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  药店国别: 日本药房
产地国家: 日本
所属类别: 抗微生物药物->喹诺酮类
处方药:处方药
包装规格: 100毫克/片 100片/盒
计价单位:
   
生产厂家中文参考译名:
大日本住友株式会社
生产厂家英文名:
Dainippon Sumitomo
该药品相关信息网址1:
http://www.ds-pharma.com/
该药品相关信息网址2:
http://www.globalnapi.com/PR_Professional.asp?ID=42
原产地英文商品名:
Spara 100mg/tab 100tabs/box
原产地英文药品名:
Sparfloxacin
中文参考商品译名:
司巴乐 100毫克/片 100片/盒
中文参考药品译名:
司帕沙星
中文参考化合物名称:
5-氨基-1-环丙基-7-(顺式-3,5-二甲基-1-哌嗪基)-6,8-二氟-1,4-二氢-4-氧喹诺啉-3-羧酸
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Applicable to various infections
英文适应病症2:
Antibacterial
临床试验期:
完成
中文适应病症参考翻译1:
适用于各种感染
中文适应病症参考翻译2:
抗菌
药品信息:

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 部分中文Spara处方资料(仅供参考)
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【药名】Spara司巴乐  
【通用名称】Sparfloxacin,司帕沙星
【药品类别】抗感染药\合成抗菌药\喹诺酮类   
【化学名称】5-氨基-1-环丙基-7-(顺式-3,5-二甲基-1-哌嗪基)-6,8-二氟-1,4-二氢-4-氧喹诺啉-3-羧酸
【其他名称】司氟沙星, 司巴乐, 司巴沙星, 帕氟沙星, 海正立特, 司帕沙星片, 朗瑞, 巴沙, 倍特巴沙, 司氟沙星片, 司帕沙星分散片, 司帕沙星胶囊, 司帕沙星颗粒, 森奥欣, 世保扶, 安利泰德, 巴康  
【外文名】Spara, Sparca, Sparlox, Torospar, Zagam, Sparfloxacin Capsules, Sparfloxacin Dispersible Tablets, Sparfloxacin Granules, Sparfloxacin Tablets  
【作用用途】对革兰阳性菌、阴性菌、厌氧菌、衣原体、支原体、分枝杆菌等均具有强大抗菌活性。对金葡菌的作用较环丙沙星强8倍;对厌氧菌的活性较环丙沙星强2~32倍;对肺炎支原体较环丙沙星、氧氟沙星和氟哌酸强8~62倍;对结核分枝杆菌的活性较环丙沙星强3~30倍。
  本药是长效喹诺酮类抗菌剂,并在氧喹啉羧酸结构式的5位中加入氨基酸、6位和8位中加入氟、7位中加入顺式3、5-二甲哌啶基。通过阻碍细菌的DNA合成而产生杀菌作用。
    对革兰阳性菌、阴性菌、厌氧菌、依原体、支原体均具有抗菌活性,用于大肠杆菌等敏感菌所致下呼吸道感染、泌尿道感染、妇科、耳鼻喉及皮肤软组织感染等。   
【适应症】适用于各种感染。 对需氧菌和厌氧菌均有效,对支原体和军团菌、衣原体也有效。   
【用量用法】成人口服:0.2g~0.3g/日,1~2次/日。根据感染的不同种类及症状,可适当增减用量。    
【注意事项】
    对本药有过敏史者禁用。
  避免日光暴晒,发现皮疹时应停止服药。有严重肾脏功能障碍、癫痫等痉挛性疾患或者有此病史者、高龄者慎用。
    对妊娠和哺乳的影响 妊娠期用药的安全性尚未被确认,因此,禁止给妊娠或有妊娠可能的妇女服用。由于本药会分泌到乳汁中,在哺乳期服用时应停止哺乳。
    对儿童的影响 尚未确立对儿童的安全性,因此,禁止给儿童用药。对老年人的影响 要从少量(如100 mg)开始,1天1次,慎重用药。   
【规格】片剂:100mg、200mg。

Spara
•Pharmacodynamics:
Spara, sparfloxacin, is a new once daily difluorinated quinolone, third generation fluoroquinolone.
Its bactericidal activity is achieved by inhibiting the A subunit of DNA gyrase, an essential enzyme in DNA replication, repair, & transcription in the bacterial cell.

