Recorded Chinese product: 依托红霉素片依托红霉素片
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
- 福建德胜药业有限公司Chinese legal name: 福建德胜药业有限公司
主要成分Active Ingredients
- 红霉素Hongmei Su
- 主要成份依托红霉素Recorded Chinese composition: 主要成份依托红霉素
药物知识说明
红霉素是一种在国家药监局注册认定的药品。该药品含有主要成份依托红霉素、红霉素-70dce127等成分。
该药品关联的活性成分包括：主要成份依托红霉素Recorded Chinese composition: 主要成份依托红霉素、红霉素Hongmei Su。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：福建德胜药业有限公司Chinese legal name: 福建德胜药业有限公司。
您可以探索含有相同成分的其他药品：主要成份依托红霉素-51df03af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: 依托红霉素片) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 主要成份依托红霉素Recorded Chinese composition: Recorded Chinese name: 主要成份依托红霉素, 红霉素Hongmei Su.
Manufacturers recorded for this product: 福建德胜药业有限公司Chinese legal name: 福建德胜药业有限公司.
Explore other medicines containing the same ingredient: products 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: 依托红霉素片Recorded Chinese product: 依托红霉素片
- 剂型Dosage form: 片剂Tablets
- 规格Specification: 按红霉素计 0.125g(12.5万单位)Recorded Chinese composition: 按红霉素计 0.125g(12.5万单位)
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
- 福建德胜药业有限公司Chinese legal name: 福建德胜药业有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H35020531
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H35020531
Manufacturer
Chinese legal name: 福建德胜药业有限公司
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H35020531
生产企业
福建德胜药业有限公司
适应症
1.本品作为青霉素过敏患者治疗下列感染的替代用药:溶血性链球菌、肺炎链球菌等所致的急性扁桃体炎、急性咽炎、鼻窦炎;溶血性链球菌所致的猩红热、蜂窝织炎;白喉及白喉带菌者;气性坏疽、炭疽、破伤风;放线菌病;梅毒;李斯特菌病等。|2.军团菌病。|3.肺炎支原体肺炎。|4.肺炎衣原体肺炎。|5.其他衣原体属、支原体属所致泌尿生殖系感染。|6.沙眼衣原体结膜炎。|7.厌氧菌所致口腔感染。|8.空肠弯曲菌肠炎。|9.百日咳。|10.风湿热复发、感染性心内膜炎(风湿性心脏病、先天性心脏病、心脏瓣膜置换术后)、预防口腔或上呼吸道感染(青霉素的替代用药)。
用法用量
口服。|1.成人一日0.75～2g,分3～4次。|2.儿童每日按体重20～30mg/kg,分3～4次。|3.治疗军团菌病,成人一次0.5～1.0g,一日4次。|4.用作风湿热复发的预防用药时,一次0.25g,一日2次。|5.用作感染性心内膜炎的预防用药时,术前1小时口服1g,术后6小时再服用0.5g。
不良反应
1.服用本品后发生肝毒性反应者较服用其他红霉素制剂为多见,服药数日或1～2周后患者可出现乏力、恶心、呕吐、腹痛、皮疹、发热等。有时可出现黄疸,肝功能试验显示淤胆,停药后常可恢复。|2.胃肠道反应有腹泻、恶心、呕吐、中上腹痛、口舌疼痛、胃纳减退等,其发生率与剂量大小有关。|3.大剂量(≥4g/日)应用时,尤其肝、肾疾病患者或老年患者,可能引起听力减退,主要与血药浓度过高(>12mg/L)有关,停药后大多可恢复。|4.过敏反应表现为药物热、皮疹、嗜酸粒细胞增多等,发生率约0.5%～1%。|5. 其他:偶有心律失常、口腔或阴道念珠菌感染。
禁忌
对红霉素类药物过敏者禁用。
注意事项
1.服用本品后出现ALT?AST?AKP?胆红素等增高者较服用其他红霉素制剂为多见。|2.溶血性链球菌感染用本品治疗时,至少需持续10日,以防止急性风湿热的发生。|3.肾功能减退患者一般无需减少用量。|4.患者对一种红霉素制剂过敏或不能耐受时,对本品也可过敏或不能耐受。|5.慢性肝病、肝功能损害者慎用。|6.因不同细菌对红霉素的敏感性存在一定差异,故应做药敏测定。|7.对诊断的干扰：红霉素可干扰Higerty法的荧光测定,使尿儿茶酚胺的测定值出现假性增高。血清碱性磷酸酶、胆红素、丙氨酸氨基转移酶和门冬氨酸氨基转移酶的测定值均可能增高。
贮藏
遮光，密封保存。
规格
按红霉素计 0.125g(12.5万单位)
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.