FDA approved Augmentin (amoxicillin/clavulanate) for Bacterial InfectionsFDA approved Augmentin for bacterial infections including sinusitis and UTIs.

FDA From the archive Source published February 13, 1996 Summary added July 23, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Augmentin for infections caused by beta-lactamase-producing bacteria when amoxicillin alone is not appropriate.

The FDA has approved Augmentin (amoxicillin and clavulanate potassium) for the treatment of several bacterial infections in adults and pediatric patients. The drug is indicated for lower respiratory tract infections, acute bacterial otitis media, sinusitis, skin and skin structure infections, and urinary tract infections caused by susceptible isolates of beta-lactamase-producing bacteria, including Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Escherichia coli, Klebsiella species, and Enterobacter species. Augmentin combines amoxicillin, a penicillin-class antibacterial, with clavulanate potassium, a beta-lactamase inhibitor, to overcome resistance. The approval underscores the importance of using this agent only when beta-lactamase production is suspected or confirmed, as it should not be used when susceptibility to amoxicillin alone is demonstrated. Clinicians should consider local susceptibility patterns when selecting therapy.

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

Mechanism of Action

Amoxicillin and clavulanate potassium is a combination of amoxicillin, a penicillin-class antibacterial, and clavulanate potassium, a beta-lactamase inhibitor. Clavulanate protects amoxicillin from degradation by beta-lactamases, extending its spectrum to include beta-lactamase-producing bacteria.

Indication & Patient Population

Augmentin is indicated for the treatment of infections in adults and pediatric patients due to susceptible isolates of the designated bacteria in the following conditions: lower respiratory tract infections (caused by beta-lactamase-producing H. influenzae and M. catarrhalis), acute bacterial otitis media (caused by beta-lactamase-producing H. influenzae and M. catarrhalis), sinusitis (caused by beta-lactamase-producing H. influenzae and M. catarrhalis), skin and skin structure infections (caused by beta-lactamase-producing S. aureus, E. coli, and Klebsiella species), and urinary tract infections (caused by beta-lactamase-producing 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.

Dosing & Administration

Adults and pediatric patients >40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on the amoxicillin component. Pediatric patients aged 12 weeks and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. Neonates and infants <12 weeks: 30 mg/kg/day divided every 12 hours, using the 125 mg/5 mL oral suspension. Augmentin may be taken without regard to meals; however, absorption of clavulanate is enhanced when taken at the start of a meal. To minimize gastrointestinal intolerance, take at the start of a meal.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Augmentin is indicated for infections caused by beta-lactamase-producing bacteria where amoxicillin alone would not be effective. It should be reserved for cases where beta-lactamase production is proven or strongly suspected, to reduce the development of drug-resistant bacteria.

The FDA has approved Augmentin (amoxicillin and clavulanate potassium) to treat certain bacterial infections in adults and children. These include sinus infections, ear infections, pneumonia, skin infections, and urinary tract infections. Augmentin is a combination of two medicines: amoxicillin (a penicillin-type antibiotic) and clavulanate potassium (which helps overcome bacterial resistance). It is used when bacteria produce an enzyme called beta-lactamase that would otherwise make amoxicillin ineffective.

This approval is for infections caused by specific bacteria, such as Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, and E. coli. Doctors should only prescribe Augmentin when they suspect or confirm that the bacteria are resistant to amoxicillin alone. Using it unnecessarily could contribute to antibiotic resistance.

For patients, this means there is a new option for stubborn infections that do not respond to standard antibiotics. However, it is not a first-choice treatment for all infections. Your doctor will decide if Augmentin is right based on your specific infection and local resistance patterns.

If you are prescribed Augmentin, take it exactly as directed. Do not share it with others or use it for future illnesses. Talk to your doctor if you have questions about your treatment or if you experience side effects like diarrhea or rash.

What this means for you:

Augmentin is a new option for certain bacterial infections, but only when amoxicillin alone won't work.

Study Details

Study typeFda approval

PublishedFeb 1996

View Original Abstract ↓

1 INDICATIONS AND USAGE Amoxicillin and Clavulanate Potassium is indicated for the treatment of infections in adults and pediatric patients, 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. Amoxicillin and Clavulanate Potassium is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta‑lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: ( 1 ) Lower respiratory tract infections Acute bacterial otitis media Sinusitis Skin and skin structure infections Urinary tract infections Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium should not be used. ( 1 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate Potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 ) Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium should not be used. Usage To reduce the development of drug‑resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate Potassium 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.

FDA approved Augmentin (amoxicillin/clavulanate) for Bacterial InfectionsFDA approved Augmentin for bacterial infections including sinusitis and UTIs.

Study Details

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FDA approved Augmentin (amoxicillin/clavulanate) for Bacterial InfectionsFDA approved Augmentin for bacterial infections including sinusitis and UTIs.

Study Details

Candidiasis prevalence of 13.46% and Cryptococcal meningitis of 3.15% among HIV-positive individuals

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Clinical research that matters. Delivered to your inbox.

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