24 HR Clarithromycin 500 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Clarithromycin extended-release tablets 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) Limitations of Use Clarithromycin extended-release tablets are indicated only for acute bacterial exacerbation of chronic bronchitis, Acute Maxillary Sinusitis, and Community-Acquired Pneumonia in adults. (1.9) To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin extended-release tablets and other antibacterial drugs, clarithromycin extended-release 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 extended-release tablets 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 extended-release tablets (in adults) 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 extended-release tablets 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) Haemophilus parainfluenzae (in adults) Moraxella catarrhalis (in adults) Mycoplasma pneumoniae , Streptococcus pneumoniae , Chlamydophila pneumoniae (in adults) 1.9 Limitations of Use Clarithromycin extended-release tablets are indicated only for Acute Maxillary Sinusitis, acute bacterial exacerbation of chronic bronchitis, and Community-Acquired Pneumonia in adults. The efficacy and safety of clarithromycin extended-release tablets in treating other infections for which clarithromycin immediate release tablets and clarithromycin granules are approved have not been established. 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 extended-release tablets and other antibacterial drugs, clarithromycin extended-release 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.
Lannett Company, Inc.
OVAL WHITE S58
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16 HOW SUPPLIED/STORAGE AND HANDLING
CLARITHROMYCIN extended-release tablets, USP are supplied as white or off-white, capsular-shaped film-coated 500 mg tablets debossed “S58” on one side and blank on the other side. 500 mg tablets: Bottles of 60 NDC 0527-1930-06 Store
CLARITHROMYCIN extended-release tablets, USP at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature].
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