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Moxatag (Amoxicillin) - Summary



MOXATAG (amoxicillin extended-release) tablets for oral administration are provided as blue film-coated, oval shaped tablets that contain 775 mg of amoxicillin as the trihydrate and are printed with ”MB-111” on one side in black edible ink.       Amoxicillin is a semi-synthetic antibiotic, an analog of ampicillin, with bactericidal activity against gram-positive and gram-negative microorganisms.

Tonsillitis and/or Pharyngitis

      MOXATAG is a penicillin-class antibacterial indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes)   in   adults and pediatric patients 12 years and older.


      To reduce the development of drug-resistant bacteria and maintain the effectiveness of MOXATAG and other antibacterial drugs, MOXATAG should be used only to treat or prevent 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 or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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Published Studies Related to Moxatag (Amoxicillin)

Response of feline eosinophilic plaques and lip ulcers to amoxicillin trihydrate-clavulanate potassium therapy: a randomized, double-blind placebo-controlled prospective study. [2012]
In this study, we evaluated the treatment of feline eosinophilic plaques and lip ulcers with amoxicillin trihydrate-potassium clavulanate (Clavamox(®); Pfizer Animal Health). Nineteen cats with clinical and cytological findings consistent with eosinophilic plaques and/or lip ulcers were enrolled...

Clinical and microbiological benefits of metronidazole alone or with amoxicillin as adjuncts in the treatment of chronic periodontitis: a randomized placebo-controlled clinical trial. [2011.09]
AIM: To evaluate the effects of the adjunctive use of metronidazole (MTZ) or MTZ+amoxicillin (AMX) in the treatment of generalized chronic periodontitis (ChP)... CONCLUSION: The adjunctive use of MTZ+AMX offers short-term clinical and microbiological benefits, over SRP alone, in the treatment of non-smokers subjects with generalized ChP. The added benefits of MTZ were less evident. (c) 2011 John Wiley & Sons A/S.

Efficacy of amoxicillin treatment in preventing postoperative complications in patients undergoing third molar surgery: a prospective, randomized, double-blind controlled study. [2011.06]
PURPOSE: The aim of the present study was to evaluate and compare the occurrence of postoperative complications in patients receiving either pre- or postoperative amoxicillin versus placebo after third molar surgery... CONCLUSION: Amoxicillin administered pre- or postoperatively demonstrated greater efficacy than placebo in preventing postoperative complications in patients undergoing third molar surgery. The best results were obtained using the postoperative protocol. Copyright (c) 2011 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Treatment of streptococcal pharyngitis with once-daily amoxicillin versus intramuscular benzathine penicillin G in low-resource settings: a randomized controlled trial. [2011.06]
BACKGROUND: Primary prevention of acute rheumatic fever is achieved by proper antibiotic treatment of group A beta -hemolytic streptococcal (GAS) pharyngitis... CONCLUSION: If compliance is a major issue, a single dose of IM BPG may be preferable for treatment of GAS pharyngitis.

Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. [2011.05.07]
BACKGROUND: Researchers have suggested that antibiotics could cure acute appendicitis. We assessed the efficacy of amoxicillin plus clavulanic acid by comparison with emergency appendicectomy for treatment of patients with uncomplicated acute appendicitis... INTERPRETATION: Amoxicillin plus clavulanic acid was not non-inferior to emergency appendicectomy for treatment of acute appendicitis. Identification of predictive markers on CT scans might enable improved targeting of antibiotic treatment. FUNDING: French Ministry of Health, Programme Hospitalier de Recherche Clinique 2002. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

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Clinical Trials Related to Moxatag (Amoxicillin)

Bioequivalence of Two Commercial Amoxicillin Suspensions [Completed]
The aim of the present study was to compare the pharmacokinetic profiles and to evaluate the bioequivalence of two commercial amoxicillin-suspension formulations in healthy Brazilian volunteers.

