FDA

Treatment of infections due to susceptible (β-lactamase-negative) strains causing the following syndromes:

• Infections of the ear, nose, and throat – due to Streptococcus spp. (α- and β-hemolytic strains), S. pneumoniae, Staphylococcus spp., or H. influenzae
• Infections of the genitourinary tract – due to E. coli, P. mirabilis, or E. faecalis.
  • Note: empiric use is not recommended by IDSA due to higher rates of resistance to E. coli and poor efficacy[3].
• Infections of the skin and skin structure – due to Streptococcus spp. (α- and β-hemolytic strains), Staphylococcus spp., or E. coli
• Infections of the lower respiratory tract – due to Streptococcus spp. (α- and β-hemolytic strains), S. pneumoniae, Staphylococcus spp., or H. influenzae
• Gonorrhea, acute uncomplicated (ano-genital and urethral infections) – due to N. gonorrhoeae (males and females). Note: amoxicillin is not recommended by the CDC for the treatment of gonorrhea due to high rates of resistance.
• H. pylori eradication to reduce the risk of duodenal ulcer recurrence in combination with other agents.

Amoxicillin ER tablet (Mmoxtag™) is indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients ≥12 y/o

NON-FDA APPROVED USES

• Lyme disease
• Non-severe Enterococcus infections
• Suppression therapy for prosthetic joint infections caused by streptococci, Enterococcus, C. acne
• Endocarditis prophylaxis
• Dental infections
• Low-risk penicillin allergies; challenge with oral penicillin "direct amoxicillin challenge"[16]