药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201811119043033.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分Baxdela处方资料(仅供参考)
Baxdela(Delafloxacin Injection,Tablets)
BAXDELA Rx
通用名称和配方:
Delafloxacin 450mg;标签。
公司:
Melinta Therapeutics
选择治疗用途:细菌感染
BAXDELA的适应症:
易感的急性细菌性皮肤和皮肤结构感染(ABSSSI)。
成人:
≥18岁:每12小时450mg,持续5-14天。 ESRD(eGFR <15mL / min / 1.73m2)或血液透析:不推荐(数据不足)。查看完整标签。
儿童:
<18岁:不推荐。
警告/注意事项:
残疾和潜在不可逆的不良反应(包括肌腱炎/肌腱断裂[特别是患者> 60岁,或肾脏,心脏或肺移植],周围神经病变或中枢神经系统影响)的风险增加;如果出现体征/症状,立即停药。肌腱疾病,周围神经病或重症肌无力的病史:避免。中枢神经系统疾病(如脑动脉硬化,癫痫)会增加癫痫发作的风险。 在出现皮疹或其他任何超敏反应的第一个迹象时停止。接受静脉注射形式的严重肾功能损害:监测血清肌酐水平,eGFR密切;如果血清肌酐水平升高,考虑改用口服形式。如果eGFR下降<15mL / min / 1.73m2则停止。怀孕。哺乳母亲。
Ineractions:
在含有镁或铝的抗酸剂,硫糖铝,金属阳离子,含有锌或铁的多种维生素或去羟肌苷(缓冲形式)之后,在这些药剂之前或之后至少2小时分别给药口服剂型。皮质类固醇激素增加腱炎/肌腱断裂的风险。对于IV:避免通过相同的IV系列含有多价阳离子(例如,钙,镁)的伴随溶液。
另见:
药理学类:
喹诺酮类。
不良反应:
恶心,腹泻,头痛,转氨酶升高,呕吐,其他中枢神经系统,心脏,胃肠道,代谢,肌肉骨骼,注射反应(见完整标签);肌腱炎/肌腱断裂,周围神经病变,过敏反应,艰难梭菌相关性腹泻。
通用可用性:
NO
Baxdela(Delafloxacin Injection, Tablets)
BAXDELA Rx
Generic Name and Formulations:
Delafloxacin 450mg; tabs.
Company:
Melinta Therapeutics
Select therapeutic use: Bacterial infections
Indications for BAXDELA:
Susceptible acute bacterial skin and skin structure infections (ABSSSI).
Adult:
≥18yrs: 450mg every 12hrs for 5–14 days. ESRD (eGFR <15mL/min/1.73m2) or hemodialysis: not recommended (insufficient data). See full labeling.
Children:
<18yrs: not recommended.
Warnings/Precautions:
Increased risk of disabling and potentially irreversible adverse reactions (including tendinitis/tendon rupture [ esp. in patients >60yrs, or those with kidney, heart or lung transplants], peripheral neuropathy, or CNS effects); discontinue immediately if signs/symptoms occur. History of tendon disorders, peripheral neuropathy, or myasthenia gravis: avoid. CNS disorders (eg, cerebral arteriosclerosis, epilepsy) that increase seizure risk. Discontinue at 1st sign of skin rash, or any other hypersensitivity. Severe renal impairment receiving IV form: monitor serum creatinine levels, eGFR closely; consider switching to oral form if serum creatinine level increases. Discontinue if eGFR falls <15mL/min/1.73m2. Pregnancy. Nursing mothers.
Ineractions:
Separate dosing of oral form with magnesium- or aluminum-containing antacids, sucralfate, metal cations, multivitamins containing zinc or iron, or didanosine (buffered forms) by at least 2hrs before or 6hrs after these agents. Increased risk of tendinitis/tendon rupture with corticosteroids. For IV: avoid concomitant solution containing multivalent cations (eg, calcium, magnesium) through same IV line.
See Also:
Pharmacological Class:
Quinolone.
Adverse Reactions:
Nausea, diarrhea, headache, transaminase elevations, vomiting, other CNS, cardiac, GI, metabolic, musculoskeletal, injection reactions (see full labeling); tendinitis/tendon rupture, peripheral neuropathy, hypersensitivity reactions, C. difficile-associated diarrhea.
Generic Availability:
NO
Expiry: 05/2021
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201811119043033.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- |