cefprozil
Cefzil

Available forms
Available by prescription only
Oral suspension: 125 mg/5 ml, 250 mg/5 ml
Tablets: 250 mg, 500 mg

Indications and dosages
 Pharyngitis or tonsillitis caused by Streptococcus pyogenes. Adults and children age 13 and older: 500 mg P.O. daily for at least 10 days.
Children ages 2 to 12: 7.5 mg/kg P.O. q 12 hours for 10 days.
 Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, or M. catarrhalis. Infants and children ages 6 months to 12 years: 15 mg/kg P.O. q 12 hours for 10 days.
 Secondary bacterial infections of acute bronchitis and acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae, or M. catarrhalis. Adults: 500 mg P.O. q 12 hours for 10 days.
 Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus or S. pyogenes. Adults and children age 13 and older: 250 mg P.O. b.i.d. or 500 mg daily to b.i.d. for 10 days.
Children ages 2 to 12: 20 mg/kg P.O. q 24 hours for 10 days.
 Acute sinusitis. Adults and children age 13 and older: 250 mg P.O. q 12 hours for 10 days. For moderate to severe infections, 500 mg P.O. q 12 hours for 10 days.
Infants and children ages 6 months to 12 years: 7.5 mg/kg P.O. q 12 hours for 10 days. For moderate to severe infections, 15 mg/kg P.O. q 12 hours for 10 days.
≡ Dosage adjustment. No adjustments are needed for patients with creatinine clearance above 30 ml/minute. For patients with creatinine clearance of 30 ml/minute or less, reduce dose by 50% but maintain dosing interval. Because drug is partially removed by hemodialysis, administer after the hemodialysis session.

Pharmacodynamics
Antibiotic action: Cefprozil interferes with bacterial cell wall synthesis during cell replication, leading to osmotic instability and cell lysis. Action is bactericidal or bacteriostatic, depending on concentration.

Pharmacokinetics
Pharmacokinetic data are derived from investigational studies that used an oral capsule form that isn’t commercially available.
Absorption: About 95% absorbed from the GI tract.
Distribution: About 36% protein-bound.
Metabolism: Probably metabolized by the liver; plasma half-life increases only slightly in patients with impaired hepatic function.
Excretion: About 60% of a dose is recovered unchanged in the urine. Plasma half-life is 1 1/3 hours in patients with normal renal function; 2 hours with impaired hepatic function; and 5 1/4 to 6 hours with end-stage renal disease. Drug is removed by hemodialysis.

Contraindications and precautions
Contraindicated in patients hypersensitive to drug or other cephalosporins. Use cautiously in breast-feeding women and patients with impaired renal function or penicillin allergy.

Interactions
Drug-drug. Aminoglycosides: May increase risk of nephrotoxicity of cephalosporins. Monitor patient closely.
Probenecid: May decrease excretion and increase blood cefprozil level. Use together cautiously.

Adverse reactions
CNS: dizziness.
GI: diarrhea, nausea, vomiting, abdominal pain.
GU: genital pruritus, vaginitis.
Hematologic: eosinophilia.
Skin: rash, urticaria, diaper rash.
Other: superinfection, hypersensitivity reactions (serum sickness, anaphylaxis).

Effects on lab test results
• May increase BUN, creatinine, ALT, AST, alkaline phosphatase, bilirubin, and LDH levels.
• May increase eosinophil count. May decrease WBC, leukocyte, and platelet counts.

Overdose and treatment
Because drug is eliminated primarily by the kidneys, hemodialysis may aid in removing drug in cases of extreme overdose, especially in patients with decreased renal function.

Special considerations
 ALERT Names of some cephalosporins are similar. Use caution when prescribing.
• Obtain specimens for culture and sensitivity tests before first dose. Therapy may begin pending test results.
• Cephalosporins may produce a false-positive test for urine glucose with tests that use copper reduction method (Benedict’s test, Fehling’s solution, or Clinitest tablets). Instead, use enzymatic methods, such as glucose enzymatic test strip. A false-negative reaction may occur in the ferricyanide test for blood glucose.
• In patient with renal impairment, monitor renal function before and during therapy.
• Drug may cause overgrowth of nonsusceptible bacteria or fungi. Observe patient for signs and symptoms of superinfection.
• Monitor patient for pseudomembranous colitis, which has been reported with nearly all antibacterial agents. It may occur in patients for whom diarrhea develops secondary to antibiotic therapy. Although most patients respond to withdrawal of drug therapy alone, it may be necessary to institute treatment with an antibacterial agent effective against Clostridium difficile, an organism linked to this disorder.
Pregnant patients
• Use during pregnancy or labor and delivery only when clearly needed.
Breast-feeding patients
• Drug appears in breast milk. Use cautiously in breast-feeding women.
Pediatric patients
• Safety and effectiveness in children younger than age 6 months for the treatment of otitis media or acute sinusitis or younger than age 2 for the treatment of pharyngitis, tonsillitis, or uncomplicated skin and skin-structure infections haven’t been established.
Geriatric patients
• Elderly patients (age 65 and older) have a higher area under the plasma-concentration-versus-time curve and lower renal clearance compared with younger subjects.

Patient education
• Tell patient to take all of drug as prescribed, even if he feels better.
• Advise patients with phenylketonuria that oral suspension contains 28 mg/5 ml phenylalanine.
• Instruct patient to call if rash or symptoms of superinfection occur.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use