Home » Drug Information » FDA-Approved Drugs » 1997
Medical Areas: Pulmonary/Respiratory Diseases
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Rhone Poulenc Rorer
Approval Status: Approved January 1997
Treatment Area: community-acquired pneumonia (CAP) and chronic bronchitis
Zagam, a new once-daily fluoroquinolonc antibiotic treatment,
has been approved for the treatment of community-acquired pneumonia
(CAP) and chronic bronchitis. Zagam has demonstrated activity in
clinical trials against a broad range of Gram-positive,
Gram-negative, and atypical pathogens that cause common lower
respiratory tract infections. In addition, Zagam is highly active
in vitro against many penicillin-resistant strains of the
Gram-positive pathogen, Streptococcus pneumoniae, as well as
multi-drug resistant strains of the Gram-negative pathogens
Haemophilus influenzae and Moraxella catarrhalis, although clinical
efficacy has not yet been established.
The recommended daily dose of Zagam for patients with normal
kidney function is two 200 mg tablets on the first day as a loading
dose, followed by one tablet every 25 hours thereafter, for a total
of 10 days of therapy.
The most frequently reported side effect of Zagam during
clinical trials was increased sensitivity to sunlight. As with
other antibiotics, QT interval prolongation, tendonitis and
gastrointestinal disturbances were observed
