{ "id": "cleocin-hcl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "CLEOCIN HCl", "generic": "盐酸克林霉素", "aliases": [ "Cleocin Hydrochloride", "盐酸克林霉素胶囊", "克林霉素胶囊", "clindamycin", "clindamycin hydrochloride", "盐酸克林霉素", "克林霉素", "0009-0331-02", "0009-0225-02", "0009-0395-14", "Cleocin 75 mg", "Cleocin 150 mg", "Cleocin 300 mg" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 DailyMed 当前 CLEOCIN HCl 口服胶囊标签（2026-04-08 更新；2026-04-09 发布，SPL v40；NDA 050162）", "dosageFormClass": "盐酸克林霉素口服胶囊：每粒相当于克林霉素 75 mg、150 mg 或 300 mg；分别展示三个 100 粒瓶装面板", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1970", "archiveSponsorText": "Pharmacia & Upjohn Company LLC（DailyMed 当前标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "CLEOCIN PHOSPHATE", "CLEOCIN T", "CLEOCIN vaginal cream", "clindamycin phosphate injection" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cleocin-hcl-clindamycin-75mg-100-capsule-bottle-ndc-0009-0331-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-04-08 更新；2026-04-09 发布，SPL v40）", "en": "Current U.S. DailyMed public label (updated 8 Apr 2026; published 9 Apr 2026, SPL v40)" }, "dosageForm": { "zh": "CLEOCIN HCl 盐酸克林霉素口服胶囊", "en": "CLEOCIN HCl clindamycin hydrochloride oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0331-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于克林霉素 75 mg；100 粒瓶装", "en": "Equivalent to clindamycin 75 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cleocin-03.jpg&setid=df9a2a41-b132-4f43-8940-b2d773b1369a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克林霉素（以盐酸克林霉素提供）", "en": "clindamycin (supplied as clindamycin hydrochloride)" }, "value": 75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "胶囊，约 16 mm，无刻痕", "en": "capsule, approximately 16 mm, unscored" }, "imprint": "Cleocin / 75 / mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 75 mg、NDC 0009-0331-02、100 粒瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cleocin-hcl-clindamycin-150mg-100-capsule-bottle-ndc-0009-0225-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-04-08 更新；2026-04-09 发布，SPL v40）", "en": "Current U.S. DailyMed public label (updated 8 Apr 2026; published 9 Apr 2026, SPL v40)" }, "dosageForm": { "zh": "CLEOCIN HCl 盐酸克林霉素口服胶囊", "en": "CLEOCIN HCl clindamycin hydrochloride oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0225-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于克林霉素 150 mg；100 粒瓶装", "en": "Equivalent to clindamycin 150 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cleocin-04.jpg&setid=df9a2a41-b132-4f43-8940-b2d773b1369a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克林霉素（以盐酸克林霉素提供）", "en": "clindamycin (supplied as clindamycin hydrochloride)" }, "value": 150, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色与绿色", "en": "light blue and green" }, "shape": { "zh": "胶囊，约 19 mm，无刻痕", "en": "capsule, approximately 19 mm, unscored" }, "imprint": "Cleocin / 150 / mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 150 mg、NDC 0009-0225-02、100 粒瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cleocin-hcl-clindamycin-300mg-100-capsule-bottle-ndc-0009-0395-14", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-04-08 更新；2026-04-09 发布，SPL v40）", "en": "Current U.S. DailyMed public label (updated 8 Apr 2026; published 9 Apr 2026, SPL v40)" }, "dosageForm": { "zh": "CLEOCIN HCl 盐酸克林霉素口服胶囊", "en": "CLEOCIN HCl clindamycin hydrochloride oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0395-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于克林霉素 300 mg；100 粒瓶装", "en": "Equivalent to clindamycin 300 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cleocin-05.jpg&setid=df9a2a41-b132-4f43-8940-b2d773b1369a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克林霉素（以盐酸克林霉素提供）", "en": "clindamycin (supplied as clindamycin hydrochloride)" }, "value": 300, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "胶囊，约 22 mm，无刻痕", "en": "capsule, approximately 22 mm, unscored" }, "imprint": "Cleocin / 300 / mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 300 mg、NDC 0009-0395-14、100 粒瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-cleocin-hcl-clindamycin-150mg-100-capsule-bottle-ndc-0009-0225-02", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cleocin-04.jpg&setid=df9a2a41-b132-4f43-8940-b2d773b1369a&type=img", "alt": "CLEOCIN