Moxatag (amoxicillin)
Company: MiddleBrooke Pharmaceuticals
Approval Status: Approved January 2008
Treatment for: tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics
Areas: Immunology/Infectious Diseases; Otolaryngology; Pediatrics/Neonatology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |
General Information
Moxatag contains amoxicillin, a semi-synthetic antimicrobial belonging to the penicillin class of antimicrobials with activity against gram-positive and gram-negative bacteria. Moxatag is an extended release tablet formulation consisting of three components, one immediate-release and two delayed-release, each containing amoxicillin. The three components are combined in a specific ratio to prolong the release of amoxicillin from Moxatag compared to immediate-release amoxicillin.
Moxatag is specifically indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adults and pediatric patients 12 yrs and older.
Moxatag is supplied as a 775 mg tablet designed for oral administration. The recommended initial dose of the drug is 775 mg once daily taken within 1 hour of finishing a meal for 10 days. The full 10-day course of therapy should be completed for effective treatment of tonsillitis and/or pharyngitis secondary to S. pyogenes. 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.
Clinical Results
FDA Approval
FDA approval of Moxatag was based on the results of a clinical
trial. This randomized, parallel-group, multi-center, double-blind,
double-dummy study enrolled adult and pediatric subjects, aged 12
years and older, with tonsillitis and/or pharyngitis secondary to
S. pyogenes. The subjects received Moxatag 775 mg QD or penicillin
VK 250 mg QID, both for 10 days. Moxatag was determined to be
non-inferior to penicillin. The results were as follows:
Modified intent-to-treat population
This included all randomized subjects with a positive throat
culture for S. pyogenes at baseline. Bacterial eradication was
observed in 79.7% of the Moxatag arm and 78% in the penicillin
arm.
Per-protocol population
This included mITT subjects who had post-therapy cultures, were
compliant with treatment, and didn’t have major protocol
violations. Bacterial eradication was observed in 85% of the
Moxatag arm and 83.4% of the penicillin arm.
Ongoing Study Commitments
- MiddleBrooke Pharma has agreed to conduct a pediatric study of
an amoxicillin extended-release formulation for the treatment of
tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes
in pediatric patients two to less than 12 years of age.
Final Report Submission: March 31, 2013
Side Effects
Adverse events associated with the use of Moxatag may include, but are not limited to, the following:
- Vulvovaginal mycotic infection
- Diarrhea
- Nausea
- Vomiting
- Headache
- Abdominal pain
Mechanism of Action
Moxatag contains amoxicillin, a semi-synthetic antimicrobial belonging to the penicillin class of antimicrobials with activity against gram-positive and gram-negative bacteria. Moxatag is an extended release tablet formulation consisting of three components, one immediate-release and two delayed-release, each containing amoxicillin. The three components are combined in a specific ratio to prolong the release of amoxicillin from Moxatag compared to immediate-release amoxicillin. Amoxicillin exerts its bactericidal action against susceptible organisms during the stage of multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide. To date there are no known mechanisms of resistance to penicillin or amoxicillin in Streptococcus pyogenes.
Literature References
Clegg HW, Ryan AG, Dallas SD, Kaplan EL, Johnson DR, Norton HJ, Roddey OF, Martin ES, Swetenburg RL, Koonce EW, Felkner MM, Giftos PM Treatment of streptococcal pharyngitis with once-daily compared with twice-daily amoxicillin: a noninferiority trial. The Pediatric Infectious Disease Journal 2006 Sep;25(9):761-7
Aguilar A, Tinoco JC, Macias M, Huicho L, Levy J, Trujillo H, Lopez P, Pereira M, Maqbool S, Bhutta ZA, Sacy RA, Deacon S Clinical and bacteriologic efficacy of amoxycillin b.d. (45 mg/kg/day) versus amoxycillin t.d.s (40 mg/kg/day) in children with group A beta-hemolytic streptococcal tonsillopharyngitis. Journal of Chemotherapy 2000 Oct;12(5):396-405
Cohen R, Levy C, Doit C, De La Rocque F, Boucherat M, Fitoussi F, Langue J, Bingen E Six-day amoxicillin vs. ten-day penicillin V therapy for group A streptococcal tonsillopharyngitis. The Pediatric Infectious Disease Journal 1996 Aug;15(8):678-82
Additional Information
For additional information regarding Moxatag or tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes, please visit the Moxatag web page.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
