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  药店国别: 美国药房
产地国家: 美国
所属类别: 作用于呼吸系统药物->咽炎
处方药:处方药
包装规格: 775毫克/片 30片/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
盐野义制药
生产厂家英文名:
SHIONOGI INC
该药品相关信息网址1:
http://www.moxatag.com/
原产地英文商品名:
MOXATAG ER TABLET 775mg/tablet 30tablets/Bottle
原产地英文药品名:
AMOXICILLIN
中文参考商品译名:
MOXATAG缓释片 775毫克/片 30片/瓶
中文参考药品译名:
阿莫西林
原产地国家批准上市年份:
2008/01/23
英文适应病症1:
pharyngitis
英文适应病症2:
tonsillitis
临床试验期:
完成
中文适应病症参考翻译1:
咽炎
中文适应病症参考翻译2:
扁桃体炎
药品信息:

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 详细处方信息以本药内容附件PDF文件(200973021291718.pdf)的“原文Priscribing Information”为准
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部分中文Moxatag处方信息仅供参考

        美FDA批准第一个1日1次用阿莫西林缓释片Moxatag用于治疗咽炎和扁桃体炎 Middlebrook制药有限公司2008年1月24日宣布,美国食品药品管理局(FDA)已批准其开发的阿莫西林(amoxacillin)775mg缓释片Moxatag,用于1日1次口服治疗12岁及以上青少年和成人的继发于酿脓链球菌感染的咽炎和(或)扁桃体炎。这两适应症也常俗称作链球菌性咽喉”,而Moxatag则是迄今在美获得批准的第一个和唯一一个1日1次用阿莫西林缓释制剂。

MOXATAG ™ (amoxicillin extended-release) Tablets is indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adults and pediatric patients 12 years and older.

MOXATAG should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacterial.

The full 10-day course of therapy should be completed for effective treatment. Patients taking MOXATAG should not chew or crush tablet.

IMPORTANT SAFETY INFORMATION
MOXATAG is contraindicated in patients with known serious hypersensitivity to amoxicillin or to other drugs in the same class or patients who have demonstrated anaphylactic reactions to beta lactams. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. If an allergic reaction occurs, MOXATAG should be discontinued and appropriate therapy instituted.

Clostridium Difficile Associated Diarrhea (CDAD) has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, MOXATAG should be discontinued and appropriate therapy instituted.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, MOXATAG should be discontinued and appropriate therapy instituted. The most common drug-related adverse reactions associated with MOXATAG observed in clinical studies are vulvovaginal mycotic infection (2.0%), diarrhea (1.7%), nausea (1.3%), vomiting (0.7%), abdominal pain (0.3%) and headache (1.0%). Please see the accompanying full Prescribing Information for additional adverse reactions for other amoxicillin products.

Warnings and Precautions
Anaphylaxis and Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with MOXATAG, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, MOXATAG should be discontinued and the patient should contact his or her physician immediately.

Clostridium difficile Associated Diarrhea (CDAD): CDAD has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. 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 the patient should contact his or her physician immediately and 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.

Drug Interactions
Taking probenecid together with MOXATAG may raise the amount of amoxicillin that is in your blood and the amount of time that the amoxicillin stays in your blood. The medical relevance of this has not been studied.

Taking antibiotics like MOXATAG may reduce the effectiveness of oral contraceptives.

Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of a penicillin-class antibiotic. The clinical significance of this interaction is not well documented.

Use in Specific Populations
MOXATAG has not been studied in patients with renal impairment; however, MOXATAG is not recommended for use in patients with severe renal impairment or patients on hemodialysis.

The safety and effectiveness of MOXATAG in pediatric patients younger than 12 years has not been established.

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 详细处方信息以本药内容附件PDF文件(200973021291718.pdf)的“原文Priscribing Information”为准
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更新日期: 2014-5-5
附件:
200973021291718.pdf    

 
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