Cefzil

[Cefprozil]

The safety and effectiveness of cefprozil in the treatment of acute sinusitis have been established in the age groups 6 months to 12 years. Use of CEFZIL in these age groups is supported by evidence from adequate and well-controlled studies of cefprozil in adults.

Safety and effectiveness in pediatric patients below the age of 6 months have not been established for the treatment of otitis media or acute sinusitis or below the age of 2 years for the treatment of pharyngitis/ tonsillitis or uncomplicated skin and skin struc-ture infections. However, accumulation of other cephalosporin antibiotics in newborn infants (resulting from prolonged drug half-life in this age group) has been reported.

Geriatric Use

Text Continues Below

---

Of the more than 4500 adults treated with CEFZIL in clinical studies, 14% were 65 years and older, while 5% were 75 years and older. When geriatric patients received the usual recommended adult doses, their clinical efficacy and safety were comparable to clinical efficacy and safety in nongeriatric adult patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals to the effects of CEFZIL cannot be excluded (see CLINICAL PHARMACOLOGY). CEFZIL is known to be substantially excreted by the kidney, and the risk of toxic reac-tions to this drug may be greater in patients with impaired renal function. Because elder-ly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function. See DOSAGE AND ADMINIS-TRATION for dosing recommendations for patients with impaired renal function.

Page:  << Prev | 1 | 2 | 3 | 4