MOXATAG SUMMARY
MOXATAG (amoxicillin extended-release) tablets for oral administration are provided as blue film-coated 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 yrs 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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NEWS HIGHLIGHTS
Published Studies Related to Moxatag (Amoxicillin)
Randomized controlled trial comparing oral amoxicillin-clavulanate and ofloxacin with intravenous ceftriaxone and amikacin as outpatient therapy in pediatric low-risk febrile neutropenia. [2009.09]
BACKGROUND: Outpatient oral therapy is infrequently used in pediatric low-risk febrile neutropenia (LRFN) as there is insufficient data regarding its equivalence as compared with parenteral therapy... CONCLUSIONS: Outpatient therapy is efficacious and safe in pediatric LRFN. There was no difference in outcome in oral versus IV outpatient therapy. Amoxycillin-clavulanate and ofloxacin may be the oral regimen of choice.
Reduced susceptibility to amoxicillin of oral streptococci following amoxicillin exposure. [2009.08]
As antibiotic pressure often triggers bacterial resistance, the use of short-duration therapies is increasingly recommended. The objective of the present study was to evaluate both the clinical efficiency and the impact on oral streptococci of a 3 day versus a 7 day amoxicillin therapy for odontogenic infection requiring tooth extraction...
Efficacy of the standard quadruple therapy versus triple therapies containing proton pump inhibitor plus amoxicillin and clarithromycin or amoxicillin-clavulanic acid and metronidazole for Helicobacter pylori eradication in children. [2009.08]
CONCLUSION: Considering these data we suggest quadruple therapy as the first line of therapy for eradication of H. pylori infection in children in our geographic area (Iran).
Effectiveness of amoxicillin/clavulanate potassium in the treatment of acute bacterial sinusitis in children. [2009.07]
OBJECTIVE: The role of antibiotic therapy in managing acute bacterial sinusitis (ABS) in children is controversial. The purpose of this study was to determine the effectiveness of high-dose amoxicillin/potassium clavulanate in the treatment of children diagnosed with ABS... CONCLUSIONS: ABS is a common complication of viral upper respiratory infections. Amoxicillin/potassium clavulanate results in significantly more cures and fewer failures than placebo, according to parental report of time to resolution of clinical symptoms.
Intravenous amoxicillin-sulbactam against Escherichia coli: optimizing the dose, component ratio and infusion time using a human pharmacodynamic model. [2009.06]
Amoxicillin-sulbactam (AMX-SUL) is an aminopenicillin/beta-lactamase inhibitor combination currently available in 29 countries which may be a suitable option for treating intra-abdominal infections. the aim of this study was to identify the optimal dose and ratio between components of this formulation through an ex-vivo human pharmacodynamic model against Escherichia coli...
Clinical Trials Related to Moxatag (Amoxicillin)
Study to Proof the Clinical and Bacteriological Non-Inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-Severe Community-Acquired Pneumonia [Recruiting]
The purpose of this study is to proof the clinical and bacteriological non-inferiority of
ampicillin/amoxicillin versus moxifloxacin in hospitalized patients with non-severe
community-acquired pneumonia.
Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-Clavulanic Acid [Recruiting]
Several case reports indicate that the use of the antibiotic combination amoxicillin and
clavulanic acid (AM-CLAVAC) can interact with warfarin pharmacodynamics. However, fever per
se might also be responsible of these warfarin overdose reports, as well as the use of high
dose paracetamol.
The aim of the present study is to determine if AM-CLAVAC can increase the pharmacodynamics
of warfarin among patients at steady state Double blinded cross over controlled study vs
placebo performed in 12 evaluable patients treated with warfarin with an INR target 2 to 3
and a stable INR and a stable dose.
Evaluation of Inflammatory Symptoms Reduction With Amoxicillin + Ketoprofen in Acute Pharyngeal- Tonsillitis in Pediatric Patients [Recruiting]
The purpose of this study is to evaluate the inflammatory symptoms and signs (hyperemia,
edema and pain) reduction after 24 hours of treatment with ketoprofen drops when associated
to amoxicillin.
A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIs [Recruiting]
The purpose of this study is to assess if a therapy with intravenous and oral moxifloxacin
is as effective as a therapy with intravenous and oral amoxicilline/clavulanate in the
treatment of complicated skin and skin structure infection.
Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh [Recruiting]
The primary aim is to establish the non-inferiority of several simplified, home-based
antibiotic regimens compared to the standard course of parenteral antibiotics for the
empiric treatment of suspected sepsis in Bangladeshi young infants whose parents refuse
hospitalization. Three alternative regimens will be compared with a standard (reference)
regimen of injectable procaine-benzyl penicillin and gentamicin once daily each for seven
days. Alternative regimens are (1) injectable gentamicin once daily and oral amoxicillin
twice daily for seven days; (2) injectable penicillin and gentamicin once daily for two days
followed by oral amoxicillin twice daily for five days; and (3) injectable gentamicin once
daily and oral amoxicillin twice daily for two days followed by oral amoxicillin twice daily
for five days.
Hypothesis
The proportion who fails treatment will be 10 percent in the reference group and the
alternative treatment groups. An alternative therapy will be considered non-inferior to the
standard therapy if the failure rate in the alternative therapy exceeds the failure rate in
the injectable therapy by less than 5 absolute percentage points.
Secondary Objectives:
- To identify baseline clinical predictors of treatment failure in severe infections in
young infants.
- To determine the proportion of relapse (young infants who were considered cured by day
7 but developed any of the signs of suspected severe infection by day 14).
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