Cefprozil is a semi-synthetic broad-spectrum cephalosporin antibiotic. Cefprozil is a cis and Trans isomeric mixture (greater than or equal 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.
Cefprozil is a white to yellowish powder with a molecular formula for the monohydrate of C18H19N3O5S•H2O and a molecular weight of 407.45.
Treatment of otitis media and infections involving the respiratory tract and skin and skin structure; active against methicillin-sensitive staphylococci, many streptococci, and various gram-negative bacilli including E. coli, some Klebsiella, P. mirabilis, H. influenzae, and Moraxella. Available dosage form in the hospital: 125MG/5ML SUSP, 250MG TAB, 250MG/5ML SUSP, 500MG TAB.
Pharyngitis/tonsillitis: Oral: 500 mg every 24 hours for 10 days
Secondary bacterial infection of acute bronchitis or acute bacterial exacerbation of chronic bronchitis: Oral: 500 mg every 12 hours for 10 days
Uncomplicated skin and skin structure infections: Oral: 250 mg every 12 hours, or 500 mg every 12-24 hours for 10 days
Action and clinical pharmacology
Cefprozil is a semi synthetic broad-spectrum cephalosporin antibiotic intended for oral administration. It has in vitro activity against a broad range of Gram-positive and Gram-negative bacteria. The bactericidal action of cefprozil results from inhibition of cell-wall synthesis.
Cefprozil is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or to any component of the cefprozil preparations
Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporin antibiotics. Concomitant administration of probenecid doubled the area under the curve for cefprozil. If an aminoglycoside is used concurrently with cefprozil, especially if high dosages of the former are used or if therapy is prolonged, renal function should be monitored because of the potentialnephrotoxicity and ototoxicity of aminoglycoside antibiotics.
Drug/Laboratory Test Interactions:
Cephalosporin antibiotics may produce a false-positive reaction for glucose in the urine with copper reduction tests (Benedict’s or Fehling’s solution or with Clinitest tablets), but not with enzyme-based tests (glucose oxidase) for glycosuria. A false negative reaction may occur in the ferricyanide test for blood glucose. The presence of cefprozil in the blood does not interfere with the assay of plasma or urine creatinine by the alkaline picrate method.
Use in pregnancy:
Reproduction studies have been performed in mice, rats and rabbits at doses 14, 7 and 0.7 times the maximum human daily dose (1000 mg) based upon mg/m2, and have revealed no evidence of harm to the fetus due to cefprozil. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk.
Less than 1.0% of a maternal dose is excreted in human milk. Caution should be exercised when Cefprozil is administered to a nursing mother. Consideration should be given to temporary discontinuation of nursing and use of formula feeding.
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 events (of probable or unknown relationship to study drug) observed in 4227 patients treated with cefprozil in clinical efficacy trials are:
Gastrointestinal: Diarrhea (2.7%), nausea (2.3%), vomiting (1.4%) and abdominal pain (0.9%).
Hepatobiliary: As with some penicillins and some other cephalosporin antibiotics, cholestatic jaundice has been reported rarely.
Hypersensitivity: Rash (1.2%), erythema (0.1%), pruritus (0.3%) and urticaria (0.07%). Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy.
CNS: Dizziness, hyperactivity, headache, nervousness, insomnia, confusion and drowsiness have been reported rarely (below 1%) and causal relationship is uncertain. All were reversible.
Other: Genital pruritus (0.8%) and vaginitis (0.7%).