BIAXIN XL SUMMARY
Clarithromycin is a semi-synthetic macrolide antibiotic.
BIAXIN Filmtab (clarithromycin tablets, USP) and BIAXIN Granules (clarithromycin for oral suspension, USP) are indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions as listed below:
Pharyngitis/Tonsillitis due to
Streptococcus pyogenes
(The usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. Clarithromycin is generally effective in the eradication of
S. pyogenes
from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present.)
Acute maxillary sinusitis due to
Haemophilus influenzae, Moraxella catarrhalis,
or
Streptococcus pneumoniae
Acute bacterial exacerbation of chronic bronchitis due to
Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis,
or
Streptococcus pneumoniae
Community-Acquired Pneumonia due to
Haemophilus influenzae, Mycoplasma pneumoniae, Streptococcus pneumoniae,
or
Chlamydia pneumoniae
(TWAR)
Uncomplicated skin and skin structure infections due to
Staphylococcus aureus,
or
Streptococcus pyogenes
(Abscesses usually require surgical drainage.)
Disseminated mycobacterial infections due to
Mycobacterium avium,
or
Mycobacterium intracellulare
BIAXIN (clarithromycin) Filmtab 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.
BIAXIN Filmtab tablets in combination with PRILOSEC (omeprazole) capsules or TRITEC (ranitidine bismuth citrate) tablets are also indicated for the treatment of patients with an active duodenal ulcer associated with
H. pylori
infection. However, regimens which contain clarithromycin as the single antimicrobial 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.
In patients who fail therapy, susceptibility testing should be done if possible. If resistance to clarithromycin is demonstrated, a non-clarithromycin-containing therapy is recommended. (For information on development of resistance see Microbiology section.) The eradication of
H. pylori
has been demonstrated to reduce the risk of duodenal ulcer recurrence.
Pharyngitis/Tonsillitis due to
Streptococcus pyogenes
Community-Acquired Pneumonia due to
Mycoplasma pneumoniae, Streptococcus pneumoniae,
or
Chlamydia pneumoniae
(TWAR)
Acute maxillary sinusitis due to
Haemophilus influenzae, Moraxella catarrhalis,
or
Streptococcus pneumoniae
Acute otitis media due to
Haemophilus influenzae, Moraxella catarrhalis,
or
Streptococcus pneumoniae
NOTE: For information on otitis media, see CLINICAL STUDIES: Otitis Media.
Uncomplicated skin and skin structure infections due to
Staphylococcus aureus,
or
Streptococcus pyogenes
(Abscesses usually require surgical drainage.)
Disseminated mycobacterial infections due to
Mycobacterium avium,
or
Mycobacterium intracellulare
BIAXIN XL Filmtab (clarithromycin extended-release tablets) are indicated for the treatment of adults with mild to moderate infection caused by susceptible strains of the designated microorganisms in the conditions listed below:
Acute maxillary sinusitis due to
Haemophilus influenzae, Moraxella catarrhalis,
or
Streptococcus pneumoniae
Acute bacterial exacerbation of chronic bronchitis due to
Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis,
or
Streptococcus pneumoniae
Community-Acquired Pneumonia due to
Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Chlamydia pneumoniae
(TWAR), or
Mycoplasma pneumoniae
THE EFFICACY AND SAFETY OF BIAXIN XL IN TREATING OTHER INFECTIONS FOR WHICH OTHER FORMULATIONS OF BIAXIN ARE APPROVED HAVE NOT BEEN ESTABLISHED.
BIAXIN Filmtab tablets and BIAXIN Granules for oral suspension are indicated for the prevention of disseminated
Mycobacterium avium
complex (MAC) disease in patients with advanced HIV infection.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of BIAXIN and other antibacterial drugs, BIAXIN 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.
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