HCl 盐酸克林霉素 150 mg、100 粒瓶装在美国 DailyMed 当前标签中的主展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v40（2026-04-09 发布）", "presentation": "CLEOCIN HCl 150 mg、NDC 0009-0225-02、100 粒瓶装主展示面", "notice": "此图只对应当前美国标签中的一个准确 150 mg、100 粒瓶装面板，用于核对品牌、通用名、每粒标示量、NDC 与包装数量；不用于鉴定真伪，也不证明另一规格、剂型、包装、市场、库存、购买资格或可替代性。", "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CLEOCIN HCl 说明书放大阅读：先分清每粒 mg、胶囊和严重腹泻警示", "en": "CLEOCIN HCl label reading: separate mg per capsule, the capsule form and the serious-diarrhoea warning" }, "summary": { "zh": "当前美国标签设有黑框警示，并分别列出 75、150、300 mg 口服胶囊。本模块帮助普通读者识别准确产品、找到需要立即求助的症状，并把个人问题带回处方和专业复核；不提供个人粒数、间隔或疗程。", "en": "The current U.S. label has a boxed warning and separately lists 75, 150 and 300 mg oral capsules. This module helps ordinary readers identify the exact product, recognise symptoms requiring prompt help and return individual questions to the prescription and professional review; it gives no personal capsule count, interval or course." }, "checks": [ { "zh": "75、150、300 mg 是每粒胶囊中相当于克林霉素的标签标示量，不是一天几粒，也不能只看总毫克数自行拿多粒小规格替代大规格、掰开胶囊或拼接疗程。", "en": "75, 150 and 300 mg are the labelled clindamycin-equivalent amounts per capsule. They do not state capsules per day and do not permit self-substituting several smaller capsules for a larger one, opening a capsule or assembling a course from a total milligram number." }, { "zh": "当前标签要求胶囊用一整杯水送服，并在躺下前至少留出 30 分钟，以降低食管刺激风险。网页只转述这一产品级标签阅读点；若吞咽困难、使用方法不清楚或实际产品不同，应先联系药师或开方团队。", "en": "The current label says to take the capsules with a full glass of water and at least 30 minutes before lying down to reduce oesophageal irritation. The site only relays this product-level label point; swallowing difficulty, uncertainty or a different product requires pharmacist or prescriber review first." }, { "zh": "标签的黑框警示说明艰难梭菌相关腹泻可发生并可能严重，症状也可能在抗菌药使用结束后出现。严重、持续或带血腹泻，明显腹痛、发热、脱水、虚弱或其他急性严重不适需要尽快使用当地医疗支持；不要自行用止泻药掩盖。", "en": "The boxed warning explains that C. difficile-associated diarrhoea can occur, may be severe and can appear after antibacterial treatment has ended. Severe, persistent or bloody diarrhoea, marked abdominal pain, fever, dehydration, weakness or another acute serious concern needs prompt local medical care; do not self-use an antidiarrhoeal medicine to mask it." }, { "zh": "CLEOCIN HCl 口服胶囊、CLEOCIN PHOSPHATE 注射剂、CLEOCIN T 外用产品和阴道用产品的成分表示、剂型、途径与标签不同；名称相近不能证明可以互换、叠加或改用。", "en": "CLEOCIN HCl oral capsules, CLEOCIN PHOSPHATE injections, CLEOCIN T topical products and vaginal products have different ingredient wording, forms, routes and labels. Similar names do not establish interchangeability, co-use or switching." } ], "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "克林霉素怎样起作用：抑制细菌蛋白质合成，不等于对所有感染都有效", "en": "How clindamycin works: inhibiting bacterial protein synthesis does not mean it treats every infection" }, "summary": { "zh": "当前美国标签的微生物学部分说明，克林霉素与细菌核糖体 50S 亚基结合并抑制蛋白质合成。机制用于解释药物类别，不能仅凭症状判断感染原因、是否敏感、该不该使用或需要多长疗程。", "en": "The microbiology section of the current U.S. label states that clindamycin binds to the bacterial 50S ribosomal subunit and inhibits protein synthesis. This explains the drug class; symptoms alone cannot identify the cause, susceptibility, whether it should be used or for how long." }, "checks": [ { "zh": "抗菌药不治疗普通病毒性感冒。相似的发热、咳嗽、咽痛、牙痛或皮肤不适可能有不同原因，不应拿剩药、与家人共用、交替吃或自行拼疗程。", "en": "Antibacterials do not treat an ordinary viral cold. Similar fever, cough, sore throat, dental pain or skin symptoms can have different causes, so do not use leftovers, share, alternate products or assemble a course yourself." }, { "zh": "标签提示克林霉素与某些药物存在代谢或药效相互作用。