{ "id": "amitiza", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "AMITIZA", "generic": "鲁比前列酮", "aliases": [ "Amitiza", "lubiprostone", "鲁比前列酮", "鲁比前列酮胶囊", "ルビプロストン", "lubiprostone capsules", "NDA 021908", "23635-508-60", "23635-524-60", "AMITIZA 8 mcg", "AMITIZA 24 mcg", "pink oval SPI", "orange oval SPI" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国：DailyMed 当前标签列出 AMITIZA 8 mcg 粉红色与 24 mcg 橙色软明胶胶囊，均为 60 粒瓶装；FDA Orange Book 将两种规格均列为处方 RLD，并将 24 mcg 列为 RS。中国大陆及其他市场的现行批准、商品名、包装和供应须另行逐项建立，不能从美国品牌或颜色推定。", "dosageFormClass": "鲁比前列酮口服软明胶胶囊：8 mcg 与 24 mcg；必须整粒吞服，不得掰开、剪开、刺破、挤出、咀嚼或目测取半", "dosageFormClassCode": "oral_solid", "route": "口服（完整软明胶胶囊）", "routeCode": "oral", "historicalApprovalEntry": "2006-01-31（美国 24 mcg 初始批准）；2008-04-29（美国 8 mcg 批准）", "archiveSponsorText": "Sucampo Pharma Americas LLC（FDA Orange Book 申请主体）；SpecGx LLC（当前 DailyMed 标签包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "AMITIZA", "Amitiza", "鲁比前列酮胶囊" ], "excludedProductCues": [ "generic lubiprostone capsule", "其他厂牌鲁比前列酮胶囊", "LINZESS", "linaclotide", "MiraLAX", "polyethylene glycol 3350", "DULCOLAX", "bisacodyl", "lactulose", "senna", "magnesium laxatives" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-amitiza-lubiprostone-8mcg-60-capsule-bottle-ndc-2363550860", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v4；2026-07-10 生效）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed brand label (SPL v4; effective 10 Jul 2026); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "AMITIZA 鲁比前列酮口服软明胶胶囊", "en": "AMITIZA lubiprostone oral soft gelatin capsule" }, "route": { "zh": "口服（完整胶囊）", "en": "oral (whole capsule)" }, "routeCodes": [ "oral" ], "productCode": "NDC 23635-508-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒鲁比前列酮 8 mcg；60 粒瓶装", "en": "Lubiprostone 8 mcg per capsule; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=amitiza-02.jpg&setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "鲁比前列酮", "en": "lubiprostone" }, "value": 8, "unit": "mcg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人一次粒数、频率、疗程或加减量指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形软明胶胶囊，约 9 mm；胶囊接缝不是可分剂量刻痕", "en": "oval soft gelatin capsule, about 9 mm; the capsule seam is not a dose-dividing score" }, "imprint": "SPI", "scoreStatus": "capsule_not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amitiza-lubiprostone-24mcg-60-capsule-bottle-ndc-2363552460", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v4；2026-07-10 生效）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed brand label (SPL v4; effective 10 Jul 2026); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "AMITIZA 鲁比前列酮口服软明胶胶囊", "en": "AMITIZA lubiprostone oral soft gelatin capsule" }, "route": { "zh": "口服（完整胶囊）", "en": "oral (whole capsule)" }, "routeCodes": [ "oral" ], "productCode": "NDC 23635-524-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒鲁比前列酮 24 mcg；60 粒瓶装", "en": "Lubiprostone 24 mcg per capsule; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=amitiza-03.jpg&setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "鲁比前列酮", "en": "lubiprostone" }, "value": 24, "unit": "mcg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人一次粒数、频率、疗程或加减量指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "椭圆形软明胶胶囊，约 9 mm；胶囊接缝不是可分剂量刻痕", "en": "oval soft gelatin capsule, about 9 mm; the capsule seam is not a dose-dividing