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warnings
WARNINGS Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, 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 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 total incidence of adverse reactions associated with the use of Staticin was approximately 13%. These were dryness (7%), oiliness (2%), pruritus (2%), tenderness (2%), desquamation (2%), erythema (1%) and irritation (1%). The following additional adverse reactions have been reported occasionally: peeling, generalized urticarial reactions and itching.