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New Antibiotic Provides Full Course of Therapy in a Single High Dose

(ARA) - Your doctor said that you have a sinus infection caused by bacteria. Think you’ll be taking an antibiotic for a week or more? Not necessarily: the U.S. Food and Drug Administration (FDA) recently approved Zmax (azithromycin extended release) for oral suspension, an innovative new single-dose liquid antibiotic that is the latest option for treating certain types of mild-to-moderate sinusitis and pneumonia in adults appropriate for oral therapy. Taken once, Zmax continues working over time to fight the infection. 

Many patients skip doses or don’t finish their antibiotic treatment, which may lead to prolonged illness, relapse and the need for retreatment (Kardas P. Review: Patient compliance with antibiotic treatment for respiratory tract infections. Journal of Antimicrobial Chemotherapy. 2002;49:897-903). A complete course of antibiotics is needed to kill harmful bacteria. An incomplete course of antibiotics often wipes out only the most vulnerable, or susceptible, bacteria, which allows relatively resistant bacteria to survive and thrive (Mayo Foundation for Medical Education and Research. Using antibiotics sensibly. Mayo Clinic Web site. 2004. Available at: http://www.mayoclinic.com/invoke.cfm?objectid=64AA7229-F0B8-4A77-9693F821552DF9D9.  Accessed May 20, 2005). In order to reduce the development of drug-resistant bacteria and maintain their effectiveness, all antibiotics should be taken exactly as prescribed. 

“The benefit of this type of short-course, high-dose therapy is that it allows patients to be treated with a single dose of antibiotic,” said Michael Niederman, M.D., Chairman, Department of Medicine, Winthrop University Hospital, and Professor of Medicine, State University of New York at Stony Brook. 

Zmax’s innovative microsphere technology allows for release of the medicine in the small intestine rather than in the stomach, which results in a favorable side-effect profile. In addition, the high tissue penetration and long half-life of azithromycin make it possible to deliver the entire course of therapy as a single dose. This “front loading” of Zmax provides high drug levels earlier in the course of infection when the bacterial burden is likely to be highest. (Gordon E, Blumer J. Rationale for single and high dose treatment regimens with azithromycin. The Pediatric Infectious Disease Journal. 2004;23(2S):102-107).

Efficacy

The Zmax adult clinical research program included outpatients with mild-to-moderate acute bacterial sinusitis (ABS), community-acquired pneumonia (CAP), and acute bacterial exacerbations of chronic bronchitis (AECB). Pfizer withdrew its application for the treatment of AECB while the FDA re-evaluates how it reviews investigational antibiotics for this indication. 

Results of pivotal studies showed that Zmax worked as well as currently available treatments dosed for 7 to 10 days, including a: 

* 10-day course of levofloxacin for the treatment of ABS

* 7-day course of levofloxacin for the treatment of mild-to-moderate CAP in patients appropriate for oral therapy

* 7-day course of clarithromycin extended release for the treatment of mild-to-moderate CAP in patients appropriate for oral therapy

Safety and Tolerability

Zmax offers a safety profile comparable to other antibiotic treatments for sinusitis and pneumonia, and is generally well tolerated. In clinical studies, side effects were generally mild to moderate. Overall, the most common treatment-related adverse reactions in adult patients receiving a single (2 g) dose of Zmax were diarrhea/loose stools (11.6 percent), nausea (3.9 percent), abdominal pain (2.7 percent), headache (1.3 percent), and vomiting (1.1 percent). In the majority of Zmax-treated patients, diarrhea resolved within two days. 

Zmax is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, or any macrolide or ketolide antibiotic. If an allergic reaction occurs, discontinue drug and institute appropriate therapy. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy for the allergic reaction is discontinued. Pseudomembranous colitis has been reported with nearly all antibacterial agents. It is important to consider this diagnosis in patients who present with diarrhea. 

For further information, including full prescribing information, please visit www.zmaxinfo.com. 

Courtesy of ARA Content

EDITOR'S NOTES: Zmax is indicated for acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae and community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy. 

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