Amoxicillin

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension, USP and other antibacterial drugs, amoxicillin for oral suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by 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. Amoxicillin for oral suspension, USP is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below: Amoxicillin for oral suspension, USP is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.

• Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 - 1.5 )
• In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.6 , 1.7 )

1.1 Infections of the Ear, Nose, and Throat due to Streptococcus species (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae .

1.2Infections of the Genitourinary

Tract due to Escherichia coli, Proteus mirabilis , or Enterococcus faecalis .

1.3Infections of the Skin and Skin

Structure due to Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli .

1.4Infections of the Lower Respiratory

Tract due to Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae .

1.5Gonorrhea, Acute Uncomplicated (ano-genital

and urethral infections) due to Neisseria gonorrhoeae . Because of high rates of amoxicillin resistance, amoxicillin for oral suspension, USP is not recommended for empiric treatment of gonorrhea. Amoxicillin for oral suspension, USP use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to amoxicillin.