1 INDICATIONS AND USAGE Amoxicillin 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 – 1.4 ) • 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 and other antibacterial drugs, amoxicillin 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 is indicated in the treatment of infections due to susceptible (ONLY beta-lactamase–negative) isolates of Streptococcus species.

(α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae .

1.2 Infections of the Genitourinary Tract Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis .

1.3 Infections of the Skin and Skin Structure Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamase–negative) isolates of Streptococcus spp.

(α- and β-hemolytic isolates only), Staphylococcus spp., or E.

coli .

1.4 Infections of the Lower Respiratory Tract Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamase–negative) isolates of Streptococcus spp.

(α- and β-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, 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 .

(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 and other antibacterial drugs, amoxicillin 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.

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Anaphylactic reactions [see Warnings and Precautions ( 5.1 )] • CDAD [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (> 1%) observed in clinical trials of amoxicillin capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.

at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common adverse reactions (> 1%) observed in clinical trials of amoxicillin capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea.

Triple therapy : The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/ lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%).

Dual therapy : The most frequently reported adverse events for patients who received double therapy amoxicillin/lansoprazole were diarrhea (8%) and headache (7%).

For more information on adverse reactions with clarithromycin or lansoprazole, refer to the Adverse Reactions section of their package inserts.

6.2 Post-Marketing or Other Experience In addition to adverse events reported from clinical trials, the following events have been identified during post-marketing use of penicillins.

Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to amoxicillin.

• Infections and Infestations: Mucocutaneous candidiasis.

• Gastrointestinal: Black hairy tongue, and hemorrhagic/pseudomembranous colitis.

Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions ( 5.2 )] .

• Hypersensitivity Reactions: Anaphylaxis [see Warnings and Precautions ( 5.1 )] .

Serum sickness–like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and urticaria have been reported.

• Liver: A moderate rise in AST and/or ALT has been noted, but the significance of this finding is unknown.

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

• Renal: Crystalluria has been reported [see Overdosage ( 10 )] .

• Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported.

These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

• Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported.

• Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported.

Most reports occurred in pediatric patients.

Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.