value": 0.3, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、减量步骤，也不是与 CATAPRES-TTS 贴剂、缓释片、口服液、注射剂或复方片的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper step or conversion to a CATAPRES-TTS patch, extended-release tablet, oral solution, injection or combination tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "MP;659", "scoreStatus": "single_score_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-generic-clonidine-ir-0-05mg-100-tablet-bottle-ndc-5281718310", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0-0-5mg-label.jpg&setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba&type=img", "alt": "TruPharma 盐酸可乐定 0.05 mg、NDC 52817-183-10、100 片瓶装的 DailyMed 官方通用药标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国通用药标签（2026）", "presentation": "0.05 mg：黄色椭圆形、有刻痕、印有 05；NDC 52817-183-10，100 片瓶装。", "notice": "此图是当前通用药包装标签，不是 CATAPRES 历史原品牌包装；只对应 NDC 52817-183-10，不代表 0.1/0.2/0.3 mg、其他瓶数、贴剂、注射剂、缓释剂、口服液、复方、其他厂商或其他市场，也不用于鉴定真伪。", "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "盐酸可乐定说明书放大阅读：每片 mg、整瓶片数、嗜睡跌倒与突然停用反跳", "en": "Clonidine enlarged label: per-tablet mg, bottle count, somnolence/falls and rebound after abrupt withdrawal" }, "summary": { "zh": "0.05、0.1、0.2、0.3 mg 是每片含量；100、500、1000 Tablets 是整瓶片数。当前片剂有刻痕，但刻痕只是准确产品的外观线索，不自动构成掰片许可。网页也不把专业说明书中的剂量或停用段落转换为个人频次、片数、减量步骤或漏服方案。", "en": "The 0.05, 0.1, 0.2 and 0.3 mg figures are amounts per tablet; 100, 500 and 1000 Tablets are bottle counts. The current tablets are scored, but a score is an exact-product appearance clue and does not automatically permit splitting. The site does not turn professional dose or withdrawal text into an individual's frequency, tablet count, taper steps or missed-dose plan." }, "checks": [ { "zh": "嗜睡、镇静、疲倦、头晕、口干和便秘较常见；老人、夜间起身或同时使用其他镇静/降压药者应优先核对意识、步态、站立性血压与跌倒风险。严重嗜睡、晕厥、受伤或意识异常应使用当地急救。", "en": "Somnolence, sedation, fatigue, dizziness, dry mouth and constipation are common. Older adults, night-time rising or co-use of sedating/blood-pressure medicines requires priority review of alertness, gait, orthostatic pressure and falls. Severe somnolence, fainting, injury or altered awareness needs local emergency care." }, { "zh": "心动过缓、传导异常和低血压风险需要结合脉搏、症状与完整药单核对。若药单还有 β 受体阻滞剂、地高辛、维拉帕米、地尔硫䓬或其他影响心率/血压的药，不要自行错开、加减或先停其中一种。", "en": "Bradycardia, conduction abnormalities and hypotension require review with pulse, symptoms and the complete medicine list. If a beta blocker, digoxin, verapamil, diltiazem or another heart-rate/blood-pressure medicine is also present, do not self-space, adjust or choose one to stop first." }, { "zh": "突然停止可乐定后可出现血压快速升高、头痛、紧张或激越、震颤等反跳表现，少数严重事件可危及生命；风险在较高剂量或合用 β 受体阻滞剂时更需重视。不要根据网页突然停药，也不要让网页生成减量表。", "en": "Abrupt clonidine withdrawal can cause a rapid pressure rise, headache, nervousness or agitation and tremor; rare severe events can be life-threatening. Risk needs particular attention at higher doses or with a beta blocker. Do not abruptly stop from a webpage or ask it to generate a taper schedule." }, { "zh": "发生呕吐、无法进食饮水、漏药、住院、手术或药盒用尽时，应尽快联系开方团队或药师处理连续用药问题；网页不能推算补服、替代剂型或临时方案。", "en": "Vomiting, inability to eat or drink, missed medicine, hospital admission, surgery or an empty pack requires prompt contact with the prescriber or pharmacist about continuity. The site cannot calculate catch-up use, a substitute formulation or a temporary plan." }, { "zh": "酒精、安眠药、阿片类、抗焦虑药、镇静性抗组胺药或其他中枢抑制药可能增加嗜睡和反应受损。