Zagam (sparfloxacin) is indicated for the treatment of adults (>/= 18 years of age) with the following infections caused by susceptible strains of the designated microorganisms:

Community-acquired pneumonia   caused by Chlamydia pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae , or Streptococcus pneumoniae

Acute bacterial exacerbations of chronic bronchitis caused by Chlamydia pneumoniae, Enterobacter cloacae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Staphylococcus aureus , or Streptococcus pneumoniae

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to sparfloxacin. Therapy with sparfloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. Culture and susceptibility testing performed periodically during therapy will provide information on the continued susceptibility of the pathogen to the antimicrobial agent and also on the possible emergence of bacterial resistance.

Zagam (sparfloxacin) can be taken with or without food.

The recommended daily dose of Zagam in patients with normal renal function is two 200-mg tablets taken on the first day as a loading dose. Thereafter, one 200-mg tablet should be taken every 24 hours for a total of 10 days of therapy (11 tablets).

The recommended daily dose of Zagam in patients with renal impairment (creatinine clearance <50 mL/min) is two 200-mg tablets taken on the first day as a loading dose. Thereafter, one 200-mg tablet should be taken every 48 hours for a total of 9 days of therapy (6 tablets).

CLINICAL STUDIES

Community-Acquired Pneumonia Studies

In two controlled clinical studies of community-acquired pneumonia conducted in the United States, sparfloxacin was compared to erythromycin and cefaclor. The patient clinical success and pathogen eradication rates for sparfloxacin were equivalent to those of the comparators. In these studies, the following pathogen eradication rates/presumed pathogen eradication rates were obtained:

Safety

The following table lists possibly and probably drug-related adverse events that occurred in these studies at an incidence of >/=2%:

Acute Bacterial Exacerbations of Chronic Bronchitis Study

In a controlled clinical study of acute bacterial exacerbations of chronic bronchitis conducted in the United States, sparfloxacin was compared to ofloxacin. In this study, the following pathogen eradication rates were obtained:

Safety

The following table lists possibly and probably drug-related adverse events that occurred in the study at an incidence of >/=2% for either compound.

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP].

Caution:   Federal law prohibits dispensing without a prescription.

Keep out of the reach of children.

References:

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA, December, 1993.

2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA, December 1993.

Distributed by Bertek Pharmaceuticals Inc.
Sugarland, TX 77478 USA
Manufactured by Rhone-Poulenc Rorer Pharmaceuticals Collegeville, Pa 19426

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