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Drugs Approved by the FDA

Drug Name: Cipro (ciprofloxacin) I.V. and Cipro (ciprofloxacin HCI) tablets

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Bayer
Approval Status: Approved December 1996
Treatment for: complicated intra-abdominal infections

General Information

Cipro (ciprofloxacin) I.V. and Cipro (ciprofloxacin HCI) tablets has been approved for use in combination with metronidazole, for treatment of complicated intra-abdominal infections caused by E. coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

This study showed that conversion to oral therapy with ciprofloxacin/metronidazole appears as effective as continued intravenous therapy in patients able to tolerate oral feedings.

Side Effects

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.

Literature References

(1)Annals of Surgery, v223, No. 3, PP. 303-315, March 1995

(2) National Foundation for Infectious Diseases, "Infectious Diseases Clinical Updates," vIII, Issue 1, pl, March 1996

(3) Gorbach, SL, "Treatment of intra-abdominal infections," Journal of Antimicrob Chemother, 31 Suppl A. pp 67-78, Jan. 1993 Source Bayer Corporation.

Additional Information

Intra-abdominal infections generally occur after the integrity of the gastrointestinal (GI) tract and are compromised by trauma, intrinsic disease, or surgery. The leakage of bacteria from within the GI tract into adjacent tissues results in infection. Experimental studies in animals and clinical trials indicated that antimicrobial therapy should provide a broad-spectrum of activity.


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Drug listing last updated on June 20, 2008

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