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CEFZIL (cefprozil) is 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 β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). (See CLINICAL STUDIES.)
NOTE: In the treatment of otitis media due to β-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific β-lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing β-lactamase inhibitors.
Acute Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains).
Lower Respiratory Tract
Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains).
Skin And Skin Structure
Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFZIL (cefprozil) and other antibacterial drugs, CEFZIL (cefprozil) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
DOSAGE AND ADMINISTRATION
CEFZIL (cefprozil) is administered orally.
|ADULTS (13 years and older)|
|UPPER RESPIRATORY TRACT|
|Acute Sinusitis||250 q12h or||10|
|(For moderate to severe infections, the higher dose should be used)||500 q12h|
|LOWER RESPIRATORY TRACT|
|Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis||500 q12h||10|
|SKIN AND SKIN STRUCTURE|
|Uncomplicated Skin and Skin Structure Infections||250 q12h or 500 q24h or 500 q12h||10|
|CHILDREN (2 years-12 years)|
|UPPER RESPIRATORY TRACTb|
|Pharyngitis/Tonsillitis||7.5 mg/kg q12h||10a|
|SKIN AND SKIN STRUCTUREb|
|Uncomplicated Skin and Skin Structure Infections||20 mg/kg q24h||10|
|INFANTS & CHILDREN (6 months-12 years)|
|UPPER RESPIRATORY TRACTb|
|Otitis Media (See INDICATIONS AND USAGE and CLINICAL STUDIES)||15 mg/kg q12h||10|
|Acute Sinusitis (For moderate to severe infections, the higher dose should be used)||7.5 mg/kg q12h or 15 mg/kg q12h||10|
| a In the treatment of infections due to Streptococcus
pyogenes, CEFZIL (cefprozil) should be administered for at least 10 days.
b Not to exceed recommended adult doses.
Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.
| Creatinine Clearance
|0-29*||50% of standard||standard|
|* Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.|
No dosage adjustment is necessary for patients with impaired hepatic function.
CEFZIL® (cefprozil) Tablets
Each light orange film-coated tablet, imprinted with "7720" on one side and "250" on the other, contains the equivalent of 250 mg anhydrous cefprozil.
Bottles of 100 Tablets..........................NDC 0087-7720-60
Each white film-coated tablet, imprinted with "7721" on one side and "500" on the other, contains the equivalent of 500 mg anhydrous cefprozil.
Bottles of 50 Tablets..........................NDC 0087-7721-50
Bottles of 100 Tablets.........................NDC 0087-7721-60
Store at controlled room temperature, 59°-86°F (15°-30° C).
CEFZIL® (cefprozil) For Oral Suspension
Each 5 mL of constituted suspension contains the equivalent of 125 mg anhydrous cefprozil.
50 mL Bottle..........................NDC 0087-7718-40
75 mL Bottle..........................NDC 0087-7718-62
100 mL Bottle........................NDC 0087-7718-64
Each 5 mL of constituted suspension contains the equivalent of 250 mg anhydrous cefprozil.
50 mL Bottle..........................NDC 0087-7719-40
75 mL Bottle..........................NDC 0087-7719-62
100 mL Bottle........................NDC 0087-7719-64
All powder formulations for oral suspension contain cefprozil in a bubble-gum flavored mixture.
Reconstitution Directions for Oral Suspension
Prepare the suspension at the time of dispensing; for ease in preparation, add water in two portions and shake well after each aliquot.
Total Amount of Water Required for Reconstitution
|Bottle Size|| Final Concentration
125 mg/5 mL
| Final Concentration
|50 mL||36 mL||36 mL|
|75 mL||54 mL||54 mL|
|100 mL||72 mL||72 mL|
After mixing, store in a refrigerator and discard unused portion after 14 days. Store at 59°-77° F (15°-25°C) prior to constitution. U.S. Patent No. 4,520,022
Bristol-Myers Squibb Company, Princeton, New Jersey 08543. USA. Rev March 2007. FDA Rev date: 9/14/2007
Last reviewed on RxList: 10/3/2007
This monograph has been modified to include the generic and brand name in many instances.
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