Cefprozil
CEFZIL
Pronunciation: sef-PROE-zil
What it isOral PBP-inhibiting second-generation cephalosporin; susceptible respiratory, ear, and skin infections.
Why this oneAdds respiratory Gram-negative coverage beyond first-generation oral cephalosporins.
What limits itRenal impairment requires adjustment; beta-lactam allergy, diarrhea, and C. difficile remain practical concerns.
Cefprozil prescription history
Animated chart of estimated U.S. prescriptions per year, Antibacterials (systemic) (1938–2026). Cefprozil enters in 1992 (estimated).
Principal riskNo FDA boxed warning.
Classes and tags
Clinical profile
Legacy pregnancy categoryB
Defining liabilityAllergy, gastrointestinal effects and agent-specific renal, hepatic, hematologic or interaction risks.
FDA label
Read the full label on DailyMed ↗
NO BOXED WARNINGS
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Pharyngitis/tonsillitis | Adults >=13 y | 500 mg q24h x10 days | ||
| Acute sinusitis | Adults >=13 y | 250 mg q12h x10 days | 500 mg q12h for moderate to severe infections | |
| Acute bacterial exacerbation of chronic bronchitis | Adults >=13 y | 500 mg q12h x10 days | ||
| Uncomplicated skin and skin-structure infections | Adults >=13 y | 250 mg q12h, or 500 mg q24h, or 500 mg q12h x10 days | ||
| Pharyngitis/tonsillitis | Children 2-12 y | 7.5 mg/kg q12h x10 days | Not to exceed adult doses | |
| Uncomplicated skin and skin-structure infections | Children 2-12 y | 20 mg/kg q24h x10 days | Not to exceed adult doses | |
| Otitis media | Infants/children 6 mo-12 y | 15 mg/kg q12h x10 days | Not to exceed adult doses | |
| Acute sinusitis | Infants/children 6 mo-12 y | 7.5 mg/kg q12h x10 days | 15 mg/kg q12h for moderate to severe infections | Not to exceed adult doses |
Renal CrCl 30-120 mL/min: standard dose and interval; CrCl 0-29: 50% of standard dose at standard interval; partly removed by hemodialysis — administer after completion of hemodialysis
Hepatic No adjustment needed
Instructions
- Oral
- S. pyogenes infections: treat at least 10 days
Available strengths
- tab 250, 500 mg
- susp 125, 250 mg/5 mL
Contraindications
- Known allergy to the cephalosporin class of antibiotics
Cautions
- Colitis including pseudomembranous colitis reported (postmarketing)
- Cephalosporins have triggered seizures, particularly in renal impairment without dose reduction — discontinue if seizures occur
- Hypersensitivity reactions reported more frequently in children than adults
Adverse reactions
- Nausea 3.5%, diarrhea 2.9%, vomiting 1%, abdominal pain 1%
- Eosinophilia 2.3%; AST/ALT elevations 2%
- Genital pruritus/vaginitis 1.6%; diaper rash and superinfection 1.5%
- Rash 0.9% (more frequent in children); dizziness 1%
- Rare postmarketing: anaphylaxis, angioedema, colitis (incl. pseudomembranous), erythema multiforme, SJS, serum-sickness-like reactions, thrombocytopenia
Pregnancy Undefined
Lactation Undefined
Cost
Generic entry2005
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Self-check
- When does cefprozil require dose adjustment?
Renal impairment. - What coverage does cefprozil add beyond first-generation oral cephalosporins?
Respiratory Gram-negative coverage.