| 简介:
部份中文头孢唑肟钠处方资料(仅供参考)
英文名:Ceftizoxime Sodium
商品名:EPOCELIN Suppositories
中文名:头孢唑肟钠栓剂
生产商:長生堂制药
エポセリン坐剤125/エポセリン坐剤250
开发单位:藤泽药品工业株式会社 (日本)
首次上市:1982年,日本
药物类别名称
合成头孢菌素制剂
批准日期:1986年8月
商標名
EPOCELIN Suppositories 125
EPOCELIN Suppositories 250
一般名
セフチゾキシムナトリウム(Ceftizoxime Sodium)
化学名
Monosodium(6R ,7R )-7-[(Z )-2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetylamino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
分子式
C13H12N5NaO5S2
分子量
405.38
構造式
性状
钠精是一种白色到淡黄色的晶体或结晶粉末。 水溶性极,难溶于甲醇,难溶于乙醇(95)。
处理注意事项
最好以 1.15° 或更低处存放。
2. 打开铝袋后,由于它可能会因光线和湿气而变黄,因此最好存放在寒冷黑暗的地方。
药用药理学
1. 抗菌行动
(1) 抗菌光谱是广泛的革兰氏阳性细菌,革兰氏阳性细菌,特别是在革兰氏阳性链球菌、肺炎球菌、大肠杆菌中的克阴性杆菌、克氏杆菌、普氏杆菌、摩根内拉、普罗维登西亚、 除了表现出强大的抗菌能力对流感细菌, 细胞细胞细胞, 肠杆菌, 塞拉蒂亚, Peptostrepcocous, 良好的抗菌性能,对厌氧细菌,包括巴氏体和前botera Melaninogenica. 工作形式是无菌的。
(2)稳定到各种细菌产生的β-乳糖酶,在β-乳糖酶生产细菌中表现出优异的抗菌性能。
2. 作用机制
作用机制是一种合成抑制细菌细胞壁,对1b青霉素结合蛋白(PBP)具有最强的亲和力,然后1a,是三个。
3.克阴性细菌的外膜渗透性好。
适应症
[细菌种类]
链球菌、肺炎球菌、大肠杆菌、细胞细胞、克雷布西拉、肠杆菌、塞拉蒂亚、普罗特乌斯、摩根拉·摩根尼、普罗维登西亚、流感、胰腺炎 , 巴氏体, 前波斯特拉梅拉尼诺基因
[适应]
急性支气管炎、肺炎、慢性呼吸道病变、膀胱炎、肾上腺炎的继发感染。
用法与用量
通常,每天20~70mg作为每公斤体重的切夫提佐西米在儿童(色度),插入到的Usus分为3-4次。应该注意的是,年龄,适当增加或减少,根据症状。
临床表现
包括比较试验(肺炎)在内的321例临床试验摘要如下。
1. 呼吸道感染
肺炎球菌、支气管炎等流感菌,肺炎有效率为94.3%(50/53例),分别为96.1%(74/77例)。 此外,在作为恋童癖肺炎控制剂的西夫希苏姆钠静脉注射剂的比较试验中,该制剂被证实具有与静脉注射剂相同的疗效。
2. 尿路感染
大肠杆菌、尿路感染经克氏杆菌等(肾上腺炎、膀胱炎)有效率为92.2%(47/51例)。
包装
制造和销售
長生堂制药有限公司
注:以上中文处方资料不够完整,使用者以原资料为准。
完整说明附件:http://www.info.pmda.go.jp/go/pack/6132700J1022_4_05/
Physicochemical findings on active ingredients
common name
Ceftizoxime sodium, Ceftizoxime Sodium (JAN)
Chemical name
Monosodium (6R, 7R) -7-[(Z) -2- (2-aminothiazol-4-yl) -2- (methoxyimino) acetylamino] -8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate
Molecular formula
C13H12N5NaO5S2
Molecular weight
405.38
Properties
It is a white to pale yellow crystalline or crystalline powder.
Very soluble in water, poorly soluble in methanol, and practically insoluble in ethanol (95).
