1 INDICATIONS AND USAGE
Amoxicillin and Clavulanate Potassiumis 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 -lactamase-producing strains), or M. catarrhalis (including -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 Potassiumfor 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 -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 suspensionand 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 Potassiumfor oral suspensionis 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 -lactamase-producing strains), or M. catarrhalis (including -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 Potassiumfor 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 -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 suspensionand other antibacterial drugs, Amoxicillin and Clavulanate Potassiumfor oral suspensionshould be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1)