CEFPROZIL- cefprozil tablet, film coated
CEFPROZIL- cefprozil powder, for suspension
Sandoz Inc
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil 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 (? 90% cis). The chemical name for the monohydrate is (6R, 7R)-7-[(R)-2-amino-2-(p-hydroxyphenyl)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 Chemical Structure
Cefprozil is a white to yellowish powder with a molecular formula for the monohydrate of C18 H19 N3 O5 S�H2 O and a molecular weight of 407.44.
Each cefprozil tablet intended for oral administration contains cefprozil equivalent to 250 mg or 500 mg of anhydrous cefprozil. In addition each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, sodium starch glycolate and titanium dioxide. The 500 mg tablets also contain ferric oxide.
Cefprozil for oral suspension is intended for oral administration. Cefprozil 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, carboxymethylcellulose sodium, citric acid anhydrous, colloidal silicon dioxide, FD & C Yellow No. 6, glycine, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, simethicone, sodium benzoate, sodium chloride, sucrose, and Tutti-Frutti flavor.
CLINICAL PHARMACOLOGY
The pharmacokinetic data were derived from the capsule formulation; however, bioequivalence has been demonstrated for the oral solution, capsule, tablet, and suspension formulations under fasting conditions.
Following oral administration of cefprozil to fasting subjects, approximately 95% of the dose was absorbed. The average plasma half-life in normal subjects was 1.3 hours, while the steady state volume of distribution was estimated to be 0.23 L/kg. The total body clearance and renal clearance rates were approximately 3 mL/min/kg and 2.3 mL/min/kg, respectively.
