Clavulanate

What it is used for

AUGMENTIN ES-600 is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with:

• Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-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) day care attendance.

Limitations of Use

AUGMENTIN ES-600 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. Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. 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 beta-lactamase-producing organisms listed above.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN ES-600 and other antibacterial drugs, AUGMENTIN ES-600 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.

Side effects, and when to stop

The following clinically significant adverse reactions are described elsewhere in labeling:

• Anaphylactic reactions
• Severe Cutaneous Adverse Reactions (SCAR)
• Drug-Induced Enterocolitis Syndrome (DIES)
• Hepatic Dysfunction
• Clostridioides difficile -Associated Diarrhea (CDAD)
• Skin Rash in Patients with Mononucleosis

Storing it

Storage

Store dry powder for oral suspension at or below 25°C (77°F). Dispense in original container. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.