网页不从药名列表自动决定能否同服；应把处方药、非处方药、止泻药、补充剂、过敏史和既往严重腹泻一起交给药师或开方团队核对。", "en": "The label notes metabolic or pharmacologic interactions with some medicines. The site does not decide co-use from a name list; give the pharmacist or prescriber all prescriptions, OTC products, antidiarrhoeals, supplements, allergies and any history of severe diarrhoea for review." }, { "zh": "机制相同或同属抗菌药不表示 CLEOCIN HCl 可以与阿莫西林、阿奇霉素、左氧氟沙星或其他抗菌药自行替换、叠加或轮换；准确病原、敏感性、感染部位、器官功能和完整药单都可能改变专业判断。", "en": "A shared mechanism or antibacterial category does not make CLEOCIN HCl self-switchable, combinable or alternatable with amoxicillin, azithromycin, levofloxacin or another antibacterial. The organism, susceptibility, infection site, organ function and complete medicine list can all change professional decisions." } ], "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CLEOCIN HCl", "generic": "盐酸克林霉素", "dosageFormClass": "盐酸克林霉素口服胶囊：每粒相当于克林霉素 75 mg、150 mg 或 300 mg；分别展示三个 100 粒瓶装面板" }, "labelSource": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "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": "2026-08-28", "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": "2026-08-28", "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": "CLEOCIN HCl 当前美国公开标签列有 75 mg、150 mg、300 mg 三种口服胶囊。本档案把每粒标示量、NDC、颜色、刻字、包装面板、黑框警示和吞服注意放在一起放大阅读；不把包装上的 mg 变成任何人的粒数、频率或疗程。", "history": "DailyMed 当前标签把 CLEOCIN HCl 与 NDA 050162 及 1970-05-22 的美国营销起始记录相连。这里的年份只定位美国监管档案；CLEOCIN PHOSPHATE 注射剂、CLEOCIN T 外用产品及阴道用产品是不同剂型和途径，不并入本口服胶囊档案。", "sourceDocuments": [ { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "NDA 050162（CLEOCIN HCl / clindamycin hydrochloride oral capsules）", "approvalTimeline": [ { "date": "1970-05-22", "title": { "zh": "当前 DailyMed 产品记录所列美国 NDA 营销起始节点", "en": "U.S. NDA marketing-start node listed in the current DailyMed product record" }, "detail": { "zh": "当前标签的三个胶囊产品表均列出 NDA 050162 与 1970-05-22 营销起始日期。该节点只定位这一美国口服胶囊档案，不建立其他市场的批准、供应、原研/仿制关系或个人适用性。", "en": "All three capsule product tables in the current label list NDA 050162 and a marketing start date of 22 May 1970. This node locates this U.S. oral-capsule record only; it does not establish approval, supply, originator/generic relationship or individual suitability in another market." }, "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-04-09", "title": { "zh": "DailyMed 当前 SPL v40 发布", "en": "Current DailyMed SPL v40 published" }, "detail": { "zh": "DailyMed 将当前标签的更新日期列为 2026-04-08，SPL v40 发布日期列为 2026-04-09。该日期定位文件版本；它不是任何人的开始用药日、频次、疗程或库存结论。", "en": "DailyMed lists the current label as updated 8 Apr 2026 and SPL v40 as published 9 Apr 2026. The date identifies the document version; it is not anyone's start date, frequency, course or a stock finding." }, "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前口服胶囊标签和三个准确瓶装面板", "en": "Current oral-capsule label and three exact bottle panels linked" }, "detail": { "zh": "本页分别记录 75、150、300 mg 胶囊的 NDC、颜色、刻字与 100 粒瓶装面板。标签页面存在不等于任何地点有库存、可购买、适合个人或可以自行换规格。", "en": "The dossier separately records the NDC, colour, imprint and 100-capsule bottle panel for 75, 150 and 300 mg capsules. A label page does not establish local stock, purchase availability, individual suitability or self-switching between strengths." } }, { "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、品牌名、NDA、包装面板或共同通用名推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, brand, NDA, package panel or shared generic name." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "包装写 150 mg，是否就表示一次吃一粒？", "en": "Does 150 mg on the pack mean one capsule per dose?" }, "answer": { "zh": "不是。150 mg 只是这粒准确胶囊中相当于克林霉素的标签标示量；个人粒数、频率、疗程与是否适用必须来自准确处方，并结合感染、过敏史、器官功能和完整药单由专业人员确认。", "en": "No. 150 mg is only the labelled clindamycin-equivalent amount in this exact capsule. Individual capsule count, frequency, course and suitability must come from the exact prescription and professional review of the infection, allergy history, organ function and complete medicine list." } }, { "question": { "zh": "胶囊太大，可以打开、倒出一半或混进食物吗？", "en": "If the capsule is too large, can it be opened, halved or mixed into food?" }, "answer": { "zh": "不要自行这样做。当前标签把 CLEOCIN HCl 定义为整粒口服胶囊，并强调足量水和躺下前间隔；页面没有证据把打开胶囊、目测分一半或混食物写成安全替代方法。请在改变前让药师或开方团队核对是否有适合的准确剂型和方案。", "en": "Do not do this yourself. The current label defines CLEOCIN HCl as an oral capsule and emphasises a full glass of water and time before lying down. The page has no evidence to present opening, visually halving or mixing the capsule as a safe alternative. Ask a pharmacist or prescriber to check an exact suitable form and plan before changing it." } } ], "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/cleocin-hcl/", "en": "https://origindrug.com/en/drugs/cleocin-hcl/" }, "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." ] }