FDA approved Augmentin (amoxicillin/clavulanate) for Bacterial InfectionsFDA approved new antibiotic Augmentin for bacterial infections

FDA From the archive Source published August 6, 1984 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; avoid if amoxicillin susceptibility is confirmed.

The FDA has approved Augmentin (amoxicillin/clavulanate potassium) for the treatment of various bacterial infections in adults and pediatric patients. The combination drug targets infections caused by beta-lactamase-producing isolates of Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Escherichia coli, Klebsiella species, and Enterobacter species. Indications include lower respiratory tract infections, acute bacterial otitis media, sinusitis, skin and skin structure infections, and urinary tract infections. Augmentin should not be used when susceptibility testing shows susceptibility to amoxicillin alone. To reduce antibiotic resistance, it should be used only for proven or strongly suspected bacterial infections.

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

Mechanism of Action

Augmentin 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 adult dose. Neonates and infants <12 weeks: 30 mg/kg/day divided every 12 hours; use of 125 mg/5 mL oral suspension is recommended. Augmentin may be taken without regard to meals; absorption of clavulanate is enhanced when taken at start of a meal. To minimize gastrointestinal intolerance, take at 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 a beta-lactam/beta-lactamase inhibitor combination used for infections caused by beta-lactamase-producing organisms. It should be reserved for cases where beta-lactamase production is suspected or confirmed, and not used when amoxicillin alone is effective.

The FDA has approved a new antibiotic called Augmentin. It combines two medicines: amoxicillin and clavulanate potassium. This drug treats bacterial infections that are resistant to amoxicillin alone. It is used for infections like sinusitis, ear infections, pneumonia, skin infections, and urinary tract infections. Augmentin is for both adults and children.

This approval means doctors have a new option for treating certain bacterial infections. The drug targets specific bacteria that produce an enzyme called beta-lactamase. These bacteria include Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Escherichia coli, and others.

However, Augmentin is not for all infections. It should only be used when the bacteria are not killed by amoxicillin alone. Using antibiotics when they are not needed can lead to antibiotic resistance. This makes infections harder to treat in the future.

If you have symptoms of a bacterial infection, talk to your doctor. They can decide if Augmentin is right for you. Do not take this drug for viral infections like the common cold or flu. Always follow your doctor's instructions.

What this means for you:

Augmentin is a new antibiotic for certain bacterial infections; use only as prescribed by your doctor.

Study Details

Study typeFda approval

PublishedAug 1984

View Original Abstract ↓

1 INDICATIONS AND USAGE AUGMENTIN 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. AUGMENTIN 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, AUGMENTIN should not be used. ( 1 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN 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, AUGMENTIN should not be used. Usage To reduce the development of drug‑resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN 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 new antibiotic Augmentin for bacterial infections

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FDA approved Augmentin (amoxicillin/clavulanate) for Bacterial InfectionsFDA approved new antibiotic Augmentin for bacterial infections

Study Details

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

New data shows prevalence of fungal infections in HIV patients

Clinical research that matters. Delivered to your inbox.

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