FDA ( U.S. Food and Drug Administration ) has approved the once-daily, broad-spectrum antibiotic Avelox ( Moxifloxacin HCl ) for a new use -- the treatment of complicated intra-abdominal infections ( cIAI ) in adults.
Avelox is the only marketed fluoroquinolone antibiotic approved by the FDA as monotherapy to treat this indication.

Intra-abdominal infections are caused by disease, trauma or surgery in the abdomen that cause bacteria to leak from the gastrointestinal tract into adjacent tissue. There are approximately 3.5 million cases in the United States each year, with many patients contracting the infection secondary to appendicitis.

With this FDA approval, Avelox is indicated for the treatment of adults with cIAI, including polymicrobial infections such as abscesses caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron or Peptostreptococcus species.

The FDA approval was based on results from clinical studies in cIAI patients showing that sequential I.V. or oral monotherapy with Avelox once daily was as effective as the widely used I.V. therapy Piperacillin-Tazobactam four times daily followed by oral Amoxicillin-Clavulanate twice daily.
Avelox was effective at eradicating key pathogens, including E. coli and the anaerobe B. fragilis, which are the most commonly encountered bacteria in cIAI.

The FDA approval to treat cIAI is the sixth indication for Avelox, which is already approved in the United States to treat acute bacterial sinusitis ( ABS ); acute bacterial exacerbation of chronic bronchitis ( ABECB ); community acquired pneumonia ( CAP ) -- including CAP caused by multi-drug resistant Streptococcus pneumoniae ( MRSP ) and penicillin-resistant Streptococcus pneumoniae ( PRSP ); uncomplicated skin and skin structure infections ( uSSSI ); and complicated skin and skin structure infections ( cSSSI ).

Two randomized, active-controlled trials in cIAI were performed. In a double-blind trial conducted primarily in North America, the efficacy of sequential I.V. or oral ( PO ) monotherapy with Avelox 400 mg once daily ( QD ) for 5-14 days was compared to I.V. Piperacillin/Tazobactam followed by PO Amoxicillin/Clavulanic acid in the treatment of patients with cIAI, including peritonitis, abscesses, appendicitis with perforation and bowel perforation. This study enrolled 681 patients, 379 of which were considered clinically evaluable. In this study, the overall success rates in evaluable patients for Avelox versus the comparator were 79.8 percent and 78.1 percent, respectively.

Complicated intra-abdominal infections arise from the hollow organs of the peritoneal cavity, including the stomach, small and large bowel, appendix and biliary system. Types of cIAI include appendicitis with perforation or abscess, intra-abdominal abscess or peritonitis ( diffuse inflammation of peritoneum lining the abdominal wall and bowel ), perforations of the stomach or bowel, and surgical site infections related to previous intra-abdominal surgery.
Generally, cIAI are acquired when the integrity of the gastrointestinal ( GI ) tract is affected as a result of previous surgery, intrinsic disease or trauma.
The leakage of bacteria from within the GI tract into adjacent tissues results in infection. In the case of post-surgical infections, cIAI are caused by nosocomial bacteria specific to the surgical site and to the specific hospital and unit.

Avelox is approved to treat: Acute Bacterial Exacerbations of Chronic Bronchitis ( ABECB ) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus or Moraxella catarrhalis; Acute Bacterial Sinusitis ( ABS ) caused by Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis; Community Acquired Pneumonia ( CAP ) caused by Streptococcus pneumoniae ( including multi-drug resistant strains ), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae or Chlamydia pneumoniae; Uncomplicated Skin and Skin Structure Infections ( uSSSI ) caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes; Complicated Skin and Skin Structure Infections ( cSSSI ) caused by methicillin- susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae or Enterobacter cloacae; and Complicated Intra-Abdominal Infections ( cIAI ) including polymicrobial infections such as abscesses caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron or Peptostreptococcus species.

Avelox is generally well tolerated, with adverse events being similar to standard therapy. The most common side effects caused by Avelox, which are usually mild, include dizziness, nausea and diarrhea. Patients should be careful about driving or operating machinery until they are sure that Avelox is not causing dizziness. Patients should inform a health care professional of other side effects.

Patients who have ever had an allergic reaction to Avelox or any of the other group of antibiotics known as "quinolones," such as Levofloxacin should avoid taking Avelox.

Patients who have been diagnosed with an abnormal heartbeat such as an arrhythmia or are using certain medications used to treat an abnormal heartbeat should avoid taking Avelox. These medications include Quinidine, Procainamide, Amiodarone and Sotalol.

Avelox is not for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. Avelox is not for children under the age of 18 years.

Convulsions have been reported in patients receiving Quinolone antibiotics. Patients should be sure to let their physician know if they have a history of convulsions.

Many antacids and multivitamins may interfere with the absorption of Avelox and may prevent it from working properly. Patients should take Avelox either 4 hours before or 8 hours after taking these products.

Source: Schering-Plough, 2005


XagenaMedicine2005