, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 6 times the human dose in mg/m2).
14. CLINICAL STUDIES
In a randomized, parallel-group, multi-center, double-blind, double-dummy study in adults and pediatrics (age≥ 12 years) with tonsillitis and/or pharyngitis secondary to S. pyogenes, MOXATAG 775 mg QD for 10 days was non-inferior to penicillin VK 250 mg QID for 10 days.
Using strict eva luability and microbiologic response criteria 4-8 days post-therapy, the following bacteriological eradication rates and statistical outcomes in the per-protocol (PPb) and modified intent-to-treat (mITT) populations were obtained (TABLE 4). The mITT population included all randomized patients with a positive throat culture for S. pyogenes at baseline. The PPb population included mITT patients who had post-therapy cultures, were compliant with treatment, and didn't have major protocol violations.
Table 4. Bacteriological Eradication Rates in Patients with Tonsillitis and/or Pharyngitis
Study
Population MOXATAG Penicillin VK Rate Difference
95% CI (%)
PPb 198/233
(85.0%) 191/229
(83.4%) 1.6 (-5.1, 8.2)
mITT 204/256
(79.7%) 206/264
(78.0%) 1.7 (-5.4, 8.7)
15. REFERENCES
Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—7th ed Clinical and Laboratory Standards Institute document M7-A7. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006.
CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—9th ed. CLSI document M2-A9 CLSI, Wayne, PA 19087-1898 2006.
CLSI. Performance Standards for Antimicrobial Susceptibility Testing; 17th Informational Supplement. CLSI document M100-S17 CLSI, Wayne, PA 19087-1898, 2007.
16. HOW SUPPLIED/STORAGE AND HANDLING
MOXATAG tablets for oral administration are provided as blue film-coated, oval-shaped tablets that contain 775 mg of amoxicillin as the trihydrate. The tablets are printed with “MB-111” on one side in black edible ink. MOXATAG is packaged in bottles and blister cards as follows:
Bottles of 30 NDC 11042-142-03
10 Tablet Card
(1 tablet per blister cavity) NDC 11042-142-02
Storage
Store at 25º C (77º F); excursions permitted to 15–30º C (59–86º F) [See USP Controlled Room Temperature.]
17. PATIENT COUNSELING INFORMATION
17.1 Instructions for Administration of MOXATAG
Patients should be informed that the recommended dose of MOXATAG is 775 mg once daily taken with food for 10 days. MOXATAG should be taken within 1 hour of finishing a meal and at approximately the same time every day.The full 10 day course of therapy should be completed for effective treatment of tonsillitis and/or pharyngitis secondary to S. pyogenes. Patients should be instructed not to chew or crush the tablet. No other forms of immedia
