FDA approved Augmentin Es-600 (amoxicillin/clavulanate potassium) for Recurrent Acute Otitis Media in ChildrenFDA approved new antibiotic for ear infections in young children

FDA From the archive Source published June 22, 2001 Summary added July 23, 2026 DOI ↗ Editorial oversight: Dr. Sofia Müller, MD · Lifespan & Whole-Person Care

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Key Takeaway

Consider Augmentin Es-600 for pediatric patients with recurrent acute otitis media and risk factors, but not for S. pneumoniae with penicillin MIC ≥4 mcg/mL.

The FDA has approved Augmentin Es-600 (amoxicillin/clavulanate potassium) oral suspension for the treatment of recurrent or persistent acute otitis media in pediatric patients. The indication is limited to children with specific risk factors: antibacterial drug exposure for acute otitis media within the preceding 3 months, and either age 2 years or younger or daycare attendance. The combination product targets infections caused by Streptococcus pneumoniae (penicillin MICs ≤2 mcg/mL), Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella catarrhalis (including β-lactamase-producing strains). Clinicians should note that acute otitis media due to S. pneumoniae alone can be treated with amoxicillin, and Augmentin Es-600 is not indicated for S. pneumoniae with penicillin MIC ≥4 mcg/mL. The approval provides a high-dose amoxicillin formulation designed to overcome resistance in this challenging patient population.

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

Mechanism of Action

Amoxicillin is a semisynthetic penicillin antibacterial that inhibits bacterial cell wall synthesis. Clavulanate potassium is a β-lactamase inhibitor that protects amoxicillin from degradation by β-lactamase enzymes, thereby extending its spectrum to include β-lactamase-producing strains of H. influenzae and M. catarrhalis.

Indication & Patient Population

Augmentin Es-600 is indicated for pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤2 mcg/mL), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains) characterized by the following risk factors: antibacterial drug exposure for acute otitis media within the preceding 3 months, and either age 2 years or younger or daycare attendance. Limitations: Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Not indicated for S. pneumoniae with penicillin MIC ≥4 mcg/mL.

Dosing & Administration

Pediatric patients less than 40 kg: 90 mg/kg/day (based on amoxicillin component) divided every 12 hours for 10 days. The oral suspension (600 mg/5 mL) provides 6.4 mg/kg/day of clavulanic acid. Dosing chart provided for weights 8-36 kg. Patients ≥40 kg: experience not available. Adults: not indicated. Hepatic impairment: dose with caution and monitor hepatic function. 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 Es-600 is a high-dose amoxicillin/clavulanate formulation specifically for pediatric patients with recurrent or persistent acute otitis media who have risk factors for resistant pathogens. It should be used only for infections proven or strongly suspected to be caused by susceptible bacteria, considering local epidemiology and susceptibility patterns.

The FDA has approved a new antibiotic called Augmentin Es-600 (amoxicillin/clavulanate potassium) for treating stubborn ear infections in children. This medicine is a liquid suspension, making it easier for kids to take. It is designed for children who have had an ear infection that came back or won't go away, and who have certain risk factors: they are 2 years old or younger, attend daycare, or have taken antibiotics for an ear infection in the past 3 months.

Augmentin Es-600 targets three types of bacteria that commonly cause ear infections: Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Some of these bacteria can make enzymes that destroy regular antibiotics, but this drug contains a special ingredient (clavulanate) that stops those enzymes. The high dose of amoxicillin helps overcome resistance.

This approval gives doctors a new tool for a tough situation. However, it is not for every child with an ear infection. For example, if the infection is caused by a certain type of Streptococcus pneumoniae that is highly resistant, this drug may not work. Also, simple ear infections caused by Streptococcus pneumoniae alone can often be treated with plain amoxicillin.

If your child has frequent or persistent ear infections, talk to your doctor. They can decide if Augmentin Es-600 is right based on your child's age, history, and the specific bacteria involved. This medicine is not a first choice for all ear infections, but it offers a targeted option for children who need it most.

What this means for you:

Augmentin Es-600 is a new option for tough ear infections in high-risk children, but not for all kids.

Study Details

Study typeFda approval

PublishedJun 2001

View Original Abstract ↓

1 INDICATIONS AND USAGE Amoxicillin and Clavulanate Potassium is indicated for the treatment of pediatric patients with Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains) characterized by the following risk factors: - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) daycare attendance [see Microbiology ( 12.4 )] Limitations of Use Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and Clavulanate Potassium for oral suspension is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC greater than or equal to 4 mcg/mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC less than or equal to 2 mcg/mL) and the β-lactamase-producing organisms listed above. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium for oral suspension and other antibacterial drugs, Amoxicillin and Clavulanate Potassium for oral suspension 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. Amoxicillin and Clavulanate Potassium for oral suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for the treatment of pediatric patients with: Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than 2 mcg/mL), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains) characterized by the following risk factors ( 1 ): - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) daycare attendance. Limitations of Use Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and Clavulanate Potassium for oral suspension is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC greater than or equal to 4 mcg/mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC less than or equal to 2 mcg/mL) and the β-lactamase-producing organisms listed above. ( 1 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium for oral suspension and other antibacterial drugs, Amoxicillin and Clavulanate Potassiumfor oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 )

FDA approved Augmentin Es-600 (amoxicillin/clavulanate potassium) for Recurrent Acute Otitis Media in ChildrenFDA approved new antibiotic for ear infections in young children

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FDA approved Augmentin Es-600 (amoxicillin/clavulanate potassium) for Recurrent Acute Otitis Media in ChildrenFDA approved new antibiotic for ear infections in young children

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