Product Description.:
LUPIN, 250
tablet , film-coated , peach , oval oblong
Debossed
Cefzil? Tablets
(cefprozil) 250 mg and 500 mg
Cefzil? for Oral Suspension
(cefprozil) 125 mg/5 mL and 250 mg/5 mL
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFZIL? and other antibacterial drugs, CEFZIL should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
CEFZIL (cefprozil) is a semi-synthetic broad-spectrum cephalosporin antibiotic.
Cefprozil is a white to yellowish powder with a molecular formula for the monohydrate of C18H19N3O5S?H2O and a molecular weight of 407.45.
CEFZIL Tablets and CEFZIL for Oral Suspension are intended for oral administration.
CEFZIL Tablets contain cefprozil equivalent to 250 mg or 500 mg of anhydrous cefprozil. In addition, each tablet contains the following inactive ingredients: cellulose, hypromellose, magnesium stearate, methylcellulose, simethicone, sodium starch glycolate, polyethylene glycol, polysorbate 80, sorbic acid, and titanium dioxide. The 250 mg tablets also contain FD&C Yellow No. 6.
CEFZIL for Oral Suspension contains cefprozil equivalent to 125 mg or 250 mg anhydrous cefprozil per 5 mL constituted suspension. In addition, the oral suspension contains the following inactive ingredients: aspartame, cellulose, citric acid, colloidal silicone dioxide, FD&C Red No. 3, flavors (natural and artificial), glycine, polysorbate 80, simethicone, sodium benzoate, sodium carboxymethylcellulose, sodium chloride, and sucrose.
INDICATIONS
CEFZIL 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 and other antibacterial drugs, CEFZIL 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.
SIDE EFFECTS
The adverse reactions to cefprozil are similar to those observed with other orally administered cephalosporins. Cefprozil was usually well tolerated in controlled clinical trials. Approximately 2% of patients discontinued cefprozil therapy due to adverse events.
The most common adverse effects observed in patients treated with cefprozil are:
Gastrointestinal: Diarrhea (2.9%), nausea (3.5%), vomiting (1%), and abdominal pain (1%).
Hepatobiliary:
