Recorded Chinese product: 硫酸奎尼丁片硫酸奎尼丁片
This is a medicine registration record from NMPA data.本页为国家药监局药品注册记录。
Labeled sections from the recorded Chinese source are included below. English wording is a reference translation when one is on file, not an official English label.本记录未接入产品级适应症/安全性标注字段。
生产企业Manufacturer
- 上海信谊天平药业有限公司Chinese legal name: 上海信谊天平药业有限公司
主要成分Active Ingredients
- 奎尼丁Kuini Ding
药物知识说明
奎尼丁是一种在国家药监局注册认定的药品。标注生产企业为上海信谊天平药业有限公司。
该药品暂无关联的活性成分信息。
该药品标注的生产企业为:上海信谊天平药业有限公司Chinese legal name: 上海信谊天平药业有限公司、上海信谊天平药业有限公司Chinese legal name: 上海信谊天平药业有限公司、上海信谊天平药业有限公司Chinese legal name: 上海信谊天平药业有限公司。
本页面内容来自国家药监局数据库,MedicineGraph在此基础上提供关系图谱和知识导航。
Medicine Knowledge
This medicine (original name: 硫酸奎尼丁片) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 上海信谊天平药业有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 上海信谊天平药业有限公司Chinese legal name: 上海信谊天平药业有限公司, 上海信谊天平药业有限公司Chinese legal name: 上海信谊天平药业有限公司, 上海信谊天平药业有限公司Chinese legal name: 上海信谊天平药业有限公司.
Source: MedicineGraph authoritative database. Relationships derived from registered product information.
这是什么What is this
- 通用名/品名Recorded product name: 硫酸奎尼丁片Recorded Chinese product: 硫酸奎尼丁片
- 剂型Dosage form: 片剂Tablets
- 规格Specification: 0.2g0.2 g
本段仅展示注册/说明书已记录的身份属性,不含适应症或用法建议。Identity attributes from registration/leaflet records only; no indications or usage advice.
生产企业Manufacturer
- 上海信谊天平药业有限公司Chinese legal name: 上海信谊天平药业有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H31020851
关联实体Relationships
信息来源Source and scope
国家药品监督管理局(中国)药品注册数据及已接入说明书字段。National Medical Products Administration (China) medicine-registration data and linked leaflet fields.
- 品名来源Name source: 10多万条药品说明书数据库 (HIGH)Package-insert database (more than 100,000 records) (HIGH)
- 生产企业来源Manufacturer source: 10多万条药品说明书数据库Package-insert database (more than 100,000 records)
- 剂型来源Dosage-form source: 10多万条药品说明书数据库Package-insert database (more than 100,000 records)
范围:当前 MedicineGraph 注册记录及已记录的精确关系;非完整目录,亦不构成疗效等同主张,也不支持换用判断。不含适应症/安全性推断。Scope: current MedicineGraph registration records and exact recorded relationships; not a complete catalog and not a claim of therapeutic equivalence. No inferred indications/safety.
本段为已核准说明书原文摘录(非改写、非AI摘要),非正式英文标签,亦不构成用药建议。 Not an official English label and not medical advice. English wording, when shown, is a reference translation of the Chinese source label.
English translation for reference. Translated from the Chinese source label. Not an official English label and not medical advice.
NMPA approval number
国药准字H31020851
Manufacturer
Chinese legal name: 上海信谊天平药业有限公司 (domestically manufactured)
Indications
English translation unavailable. The original Chinese source label remains available below.
Dosage and administration
English translation unavailable. The original Chinese source label remains available below.
Adverse reactions
English translation unavailable. The original Chinese source label remains available below.
Contraindications
English translation unavailable. The original Chinese source label remains available below.
Precautions
English translation unavailable. The original Chinese source label remains available below.
Storage
English translation unavailable. The original Chinese source label remains available below.
Specification
English translation unavailable. The original Chinese source label remains available below.
