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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗微生物药物->碳青霉烯类
处方药:处方药
包装规格: 250毫克/瓶 10瓶/盒
计价单位:
   
生产厂家英文名:
SHIONOGI INC
该药品相关信息网址1:
http://www.doribax.com/doribax/index.html
该药品相关信息网址2:
http://hi.baidu.com/jhy9928/blog/item/0fe1cc60ea00dbdc8cb10d19.html
原产地英文商品名:
Doribax 250mg 10 vials
原产地英文药品名:
DORIPENEM
中文参考商品译名:
DORIBAX 250毫克/瓶 10瓶/盒
中文参考药品译名:
多尼培南
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Complicated intra-abdominal infections
英文适应病症2:
Complicated urinary tract infections (including pyelonephritis)
临床试验期:
完成
中文适应病症参考翻译1:
复杂性腹腔内感染
中文适应病症参考翻译2:
复杂性泌尿道感染( 包括肾盂肾炎)
药品信息:

Information on Doribax

INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORIBAX™ and other antibacterial drugs, DORIBAX™ should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.DORIBAX™ (doripenem for injection) is indicated as a single agent for the treatment of complicated intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides caccae, Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Streptococcus intermedius, Streptococcus constellatus and Peptostreptococcus micros.Complicated Urinary Tract Infections, Including Pyelonephritis
DORIBAX™ (doripenem for injection) is indicated as a single agent for the treatment of complicated urinary tract infections, including pyelonephritis caused by Escherichia coli including cases with concurrent bacteremia, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Acinetobacter baumannii.

DOSAGE AND ADMINISTRATION
Recommended Dosage
The recommended dosage of DORIBAX™ is 500 mg administered every 8 hours by intravenous infusion over one hour in patients ≥18 years of age.
Duration includes a possible switch to an appropriate oral therapy, after at least 3 days of parenteral therapy, once clinical improvement has been demonstrated.
Duration can be extended up to 14 days for patients with concurrent bacteremia.

Storage of Constituted Solutions
Upon constitution with sterile water for injection or 0.9% sodium chloride (normal saline) injection, DORIBAX suspension in the vial may be held for 1-hour prior to transfer and dilution in the infusion bag.

CONTRAINDICATIONS
DORIBAX™ is contraindicated in patients with known serious hypersensitivity to doripenem or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams.

WARNINGS AND PRECAUTIONS
1 Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) and serious skin reactions have been reported in patients receiving beta-lactam antibiotics. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. Before therapy with DORIBAX™ is instituted, careful inquiry should be made to determine whether the patient has had a previous hypersensitivity reaction to other carbapenems, cephalosporins, penicillins or other allergens. If this product is to be given to a penicillin- or other beta-lactam-allergic patient, caution should be exercised because cross-hyperreactivity among beta-lactam antibiotics has been clearly documented.If an allergic reaction to DORIBAX™ occurs, discontinue the drug. Serious acute hypersensitivity (anaphylactic) reactions require emergency treatment with epinephrine and other emergency measures, including oxygen, IV fluids, IV antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated.

2 Interaction with Valproic Acid
Due to a drug interaction, patients with seizure disorders controlled with valproic acid or sodium valproate will be at an increased risk for breakthrough seizures when treated with DORIBAX™ concomitantly. Reduction in serum valproic acid concentrations to below the therapeutic concentration range (50 to 100 mcg/mL) was observed by 12 hours after the initiation of doripenem in healthy subjects co-administered both drugs. A similar drug interaction involving other carbapenem antibacterials and valproic acid has been described in published case reports. In some of these reports, increasing the dose of valproic acid or sodium valproate did not result in increased valproic acid serum concentrations. Alternative antibacterial therapies should be considered for patients receiving valproic acid or sodium valproate. If administration of DORIBAX™ is necessary, supplemental anti-convulsant therapy should be considered.

3 Clostridium difficile-Associated Diarrhea
Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile.C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

4 Development of Drug-Resistant Bacteria
Prescribing DORIBAX™ in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

5 Pneumonitis with Inhalational Use
When DORIBAX™ has been used investigationally via inhalation, pneumonitis has occurred. DORIBAX™ should not be administered by this route.


