{ "id": "klor-con", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "KLOR-CON", "generic": "氯化钾", "aliases": [ "Klor-Con", "氯化钾缓释片", "氯化钾缓释片剂", "potassium chloride extended-release tablets", "Klor-Con 8", "Klor-Con 10", "potassium chloride", "potassium chloride extended release", "氯化钾", "KLOR-CON 8", "KLOR-CON 10", "NDA 019123", "0245-5315-11", "0245-5316-11", "KC 8", "KC 10", "8 mEq 600 mg", "10 mEq 750 mg" ], "marketBrandNames": [ { "name": "KLOR-CON", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 019123；8 mEq 与 10 mEq 均为处方 RLD，10 mEq 同时为 RS；当前标签有两个准确 100 片瓶装面板。", "en": "NDA 019123; both 8 mEq and 10 mEq are prescription RLD products, with 10 mEq also listed as RS; the current label has two exact 100-tablet bottle panels." }, "source": { "id": "src_b862263240da2496", "label": "FDA Drugs@FDA：KLOR-CON NDA 019123 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019123", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 NDA 品牌标签列 KLOR-CON 8 mEq（600 mg 氯化钾）与 10 mEq（750 mg 氯化钾）薄膜衣缓释片及两个准确 100 片瓶装面板。FDA Orange Book 当前将两规格列为处方 RLD，并将 10 mEq 列为 RS。公开标签和 RLD 状态不证明实时库存、购买资格、个人需要补钾或可与 KLOR-CON M、溶液、粉剂、注射剂互换。", "dosageFormClass": "氯化钾蜡基质薄膜衣缓释口服片：每片 8 mEq（600 mg 氯化钾）或 10 mEq（750 mg 氯化钾）；必须整片吞服，不得压碎、咀嚼或含吮；不是 KLOR-CON M 微囊化缓释片", "dosageFormClassCode": "oral_modified_release", "route": "口服（高风险电解质准确产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "1948（当前标签所列美国初始批准）；1986-04-17（NDA 019123 准确产品批准）", "archiveSponsorText": "Upsher-Smith Laboratories, LLC（DailyMed 当前标签与 FDA Orange Book 当前申请主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "KLOR-CON M", "Klor-Con M10", "Klor-Con M15", "Klor-Con M20", "potassium chloride oral solution", "potassium chloride powder", "potassium chloride injection" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-klor-con-potassium-chloride-8meq-600mg-100-tablet-bottle-ndc-0245531511", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布；处方信息 2018-10 修订）", "en": "Current U.S. DailyMed NDA brand label (SPL v6; published 16 Jul 2025; prescribing information revised Oct 2018)" }, "dosageForm": { "zh": "KLOR-CON 氯化钾薄膜衣缓释口服片", "en": "KLOR-CON potassium chloride film-coated extended-release oral tablet" }, "route": { "zh": "口服（完整缓释片产品身份字段）", "en": "oral (intact extended-release tablet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0245-5315-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯化钾 600 mg，相当于钾 8 mEq；100 片瓶装", "en": "Potassium chloride 600 mg, equivalent to potassium 8 mEq per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=klor-con-01.jpg&setid=1ff53330-065c-4213-9c0c-ac498621d09d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯化钾", "en": "potassium chloride" }, "value": 600, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片氯化钾质量；不是个人片数、频率、疗程或补服指令", "en": "potassium chloride mass per tablet; not an individual's tablet count, frequency, course or make-up instruction" } }, { "ingredient": { "zh": "钾（氯化钾所提供的电解质当量）", "en": "potassium (electrolyte equivalent supplied by potassium chloride)" }, "value": 8, "unit": "mEq", "basisCode": "per_tablet", "basisLabel": { "zh": "每片钾的毫当量；mEq 与 mg 不是可以脱离成分直接换算的同一单位", "en": "milliequivalents of potassium per tablet; mEq and mg are not one unit that can be converted without the named substance" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片处方药瓶装标签展示面", "en": "100-tablet prescription bottle label panel" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "圆形、无刻痕薄膜衣缓释片，约 11 mm", "en": "round, unscored film-coated extended-release tablet, approximately 11 mm" }, "imprint": "KC / 8", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-klor-con-potassium-chloride-10meq-750mg-100-tablet-bottle-ndc-0245531611", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布；处方信息 