中文说明书原文Original Chinese source label
批准文号
国药准字H31020851
生产企业
上海信谊天平药业有限公司(国产)
适应症
1.本品主要适用于心房颤动或心房扑动经电转复后的维持治疗。|2.本品虽对房性早搏、阵发性室上性心动过速、预激综合征伴室上性心律失常、室性早搏、室性心动过速有效,并有转复心房颤动或心房扑动的作用,但由于不良反应较多,目前已少用。|3.肌注及静注已不再使用。
用法用量
口服给药:成人应先试服0.2g,观察有无过敏及特异质反应。|1.成人常用量:一次0.2~0.3g,每日3~4次。|2.转复心房颤动或心房扑动,第一日0.2g,每2小时1次,连续5次;如无不良反应,第二日增至每次0.3g,第三日每次0.4g,每2小时1次,连续5次。每日总量不宜超过2.4g。|3.恢复窦性心律后改为维持量,一次0.2~0.3g,每日3~4次。|4.成人处方极量:每日3g(一般每日不宜超过2.4g),应分次给予。
不良反应
1.本品治疗指数低,约1/3的患者发生不良反应。|2.心血管:本品有促心律失常作用,产生心脏停搏及传导阻滞,较多见于原有心脏病患者,也可发生室性早搏、室性心动过速及室颤。心电图可出现P-R间期延长、QRS波增宽,一般与剂量有关。可使心电图Q-T间期明显延长,诱发室性心动过速(扭转性室性心动过速)或室颤,可反复自发自停,发作时伴晕厥现象,此作用与剂量无关,可发生于血药浓度尚在治疗范围内或以下时。本品可使血管扩张产生低血压,个别可发生脉管炎。|3.胃肠道不良反应:很常见。包括恶心、呕吐、痛性痉挛、腹泻、食欲下降、小叶性肝炎及食道炎。|4.金鸡纳反应:可产生耳鸣、胃肠道障碍、心悸、惊厥、头痛及面红。视力障碍如视物模糊、畏光、复视、色觉障碍、瞳孔散大、暗点及夜盲。听力障碍、发热、局部水肿、眩晕、震颤、兴奋、昏迷、忧虑,甚至死亡。一般与剂量有关。|5.特异质反应:头晕、恶心、呕吐、冷汗、休克、青紫、呼吸抑制或停止。与剂量无关。|6.过敏反应:各种皮疹,尤以荨麻疹、瘙痒多见,发热、哮喘、肝炎及虚脱。与剂量无关。|7.肌肉:使重症肌无力加重。使CPK酶增高。|8.血液系统:血小板减少、急性溶血性贫血、粒细胞减少、白细胞分类左移、中性粒细胞减少。
禁忌
1.对该药过敏者或曾应用该药引起血小板减少性紫癜者禁用。|2.该药禁用于没有起搏器保护的Ⅱ度或Ⅲ度房室传导阻滞、病态窦房结综合征。
注意事项
1.对于可能发生完全性房室传导阻滞(如地高辛中毒、Ⅱ度房室传导阻滞、严重室内传导障碍等) 而无起搏器保护的病人,要慎用。|2.饭后2小时或饭前1小时服药并多次饮水可加快吸收,血药浓度峰值的出现提早、升高。与食物或牛奶同服可减少对胃肠道的刺激,不影响生物利用度。|3.当每日口服量超过1.5g时,或给有不良反应的高危病人用药,应住院,监测心电图及血药浓度。每天超过2g时应特别注意心脏毒性。|4.转复心房扑动或心房颤动时,为了防止房室间隐匿性传导减轻而导致1:1下传,应先用洋地黄制剂或β阻滞剂,以免室率过快。|5.长期用药需监测肝、肾功能,若出现严重电解质紊乱或肝、肾功能异常时需立即停药。|6.加强心电图检测,QRS间期超过药前20%应停药。
贮藏
密闭、在干燥处保存。
规格
0.2g
信息来源Source and scope
国家药品监督管理局(中国)药品注册数据。National Medical Products Administration (China) medicine-registration data.
范围:当前 MedicineGraph 注册记录及已记录的精确关系;非完整目录,亦不构成疗效等同主张,也不支持换用判断。Scope: current MedicineGraph registration records and exact recorded relationships; not a complete catalog and not a claim of therapeutic equivalence.