近日，美国FDA批准每日口服1次的新控释片Moxatag（amoxicillin 阿莫西林 775mg）上市，用于治疗成人及12岁以上儿童化脓链球菌引起的咽炎和（或）扁桃体炎（通常称为链球菌喉）。
MiddleBrook Pharmaceuticals采用其一日1次脉冲系统（Pulsys）专利释药技术是基于下述发现：在相对短的细菌自然生命周期中，抗生素以脉冲的形式与细菌接触，尤其是在服药后初始6～8小时内有3～5次脉冲释药，消灭细菌和疗效优于常规治疗方案。在临床前研究中发现，一些抗生素脉冲给药不仅可杀灭更多的细菌和更好地预防耐药菌株的出现，而且可显著降低药物剂量。
批准日期：2018年1月29日 公司：VERNALIS制药
MOXATAG（阿莫西林[amoxicillin]）控释片,供口服使用
SPL未分类的部分
为了减少耐药细菌的发展并保持MOXATAG和其他抗菌药物的有效性，MOXATAG应仅用于治疗或预防已证实或强烈怀疑由细菌引起的感染。
作用机制
阿莫西林是一种抗菌药物。[见临床药理学]
适应症和用法
MOXATAG是一种青霉素类抗菌药，用于治疗成人和12岁或12岁以上儿童患者的化脓性链球菌继发的扁桃体炎和/或咽炎。
剂量和给药
扁桃体炎和/或咽炎：每天一次775毫克，连续10天。
不要咀嚼或压碎片剂。
剂量形式和强度
片剂：775mg
禁忌症
已知对阿莫西林或同一类别的其他药物或已证实对β-内酰胺类过敏反应的患者有严重超敏反应的患者。
警告和注意事项
在青霉素治疗的患者中已经报道了严重且偶尔致命的超敏反应（过敏性）反应。严重的过敏反应需要立即用肾上腺素紧急治疗。氧气，静脉注射类固醇和气道管理，包括插管，也应按照指示给药。
艰难梭菌相关性腹泻（从轻度腹泻到致命性结肠炎）：评估腹泻是否发生。
不良反应
最常见的药物相关不良反应（发生率≥1.0％）是外阴阴道真菌感染，腹泻，恶心，呕吐和头痛。
药物相互作用
Probenecid可降低阿莫西林的肾小管分泌。同时使用阿莫西林和丙磺舒可导致阿莫西林血液水平升高和延长。
用于特定人群
儿科：MOXATAG在12岁以下儿科患者中的安全性和有效性尚未确定。
肾损伤：MOXATAG尚未在肾功能不全患者中进行过研究;然而，对于严重肾功能不全的患者，通常建议减少阿莫西林的剂量。因此，不建议将MOXATAG用于严重肾功能不全（CrCl <30mL/min）或血液透析患者。
包装提供/存储和处理
用于口服给药的MOXATAG片剂以蓝色薄膜包衣的椭圆形片剂形式提供，其含有775mg阿莫西林作为三水合物。 片剂在黑色食用油墨的一面印有“MB-111”。
MOXATAG包装在瓶子和泡罩卡中，如下所示：
瓶子30 NDC 11042-142-03
10平板电脑卡
（每个泡罩腔1片）NDC 11042-142-02
存储
储存在25ºC（77ºF）; 允许偏移15-30ºC（59-86ºF）[见USP受控室温]
MOXATAG(amoxicillin extended-release) Tablets
What is Amoxicillin 775 MG Extended Release Oral Tablet[Moxatag]
Treating infections caused by certain bacteria. It is also used with other medicines to treat Helicobacter pylori infection and ulcers of the small intestines.
Amoxicillin 775 MG Extended Release Oral Tablet[Moxatag] is a penicillin antibiotic. It works by killing sensitive bacteria.
Important safety information:
Amoxicillin 775 MG Extended Release Oral Tablet[Moxatag]may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Amoxicillin 775 MG Extended Release Oral Tablet [Moxatag] with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Amoxicillin 775 MG Extended Release Oral Tablet[Moxatag]only works against bacteria; it does not treat viral infections.
Be sure to use Amoxicillin 775 MG Extended Release Oral Tablet [Moxatag] for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
Long-term or repeated use of Amoxicillin 775 MG Extended Release Oral Tablet [Moxatag] may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
Do not receive a live vaccine(eg, oral typhoid vaccine)while you are taking Amoxicillin 775 MG Extended Release Oral Tablet[Moxatag]. Talk with your doctor before you receive any vaccine.
Hormonal birth control(eg, birth control pills)may not work as well while you are using Amoxicillin 775 MG Extended Release Oral Tablet [Moxatag]. To prevent pregnancy, use an extra form of birth control (eg, condoms).
Brown, yellow, or gray tooth discoloration has occurred rarely in some patients taking Amoxicillin 775 MG Extended Release Oral Tablet [Moxatag]. It occurred most often in children. The discoloration was reduced or removed by brushing or dental cleaning in most cases. Contact your doctor if you experience this effect.
Diabetes patients - Amoxicillin 775 MG Extended Release Oral Tablet [Moxatag] may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed if you use Amoxicillin 775 MG Extended Release Oral Tablet[Moxatag]for a long period of time. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Caution is advised when using Amoxicillin 775 MG Extended Release Oral Tablet[Moxatag]in CHILDREN younger than 3 months old; they may be more sensitive to its effects.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Amoxicillin 775 MG Extended Release Oral Tablet [Moxatag] while you are pregnant. Amoxicillin 775 MG Extended Release Oral Tablet [Moxatag] is found in breast milk. If you are or will be breast-feeding while you use Amoxicillin 775 MG Extended Release Oral Tablet [Moxatag], check with your doctor. Discuss any possible risks to your baby.
Amoxicillin 775 MG Extended Release Oral Tablet [Moxatag] side effects
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; nausea; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavior changes; bloody stools; confusion; dark urine; fever, chills, or persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe stomach pain or cramps; unusual bruising or bleeding; unusual tiredness or weakness; vaginal discharge or irritation; white patches in the mouth or on the tongue; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6c0e721-2021-4983-a305-49bdf8f135a9