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warnings
Warnings Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in s everity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who pres ent with diarrhea subs equent 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 one 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 drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
Adverse Reactions In controlled clinical trials, the incidence of burning associated with Erythromycin Topical Gel USP, 2% was approximately 25%. The following additional local adverse reactions have been reported occasionally: peeling, dryness, itching, erythema, and oiliness. Irritation of the eyes and tenderness of the skin have also been reported with the topical use of erythromycin. A generalized urticarial reaction, possibly related to the use of erythromycin, which required systemic steroid therapy has been reported. To report SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc., at 1-856-697-1441 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.