US FDA Approves Single-Dose Treatment For Pediatric Ear Infections
January 8, 2002 | 12:00am
NEW YORK -- Pfizer Inc said recently that the U.S. Food and Drug Administration has approved Zithromax (azithromycin for oral suspension) as both a single-dose regimen and a three-day regimen for the treatment of acute otitis media in pediatric patients.
Azithromycin for oral suspension as a single dose or three-day regimen provides a full course of therapy, while most currently available antibiotics require 10 days of multi-dose treatment. It has unique attributes that include high and sustained drug levels in infected tissues, which make short-course dosing possible.
Developed and marketed by Pfizer, azithromycin was approved in 1995 as a once-daily, five-day treatment for use in children with acute otitis media caused by the three most common bacterial pathogens Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis.
Acute otitis media, which is an inflammation of the middle ear, is the most common bacterial infection in young children and accounts for at least 30 million sick child visits to doctors each year. If left untreated, acute otitis media can result in perforation of the eardrum, hearing impairment and possible delay in speech and learning development. Antibiotic treatment should only be used for those infections caused by bacteria and only a physician can decide if antibiotic therapy is appropriate.
"Zithromax delivered as a single-dose regimen represents a breakthrough for physicians in treating ear infections in children," said Joseph Feczko, M.D., Pfizer's Senior Vice President of Medical and Regulatory Operations. "This new Zithromax regimen provides patients with the important benefit of completing the full course of medication in a single dose. As a single-dose regimen it offers patients effective treatment and a favorable side effect profile."
The single-dose Zithromax clinical program involved patients with acute otitis media between the ages of six months and 12 years. In one trial, a single dose of azithromycin was as effective as Augmentin (amoxicillin/clavulanate potassium) taken twice a day for 10 days. Furthermore, 99 percent of patients taking the single dose of azithromycin were compliant with their regimen.
Fewer patients receiving a single dose of azithromycin reported treatment related side effects than those receiving Augmentin. The most common treatment-related side effects of the single-dose regimen of Zithromax oral suspension were vomiting, diarrhea/loose stools, and abdominal pain. It should not be taken by patients with a hypersensitivity to azithromycin, erythromycin or any macrolide antibiotic.
The company said it expects to introduce azithromycin as a single dose regimen in the United States in early 2002. Pfizer also said it will launch a broad-based education campaign to health care providers and patients about the proper diagnosis and treatment of acute otitis media.
Zithromax was first approved in the United States in 1992 in capsule form for adults as the first once-daily, five-day oral antibiotic for the treatment of community-acquired respiratory infections and skin infections.
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best-known consumer products.
Azithromycin for oral suspension as a single dose or three-day regimen provides a full course of therapy, while most currently available antibiotics require 10 days of multi-dose treatment. It has unique attributes that include high and sustained drug levels in infected tissues, which make short-course dosing possible.
Developed and marketed by Pfizer, azithromycin was approved in 1995 as a once-daily, five-day treatment for use in children with acute otitis media caused by the three most common bacterial pathogens Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis.
Acute otitis media, which is an inflammation of the middle ear, is the most common bacterial infection in young children and accounts for at least 30 million sick child visits to doctors each year. If left untreated, acute otitis media can result in perforation of the eardrum, hearing impairment and possible delay in speech and learning development. Antibiotic treatment should only be used for those infections caused by bacteria and only a physician can decide if antibiotic therapy is appropriate.
"Zithromax delivered as a single-dose regimen represents a breakthrough for physicians in treating ear infections in children," said Joseph Feczko, M.D., Pfizer's Senior Vice President of Medical and Regulatory Operations. "This new Zithromax regimen provides patients with the important benefit of completing the full course of medication in a single dose. As a single-dose regimen it offers patients effective treatment and a favorable side effect profile."
The single-dose Zithromax clinical program involved patients with acute otitis media between the ages of six months and 12 years. In one trial, a single dose of azithromycin was as effective as Augmentin (amoxicillin/clavulanate potassium) taken twice a day for 10 days. Furthermore, 99 percent of patients taking the single dose of azithromycin were compliant with their regimen.
Fewer patients receiving a single dose of azithromycin reported treatment related side effects than those receiving Augmentin. The most common treatment-related side effects of the single-dose regimen of Zithromax oral suspension were vomiting, diarrhea/loose stools, and abdominal pain. It should not be taken by patients with a hypersensitivity to azithromycin, erythromycin or any macrolide antibiotic.
The company said it expects to introduce azithromycin as a single dose regimen in the United States in early 2002. Pfizer also said it will launch a broad-based education campaign to health care providers and patients about the proper diagnosis and treatment of acute otitis media.
Zithromax was first approved in the United States in 1992 in capsule form for adults as the first once-daily, five-day oral antibiotic for the treatment of community-acquired respiratory infections and skin infections.
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best-known consumer products.
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