1 INDICATIONS AND USAGE
Clarithromycin is 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 and other antibacterial drugs, clarithromycin 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 the treatment of mild to moderate infections caused by susceptible isolates due to
Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or
Streptococcus pneumoniae [see Indications and Usage (
1.9)].
1.2 Acute Maxillary Sinusitis
Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to
Haemophilus influenzae, Moraxella catarrhalis, or
Streptococcus pneumoniae [see Indications and Usage (
1.9)].
1.3 Community-Acquired Pneumonia
Clarithromycin tablets, USP are indicated
[see Indications and Usage (
1.9)]
for the treatment of mild to moderate infections caused by susceptible isolates due to:
Haemophilus influenzae (in adults)
Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae
1.4 Pharyngitis/Tonsillitis
Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to
Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy.
1.5 Uncomplicated Skin and Skin Structure Infections
Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to
Staphylococcus aureus, or Streptococcus pyogenes.
1.6 Acute Otitis Media
Clarithromycin tablets, USP are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to
Haemophilus influenzae, 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 to moderate infections caused by susceptible isolates due to
Mycobacterium avium or
Mycobacterium intracellulare in patients with advanced HIV infection
[see Clinical Studies (
14.1)].
1.8
Helicobacter pylori Infection and Duodenal Ulcer Disease
Clarithromycin tablet, USP is given in combination with other drugs in adults as described below to eradicate
H. pylori. The eradication of
H. pylori has been demonstrated to reduce the risk of 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 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, USP in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with
H. pylori infection. Regimens which contain clarithromycin tablets, USP as the single antibacterial 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.
1.9 Limitations of Use
There is resistance to macrolides in certain bacterial infections caused by
Streptococcus pneumoniae and
Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated.
1.10 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin 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.