Recorded Chinese product: 硝苯地平缓释胶囊硝苯地平缓释胶囊
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
- 哈药集团制药总厂Chinese legal name: 哈药集团制药总厂
主要成分Active Ingredients
- 二甲基-(-硝基苯基Erjia Jixiao Jiben Ji
- 二氢Er Qing
- 吡啶二甲酸二甲酯Biding Erjia Suaner Jiazhi
药物知识说明
二甲基-(-硝基苯基是一种在国家药监局注册认定的药品。该药品含有二氢-fecab7ab等成分。
该药品关联的活性成分包括：二氢Er Qing。这些成分信息来自国家药监局数据库。
该药品标注的生产企业为：哈药集团制药总厂Chinese legal name: 哈药集团制药总厂。
您可以探索含有相同成分的其他药品：二氢-fecab7ab成分药品。
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: 硝苯地平缓释胶囊) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 二氢Er Qing.
Manufacturers recorded for this product: 哈药集团制药总厂Chinese legal name: 哈药集团制药总厂.
Explore other medicines containing the same ingredient: 二氢 productsProducts containing this recorded ingredient.
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: 硝苯地平缓释胶囊Recorded Chinese product: 硝苯地平缓释胶囊
- 剂型Dosage form: 胶囊剂Capsules
- 规格Specification: 20mg。20 mg
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.
主要成分Ingredients
生产企业Manufacturer
- 哈药集团制药总厂Chinese legal name: 哈药集团制药总厂
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H19980107
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H19980107
Manufacturer
Chinese legal name: 哈药集团制药总厂 (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
Protect from light and keep tightly closed.
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H19980107
生产企业
哈药集团制药总厂(国产)
适应症
1、高血压（单独或与其它降压药合用）。2、心绞痛：尤其是变异型心绞痛。
用法用量
1? 空腹整粒吞服，不得嚼碎或掰开服用。2? 从小剂量开始服用。初始剂量为20mg/次，最大剂量为60mg/次，一日一次。日服最大剂量不超过120mg。3? 硝苯地平的剂量应视患者的耐受性和对心绞痛的控制情况逐步调整。增加剂量前需监测患者血压。 如患者症状明显，可根据患者对药物的反应，缩短剂量调整期。4? 停药时未观察到“反跳”症状，但是仍需逐步减量，并严密观察患者情况。5? 普通制剂的剂量可安全的替换成缓释制剂的剂量。例如：普通制剂30mg/次，一日三次，可替换为缓释制剂90mg/次，一日一次。
不良反应
1.常见不良反应有外周水肿（与剂量成正比）；头痛等。2.与本品关系不确定的不良反应：头晕；恶心；便秘；乏力；面部潮红和热觉。3.1%-3%不良反应：胸痛;腿痛;感觉异常;眩晕;皮疹;腿部抽筋;鼻出血;鼻炎;阳痿;尿频等。4.＜1%不良反应:蜂窝织炎;寒战;面部水肿;颈痛;骨盆痛;房颤;心动过缓;心脏停博;早博;低血压;心悸;静脉炎;体位性低血压;心动过速;焦虑;性欲减退;抑郁;失眠;嗜睡;搔痒症;盗汗;腹痛;腹泻;口干;消化不良;食道炎;胃胀;胃肠道出血;呕吐;淋巴结病;痛风;消瘦；关节痛；关节炎；肌痛；呼吸困难；咳嗽；咽炎；视力模糊；弱视；结膜炎；复视；肾结石等。5.罕见不良反应:过敏性肝炎;秃头;贫血;抗核抗体阳性关节炎;红斑性肢痛病；剥6.脱性皮炎；发烧；齿龈增生；男性乳房发育；白细胞减少；情绪波动；肌肉痛；神经过敏；紫癜；颤抖；睡眠失调；Stevens-Johnson综合征；昏厥；血小板减少；中毒性表皮融节坏死；血药浓度峰值时瞬间失明；震颤；风疹等。
禁忌
对硝苯地平过敏者禁用。
注意事项
1、低血压：绝大多数患者服用硝苯地平后仅有轻度低血压反应，个别患者出现严重的低血压症状。这种反应常发生在剂量调整期或加量时，特别是合用b-受体阻滞剂时。在此期间需监测血压，尤其合用其它降压药时。2、外周水肿：患者发生轻中度外周水肿与服用剂量成正比，与动脉扩张有关。水肿多初发于下肢末端，可用利尿剂治疗。对于伴充血性心力衰竭的患者，需分辨水肿是否由于左室功能进一步恶化所致。3、对诊断的干扰：应用本品时偶见碱性磷酸酶、肌酸磷酸激酶、乳酸脱氢酶、门冬氨酸氨基转移酶和丙氨酸氨基转移酶升高，一般无临床症状，但曾有报道胆汁淤积和黄疸；血小板聚集度降低，出血时间延长；直接Coomb实验阳性伴/不伴溶血性贫血。4、肝肾功能不全、正在服用b-受体阻滞剂者应慎用，宜从小剂量开始，以防诱发或加重低血压，增加心绞痛、心力衰竭、甚至心肌梗死的发生率。慢性肾衰患者应用本品时偶有可逆性血尿素氮和肌酐升高，与硝苯地平的关系不够明确。
贮藏
遮光、密封保存。
规格
20mg。
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.