(sef PROE zil)
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)
Generic: 250 mg, 500 mg
- Antibiotic, Cephalosporin (Second Generation)
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.
Well absorbed (95%)
Vd: 0.23 L/kg
Urine (~60% as unchanged drug)
Time to Peak
Serum: Fasting: 1.5 hours
Infants and Children (6 months to 12 years): 1.5 hours
Normal renal function: 1.3 hours
Renal impairment: 5.2 hours
Renal failure: 5.9 hours
Hepatic impairment: 2 hours
Special Populations: Elderly
AUC is about 35% to 60% higher.
Use: Labeled Indications
Acute bacterial exacerbation of chronic bronchitis: Treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis caused by S. pneumoniae, H. influenzae (including beta-lactamase–producing strains), and M. catarrhalis (including beta-lactamase–producing strains).
Otitis media: Treatment of mild to moderate otitis media caused by S. pneumoniae, Haemophilus influenzae (including beta-lactamase–producing strains), and Moraxella (Branhamella) catarrhalis (including beta-lactamase–producing strains).
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.
Skin and skin-structure infections, uncomplicated: Treatment of mild to moderate uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) and S. pyogenes.
Hypersensitivity to cefprozil, any component of the formulation, or other cephalosporins
Acute bacterial exacerbation of chronic bronchitis: 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)
Skin and skin-structure infections, uncomplicated: Oral: 250 to 500 mg every 12 hours, or 500 mg every 24 hours for 10 days
Refer to adult dosing.
Acute bacterial exacerbation of chronic bronchitis: Children >12 years and Adolescents: Refer to adult dosing.
Otitis media: Oral: Infants ≥6 months and Children: 15 mg/kg/dose every 12 hours for 10 days (maximum: 500 mg/dose)
Children 2 to 12 years: Oral: 7.5 mg/kg/dose every 12 hours for 10 days (administer for ≥10 days if due to S. pyogenes) (maximum: 500 mg/day)
Children >12 years and Adolescents: Refer to adult dosing.
Skin and skin-structure infections, uncomplicated:
Children 2 to 12 years: Oral: 20 mg/kg/day once every 24 hours for 10 days (maximum: 1,000 mg/day)
Children >12 years and Adolescents: Refer to adult dosing.
Urinary tract infection (off-label use): Infants and Children 2 to 24 months: Oral: 15 mg/kg/dose twice daily for 7 to 14 days (AAP, 2011)
Dosing: Renal Impairment
Manufacturer's labeling: Infants, Children, Adolescents, and Adults: 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 (Aronoff, 2007):
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
Infants, Children, and Adolescents: Oral:
Recommendations based on 30 mg/kg/day divided every 12 hours in patients with normal renal function:
GFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.
GFR <29 mL/minute/1.73 m2: 7.5 mg/kg/dose every 12 hours
ESRD on hemodialysis: 7.5 mg/kg/dose every 12 hours; supplement with 5 mg/kg/dose after dialysis on dialysis days
Peritoneal dialysis: 7.5 mg/kg/dose every 12 hours
Dosing: Hepatic Impairment
No dosage adjustment necessary.
Oral suspension: Refer to manufacturer’s product labeling for reconstitution instructions. Shake well.
Oral: Administer without regard to meals. Administer around the clock to promote less variation in peak and trough serum levels.
Oral suspension may contain phenylalanine; consult product labeling.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Refrigerate suspension after reconstitution; discard after 14 days.
Aminoglycosides: Cephalosporins (2nd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy
Probenecid: May increase the serum concentration of Cephalosporins. 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. Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy
Positive direct Coombs, false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest, Fehling's solution), but not with enzyme-based tests for glycosuria (eg, Clinistix). A false-negative reaction may occur in the ferricyanide test for blood glucose.
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%)
Hepatic: Increased serum transaminases (2%)
<1% (Limited to important or life-threatening): 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
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.
• 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.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
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.
Monitor renal function at baseline and as clinically indicated. Monitor for signs of anaphylaxis during first dose.
Pregnancy Risk Factor
Adverse events were not observed in animal reproduction studies.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience nausea or diarrhea. Have patient report immediately to prescriber bruising, bleeding, severe loss of strength and energy, seizures, urinary retention, change in amount of urine passed, vaginitis, or signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
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