CEFPROZIL (Page 5 of 6)

Renal Impairment:

Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.

Creatinine Clearance ( mL / min ) Dosage ( mg ) Dosing Interval
*
Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.
30 to 120 standard standard
0 to 29* 50% of standard standard

Hepatic Impairment:

No dosage adjustment is necessary for patients with impaired hepatic function.

HOW SUPPLIED

Cefprozil tablets USP, 500 mg are available as follows:

20 TABLET in a BOTTLE (53217-031-20)

Each white, film-coated, oval tablet debossed with ‘LUPIN’ on one side and ‘500’ on the other side, contains the equivalent of 500 mg anhydrous cefprozil.

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

Repackaged by

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

CLINICAL STUDIES

Study One:

In a controlled clinical study of acute otitis media performed in the United States where significant rates of ß-lactamase- producing organisms were found, cefprozil was compared to an oral antimicrobial agent that contained a specific ß-lactamase inhibitor. In this study, using very strict evaluability criteria and microbiologic and clinical response criteria at the 10 to 16 days post-therapy follow-up, the following presumptive bacterial eradication/clinical cure outcomes (i.e., clinical success) and safety results were obtained:

U.S. Acute Otitis Media Study

Cefprozil vs β-lactamase inhibitor-containing control drug

EFFICACY:

Pathogen % of Cases with Pathogen ( n = 155 ) Outcome
S . pneumoniae 48.4% cefprozil success rate 5% better than control
H . influenzae 35.5% cefprozil success rate 17% less than control
M . catarrhalis 13.5% cefprozil success rate 12% less than control
S . pyogenes 2.6% cefprozil equivalent to control
Overall 100.0% cefprozil success rate 5% less than control

SAFETY:

The incidences of adverse events, primarily diarrhea and rash* , were clinically and statistically significantly higher in the control arm versus the cefprozil arm.

* The majority of these involved the diaper area in young children.

Age Group Cefprozil Control
6 months to 2 years 21% 41%
3 to 12 years 10% 19%

Study Two:

In a controlled clinical study of acute otitis media performed in Europe, cefprozil was compared to an oral antimicrobial agent that contained a specific ß-lactamase inhibitor. As expected in a European population, this study population had a lower incidence of ß-lactamase-producing organisms than usually seen in U.S. trials. In this study, using very strict evaluability criteria and microbiologic and clinical response criteria at the 10 to 16 days post-therapy follow-up, the following presumptive bacterial eradication/clinical cure outcomes (i.e., clinical success) were obtained:

European Acute Otitis Media Study

Cefprozil vs β-lactamase inhibitor-containing control drug

EFFICACY:

Pathogen % of Cases with Pathogen ( n = 47 ) Outcome
S . pneumoniae 51.0% cefprozil equivalent to control
H . influenzae 29.8% cefprozil equivalent to control
M . catarrhalis 6.4% cefprozil equivalent to control
S . pyogenes 12.8% cefprozil equivalent to control
Overall 100.0% cefprozil equivalent to control

SAFETY:

The incidence of adverse events in the cefprozil arm was comparable to the incidence of adverse events in the control arm (agent that contained a specific ß-lactamase inhibitor).

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