2018-10 修订）", "en": "Current U.S. DailyMed NDA brand label (SPL v6; published 16 Jul 2025; prescribing information revised Oct 2018)" }, "dosageForm": { "zh": "KLOR-CON 氯化钾薄膜衣缓释口服片", "en": "KLOR-CON potassium chloride film-coated extended-release oral tablet" }, "route": { "zh": "口服（完整缓释片产品身份字段）", "en": "oral (intact extended-release tablet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0245-5316-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯化钾 750 mg，相当于钾 10 mEq；100 片瓶装", "en": "Potassium chloride 750 mg, equivalent to potassium 10 mEq per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=klor-con-02.jpg&setid=1ff53330-065c-4213-9c0c-ac498621d09d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯化钾", "en": "potassium chloride" }, "value": 750, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片氯化钾质量；不是个人片数、频率、疗程或补服指令", "en": "potassium chloride mass per tablet; not an individual's tablet count, frequency, course or make-up instruction" } }, { "ingredient": { "zh": "钾（氯化钾所提供的电解质当量）", "en": "potassium (electrolyte equivalent supplied by potassium chloride)" }, "value": 10, "unit": "mEq", "basisCode": "per_tablet", "basisLabel": { "zh": "每片钾的毫当量；mEq 与 mg 不是可以脱离成分直接换算的同一单位", "en": "milliequivalents of potassium per tablet; mEq and mg are not one unit that can be converted without the named substance" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片处方药瓶装标签展示面", "en": "100-tablet prescription bottle label panel" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、无刻痕薄膜衣缓释片，约 13 mm", "en": "round, unscored film-coated extended-release tablet, approximately 13 mm" }, "imprint": "KC / 10", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-klor-con-potassium-chloride-8meq-600mg-100-tablet-bottle-ndc-0245531511", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=klor-con-01.jpg&setid=1ff53330-065c-4213-9c0c-ac498621d09d&type=img", "alt": "KLOR-CON 8 mEq、每片氯化钾 600 mg、100 片、NDC 0245-5315-11 的美国 DailyMed 当前包装标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前 SPL v6；2025-07-16 发布", "presentation": "KLOR-CON 氯化钾缓释片，每片 8 mEq（600 mg 氯化钾），100 片瓶装，NDC 0245-5315-11。", "notice": "此图只对应所引美国当前标签中的 8 mEq（600 mg）、100 片瓶装；不代表 10 mEq、500 片或单位剂量包装、KLOR-CON M、液体、粉剂、注射剂、其他厂牌、其他市场或实时库存。它不用于鉴定真伪，也不生成个人片数、频率或补钾方案。", "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "KLOR-CON 说明书放大阅读：mEq 不是 mg，空壳不是补服依据", "en": "KLOR-CON label reading: mEq is not mg, and an empty matrix is not a reason to repeat" }, "summary": { "zh": "8 mEq（600 mg）和 10 mEq（750 mg）分别把钾的电解质当量与氯化钾质量写在同一药盒上。当前 KLOR-CON 标签要求整片吞服，不得压碎、咀嚼或含吮。蜡基质可能在粪便中看起来像空壳，这不表示药物没吸收，也不能自行补一片。", "en": "The 8 mEq (600 mg) and 10 mEq (750 mg) labels place the potassium electrolyte equivalent and potassium chloride mass on the same pack. The current KLOR-CON label says to swallow the tablet whole without crushing, chewing or sucking. Its wax matrix may be visible in stool; that does not prove failed absorption and is not a reason to repeat a tablet." }, "checks": [ { "zh": "mEq（毫当量）描述特定离子的电解质当量；mg 描述特定物质的质量。8 mEq 对应本产品每片 600 mg 氯化钾，10 mEq 对应 750 mg 氯化钾，但不能把这个关系拿去换算其他成分、液体浓度、注射剂或个人片数。", "en": "mEq describes the electrolyte equivalent of a named ion, while mg describes the mass of a named substance. In this product, 8 mEq corresponds to 600 mg potassium chloride per tablet and 10 mEq to 750 mg, but that relationship must not be transferred to another ingredient, liquid concentration, injection or personal tablet count." }, { "zh": "本档案的 KLOR-CON 是蜡基质、无刻痕缓释片，标签要求整片吞服。不得因想减半就压碎、咀嚼、含吮或自行掰分。