Version May 2024
Chronic bronchitis, acute bacterial exacerbation: Oral: 500 mg every 12 hours for 10 days.
Pharyngitis/tonsillitis: Oral: 500 mg every 24 hours for 10 days (administer for ≥10 days if due to S. pyogenes).
Rhinosinusitis, acute bacterial:
Note: In uncomplicated acute bacterial rhinosinusitis, initial observation and symptom management without antibiotic therapy is appropriate in most patients. Reserve antibiotic therapy for poor follow-up or lack of improvement over the observation period (Ref). Given S. pneumoniae resistance, cefprozil is not recommended for the empiric treatment of acute bacterial rhinosinusitis (Ref).
Oral: 250 or 500 mg every 12 hours (Ref); typical duration is 5 to 7 days (Ref).
Skin and soft tissue infection: Oral: 250 or 500 mg every 12 hours, or 500 mg every 24 hours for 10 days (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Manufacturer's labeling: Oral:
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: Reduce dose by 50%.
End-stage renal disease (ESRD) on hemodialysis: Give dose after dialysis on dialysis days.
Alternative recommendations (Ref): Oral:
Note: Renally adjusted dose recommendations are based on doses of 250 to 500 mg every 12 hours.
CrCl >50 mL/minute: No dosage adjustment necessary.
CrCl <50 mL/minute: Administer 50% of usual dose every 12 hours.
Intermittent hemodialysis (IHD): Supplement with 250 mg after dialysis on dialysis days.
Peritoneal dialysis: Administer 50% of usual dose every 12 hours.
No dosage adjustment necessary.
Refer to adult dosing.
(For additional information see "Cefprozil: Pediatric drug information")
General dosing, susceptible infection (Ref): Infants, Children, and Adolescents: Oral: Mild to moderate infection: 7.5 to 15 mg/kg/dose twice daily; maximum single dose: 500 mg/dose.
Chronic bronchitis, acute bacterial exacerbation: Adolescents: Oral: 500 mg every 12 hours for 10 days.
Otitis media, acute: Infants ≥6 months and Children: Oral: 15 mg/kg/dose every 12 hours for 10 days; maximum single dose: 500 mg/dose. Note: Cefprozil is not routinely recommended as a treatment option in the acute otitis media guidelines (Ref).
Pharyngitis/tonsillitis:
Children ≥2 years: Oral: 7.5 mg/kg/dose every 12 hours for 10 days; maximum single dose: 500 mg/dose.
Adolescents: Oral: 500 mg every 24 hours for 10 days.
Rhinosinusitis: Note: The role of cefprozil in the management of acute bacterial sinusitis is limited; other options may be preferred (Ref):
Infants ≥6 months and Children: Oral: 7.5 to 15 mg/kg/dose every 12 hours for 10 days; maximum single dose: 500 mg/dose.
Adolescents: Oral: 250 to 500 mg every 12 hours for 10 days.
Skin and skin structure infection, uncomplicated: Oral:
Children ≥2 years: 20 mg/kg/dose once daily for 10 days; maximum single dose: 500 mg/dose.
Adolescents: 250 mg every 12 hours or 500 mg every 12 to 24 hours for 10 days.
Urinary tract infection: Oral: Infants ≥2 months and Children ≤2 years: 15 mg/kg/dose twice daily for 7 to 14 days (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Manufacturer's labeling: Infants ≥6 months, Children, and Adolescents: Oral:
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: Reduce usual recommended dose by 50%.
End-stage renal disease on hemodialysis: Give dose after dialysis on dialysis days.
Alternative recommendations: The following recommendations have been used by some clinicians (Ref): Note: Renally adjusted dose recommendations are based on a usual dose of 30 mg/kg/day divided every 12 hours.
Infants, Children, and Adolescents: Oral:
GFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.
GFR <30 mL/minute/1.73 m2: 7.5 mg/kg/dose every 12 hours.
Intermittent hemodialysis: ~55% is removed by hemodialysis; 7.5 mg/kg/dose every 12 hours; administer an additional 5 mg/kg/dose after dialysis session.
Peritoneal dialysis: 7.5 mg/kg/dose every 12 hours.
Infants, Children and Adolescents: No dosage adjustment necessary
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not always defined.
1% to 10%:
Central nervous system: Dizziness (1%)
Dermatologic: Diaper rash (2%), genital pruritus (2%)
Gastrointestinal: Nausea (4%), diarrhea (3%), abdominal pain (1%), vomiting (1%)
Genitourinary: Vaginitis
Hepatic: Increased serum transaminases (2%)
Infection: Superinfection
<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, arthralgia, cholestatic jaundice, confusion, drowsiness, eosinophilia, erythema multiforme, fever, headache, hyperactivity, increased blood urea nitrogen, increased serum creatinine, insomnia, leukopenia, pseudomembranous colitis, serum sickness, skin rash, Stevens-Johnson syndrome, thrombocytopenia, urticaria
Hypersensitivity to cefprozil, any component of the formulation, or other cephalosporins.
