Cefprozil

AND CLINICAL USE ................................................................................... 3 CONTRAINDICATIONS ........................................................................................................ 4 WARNINGS AND PRECAUTIONS .......................................................................................

4 ADVERSE REACTIONS ......................................................................................................... 6 DRUG INTERACTIONS .........................................................................................................

8 DOSAGE AND ADMINISTRATION ..................................................................................... 8 OVERDOSAGE........................................................................................................................

9 ACTION AND CLINICAL PHARMACOLOGY. ................................................................... 9 STORAGE AND STABILITY .............................................................................................. 11 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................

INDICATIONS AND USAGE

Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Upper Respiratory Tract: Pharyngitis/Tonsillitis: Caused by Streptococcus pyogenes .

NOTE:

The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present.

Otitis Media:

Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). ) NOTE: In the treatment of otitis media due to ß-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific ß-lactamase inhibitor.