General: In the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including macrolides and may range in severity from mild to severe.
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Clarithromycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate.
Use in lactation: It is not known whether clarithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when clarithromycin is administered to a nursing woman.
Use in children: Safety and effectiveness of clarithromycin in children <6 months have not been established.