score" }, "imprint": "SPI", "scoreStatus": "capsule_not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-amitiza-lubiprostone-8mcg-60-capsule-bottle-ndc-2363550860", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=amitiza-02.jpg&setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4&type=img", "alt": "AMITIZA 鲁比前列酮 8 mcg、NDC 23635-508-60、60 粒瓶装的美国 DailyMed 官方标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v4；2026-07-10 生效", "presentation": "AMITIZA 每粒鲁比前列酮 8 mcg，粉红色椭圆形软明胶胶囊，印有 SPI，NDC 23635-508-60，60 粒瓶装。", "notice": "此图只对应当前美国标签中的 8 mcg、NDC 23635-508-60、60 粒瓶装；不代表 24 mcg、其他厂牌、其他市场包装、实时库存或个人粒数，不用于鉴定真伪。", "source": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AMITIZA 说明书放大阅读：微克、整粒软胶囊、腹泻与低血压", "en": "AMITIZA label reading: micrograms, whole softgel, diarrhoea and low blood pressure" }, "summary": { "zh": "先核对 AMITIZA、鲁比前列酮、8 或 24 mcg、粉红／橙色、SPI 印字和准确 NDC。不要把微克看成毫克，也不要把 60 粒瓶装误当一次使用数量。", "en": "Check AMITIZA, lubiprostone, 8 or 24 mcg, pink/orange colour, SPI imprint and the exact NDC. Do not read micrograms as milligrams or mistake a 60-capsule bottle count for an amount to take." }, "checks": [ { "zh": "8 mcg 与 24 mcg 是每粒强度；1 mg 等于 1,000 mcg 只是单位关系。不要按颜色、数字或既往药盒自行改规格、加粒数或轮换。", "en": "8 mcg and 24 mcg are strengths per capsule; 1 mg equals 1,000 mcg as a unit relationship only. Do not self-change strength, capsule count or alternate products from colour, numbers or a previous pack." }, { "zh": "当前标签要求整粒吞服，不得掰开或咀嚼。软胶囊没有可取半的刻痕；不要剪开、刺破、挤出、吸取或保存部分内容物。吞咽困难应先联系药师或开方团队寻找准确替代路径。", "en": "The current label says to swallow capsules whole and not break apart or chew. A softgel has no score for taking half; do not cut, puncture, squeeze out, measure or store part of its contents. For swallowing difficulty, first contact a pharmacist or prescribing team for an exact alternative route." }, { "zh": "标签要求与食物和水同服，并提示食物可能减轻恶心。网页不把这条转成个人时间表；持续恶心、呕吐、无法进食饮水或症状加重时应联系治疗团队。", "en": "The label says to take it with food and water and notes that food may reduce nausea. The site does not turn this into a personal timetable; contact the care team for persistent nausea, vomiting, inability to eat or drink, or worsening symptoms." }, { "zh": "标签提示严重腹泻时不要继续使用并联系医务人员；腹泻或呕吐可能伴随晕厥和低血压。老人、近期脱水或同时使用降压药者出现明显头晕、站立不稳或晕厥，应尽快取得专业评估；意识异常、严重气促或其他急性严重表现应立即使用当地急救。", "en": "The label says not to use it during severe diarrhoea and to contact a healthcare provider; diarrhoea or vomiting may occur with syncope and hypotension. Older people, those recently dehydrated or taking blood-pressure-lowering medicines should obtain prompt assessment for marked dizziness, unsteadiness or fainting; use local emergency care immediately for altered consciousness, severe breathlessness or another acute severe feature." }, { "zh": "已知或怀疑机械性胃肠梗阻属于禁忌边界，不是靠多吃泻药处理的普通便秘。明显腹胀并持续加重、反复呕吐、剧烈腹痛、不能排气排便或其他急性危险表现应立即就医。", "en": "Known or suspected mechanical gastrointestinal obstruction is a contraindication boundary, not ordinary constipation to treat by adding laxatives. Seek urgent care for progressively severe distension, repeated vomiting, severe abdominal pain, inability to pass stool or gas, or another acute warning feature." }, { "zh": "把 MiraLAX／聚乙二醇、乳果糖、比沙可啶、番泻叶、含镁泻药、其他处方泻药、降压药、阿片类与补充剂列在同一张药单上。不要自行叠加、轮换或停掉其中一种；标签还提示二苯庚烷类阿片（如美沙酮）可能降低鲁比前列酮作用。", "en": "Put MiraLAX/polyethylene glycol, lactulose, bisacodyl, senna, magnesium laxatives, other prescription laxatives, blood-pressure medicines, opioids and supplements on one list. Do not self-combine, alternate or stop one; the label also notes that diphenylheptane opioids such as methadone may reduce lubiprostone's effect." } ], "source": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "鲁比前列酮怎样起作用：局部激活氯离子通道，增加肠腔液体", "en": "How lubiprostone works: local chloride-channel activation increases intestinal fluid" }, "summary": { "zh": "当前标签将鲁比前列酮描述为局部作用的氯离子通道激活剂，可激活肠上皮顶端膜的 ClC-2 通道并增加富含氯离子的肠液分泌。