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| |  CIPRO Cleared by FDA to Treat Complicated Intra-Abdominal Infections WEST HAVEN, Conn., Dec. 30, 1996 -- Bayer Corporation, Pharmaceutical Division, announced today that it received clearance from the U.S. Food and Drug Administration (FDA) to market its widely-prescribed antibacterial therapy, CIPRO(R) (ciprofloxacin) I.V. and CIPRO (ciprofloxacin HCl) tablets -- used in combination with metronidazole -- for treatment of complicated intra-abdominal infections caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis. For treatment of complicated intra-abdominal infections, sequential therapy (parenteral to oral) with CIPRO I.V./CIPRO tablets (in combination with metronidazole) can be instituted at the discretion of the physician. "Research suggests that in many cases, sequential therapy can have cost savings implications, as it can accelerate moving a patient from hospital to home," said Dr. Steven Jungerwirth, Director, Anti-Infective Medical Research, Bayer Corporation, Pharmaceutical Division. After reviewing the supplemental new drug application, the FDA cleared the complicated intra-abdominal infections indication for CIPRO I.V. and tablets on October 10, 1996. Results of a randomized, double-blind, multicenter trial demonstrating statistical equivalence between ciprofloxacin/metronidazole I.V. and imipenem/cilastatin I.V. in the treatment of complicated intra-abdominal infections led to clearance for this indication. This study also showed that conversion to oral therapy with ciprofloxacin/metronidazole appears as effective as continued intravenous therapy in patients able to tolerate oral feedings.(A) Intra-abdominal infections generally occur after the integrity of the gastrointestinal (GI) tract is compromised by trauma, intrinsic disease, or surgery. The leakage of bacteria from within the GI tract into adjacent tissues results in infection.(B) Experimental studies in animals and clinical trials indicate that antimicrobial therapy should provide a broad-spectrum of activity.(C) The most commonly reported side effects of therapy with CIPRO tablets are nausea, diarrhea, vomiting, abdominal pain/discomfort, headache, rash and restlessness. In therapy with CIPRO I.V., the most commonly reported side effects are nausea, diarrhea, central nervous system disturbance and local I.V. site reactions. Tradition of Success CIPRO tablets and CIPRO I.V. have been marketed by Bayer Corporation in the U.S. since 1987 and 1991 respectively for the treatment of a wide variety of infectious diseases in adults including urinary tract infections, lower respiratory infections, bone and joint infections, and skin and skin structure infections. Since its introduction, more than 80 million prescriptions for CIPRO have been dispensed in the U.S., making it one of the most widely-prescribed drugs in the country. Bayer Corporation is a research-based company with major businesses in health care and life sciences, chemicals and imaging technologies. The company had 1995 sales of $8 billion with a net income of $227.5 million and employs 23,500 people. Capital expenditures for 1995 totaled $570 million, and $526 million was spent for research and development. Bayer Corporation, with headquarters in Pittsburgh, is a member of the worldwide Bayer Group, a $31 billion chemical and pharmaceutical company based in Leverkusen, Germany. (A) Annals of Surgery, v223, No. 3, pp. 303-315, March 1996 (B) National Foundation for Infectious Diseases, Infectious Diseases Clinical Updates, vIII, Issue 1, pl, March 1996 (C) Gorbach, SL, "Treatment of intra-abdominal infections," Journal of Antimicrob Chemother, 31 Suppl A. pp67-78, Jan. 1993
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