驾驶、操作机器或夜间独行前应按标签和专业建议确认个人反应，不要用网页给出‘安全’许可。", "en": "Alcohol, sleep medicines, opioids, anxiolytics, sedating antihistamines or other CNS depressants can add somnolence and impaired reactions. Confirm individual response under the label and professional advice before driving, operating machinery or walking alone at night; the site cannot issue a 'safe' permission." } ], "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "可乐定怎样影响血压：作用于脑干 α 肾上腺素能受体并降低交感神经输出", "en": "How clonidine affects blood pressure: brainstem alpha-adrenoreceptors and reduced sympathetic outflow" }, "summary": { "zh": "FDA 标签说明可乐定刺激脑干 α 肾上腺素能受体，降低中枢交感神经传出，并可降低外周阻力、心率和血压。这个机制有助理解嗜睡、低血压、心动过缓和突然停用反跳，但不能预测个人反应，也不能计算片数、频次、减量或剂型转换。", "en": "The FDA label says clonidine stimulates brainstem alpha-adrenoreceptors, reduces central sympathetic outflow, and can lower peripheral resistance, heart rate and blood pressure. This helps explain somnolence, hypotension, bradycardia and rebound after abrupt withdrawal, but cannot predict an individual's response or calculate tablet count, frequency, taper or formulation conversion." }, "checks": [ { "zh": "口服普通片、贴剂、缓释片、口服液和注射剂即使都含可乐定，也有不同释放方式、规格基础和用途；不能只按相同通用名或 mg 自行换算、拼接或替换。", "en": "Immediate-release tablets, patches, extended-release tablets, oral solution and injection can all contain clonidine yet differ in release, strength basis and use. A shared generic name or milligram figure does not permit self-conversion, assembly or substitution." }, { "zh": "共同降低血压或心率不代表可乐定能与 β 受体阻滞剂、部分钙通道阻滞剂、地高辛或其他降压药自行叠加；完整药单、脉搏、血压和症状需要一起核对。", "en": "A shared effect on pressure or heart rate does not permit self-combining clonidine with a beta blocker, certain calcium-channel blockers, digoxin or another antihypertensive. Review the complete list, pulse, pressure and symptoms together." }, { "zh": "机制不能决定谁应使用可乐定，也不能从一次家庭血压读数判断加量、减量或停药。网页只帮助识别准确产品、来源和说明书边界。", "en": "Mechanism cannot decide who should use clonidine or infer an increase, decrease or stop from one home pressure reading. The site only helps identify the exact product, source and label boundary." } ], "source": { "id": "src_9504fec72f88facb", "label": "FDA：CATAPRES（clonidine hydrochloride）NDA 017407 历史口服普通片标签（2009 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CATAPRES / clonidine oral", "generic": "盐酸可乐定普通片", "dosageFormClass": "盐酸可乐定普通口服片；不并入本档案包装身份的产品包括 CATAPRES-TTS 经皮给药系统、DURACLON 注射剂、KAPVAY/JENLOGA/NEXICLON XR 缓释制剂、JAVADIN 口服液、COMBIPRES 固定复方及其他含可乐定产品。共同通用名或 mg 数字不建立剂型换算、频次、减量、分片或替换结论。" }, "labelSource": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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." } }, { "source": { "id": "src_9504fec72f88facb", "label": "FDA：CATAPRES（clonidine hydrochloride）NDA 017407 历史口服普通片标签（2009 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "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": "2026-09-02", "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." } }, "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": "CATAPRES 是盐酸可乐定普通片的美国历史原研/RLD；本页可见包装属于当前通用药，不是原品牌。