部份中文阿贝卡星处方资料(仅供参考) 【中文品名】阿贝卡星 【药效类别】抗生素>氨基糖甙类>卡那霉素类 【通用药名】ARBEKACIN 【别 名】1665-RB, AHB-DKB, HABA-DKB, Habekacin, HBK 【化学名称】 O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[2,6-diamino-2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→4)]-1-N-[(2S)-4-amino-2-hydroxybutanoyl]-2-deoxy-D-streptamine 【CA登记号】[51025-85-5] 【结 构 式】
【分 子 式】C22H44N6O10 【分 子 量】552.62(ただし遊離塩基) 【收录药典】 【开发单位】明治制果 【首次上市】1990年,日本 【性 状】硫酸阿贝卡星是一种白色粉末。它是易溶于水,并且在乙醇(99.5)几乎不溶 【用 途】为一种地贝卡星类似物,对革兰氏阳性和阴性菌以及大多数临床分离出的耐庆大霉素的菌种,包括绿脓杆菌和粘质沙雷氏菌有效,对大多数氨基糖甙灭活酶有高度抵抗力。 【用法用量】 1. 成人 一天一次150-200毫克,用药时间30分钟至2小时,以静脉内输注。也有可能是分配静脉滴注在一天150-200毫克的两倍。此外,当静脉内给药是困难的,也可以被肌内注射一次或每天分为2次0.99-200毫克。剂量可根据年龄,体重和症状进行调整。 2. 小児 4-6毫克 1天/千克,用药时间30分钟,以静脉内输注。如果必要的话,每日1次4〜6毫克(效价)/ kg至可以是分配滴注两种。剂量可根据年龄,体重和症状进行调整。 【药 理】 1. 抗菌作用 (1)具有抗耐甲氧西林金黄色葡萄球菌(MRSA)很强的抗菌活性,这表明在氨基糖苷类抗生素最好的抗菌。 (2) 对各种灭活由MRSA产生的酶的稳定。 (3) 这表明对实验性MRSA感染的小鼠施用环磷酰胺减少感染的防守出色的保护效果。也显示出对由MRSA试验鼠皮下脓肿优异的保护作用。 2. 耐性获得 虽然体内获得性抗性试验中观察到的获得性抗性使用小鼠MRSA,体外获得性抗性测试通过由于MIC的增加而增加的传代培养方法中观察到,抗细菌表达的临床的可能性不能否认。 3. 作用机序 通过抑制细菌蛋白质合成显示出抗微生物活性,它的效果是杀菌。 包装规格: 硫酸阿贝卡星注射液 25毫克:10安瓿/盒 25毫克/0.5毫升 75毫克:10安瓿/盒 75毫克/1.5毫升 100毫克:10安瓿/盒 100毫克/2毫升 200毫克:10安瓿/盒 200毫克/4毫升 制造厂商 明治制果药业有限公司 完整处方资料附件:http://www.info.pmda.go.jp/go/pack/6119400A1069_1_09/ Announcing new release of HABEKASIN® injection 200 mg for treatment of MRSA infection Meiji Seika Kaisha (Headquarters: Chuo-ku, Tokyo; president: Tadaharu Sato) received approval for manufacturing and marketing on February 29 this year, and has received methicillin-resistant Staphylococcus aureus (MRSA) We will inform you that we will release the Havelikashin ® injection 200 mg (generic name: arbekasin sulfate injection) for infectious disease treatment on June 30. "Havekacin® injection" is an aminoglycoside antimicrobial drug developed by the Company and was approved in 1990 as the first medicament for MRSA infection in Japan and has been used as a drug highly useful for MRSA infection up to this day . This release of "HABEKASIN® injection 200 mg" is based on the administration method that divides 200 mg daily dose for adults, which is the dosage at the time of initial approval, into two doses, from the administration method approved on February 29 this year It corresponds to partial change of dosage and dose for once-a-day administration. Partial change of dosage/dose is to bring the benefit of this drug which shows the short-term bactericidal action depending on the concentration of the drug to higher therapeutic effect. Regarding the therapeutic effects of antibiotics and the side effects/resistance tolerance, it has been pointed out in recent years that they are related to the pharmacokinetics of drugs. From the viewpoint of proper use of pharmaceuticals, PK/PD (pharmacokinetics and drugs Dynamics) Appropriate administration design of antibiotics based on theory is emphasized. Aminoglycoside antibiotics have been found to correlate with the maximum blood concentration and efficacy, and at the same time it has been found that there is a correlation between the lowest blood level and the occurrence of side effects, and also in this drug, the clinical drug As a result of extensive studies on the establishment of an appropriate administration method suitable for drug properties by carrying out blood monitoring, it was effective to raise the maximum blood concentration to 9 to 20 μg/ml as a guideline by administration once a day On the other hand, clinical results were suggested suggesting that suppression of the lowest blood level to 2 μg/ml or less, which is regarded as a safe area for avoiding side effects, is the optimal treatment method. Based on this fact, we applied for approval for partial change of dosage/dose, but in addition to applying from our company for partial change of dosage/dose, in addition to applying for improvement of treatment effect and suppression of resistant bacteria, It is the circumstance that the request form was submitted to the Ministry of Health, Labor and Welfare from the corporation Japan Chemotherapy Society, and it was also the content that was desired in the clinical setting. We will add the 200 mg formulation released this time to existing "HABEKACIN® injection" and will further contribute to the treatment of domestic MRSA infection. Product outline of "HABEKACIN® injection 200 mg" Sales name: "HABEKACIN® injection 200 mg" Common name: arbekasin sulfate injection Ingredients · Content: (HABEKACIN® injection 200 mg) Contains 200 mg (potency) of arbekasin sulfate in 1 ml ampule 4 ml. Adaptive fungal species: Methicillin-resistant Staphylococcus aureus (MRSA) sensitive to arbekacin Indications Sepsis, pneumonia Dosage/administration (administration to adults) Usually, as an arbekasin sulfate for adults, intravenously drip infusion over 150 minutes to 200 mg (titer) once a day for 30 minutes to 2 hours. If necessary, intravenous drip infusion can be done in two divided doses of 150 to 200 mg (potency) a day. When it is difficult to intravenously administer it, intramuscular injection of 150 to 200 mg (titer) per day can be performed once or twice a day as arbekasin sulfate. Incidentally, it increases and decreases according to age and symptoms as appropriate. (Administration to children) Usually, as an arbekasin sulfate for adults, intravenous drip infusion is intravenously infused over a period of 30 minutes, 4 to 6 mg (potency)/Kg once a day. If necessary, intravenous drip infusion can be done in two divided doses of 4 to 6 mg (potency)/Kg per day. Incidentally, it increases and decreases according to age and symptoms as appropriate. Manufacturer selling agency: Meiji Seika Co., Ltd. Manufacture and sale approval date: February 29, 2008 Drug Price Listing Date: 20th June 2008
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