Indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below:

Infections of the Ear, Nose, and Throat:

• Amoxicillin capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) are indicated in the treatment of infections of the ear, nose, and throat due to susceptible (ONLY β-lactamase negative) isolates of Streptococcus species (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.

Infections of the Genitourinary Tract:

• Amoxicillin capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) are indicated in the treatment of genitourinary tract infections due to susceptible (ONLY β-lactamase negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.

Infections of the Skin and Skin Structure:

• Amoxicillin capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) are indicated in the treatment of skin and skin infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli.

Infections of the Lower Respiratory Tract:

• Amoxicillin capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) are indicated in the treatment of infections of the lower respiratory tract due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.

Helicobacter Pylori Infection:

• Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole:

Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is 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, in combination with lansoprazole delayed-release capsules as dual therapy, is 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. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including AMOXIL, and may range in severity from mild diarrhea to fatal colitis.

Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients.

A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus amoxicillin should not be administered to patients with mononucleosis.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin.

Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.

Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported.

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.

Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants.

The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone.

Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin.

There are no adequate and well-controlled studies in pregnant women.

Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.

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• Chlamydia infection. GoToSource

• Use preoperatively to reduce failure of dental implants. GoToSource

• Typhoid fever. GoToSource

• Lyme disease. GoToSource

• Post-exposure inhalational anthrax. GoToSource

• Prophylaxis in head and neck cancer surgery. GoToSource

• Severe acute malnutrition. GoToSource

• Actinomycotic brain abscess. GoToSource

Tooth enamel defects in permanent teeth. GoToSource 

Liver failure. GoToSource 

Cholestatic hepatitis (decreased or impaired bile flow from liver to duodenum). GoToSource

Generalized exanthematous pustulosis (severe skin reaction). GoToSource

Stevens-johnson syndrome (severe skin reaction). GoToSource

Drug rash eosinophilia and systemic symptoms (severe skin reaction). GoToSource

Clostridium difficile associated diarrhea. GoToSource

Abnormal prolongation of prothrombin time (increased international normalized ratio) with significant bleeding when used with warfarin. GoToSource

Anaphylaxis (life-threatening allergic reaction). GoToSource

Hemolytic anemia (red blood cells are destroyed faster than they can be made). GoToSource

Use in early pregnancy associated with an increased risk of oral clefts. GoToSource

Lawsuits filed for stevens-johnson syndrome.