BIAXIN- clarithromycin tablet, film coated
BIAXIN- clarithromycin tablet, film coated, extended release
BIAXIN- clarithromycin granule, for suspension
AbbVie Inc.
1 INDICATIONS AND USAGE
1.1 Acute Bacterial Exacerbation of Chronic Bronchitis
BIAXIN (Filmtab, Granules) and BIAXIN XL Filmtab 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
BIAXIN (Filmtab, Granules) and BIAXIN XL Filmtab (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
BIAXIN (Filmtab, Granules) and BIAXIN XL Filmtab 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 (BIAXIN XL Filmtab in adults)
Moraxella catarrhalis (BIAXIN XL Filmtab in adults)
Mycoplasma pneumoniae , Streptococcus pneumoniae , Chlamydophila pneumoniae (BIAXIN XL Filmtab [in adults]; BIAXIN Filmtab and BIAXIN Granules [in adults and pediatric patients])
1.4 Pharyngitis/Tonsillitis
BIAXIN Filmtab and BIAXIN Granules 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
BIAXIN Filmtab and BIAXIN Granules 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
BIAXIN Filmtab and BIAXIN Granules 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
BIAXIN Filmtab and BIAXIN Granules 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
BIAXIN Filmtab 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)].
BIAXIN Filmtab 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.
BIAXIN Filmtab 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 BIAXIN Filmtab 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.