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详细处方信息以本药内容附件PDF文件(20145820012111.pdf)的“原文Priscribing Information”为准
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部分中文 DORIBAX 处方信息(仅供参考)

【商品名】多尼培南 

【临床应用】
1. 美国FDA 批准适应证:(1) 用于多种细菌引起的复杂性腹腔内感染。(2) 用于多种细菌引起的复杂性泌尿道感染( 包括肾盂肾炎)。
2. 日本厚生省批准适应证:(1) 腹膜炎、腹腔内脓疡、胆囊炎、胆管炎。(2) 复杂性膀胱炎、肾盂肾炎、急性或慢性前列腺炎、副睾丸炎、子宫内感染、子宫附件炎。(3) 咽头炎、喉头炎、扁桃体炎( 含扁桃周围炎、扁桃周围脓肿)、肺炎、肺脓疡、脓胸、慢性呼吸系统病变的二次感染。(4) 外伤、烧烫伤及手术创伤等的二次感染,深层性皮肤感染( 淋巴管炎、淋巴结炎)。(5) 眼窝感染、角膜炎( 含角膜溃疡)、眼内炎( 含全眼球炎)、中耳炎。(6) 败血症、感染性心内膜炎、骨髄炎、关节炎、腭骨周边的蜂巢炎、腭炎。
【药理】
药效学
本药为β- 内酰胺类中碳青霉烯类抗生素。
作用机制 本药通过与青霉素结合蛋白(PBP) 结剂量范围呈线性。肾损害患者和老年人中AUC 升高。本药的平均血浆蛋白结合率约为8.1%,结合率与血药浓度相关,分布容积为16.8L(8.09~55.5L)。本药可经脱氢肽酶-I 代谢为无活性的开环代谢物( 多尼培南-M1),但主要以原型药经肾清除,健康成人接受500mg 本药,48 小时内尿液中回收70%的原型药和15% 的开环代谢物。在健康成人中,本药的平均血浆终末半衰期约为1 小时,平均血浆清除率为15.9L/h,平均肾清除率为10.8L/h。肾功能正常者按每8 小时500mg 或1g 多次静脉输注7~10 日,未发现本药累积。
遗传与生殖毒性
(1) 遗传毒性:本药在细菌回复突变试验、中国颊鼠肺成纤维细胞的染色体畸变试验、小鼠骨髓微核试验未显示致突变性。(2) 生殖毒性:一日1g/kg对大鼠静注本药( 大于人类剂量一次500mg,8 小时1 次时暴露量的1.5 倍,根据AUC 计),对雄性和雌性大鼠的生育力及后代的生殖能力无不良影响。本药在大鼠中剂量高达一日1g/kg 和家兔中剂量高达一日50mg/kg( 至少是人类剂量一次500mg,8 小时1 次时暴露量的0.8 倍,根据AUC 计),未见致畸性。(3) 致癌性:尚无本药长期动物试验研究资料。
【注意事项】
1. 交叉过敏 β- 内酰胺抗生素类之间有交叉过敏。
2. 禁忌证 对本药或对其他β- 内酰胺类抗生素过敏者( 国外资料)。
3. 慎用 哺乳妇女( 国外资料)。
4. 药物对儿童的影响 儿童用药的安全性和有效性尚未确立。
5. 药物对老人的影响 本药在老年人中的暴露量增加,且老年人易出现肾功能减退或肾前性氮血症,不良反应的发生风险高于其他人群。
6. 药物对妊娠的影响 孕妇用药尚无充分、良好的对照研究资料,孕妇仅在确有必要时方可使用。美国食品药品管理局(FDA) 对本药的妊娠安全性分级为B 级。
7. 药物对哺乳的影响 尚不明确本药是否分泌入乳汁中,哺乳妇女应慎用。
8. 用药前后及用药时应当检查或监测 老年患者和中至重度肾功能损害者应定期检查肾功能。
【不良反应】
[ 国外不良反应参考]
可见过敏反应,史-约综合征(Stevens-Johnson Syndrome)、中毒性表皮坏死松解症、间质性肺炎、癫痫发作。此外,临床试验中出现以下不良反应:
1. 心血管系统 常见静脉炎。
2. 泌尿生殖系统 可见外阴真菌感染、肾损害、肾衰竭。
3. 神经系统 常见头痛。
4. 肝脏 可见丙氨酸氨基转移酶升高、天门冬氨酸氨基转移酶升高。
5. 胃肠道 常见恶心、腹泻,还可见口腔念珠菌病、艰难梭状芽孢杆菌相关的腹泻(CDAD)。
6. 血液 可见贫血。
7. 皮肤 常见皮疹,可见瘙痒、斑疹、丘疹、荨麻疹、过敏性皮炎和大疱性皮炎、红斑、多形性红斑。
8. 其他 可见耐药菌的出现。
【药物相互作用】
药物-药物相互作用
1. 丙磺酸可干扰肾小管对本药的主动排泄,造成本药血浆浓度升高,AUC 升高75%,血浆半衰期延长53%。
2. 本药可能抑制丙戊酸葡糖醛酸苷水平,使丙戊酸血清浓度显著降低,故合并用药后应频繁监测丙戊酸血清浓度。如果丙戊酸血清浓度不能维持在治疗范围或出现癫痫发作,应考虑采用其他抗菌药或抗惊厥治疗。
3. 本药对经细胞色素P450 同工酶代谢途径的药物的代谢无抑制作用。
4. 本药对其他抗生素( 如左氟沙星、阿米卡星、甲氧苄啶-磺胺甲恶唑、达托霉素、利奈唑胺和万古霉素) 无相互拮抗作用。
【给药说明】
1. 配伍禁忌:尚未确定本药与其他药品的配伍禁忌,不得将本药与含其他药品的溶液混合使用。
2. 注射液的配制:(1) 首先配制成混悬液:用10mL的无菌注射用水或0.9% 氯化钠注射液配制得到浓度为50mg/mL 的混悬液。此混悬液不可直接使用。(2) 配制500mg 供常规使用:将混悬液加入到含100mL 生理盐水或5% 葡萄糖的输液袋中,轻轻摇动,直至澄清,得到可供输注的溶液(4.5mg/mL)。配制250mg 供中至重度肾损害患者使用:按照上述方法配成可供输注的溶液,从该输液袋中除去55mL 并丢弃, 剩余溶液250mg(4.5mg/mL) 即为可用。
3. 从上述混悬液配好后到转入输液袋中稀释,至多可保留1 小时,配制的混悬液或输注溶液均不应冷冻,输注溶液放置时间不宜过长。
4. 因吸入给药可导致肺炎,故不得采用此种方式给药。
5. 胃肠外治疗至少3 日后若临床症状得以改善,可改为口服治疗方案。
6. 用药后怀疑或确诊为CDAD,与对抗艰难梭状芽孢杆菌无关的正在使用的抗生素需停用。如有必要可给予适当的液体和电解质或补充蛋白质,采用抗生素控制艰难梭状芽孢杆菌。
7. 一旦发生过敏反应立即停药,严重的急性过敏反应需采用肾上腺素和其他临床急救措施,包括输氧、静脉输液、静脉输注抗组胺类药、给予皮质类固醇类药和胺类升压药及呼吸道处理。
8. 用药过量时,应停用并采取一般支持疗法或血液透析。
【用法与用量】
[ 国外用法用量参考]
成人· 常规剂量
  · 静脉滴注
 美国FDA 批准用法用量:对伴发菌血症的患者,疗程可持续14 日。(1) 复杂性腹腔内感染:一次500mg,每8 小时1 次,1 小时输注完,5~14 日为一疗程。(2) 复杂性泌尿道感染( 包括肾盂肾炎) : 一次500mg,每8 小时1 次,1 小时输注完,10 日为一疗程。
 老年人剂量
肾功能损害的老年人应适当调整剂量,而肾功能正常的老年患者,不推荐进行剂量调整。
【制剂与规格】
注射用多尼培南 (1)250mg。(2)500mg。贮法:25℃(15~30℃ ) 下保存。