名称相近的 KLOR-CON M 是不同微囊化制剂，其标签中的掰分或水分散路径不能套用于本产品。", "en": "This dossier covers an unscored wax-matrix KLOR-CON extended-release tablet whose label says to swallow whole. Do not crush, chew, suck or divide it to make a smaller amount. Similarly named KLOR-CON M is a different microencapsulated formulation, and its splitting or water-dispersion route must not be transferred to this product." }, { "zh": "氨苯蝶啶或阿米洛利同用在当前标签中属于禁忌。ACE 抑制剂、ARB、螺内酯、依普利酮、阿利吉仑及 NSAID 也可能增加高钾风险；不要因都在一张药单上就自行停某一种，应尽快让药师或临床医生核对血钾、肾功能和完整药单。", "en": "Current labelling contraindicates co-use with triamterene or amiloride. ACE inhibitors, ARBs, spironolactone, eplerenone, aliskiren and NSAIDs may also increase hyperkalaemia risk. Do not stop a medicine yourself because both appear on a list; obtain prompt review of potassium, kidney function and the complete medicine list." }, { "zh": "老年人更常见肾、心脏功能下降和多种药同用；高钾有时早期没有明显症状。网页不能从药盒或感觉判断血钾，也不能用香蕉、补充剂或含钾盐替代化验和专业评估。", "en": "Older adults more often have reduced kidney or cardiac function and multiple medicines, while hyperkalaemia may initially have no obvious symptoms. A pack or symptom cannot tell this site the potassium level, and bananas, supplements or potassium-containing salt substitutes do not replace laboratory and professional assessment." }, { "zh": "严重呕吐、持续或剧烈腹痛、明显腹胀、黑便或消化道出血需要及时医疗评估；严重胸部不适、晕厥、显著肌无力或心律异常感应使用当地急救服务。网页不等待这些症状自行消退，也不从症状推断个人补钾量。", "en": "Severe vomiting, persistent or severe abdominal pain, marked distension, black stools or gastrointestinal bleeding need timely medical assessment. Severe chest symptoms, fainting, marked muscle weakness or a sense of abnormal rhythm warrants local emergency care. The site does not wait for these symptoms to resolve or infer a personal potassium amount from them." }, { "zh": "粪便中可能看到未吸收的蜡基质空壳；这与 GLUCOTROL XL 等其他缓释系统同样强调‘外壳可见不等于漏吸收’，但不同产品不能因此合并、替换或重复服用。", "en": "The unabsorbed wax matrix may be visible in stool. Like the empty-shell literacy of some other extended-release systems such as GLUCOTROL XL, a visible shell does not mean failed absorption, but the products must not be merged, substituted or repeated on that basis." } ], "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氯化钾怎样起作用：补充钾离子，不等于看到利尿药就自动补钾", "en": "How potassium chloride works: replenishing potassium does not mean automatically adding it to a diuretic" }, "summary": { "zh": "钾是细胞内主要阳离子，参与神经冲动传导、心肌和骨骼肌收缩以及肾功能。KLOR-CON 的蜡基质延缓局部释放，钾在小肠离开前被吸收，基质本身不吸收。机制说明为什么需要血钾、肾功能和药物联用信息，却不能替个人决定是否补钾或吃几片。", "en": "Potassium is a principal intracellular cation involved in nerve transmission, cardiac and skeletal-muscle contraction and renal function. KLOR-CON uses a wax matrix to slow local release; potassium is absorbed before leaving the small intestine while the matrix itself is not absorbed. This mechanism explains why potassium, kidney function and co-medications matter, but cannot decide whether an individual needs supplementation or how many tablets to take." }, "checks": [ { "zh": "袢利尿药或噻嗪类药可能影响钾，但保钾利尿药、ACEI、ARB、ARNI、螺内酯、NSAID、肾功能变化和饮食补充剂又可能把风险推向另一方向。不能仅凭‘用了利尿药’就自动加 KLOR-CON。", "en": "Loop or thiazide diuretics may affect potassium, while potassium-sparing diuretics, ACE inhibitors, ARBs, ARNIs, spironolactone, NSAIDs, kidney-function changes and supplements may shift risk in another direction. ‘Taking a diuretic’ alone does not permit automatically adding KLOR-CON." }, { "zh": "8 mEq/600 mg 与 10 mEq/750 mg 是两个准确产品强度；mEq 不等同于片数。网页不把化验值、体重、利尿药剂量或每日摄入换成个人片数，也不提供漏服补服算法。", "en": "8 mEq/600 mg and 10 mEq/750 mg are two exact product strengths; mEq is not a tablet count. The site does not convert a laboratory value, body weight, diuretic amount or daily intake into a personal tablet count and provides no missed-use algorithm." }, { "zh": "全基因筛查不是本站为常规补钾设定的通用前提。