Clarithromycin (Clarithromycin) - Indications and Dosage

INDICATIONS AND 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.

THE EFFICACY AND SAFETY OF CLARITHROMYCIN EXTENDED-RELEASE TABLETS IN TREATING OTHER INFECTIONS FOR WHICH OTHER FORMULATIONS OF CLARITHROMYCIN ARE APPROVED HAVE NOT BEEN ESTABLISHED.

DOSAGE AND ADMINISTRATION

Clarithromycin extended-release tablets should be taken with food.

Clarithromycin extended-release tablets should be swallowed whole and not chewed, broken or crushed.

ADULT DOSAGE GUIDELINES
	Clarithromycin Extended-Release Tablets
Infection	Dosage (q24h)	Duration (days)
Acute maxillary sinusitis due to	1 gram	14
H. influenzae
M. catarrhalis
S. pneumoniae
Acute exacerbation of chronic bronchitis due to
H. influenzae	1 gram	7
H. parainfluenzae	1 gram	7
M. catarrhalis	1 gram	7
S. pneumoniae	1 gram	7
Community-Acquired Pneumonia due to
H. influenzae	1 gram	7
H. parainfluenzae	1 gram	7
M. catarrhalis	1 gram	7
S. pneumoniae	1 gram	7
C. pneumoniae	1 gram	7
M. pneumoniae	1 gram	7

HOW SUPPLIED

Clarithromycin extended-release tablets, 1000 mg are yellow-colored, oval-shaped, film coated tablets imprinted with ‘RB 36’ in black ink on one side and plain on the other side. They are supplied as follows:

NDC 63304-971-03 Bottles of 10

NDC 63304-971-54 Blister unit-dose of 14

NDC 63304-971-05 Bottles of 500

NDC 63304-971-70 Blister unit-dose of 70

Store at 20 - 25° C (68 - 77° F) (See USP Controlled Room Temperature)