药品信息:
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DAIICHI SANKYO COMPANY, LTD (hereafter; DAIICHI SANKYO) announced it received approval on January 25 for its broad-spectrum antibacterial agent Gracevit(R) (generic name: sitafloxacin hydrate) from the Japanese Ministry of Health, Labour and Welfare. Gracevit(R) is to be marketed in 50 mg tablet form and as a 10% fine granular preparation.
DAIICHI SANKYO currently markets Cravit(R), which is in the same class as Gracevit(R), in tablet form and as a fine granular preparation. Cravit(R) is highly acclaimed for its clinical efficacy and safety. However, Gracevit(R) exhibits potent antibacterial activity with a broad spectrum and DAIICHI SANKYO expects it to be clinically effective in severe cases of bacterial infection, relapse/recrudescence of infection and infections where resistant bacteria are the suspected cause. The anticipated Gracevit(R) can be prescribed as the new quinolone oral antibacterial agent.
Promoting drug compliance and ensuring safety for Gracevit(R) are top priorities for DAIICHI SANKYO and the company is set to provide information for these purposes. In addition to Cravit(R), DAIICHI SANKYO is confident Gracevit(R) can further contribute to the treatment of infectious diseases.
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日本厚生省批准第一制药三共株式会社(Daiichi Sankyo)的广谱抗生素西他沙星水合物50 mg片和10%细粒剂(sitafloxacin hydrate,商Gracevit)上市,用于治疗严重难治的细菌感染。
本品系一新颖的N-1-氟环丙基喹诺酮,对耐甲氧西林金黄色葡萄球菌、耐甲氧西林表皮葡萄球菌、厌氧菌(包括脆弱类杆菌)以及支原体、衣原体等均具较强的抗菌活性。化学结构上有一顺式(1R,5R)-2-氟环丙胺基团,显示良好的药代动力学特性,且可减少不良反应。该药不仅显著增强抗革兰阳性菌活性,而且对临床分离的许多耐氟喹诺酮类的菌株也具抗菌活性。
本品体外抗菌活性的研究表明,其具广谱抗菌作用,不仅对革兰阴性菌有抗菌活性,而且对革兰阳性菌以及对许多临床常见耐氟喹诺酮类菌株也有良好杀菌作用。本品口服吸收好、生物利用度大于70%,组织分布广,在中枢神经系统外的多种组织中的药物浓度均高于血清药物浓度,因此,本品可望成为治疗呼吸道、泌尿生殖道、腹腔以及皮肤软组织等单一或混合细菌感染的重要药物。
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