Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus. Clarithromycin has demonstrated adverse effects of pregnancy outcome and/or embryo-fetal development in monkeys, rats, mice, and rabbits at doses that produced plasma levels 2 to 17 times. The serum levels achieved in humans treated at the maximum recommended human doses.
Pseudomembranous colitis has been with nearly all antibacterial agents, including clarithromycin and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by clostridium difficile is a primary cause of "antibiotic-associated colitis".
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with antibacterial drug clinically effective against Clostridium difficile colitis.
This product contains TARTRAZINE (FDC Yellow #5) which can cause allergic reactions such as angioedema, asthma, urticaria and anaphylactic shock. Some of the reports have dealt with cross-sensitivity, especially with aspirin, although the connection with aspirin has been questioned.