•Spectrum of activity:
Spara has broad spectrum bactericidal activity.  It is active against gram-ve microorganisms, expanded activity against gram+ve bacteria and against atypical pathogens.

The presence of 2 fluorine atoms & 2 methyl groups in the piperazinyl ring provide increased potency against gram-ve organisms & broaden the spectrum to include gram+ve organisms.

It is active against:
•gram-positive aerobic cocci such as penicillin-sensitive & penicillin-resistant Streptococcus pneumoniae, Staphylococcus aureus.
•gram-positive aerobic bacilli such as: Mycobacteria tuberculosis.
•gram-negative aerobic cocci such as: Moraxella catarrhalis, Neisseria gonorrhoea.
•gram-negative aerobic bacilli such as: Haemophilus influenzae, Haemophilus parainfluenzae, Legionella, Enterobacter cloacae, Klebsiella pneumoniae, Salmonella typhi, Shigella.
•atypical pathogens such as: Mycoplasma pneumoniae, Mycoplasma hominis, Chlamydiae pneumoniae.

•Pharmacokinetics:
Spara is well absorbed after oral administration with a bioavailability of 92% & peak plasma concentration occurring at 3-6 hours.  Food  may decrease the rate, but not the extent of  absorption. 

It exhibits larger volumes of distribution.  It is distributed widely into many tissues of the body specially into respiratory tract tissues & fluids.  Its plasma protein binding is about 45%.

It is metabolised in the liver by glucuronidation & has an elimination half-life of about 20 hours, allowing once daily dose.

It is excreted in equal amounts in the faeces & urine as unchanged drug & as the glucuronide metabolite.

•Indications:   
Spara is indicated in:
1- Respiratory tract infections: in community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, acute sinusitis & bronchiestasis.
2- Skin & soft tissue infections: infected wounds, furunculosis, cellulitis, carbuncles, impetigo, erysipelas, etc....
3- Post-surgical infections.
4- Urinary tract infections
5- Gynaecological infections: pelvic inflammatory disorders.
6- Sexually transmitted disease: uncomplicated gonorrhoea, non-gonococcal urethritis, cervicitis due to Chlamydia trachomatis.
7- Gastro-intestinal infections.

•Contraindications:   
Spara should not be administered to patients with a history of hypersensitivity reactions to sparfloxacin or any product of the quinolones family.

It is not recommended during pregnancy, lactation & not to be given to children.

Patients suffering from QT interval prolongation.

Patients taking antiarrhythmics, tricyclic antidepressants, erythromycin, & terfenadine.

•Precautions:
Tendon damage: at the 1st sign of pain or inflammation, patients taking quinolones should discontinue the treatment & rest the affected limb until tendon symptoms have resolved.

Exposure to excessive sunlight should be considered to avoid photosensitivity reactions.

QT interval prolongation (1.3%), which returns to baseline within 48 hours of the last dose.

Dosage adjustment is required in severe renal impairment.

•Side effects:   
Spara is generally well tolerated, however it has the adverse effects of other quinolones which include gastro-intestinal effects as diarrhoea, abdominal pain, nausea, vomiting, anorexia, stomatitis.  Headache, dizziness, insomnia, tremors.

•Dosage & administration:    
Adult with normal renal function: the recommended daily dose of Spara two tablets to be taken once on the first day as a loading dose, then, one tablet to be taken daily for a total of 10 days of therapy (11 tablets).

Adult with renal function impairment: two tablets to be taken on the first day as a loading dose, then, one tablet  every 48 hours for a total of 9 days of therapy (6 tablets).

N.B: Adequate fluid intake is advisable during therapy & avoid any antacids containing aluminium, magnesium, & calcium at the same time of therapy.

•Presentation:
Store in dry place, at room temperature away from light.

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更新日期: 2013-04-09
附件:
 
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