1 INDICATIONS AND USAGE
Amoxicillin tablets, USP are 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. (
1.1to
1.4)
In combination for treatment of
H. pylori infection and duodenal ulcer disease. (
1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets, USP and other antibacterial drugs, amoxicillin tablets, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (
1.6)
1.1 Infections of the Ear, Nose, and Throat:
Amoxicillin tablets, USP are indicated in the treatment of infections due to susceptible (ONLY -lactamase-negative) isolates of
Streptococcus species. (-and -hemolytic isolates only),
Streptococcus pneumoniae,
Staphylococcus spp., or
Haemophilus influenzae.
1.2 Infections of the Genitourinary Tract:
Amoxicillin tablets, USP are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Escherichia coli, Proteus mirabilis, or
Enterococcus faecalis.
1.3 Infections of the Skin and Skin Structure:
Amoxicillin tablets, USP are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Streptococcus spp. (-and -hemolytic isolates only),
Staphylococcus spp., or
E. coli.
1.4 Infections of the Lower Respiratory Tract:
Amoxicillin tablets, USP are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Streptococcus spp. (-and -hemolytic isolates only),
S. pneumoniae, Staphylococcus spp., or
H. influenzae.
1.5
Helicobacter pylori Infection
Triple therapy for
Helicobacter pylori with clarithromycin and lansoprazole:
Amoxicillin tablets, USP, in combination with clarithromycin plus lansoprazole as triple therapy, are indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Dual therapy for
H. pylori with lansoprazole:
Amoxicillin tablets, USP, in combination with lansoprazole delayed-release capsules as dual therapy, are indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer)
who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets, USP and other antibacterial drugs, amoxicillin tablets, 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.