0.05/0.1/0.2/0.3 mg 是每片含量，100/500/1000 Tablets 是整瓶片数。说明书重点涉及嗜睡、镇静、口干、头晕、站立性低血压、心动过缓和跌倒，以及突然停用后的反跳性高血压、头痛、紧张/激越和震颤。网页不生成个人频次、减量、停药或剂型转换方案。", "history": "CATAPRES 口服片于 1974 年在美国获批。历史品牌 0.1、0.2、0.3 mg RLD 当前均为 DISCN，且并非因安全性或有效性撤回。DailyMed 当前页面则展示 ANDA 070923 的十个通用药瓶装身份，其中 0.05 mg 是当前通用药标签规格，不应倒写成历史 CATAPRES RLD。CATAPRES-TTS 贴剂、DURACLON 注射剂、缓释制剂、口服液与 COMBIPRES 复方均为不同准确产品。", "sourceDocuments": [ { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_9504fec72f88facb", "label": "FDA：CATAPRES（clonidine hydrochloride）NDA 017407 历史口服普通片标签（2009 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_bbd63a95cbbe6561", "label": "FDA：CATAPRES 口服普通片 NDA 017407 的 1974 年批准、RLD 与剂型历史（NDA 022331 审评）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022331s000_ChemR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "CATAPRES NDA 017407（历史原研/RLD）；clonidine hydrochloride ANDA 070923（当前通用药标签）", "approvalTimeline": [ { "date": "1974-09", "title": { "zh": "CATAPRES 口服普通片在美国获批", "en": "U.S. approval of CATAPRES immediate-release oral tablets" }, "detail": { "zh": "FDA 审评把 CATAPRES NDA 017407 记录为 1974 年 9 月批准的可乐定盐酸盐口服普通片，并列为 RLD。", "en": "FDA review records CATAPRES NDA 017407 as clonidine hydrochloride immediate-release oral tablets approved in Sep 1974 and identifies it as the RLD." }, "source": { "id": "src_bbd63a95cbbe6561", "label": "FDA：CATAPRES 口服普通片 NDA 017407 的 1974 年批准、RLD 与剂型历史（NDA 022331 审评）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022331s000_ChemR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2009", "title": { "zh": "FDA 历史 CATAPRES 标签版本", "en": "Historical FDA CATAPRES label version" }, "detail": { "zh": "FDA 保存 0.1、0.2、0.3 mg CATAPRES 口服片标签；用于历史与安全追溯，不代表当前品牌供应。", "en": "FDA preserves a label for CATAPRES 0.1, 0.2 and 0.3 mg oral tablets. It supports history and safety tracing and does not establish current brand supply." }, "source": { "id": "src_9504fec72f88facb", "label": "FDA：CATAPRES（clonidine hydrochloride）NDA 017407 历史口服普通片标签（2009 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-04-30", "title": { "zh": "当前 TruPharma 通用药标签生效", "en": "Current TruPharma generic label became effective" }, "detail": { "zh": "ANDA 070923 当前标签列出四个每片强度、十个瓶装 NDC 与六个准确包装面板。", "en": "The current label under ANDA 070923 lists four per-tablet strengths, ten bottle NDCs and six exact package panels." }, "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 CATAPRES 口服普通片", "en": "United States — CATAPRES immediate-release oral tablets" }, "status": { "zh": "历史原研/RLD，已停市", "en": "Historical originator/RLD; discontinued" }, "detail": { "zh": "NDA 017407；0.1、0.2、0.3 mg 当前均为 DISCN，且并非因安全性或有效性撤回。", "en": "NDA 017407; the 0.1, 0.2 and 0.3 mg rows are DISCN and not withdrawn for safety or effectiveness." } }, { "market": { "zh": "美国当前通用药", "en": "United States — current generic" }, "status": { "zh": "当前公开通用药标签", "en": "Current public generic