机制帮助理解软化和推进边界，但不能诊断便秘原因或生成个人方案。", "en": "The current label describes lubiprostone as a locally acting chloride-channel activator that activates apical ClC-2 channels and increases chloride-rich intestinal fluid secretion. The mechanism helps explain the softening and transit boundary but cannot diagnose the cause of constipation or generate an individual regimen." }, "checks": [ { "zh": "AMITIZA 与 LINZESS、MiraLAX、DULCOLAX、乳果糖或番泻叶并非同一种药；不能从‘都通便’推导叠加、轮换或毫克／微克换算。", "en": "AMITIZA is not the same medicine as LINZESS, MiraLAX, DULCOLAX, lactulose or senna. A shared constipation context does not justify combining, alternating or milligram/microgram conversion." }, { "zh": "药物机制不能排除梗阻、出血、感染、代谢异常或其他病因。新出现或明显改变的排便问题，尤其伴随危险表现，应由专业人员评估。", "en": "A mechanism cannot rule out obstruction, bleeding, infection, metabolic disease or another cause. New or markedly changed bowel symptoms, especially with warning features, require professional assessment." }, { "zh": "评价效果和不适时应同时记录实际药盒、开始时间、饮水与进食变化、其他泻药、阿片类、降压药、腹泻、头晕和跌倒，而不是只记录‘便秘好没好’。", "en": "When reviewing benefit and harm, record the actual pack, start date, changes in intake, other laxatives, opioids, blood-pressure medicines, diarrhoea, dizziness and falls—not only whether constipation improved." } ], "source": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "AMITIZA", "generic": "鲁比前列酮", "dosageFormClass": "鲁比前列酮口服软明胶胶囊：8 mcg 与 24 mcg；必须整粒吞服，不得掰开、剪开、刺破、挤出、咀嚼或目测取半" }, "labelSource": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：AMITIZA NDA 021908 的 24 mcg 与 8 mcg 均列为处方 RLD；24 mcg 同时为 RS（数据复核日 2026-08-30）", "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": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "AMITIZA 是鲁比前列酮软明胶胶囊。普通人先看四件事：8 和 24 的单位是 mcg（微克），60 是每瓶粒数；软胶囊必须整粒吞服，不能剪开挤出一半；标签要求与食物和水同服；严重腹泻、呕吐、头晕、晕厥、低血压或呼吸困难需要及时联系专业人员。老人或同时使用降压药、其他泻药、阿片类药物时，更应把完整药单与实际药盒一起核对。网页不生成个人粒数、频次、疗程、加量、减量或换药方案。", "history": "FDA Orange Book 记录 AMITIZA 24 mcg 于 2006-01-31 批准，8 mcg 于 2008-04-29 批准。当前 DailyMed 标签 SPL v4 于 2026-07-10 生效，列出两个准确 NDC 和软胶囊外观。历史批准节点不代表任何地区当前有货，也不能代替现行处方、当地说明书和个人用药评估。", "sourceDocuments": [ { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：AMITIZA NDA 021908 的 24 mcg 与 8 mcg 均列为处方 RLD；24 mcg 同时为 RS（数据复核日 2026-08-30）", "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" }, { "id": "src_a1347c842989dea8", "label": "FDA Drugs@FDA：AMITIZA NDA 021908 产品与批准记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021908", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "approval_history", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 021908（AMITIZA／lubiprostone capsules）", "approvalTimeline": [ { "date": "2006-01-31", "title": { "zh": "FDA 批准 AMITIZA 24 mcg", "en": "FDA approved AMITIZA 24 mcg" }, "detail": { "zh": "Orange Book 当前产品 001 记录 24 mcg 处方胶囊为 RLD 与 RS。", "en": "Current Orange Book product 001 records the 24 mcg prescription capsule as both RLD and RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：AMITIZA NDA 021908 的 24 mcg 与 8 mcg 均列为处方 RLD；24 mcg 同时为 RS（数据复核日 2026-08-30）", "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": "2008-04-29", "title": { "zh": "FDA 批准 AMITIZA 8 mcg", "en": "FDA approved AMITIZA 8 mcg" }, "detail": { "zh": "Orange Book 当前产品 002 记录 8 mcg 处方胶囊为 RLD，RS 为 No。", "en": "Current Orange Book product 002 records the 8 mcg prescription capsule as RLD with RS marked No." