Home » Drug Information » FDA-Approved Drugs » 1996
Medical Areas: Gastroenterology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Bayer
Approval Status: Approved December 1996
Treatment Area: complicated intra-abdominal infections
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.
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.
(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.
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.
