Cefzil® (CEFPROZIL) Tablets
250 mg and 500 mg
Cefzil® (CEFPROZIL)
for Oral Suspension
125 mg/5 mL and 250 mg/5 mL
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFZIL® ( cefprozil ) 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
Cefprozil is a semi-synthetic broad-spectrum cephalosporin antibiotic.
Cefprozil is a cis and trans isomeric mixture (³ 90% cis). The chemical name for the monohydrate is (6R,7R)-7-((R)-2-amino-2-(p-hydroxy-phenyl)acetamido) -8-oxo-3-propenyl-5-thia-1-azabicyclo (4.2.0)oct-2-ene-2-carboxylic acid monohydrate, and the structural formula is:
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, hydroxypropylmethylcellulose, 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.