Drug class name
Synthetic cephalosporin preparation
Sales name
Eposerin suppository 125/250
composition
Ingredients and contents (in one piece)
Japan Bureau ceftizoxim sodium 125 mg / 250 (titer)
Additive
Sodium caprate, hard fat
Contraindication
Patients who have a history of shock due to the ingredients of this drug
Effect or effect
Adapted bacterial species
Streptococcus species sensitive to ceftizoxime, Streptococcus pneumoniae, Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Serratia, Proteus, Morganella morgani, Providencia, H. influenzae, Peptostreptococcus, Bacteroides, Prevotella. Melaninogenica
Indication
Acute bronchitis, pneumonia, secondary infection of chronic respiratory disease, cystitis, pyelonephritis
In children, usually 20 to 70 mg (titer) of ceftizoxim / kg body weight / day is divided into 3-4 times and inserted into the anus.
The dosage may be adjusted according to the age and symptoms.
In principle, in order to prevent the development of resistant bacteria etc., the sensitivity of the drug should be confirmed, and the administration should be for a minimum period necessary for the treatment of the disease.
In patients with severe renal impairment, blood levels will be maintained, so the dosage should be reduced according to the degree of renal impairment and used at intervals.
Careful administration
Patients with a history of hypersensitivity to penicillin antibiotics
Patients who are prone to cause allergic symptoms such as bronchial asthma, rash, urticaria etc.
Patients with severe renal impairment (see "Usage and Dose Related Usage Notes" section)
Patients with poor oral intake or patients with parenteral nutrition or with poor general condition [Because symptoms of vitamin K deficiency may occur, make sure that observation is sufficient. ]
Serious side effects
shock
As shock (less than 0.1%) may occur, observation should be carried out sufficiently. If discomfort, feeling of mouth abnormality, wheezing, dizziness, palpitation, palpitation, tinnitus, sweating etc. occur, discontinue administration and take appropriate measures. To do.
Anaphylactic symptoms
Anaphylaxis-like symptoms (respiratory distress, general flushing, angioedema, urticaria etc.) (less than 0.1%) may occur. Therefore, observe carefully and if any abnormalities are observed, discontinue administration and appropriate. Performing the treatment.
Blood disorder
Pancytopenia (less than 0.1%), agranulocytosis (less than 0.1%, initial symptoms: fever, sore throat, headache, fatigue etc), hemolytic anemia (less than 0.1%, initial symptoms: fever, hemoglobinuria, anemia Symptoms etc.), thrombocytopenia (less than 0.1%, initial symptoms: petechiae, purpura, etc.) may occur. Therefore, conduct regular examinations such as periodical examination, and if abnormalities are observed, administration Stop and take appropriate action.
Liver disorder
As jaundice (less than 0.1%), AST (GOT), ALT (GPT), Al-P increase (each less than 0.1 to 5%) may appear, etc. If any abnormalities are observed, discontinue administration and take appropriate measures.
Kidney disorder
Serious renal failure such as acute renal failure (less than 0.1%) may occur. Therefore, conduct regular observation such as periodical examination, and if any abnormality is found, stop administration and appropriate. Performing the treatment.
Colitis
Serious colitis (less than 0.1%) with bloody stools such as pseudomembranous colitis may occur. If abdominal pain or frequent diarrhea occurs, stop administration immediately and take appropriate measures.
Interstitial pneumonia, PIE syndrome
Interstitial pneumonia with fever, cough, dyspnea, chest x-ray abnormality, eosinophilia etc., PIE syndrome (less than 0.1% each) etc. may appear, so when such symptoms appear Discontinue administration and take appropriate measures such as administration of corticosteroids.
Pharmacology
Antibacterial action
The antibacterial spectrum covers a wide range of gram-positive bacteria and gram-negative bacteria, and in particular gram-positive cocci, Streptococcus, pneumococci, gram-negative bacilli, Escherichia coli, Klebsiella, Proteus, Morganella morganii, Providencia, influenzae etc. In addition to its strong antibacterial activity, it also exhibits excellent antibacterial activity against anaerobic bacteria including Citrobacter, Enterobacter, Serratia, Peptostreptococcus, Bacteroides and Prevotella melaninogenica. The mode of action is bactericidal 6) -9).
It is stable to β-lactamase produced by various bacteria and exhibits excellent antibacterial activity against β-lactamase-producing bacteria 6) 10) 11).
Mechanism of action
The mechanism of action is inhibition of bacterial cell wall synthesis, with the highest affinity for penicillin binding protein (PBP) 1b, followed by 1a, 3. Also, the outer membrane permeability of gram negative bacteria is good12) -14).
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