美国FDA2007-10-17 消息

FDA批准治疗难治的尿路感染和腹腔内感染的新药

FDA已批准500mg多利培南静脉输液用于治疗难治的尿路感染和腹腔内感染的新药,其商品名为Doribax,本品已对一系列菌株显示出它是一个有效的治疗药物。
FDA科学和医疗规化副理事,药品评价和研究中心的医务主任和代理主管Janet Woodcock医学博士认为“对治疗严重细菌感染的住院患者来说,这是一个有意义的新药。”
在若干多中心,多国家的临床研究中,本品对治疗难治的尿路感染的治愈率比得上当前的处方药左氧氟沙星,对治疗难治的腹腔内感染的治愈率比得上美罗培南。
最常见的副作用有头痛,恶心,腹泻,皮疹和静脉炎。另外,发生过敏反应,有些可需立即处治。
本品用于小儿科患者的安全性和有效性尚未确定。可否用于孕妇亦未作研究,仅在确有必要时,方可用于怀孕患者。

本品由美国Johnson and Johnson Pharmaceutical Research and Development, LLC生产。

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详细处方信息以本药内容附件PDF文件(20145820012111.pdf)的“原文Priscribing Information”为准
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更新于2011-3-28

更新日期: 2014-04-01
附件:
20145820012111.pdf    

 
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