更直接的核对信息通常包括准确产品、血钾趋势、肾功能、心电图与临床状态、酸碱和其他电解质，以及完整药单。", "en": "Whole-genome screening is not a universal prerequisite set by this site for routine potassium supplementation. More directly relevant review usually includes the exact product, potassium trend, kidney function, ECG and clinical status, acid-base and other electrolytes, and the complete medicine list." } ], "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "KLOR-CON", "generic": "氯化钾", "dosageFormClass": "氯化钾蜡基质薄膜衣缓释口服片：每片 8 mEq（600 mg 氯化钾）或 10 mEq（750 mg 氯化钾）；必须整片吞服，不得压碎、咀嚼或含吮；不是 KLOR-CON M 微囊化缓释片" }, "labelSource": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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." } }, { "source": { "id": "src_b862263240da2496", "label": "FDA Drugs@FDA：KLOR-CON NDA 019123 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019123", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "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." } }, { "source": { "id": "src_902e9a72d4fa6ba6", "label": "DailyMed（NLM）：KLOR-CON M 微囊化氯化钾缓释片当前美国标签（用于严格区分制剂）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b89910f6-4ff5-4a62-8269-696f7c10e4f6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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": "2026-08-29", "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." } }, "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": "KLOR-CON 是氯化钾蜡基质缓释片。药盒上的 8 mEq（600 mg）或 10 mEq（750 mg）不是两个可以任选的剂量写法：mEq 表示钾的电解质当量，mg 表示氯化钾质量，两者必须连同成分一起读。该缓释片要整片吞服，不能把 KLOR-CON M 的掰分或水分散说明套过来。老人若同时使用 ACEI、ARB、螺内酯、氨苯蝶啶、阿米洛利或 NSAID，更需要把肾功能、血钾和完整药单一起核对。", "history": "当前 FDA 标签把 KLOR-CON 的美国初始批准年份列为 1948；准确 NDA 019123 的 8 mEq 与 10 mEq Klor-Con 产品于 1986-04-17 获批。DailyMed 当前 SPL v6 于 2025-07-16 发布，并展示 8 mEq/600 mg 与 10 mEq/750 mg 两个 100 片瓶装面板。页面把历史、当前标签、包装和 Orange Book 身份分开呈现。", "sourceDocuments": [ { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_b862263240da2496", "label": "FDA Drugs@FDA：KLOR-CON NDA 019123 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019123", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_018f1dfad470f546", "label": "FDA：KLOR-CON NDA 019123 原始审评资料（1986）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/NDA/pre96/019123_s000.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_902e9a72d4fa6ba6", "label": "DailyMed（NLM）：KLOR-CON M 微囊化氯化钾缓释片当前美国标签（用于严格区分制剂）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b89910f6-4ff5-4a62-8269-696f7c10e4f6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 019123（KLOR-CON potassium chloride extended-release tablets）", "approvalTimeline": [ { "date": "1948", "title": { "zh": "当前标签所列美国初始批准年份", "en": "U.S. initial-approval year stated in the current label" }, "detail": { "zh": "这是当前标签的历史起点字段，不单独证明 NDA 019123 两个准确产品的批准日、当前供应或个人适用性。", "en": "This is a historical initial-approval field in the current label; alone it does not establish the approval date of the two exact NDA 019123 products, current supply or individual suitability." }, "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1986-04-17", "title": { "zh": "FDA 批准 NDA 019123 的 KLOR-CON 8/10 mEq", "en": "FDA approved KLOR-CON 8/10 mEq under NDA 019123" }, "detail": { "zh": "FDA 原始审评资料与当前 Orange Book 将蜡基质缓释片、8/10 mEq 产品和该 NDA 相连。", "en": "FDA original-review material and the current Orange Book connect the wax-matrix extended-release 8/10 mEq products with this NDA." }, "source": { "id": "src_018f1dfad470f546", "label": "FDA：KLOR-CON NDA 019123 原始审评资料（1986）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/NDA/pre96/019123_s000.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-07-16", "title": { "zh": "DailyMed 当前 SPL v6 发布", "en": "Current DailyMed SPL v6 published" }, "detail": { "zh": "当前记录展示两个准确 100 片瓶装面板、mEq/mg、整片吞服、空壳、肾功能、胃肠道和联用边界。", "en": "The current record displays two exact 100-tablet bottle panels and the mEq/mg, intact-tablet, empty-matrix, kidney, gastrointestinal and co-medication boundaries." }, "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前处方 RLD 缓释片；10 mEq 为 RS", "en": "Current prescription RLD extended-release tablets; 10 mEq is RS" }, "detail": { "zh": "两个 100 片瓶装面板已逐项建立。