label" }, "detail": { "zh": "ANDA 070923；0.05/0.1/0.2/0.3 mg，共十个瓶装 NDC；监管标签不等于实时库存。", "en": "ANDA 070923; 0.05/0.1/0.2/0.3 mg across ten bottle NDCs. A regulatory label is not live stock." } }, { "market": { "zh": "贴剂、注射剂、缓释剂、口服液与复方", "en": "Patch, injection, extended-release, oral solution and combination" }, "status": { "zh": "不同准确产品", "en": "Separate exact products" }, "detail": { "zh": "CATAPRES-TTS、DURACLON、KAPVAY/JENLOGA/NEXICLON XR、JAVADIN 与 COMBIPRES 不并入口服普通片包装，也不建立换算。", "en": "CATAPRES-TTS, DURACLON, KAPVAY/JENLOGA/NEXICLON XR, JAVADIN and COMBIPRES are not merged into the immediate-release oral packs and do not establish a conversion." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地品牌、规格、包装或供应", "en": "Local brand, strength, pack and supply are not established" }, "detail": { "zh": "必须按当地药监记录、现行说明书和手中药盒逐项核对。", "en": "Check the local regulator, current label and pack in hand item by item." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "照片里的是 CATAPRES 原研药瓶吗？", "en": "Is the pictured bottle the original CATAPRES product?" }, "answer": { "zh": "不是。图片是 TruPharma ANDA 070923 当前通用药包装面板；CATAPRES 只作为历史原研/RLD 身份展示，本页没有把通用药图片冒充原品牌。", "en": "No. The image is a current TruPharma generic package panel under ANDA 070923. CATAPRES is shown only as the historical originator/RLD identity, and no generic image is presented as the original brand." } }, { "question": { "zh": "有刻痕，是不是可以自己掰片或减量？", "en": "The tablet is scored. Can I split it or taper it myself?" }, "answer": { "zh": "不能由刻痕或算术自行决定。刻痕只帮助核对准确外观；分片、减量和停用还涉及处方、准确产品、个人情况和反跳风险，必须由负责团队或药师给出方案。", "en": "Not from a score or arithmetic alone. The score only helps check exact appearance. Splitting, tapering and stopping depend on the prescription, exact product, individual context and rebound risk and require the responsible team or pharmacist." } }, { "question": { "zh": "口服可乐定能直接换成 CATAPRES-TTS 贴剂吗？", "en": "Can oral clonidine be directly replaced with a CATAPRES-TTS patch?" }, "answer": { "zh": "网页不能这样决定。贴剂按每日标称释放量和一周经皮系统标示，口服片按每片 mg 标示；释放方式、起效时程和连续用药边界不同，不能用共同成分或数字自行换算。", "en": "The site cannot make that decision. The patch is labelled by nominal daily delivery from a one-week transdermal system, while oral tablets state milligrams per tablet. Release and time-course boundaries differ, so a shared ingredient or number cannot create a self-conversion." } }, { "question": { "zh": "为什么不能突然停可乐定？", "en": "Why should clonidine not be stopped abruptly?" }, "answer": { "zh": "标签记录突然停止后可能出现反跳性血压升高、头痛、紧张/激越和震颤，少数严重事件可危及生命。若漏药、呕吐、住院或药物即将用尽，应尽快联系开方团队或药师，而不是由网页生成补服或减量表。", "en": "The label records rebound pressure elevation, headache, nervousness/agitation and tremor after abrupt withdrawal, with rare life-threatening events. Missed medicine, vomiting, hospital admission or a nearly empty supply needs prompt prescriber or pharmacist contact rather than a web-generated catch-up or taper schedule." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/catapres-clonidine-oral/", "en": "https://origindrug.com/en/drugs/catapres-clonidine-oral/" }, "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." ] }