What is clarithromycin used for?

Indications and Usage, quoted from the label by Sportpharm LLC (ANDA210459). Cross-references to other label sections are left out.

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].

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.

Community-Acquired Pneumonia

Clarithromycin tablets, USP are indicatedfor the treatment of mild to moderate infections caused by susceptible isolates due to:

· Haemophilus influenzae(in adults)

· Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae

Pharyngitis/Tonsillitis

Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenesas an alternative in individuals who cannot use first line therapy.

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.

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.

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 aviumor Mycobacterium intracellularein patients with advanced HIV infection.

Helicobacter pyloriInfection and Duodenal Ulcer Disease

Clarithromycin tablets, USP are given in combination with other drugs in adults as described below to eradicate H. pylori. The eradication of H. pylorihas been demonstrated to reduce the risk of duodenal ulcer recurrence.

· 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. pyloriinfection 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.

Limitations of Use

There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniaeand Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated.

Usage

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.

Source: DailyMed label, set id de33ba3a-9df1-4076-8d5f-b603d2698096, version 1, effective April 17, 2026. NDC 85766-197, one of 36 listings for this product.

Indications and Usage, quoted from the label by Sandoz Inc (ANDA065144). Cross-references to other label sections are left out.

Acute Bacterial Exacerbation of Chronic Bronchitis

Clarithromycin 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.

Acute Maxillary Sinusitis

Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

Community-Acquired Pneumonia

Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to:

• Haemophilus influenzae (in adults)
• Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae (in adults and pediatric patients)

Pharyngitis/Tonsillitis

Clarithromycin tablets 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.

Uncomplicated Skin and Skin Structure Infections

Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus, or S treptococcus pyogenes.

Acute Otitis Media

Clarithromycin tablets 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.

Treatment and Prophylaxis of Disseminated Mycobacterial Infections

Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium or Myc obacterium intracellulare in patients with advanced HIV infection.

Helicobacter pylori Infection and Duodenal Ulcer Disease

Clarithromycin tablets are 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.

• Clarithromycin tablets 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 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 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.

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.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin 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.

Source: DailyMed label, set id b98b02bb-2609-49a0-b29f-e5911aa0cbc1, version 23, effective May 30, 2023. NDC 0781-1961, one of 10 listings for this product.

Indications and Usage, quoted from the label by Solaris Pharma Corporation (ANDA208987). Cross-references to other label sections are left out.

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.

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.

Community-Acquired Pneumonia

Clarithromycin extended-release tablets are indicated 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)

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 pneumoniaeand Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated.

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.

Source: DailyMed label, set id 4d4303f8-88dd-8b88-e063-6394a90ab48f, version 1, effective March 17, 2026. NDC 73473-911, one of 5 listings for this product.