1 INDICATIONS AND USAGE
Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients (1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults (1.8)
Limitations of Use
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 bacteria. (1.9)
1.1 Acute Bacterial Exacerbation of Chronic Bronchitis
Clarithromycin tablets, USP are indicated in adults for thetreatment of mild to moderate infections caused by susceptible isolates due to Haemophilusinfluenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[seeIndications and Usage(1.9)].
1.2
Acute Maxillary Sinusitis
Clarithromycin tablets, USP are indicated for thetreatment of mild to moderate infections caused by susceptible isolates due to Haemophilusinfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Indications and Usage(1.9)].
1.3
Community-Acquired Pneumonia
Clarithromycin tablets, USP are indicated [see Indications andUsage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates dueto:
Haemophilus influenzae (inadults)
Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae
1.4
Pharyngitis/Tonsillitis
Clarithromycin tablets, USP are indicated for the treatment of mild tomoderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternativein individuals who cannot use first linetherapy.
1.5
Uncomplicated Skin and Skin Structure Infections
Clarithromycin tablets, USP are indicated for the treatment of mild tomoderate infections caused by susceptible isolates due to Staphylococcus aureus, orStreptococcus pyogenes.
1.6
Acute Otitis Media
Clarithromycin tablets, USP are indicated in pediatric patients for the treatmentof mild to moderate infections caused by susceptible isolates due to Haemophilusinfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Clinical Studies(14.2)].
1.7
Treatment and Prophylaxis of Disseminated Mycobacterial Infections
Clarithromycin tablets, USP are indicated for the treatment of mild tomoderate infections caused by susceptible isolates due to Mycobacterium avium orMycobacterium intracellulare in patients with advanced HIV infection [see Clinical Studies(14.1)].
1.8 Helicobacter pylori Infection and Duodenal Ulcer Disease
Clarithromycin tablets, USP are given in combination with other drugs in adults as described belowto eradicate H. pylori. The eradication of H. pylori has been demonstrated to reduce the riskof duodenal ulcer recurrence [see Clinical Studies(14.3)].
Clarithromycin tablets, USP in combination with amoxicillin and PREVACID (lansoprazole)or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated forthe treatment of patients with H. pylori infection and duodenal ulcer disease (active orfive-yearhistory of duodenal ulcer) to eradicate H.pylori.
Clarithromycin tablets, USP in combination with PRILOSEC (omeprazole) capsules are indicatedfor the treatment of patients with an active duodenal ulcer associated with H. pyloriinfection. Regimens which contain clarithromycin tablets, USP as the single antibacterial agent are more likelyto be associated with the development of clarithromycin resistance among patients whofail therapy. Clarithromycin-containing regimens should not be used in patients with knownor suspected clarithromycin resistant isolates because the efficacy of treatment is reduced inthis setting.
1.9
Limitations of Use
There is resistance to macrolides in certain bacterial infections caused byStreptococcus pneumoniae and Staphylococcus aureus. Susceptibility testing should be performedwhen clinicallyindicated.
1.10
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness ofclarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections thatare proven or strongly suspected to be caused by susceptible bacteria. When cultureand susceptibility information are available, they should be considered in selecting ormodifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibilitypatterns may contribute to the empiric selection oftherapy.