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First Single-Dose Oral Antibiotic Zmax (Azithromycin Extended Release) Available in US Pharmacies for Adults with Certain Types of Sinusitis and Pneumonia

NEW YORK, N.Y. -- August 18, 2005 -- Pfizer Inc announced today that Zmax™ (azithromycin extended release) for oral suspension, a one-dose-only treatment for mild-to-moderate acute bacterial sinusitis (ABS) and community-acquired pneumonia (CAP) in adults appropriate for oral therapy, is now available by prescription in pharmacies across the United States.

The U.S. Food and Drug Administration approved Zmax in June for the treatment of certain types of mild-to-moderate ABS and CAP in adults appropriate for oral therapy.

Zmax provides a full course of treatment in one dose, making it easier for patients to finish their antibiotic as prescribed. Research has shown that more than 40 percent of patients fail to take all of their antibiotics as prescribed. Failure to complete therapy has been associated with treatment failure, deterioration of health, additional visits to physicians and hospital admissions, and increased medical costs. In pivotal trials, 100 percent of Zmax-treated patients completed therapy.

"Single-dose therapy offers the potential for optimized clinical outcomes because it makes it hard for patients to skip doses or fail to complete the treatment regimen," said Dr. Michael Niederman, Chairman, Department of Medicine, Winthrop University Hospital, and Professor of Medicine, State University of New York at Stony Brook.

In Zmax clinical studies, side effects were generally mild to moderate, and overall, the most common treatment-related adverse reactions in adult subjects were diarrhea/loose stools (11.6%), nausea (3.9%), abdominal pain (2.7%), headache (1.3%), and vomiting (1.1%). In the majority of Zmax-treated patients, diarrhea resolved within two days.

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.

Zmax is contraindicated in patients with hypersensitivity to azithromycin, erythromycin, or any other macrolide or ketolide antibiotic. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted. 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.


SOURCE: Pfizer Inc.

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