Clarithromycin

CLARITHROMYCIN- clarithromycin tablet, film coated
Wockhardt USA LLC.

1 INDICATIONS AND USAGE

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 (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 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)
  • Haemophilus parainfluenzae (in adults)
  • Moraxella catarrhalis (in adults)
  • Mycoplasma pneumoniae , Streptococcus pneumoniae , Chlamydophila pneumoniae (in adults and pediatric patients)

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 tablets, 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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Clarithromycin tablets may be given with or without food.

2.2 Adult Dosage

The recommended dosages of clarithromycin tablets for the treatment of mild to moderate infections in adults are listed in Table 1.

Table 1. Adult Dosage Guidelines
Clarithromycin Tablets
Infection Dosage (every 12 hours) Duration (days)
Acute bacterial exacerbation of chronic bronchitis 250 to 500 mga 7b to 14
Acute maxillary sinusitis 500 mg 14
Community-acquired pneumonia 250 mg 7d to 14
Pharyngitis/Tonsillitis 250 mg 10
Uncomplicated skin and skin structure infections 250 mg 7 to 14
Treatment and prophylaxis of disseminated Mycobacterium avium disease [see Dosage and Administration (2.5)] 500 mge
H.pylori eradication to reduce the risk of duodenal ulcer recurrence with amoxicillin and omeprazole or lansoprazole [see Dosage and Administration (2.3)] 500 mg 10 to 14
H.pylori eradication to reduce the risk of duodenal ulcer recurrence with omeprazole [see Dosage and Administration (2.3)] 500 mg every 8 hours 14
a For M. catarrhalis and S. pneumoniae use 250 mg. For H. influenzae and H. parainfluenzae , use 500 mg.b For H. parainfluenzae , the duration of therapy is 7 days.d For H. influenzae , the duration of therapy is 7 days.e Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

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