Amoxicillin-clavulanate potassium indications and usage

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Amoxicillin-clavulanate potassium
AUGMENTIN® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Mohamed Moubarak, M.D. [2]

Indications and Usage

To reduce the development of drug‑resistant bacteria and maintain the effectiveness of AUGMENTIN (amoxicillin/clavulanate potassium) and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused by susceptible 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.

AUGMENTIN® is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:

  • Lower Respiratory Tract Infections

caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis.

  • Acute Bacterial Otitis Media

caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis.

  • Sinusitis

caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis.

  • Skin and Skin Structure Infections

caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.

  • Urinary Tract Infections

caused by beta‑lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.

  • Limitations of Use

When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, AUGMENTIN should not be used.[1]

References

  1. "AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]". Text " accessdate" ignored (help)

Adapted from the FDA Package Insert.