INDICATIONS AND USAGE
Clarithromycin tablets are indicated for the treatment of mild to
moderate infections caused by susceptible strains of the designated
microorganisms in the conditions as listed below:
AdultsPharyngitis/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
Clarithromycin tablets in combination with amoxicillin and lansoprazole or
omeprazole delayed-release capsules, as triple therapy, are indicated for the
treatment of patients with H. pylori infection and
duodenal ulcer disease (active or five-year history of duodenal ulcer) to
eradicate H. pylori.
Clarithromycin tablets in combination with omeprazole capsules or ranitidine
bismuth citrate tablets are also indicated for the treatment of patients with an
active duodenal ulcer associated with H. pylori
infection. However, regimens which contain clarithromycin as the single
antimicrobial agent are more likely to be associated with the development of
clarithromycin resistance among patients who fail therapy.
Clarithromycin-containing regimens should not be used in patients with known or
suspected clarithromycin resistant isolates because the efficacy of treatment is
reduced in this setting.
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.
ChildrenPharyngitis/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
ProphylaxisClarithromycin tablets are 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 tablets and other antibacterial drugs,
clarithromycin tablets 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.