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Pronunciation:

(sef PROE zil)

U.S. Brand Names:

Cefzil®

Generic Available:

Canadian Brand Names:

Cefzil®

Use:

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.

Pregnancy Risk Factor:

Lactation:

Enters breast milk/use caution (AAP rates "compatible")

Contraindications:

Hypersensitivity to cefprozil, any component of the formulation, or other cephalosporins

Warnings/Precautions:

Modify dosage in patients with severe renal impairment; prolonged use may result in superinfection; use with caution in patients with a history of penicillin allergy especially IgE-mediated reactions (eg, anaphylaxis, urticaria). May cause antibiotic-associated colitis or colitis secondary to C. difficile.

Adverse Reactions:

1% to 10%:

Central nervous system: Dizziness (1%)

Dermatologic: Diaper rash (2%)

Gastrointestinal: Diarrhea (3%), nausea (4%), vomiting (1%), abdominal pain (1%)

Genitourinary: Vaginitis, genital pruritus (2%)

Hepatic: Transaminases increased (2%)

Miscellaneous: Superinfection

<1%: Anaphylaxis, angioedema, pseudomembranous colitis, rash, urticaria, erythema multiforme, serum sickness, Stevens-Johnson syndrome, hyperactivity, headache, insomnia, confusion, somnolence, leukopenia, eosinophilia, thrombocytopenia, elevated BUN, elevated creatinine, arthralgia, cholestatic jaundice, fever

Reactions reported with other cephalosporins include seizure, toxic epidermal necrolysis, renal dysfunction, interstitial nephritis, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, pancytopenia, agranulocytosis, colitis, vaginitis, superinfection

Overdosage/Toxicology:

Symptoms of overdose include neuromuscular hypersensitivity and convulsions. Many beta-lactam containing antibiotics have the potential to cause neuromuscular hyperirritability or convulsive seizures. Hemodialysis may be helpful to aid in removal of the drug from blood; otherwise, treatment is supportive or symptom-directed.

Drug Interactions:

Increased effect: Probenecid may decrease cephalosporin elimination

Increased toxicity: Aminoglycosides and furosemide may increase nephrotoxic potential

Ethanol/Nutrition/Herb Interactions:

Food: Food delays cefprozil absorption.

Mechanism of Action:

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Pharmacodynamics/Kinetics:

Absorption: Well absorbed (94%)

Distribution: Low amounts enter breast milk

Protein binding: 35% to 45%

Half-life elimination: Normal renal function: 1.3 hours

Time to peak, serum: Fasting: 1.5 hours

Excretion: Urine (61% as unchanged drug)

Dosage:

Oral:

Infants and Children >6 months to 12 years: Otitis media: 15 mg/kg every 12 hours for 10 days

Pharyngitis/tonsillitis:

Children 2-12 years: 7.5 -15 mg/kg/day divided every 12 hours for 10 days (administer for >10 days if due to S. pyogenes); maximum: 1 g/day

Children >13 years and Adults: 500 mg every 24 hours for 10 days

Uncomplicated skin and skin structure infections:

Children 2-12 years: 20 mg/kg every 24 hours for 10 days; maximum: 1 g/day

Children >13 years and Adults: 250 mg every 12 hours, or 500 mg every 12-24 hours for 10 days

Secondary bacterial infection of acute bronchitis or acute bacterial exacerbation of chronic bronchitis: 500 mg every 12 hours for 10 days

Dosing adjustment in renal impairment: Clcr<30 mL/minute: Reduce dose by 50%

Hemodialysis: Reduced by hemodialysis; administer dose after the completion of hemodialysis

Administration:

Administer around-the-clock to promote less variation in peak and trough serum levels. Chilling the reconstituted oral suspension improves flavor (do not freeze).

Monitoring Parameters:

Assess patient at beginning and throughout therapy for infection; monitor for signs of anaphylaxis during first dose

Test Interactions:

Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction

Dietary Considerations:

May be taken with food. Oral suspension contains phenylalanine 28 mg/5 mL.

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Take as directed, at regular intervals around-the-clock (with or without food). Chilling oral suspension improves flavor (do not freeze). Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. Complete full course of medication, even if you feel better. May cause false test results with Clinitest®; use of another type of glucose testing is preferable. May cause dizziness (use caution when driving or engaging in potentially hazardous tasks until response to drug is known); nausea or vomiting (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); or diarrhea (yogurt, boiled milk, or buttermilk may help). Report changes in urinary pattern (decreased output); vaginal burning, itching, or drainage; unresolved diarrhea; or opportunistic infection (vaginal itching or drainage, sores in mouth, blood in urine or stool, unusual fever or chills). Breast-feeding precaution: Consult prescriber if breast-feeding.

Nursing Implications:

Assess patient at beginning and throughout therapy for infection.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause nervousness; case reports of euphoria, delusion, illusions, and depersonalization with cephalosporins

Mental Health: Effects on Psychiatric Treatment:

May rarely cause neutropenia; use caution with clozapine and carbamazepine

Dosage Forms:

Powder for oral suspension, as anhydrous: 125 mg/5 mL (50 mL, 75 mL, 100 mL); 250 mg/5 mL (50 mL, 75 mL, 100 mL) [contains phenylalanine 28 mg/5 mL and sodium benzoate; bubble gum flavor]

Tablet, as anhydrous: 250 mg, 500 mg

International Brand Names:

Arzimol® (ES); Brisoral® (ES); Cefprozil® (AT); Cefzil® (BR, CA, CZ, GB, HR, HU, ID, PL, RO, SI, YU); Cronocef® (IT); Primaceph® (YU); Procef® (AT, CH, CL, CO, CR, EC, GT, HN, IT, MX, PA, SG, SV, TH); Prozef® (ZA); Rozicel® (IT); Serozil® (TR)

References

"American Academy of Pediatrics Committee on Drugs. The Transfer of Drugs and Other Chemicals Into Human Milk,"Pediatrics, 2001, 108(3):776-89.

Arguedas AG, Zaleska M, Stutman HR, et al, "Comparative Trial of Cefprozil vs Amoxicillin Clavulanate Potassium in the Treatment of Children With Acute Otitis Media With Effusion,"Pediatr Infect Dis J, 1991, 10(5):375-80.

Barriere SL, "Review of In Vitro Activity, Pharmacokinetic Characteristics, Safety, and Clinical Efficacy of Cefprozil, a New Oral Cephalosporin,"Ann Pharmacother, 1993, 27(9):1082-9.

Gainer RB 2nd, "Cefprozil: A New Cephalosporin; Its Use in Various Clinical Trials,"South Med J, 1995, 88(3):338-46.

Lowery N, Kearns GL, Young RA, et al, "Serum Sickness-Like Reactions Associated With Cefprozil Therapy,"J Pediatr, 1994, 125(2):325-8.

Marshall WF and Blair JE, "The Cephalosporins,"Mayo Clin Proc, 1999, 74(2):187-95.

Schatz BS, Karavokiros KT, Taeubel MA, et al, "Comparison of Cefprozil, Cefpodoxime Proxetil, Loracarbef, Cefixime, and Ceftibuten,"Ann Pharmacother, 1996, 30(3):258-68.

Shukla UA, Pittman KA, and Barbhaiya RH, "Pharmacokinetic Interactions of Cefprozil With Food, Propantheline, Metoclopramide, and Probenecid in Healthy Volunteers,"J Clin Pharmacol, 1992, 32(8):725-31.

Shyu WC, Pittman KA, Wilber RB, et al, "Pharmacokinetics of Cefprozil in Healthy Subjects and Patients With Hepatic Impairment,"J Clin Pharmacol, 1991, 31(4):372-6.

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