INDICATIONS AND USAGE
Clarithromycin for oral suspension, USP is indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below:
Adults
Pharyngitis/Tonsillitis due to Streptococcus
pyogenes (The usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. Clarithromycin is generally effective in the eradication of S.
pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present.)
Acute maxillary sinusitis due to Haemophilus
influenzae
, Moraxella
catarrhalis
, or Streptococcus
pneumoniae
Acute bacterial exacerbation of chronic bronchitis due to Haemophilus
influenzae
,
Haemophilus
parainfluenzae
, Moraxella
catarrhalis
, or Streptococcus
pneumoniae
Community-Acquired Pneumonia due to Haemophilus
influenzae
, Mycoplasma
pneumoniae
, Streptococcus
pneumoniae
, or Chlamydia
pneumoniae (TWAR).
Uncomplicated skin and skin structure infections due to Staphylococcus
aureus
, or Streptococcus
pyogenes
(Abscesses usually require surgical drainage.)
Disseminated mycobacterial infections due to Mycobacterium
avium
, or Mycobacterium
intracellulare
In patients who fail therapy, susceptibility testing should be done if possible. If resistance to clarithromycin is demonstrated, a non-clarithromycin-containing therapy is recommended. (For information on development of resistance see Microbiology section.) The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence.
Children
Pharyngitis/Tonsillitis due to Streptococcus
pyogenes
Community-Acquired Pneumonia due to Mycoplasma
pneumoniae
, Streptococcus
pneumoniae
, or Chlamydia
pneumoniae (TWAR)
Acute maxillary sinusitis due to Haemophilus
influenzae
, Moraxella
catarrhalis
, or Streptococcus
pneumoniae
Acute otitis media due to Haemophilus
influenzae
, Moraxella
catarrhalis
, or Streptococcus
pneumoniae
NOTE: For information on otitis media, see
CLINICAL STUDIES: Otitis Media.
Uncomplicated skin and skin structure infections due to Staphylococcus
aureus
, or Streptococcus
pyogenes (Abscesses usually require surgical drainage.)
Disseminated mycobacterial infections due to Mycobacterium
avium
, or Mycobacterium
intracellulare
Prophylaxis
Clarithromycin for oral suspension, USP is indicated for the prevention of disseminated Mycobacterium
avium
complex (MAC) disease in patients with advanced HIV infection.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin for oral suspension, USP 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.