No

Antibiotic, Cephalosporin (Second Generation)

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.

B

Hypersensitivity to cefprozil or any component or cephalosporins

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

1% to 10%:

Central nervous system: Dizziness (1%)

Dermatologic: Diaper rash (1.5%)

Gastrointestinal: Diarrhea (2.9%), nausea (3.5%), vomiting (1%), abdominal pain (1%)

Genitourinary: Vaginitis, genital pruritus (1.6%)

Hepatic: Increased transaminases (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

Other reactions with cephalosporins include: Seizures, toxic epidermal necrolysis, renal dysfunction, interstitial nephritis, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, pancytopenia, agranulocytosis, colitis, vaginitis, superinfection

After acute overdose, most agents cause only nausea, vomiting, and diarrhea, although neuromuscular hypersensitivity and seizures are possible, especially in patients with renal insufficiency; many beta-lactam antibiotics have the potential to cause neuromuscular hyperirritability or seizures

Hemodialysis may be helpful to aid in the removal of the drug from the blood but not usually indicated, otherwise most treatment is supportive or symptom directed following GI decontamination

Increased effect: Probenecid may decrease cephalosporin elimination

Increased toxicity: Furosemide, aminoglycosides may be a possible additive to nephrotoxicity

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.

Absorption: Oral: Well absorbed (94%)

Distribution: Low distribution into breast milk

Protein binding: 35% to 45%

Half-life, elimination: 1.3 hours (normal renal function)

Peak serum levels: 1.5 hours (fasting state)

Elimination: 61% excreted unchanged in urine

Oral:

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: Cl_cr <30 mL/minute: Reduce dose by 50%

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

May be taken with food, however, there is delayed absorption

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

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

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

May rarely cause neutropenia; use caution with clozapine and carbamazepine

No information available to require special precautions

No effects or complications reported

Take as directed, at regular intervals around-the-clock (with or without food). Chilling oral suspension improves flavor (do not freeze). Complete full course of medication, even if you feel better. Drink 2-3 L fluid/day. If diarrhea occurs, yogurt or buttermilk may help. May cause false-positive test with Clinitest®; use another form of testing. May interfere with oral contraceptives; additional contraceptive measures are necessary. Report severe, unresolved diarrhea; vaginal itching or drainage; sores in mouth; blood, pus, or mucus in stool or urine; easy bleeding or bruising; unusual fever or chills; rash; or respiratory difficulty. Breast-feeding precautions: Consult prescriber if breast-feeding.

Administer around-the-clock to promote less variation in peak and trough serum levels

Assess patient at beginning and throughout therapy for infection

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)

Tablet, as anhydrous: 250 mg, 500 mg

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.