Concerns related to adverse effects:
• Hypersensitivity: If a serious hypersensitivity reaction occurs, discontinue and institute emergency supportive measures, including airway management and treatment (eg, epinephrine, antihistamines and/or corticosteroids).
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Gastrointestinal disease: Use with caution in patients with a history of gastrointestinal disease, particularly colitis.
• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982). Some data suggest that benzoate displaces bilirubin from protein-binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.
• Phenylalanine: Some products may contain phenylalanine.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Oral:
Generic: 125 mg/5 mL (50 mL, 75 mL, 100 mL); 250 mg/5 mL (50 mL, 75 mL, 100 mL)
Tablet, Oral:
Generic: 250 mg, 500 mg
Yes
Suspension (reconstituted) (Cefprozil Oral)
125 mg/5 mL (per mL): $0.42
250 mg/5 mL (per mL): $0.77
Tablets (Cefprozil Oral)
250 mg (per each): $4.38
500 mg (per each): $9.04
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Oral:
Generic: 125 mg/5 mL (50 mL, 75 mL, 100 mL); 250 mg/5 mL (75 mL, 100 mL)
Tablet, Oral:
Generic: 250 mg, 500 mg
Oral: Administer without regard to meals. Administer around the clock to promote less variation in peak and trough serum levels.
Oral: Administer without regard to meals. Shake suspension well before each use.
Acute bacterial exacerbation of chronic bronchitis: Treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis.
Otitis media: Treatment of mild to moderate otitis media caused by S. pneumoniae, H. influenzae, and M. catarrhalis.
Pharyngitis/tonsillitis: Treatment of mild to moderate pharyngitis/tonsillitis caused by Streptococcus pyogenes.
Limitations of use: Cefprozil is generally effective in the eradication of S. pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present.
Rhinosinusitis, acute bacterial: Treatment of mild to moderate acute bacterial rhinosinusitis caused by S. pneumoniae, H. influenzae, and M. catarrhalis. Note: Clinical practice guidelines do not recommend cefprozil as initial empiric treatment of acute bacterial rhinosinusitis due to variable rates of resistance among S. pneumoniae (Ref).
Skin and soft tissue infection: Treatment of mild to moderate uncomplicated skin and skin-structure infections caused by Staphylococcus aureus and S. pyogenes.
Cefprozil may be confused with ceFAZolin, cefuroxime
Cefzil may be confused with Ceftin
Substrate of OAT1/3
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminoglycosides: Cephalosporins may enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration of Aminoglycosides. Risk C: Monitor therapy
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Furosemide: May enhance the nephrotoxic effect of Cephalosporins. Risk C: Monitor therapy
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Food delays cefprozil absorption. Management: May administer with food.
Adverse events were not observed in animal reproduction studies.
Small amounts of cefprozil are excreted in breast milk. The manufacturer recommends that caution be exercised when administering cefprozil to nursing women. Nondose-related effects could include modification of bowel flora.
Some products may contain phenylalanine.
Monitor renal function at baseline and as clinically indicated. Monitor for signs of anaphylaxis during first dose.
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: Well absorbed (95%).
Distribution: Vd: 0.23 L/kg.
Protein binding: ~36%.
Bioavailability: 95%.
Half-life elimination:
Infants ≥6 months and Children: 1.5 hours.
Adults:
Normal: 1.3 hours.
Kidney impairment: Up to 5.2 hours (dependent upon degree of kidney impairment).
Kidney failure: Up to 5.9 hours.
Hepatic impairment: ~2 hours.
Time to peak, serum:
Infants ≥6 months and Children: 1 to 2 hours.
Adult: Fasting: 1.5 hours.
Excretion: Urine (~60% as unchanged drug).
Older adult: AUC is about 35% to 60% higher.
Anti-infective considerations:
Parameters associated with efficacy: Time dependent; associated with time free drug concentration (fT) > minimum inhibitory concentration (MIC): Goal: ≥40% to 50% (fT) > MIC (bacteriostatic), ≥60% to 70% (fT) > MIC (bactericidal) (Craig 1996; Craig 1998; Turnidge 1998).
Expected drug exposure in patients with normal renal function:
Pediatric patients, Cmax (peak):
Steady state: Infants ≥6 months of age and children ≤4 years of age: 15 mg/kg/dose twice daily: 9.18 mg/L (Nicolau 2007).
Single dose: Infants ≥8 months of age and children:
15 mg/kg, single dose: 11.16 ± 2.45 mg/L (Sáez-Llorens 1990).
30 mg/kg, single dose: 15.93 ± 3.22 mg/L (Sáez-Llorens 1990).
Adults, Cmax (peak): 500 mg twice daily, steady state: 10.4 ± 1.3 mg/L (Barbhaiya 1990).
Postantibiotic effect: Generally <1 hour; varies based on organism (Craig 1991; Craig 1998).
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