Treatment of acute otitis media (AOM) caused by β-lactamase producing H. influenzae or M. catarrhalis. AAP, AAFP, CDC, and others recommend fixed combination of amoxicillin and clavulanate (instead of amoxicillin) for initial treatment of AOM in those with severe illness (moderate to severe otalgia or fever ≥39°C) or when the infection is suspected of being caused by β-lactamase-producing Haemophilus influenzae or Moraxella catarrhalis.
Treatment of persistent or recurrent AOM caused by H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae (penicillin MIC ≤2 mcg/mL) in pediatric patients. Drug of choice for retreatment of AOM that has not responded to other anti-infectives (e.g., no response to amoxicillin within 48–72 hours). Not indicated for AOM caused by S. pneumoniae with penicillin MIC ≥4 mcg/mL.
Has been used for management of otitis media with effusion† (OME). Anti-infectives not usually recommended; they provide only limited benefit in enhancing resolution of effusion and may promote resistance. AAP, AAFP, and others recommend watchful waiting for 3 months from date of effusion onset or diagnosis in those 2 months to 12 years of age who are not at risk for speech, language, or learning problems; some suggest a short course of anti-infectives may be considered for possible short-term benefits when parent and/or caregiver expresses a strong aversion to impending surgery. If anti-infectives are used for treatment, amoxicillin and clavulanate or amoxicillin recommended.
Pharyngitis and Tonsillitis
Treatment of symptomatic patients who have multiple, recurrent episodes of pharyngitis known to be caused by S. pyogenes (group A β-hemolytic streptococci)†.
Not a drug of choice for treatment of streptococcal pharyngitis and tonsillitis, but one of several possible alternatives recommended by AAP, IDSA , and AHA when multiple episodes occur and the patient fails to respond to drugs of choice (oral penicillin V, IM penicillin G benzathine, oral amoxicillin).
Consider that multiple, recurrent episodes of symptomatic pharyngitis occurring within several months to years may indicate that the patient is a streptococcal carrier experiencing repeated episodes of nonstreptococcal (e.g., viral) pharyngitis; treatment not usually recommended for streptococcal pharyngeal carriers.
Respiratory Tract Infections
Treatment of acute sinusitis and lower respiratory tract infections caused by susceptible H. influenzae or M. catarrhalis.
Treatment of acute sinusitis or community-acquired pneumonia (CAP) caused by or suspected to be caused by β-lactamase-producing pathogens (i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, Klebsiella pneumoniae, oxacillin-susceptible Staphylococcus aureus).
Treatment of acute sinusitis or CAP caused by or suspected of being caused by S. pneumoniae with reduced penicillin susceptibility (i.e., penicillin MIC 2 mcg/mL). Not indicated for treatment of infections caused by S. pneumoniae with penicillin MIC ≥4 mcg/mL.
Recommended by IDSA and ATS as an alternative for outpatient empiric treatment of CAP in immunocompetent adults; ATS recommends use with a macrolide or doxycycline in those with cardiopulmonary disease and/or other factors that increase risk for multidrug-resistant S. pneumoniae or gram-negative bacteria.
Skin and Skin Structure Infections
Treatment of skin or skin structure infections (e.g., abscesses, cellulitis, impetigo) caused by β-lactamase-producing S. aureus, Escherichia coli, or Klebsiella.
Urinary Tract Infections (UTIs)
Treatment of UTIs caused by β-lactamase-producing E. coli, Klebsiella, or Enterobacter.
Useful for outpatient treatment of recurrent UTIs or UTIs acquired in hospitals or nursing homes likely to be caused by drug-resistant S. aureus, Enterococcus, or gram-negative bacilli. In severe gram-negative infections, consider concomitant use of an aminoglycoside (amikacin, gentamicin, tobramycin).
Active Tuberculosis
Alternative recommended by ATS and others for use in multiple-drug regimens for treatment of active tuberculosis† in patients with multidrug-resistant Mycobacterium tuberculosis.
Bite Wounds
Empiric treatment of animal or human bites†. Active against most likely bite pathogens, including anaerobes, Staphylococcus, Eikenella corrodens, Pasteurella multocida.
Alternative for treatment of infections caused by P. multocida† or E. corrodens†.
Pelvic Inflammatory Disease
Treatment of acute pelvic inflammatory disease† (PID).
Not a drug of choice for PID. According to CDC, may be effective when used in conjunction with doxycycline, but GI adverse effects may limit compliance.
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