监管与包装记录不证明实时库存、购买资格、个人适用性或与其他氯化钾制剂可替代。", "en": "Two 100-tablet bottle panels are recorded individually. Regulatory and package records do not establish real-time stock, purchasing eligibility, individual suitability or interchangeability with another potassium chloride formulation." } }, { "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 records not established" }, "detail": { "zh": "不从美国品牌名、相同成分、mEq/mg 数字或包装颜色推定当地批准、剂型、供应、原研/仿制关系或可替代性。", "en": "No local approval, dosage form, supply, originator/generic relationship or interchangeability is inferred from a U.S. brand name, shared ingredient, mEq/mg figures or pack colour." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "8 mEq（600 mg）是不是表示一片里有 608 mg？", "en": "Does 8 mEq (600 mg) mean the tablet contains 608 mg?" }, "answer": { "zh": "不是相加关系。600 mg 是每片氯化钾质量，8 mEq 是该氯化钾所提供钾离子的电解质当量；它们是同一产品强度的两种计量描述，不应相加，也不能脱离成分换算其他药。", "en": "No. The 600 mg is the potassium chloride mass per tablet, while 8 mEq is the electrolyte equivalent of potassium supplied by it. They are two measurements describing one product strength, not numbers to add or transfer to another medicine." } }, { "question": { "zh": "缓释片太大，能掰一半或泡水吗？", "en": "The extended-release tablet is large. Can it be halved or dispersed in water?" }, "answer": { "zh": "本档案对应的 KLOR-CON 蜡基质片无刻痕，当前标签要求整片吞服并明确不得压碎、咀嚼或含吮。不要把 KLOR-CON M 的不同说明套用过来；有吞咽困难应联系药师或开方团队核对合适的准确制剂。", "en": "This dossier covers an unscored wax-matrix KLOR-CON tablet whose current label says to swallow whole and not crush, chew or suck. Do not transfer different KLOR-CON M instructions. A swallowing difficulty requires review of the exact suitable formulation with a pharmacist or prescriber." } }, { "question": { "zh": "已经吃螺内酯或沙坦类药，还能一起吃吗？", "en": "Can it be taken with spironolactone or an ARB?" }, "answer": { "zh": "网页不能仅凭药名决定。当前标签提示 RAAS 抑制剂会增加钾潴留风险，需要密切监测；氨苯蝶啶和阿米洛利同用更属于标签禁忌。请不要自行停药或加药，应让专业人员结合血钾、肾功能和完整药单处理。", "en": "The site cannot decide from names alone. Current labelling says RAAS inhibitors increase potassium-retention risk and require close monitoring; co-use with triamterene or amiloride is contraindicated. Do not stop or add a medicine yourself; professional review needs potassium, kidney function and the complete medicine list." } } ], "relatedMedicineChecks": [ { "target": { "id": "aldactone", "brand": "Aldactone", "generic": "螺内酯", "canonicalUrls": { "zh": "https://origindrug.com/drugs/aldactone/", "en": "https://origindrug.com/en/drugs/aldactone/" } }, "title": { "zh": "与 ALDACTONE／螺内酯同在药单上时：先核对血钾、肾功能与完整药单", "en": "When ALDACTONE / spironolactone is on the same list: review potassium, kidney function and the complete medicine list first" }, "summary": { "zh": "当前 KLOR-CON 标签把螺内酯列为可能增加高钾血症风险的药物。请把两盒药、全部处方药与非处方药、补充剂、含钾盐替代品及近期血钾和肾功能结果一起交给药师或开方团队核对。本卡片不判断能否同用，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current KLOR-CON label identifies spironolactone as a medicine that may increase hyperkalaemia risk. Bring both packs, all prescription and nonprescription medicines, supplements, potassium-containing salt substitutes and recent potassium and kidney-function results to a pharmacist or prescribing team. This card does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-units-and-concentrations", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/klor-con/", "en": "https://origindrug.com/en/drugs/klor-con/" }, "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." ] }