Cefzil

[Cefprozil]

Chromosomal aberrations were not observed in bone marrow cells from rats dosed orally with over 30 times the highest recommended human dose based upon mg/ m 2 .

Impairment of fertility was not observed in male or female rats given oral doses of cef-prozil up to 18.5 times the highest recommended human dose based upon mg/ m 2 .

Pregnancy:

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Teratogenic Effects.

Pregnancy Category B

Reproduction studies have been performed in rabbits, mice, and rats using oral doses of cefprozil of 0.8, 8.5, and 18.5 times the maximum daily human dose (1000 mg) based upon mg/ m 2 , and have revealed no harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

Cefprozil has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.

Nursing Mothers

Small amounts of cefprozil (< 0.3% of dose) have been detected in human milk follow-ing administration of a single 1 gram dose to lactating women. The average levels over 24 hours ranged from 0.25 to 3.3 µg/ mL. Caution should be exercised when CEFZIL is administered to a nursing woman, since the effect of cefprozil on nursing infants is unknown.

Pediatric Use:

(See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.) The safety and effectiveness of cefprozil in the treatment of otitis media have been established in the age groups 6 months to 12 years. Use of CEFZIL (cefprozil) for the treatment of otitis media is supported by evidence from adequate and well-controlled studies of cefprozil in pediatric patients. (See CLINICAL STUDIES.)

The safety and effectiveness of cefprozil in the treatment of pharyngitis/ tonsillitis or uncomplicated skin and skin structure infections have been established in the age groups 2 to 12 years. Use of CEFZIL for the treatment of these infections is sup-ported by evidence from adequate and well-controlled studies of cefprozil in pediatric patients.

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