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：AMITIZA NDA 021908 的 24 mcg 与 8 mcg 均列为处方 RLD；24 mcg 同时为 RS（数据复核日 2026-08-30）", "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": "2026-07-10", "title": { "zh": "当前 DailyMed 标签生效", "en": "Current DailyMed label became effective" }, "detail": { "zh": "SPL v4 列出两个准确 NDC、60 粒瓶装、SPI 印字、整粒吞服规则及当前安全信息。", "en": "SPL v4 lists two exact NDCs, 60-capsule bottles, SPI imprint, whole-capsule rule and current safety information." }, "source": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "两种处方 RLD 规格当前列示；两个准确 60 粒瓶装面板", "en": "Two prescription RLD strengths currently listed; two exact 60-capsule bottle panels" }, "detail": { "zh": "NDC 23635-508-60 对应 8 mcg 粉红色软胶囊；NDC 23635-524-60 对应 24 mcg 橙色软胶囊。监管在册和图像不证明药房实时库存、购买资格或个人适用性。", "en": "NDC 23635-508-60 is the 8 mcg pink softgel; NDC 23635-524-60 is the 24 mcg orange softgel. Regulatory listing and images do not establish live pharmacy stock, purchasing eligibility or individual suitability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行产品记录", "en": "Current product record not established" }, "detail": { "zh": "不从美国品牌、NDA、软胶囊颜色或微克数字推定当地批准、商品名、供应、原研／参比关系或可替代性。", "en": "No local approval, brand, supply, originator/reference relationship or interchangeability is inferred from a U.S. brand, NDA, softgel colour or microgram figure." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "AMITIZA 软胶囊可以剪开吃一半吗？", "en": "Can an AMITIZA softgel be cut and half taken?" }, "answer": { "zh": "不能。当前标签要求整粒吞服，不得掰开或咀嚼；也不要刺破、挤出或目测取半。吞咽困难请让药师或开方团队核对可用的准确替代路径。", "en": "No. The current label says to swallow it whole and not break apart or chew; do not puncture, squeeze out or estimate half. Ask a pharmacist or prescribing team to check an exact alternative route for swallowing difficulty." } }, { "question": { "zh": "8 mcg 和 24 mcg 可以自己换吗？", "en": "Can I switch between 8 mcg and 24 mcg myself?" }, "answer": { "zh": "不能。它们是每粒不同强度，适用边界和个人方案须由熟悉病情的专业人员按当前说明书核对。网页不提供换算、加粒或减粒指令。", "en": "No. They are different strengths per capsule; the relevant use boundary and individual plan require a professional who knows the clinical context and current label. The site provides no conversion or capsule-count adjustment." } }, { "question": { "zh": "还能同时用 MiraLAX、乳果糖或比沙可啶吗？", "en": "Can MiraLAX, lactulose or bisacodyl be used at the same time?" }, "answer": { "zh": "网页不能据此给个人合用结论。请把所有处方药、非处方泻药、补充剂、排便记录、腹泻和头晕情况交给医生或药师核对，避免重复作用与脱水。", "en": "The site cannot make an individual co-use decision. Give the clinician or pharmacist every prescription medicine, OTC laxative, supplement, bowel record, diarrhoea and dizziness detail to review for duplication and dehydration." } }, { "question": { "zh": "老人吃降压药后又腹泻、头晕怎么办？", "en": "What if an older person taking blood-pressure medicine develops diarrhoea and dizziness?" }, "answer": { "zh": "应尽快联系治疗团队。标签提示腹泻或呕吐可伴随晕厥和低血压，降压药可能增加风险；明显站立不稳、晕厥、意识异常或严重气促应立即使用当地急救。", "en": "Contact the care team promptly. The label notes syncope and hypotension with diarrhoea or vomiting, and blood-pressure-lowering medicines may increase risk. Use local emergency care immediately for marked unsteadiness, fainting, altered consciousness or severe breathlessness." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "family-medicine-list-for-pharmacist", "medicine-review-for-older-adults" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/amitiza/", "en": "https://origindrug.com/en/drugs/amitiza/" }, "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." ] }