The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children [Recruiting]
The goal of this study is to determine whether amoxicillin (AMX) alone has an appreciable effect on upper gastrointestinal motility compared to placebo. In particular, induction of phase III of the interdigestive migrating motor complex (MMC) by AMX will be the primary outcome of the study. MMCs are periodic waves of electrical activity resulting in muscular contractions that pass through the walls of the stomach and intestinal tract during the fasting state. It is characterized by an initial period where there is a minimal electrical activity and muscular contraction (phase I), followed by a gradual increase in the frequency of contractions (phase III) that often leads to a characteristic cluster of contractions (phase III). This cycle occurs only in the fasting state in normal individuals and the frequency of phase III is quite varied, dependent on age and the presence of any underlying abnormalities in gastrointestinal motility. Secondary outcomes will include characteristics of the MMC, patient demographics in responders and non-responders, and the safety profile of AMX at the intervention dose.

Cotrimoxazole Versus Amoxicillin in the Treatment of Community Acquired Pneumonia in Children Aged 2-59 Months [Completed]
The investigators hypothesized that Oral amoxicillin (25mg/kg/dose bid) given to children aged 2-59 months with pneumonia, would lead to better clinical outcome on day three in 89. 9% of the children compared to 77. 0% of children receiving oral cotrimoxazole (8 mg/kg/dose trimethoprim, 40 mg/kg/dose sulphamethoxazole). A double blind randomized controlled trial was conducted in the Assessment Center of Mulago Hospital. Children with non-severe pneumonia were randomized to receive either oral amoxicillin (25 mg/kg/dose) or cotrimoxazole (trimethoprim 8 mg/kg and sulphamethoxazole 40 mg/kg) and followed up on day 3 and 5 of treatment. The primary outcome measures were normalization of respiratory rate by day 3 of treatment. Secondary outcome measures were antimicrobial susceptibility to cotrimoxazole and amoxicillin.

Clarithromycin, Amoxicillin, and Metronidazole Based Regimens to Treat Helicobacter Pylori Infections in Colombia [Completed]
More than half of the world's population is infected with Helicobacter pylori, a bacterium that colonizes the human stomach. Although most infected subjects live free of symptoms and disease outcomes (except superficial gastritis), only a few develop peptic ulcers or gastric cancer, while some others may develop non-ulcer dyspepsia. Current clinical practice for the management of peptic ulcer disease includes testing for and treating H. pylori, if present. Although there are triple therapies that contain 2 antibiotics plus a bismuth compound, a proton-pump inhibitor, or a H2-receptor antagonist which are effective at eliminating H. pylori in Europe and North America, these treatments are dramatically less effective in developing countries. Our recent meta-analysis showed quadruple therapies containing clarithromycin, amoxicillin, metronidazole and a proton pump inhibitor to be effective in the presence of clarithromycin or metronidazole resistance. However, this regimen has yet to be tested in a developing country. Therefore, in the current randomized clinical trial in Pasto, Colombia, we aim to examine the effectiveness of clarithromycin, amoxicillin, metronidazole with and without a proton pump inhibitor compared to the Food and Drug Administration approved 10-day regimen containing clarithromycin, amoxicillin and omeprazole. Since antibiotic therapy is most effective within a specific gastric pH range, and since mutifocal atrophy results in damage and loss of the acid producing parietal cells, we will test the efficacy of our modified therapy stratified by diagnosis of multifocal atrophic gastritis.

Trial of Amoxicillin Compared With Placebo for Pneumonia in Children Aged 2-59 Months [Completed]
Many children with "non-severe pneumonia" (cough and fast breathing) have neither clinical pneumonia as assessed by physicians nor pneumonia on chest radiographs. Inappropriate use of antibiotics for these cases is leading to resistant strains of bacteria in the community. Evidence shows that almost 50% of antibiotic prescription is unnecessary. As over half of antibiotic prescription for ARI are not necessary since most of these infections are viral and do not respond to antibiotic therapy which will be source of resistance in the community. To address this issue the investigators conducted this randomized, double blind placebo controlled clinical trial of oral Amoxicillin versus placebo in children with non-severe pneumonia taking into account all the necessary safety precautions for their well being. The study hypothesis was that the clinical outcome of children 2 to 59 months of age with cough and fast breathing (WHO defined non-severe pneumonia) with or without wheezing is equivalent, whether they are treated with amoxicillin or placebo.

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Page last updated: 2013-02-10

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