Amoxicillin TABLET, COATED
Refer to the “Also Known As” section to reference different products that include the same medication as Amoxicillin.
Brand Name: Amoxicillin
Generic Name: AMOXICILLIN
Drug Type: HUMAN PRESCRIPTION DRUG
Dosage Form: TABLET, COATED
Data Current As Of: 2019-12-23
indications & usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, Amoxicillin Tablets 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 Tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of the designated bacteria in the conditions listed below:
Amoxicillin Tablets 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. (1.1 – 1.5)
In combination for treatment of H. pylori infection and duodenal ulcer disease. (1.6, 1.7)
infections of the ear, nose, & throat
– due to Streptococcus species.
(α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
infections of the genitourinary tract
– due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
infections of the skin & skin structure
– due to Streptococcus spp.
(α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli.
infections of the lower respiratory tract
– due to Streptococcus spp.
(α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
gonorrhea, acute uncomplicated (ano-genital & urethral infections)
– due to Neisseria gonorrhoeae.
Because of high rates of amoxicillin resistance, Amoxicillin Tablets are not recommended for empiric treatment of gonorrhea. Amoxicillin Tablets use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to amoxicillin.
triple therapy for helicobacter pylori with clarithromycin & lansoprazole
Amoxicillin Tablets, 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, 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.
patient counseling information
information for patients
- Patients should be advised that amoxicillin tablets may be taken every 8 hours or every 12 hours, depending on the dose prescribed.
- Patients should be counseled that antibacterial drugs, including amoxicillin tablets, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin tablets or other antibacterial drugs in the future.
- Patients should be counseled that diarrhea is a common problem caused by antibiotics, and it usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
- Patients should be aware that amoxicillin tablets contains a penicillin class drug product that can cause allergic reactions in some individuals.
West-Ward Pharmaceuticals Corp.
Eatontown, NJ 07724 USA
P.O. Box 182400
Amman 11118 – Jordan
Revised October 2018
Amoxicillin Tablets, USP
also known as