FDA approved Augmentin XR (amoxicillin/clavulanate) for Community-Acquired Pneumonia and Acute Bacterial SinusitisFDA approved new antibiotic Augmentin XR for pneumonia and sinusitis.

FDA From the archive Source published September 25, 2002 Summary added July 23, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Augmentin XR for community-acquired pneumonia or acute bacterial sinusitis in patients ≥40 kg with suspected beta-lactamase-producing pathogens or S. pneumoniae with penicillin MIC=2 mcg/mL.

The FDA has approved Augmentin XR (amoxicillin and clavulanate potassium extended-release tablets) for the treatment of community-acquired pneumonia and acute bacterial sinusitis in adults and pediatric patients weighing at least 40 kg who can swallow tablets. The approval covers infections caused by confirmed or suspected beta-lactamase-producing pathogens, including H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae, or methicillin-susceptible S. aureus, as well as S. pneumoniae with reduced susceptibility to penicillin (penicillin MICs equal to 2 mcg/mL). The extended-release formulation allows twice-daily dosing at 4,000 mg/250 mg per day, taken at the start of a meal to enhance amoxicillin absorption and minimize gastrointestinal intolerance. Clinicians should note that Augmentin XR is not indicated for S. pneumoniae with penicillin MICs ≥4 mcg/mL, and data are limited for infections with MICs ≥4 mcg/mL. The approval provides an option for patients requiring higher amoxicillin doses for these respiratory infections.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Amoxicillin and Clavulanate Potassium Extended Release Tablets is a combination of amoxicillin, a penicillin-class antibacterial, and clavulanate potassium, a beta-lactamase inhibitor.

Indication & Patient Population

Indicated for treatment of adults and pediatric patients weighing ≥40 kg who are able to swallow tablets with community-acquired pneumonia or acute bacterial sinusitis due to confirmed or suspected beta-lactamase-producing pathogens (H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae, or methicillin-susceptible S. aureus) and S. pneumoniae with reduced susceptibility to penicillin (penicillin MICs equal to 2 mcg/mL). Limitations: Not indicated for S. pneumoniae with penicillin MICs ≥4 mcg/mL; data are limited for infections due to S. pneumoniae with penicillin MICs ≥4 mcg/mL.

Dosing & Administration

Recommended dosage: 4,000 mg/250 mg daily in divided doses (two 1,000 mg/62.5 mg tablets every 12 hours) at the start of a meal. Duration: acute bacterial sinusitis 10 days; community-acquired pneumonia 7 to 10 days. Tablets can be split in half along the score line; both halves must be taken immediately. Not recommended with a high-fat meal. Not substitutable on a mg-to-mg basis with other formulations.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Augmentin XR provides a twice-daily extended-release option for community-acquired pneumonia and acute bacterial sinusitis in patients ≥40 kg, specifically targeting beta-lactamase-producing pathogens and S. pneumoniae with reduced penicillin susceptibility (MIC=2 mcg/mL). It is not indicated for penicillin-resistant S. pneumoniae with MIC ≥4 mcg/mL.

The FDA has approved a new antibiotic called Augmentin XR. It is an extended-release tablet that contains amoxicillin and clavulanate potassium. This medicine treats two types of infections: community-acquired pneumonia and acute bacterial sinusitis. These are common infections that affect the lungs and sinuses.

Augmentin XR is for adults and children who weigh at least 40 kilograms (about 88 pounds) and can swallow tablets. It is taken twice a day, at the start of a meal. Taking it with food helps the body absorb the medicine better and may reduce stomach upset.

This approval means doctors have a new option for patients who need a higher dose of amoxicillin for these infections. The medicine works against certain bacteria, including some that are resistant to other antibiotics. However, it is not effective against all types of bacteria. For example, it should not be used for infections caused by Streptococcus pneumoniae with very high resistance levels.

If you or your child has pneumonia or sinusitis, talk to your doctor about whether Augmentin XR is right for you. Your doctor can determine the cause of the infection and choose the best treatment. Always take antibiotics exactly as prescribed.

What this means for you:

Augmentin XR is a new twice-daily antibiotic for pneumonia and sinusitis, but it is not for all bacterial infections.

Study Details

Study typeFda approval

PublishedSep 2002

View Original Abstract ↓

1 INDICATIONS AND USAGE Amoxicillin and Clavulanate Potassium Extended Release Tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected beta-lactamase-producing pathogens (i.e., H. influenzae , M. catarrhalis , H. parainfluenzae , K. pneumoniae , or methicillin-susceptible S. aureus ) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL). Limitations of Use Amoxicillin and Clavulanate Potassium Extended Release Tablets is not indicated for the treatment of infections due to S. pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL. Data are limited with regard to infections due to S. pneumoniae with penicillin MICs greater than or equal to 4 mcg/ mL [see Clinical Studies (14) ]. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release Tablets should be used only to treat or prevent 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. In patients with community-acquired pneumonia in whom penicillin-resistant S. pneumoniae is suspected, bacteriological studies should be performed to determine the causative organisms and their susceptibility when Amoxicillin and Clavulanate Potassium Extended Release Tablets is prescribed. Acute bacterial sinusitis or community-acquired pneumonia due to a penicillin-susceptible strain of S. pneumoniae plus a beta-lactamase-producing pathogen can be treated with another amoxicillin and clavulanate potassium product containing lower daily doses of amoxicillin (i.e., 500 mg every 8 hours or 875 mg every 12 hours). Acute bacterial sinusitis or community-acquired pneumonia due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and Clavulanate Potassium Extended Release Tablets is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for treatment of adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected beta-lactamase-producing pathogens (i.e., H. influenzae , M. catarrhalis , H. parainfluenzae , K. pneumoniae , or methicillin-susceptible S. aureus ) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL). (1) Limitations of Use Amoxicillin and Clavulanate Potassium Extended Release Tablets is not indicated for the treatment of infections due to S. pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL. Data are limited with regard to infections due to S. pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL. (1) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria . (1)

FDA approved Augmentin XR (amoxicillin/clavulanate) for Community-Acquired Pneumonia and Acute Bacterial SinusitisFDA approved new antibiotic Augmentin XR for pneumonia and sinusitis.

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FDA approved Augmentin XR (amoxicillin/clavulanate) for Community-Acquired Pneumonia and Acute Bacterial SinusitisFDA approved new antibiotic Augmentin XR for pneumonia and sinusitis.

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

Adding Antibiotics to Bone Surgery Didn't Lower Infection Risk

Clinical research that matters. Delivered to your inbox.

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